[House Hearing, 112 Congress] [From the U.S. Government Publishing Office] THE FISCAL YEAR 2013 BUDGET REQUEST FOR THE DEPARTMENT OF HOMELAND SECURITY'S OFFICE OF HEALTH AFFAIRS ======================================================================= HEARING before the SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND COMMUNICATIONS of the COMMITTEE ON HOMELAND SECURITY HOUSE OF REPRESENTATIVES ONE HUNDRED TWELFTH CONGRESS SECOND SESSION __________ MARCH 29, 2012 __________ Serial No. 112-81 __________ Printed for the use of the Committee on Homeland Security [GRAPHIC] [TIFF OMITTED] CONGRESS.13 Available via the World Wide Web: http://www.gpo.gov/fdsys/ __________ U.S. GOVERNMENT PRINTING OFFICE 76-601 WASHINGTON : 2013 ----------------------------------------------------------------------- For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, Washington, DC 20402-0001 COMMITTEE ON HOMELAND SECURITY Peter T. King, New York, Chairman Lamar Smith, Texas Bennie G. Thompson, Mississippi Daniel E. Lungren, California Loretta Sanchez, California Mike Rogers, Alabama Sheila Jackson Lee, Texas Michael T. McCaul, Texas Henry Cuellar, Texas Gus M. Bilirakis, Florida Yvette D. Clarke, New York Paul C. Broun, Georgia Laura Richardson, California Candice S. Miller, Michigan Danny K. Davis, Illinois Tim Walberg, Michigan Brian Higgins, New York Chip Cravaack, Minnesota Cedric L. Richmond, Louisiana Joe Walsh, Illinois Hansen Clarke, Michigan Patrick Meehan, Pennsylvania William R. Keating, Massachusetts Ben Quayle, Arizona Kathleen C. Hochul, New York Scott Rigell, Virginia Janice Hahn, California Billy Long, Missouri Ron Barber, Arizona Jeff Duncan, South Carolina Tom Marino, Pennsylvania Blake Farenthold, Texas Robert L. Turner, New York Michael J. Russell, Staff Director/Chief Counsel Kerry Ann Watkins, Senior Policy Director Michael S. Twinchek, Chief Clerk I. Lanier Avant, Minority Staff Director ------ SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND COMMUNICATIONS Gus M. Bilirakis, Florida, Chairman Scott Rigell, Virginia Laura Richardson, California Tom Marino, Pennsylvania, Vice Hansen Clarke, Michigan Chair Kathleen C. Hochul, New York Blake Farenthold, Texas Bennie G. Thompson, Mississippi Robert L. Turner, New York (Ex Officio) Peter T. King, New York (Ex Officio) Kerry A. Kinirons, Staff Director Natalie Nixon, Deputy Chief Clerk Vacant, Minority Professional Staff Member C O N T E N T S ---------- Page Statements The Honorable Gus M. Bilirakis, a Representative in Congress From the State of Florida, and Chairman, Subcommittee on Emergency Preparedness, Response, and Communications: Oral Statement................................................. 1 Prepared Statement............................................. 2 The Honorable Laura Richardson, a Representative in Congress From the State of California, and Ranking Member, Subcommittee on Emergency Preparedness, Response, and Communications: Oral Statement................................................. 3 Prepared Statement............................................. 4 The Honorable Bennie G. Thompson, a Representative in Congress From the State of Mississippi, and Ranking Member, Committee on Homeland Security: Prepared Statement............................................. 5 Witness Dr. Alexander G. Garza, Assistant Secretary for Health Affairs, Chief Medical Officer, U.S. Department of Homeland Security: Oral Statement................................................. 6 Prepared Statement............................................. 8 Appendix Questions Submitted by Chairman Gus M. Bilirakis for Alexander G. Garza.......................................................... 21 THE FISCAL YEAR 2013 BUDGET REQUEST FOR THE DEPARTMENT OF HOMELAND SECURITY'S OFFICE OF HEALTH AFFAIRS ---------- Thursday, March 29, 2012 U.S. House of Representatives, Subcommittee on Emergency Preparedness, Response, and Communications, Committee on Homeland Security, Washington, DC. The subcommittee met, pursuant to call, at 10:36 a.m., in Room 311, Cannon House Office Building, Hon. Gus M. Bilirakis [Chairman of the subcommittee] presiding. Present: Representatives Bilirakis and Richardson. Mr. Bilirakis. Good morning. Thanks for being so patient, by the way. But the Subcommittee on Emergency Preparedness, Response, and Communications will come to order. The subcommittee is meeting today to receive testimony from Dr. Garza on the President's fiscal year 2013 budget request for the Office of Health Affairs. I now recognize myself to make an opening statement. I am pleased to welcome back Dr. Garza before the subcommittee to discuss the President's budget request for the Office of Health Affairs. Welcome, sir. The Office of Health Affairs' mission is to provide health and medical expertise in support of the Department's mission, to prepare for, respond to, and recover from all hazards impacting the Nation's security. OHA is charged with helping to protect the health of Americans in the case of, God forbid, a National incident with health consequences. This subcommittee maintains great interest in ensuring that OHA's request and ultimate use of appropriated funds are indeed providing enhanced health security for the Nation. The President's fiscal year 2013 budget request included $166 million for OHA, a slight decrease over the fiscal year 2012 appropriation. As for previous years, the BioWatch program accounts for the vast majority of this spending. BioWatch is far and away the most expensive activity of OHA's, comprising $125 million, or 75 percent of its request this year. Forty million dollars of the BioWatch request is proposed for continued testing of the next generation technology known as Gen III. If successful, this new system would enable a drastic decrease in detection time, from the current 12 to 36 hours, down to 4 to 6 hours. It would also provide detectors that function reliably indoors. As I relayed at our fiscal year 2012 budget hearing, such milestones could represent important advances, but only if we actually achieve those milestones. I and other Members have become increasingly concerned about the viability of this developing technology, and also about OHA's ability to deploy on time and within budget. Any new BioWatch program, particularly one that will cost $5.7 billion, must prove that it provides a substantial improvement over current technologies, and that communities in which it will be deployed are fully on board with using it. In addition to BioWatch, I also look forward to discussing with Dr. Garza, the National Biosurveillance and Integration Center, NBIC. NBIC seeks to fuse myriad biosurveillance data to provide early detection of an event of National significance, whether a devastating food-borne outbreak, or an airborne release of anthrax. The $8 million request for NBIC is difficult to understand in light of the absence of demonstrable success of the NBIC, and also in light of the continued absence of a promised new strategic plan. Dr. Garza's comments on this, as well as on how the new biosurveillance pilot programs outlined in the request will help achieve integrated biosurveillance of course will be appreciated. Although BioWatch and NBIC comprise about 80 percent of your request, I also look forward to hearing how the fiscal year 2013 budget plan supports other activities, such as medical countermeasure distribution, to DHS employees and first responders, information sharing with State and local partners, and facilitation of agricultural security. Then also, by the way, I would like to point out Dr. Garza's good work in procuring medical countermeasures for DHS employees ahead of other Federal agencies. Congratulations, sir. Thank you very much for your good work. Very much appreciated. In light of continued risks to human and animal health from terrorists and from Mother Nature, the level of attention in funding these activities receive continues to be a priority of this subcommittee. With that, I once again welcome you, Dr. Garza. I look forward to your testimony. [The statement of Chairman Bilirakis follows:] Prepared Statement of Chairman Gus M. Bilirakis March 29, 2012 I'm pleased to welcome back Dr. Garza before the subcommittee to discuss the President's budget request for the Office of Health Affairs. The Office of Health Affairs' mission is to provide health and medical expertise in support of the Department's mission to prepare for, respond to, and recover from all hazards impacting the Nation's security. OHA is charged with helping to protect the health of Americans in the case of a National incident with health consequences. This subcommittee maintains great interest in ensuring that OHA's request and ultimate use of appropriated funds are indeed providing enhanced health security for the Nation. The President's fiscal year 2013 budget request includes $166 million for OHA, a slight decrease over the fiscal year 2012 appropriation. As per previous years, the BioWatch Program accounts for the vast majority of this spending. BioWatch is, far and away, the most expensive activity of the Office of Health Affairs, comprising $125 million, or 75 percent, of its request this year. Forty million dollars of the BioWatch request is proposed for continued testing of the next-generation technology known as Gen-3. If successful, this new system would enable a drastic decrease in detection time from the current 12 to 36 hours, down to 4 to 6 hours. It would also provide detectors that function reliably indoors. As I relayed at our fiscal year 2012 budget hearing, such milestones could represent important advances, but only if we actually achieve those milestones. I and other Members have become increasingly concerned about the viability of this developing technology, and also about OHA's ability to deploy it on time and within budget. Any new BioWatch Program--particularly one that will cost $5.7 billion--must prove that it provides a substantial improvement over current technologies, and that communities in which it will be deployed are fully on board with using it. In addition to BioWatch, I also look forward to discussing with Dr. Garza the National Biosurveillance and Integration Center. NBIC seeks to fuse myriad biosurveillance data to provide early detection of an event of National significance, whether a devastating food-borne outbreak or an airborne release of anthrax. The $8 million request for NBIC is difficult to understand in light of the absence of demonstrable success of the NBIC, and also in light of the continued absence of the promised new strategic plan. Dr. Garza's comments on this, as well as on how the new biosurveillance pilot programs outlined in the request will help achieve integrated biosurveillance, will be appreciated. Although BioWatch and NBIC comprise about 80 percent of your request, I also look forward to hearing how the fiscal year 2013 budget plan supports other activities, such as medical countermeasure distribution to DHS employees and first responders, information sharing with State and local partners, and facilitation of agricultural security. In light of continued risks to human and animal health from terrorists and from Mother Nature, the level of attention and funding these activities receive continues to be a priority for this subcommittee. With that, I once again want to welcome Dr. Garza. We look forward to your testimony. Mr. Bilirakis. Now I would like to recognize our Ranking Member for any comments she might make. You are recognized, Ms. Richardson. Ms. Richardson. Yes, good morning. Before I begin, I would like to take a moment to thank Chairman Bilirakis and the Majority staff for working with me yesterday and my staff during the full committee mark up of H.R. 3563, and your kindness to include our amendment that would help improve participation of the educational institutions in the Integrated Public Alert Warning System, which we both firmly support. So I wanted to personally thank all of you. Mr. Bilirakis. My pleasure. Thank you for all your good work as well. Ms. Richardson. No problem. So, regarding today's hearing, we want to acknowledge our lone witness here and thank you for your testimony in advance. I appreciate the opportunity to discuss the activities carried out by the Department of Homeland Security's Office of Health Affairs and the fiscal year 2013 budget request for the office. When you testified before this panel last year, I expressed my concern that the Office of Health Affairs was having a difficult time defining its mission being attributed to the growing pains, some would say, by the administration's reorganization that had occurred. The Office of Health Affairs was administratively created to assist the statutorily-created chief medical officer. Under this statute, the chief medical officer is charged with the responsibilities of advising the Secretary on public health issues and to coordinate bio defense and medical preparedness activities within the Department, among other Federal agencies, and with the State and local governments. Under our discussion today is BioWatch, as the Chairman alluded to, and the National Biosurveillance Integration System, that is consuming 80 percent of the full year 2013 budget request for this office. Consequently, the National Academy of Sciences has raised questions about the efficiency of these programs. Likewise, Federal watchdogs have determined that the BioWatch program has suffered from some growing pains, others might call management issues, and upgrades of the development and the delays of the Generation III technologies. Setting aside these questions, I am concerned about the BioWatch's coordination with State and local public health officials. It is my understanding that the Office of Health Affairs lacks the authority to compel information sharing by other Federal agencies. The development of this information-sharing framework is the essence of this program. One GAO report found that the NBIC resorted to gathering information publicly, available on the internet. This certainly isn't the best use of our taxpaying dollars and the expertise that we hope to enjoy. I have been assured that the strategy to improve NBIC is forthcoming. However, it is my understanding that strategy has not been shared yet with this committee. As your authorizers, we need to understand the strategy to properly evaluate your budget request. I encourage you today to provide necessary information and understanding, that we might continue to support the programs. With that, I thank you for being here. I look forward to your testimony. I yield back the balance of my time. [The statement of Ranking Member Richardson follows:] Prepared Statement of Ranking Member Laura Richardson March 29, 2012 I appreciate the opportunity to discuss the activities carried out by the Department of Homeland Security's Office of Health Affairs and the fiscal year 2013 budget request for the Office. When you testified before this panel last year, I expressed my concern that the Office of Health Affairs was suffering from an identity crisis. The Office's difficulty in defining its mission have been attributed to growing pains and the fact that it came about as the result of an administrative reorganization. Without a statutory authorization to guide it, the Office's mission seemed to lack clarity and consistency. Recently, the Office appears to be morphing from a policy office to a program office. The Office of Health Affairs was administratively created to assist the statutorily-created chief medical officer. Under the statute, the chief medical officer is charged with the responsibilities of advising the Secretary on public health issues and to coordinating biodefense and medical preparedness activities within the Department, among other Federal agencies, and with State and local governments. Since its inception, the number of Full-Time Equivalents in the Office of Health Affairs has nearly doubled. BioWatch and the National Biosurveillance Integration System consume 80% of the fiscal year 2013 budget request for the office. Most troubling is that GAO and the National Academy of Sciences have raised questions about the efficacy and efficiency of these programs. Federal watchdogs have determined that the BioWatch program has suffered from poor management of upgrades and developmental delays of Generation 3 technologies. Setting aside these management questions, I am also concerned about BioWatch's coordination with State and local public health officials. Unfortunately, concerns about the BioWatch program are not the only concerns. The National Biosurviellance Integration Center also suffers from efficacy concerns. It is my understanding that the Office of Health Affairs lacks the authority to compel information sharing by other Federal agencies. The development of this information-sharing framework is the essence of this program. One GAO report found that NBIC resorted to gathering information publicly available on the internet. This does not seem to be an effective use of taxpayer dollars. I have been assured that a strategy to improve NBIC is forthcoming. However, the strategy has not been shared with this committee. As your authorizers, we need to understand this strategy to properly evaluate your budget request. I encourage you to make it available to us. Dr. Garza, I look forward to hearing your plans to address these concerns. Mr. Bilirakis. I thank the Ranking Member for her statement. I want to remind other Members of the subcommittee, you are reminded that opening statements may be submitted for the record. [The statement of Ranking Member Thompson follows:] Prepared Statement of Ranking Member Bennie G. Thompson March 29, 2012 Congress cut funding for the Department of Homeland Security by $2 billion in fiscal year 2012. Less money for the Department meant that programs like the Metropolitan Medical Response System had to be consolidated into larger grant programs. Funding for University Programs and Research and Development programs were dramatically reduced. I raised my concerns about the wisdom of these budget cuts when Congress passed the fiscal year 2012 appropriations bill at the end of last year. I am not here to belabor those issues. But it is important to understand the context in which we must review all budget requests. The prospect of sequestration looms, and my friends on the other side of the aisle have indicated their intention to protect certain sacred cows. These pressures will force this committee to assure that Homeland Security dollars are spent on programs that are effective, efficient, and contribute to the safety and security of this Nation. To that end, we must take a serious look at Generation 3 of BioWatch. According to DHS, over the last 10 years, we have spent $800 million for BioWatch. During that time, the feasibility of the technology has been called into question by the National Academy of Sciences and there is only one potential vendor. In light of the current fiscal climate, we need to begin to ask hard questions about the feasibility of continued support. Mr. Bilirakis. Now I am pleased to welcome Dr. Garza back to the subcommittee. Dr. Garza is the assistant secretary for health affairs and chief medical officer of the Department of Homeland Security. He manages the Department's medical and health security matters, oversees the health aspects of contingency planning for all chemical, biological, radiological, and nuclear hazards, and leads a coordinated effort to ensure the Department's preparing to respond to biological and chemical weapons of mass destruction. Prior to joining the Department in August 2009, Dr. Garza spent 13 years as a practicing physician and medical educator. He most recently served as the director of military programs at the ER One Institute at the Washington Hospital Center, and has served as the associate medical director of the emergency medical services for the State of New Mexico, and the director of EMS for Kansas City, Missouri Health Department. Dr. Garza holds a medical degree from the University of Missouri Columbia School of Medicine, a masters of public health from St. Louis University's School of Public Health, and a bachelors of science in biology from the University of Missouri in Kansas City. Prior to earning his medical degree, he served as a paramedic and an emergency medical technician. He is a fellow at the American College of Emergency Physicians and a member of the American Public Health Association. Again, welcome, Dr. Garza. Your entire written statement will appear in the record. I ask that you summarize your testimony. You are now recognized for 5 minutes. STATEMENT OF ALEXANDER G. GARZA, ASSISTANT SECRETARY FOR HEALTH AFFAIRS, CHIEF MEDICAL OFFICER, U.S. DEPARTMENT OF HOMELAND SECURITY Dr. Garza. Thank you, sir. Chairman Bilirakis, Ranking Member Richardson, and distinguished Members of the committee, thank you for the opportunity to testify before you today. I would like to share with you some of OHA's accomplishments over the past year and my priorities for the coming year. As you are aware and as you have expressed, the Office of Health Affairs provides health and medical expertise in support of the DHS mission to prepare for, respond to, and recover from all threats. I view OHA's mission as protecting the United States from the impact of health threats, regardless of whether they are naturally occurring, manmade, intentional, or accidental. I often say that we look at health through the prism of National security. Our health expertise is unique within DHS. Our security outlook is unique within the health field. Over the past year, OHA has accomplished much towards our mission. As part of OHA's goal to build National resilience against health incidents, we have worked to improve programs in biodefense and chemical defense, strengthened our outreach in State and local public health officials, and developed key programs to promote health within the Department. Starting with our BioWatch program, this continues to be the only Federally-managed, locally-operated, Nation-wide biosurveillance system, designed to detect the intentional release of select aerosolized biological agents. This is an invaluable resource for the Nation. However, its strength is really in the symbiotic relationship with our partners at the State and local levels, making this truly a biodefense system, and not merely a biodetection system. In addition to our day-to-day operations, BioWatch also supports multiple National special security events, which will keep them quite busy this year. BioWatch has made tremendous strides over the past year. We continue to mature our laboratory capabilities. We have introduced a Critical Reagent Program from the Department of Defense into our BioWatch labs, and have implemented a comprehensive quality assurance program. In the coming year, in addition to continuing to improve our current operations, we will move forward with the development and testing of our the Next Generation Biodetection technology. The National Biosurveillance Integration Center, or the Center, has been made especially significant progress this year, including the upcoming launch of an effective strategy. This strategy will be defined by the extraordinary collaboration from inter-agency partners, as well as the private sector and State and local officials. In addition to the new strategy, the Center continues to provide day-to-day situational awareness of biological events of concern. As an example of this, in May 2011 in the E. coli outbreak in Germany, at the request of the National Security Staff, the Center executed an NBIC notification protocol, bringing together multiple Federal agencies. As a result of this collaborative effort, American citizens at home and abroad were given up-to-date information about the outbreak, how to stay safe. The U.S. Customs and Border Protection were able to use this information to target imports that may have posed a risk to the United States. We view this type of collaboration as just one component of the future of the Center. As you know, the threat posed by attacks using chemical agents is both very real and very troubling. Our Chemical Defense Program has made tremendous strides this year, assisting State and local jurisdictions to evaluate chemical defense capabilities, through a demonstration project in partnership with the city of Baltimore and the Maryland Transit Authority. The Chemical Defense Program has also rightly focused on post-incident planning, including the decontamination of people following a chemical attack, by developing best practice protocols in line with the best possible science. In the coming year, we will continue to improve our chemical defense capabilities to meet this threat. We have also continued our efforts with our State and local partners, as well as to ensure that they had information about the threats. OHA continues to help States identify where they need to develop additional capabilities, provide information on best practices, grants, and training. As you have mentioned, OHA is charged with protecting the DHS workforce. The potential health threats facing DHS employees are diverse. As the chief medical officer, I along with my office work to address issues ranging from resilience and wellness, developing quality measures for medical, and the protection of employees against biological attacks. OHA's Medical Countermeasures Initiative provides DHS personnel with immediate access to protective measures in the event of a biological attack. We procured medical countermeasures for the entire DHS workforce. This will ensure that the United States will continue to have a robust National security posture in the event that our workforce needs to respond. In addition, OHA has initiated the Medical Quality Management Program to work to standardize health and medical policy across the Department, and have initiated a new program with medical liaison officers. These are just a few of the many achievements that that we have accomplished over the past year. We recognize the challenges that will need to be addressed in the upcoming year. We will redouble our efforts to meet them. I want to thank this committee for your continued interest and support, and for the opportunity to testify before you today. I look forward to answering any questions that you might have. Thank you. [The statement of Dr. Garza follows:] Prepared Statement of Alexander G. Garza March 29, 2012 Chairman Bilirakis, Ranking Member Richardson, and distinguished Members of the committee: Thank you for the opportunity to speak to you regarding the fiscal year 2013 budget for the Office of Health Affairs. I appreciate the opportunity to update you on our progress from last year in addressing homeland security issues with health impacts. As you are well aware, the Office of Health Affairs (OHA) provides health and medical expertise in support of the DHS mission to prepare for, respond to, and recover from all threats. OHA's responsibilities include: Serving as the principal advisor to the Secretary and FEMA Administrator on medical and public health issues; leading and coordinating biological and chemical defense activities; providing medical and scientific expertise to support DHS preparedness and response efforts; and leading the Department's workforce health and medical oversight activities. OHA also serves as the primary DHS point of contact for State and local governments on medical and public health issues. OHA has four strategic goals that coincide with the strategic goals of the Department: 1. Provide expert health and medical advice to DHS leadership; 2. Build National resilience against health incidents; 3. Enhance National and DHS medical first responder capabilities; and 4. Protect the DHS workforce against health threats. Today I will discuss how we are working to achieve our mission and goals and how our fiscal year 2013 budget will support these efforts. goal 1: provide expert health and medical advice to dhs leadership Coordinated medical oversight ensures that the care rendered by both our occupational health system and our operational medicine system is uniform and consistent with National standards. To fulfill our statutory responsibility to provide expert health and medical advice to leadership throughout DHS, OHA is working with DHS components to build a Medical Liaison Program. Medical Liaison Officers (MLOs) are OHA physicians that work with DHS components to ensure consistent health and medical advice is provided across DHS. MLOs will provide dedicated support on guidance related to operational decisions as well as occupational health and workforce readiness issues. MLOs will also develop pre-deployment guidance to personnel deployed both domestically and abroad and strengthen the capability and capacities to provide medical countermeasures to our deployed workforce. Ultimately, this program will enhance consistency across DHS on health and medical issues, while providing each component with information tailored to their specific operational needs. Recently, OHA's Federal Emergency Management Agency (FEMA) MLO served as the lead medical/public health representative for FEMA's Whole Community Executive Steering Committee, which developed the country's first-ever National Preparedness Goal under Presidential Policy Directive 8. OHA is working to expand the presence of MLOs to additional components to improve the quality of health and medical advice to support DHS operations and the DHS workforce. This year, we hope to have a total of four MLOs on board. OHA is also creating a centralized DHS medical credentialing management system that ensures verification of medical provider credentials. This system is used to verify DHS employee qualifications, licensure information, and relevant health care provider data and has increased the ability to track and provide care to those within DHS. Currently 63% of DHS medical providers have been credentialed and that number continues to climb as we identify practitioners throughout DHS. Future plans include integration of the Medical Credentialing Management and Learning Management Systems to provide real-time credentialing status and data to operational components, allowing for distributed training and education that reduces cost, improves efficiencies, and supports operational medical programs. The fiscal year 2013 budget request supports the development of the MLO program and our work in workforce credentialing management, which will institute a ``One DHS'' policy for medical and health issues. goal 2: build national resilience against health incidents OHA operates, manages, and supports the Department's biological defense and surveillance programs. Two programs that provide biological threat awareness capacity are BioWatch and the National Biosurveillance Integration Center (the Center). Detection One of OHA's primary responsibilities is to mitigate the consequences of biological incidents through early detection. The BioWatch Program identifies the release of an aerosolized biological agent and provides an alert to public health officials, allowing for a faster response and the rapid provision of medical countermeasures. The BioWatch Program is an example of a key partnership between Federal, State, and local government. BioWatch is the only Federally- managed, locally-operated Nation-wide bio-surveillance system designed to detect the intentional release of select aerosolized biological agents. Deployed in more than 30 metropolitan areas throughout the country, the system is a collaborative effort of health personnel at all levels of government. Current detection capabilities, termed BioWatch Generation 1 and 2 (Gen 1/2), consist of outdoor aerosol collectors whose filters are manually retrieved for subsequent analysis in a Laboratory Response Network (LRN) facility. In addition to the more than 30 cities that Gen 1/2 operates in on a daily basis, BioWatch has supported several National Special Security Events with additional collectors, personnel, and laboratory support, providing an additional layer of protection and security. The BioWatch Program continues to collaborate with partners to improve laboratory capabilities and leverage existing knowledge and resources. This year, BioWatch, in close collaboration with the Centers for Disease Control and Prevention (CDC), the Department of Defense (DoD), the Department of Energy (DOE) National Laboratories, the Association of Public Health Laboratories (APHL), and State and local public health laboratories, successfully implemented the use of the DoD Critical Reagent Program assays to conduct initial screening for the aerosol release of bioterrorism agents. Coupling these assays with CDC LRN assays for confirmation provides significantly increased confidence in the analytical results of BioWatch samples. The BioWatch Program has also developed and implemented a comprehensive Quality Assurance (QA) program. Recently made operational, the Laboratory QA Program Plan (QAPP) was developed in close collaboration with State and local public health laboratories and provides the quality assurance framework for BioWatch laboratory operations. An example of the Laboratory QAPP is the use of QA samples that provide an expected result into the daily analysis at every lab. The data from these samples provides accurate insights into false positive and false negative laboratory results and provides better confidence in laboratory results. While the Gen 1/2 system is extremely beneficial, it is labor- intensive and results may not be available until 12-36 hours after the release of a biological agent has occurred. To shorten the time to detect, OHA has been testing the next generation of BioWatch, Generation 3 (Gen-3) for eventual procurement, which will reduce the time of detection of a biological agent by using automated detection. DHS believes that early detection is an essential part of an effective biodefense posture as reducing the time to detect is imperative to saving thousands of lives. The fiscal year 2013 budget funds continues the current operations of the Gen 1/2 BioWatch detection network and continues development and testing of the next generation technology to expedite response times. Biosurveillance Another key element to an overarching biodefense framework is biosurveillance. OHA is focused on developing and maintaining an integrated, real-time surveillance picture. The National Biosurveillance Integration System (NBIS) enhances the identification, location, and tracking of biological events potentially impacting homeland security by uniquely integrating information and data and leveraging interagency communications and relationships. NBIS supports prevention and mitigation of such events by providing timely notifications and on-going situational awareness to enhance response of Government agencies. NBIS is a community of Federal, State, local, territorial, and Tribal agencies, as well as international and private- sector organizations that shares a common goal of protecting the United States from biological threats. NBIS values trusted relationships and collaboration across various organizational boundaries. The National Biosurveillance Integration Center (the Center) housed within OHA, coordinates comprehensive National biosurveillance and situational awareness contributed by members of the NBIS. The Center's mission is to rapidly identify, characterize, localize, and track a biological event of National concern; integrate and analyze information relating to human health, animal, plant, food, water, and environmental domains; disseminate alerts and pertinent information; and oversee development and operation of the NBIS. The May 2011 E. coli outbreak in Germany is a recent example of how NBIS can be used to enhance response to a health security incident. During this incident, NBIS made subject matter experts available to answer existing concerns about the potential origin and virulence of the associated E. coli strain, and facilitated communication between Federal agencies. Sixty-one individuals representing 13 Federal staffs, agencies, or departments participated in this process. As a result of this collaborative effort, American citizens at home and abroad were given up-to-date information about the outbreak and how to stay safe. Additionally, U.S. Customs and Border Protection (CBP) was able to use this information to target imports that may have posed a risk to the United States. NBIS and the Center continue to work towards tackling the inherent difficulties of integrated biosurveillance. OHA has spent the last year working with the Federal interagency, State and local partners, and private sector stakeholders to develop a new strategy to improve integrated biosurveillance. With the new strategy, OHA is striving to meet National priorities, mitigate impacts of biological events, and make significant improvements in collaboration, information integration and sharing, analysis, and reporting. In the mean time, OHA is continuously examining potential areas for improved collaboration and situational awareness. The Center is supporting a demonstration project in North Carolina called the National Collaborative for Bio-Preparedness (NCB-P). The aim is to validate integrated information sharing of public health, animal surveillance, environmental monitoring, and other biosurveillance information on the State level. The Center is also developing projects that pilot improved information sharing with the private sector and Federal partners, as well as leveraging existing information technology (IT) and biosurveillance resources at agencies such as the Department of Defense (DoD) and CDC. The fiscal year 2013 budget request increases resources for OHA to move forward with the new strategy for the Center and support more pilot projects. Chemical Defense OHA's Chemical Defense Program (CDP) aims to provide Federal, State, and local governments with knowledge and tools to build and sustain a viable framework for preparedness and response to high- consequence chemical events. To build a response knowledge base, OHA partnered with the Department of Health and Human Services (HHS) to host a symposium on the decontamination of humans after a chemical attack. This symposium brought together leading Federal, State, and local officials to examine decontamination guidance and research gaps. By ensuring response activities are based on the best possible science, OHA is helping first responders save lives after a chemical incident. OHA launched a partnership with the Maryland Transit Administration and the City of Baltimore to develop chemical defense techniques for subway mass transit. This demonstration project is the next step in the work that began last year which evaluated chemical detection technology, providing local jurisdictions with expert evaluation of potential capabilities. OHA is looking to expand this program to additional jurisdictions and is developing criteria to allow jurisdictions to submit proposals for demonstration projects. The fiscal year 2013 budget request, in addition to anticipated carry-over funding from fiscal year 2012, will allow CDP to move forward with these initiatives. Improving Public Health Information Sharing and State and Local Capabilities OHA works to improve State and local capabilities through information-sharing efforts. OHA has developed a new program to sponsor as many as 100 security clearances for key State and local health officials to facilitate the sharing of classified health threat information. OHA works with the Office of Intelligence and Analysis (I&A) to enhance information sharing with State and local health officials by providing classified health threat briefings on emerging threats. This year, OHA provided State and local officials with this information through briefings held jointly with events such as the BioWatch Workshop and conferences hosted by the Association of State and Territorial Health Officials (ASTHO), the National Association of County and City Health Officials (NACCHO), and the Association of Public Health Laboratories (APHL). OHA also works with the National Operations Center (NOC) within the Office of Operations Coordination and Planning to provide key health information for the NOC's situational awareness reports, such as contamination following the 2011 Fukushima Daichi nuclear disaster. These reports are produced and distributed by the NOC to homeland security enterprise partners. By ensuring State and local health officials have information on current threats, they can better direct their preparedness efforts to meet those threats. Public health officials can bring valuable insights into the fusion center environment, shaping preparedness efforts, response, and recovery. OHA is also working to bring help bring those public health and medical partners in to fusion centers by providing guidance documents and technical assistance to facilitate the establishment of information exchange between public health and other homeland security partners to share appropriate health-related threat intelligence. OHA has also worked to help States identify where they need to develop additional capabilities, and has provided information on best practices, and training. For example, OHA partnered with the National Center for Food Protection and Defense (NCFPD) to develop the Food Sector Food and Agriculture Readiness Measurement Toolkit (FARM Toolkit). The FARM Toolkit allows the States to self-assess the strengths of their food emergency response plans and identify areas for potential improvement through a survey tool. The survey assesses the level of preparedness in the food sector, level of integration of the food sector into the emergency management community, current emergency management capabilities of the food sector, and the emergency management needs of the food sector. Upon receiving the survey results, an integrated database returns relevant information on best practices, planning, training, and funding resources--all designed to help State and local communities improve their preparedness for adverse food incidents. OHA also developed a partner page on the Lessons Learned Information Sharing (LLIS.gov) portal where emergency response providers and homeland security officials can access an on-line network of content related to lessons learned, best practices, and innovative ideas on food, agriculture, and veterinary defense. Best practices help States leverage lessons learned to improve their capabilities and planning. The fiscal year 2013 budget request will continue to support public health information sharing and capability development initiatives. goal 3: enhance national and dhs medical first responder capabilities To enhance National and DHS medical first responder capabilities, OHA works with emergency medical services (EMS) program coordinators throughout DHS to protect our workforce and facilitate treatment of life-threatening and common medical or traumatic events. Within the past year, OHA developed protocols that outline the care that medical technicians and paramedics should administer to patients. First, OHA developed protocols for Basic Life Support (BLS) and Advanced Life Support (ALS). The BLS/ALS protocols describe common signs and symptoms and provide treatment options associated with common pre-hospital injuries or illnesses encountered by DHS EMS personnel and align with National EMS standards of care. Second, in collaboration with several other Federal agencies such as the DoD and the Department of Justice (DOJ), OHA created the Austere Emergency Medical Support (AEMS) Field Guide and Training Program. This program provides support to select and highly qualified DHS EMS personnel who are deployed to austere, remote, high-threat, and disaster environments. To ensure medical proficiency with the content in the field guide, DHS-OHA conducted the first training in January 2012 with a class of 25 DHS EMS Paramedics. OHA recently published the first DHS EMS Strategic Plan. This plan will ensure EMS education, training, scopes of practice, and quality assurance practices are consistent across DHS and compliant with National standards. Through cross-component collaboration and standardization, patient outcomes may improve and EMS programmatic costs may decrease. OHA has also reached out to medical first responders to raise awareness of human trafficking. As part of DHS's Blue Campaign, the Department's initiative to fight human trafficking, OHA, FEMA, and the U.S. Fire Administration produced a video for first responders regarding indicators of human trafficking they might encounter and what they can do to help victims. We also developed tailored indicator cards to include health-related indicators that first responders, such as firefighters and EMTs, may notice. We've been working with our partners in the EMS community to get these resources out to the field through a variety of stakeholder events. The fiscal year 2013 budget request will support the continued development of resources and capabilities for medical first responders both within DHS and in our local communities. goal 4: protect the dhs workforce against health threats The potential health threats facing the DHS workforce are diverse and as Chief Medical Officer, I am working to address issues ranging from resilience and wellness to the protection of employees following a biological attack. We know the stress that comes from carrying out the DHS mission can take its toll on the workforce. Secretary Napolitano asked that we improve resilience and wellness in the DHS workforce to ensure employees have the tools necessary to manage this stress while supporting the mission. Our program, DHSTogether, has conducted DHS- wide training and held two symposiums on employee resilience. The fiscal year 2013 budget request will allow OHA to continue to work with components on improving employee resilience through additional training support for employees and managers. OHA's Medical Countermeasures (MCM) Initiative provides DHS personnel with immediate access to life-saving medications in the event of a biological attack to ensure front-line operations can continue. At this time, we have purchased MCM for 100 percent of the DHS workforce, which includes working animals and critical contractors. This year, OHA delivered nearly 200,000 courses of medical countermeasures (MCM) to 127 field locations. The fiscal year 2013 budget request will allow OHA's MCM program to maintain the DHS antibiotic and antiviral stockpile and expand pre-positioned MCM to an additional 350 DHS field locations. conclusion Thank you again for the opportunity to testify regarding OHA's work and our fiscal year 2013 budget request. I look forward to your questions. Mr. Bilirakis. Thank you for your testimony. I will recognize myself for 5 minutes for questioning. Dr. Garza, on BioWatch, the President's request included $125 million for BioWatch, for the program, an increase of $11 million over the enacted 2012 figure. Of this amount, $39.9 million is intended for continued testing for the Next Generation Gen III System. This is an increase in $16 million-- that is my understanding--66 percent over 2012. The GAO is currently working on an investigation of BioWatch Gen III--I know you are aware of that--due to serious concerns over this procurement by Members of both the House and the Senate and, of course, our committee. There has been no comprehensive cost/benefit analysis done to ensure that all these millions, $5.7 billion actually, in fact, over the project's lifetime, will buy down risks sufficient to justify the expenditure. Can you please explain to the Members of this subcommittee how you can justify further expenditures on this program in the absence of a cost/benefit analysis that gets an analysis of a broad set of alternatives, as well as other important data collection, to ensure that what will ultimately be a multi-billion dollar program procurement-- of course, it has to be sound. So I will give you the opportunity to respond to that. Dr. Garza. Yes, thank you, sir. It is a very good question. It is appropriate for you to ask about spending taxpayer dollars. You are correct that there is an increase in the budget request for 2013 as part of the normal acquisition program that has been going through. So the budget numbers are going to vary from year to year depending on what the acquisition strategy is doing during that particular amount of time. The acquisition strategy that we have developed for the BioWatch program is very robust. It has to meet certain milestones before it can progress to the next phase, which I think makes it give me a lot of comfort and it gives the Department more comfort knowing that we are not going to be spending money unless our program is able to meet the certain goals that we have established for it. So in terms of buying down risk, that is what the acquisition program is all about. It is making sure that we are addressing the risks both to the Department and to the Nation. To the Department to make sure that we are not spending money foolishly on equipment that is not going to do what it is supposed to do, but also balancing that risk to the Nation as well, and looking at what would be the impact of a biological attack within the country. Now as we realized in 2001, with the bio attacks which we just celebrated the 10th anniversary of, the recovery amounts from a biological attack during that year were in the billions of dollars. So combined with our risk-averse strategy in the acquisition process, we feel like we are doing a very good job of balancing the risk/benefit ratio. Although I certainly would not be opposed to anybody doing a risk/benefit analysis, I feel like we have already incorporated enough of that into the acquisition strategy to make it much more comfortable for us moving forward. I am sorry, sir. Did I miss another part of your---- Mr. Bilirakis. Follow up on the--sure, let me follow up on BioWatch. Last year, fiscal year 2012, back and forth between the Department of Homeland Security and the OMB, we learned that OMB was questioning DHS and OHA's handling of the BioWatch program in terms of cost controls and financial reporting, and that the program's cost growth and delays required a more conservative approach for fiscal year 2012. Describe to this committee how your budget request reflects a conservative approach and improved management practices. Dr. Garza. Absolutely, sir. So the budget request is always tied to the acquisition strategy. But it is also tied to the timeliness that we can get certain things accomplished in the Gen III program. It is a very technically difficult program. So we always have to remember that this equipment, this technology has never been accomplished before. So we don't really have a template that we can say, we think we are going to meet data on this date exactly. So in order to balance the risk to the Department of, we don't want to rush through testing and evaluation, we want to make sure that all of these issues work, versus the risk to the Nation of we have to have technology that meets the goal of protecting the Nation. That is a tricky balance to strike. So you bump that up against the budget cycle as well, and if you have a slide in any sort of testing and evaluation, that is going to impact your budget dollars, because, frankly, you can't do testing unless you meet certain dates. So it is a very complex acquisition. I think we have done a very good job of improving our financial reporting with OMB. We speak with them frequently. We make sure that our documents are in on time. I think we have accomplished quite a bit in making sure that we are being fiscally responsible, that we are meeting our acquisition guidelines, and that we are taking appropriate risk precautions, both for the Department and for the Nation. Mr. Bilirakis. Okay. Thank you very much. My time has expired. So now I will recognize Ms. Richardson for 5 minutes. Just to let you know, I plan to go at least one more round after this. Thank you. You are recognized for 5. Ms. Richardson. Dr. Garza, did I hear you say when we could expect the strategy to be done? I heard you reference it, but I didn't hear a date. Dr. Garza. Yes, ma'am. I am assuming you are talking about the NBIC strategy. Is that correct, ma'am? Ms. Richardson. Yes. Dr. Garza. Yes. So the NBIC strategy has just finished its final round of comment and adjudication with the members of the NBIC. That was done last week with the working group, who will be taking it to the principals I believe in the next 2 weeks. After we have all of those comments vetted, adjudicated, I would project the strategy coming out probably within 2 months or so. Ms. Richardson. Okay. Assuming that we do have a strategy, how will you be able to implement the strategy and necessary improvements with $4 million less that is being recommended in your budget? Dr. Garza. Yes, ma'am. So part of the decline to the budget going into fiscal year 2013 is due to some of our pilot projects that we will be funding going forward because we anticipate them then becoming an on-going process within the NBIC. So the goal of the new strategy is making sure that the projects that we are going to be doing can become incorporated into the normal processes of the NBIC, where they won't require as much up-front costs, but will rather become part of the continuing evolution of the NBIC. So we don't anticipate needing those funds going forward. Ms. Richardson. So you are saying that you believe you will be able to adequately meet the affairs of your office with $8 million? Dr. Garza. I believe so. Yes, ma'am. Ms. Richardson. Okay. One of the biggest issues we talked about before was the inadequate participation by the other Federal agencies that participate in NBIC. Can you give us an update of where we are on that? Dr. Garza. Yes, ma'am. So that ties into the strategic planning process as well. So you are absolutely right that we had a difficult time with inter-agency partners participating within the NBIC process. But as you pointed out, the statutory language for the NBIC is not ``you shall'', it is ``you may''. It is not ``you shall.'' I think that is appropriate actually, because I want people to be coming to the center or to the system because they see the value in it. So one of the things with the strategy that we made sure we do is we made sure it wasn't DHS-centric, that we made sure that it was system-centric. That means going and talking with each of the individual agencies to see what their needs were, to see what they saw of the system, how they could improve it, how they could contribute, and what they desire out of the system. So that is why it took a little bit longer than normal to develop a strategic process. But it also gave us buy-in from those institutions, because now it is them helping develop the strategy. So they have buy into it. I can just tell you anecdotally, from own experiences, is that we have had quite a bit of enthusiasm and interest in working with the Center. That gives value out to the individual agencies. So I can't give you any, you know, concrete numbers that say, you know, this is how much we have improved in the interaction. But I can tell you that I think our relationships with the other agencies are dramatically improved. Ms. Richardson. Do you feel they are adequate? Dr. Garza. I think they are evolving. I think they adequate right now for where we are. I think in the time to come that those relationships will continue to grow, that will continue to find novel ways of looking at data and to bring data in. I think we will continue to refine processes. I think people will contribute more. I think it is a good springboard now to get better and better. Ms. Richardson. As you know, the administration has combined various programs and funding together. MMRS is a popular and effective program that has been now consolidated with UASI and some of the State homeland security programs. Why do you think we should continue to fund NBIC over programs like MMRS or other State and local programs? Dr. Garza. Yes, ma'am. Although I don't---- Ms. Richardson. Besides you wanting to keep your job. Dr. Garza. Right, exactly. Although, you know, I am never one for trying to pit one program against another, but I do recognize economic difficulties where you have to make difficult choices. So the answer to that I would give is that the NBIC, what we envision it to be is a National asset that can help not only the Federal inter-agencies, but I think the whole of the Nation. So part of that is, as I expressed before, helping Federal agencies with information, with analyses that they might have not otherwise had, because they're siloed in their data. But also reaching out to the State and locals, which was-- effectiveness. We have done this in a couple of ways. One of those is giving them access to some of our common operating pictures, and then also developing our pilots to make sure that we are including the State and locals. So I think we can become a force multiplier with the States from a biosurveillance standpoint, which will give them a capacity that they haven't had before. Ms. Richardson. I will yield at this time, since I am down to about 19 seconds. Or actually I am over. Thank you, sir. Mr. Bilirakis. We are going to go one more round anyway. So I will recognize myself for 5 minutes. Please provide an update on the status of the guidance for protecting the responders' health during the first week following a wide-area aerosol anthrax attack. This guidance has been languishing in the clearance process for years. Tell us why the guidance has been delayed. But first give us the update. When will the guidance be released? Dr. Garza. Yes, sir, excellent question. This is something that I think has been very important to our office. As you have correctly noted, this has been a long time coming. Frankly, you know, we have been working on it very hard for the past couple years. It seems like this is a normal part of how you get things done, is you can do that 90 percent fairly quickly but that last 10 percent, that always seems to hold you back. We are at that last 10 percent right. So the document, I believe, is at almost the 99 percent right now. We have had the final vetting of comments, the adjudication of certain issues. We have been working with, you know, a whole smattering of the Federal inter-agency, HHS, NIOSH, OSHA, EPA. Everyone seems to be on board now. As you know, you are going to be having a hearing here in a couple weeks about medical countermeasures. So I fully anticipate that this report will be done, I am hoping, by that hearing. I know that it is on schedule to go up to the Domestic Resiliency Group for adjudication. So I anticipate it being very shortly. I hate to give you an exact date, but I would say that we are rounding third and we are heading for home right now. Mr. Bilirakis. Can you keep us informed on that, because it is very, very important, as you know? Dr. Garza. Absolutely. Mr. Bilirakis. One last question: The Food, Agriculture, and Veterinary Division with OHA is responsible for the agriculture security activities of the Department. This small office has typically been funded at fairly modest levels, as you know, about at $720,000, and this year actually down to $640,000. This office works toward animal and agricultural health and providing planning tools at the local level to support this. But very little elaboration in the budget was provided as to what this money would be used for. What will this $640,000 be used for? Why isn't it transparent in the budget? Dr. Garza. Yes, sir. I think you rightly stated that food-- that is a very important mission within our office, and I think sometimes under-appreciated, how important it is, and how important food security is for this Nation. As you will remember during H1N1, when it first broke, it wasn't called H1N1. It was called Swine Flu. That had a devastating attack on the pork industry, to the tune of billions of dollars. So we are very keen to not even issues that affect our stock can have a direct effect on the economy of this Nation, which is very important. So the things that FAV focuses on is, first, interacting with the Federal inter-agency, so with the USDA, FDA, but also interacting within the DHS assets that implement the regulations. So that is particularly CDP, who does inspections. The thing that we have been most focusing on, though, is helping out the State and locals as well. We do that through a couple of different mechanisms. One is through building tools and guidance for them. So part of this is building them guidance so that they can look within their State and localities to see how prepared they would be for a food emergency. They can tally up where they are, where the challenges are. So they can direct resources and funding through that. So part of that has been going towards that effort. I will apologize to you. I don't have an exact breakdown of where the money goes, but, you know, I would be happy to get the information back to your office, to tell you exactly all the efforts that---- Mr. Bilirakis. Please do. I am sure the Ranking Member will be interested as well. Dr. Garza. Absolutely. Mr. Bilirakis. You can get back to us on that as well. All right, well, I will yield back the balance of my time. I will recognize the Ranking Member for 5 minutes. Ms. Richardson. My next question has to do with the deployment of Gen III technology that has repeatedly been delayed. Only one vendor has completed phase one of the testing. I understand that part of the reason for the delay in the deployment is due to a technical feasibility issue. How has OHA addressed the feasibility issue? Or is that the reason? Dr. Garza. So I would have to make sure I understand what technical feasibility--what you meant by that. But let me explain to you some of the reasons why some of these issues have come up. So you are absolutely correct that one vendor has gotten through phase one testing. We are having a pause right now before we go to phase two, to go over the data from all of our phase one testing, to look at what things are going well, and what things need to be looked at further. So again, it is a first-of-kind technology. Nobody else in the world has developed this type of technology. So the pause after the phase one of acquisition is very important, so that we can take a look at, hey, what are the things that worked very, very well in phase one; what are the things that didn't work as well as we needed them to, so that we can then go back and say, look, these things are either exactly where they need to be or they need to be improved upon. It is the same sort of development process that goes through with any complex technological development. You know, I always use the example of the iPhone. Look, the iPhone, when it first came out, had challenges. Have to go back and do engineering changes to improve it. That is exactly what this is supposed to do during this acquisition process. We take a look at what things did it do well on, what things didn't it do well on, what things can we improve on. Then, frankly: Is this what we really need going forward? So the acquisition process has those dates built in to make sure that we are doing what we are supposed to be doing, but, frankly, doing what the Nation needs as well. Ms. Richardson. Would you say Gen III is on track? Dr. Garza. I would say Gen III is appropriately where it should be right now, which is---- Ms. Richardson. I am sorry. Would you say it is on track? Dr. Garza. Well, it depends if you are looking at the acquisition time line, as you are looking at, hey, this is new technology. If you are looking at the acquisition time line, it slips. Absolutely, it slips. But as I mentioned before, this is to be expected in complex technology development. Ms. Richardson. Dr. Garza, I think you know I am supportive. It is obvious that I am supportive of the administration. But in all fairness, I need for you to really clearly answer the question. The reason why I am asking the question is we, as Members of Congress, we end up, you know, supporting funding of various programs, projects, services and so on. You know, some of us have had the opportunity to see projects go on way too long, only halfway to the end, that they really not be feasibly attainable. Meanwhile, we have spent, you know, millions and billions. So it is a responsibility question on our part. I am asking you, in your professional opinion, is Gen III on track? That is what I am asking you, yes or no? Dr. Garza. Right. I truly appreciate your oversight of this. Believe me, we need oversight of important acquisitions. My professional opinion is it is right where it needs to be. Now there is going to be slips in the schedule. There is nothing that I can do or that anybody can do to prevent those. Ms. Richardson. I am not asking where it needs to be. I am asking you, do you believe that the project, given the testing that has been done so far, is something that is potentially feasible and attainable? Dr. Garza. Yes. Ms. Richardson. Within what approximate time frame would you expect Gen III to be deployed? Dr. Garza. Well, we have to make sure we go through our acquisition strategy time line first. So I make no guarantees that it will make it through the next phase of testing. So why this acquisition strategy was built with these milestones here. So the next phase of testing will, again, test another part of the system. So we have to make sure that it is hitting all those marks before we even talk about procuring a machine. We don't want to invest, you know, the $5.7 billion over the lifetime of the program unless we are relatively sure-- absolutely sure that this is going to fit the bill. So we are still in that testing and evaluation period right now. I make no guarantees that it will go through procurement. But what we need to do is have robust testing and evaluation, to make sure that we are making the correct procurement decisions. That is the important part. Ms. Richardson. So are you anticipating 2 years, 5 years, 10 years? Dr. Garza. The fiscal year 2013 schedule has a four-city operational testing and evaluation period on there, which, frankly, will take time. We need to run the machines in different environments, you know. So I would have to look at our acquisition time line again, but I am thinking the procurement decision would probably come around 18 months or so, after we complete including testing and all the data acquisitions and looking at data. Ms. Richardson. Okay. My last question is referring to overlapping responsibilities. The Office of Safety and Environmental Programs within the under secretary of management is responsible for establishing DHS-wide safety and health programs. Therefore it appears to be some overlap between the occupational health efforts undertaken by OHA and the office residing in the management directorate. Please describe how the missions and the efforts of these two offices differ. Dr. Garza. Yes, ma'am. There is an important difference. So our office focuses mostly on the occupational health side. We have these developed guidelines with OSEP, up at the Office of Management, to make sure that everybody knows what each other is doing. Management has been more concerned with workplace safety issues, more so than occupational health issues. I think that is appropriate, since it was in a management office. But we have brought on a new occupational health position, retired from the DOD, very experienced. He has been there only a couple months, but he has already done a lot of good work. But I think we do have a very good working relationship with OSEP and USM. I think we clearly understand where each others' lanes are. We work with each other quite frequently. Ms. Richardson. Provide to the committee where your lanes are, what those differences are. Dr. Garza. Absolutely. Ms. Richardson. Thank you. Mr. Bilirakis. Thank you very much. I have nothing further. I want to thank the Ranking Member for her questions and, Dr. Garza, for your valuable testimony. Then we may have some questions afterwards. Again, the Members of the subcommittee may have some additional questions for you. We ask you to respond in writing, sir. The hearing record will be open for 10 days. Without objection, the subcommittee stands adjourned. Thank you. Thanks to the audience for all your patience as well. [Whereupon, at 11:14 a.m., the subcommittee was adjourned.] A P P E N D I X ---------- Questions Submitted by Chairman Gus M. Bilirakis for Alexander G. Garza biowatch Question 1. Knowing what you know about the biothreat, do you personally believe that BioWatch is contributing to our overall surveillance capability in a meaningful manner? In what specific way(s) are the results being integrated with other surveillance mechanisms? Answer. Response was not received at the time of publication. Question 2a. Several Federal agencies, including CDC, DHS, EPA, and FBI have responsibility for parts of the response to a BioWatch Actionable Result (BAR) (laboratory analysis, detection, remediation, and law enforcement investigation respectively). FEMA's role is unclear and they are rarely (if ever) engaged in multi-agency planning workgroups. Which agency has responsibility for coordinating the Federal response to a BAR? Answer. Response was not received at the time of publication. Question 2b. How does a BAR differ from what is known as a ``CDC actionable event''? Answer. Response was not received at the time of publication. Question 2c. How does the Biological Agent Threat Response protocol integrate with the Federal BioWatch response, and how is it coordinated with the BioWatch National Conference Call? Answer. Response was not received at the time of publication. Question 3a. I understand that further procurement actions for BioWatch Gen-3 have been postponed due to the Department's decision to conduct a comprehensive biodefense strategy review to ensure Departmental capabilities are appropriate and well-grounded. Can you tell us the status of this review, and whether it was prompted by concerns about the capabilities of the Gen-3 prototype system? Answer. Response was not received at the time of publication. Question 3b. OHA staff indicated that this delay will impact both the fiscal year 2012 and fiscal year 2013 planned expenditures for the Gen-3 program. Can you elaborate on how the planned rollout time line will be altered by this review? Answer. Response was not received at the time of publication. Question 3c. Are there outcomes being considered by Review Panel that could significantly impact the Gen-3 program? Answer. Response was not received at the time of publication. Question 3d. To your knowledge, has this review impacted other acquisition activities within the Department? Answer. Response was not received at the time of publication. Question 4a. OHA expended significant resources to test the current candidate technology in a field test 1 year ago in Chicago. What were the results of this testing? Answer. Response was not received at the time of publication. Question 4b. When will the data from the Phase 1 Chicago field test be made available for public and/or stakeholder review? Answer. Response was not received at the time of publication. Question 5. Please describe, in detail, the ways in which OHA and the Science and Technology Directorate are cooperating on development and deployment of Gen-3 systems. Answer. Response was not received at the time of publication. Question 6. By how much do you expect to reduce the casualty rates once the Gen-3 system is fully deployed? Answer. Response was not received at the time of publication. Question 7a. The BioWatch program involves testing for agents despite the fact that treatments for some of those agents are not necessarily available. Why should local governments test for BioWatch agents for which there exists no medical guidance, or capability to prevent or treat? Answer. Response was not received at the time of publication. Question 7b. What protocol does OHA propose they follow in the event of a positive result? Answer. Response was not received at the time of publication. national biosurveillance and integration center (nbic) Question 8a. The budget request for NBIC includes an increase of $1.0 million for the development of pilot projects with partners in the Government and private sectors to address core biosurveillance capabilities such as collaboration, information integration and sharing, and data analysis and reporting. These projects are proposed as part of the new ``emergent strategy'' for NBIC. How does OHA envision these pilot projects integrating into an overall picture of improved, integrated National biosurveillance? How will they build upon and integrate with the on-going National Collaborative for Bio-Preparedness project, which I understand will also continue to be funded? Answer. Response was not received at the time of publication. Question 8b. What metrics have been established to assess individual programs' short-term success as well as their contribution towards longer-term integrated biosurveillance goals? Answer. Response was not received at the time of publication. Question 8c. How are the funds being distributed across the individual pilot projects and what are the time frames for pilot program roll-outs? Answer. Response was not received at the time of publication. Question 8d. What is the current status of those programs that have already been initiated? Answer. Response was not received at the time of publication. Medical Countermeasures Question 9. You have requested $1.9 million for a new Medical Countermeasures Program to implement the Executive Order that requires you to provide MCMs to your employees. The goal is to ensure maintenance of mission-essential Executive Branch functions. With this funding, OHA will develop a strategy and provide antivirals and antibiotics to cover the DHS workforce, critical contractors, and those in care and custody in the event of a pandemic or other health threat. Is specific threat or risk assessment information used to inform DHS' MCM procurement strategy? Is there a formal process for prioritizing procurement decisions? Answer. Response was not received at the time of publication. Chemical Defense Program Question 10a. Previously the Chemical Defense Program sponsored a Transit Demonstration Project in Baltimore. What is the status of this project? Answer. Response was not received at the time of publication. Question 10b. Does the reduction in funding for the Chemical Defense Program suggest a cancellation or elimination of these types of projects? Answer. Response was not received at the time of publication. Question 10c. Has OHA decided not to fund additional pilot activities with transit agencies? Answer. Response was not received at the time of publication. General CBRN Defense Question 11a. Recent developments in the news regarding the H5N1 virus, or bird flu, have raised serious concerns over whether the proper infrastructure is in place to prevent dual-use research from being misused. In your role advising the Secretary and other Department leaders on health and medical matters, and in fulfilling OHA's mission to provide health security, in what way have you and your staff been involved in the current debate as well as in the on-going debates about dual-use research generally? Answer. Response was not received at the time of publication. Question 11b. Is DHS sufficiently involved in these discussions in your opinion? Answer. Response was not received at the time of publication. Question 12. Homeland Security Presidential Directive--10 (Biodefense for the 21st Century) issued in 2004 called for the Department of Homeland Security, in coordination with other appropriate Federal departments and agencies, to develop comprehensive coordinated risk communication strategies to facilitate emergency preparedness for biological weapons attacks. This includes travel and citizen advisories, international coordination and communication, and response and recovery communications in the event of a large-scale biological attack. Has a coordinated risk communication strategy for biological attacks been issued to date? If not, when can we expect to see it? Answer. Response was not received at the time of publication. agricultural security Question 13. The S&T Directorate requested no funds for the National Bio and Agro-Defense Facility, which was envisioned to support the Nation's agricultural security. Agricultural security is a common goal shared with your office. S&T is apparently reconsidering even the very need for such a lab. In light of decreased funding requested for your office for agriculture defense activities, combined with this lack of request from S&T, please relate to the committee whether this decreased emphasis is due to perceived decrease in threat on the part of the Department, or simply tough decisions in a tight budget environment. Answer. Response was not received at the time of publication. response and remediation Question 14a. There are no Federal guidelines on indoor, outdoor, or mass transit remediation following a biological release. If a large city such as New York were to apply the standards used to remediate the Senate Hart Building following the 2001 attacks to a large area release in Manhattan, it could take anywhere from 50 to 300 years to complete. When can local governments expect guidance from the Federal Government to recover from a large-scale release? Do you work with the EPA on providing such standards? Answer. Response was not received at the time of publication. Question 14b. In the event of a false reactive identification of an organism, is the Federal Government willing to indemnify local governments for costs that would be associated with acting in response to a positive BioWatch result? Has OHA been a part of any such discussion? Answer. Response was not received at the time of publication. state and local coordination Question 15. The economic difficulties of the last few years have had profound impacts on State and local workforces. Many employees in State and local health departments have lost their jobs, and I wonder to what extent planning, exercising, and response activities are suffering. Have you uncovered severe challenges at the State and local level due to the budget downturn, or for other reasons? Answer. Response was not received at the time of publication.