[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/

                               __________



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                     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

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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.

                                 
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