[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]



                 BIOWATCH PRESENT AND FUTURE: MEETING 
              MISSION NEEDS FOR EFFECTIVE BIOSURVEILLANCE?

=======================================================================

                             JOINT HEARING

                               before the

                SUBCOMMITTEE ON EMERGENCY PREPAREDNESS,
                      RESPONSE, AND COMMUNICATIONS

                                and the

                     SUBCOMMITTEE ON CYBERSECURITY,
                       INFRASTRUCTURE PROTECTION,
                       AND SECURITY TECHNOLOGIES

                                 of the

                     COMMITTEE ON HOMELAND SECURITY
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED TWELFTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 13, 2012

                               __________

                           Serial No. 112-117

                               __________

       Printed for the use of the Committee on Homeland Security



[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


      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
                                     Laura Richardson, California
Scott Rigell, Virginia               Hansen Clarke, Michigan
Tom Marino, Pennsylvania, Vice       Kathleen C. Hochul, New York
    Chair                            Bennie G. Thompson, Mississippi 
Blake Farenthold, Texas                  (Ex Officio)
Robert L. Turner, New York
Peter T. King, New York (Ex 
    Officio)
                   Kerry A. Kinirons, Staff Director
                   Natalie Nixon, Deputy Chief Clerk
               Vacant, Minority Professional Staff Member

                                 ------                                

SUBCOMMITTEE ON CYBERSECURITY, INFRASTRUCTURE PROTECTION, AND SECURITY 
                              TECHNOLOGIES

                Daniel E. Lungren, California, Chairman
Michael T. McCaul, Texas             Yvette D. Clarke, New York
Tim Walberg, Michigan, Vice Chair    Laura Richardson, California
Patrick Meehan, Pennsylvania         Cedric L. Richmond, Louisiana
Billy Long, Missouri                 William R. Keating, Massachusetts
Tom Marino, Pennsylvania             Bennie G. Thompson, Mississippi 
Peter T. King, New York (Ex              (Ex Officio)
    Officio)
                    Coley C. O'Brien, Staff Director
                 Zachary D. Harris, Subcommittee Clerk
        Chris Schepis, Minority Senior 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.....................     1
The Honorable Laura Richardson, a Representative in Congress From 
  the State of California, and Ranking Member, Subcommittee on 
  Emergency Preparedness, Response, and Communications...........     3
The Honorable Daniel E. Lungren, a Representative in Congress 
  From the State of California, and Chairman, Subcommittee on 
  Cybersecurity, Infrastructure Protection, and Security 
  Technologies...................................................     4
The Honorable Yvette D. Clarke, a Representative in Congress From 
  the State of New York, and Ranking Member, Subcommittee on 
  Cybersecurity, Infrastructure Protection, and Security 
  Technologies...................................................     6
The Honorable Bennie G. Thompson, a Representative in Congress 
  From the State of Mississippi, and Ranking Member, Committee on 
  Homeland Security:
  Prepared Statement.............................................     8

                               Witnesses

Dr. Alexander G. Garza, M.D., MPH, Assistant Secretary for Health 
  Affairs, Chief Medical Officer, U.S. Department of Homeland 
  Security:
  Oral Statement.................................................     9
  Prepared Statement.............................................    10
Mr. Rafael Borras, Under Secretary for Management, U.S. 
  Department of Homeland Security:
  Oral Statement.................................................    12
  Prepared Statement.............................................    14
Mr. William O. Jenkins, Jr., Director, Homeland Security and 
  Justice Issues, Government Accountability Office:
  Oral Statement.................................................    15
  Prepared Statement.............................................    17
Ms. Frances Phillips, Deputy Secretary, Public Health Services, 
  Department of Health and Mental Hygiene, State of Maryland:
  Oral Statement.................................................    25
  Prepared Statement.............................................    27

                                Appendix

Questions From Chairman Gus M. Bilirakis for Alexander G. Garza..    39
Questions From Chairman Daniel E. Lungren for Alexander G. Garza.    40
Questions From Chairman Gus M. Bilirakis for Rafael Borras.......    40

 
   BIOWATCH PRESENT AND FUTURE: MEETING MISSION NEEDS FOR EFFECTIVE 
                            BIOSURVEILLANCE?

                              ----------                              


                      Thursday, September 13, 2012

     U.S. House of Representatives,        
      Committee on Homeland Security,      
   Subcommittee on Emergency Preparedness, 
          Response, and Communications, and
     Subcommittee on Cybersecurity, Infrastructure 
             Protection, and Security Technologies,
                                            Washington, DC.
    The subcommittees met, pursuant to call, at 3:14 p.m., in 
Room 311, Cannon House Office Building, Hon. Gus M. Bilirakis 
[Chairman of the Subcommittee on Emergency Preparedness, 
Response, and Communications] presiding.
    Present: Representatives Bilirakis, Lungren, Marino, Clarke 
of New York, and Richardson.
    Mr. Bilirakis. Good afternoon. The joint hearing of the 
Committee on Homeland Security Subcommittee on Emergency 
Preparedness, Response, and Communications and the Subcommittee 
on Cybersecurity, Infrastructure Protection, and Security 
Technologies will come to order.
    The subcommittees are meeting today to receive testimony on 
the Department of Homeland Security's biosurveillance efforts 
and particularly the BioWatch program.
    I now recognize myself for my own statement.
    Established in 2003 in the wake of the anthrax attacks that 
killed five people, the BioWatch program was the first 
Nationally-deployed system designed to detect an aerosol attack 
with anthrax and other agents of bioterrorism. Now very near 
the 11th, of course the 11th anniversary of the attacks that 
prompted the program's development, it is time to take a step 
back and ask what Gen-2 has accomplished for us, what it has 
not achieved, and how we can better understand its relevancy to 
an overall biodetection architecture that must be dynamic and 
capable of meeting evolving threats.
    BioWatch is currently in its second generation known as 
Gen-2, and accounts for the vast majority of the budget at the 
Office of Health Affairs.
    The Department of Homeland Security is currently in the 
process of testing technology for a third generation of 
BioWatch known as Gen-3. Gen-3 would be a lab in the box, 
eliminating the need for daily collection of samples, and, if 
successfully implemented, the detection time could be reduced 
from the current 12 to 36 hours down to 4 to 6 hours. This goal 
is certainly laudable; however, Chairman Lungren and I have 
expressed serious concerns about the status of this 
acquisition.
    One of the many important functions of the Congress is to 
ensure we avoid and eliminate wasteful spending. This becomes 
even more vital in the difficult times, of course, that we are 
currently facing. Yet I am concerned that without corrective 
action, we may be heading down a path at DHS with a Gen-3 
procurement that we have been down before, and with the 
potential life-cycle costs of $5.8 billion, among the most 
costly DHS acquisitions; we cannot afford to fail.
    Over the course of its existence, DHS has seen a number of 
failed large-scale acquisitions, be it through a failure to 
conduct an analysis of alternative or cost-benefit analysis or 
to adequately define requirements. We must ensure that BioWatch 
does not go down the way of SBInet or the ASP program. However, 
I am concerned that DHS is not taking appropriate steps to 
ensure the success of 
Gen-3. As the GAO notes in its report, without a systematic 
effort to justify the need for the acquisition and the control 
of its costs, benefits, and risks, DHS has pursued goals and 
requirements for 
Gen-3 with limited assurance that they represent an optimal 
solution.
    I am pleased our subcommittees could convene today to 
consider the future of BioWatch, and particularly the findings 
of GAO's report as it pertains to Gen-3.
    Chairman Lungren and I have posed numerous questions to the 
Department about the Gen-3 procurement, but have not received 
satisfactory responses. How can we proceed with procurement of 
a new system when we don't fully understand the capabilities of 
the current system? Where is the cost-benefit analysis that 
proves that this generation system will be sufficient--would be 
of sufficient improvement over the existing system? Where is 
the analysis of alternatives that says that BioWatch 3 is the 
answer versus improving the Gen-2 system or investing in 
improved performance and data integration? How is it possible 
that the Department is down to only one single competitor when 
we know, without a doubt, that many engineering and 
biotechnology companies are making biodetectors for the 
Department of Defense and even for DHS itself?
    I am hopeful that our witnesses will provide us with 
answers to these and other important questions about the future 
of this program today.
    It is also important to recognize that BioWatch is one 
component of an overall biosurveillance architecture which must 
be multifaceted in order to be successful. I look forward to 
hearing from Dr. Garza on recent developments with OHA's other 
biosurveillance initiatives and how they will help us achieve 
true situational awareness to the greatest extent possible.
    We all want to ensure our Nation has a comprehensive 
biosurveillance capability in place; however, we must be smart 
about how we accomplish this goal. We must ensure that the 
development and procurement of the next generation of BioWatch 
is based on sound science, we are getting an appropriate return 
on our investment, and that we do not lose sight of the greater 
goal by harnessing all our resources toward one single and 
static technology.
    With that, I welcome our witnesses, and I look forward to 
your testimony and working with you to ensure we have an 
effective program in place.
    The Chairman now recognizes the Ranking Member on the 
Subcommittee on Emergency Preparedness, Response, and 
Communications, the gentle lady from California, Ms. 
Richardson. You are recognized for your statement.
    Ms. Richardson. Thank you. Good afternoon, our witnesses 
here today, and thank you Chairman Bilirakis and Mr. Lungren 
and Ranking Member Clarke for us all coming together on this 
very important joint hearing.
    As Ranking Member on the Subcommittee on Emergency 
Preparedness, Response, and Communications, I am committed to 
ensuring that the money allocated to make our communities safer 
and that mitigate the devastation that follows a major incident 
is carefully targeted to develop the best solutions to pressing 
capability gaps. We must ask whether, however, it is 
appropriate to invest in the potential of technologies when 
simple cost-effective solutions might suffice as well.
    In March 2008, DHS advanced its integrated planning 
guidance for year 2012 through 2014, which included specific 
criteria for the generation of the BioWatch, although the 
Department has not engaged in the process of identifying the 
capability and determining whether addressing it is worth the 
cost.
    One of the trends that has been reported that we need to 
bring clarification to today is the GAO's report, and in that 
report it appears that it has been a foregone conclusion that 
automated biodetection was the only way to make BioWatch 
technology cheaper and faster. The momentum of this acquisition 
process appears to have been driven potentially by individuals 
who were wedded to the concepts of deploying an automated 
biodetection system regardless of the increasing costs, the 
questionable benefits and the repeated delays.
    At this point we are all looking at the fact of spending 
$104 million that we have invested in developing Gen-3 that 
could have been potentially spent on local and State 
governments that could have invested the money in a very 
effective way to protect the citizens.
    It is unfortunate that we do not know who made these 
decisions or why at the time; however, continuing on a faulty 
procurement process does not seem to be most prudent for us.
    Steps in the acquisition process designed to inject thought 
and analysis into the process were completed in a cursory 
manner to speed along the process. Although I am pleased that 
the Department has agreed to partially adopt the GAO's 
recommendations and to reevaluate the mission need, and the 
alternatives and the update associated with the cost and the 
scheduled information, I am concerned that this will occur 
simultaneously while the 
Gen-3 is in the performance testing phase. Simultaneously 
conducting an analysis of alternatives while performance 
testing will allow payment for a product that the Government 
may never use.
    Finally, I am concerned that the performance testing that 
sets stage for a predetermined outcome. Now, I come from 
California, and the Los Angeles Times has been covering this 
issue pretty heavily and reported, released yesterday, marked 
an opportunity to stop and reevaluate Gen-3 and assess where 
BioWatch fits into our Federal biosurveillance efforts.
    For almost a decade now many have believed that BioWatch is 
the answer that we have sought. The Los Angeles Times has also 
reported that there have been 56 BioWatch actionable alerts 
since the program's inception; however, no jurisdiction has 
ever initiated the distribution of the countermeasures as a 
result.
    Although I understand that the BioWatch program office has 
improved with its guidance, and I want to commend Dr. Garza for 
your work, and you have always been here, and have faced the 
music, and answered the questions and made the commitments to 
address the concerns of this committee, so that has been a part 
of the process that we have witnessed, although we are still 
concerned and remain concerned of the continuation of this 
program.
    I look forward to the testimony of all the witnesses today, 
and above all we have to remember in all times, even these 
tough times, that it is our ultimate responsibility to make 
sure that the scarce resources that we have available are spent 
appropriately.
    With that I yield back the balance of my time.
    Mr. Bilirakis. Thank you very much.
    The Chairman now recognizes the Chairman of the 
Subcommittee on Cybersecurity, Infrastructure Protection, and 
Security Technology, the gentleman from California, Mr. 
Lungren.
    Mr. Lungren. Thank you very much, Mr. Chairman.
    In just a few weeks, as you suggested, we do mark the 11th 
anniversary of the anthrax attacks. Since that difficult time, 
initiatives ranging from screening the mail to monitoring the 
environment, to integrating National biosurveillance efforts 
have been undertaken in a vigorous effort to identify the 
presence of harmful infectious agents. But after 11 years of 
refining our detection technology and fostering information-
sharing partnerships, the question remains: Have we improved 
our capability substantially to identify and respond to a 
biological attack?
    Today it is our purpose to examine the Department of 
Homeland Security's BioWatch program and how effective it has 
been in countering the biothreat. As my colleague Chairman 
Bilirakis has indicated, we need to put this program in proper 
perspective. We know from our oversight and from lots of good 
work from the GAO, the DHS, other Federal agencies, and States 
and localities have taken many steps to improve 
biosurveillance. But truly integrated surveillance remains to 
be achieved.
    Efforts to establish a working National biosurveillance and 
integration center, while not without flaws, however, have at 
least demonstrated where some of our capability gaps remain. 
The problems are not intractable, nor do I suggest that they 
are.
    What is necessary is a well-thought-out architecture that 
balances the contributions of static and dynamic sensors. Many 
good ideas, some in the research phase, some being piloted, 
some operational, are already making positive contributions. 
Astute physicians and advanced patient-side diagnostics may 
play an important role far earlier in the wake of an attack 
than that for which they are commonly given credit.
    The DHS Science and Technology Directorate is working on a 
number of advanced biodetection efforts, and we hope to hear 
from our witnesses how these might complement our efforts to 
automate BioWatch. We have heard over the years from many 
constituencies about the successes and challenges of the 
deployed BioWatch system Generation 2. The good news is that 
through this program, many U.S. localities have been able to 
partner with their Federal Government and with each other to 
enhance their biosurveillance capabilities.
    BioWatch, in fact, depends on the very important 
contributions from State and local public health laboratories, 
and their service to this program is essential, and for that 
and we thank them. But the Gen-2 system has its deficiencies, 
and I look forward to hearing from Dr. Garza about the 
Department's plan to mitigate them.
    To meet some of Gen-2's lack of capacity, OHA has proposed 
BioWatch Generation 3, an advanced automated detection system 
undergoing DHS acquisition.
    The GAO, at least from the written testimony that I have 
perused, will tell us today that DHS did not fully develop 
critical information for decision making on this major 
acquisition, with life-cycle cost estimates now approaching $6 
billion.
    As has been mentioned, delays now put full deployment, if 
approved, as I understand it, at the year 2022. If 
biosurveillance is such an urgent need, do we need more to 
ensure that we are not going to wait for 10 more years to 
improve the program?
    Those are some of the questions I have got. I look forward 
to hearing from our witnesses as to what we can do now to make 
us more secure from the biothreat.
    GAO has offered several recommendations for how DHS can 
self-correct this acquisition. DHS agreed with GAO's 
recommendations and plans to implement them, but is 
nevertheless pushing forward with the acquisition process to 
avoid further delays. I understand both sides of that equation, 
but it will be interesting to see how you address those. My 
concern is not the delays, but whether multiple acquisition 
weaknesses identified by our committee's oversight hearings 
have been addressed, and whether this very expensive 
acquisition will be properly handled.
    We have already spent $100 million on Gen-3, and even in 
Washington that is a lot of money. The House has not provided 
funds for fiscal year 2013. If we support this program, we have 
to just justify to our colleagues as to why we should continue 
to fund it in substantial ways. Shouldn't an acquisition of 
this size have a cost-benefit analysis at the very least to 
justify in our minds going forward? But we also have the burden 
as this committee to convince our colleagues that there is a 
cost-benefit analysis that justifies it.
    We also need to understand all the opportunities to protect 
human life from bioattack before we adopt a specific path 
forward. We can only do this with a thorough analysis of 
alternatives, which should include proposals to refine and 
improve the Gen-2 system--as least this is my thought--before 
pushing forward to the next generation.
    Rapid post-event detection is unquestionably critical, but 
clearly we need to refine our focus on defining the problem and 
then determining the total architecture, from hardware to 
software to the human element, that can best meet the 
challenge. I would like to see a truly open competition where 
all the bright minds in small business, big industry, our 
National labs, all of them come together to meet the challenge.
    So I look forward to the testimony. We were going to start 
at 3 o'clock. We were interrupted by votes. Unfortunately for 
me I have other things that I have got to meet as well, so I 
will remain here as long as possible, but I will assure you 
that we will go over with a fine-tooth comb your written and 
your oral presentation. So I thank you.
    Mr. Bilirakis. The Chairman now recognizes the Ranking 
Member of the Subcommittee on Cybersecurity, Infrastructure 
Protection, and Security Technologies, the gentlewoman from New 
York Ms. Clarke. You are recognized for your statement.
    Ms. Clarke of New York. Thank you very much, Mr. Chairman, 
and good afternoon to you, Ranking Member Richardson, and of 
course to Chairman Lungren, and thank you for holding this 
hearing on our efforts to assess the BioWatch program.
    I would like to also acknowledge and thank today's 
witnesses for being here to testify before us today.
    The Nation's capacity to respond to bioterrorism depends in 
part on the ability of clinicians and public health officials 
to detect, manage, and communicate during a bioterrorism event. 
Information technologies and decision support systems have the 
potential to aid clinicians and public health officials to 
respond effectively to a bioterrorist attack. The information 
that public health officials require to prepare for and respond 
to a bioterrorism event can be considered in relation to the 
decisions they must make, the interpretation of the 
surveillance data, the investigation of outbreaks, the 
institution of epidemiologic control measures, and the issuance 
of surveillance alerts.
    If we are going to do detection systems right, there are 
capabilities we must have: Portability, a large number of 
samples that can be run simultaneously, a large number of 
biothreat agents that can be identified, and whether both 
toxins or organisms can be identified. As we have seen from 
previous efforts, these capabilities are not easy to achieve.
    It seems clear that the private sector does not yet assess 
or possess the technological expertise necessary to produce 
next and future generation versions of BioWatch. I believe it 
makes sense that DHS S&T should resume responsibilities for the 
R&D required. It has become clear that OHA is not, nor was it 
ever, envisioned by Congress to be an R&D organization.
    BioWatch contract management has historically been 
problematic, but it has been difficult determining exactly why. 
What is clear is that OHA has had to put a stop to Gen-2.5 and 
now Gen-3.0, but well after a lot of money has been spent. Too 
much money being spent should be an indicator to managers that 
there is something wrong. It is also not clear to me why the 
management directorate did not step in earlier.
    Let me put a little historical perspective on this issue. 
Years ago OHA handled the interface with the State and local 
public health labs that house BioWatch-related activities 
poorly. OHA leadership recognized this and made some positive 
changes. The relationships have improved since then, with money 
going into the States and locals just recently. However, as 
recent media stories and previous testimony have indicated, no 
one has very much faith in the BioWatch system even as it 
stands right now, including the public health lab directors.
    There is a question as to whether OHA or S&T have been 
keeping up with the technology changes used by other agencies. 
For example, why is the Secret Service using different 
biological-sensor technology than BioWatch? Where is DOD with 
their continued development of biological sensors, and how, if 
at all, is that information being shared with DHS or anyone 
else?
    Importantly, the majority of OHA's budget goes to NBIC and 
BioWatch. If funding were to be cut for NBIC and BioWatch, and 
funds for R&D were to be given back to S&T, then there wouldn't 
be that much left for whatever else OHA does.
    From an oversight perspective, one has to ask whether what 
is left at OHA would constitute an entire office at DHS with 
its own assistant secretary and staff. As I remember, the 
original model for OHA was just the chief medical officer, one 
person, with two other people assisting. GAO has noted on a 
number of occasions in assessing contractors in the workforce 
and DHS that use of contractors to perform certain functions 
can place the Government at risk of transferring Government 
responsibilities to contractors, and potentially results in the 
loss of Government control over and accountability for policy 
and program decisions.
    In its latest findings, GAO told DHS to stop BioWatch in 
its tracks, and reevaluate the mission need and alternatives, 
and develop performance schedule and cost information in 
accordance with guidance and good acquisition practices. That 
is about as blunt as you can get.
    Is it true that DHS plans to proceed with the acquisition 
of 
Gen-3 while implementing acquisition and performance guidelines 
to avoid further delay? I hope we will find out today.
    GAO believes the recommendation should be enacted before 
DHS proceeds with the acquisition as discussed in this report, 
and I agree with GAO.
    The Secretary should be more involved in this problem. 
There are substantial sums of taxpayer money, over $5 billion, 
at stake here, and a huge amount of the money already spent to 
no productive end. My colleagues on our two subcommittees have 
written the Secretary in detail about our concerns with this 
program. DHS should act now, follow GAO's recommendations, and 
with haste.
    With that, Mr. Chairman, I yield back.
    Mr. Bilirakis. Thank you, Ms. Clarke. I appreciate it very 
much.
    I am pleased to welcome our distinguished panel of 
witnesses at this time. Our first witness is Dr. Alexander 
Garza. Dr. Garza is the assistant secretary for health 
affairs----
    Ms. Clarke of New York. Excuse me. I am sorry, Mr. 
Chairman.
    Mr. Bilirakis. You are recognized.
    Ms. Clarke of New York. Thank you so much, Mr. Chairman.
    I wanted to ask unanimous consent to submit for the record 
the testimony statement of Ranking Member Thompson.
    Mr. Bilirakis. Without objection, so ordered.
    Ms. Clarke of New York. Thank you, Mr. Chairman.
    [The statement of Mr. Thompson follows:]
             Statement of Ranking Member Bennie G. Thompson
                           September 13, 2012
    As many of us remember, one week after the September 11 attacks, 
the Nation was subjected to anthrax attacks. Envelopes containing a 
powder laced with anthrax spores were delivered in the mail and were 
directed at Capitol Hill offices and various media outlets. These 
poisoned envelopes killed 5 people and infected 17 others. According to 
the FBI, the ensuing investigation became ``one of the largest and most 
complex in the history of law enforcement.''
    The legislative response to these attacks was to enact a measure 
that would provide an early warning system to detect the release of 
harmful biological or chemical compounds in our major cities. We called 
the program BioShield. Eleven years and $800 million dollars later, the 
program is called BioWatch. Eleven years and $800 million dollars 
later, we still do not have an early warning system that can quickly 
and efficiently detect the release of a harmful biological or chemical 
compound in our major cities. Eleven years and $800 million dollars 
later, it is time to reconsider the likelihood of the risk and adjust 
our priorities.
    Although today's hearing is about Generation 3 of BioWatch, I 
wanted to provide the historical context of this program because we 
must understand that we are on Generation 3 because Generations 1 and 2 
did not work. The technological component of this program, which 
originally began in 2003, has suffered from poor planning, poor 
execution, and poor performance throughout its life cycle.
    We should seriously consider whether the technology Congress 
envisioned is capable of being produced. It seems that the answer is--
not yet. GAO recommends that before continuing with the acquisition, 
DHS reevaluate the mission need, investigate alternatives and develop 
performance, schedule, and cost information. Given the history of this 
program and the $800 million that has been spent, GAO's recommendations 
seem reasonable and sound.
    I urge DHS to reconsider its plan to proceed with the acquisition. 
Before yielding back, I want to make note that not all of BioWatch 
should be reconsidered. It is my understanding that the program has 
strengthened interactions and partnerships between the Federal, State, 
and local public health community. The increased interaction and 
information sharing that has come about as a result of those 
relationships will serve this Nation well. We know that those 
relationships were important a few years ago when we were concerned 
about a flu pandemic.
    The interaction among the public health sector helped this Nation 
quickly mobilize, take preventive action, and provide precautionary 
vaccines to millions of people. So Mr. Chairman, whatever the fate of 
Biowatch, I think we all benefit by continuing to provide grants and 
other incentives for the public health community to work together.

    Mr. Bilirakis. Dr. Garza is the assistant secretary for 
health affairs and chief medical officer of the Department of 
Homeland Security.
    Following Dr. Garza we will hear from Mr. Rafael Borras, 
and he is the under secretary for management at the Department 
of Homeland Security, a position he has held since April 2010.
    Next we will hear the testimony from Mr. William Jenkins. 
Mr. Jenkins is director of homeland security and justice issues 
at the United States Government Accountability Office.
    Finally, we will hear--we will receive testimony from Ms. 
Frances Phillips. Ms. Phillips is the deputy secretary for 
public health services for the Maryland Department of Health 
and Mental Hygiene, a position she has held since December 
2008.
    I want to welcome the witnesses. Your entire written 
statements will appear in the record. I ask that you summarize 
your testimony for 5 minutes. We will begin with Dr. Garza.
    Welcome, sir. Thank you. You are recognized.

STATEMENT OF ALEXANDER G. GARZA, M.D., MPH, ASSISTANT SECRETARY 
 FOR HEALTH AFFAIRS, CHIEF MEDICAL OFFICER, U.S. DEPARTMENT OF 
                       HOMELAND SECURITY

    Dr. Garza. Thank you, Chairmen Bilirakis, Lungren, Ranking 
Members Richardson and Clarke, and distinguished Members, thank 
you for inviting me to speak with you today. I appreciate the 
opportunity to update you on the Office of Health Affairs 
BioWatch program, and I am honored to testify with Under 
Secretary Borras, Director Jenkins, and Ms. Phillips.
    Terrorism continues to be a threat to our Nation, including 
the use of biological organisms as a means. In fact, in a 
recent publication by a known terrorist organization, it was 
stated that the use of poisons or chemical-biological weapons 
against population centers is allowed and is strongly 
recommended due to its great effect on the enemy.
    Recent events also demonstrate the potential lethality and 
complexities of response to biological agents. Just last month 
in a small village in Russia, 14 people were hospitalized and 1 
person died from an outbreak of anthrax. Local authorities 
declared a state of emergency, quarantined the area, and began 
vaccinating people and animals, but only after people were sick 
and dead.
    We also know that with rapid advances in biotechnology and 
life sciences, the barrier to successfully using biological 
agents as a method of terrorism has never been lower.
    Though the risk of using biological agents is constantly 
shifting and evolving, one thing is clear: BioWatch has the 
potential to provide early warning to public health officials 
before sick and dying people show up in the emergency 
department. It complements public health surveillance systems 
and ultimately can save lives.
    As you know, BioWatch is the Nation's only Federally-
managed, locally-operated Nation-wide biosurveillance system 
designed to detect select aerosolized biological agents. The 
system is collaborative. It is an effort across all levels of 
government, supported by a Nation-wide network of lab 
personnel, local public health officials, responders, and 
Federal partners.
    The program's current capabilities consist of air 
collectors with a filter that requires manual retrieval and 
analysis at a local public health lab. If the analysis 
indicates that a filter contains DNA from an organism of 
concern, the local lab director declares a BioWatch Actionable 
Result, or a BAR.
    Now, allow me to clarify some misconceptions about what a 
BAR means. It is a detection of targeted DNA. It has never been 
promoted nor described as a declaration of a bioterrorist 
attack. Humans decide what is an act of terrorism, not 
machines. Furthermore, a BAR does not dictate any public 
action. It is a piece of data.
    While the current BioWatch system is extremely beneficial, 
as you mentioned, it is resource-intensive, and the results may 
not be readily available. This is time that is required to 
deploy medical countermeasures. It is clear that technology 
needs to improve if we are ever to defeat the tyranny of time 
imposed by these agents. This is consistent with the 
President's National Strategy For Biosurveillance, which 
states, ``Rapid detection and enhanced situational awareness 
are critical to saving lives and improving incident outcome.''
    Automated biodetection eliminates the need for manual 
filter retrieval, can provide continuous sample collection and 
analysis, and have results transmitted virtually to public 
health officials. These capability improvements are encompassed 
in the next generation of biological detectors known as 
Generation 3, or Gen-3. All told, this automated detection 
technology holds the promise of reducing the detection from the 
current 12 to 36 hours to 4 to 6.
    What I am describing here is a game-changer. Moving from 
manual retrieval and analysis to essentially a lab in a box 
would bring DHS and National security to the leading edge of 
detection technology. This type of leading-edge technology 
demands a complex and agile strategy that can accommodate 
iterative improvements while ensuring that rigorous performance 
standards are met. This is exactly how we approach this 
acquisition.
    Phase 1 testing for Gen-3 acquisition was completed in June 
2011 and assessed the maturity and technical capability of the 
biotechnology market, including assay and field testing.
    Besides the technical work, BioWatch continues to make 
certain that Generation 3 acquisition is consistent with 
Department directives. DHS concurs with the two GAO 
recommendations, and we are moving forward in a manner that 
ensures best practice compliance. Where we differ on is the 
execution. To that end, Under Secretary Borras chaired a 
meeting of the Acquisition Review Board for Generation 3 
acquisition on August 16, where the release of solicitation for 
an analysis of alternatives including a cost-benefit study and 
a request for proposals for performance testing was 
conditionally approved.
    In addition, OHA will deliver required acquisition 
documents for approval and meet again with the ARB before 
awarding of performance contracts.
    I appreciate this subcommittee's interest in BioWatch and 
Generation 3 acquisition and your continued partnership as we 
work to improve the Nation's biosurveillance.
    Thank you for the opportunity to appear before you today, 
and I look forward to answering any questions.
    [The prepared statement of Dr. Garza follows:]
                Prepared Statement of Alexander G. Garza
                           September 13, 2012
    Chairmen Bilirakis & Lungren, and distinguished Members of the 
subcommittees: Thank you for inviting me to speak with you today. I 
appreciate the opportunity to update you on the Office of Health 
Affairs' (OHA) BioWatch Program and I'm honored to testify with Under 
Secretary Borras and my distinguished colleague from the Government 
Accountability Office.
    Bioterrorism remains a continuing threat to the security of our 
Nation. We know that terrorist organizations continue to call for 
chemical, biological, radiological, nuclear, and explosive (CBRNE) 
attacks targeting the West.
    At the same time, the rapid global development of biotechnology, 
which provides important new capabilities for industry, medicine, and 
scientific research, is also making the capability to develop 
biological weapons increasingly accessible. The threat environment is 
constantly evolving and the early detection of a biological attack, as 
supported by the BioWatch Program, is an essential part of an effective 
biodefense posture.
    As you know, the BioWatch Program is the Nation's only Federally-
managed, locally-operated Nation-wide biosurveillance 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.
    In accordance with the President's July 2012 National Strategy for 
Biosurveillance, the BioWatch Program is strengthening local 
partnerships and building capacity to improve biosurvelliance, enabling 
rapid, well-informed decision-making. BioWatch is supported by a 
network of laboratory personnel, local public health and responder 
personnel, and Federal partners including the Centers for Disease 
Control and Prevention (CDC), the Federal Bureau of Investigation, the 
Department of Defense and the Environmental Protection Agency.
    The current detection capabilities used by the BioWatch Program 
consist of outdoor aerosol collectors whose filters are manually 
retrieved for subsequent analysis in a State or county public health 
laboratory that is a member of the CDC Laboratory Response Network 
(LRN). The results are generally received 8-10 hours after sample 
delivery to the laboratory. If the analysis indicates the filter 
contains genetic material from an organism of concern, a BioWatch 
Actionable Result (BAR) is declared by the director of that public 
health laboratory or their designee. To be clear, a BAR does not mean a 
terrorist attack has occurred, a viable agent has been released, or 
that people have been exposed. Additional information is needed to 
determine if an attack has occurred and if there is a risk to public 
health. A BAR simply means that targeted DNA is present.
    Each BioWatch jurisdiction has a BioWatch Advisory Committee (BAC) 
made up of State, local, and Federal partners who operate the program 
and are responsible for leading response efforts. When a BAR has been 
declared, the BAC is informed within 1 hour and a National conference 
call is generally conducted within 2 hours. The National conference 
call brings together all the necessary State, local, and Federal 
response partners, allowing for rapid characterization of the public 
health threat, if any, and can put into motion the actions necessary to 
save lives. These actions may include deploying medical countermeasures 
or notifying hospitals to be aware of certain symptoms. An early 
warning of an attack allows exposed populations to protect themselves 
before they become acutely and critically sick, reducing symptomatic 
cases and casualties. By providing such warning for certain biological 
threat agents, the BioWatch Program complements and strengthens the 
existing public health surveillance system and allows information to be 
rapidly shared with health care providers. Such early warning may also 
empower the U.S. Government to take actions to further protect the 
country from follow-on attacks.
    Fostering preparedness is a key part of BioWatch operations. To 
this end, the BioWatch Program provides guidance documents to assist 
jurisdictions in preparing response plans and conducts exercises of the 
notification and response processes. Additionally, the BioWatch Program 
manages the National notification process and offers laboratory 
support, environmental sampling, and event modeling.
    While the current BioWatch 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. In the event of a 
bioterrorism attack, a shorter time to detect could mean thousands of 
additional lives saved. The incubation periods of biological agents 
vary, but in general, the rapid deployment of medical countermeasures 
is critical to saving as many lives as possible.
    As the National Strategy for Biosurveillance states, we must foster 
innovation to facilitate new biosurveillance activities--including new 
detection technologies. To give public health officials the timeliest 
information possible to help them make these high-consequence 
decisions, the Department of Homeland Security (DHS) determined that it 
should test the viability of developed autonomous biodetection 
technology. Congress supported this approach in the 2009 DHS 
Appropriations Act, by calling for a competitive bid process for Phase 
I of the BioWatch Generation 3 (Gen-3) acquisition.\1\ DHS implemented 
the Gen-3 acquisition, which aims to reduce the time between potential 
exposure and confirmation of a potential biological attack through 
automated detection.
---------------------------------------------------------------------------
    \1\ See pages 655-656 of the House Appropriations committee print, 
H.R. 2638; Pub. L. 110-329, which presents the final legislative text 
and explanatory statement.
---------------------------------------------------------------------------
    Automated detection will eliminate the need for manual filter 
retrieval and is intended to provide continuous collection and analysis 
of samples within the unit. The results of this automated analysis 
would be transmitted electronically to public health officials. With 
Gen-3, the time to detect could be reduced to 4-6 hours, handing back 
precious time to public health officials faced with responding to a 
potential bioterrorism event.
    Moving from the manual analysis of a filter towards what would 
essentially be a ``laboratory in a box,'' marks a true sea change, 
bringing DHS to the forefront of state-of-the-art biological detection 
technology. However, acquiring a first-of-kind technology requires a 
robust and agile acquisition strategy that can accommodate iterative 
improvements and open competition, while ensuring rigorous performance 
standards are met.
    Phase I testing for the Gen-3 acquisition, which was completed in 
June 2011, assessed the maturity and technical capability of the 
biodetection technology market against a robust set of system 
requirements. To accomplish this goal, Phase I included assay/
characterization testing and field testing of candidate Gen-3 
detectors. We are currently preparing to enter Phase II, which will 
allow us to test a small number of production-level units to ensure 
they meet performance standards. Once they do, the remainder of the 
Phase II acquisition will be a full and open competition, and vendors 
will be evaluated equally in accordance with the terms of the Request 
for Proposal (RFP).
    At the outset of the Gen-3 acquisition, OHA followed prior existing 
guidance which has since been revised as the Department has matured its 
acquisition process. I appreciate the Government Accountability 
Office's (GAO) draft report on the status of the Gen-3 acquisition and 
we are currently working to develop, revise, and update the requisite 
acquisition documentation as appropriate and in line with current 
Departmental acquisition directives. I will continue to partner with 
Under Secretary Borras to ensure we meet the rigorous standards called 
out in the Department's acquisitions directives.
    To that end, Under Secretary Borras chaired an Investment Review 
Board (IRB) meeting for the Gen-3 acquisition on August 16, 2012. The 
Acquisition Decision Authority (ADA) gave contingent approval for the 
BioWatch Program to release the solicitation for an analysis of 
alternatives (AoA) and the RFP for Gen-3 Phase II Stage 1, which 
provides for performance testing of a small number of detector units 
from each competitively-selected vendor. These next steps are 
contingent upon the BioWatch Program updating and receiving approval of 
the system's Operational Requirements Document and several other 
acquisition documents. OHA will return to the IRB prior to awarding a 
Phase II performance testing contract.
    This course of action addresses the core of GAO's recommendations 
which call for a re-evaluation of the mission need and an AoA based on 
cost-benefit and risk information, as well as updates to acquisition 
documents to consider cost-benefit and risk information. As a result of 
the guidance provided in the last IRB, we are in the process of 
updating the Mission Need Statement, commissioning an independent 
organization to conduct the AoA, which will include a cost-benefit 
analysis, and updating all the required documents to ensure they comply 
with the current Departmental guidance for acquisitions as outlined in 
Management Directive 102-01.
    I appreciate the subcommittees' oversight of the BioWatch Program 
and the 
Gen-3 acquisition as well as your continued partnership as we work to 
improve our Nation's biosurveillance. Thank you for the opportunity to 
appear before you today. I look forward to your questions.

    Mr. Bilirakis. Thank you, Dr. Garza.
    Now we will call on Secretary Borras. You are recognized 
for 5 minutes, sir.

  STATEMENT OF RAFAEL BORRAS, UNDER SECRETARY FOR MANAGEMENT, 
              U.S. DEPARTMENT OF HOMELAND SECURITY

    Mr. Borras. Thank you, Chairman Bilirakis, Chairman 
Lungren, Ranking Member Richardson, and Ranking Member Clarke, 
and other distinguished Members of the committee, I appreciate 
the opportunity to appear here today.
    I am pleased to be here with Dr. Alexander Garza, along 
with my other distinguished colleagues on this panel. While Dr. 
Garza described the history and the objectives of the BioWatch 
program, I would like to discuss with you very briefly how we 
have been maturing our acquisition and oversight procedures to 
help minimize the risk for important Department of Homeland 
Security programs, in this case specifically BioWatch Gen-3.
    As Chief Acquisition Officer for DHS, I oversee the 
policies, processes, and procedures used to acquire and oversee 
more than $18 billion of goods and services each year. I have 
focused significant attention on improving the analysis and the 
rigor for all phases of acquisition life cycle during my tenure 
from the requirements development phase through implementation. 
This includes applying a more disciplined approach and 
requiring more detail analysis before authorizing programs to 
proceed to the next phase of development and life cycle.
    The technical requirements for the BioWatch and Gen-3 
technology are highly specialized and complex. I am pleased 
that our Science and Technology Directorate is working closely 
with the Office of Health Affairs on the technical strategy for 
the third generation of BioWatch.
    The Office of Program Accountability and Risk Management, 
which reports directly to me, is also working closely with S&T 
and OHA to provide high-quality acquisition management support. 
The record of the Department's acquisition oversight for 
BioWatch 
Gen-3 is clear. Since 2009, BioWatch Gen-3 program has been 
reviewed by the Department's Acquisition Review Board five 
times. Most recently I directed the BioWatch Gen-3 program to 
refine the developmental and operational test and evaluation 
subphases based on the findings from the study conducted by the 
Government Accountability Office and an independent assessment 
commissioned by the Secretary and carried out with the Homeland 
Security Studies and Analysis Institute.
    I also gave contingent approval to release two competitive 
procurements. The first is to conduct analysis of alternatives 
to identify and document an optimal solution for the identified 
mission capability gap, and the second is to conduct a system 
performance testing that verifies attainment of technical 
performance and validates required operational effectiveness 
and suitability.
    Prior to any award of Gen-3 performance testing contract, 
the program must be reviewed again by the Acquisition Review 
Board to evaluate the results of the testing and to determine 
if the program is able to meet the revised targets of the 
program plan.
    Regarding costs, I, too, have concerns regarding the life-
cycle costs of this program and have directed the program 
leadership to develop a more credible cost estimate which 
provides an exhaustive and structured accounting of all the 
resources and associated cost elements.
    At DHS we have worked diligently to improve our acquisition 
processes, and these efforts have produced more effective 
governance and significant improvements to the future of our 
current acquisitions. The BioWatch Gen-3 program is an example 
of the application of these improved processes. I will continue 
to evaluate the risk of this program in my role as the 
Department's Chief Acquisition Officer and as the chair of the 
Acquisition Review Board, and will only provide authorization 
to proceed when pre-established criteria are met.
    While there is still much work to do, the Department has 
made significant strides to improve our acquisition and 
investment management. We are making progress. Our investment 
decisions are now more empirically driven, and qualified 
technical expertise is available to support program managers at 
each phase of the life cycle.
    Thank you again for the opportunity to testify regarding 
the improvements in our acquisition investment, and 
specifically the BioWatch Gen-3 program.
    [The prepared statement of Mr. Borras follows:]
                  Prepared Statement of Rafael Borras
                           September 13, 2012
    Chairman Bilirakis, Chairman Lungren, Ranking Member Richardson, 
Ranking Member Clarke, and other distinguished Members of the 
committees, I thank you for the opportunity to appear before you today.
    As Chief Acquisition Officer, I oversee the policies, processes, 
and procedures used to acquire and oversee over $18 billion in goods 
and services each year. During my tenure, I have focused significant 
attention on improving the analysis and rigor for all phases of the 
acquisition life cycle, from the requirements-development phase through 
implementation. This includes applying a more disciplined approach and 
requiring more detailed analysis before authorizing programs to proceed 
to the next phase of the life cycle. Historically, we have sometimes 
let urgency outweigh prudence when making investment decisions. This 
has sometimes resulted in well-documented programmatic failures.
    When I first arrived at DHS over 2 years ago, the organization was 
in the process of strengthening its acquisition policies and 
procedures. I directed our program management function to ensure any 
new procedures be steeped in established management principles and 
balance risk mitigation with the need for rapid deployment. I wanted an 
oversight process with clear and logical approval ``gateposts'' and 
business intelligence which could ``flag'' programs that were off 
track. Finally, I asked that risk be a significant factor at all 
acquisition decision events, especially at the planning phase when 
strategies are developed. While the preference is to seek ``existing'' 
technologies, I understand the Department's mission may sometimes 
require development of higher-risk, emerging technology.
    In the past year, we have solidified a vast majority of our 
policies and procedures and worked with each component so they 
understand the rigor expected for all new programs. For some existing 
programs that were not subject to the rigors of our new policies and 
procedures, we asked that they provide additional documentation before 
they could proceed to the next phase of implementation.
    Today, I am here to discuss how the Management Directorate is 
supporting the success of the BioWatch program and how our maturing 
acquisition and oversight procedures are minimizing risk.
     biowatch gen-3 investment and acquisition oversight activities
    Dr. Garza provides a detailed description of the history and 
objectives for the BioWatch program. I will, therefore, not repeat this 
information to the committee. It is clear that the program has a long 
history and its opportunity for success relies both on emerging 
technology and well-coordinated partnerships with industry, other 
Federal agencies and State/local governments. The technical 
requirements for this technology are complex and I am pleased that our 
Science and Technology (S&T) Directorate is working closely with the 
Office of Health Affairs (OHA) on the technical strategy for the third 
generation (Gen-3).
    As indicated by Dr. Garza, there have been some schedule delays in 
the acquisition of Gen-3 technology for the BioWatch program because 
earlier generations were governed by outdated, less rigorous standards. 
I am confident that our technical, acquisition, and oversight 
environments are sufficiently settled so future generations of BioWatch 
equipment will be well-supported.
    S&T is in a unique position to evaluate new and emerging 
technologies against capability gaps, which will increase technological 
expertise and assist the Department in making better technology ``buy'' 
decisions. S&T and OHA are working closely to pursue this highly 
specialized detection technology while the Office of Program 
Accountability and Risk Management (PARM), which reports directly to 
me, is positioned to offer high-quality acquisition management support.
    In October 2009, the Deputy Secretary led an Acquisition Review 
Board to review its Phase 1 testing, which resulted in authorization 
for the program to proceed; however, OHA was required to provide a 
quarterly report to the Deputy Secretary and to my predecessor. The 
July 2010, program review examined initial performance of the BioWatch 
Gen-3 Assay Evaluation Test and resulted in the authorization to 
execute the remainder of the BioWatch Gen-3 Phase 1 test events.
    I conducted program reviews of BioWatch in December 2010, April 
2011, and August 2012. The first Acquisition Review Board was a program 
review focused on challenges with BioWatch Gen-3 testing, which 
highlighted vendor failure during Phase I testing. The April 2011 
review focused on the constraints of testing due to the testing 
environment in Chicago. All work under the BioWatch Gen-3 Phase I 
testing contract was completed at a cost of about $50 million. These 
reviews resulted in additional requirements for the BioWatch Gen-3 
Program, including: The development of an acquisition plan; the 
completion of program planning through development of a life-cycle cost 
estimate; the creation of a concept of operations; and the creation of 
an integrated logistics support plan. All of these requirements were 
conditions precedent to the program progressing to its next acquisition 
milestone.
    In February 2012, the program requested I convene an ARB to obtain 
approval to release the BioWatch Gen-3 Phase II performance testing 
solicitation. Since the program had not completed the conditions set 
forth in prior program reviews, the BioWatch Gen-3 request was denied. 
Both the Program Management and Cost Estimating COEs worked with 
BioWatch Gen-3 on program and cost challenges to assist them in getting 
ready for this milestone. OHA submitted the required acquisition 
documentation for the program to the Department for review in July 
2012.
    The BioWatch program presents challenging acquisition issues under 
the most optimal circumstances, but this form of acquisition is not 
unique. There are no current, active procurements for BioWatch Gen-3. 
The first and second generations are in the operations and maintenance 
phase--and were prior to my tenure--while third generation technology 
is within the acquisition life cycle and is currently working through 
technology demonstration and planning. As chair of the Acquisition 
Review Board, I will continue to monitor the progress of the program 
and will not allow Gen-3 to proceed unless it is meeting actions from 
the ADM.
    I directed the BioWatch program to refine the developmental and 
operational test and evaluation sub-phases earlier this month based 
partially on the findings from a study conducted by the Government 
Accountability Office (GAO) and an independent assessment commissioned 
by the Secretary and carried out by the Homeland Security Studies and 
Analysis Institute (HSSAI). I granted contingent approval to release 
two competitive solicitations. The first is to conduct an Analysis of 
Alternatives (AoA) and the second to conduct system performance 
testing. This is contingent upon the Chief Procurement Officer's 
approval of the Acquisition Plan and the Acquisition Review Board's 
approval of a Gen-3 Integrated Master Schedule. Prior to the award of 
the BioWatch Gen-3 performance testing contract, the program must be 
reviewed again by the ARB to determine if the program is able to meet 
the revised targets in the program plan.
                               conclusion
    DHS has worked diligently to improve its acquisition processes and 
these efforts have produced more effective governance and significant 
improvements to future and current acquisitions. The BioWatch program 
is an example of the successful application of the Department's 
improved acquisition oversight process. The program has accepted 
feedback from the Department and been open to revising strategies to 
ensure that risk is balanced against benefits. I will continue to 
evaluate the risk of this program in my role as the Department's Chief 
Acquisition Officer and will only provide authorization to proceed when 
pre-established criteria are met.
    While there is still much work to do, the Department has made 
significant strides to improve acquisition and investment management 
for the Department's portfolio of major programs. I believe we are 
making progress to shifting the paradigm so investment decisions are 
more empirically driven and there is qualified technical expertise to 
support program managers at each phase of the life cycle.

    Mr. Bilirakis. Thank you, Secretary Borras.
    Now we will recognize Mr. Jenkins for 5 minutes.

   STATEMENT OF WILLIAM O. JENKINS, JR., DIRECTOR, HOMELAND 
 SECURITY AND JUSTICE ISSUES, GOVERNMENT ACCOUNTABILITY OFFICE

    Mr. Jenkins. Chairmen Bilirakis and Lungren, Ranking 
Members Richardson and Clarke, and other distinguished Members 
of the subcommittee, I appreciate the opportunity to be here 
today to discuss our work on biosurveillance generally and 
specifically on our report on BioWatch released yesterday.
    A large-scale biological event, such as a terrorist attack 
with a deadly pathogen or a naturally-occurring pandemic, could 
result in hundreds of thousands of casualties and have 
devastating effects on the Nation. Recognizing that a 
bioterrorist attack could be difficult to prevent, attention 
has been focused on biosurveillance; that is, the ability to 
quickly detect and characterize a biological attack or the 
emergence and spread of a deadly infectious disease.
    The new National Biosurveillance Strategy states that the 
goal of biosurveillance is to achieve a well-integrated 
National enterprise that saves lives by providing essential 
information for better decision making at all levels. Reliable 
early detection is a key component of effective 
biosurveillance, which includes a wide variety of programs and 
activities by Federal, State, and local governments, hospitals, 
doctors, and others.
    Determining how much to invest in what program requires an 
objective assessment of the key capabilities each activity or 
program is intended to address. Gen-3's estimated life-cycle 
costs, some $5.8 billion, makes it one of the largest DHS 
acquisitions, and the question is whether it justifies that 
level of investment.
    DHS has developed a sound formal acquisition process, but 
the BioWatch program has not fulfilled some of the key 
requirements of the first two phases of the process. These two 
phases are intended to: No. 1, conduct an analysis that 
identifies the capability gap or other mission need and why 
that need warrants the investment of resources. This results in 
a mission needs statement; No. 2, select an optimal solution to 
meet the mission need by evaluating viable alternatives based 
on cost, benefits, and risk. The result is an analysis 
alternatives document.
    Abbreviated forms of both these analyses were completed on 
an expedited basis in 2009, but neither met the requirements of 
the DHS acquisition life cycle framework.
    First, the mission needs analysis. The purpose of the 
mission needs statement is to identify a need, not to specify a 
solution for meeting that need. In March 2008, the Secretary of 
DHS issued the DHS Integrated Planning Guidance, which sets 
specific goals for BioWatch that are still the basic Gen-3 
goals: Develop a lab in a box, reduce costs by more than 50 
percent, and shorten notification times to 6 hours or less. The 
October 2009 mission needs statement basically reiterated those 
specific goals. We interviewed multiple officials in various 
DHS offices who had knowledge of the process used to justify 
the need for Gen-3. None could describe the processes, if any, 
DHS followed to determine that need. Rather, we were told that 
there was a departmental consensus that automated detection was 
needed and could save lives.
    Second, the analysis of alternatives is intended to 
identify the best solutions to meet the approved need. The 2009 
analysis for BioWatch did not reflect a systematic effort to 
identify an optimal solution based on cost-benefit and risk 
information. It fell short in three areas.
    No. 1, it considered only two alternatives, Gen-2 with more 
frequent filter collection and Gen-3. The DHS guidance calls 
for a minimum of three alternatives.
    No. 2, it used only one cost metric, cost per detection 
cycle, that favored Gen-3.
    No. 3, it contained no analysis of benefits. Rather, it 
assumed that earlier detection would save lives and limit 
economic losses, a basic benefit of all biosurveillance efforts 
worthy of investment.
    The Gen-3 program is pushing the frontiers of technology, 
and experience has shown that such programs often encounter 
unexpected difficulties, delays, and cost increases. Given the 
growing cost of BioWatch and the fact that estimated full 
deployment is almost a decade away, it would be prudent to step 
back and conduct a careful mission needs analysis and an 
independent analysis of alternatives to meet the defined need. 
The results of those analyses may still lead to Gen-3, but they 
may not.
    Because the current 2000 missions needs statement 
presupposes the need for Gen-3, we are concerned that an 
analysis of alternatives based on that needs statement would be 
unlikely to foster alternatives much different from Gen-3. We 
appreciate that DHS, in its response to our recommendations, is 
willing to reevaluate Gen-3, but it appears somewhat 
contradictory to us to do so at the same time it is issuing a 
contract solicitation and considering proposals to move to the 
next phase of Gen-3 testing.
    That concludes my statement, Mr. Chairman. I would be 
pleased to respond to any questions you or other Members of the 
subcommittees may have.
    [The prepared statement of Mr. Jenkins follows:]
             Prepared Statement of William O. Jenkins, Jr.
                           September 13, 2012
                             gao highlights
    Highlights of GAO-12-994T, a testimony before the Subcommittees on 
Emergency Preparedness, Response, and Communications and Cybersecurity, 
Infrastructure Protection, and Security Technologies, Committee on 
Homeland Security, House of Representatives.
Why GAO Did This Study
    A catastrophic biological event could have devastating 
consequences. The U.S. Government has efforts to provide early 
detection and warning of biological threats. DHS's BioWatch, which aims 
to detect certain pathogens in the air, is one such program. DHS has 
been pursuing a third generation of BioWatch technology (Gen-3) to 
further enhance detection. GAO has published a series of reports on 
National biosurveillance efforts, including a report released today on 
DHS's efforts to acquire Gen-3. This statement discusses: (1) Prior 
biosurveillance work and related Federal efforts, (2) today's report on 
the Gen-3 acquisition, and (3) prior strategy recommendations and the 
White House's July 2012 National Strategy for Biosurveillance. This 
statement is based on GAO reports published from December 2009 to 
September 2012 and GAO's review of the National Strategy for 
Biosurveillance in relation to prior GAO recommendations for a National 
biosurveillance strategy.
What GAO Recommends
    In prior reports, GAO made biosurveillance recommendations to DHS 
and the White House Homeland Security Council. DHS concurred with prior 
recommendations. The White House did not comment. In today's report, 
GAO recommended that before continuing the Gen-3 acquisition, DHS 
reevaluate the mission need and alternatives and update associated 
performance, schedule, and cost information. DHS concurred but stated 
it plans to reevaluate the acquisition and pursue performance testing 
concurrently. We believe DHS should first develop the critical 
information we recommended.
   biosurveillance.--observations on biowatch generation-3 and other 
                            federal efforts
What GAO Found
    The Department of Homeland Security (DHS) and the White House have 
acted to strengthen biosurveillance consistent with prior GAO 
recommendations made from December 2009 through October 2011. In August 
2012, DHS issued a strategic plan for its National Biosurveillance 
Integration Center (NBIC) that officials say was written in 
coordination with Federal partners and designed to respond to GAO's 
December 2009 findings that NBIC did not have key resources to carry 
out its mission, in part due to collaboration issues it faced. In July 
2012, the White House released the National Strategy for 
Biosurveillance, which describes guiding principles, core functions, 
and enablers for strengthening biosurveillance. In June 2010, GAO 
recommended a National biosurveillance strategy to provide a unifying 
framework for building and maintaining a National biosurveillance 
capability. In October 2011, GAO also recommended the strategy account 
for the need to leverage resources and respond to challenges while 
partnering with non-Federal entities. The July 2012 strategy partially 
responds to the issues GAO called for such a strategy to address, but 
does not fully address them, as discussed below. A strategic 
implementation plan is to be published within 120 days of strategy 
issuance (October 2012), and may align the strategy more fully with the 
array of issues GAO identified.
    DHS approved the Generation-3 (Gen-3) acquisition in October 2009, 
but it did not fully engage its acquisition framework to ensure that 
the acquisition was grounded in a justified mission need and that it 
pursued an optimal solution. The performance, schedule, and cost 
expectations presented in required documents when DHS approved the 
acquisition were not developed in accordance with DHS guidance and good 
acquisition practices--like accounting for risk in schedule and cost 
estimates. Since October 2009, the estimated date for full deployment 
has been delayed from fiscal year 2016 to fiscal year 2022. The 2009 
life-cycle cost estimate--a point estimate unadjusted for risk--was 
$2.1 billion. In June 2011, DHS provided a risk-adjusted estimate at 
the 80 percent confidence level of $5.8 billion. Several steps remain 
before DHS can fully deploy Gen-3 including additional performance 
testing, operational testing, and developing location-specific 
deployment plans.
    The White House's National Strategy for Biosurveillance serves as a 
foundation for enterprise-wide efforts and begins to define mission, 
goals, and objectives, as we called for in making the June 2010 
strategy recommendation; however, the strategy does not yet offer the 
mechanism GAO recommended to identify resource and investment needs, 
including investment priorities. Accordingly, the biosurveillance 
enterprise remains without a framework to guide the systematic 
identification of risk, assessment of resources needed to address those 
risks, and the prioritization and allocation of investment across the 
entire enterprise. In recommending a National strategy, GAO recognized 
the challenges individual Federal programs and agencies face 
prioritizing resources to help ensure a coherent effort across the 
dispersed biosurveillance enterprise. Today's report on Gen-3 offers a 
timely and concrete example of this challenge--to assess the extent to 
which Gen-3 warrants the investment of scarce resources when the 
incremental value of the environmental monitoring Gen-3 offers is 
considered as part of a layered biosurveillance strategy.
    Chairmen Bilirakis and Lungren and Members of the subcommittees: I 
am pleased to have the opportunity to be here today to discuss our 
biosurveillance work, with particular focus on the Department of 
Homeland Security's (DHS) BioWatch Generation-3 (Gen-3) program.\1\ A 
catastrophic biological event, such as a terrorist attack with a weapon 
of mass destruction or a naturally-occurring pandemic, could cause 
thousands of casualties or more, weaken the economy, damage public 
morale and confidence, and threaten National security. In recent years, 
there has been an increasing awareness of the potential for biological 
agents to be used as weapons of mass destruction and of the threat of 
catastrophic effects arising from emerging strains of infectious 
disease. For example, events like the 2001 Amerithrax incident, which 
killed 5 people and sickened 17, and the global pandemic resulting from 
emergence of a novel strain of influenza in 2009, have brought 
increased attention to intentional and naturally-occurring biological 
threats.
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    \1\ The National Strategy for Biosurveillance defines 
``biosurveillance'' as the process of gathering, integrating, 
interpreting, and communicating essential information related to all-
hazards threats or disease activity affecting human, animal, or plant 
health to achieve early detection and warning, contribute to overall 
situational awareness of the health aspects of an incident, and enable 
better decision-making at all levels.
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    The U.S. Government has a long history of employing disease 
surveillance activities to help limit malady, loss of life, and 
economic impact. Traditional disease surveillance activities involve 
trained professionals engaged in monitoring, investigating, confirming, 
and reporting in an effort to further various missions including, but 
not limited to, detecting signs of pathogens in humans, animals, 
plants, food, and the environment. However, in recent years, experts 
and practitioners, reacting to an increasing awareness of the speed and 
intensity with which a biological weapon of mass destruction or highly 
pathogenic strain of emerging infectious disease could affect the 
Nation, have sought to augment traditional surveillance activities with 
biosurveillance programs and systems. DHS's BioWatch program is an 
example of such an effort. It aims to reduce the time required to 
recognize and characterize potentially catastrophic aerosolized attacks 
by detecting the presence of five biological agents--considered to be 
at a high risk for weaponized attack--in the air.
    The currently deployed BioWatch technology--Generation-2 (Gen-2)--
can take 12 to 36 hours to confirm the presence of pathogens. DHS has 
been pursuing Gen-3 with the goal of implementing a system that will 
perform automated testing, potentially generating a result in under 6 
hours and eliminating certain labor costs. Expressing questions about 
whether DHS had undertaken a rigorous effort to help guide its Gen-3 
decision making, two subcommittees of this committee asked us to 
examine issues related to the Gen-3 acquisition. Today, we released a 
report that evaluates the acquisition decision-making process for Gen-
3.\2\ In addition, since December 2009, we have published three other 
reports about efforts across the Federal Government and with non-
Federal partners to enhance the Nation's biosurveillance 
capabilities.\3\ This statement: (1) Describes recent Federal efforts 
that align with our biosurveillance work published from December 2009 
through October 2011, (2) discusses our Gen-3 acquisition findings, and 
(3) makes observations about our prior strategy recommendations and the 
White House's recently released National Strategy for Biosurveillance.
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    \2\ GAO, Biosurveillance: DHS Should Reevaluate Mission Need and 
Alternatives Before Proceeding With BioWatch Generation-3 Acquisition, 
GAO-12-810 (Washington, DC: Sept. 10, 2012).
    \3\ GAO, Biosurveillance: Developing a Collaboration Strategy Is 
Essential to Fostering Interagency Data and Resource Sharing, GAO-10-
171 (Washington, DC: Dec. 18, 2009); Biosurveillance: Efforts to 
Develop a National Biosurveillance Capability Need a National Strategy 
and a Designated Leader, GAO-10-645 (Washington, DC: June 30, 2010); 
and Biosurveillance: Nonfederal Capabilities Should Be Considered in 
Creating a National Biosurveillance Strategy, GAO-12-55 (Washington, 
DC: Oct. 31, 2011).
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    To describe recent Federal efforts that align with our work 
published from December 2009 through October 2011, we reviewed the 
National Biosurveillance Integration Center Strategic Plan and the 
National Strategy for Biosurveillance, and obtained information from 
DHS officials. To develop findings in the report released today about 
Gen-3, which this statement is largely based on, we reviewed DHS's 
acquisition guidance, including Acquisition Management Directive 102-
01. Additionally, we reviewed acquisition documentation and interviewed 
agency officials from the BioWatch program and other DHS offices with 
development, policy, and acquisition responsibilities. We then compared 
the information developed from our documentation review and interviews 
against the guidance. More detailed information on our scope and 
methodology appears in our published work. To make observations about 
the National Strategy for Biosurveillance, we analyzed the strategy and 
assessed its alignment with findings and recommendations about a the 
need for a National biosurveillance strategy in prior work. We 
conducted this work from August 2012 to September 2012 in accordance 
with generally accepted Government auditing standards. Those standards 
require that we plan and perform the audit to obtain sufficient, 
appropriate evidence to provide a reasonable basis for our findings and 
conclusions based on our audit objectives. We believe that the evidence 
obtained provides a reasonable basis for our findings and conclusions 
based on our audit objectives.
  dhs and the white house have taken action to enhance biosurveillance
    In December 2009, we published a report assessing DHS's efforts to 
establish the National Biosurveillance Integration Center (NBIC). We 
reported that NBIC was not fully equipped to carry out its mission 
because it lacked key resources--data and personnel--from its partner 
agencies, a situation that could be at least partially attributed to 
collaboration challenges NBIC faced. We recommended that NBIC work with 
its Federal partners to develop a strategy to enhance collaboration--
including sharing data, personnel, and other resources--and to 
establish effectiveness measures for that collaboration. DHS generally 
concurred with our findings and recommendations and stated that NBIC 
would work with its partners to develop a collaboration strategy to 
clarify both the mission space and roles and responsibilities for all 
partners.\4\ In August 2012, DHS issued the National Biosurveillance 
Integration Center Strategic Plan. According to DHS officials, the plan 
articulates a clear approach with a series of measurable steps and 
initiatives to enhance the Nation's biosurveillance capability. In late 
August 2012, when providing us with a copy of the strategy, officials 
stated that they believe it satisfies the intent of our 
recommendations. Officials said the plan was written in coordination 
with NBIC's Federal partners and is the result of a deliberative 
process examining NBIC's current capabilities and capability gaps. We 
are currently assessing the extent to which the plan fully responds to 
the recommendations.
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    \4\ GAO-10-171.
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    In June 2010, we reported on Federal efforts that support a 
National biosurveillance capability and the extent to which mechanisms 
were in place to guide the development of a National biosurveillance 
capability. We reported that a National biosurveillance capability 
would largely rely on an interagency effort because the activities and 
accompanying resources that support the capability--personnel, 
training, equipment, and systems--are dispersed across a number of 
Federal agencies. However, we found that the Federal Government did not 
have a unifying framework and structure for integrating dispersed 
capabilities and responsibilities and no Federal agency had authority 
to guide and oversee the development and implementation of a National 
effort that encompassed all stakeholders with biosurveillance 
responsibilities. We concluded that without such a framework and an 
entity with the authority, resources, time, and responsibility for 
guiding its implementation, it would be very difficult to create an 
integrated approach to building and sustaining a National 
biosurveillance capability. We recommended that the Homeland Security 
Council within the White House direct the National Security Staff to 
identify, in consultation with relevant Federal agencies, a focal point 
to lead the development of such a strategy.
    Our June 2010 report also noted that a National biosurveillance 
capability depends upon participation from State, local, and Tribal 
governments, because few of the resources required to support the 
capability are wholly owned by the Federal Government. In October 2011, 
we reported on how the Federal Government worked with its non-Federal 
partners to support biosurveillance, activities those partners 
identified as essential to their biosurveillance efforts, and 
particular challenges those partners faced. We recommended that the 
strategy we called for in June 2010 incorporate a means to leverage 
existing efforts that support non-Federal biosurveillance capabilities, 
consider challenges that non-Federal jurisdictions face, and include a 
framework to develop a baseline and gap assessment of non-Federal 
jurisdictions' biosurveillance capabilities.\5\ The White House did not 
comment on these recommendations.
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    \5\ GAO-12-55.
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    In July 2012, the White House released the National Strategy for 
Biosurveillance to describe the U.S. Government's approach to 
strengthening biosurveillance. The strategy describes guiding 
principles, core functions, and enablers for strengthening 
biosurveillance. The strategy states that its approach emphasized 
teamwork between and within Federal departments, across all layers of 
government, and with private-sector partners. A strategic 
implementation plan is to be completed within 120 days of the strategy 
issuance. The strategy does not fully meet the intent of our June 2010 
and October 2011 recommendations, as discussed later in this statement, 
but it is possible that it will when the implementation plan is 
complete.
dhs did not develop critical knowledge before proceeding with the gen-3 
                              acquisition
DHS Proceeded With the Gen-3 Acquisition Before Establishing a Mission 
        Need
    DHS approved the Gen-3 acquisition in October 2009 without fully 
developing critical knowledge that would help ensure sound investment 
decision making, pursuit of optimal solutions, and reliable 
performance, cost, and schedule information. Specifically, DHS did not 
engage the initial phase of its Acquisition Life-cycle Framework, which 
is designed to help ensure that the mission need driving the 
acquisition warrants investment of limited resources.\6\ In the 
Acquisition Life-Cycle Framework design, it is not the purpose of the 
Mission Needs Statement to specify a technical solution. Rather it is 
to serve as a touchstone for subsequent acquisition efforts by focusing 
on the capability gap to help articulate and build consensus around the 
goals and objectives for a program.
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    \6\ According to DHS officials, the Gen-3 acquisition was on-going 
when Acquisition Management Directive 102-01 was issued. The officials 
said that many DHS programs that were on-going in 2009 faced similar 
challenges. Nevertheless, DHS Management Directive 1400, which preceded 
Acquisition Management Directive 102-01, was similarly designed to, 
among other things, ensure that investments directly support and 
further DHS's missions. Like Acquisition Management Directive 102-01, 
Management Directive 1400 describes a phased life-cycle investment 
construct in which the first step is defining the mission need in a 
Mission Needs Statement. As with the Mission Need Statement called for 
in Acquisition Management Directive 102-01, the statement in Management 
Directive 1400 was to be a high-level description of a capability gap 
rather than a specific solution.
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    However, DHS began to pursue a specific autonomous detection 
solution well before completing a Mission Needs Statement. 
Specifically, DHS's Integrated Planning Guidance (IPG) for fiscal years 
2010-2014, which was finalized in March 2008, included specific goals 
for the next generation of BioWatch--to deploy in all major cities an 
autonomous BioWatch detection device reducing the operating cost per 
site by more than 50 percent and warning time to less than 6 hours. The 
purpose of DHS's IPG is to communicate the Secretary's policy and 
planning goals to component-level decision makers to inform their 
programming, budgeting, and execution activities. As such, this 
specific set of goals for BioWatch Gen-3 demonstrates that DHS 
leadership had established a course for the acquisition by March 2008, 
in advance of efforts to define the mission need through the Mission 
Needs Statement process, which was finalized more than a year and a 
half later.
    DHS officials in multiple departments described a climate, in the 
wake of the September 11, 2001, terrorist attacks and the subsequent 
Amerithrax attacks, in which the highest levels of the administration 
expressed interest in quickly deploying the early generation BioWatch 
detectors and improving their functionality--as quickly as possible--to 
allow for faster detection and an indoor capability. BioWatch officials 
stated that they were aware that the Mission Needs Statement prepared 
in October 2009 did not reflect a systematic effort to justify a 
capability need, but stated that the department directed them to 
proceed because there was already departmental consensus around the 
solution. Accordingly, the utility of the Mission Needs Statement as a 
foundation for subsequent acquisition efforts was limited.
DHS Did Not Systematically Analyze Alternatives
    Additionally, DHS did not use the processes established by its 
Acquisition Life-cycle Framework to systematically ensure that it was 
pursuing the optimal solution--based on cost, benefit, and risk--to 
mitigate the capability gap identified in the Mission Needs Statement. 
The DHS Acquisition Life-cycle Framework calls for the program office 
to develop an Analysis of Alternatives that systematically identifies 
possible alternative solutions that could satisfy the identified need, 
considers cost-benefit and risk information for each alternative, and 
finally selects the best option from among the alternatives.
    However, the Analysis of Alternatives prepared for the Gen-3 
acquisition did not reflect a systematic decision-making process. For 
example, in addition to--or perhaps reflecting--its origin in the 
predetermined solution from the Mission Needs Statement, the Analysis 
of Alternatives did not fully explore costs or consider benefits and 
risk information as part of the analysis. Instead, the Analysis of 
Alternatives focused on just one cost metric that justified the 
decision to pursue autonomous detection--cost per detection cycle--to 
the exclusion of other cost and benefit considerations that might have 
informed decision makers.\7\ Additionally, the Analysis of Alternatives 
examined only two alternatives, though the guidance calls for at least 
three. The first alternative was the currently deployed Gen-2 
technology with a modified operational model (which by definition was 
unable to meet the established goals). The second alternative was the 
complete replacement of the deployed Gen-2 program with an autonomous 
detection technology and expanded deployment.
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    \7\ Cost per detection cycle is the cost each time an autonomous 
detector tests the air for pathogens or the cost each time a Gen-2 
filter is manually collected and tested in a laboratory.
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    BioWatch program officials acknowledged that other options--
including but not limited to deploying some combination of both 
technologies, based on risk and logistical considerations--may be more 
cost-effective. As with the Mission Needs Statement, program officials 
told us that they were advised that a comprehensive Analysis of 
Alternatives would not be necessary because there was already 
departmental consensus that autonomous detection was the optimal 
solution.
    Because the Gen-3 Analysis of Alternatives did not evaluate a 
complete solution set, did not consider complete cost information, did 
not consider benefits, and did not include a cost-benefit analysis, it 
does not provide information on which to base trade-off decisions. For 
example, it does not provide information about the extent to which 
various aspects of the solution--such as the number of participating 
jurisdictions--results in a reduction of risk and at what cost. Given 
the uncertainty related to Gen-3's costs, benefits, and risk mitigation 
potential, DHS does not have reasonable assurance that the strategy of 
expanding and completely replacing the existing Gen-2 program with 
autonomous detection technology is the most cost-effective solution.
DHS Did Not Fully Develop Performance, Cost, and Schedule Information
    In October 2009, DHS approved the Gen-3 acquisition at Acquisition 
Decision Event (ADE) 2A--one of the key formal decision points in DHS's 
Acquisition Life-cycle Framework--based on information contained in 
acquisition documents provided by the BioWatch program. One critical 
purpose of the ADE-2A documentation set required by DHS's acquisition 
guidance is to describe the expected performance, cost, and schedule 
parameters for an acquisition. However, the ADE-2A Acquisition Decision 
Memorandum stated that significant data necessary for the proper 
adjudication of an ADE-2A decision were missing. Further, we reported 
that some performance, cost, and schedule expectations presented at 
ADE-2A were not developed in accordance with DHS guidance and good 
acquisition practices--like accounting for risk in schedule and cost 
estimates.
    On the basis of the Gen-3 documentation submitted at ADE-2A, DHS 
expected to acquire a system that would cost $2.1 billion, be fully 
deployed by fiscal year 2016, and meet certain performance 
requirements. However, the performance, cost, and schedule parameters 
for the Gen-3 acquisition have changed. Specifically, certain 
performance requirements have been revised, the estimated date for full 
deployment has been delayed from fiscal year 2016 to fiscal year 2022, 
and the expected life-cycle cost has changed from the $2.1 billion 
point estimate prepared for ADE-2A to a risk-adjusted $5.8 billion 
estimate, calculated at the 80 percent confidence level.\8\
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    \8\ The $2.1 billion life-cycle cost estimate (a point estimate) 
submitted at ADE-2A was the estimate used for planning purposes at the 
time. In the June 2011 Life-cycle Cost Estimate, the BioWatch program 
recommended the 80 percent confidence level for planning purposes. We 
present these estimates here in comparison because they are the two 
estimates used for planning purposes. However, it is important to note 
that June 2011 estimates at the 28 percent and 80 percent confidence 
level are risk adjusted and the 2009 point estimate is not. The point 
estimate at the 28 percent confidence level in the June 2011 Life-Cycle 
Cost Estimate was $3.8 billion. The confidence level indicates the 
probability that the actual cost will be at or below the estimate. For 
example, the June 2011 estimate of $5.8 billion conveys that (at the 
time of that estimate) the program anticipated 80 percent probability 
that the cost would be $5.8 billion or less.
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    BioWatch program officials told us that they had to prepare ADE-2A 
documentation quickly because ADE-2A had been accelerated by more than 
a year. Additionally, DHS officials from multiple offices described a 
climate around the time of ADE-2A in which the department's business 
processes--including acquisition practices--were maturing and thus were 
less rigorous in their adherence to best practices for cost and 
schedule estimating. However, in the absence of complete and reliable 
information, DHS had limited assurance that the acquisition would 
successfully deliver the intended capability within cost and on 
schedule. Comprehensive and systematic information developed using good 
practices for cost and schedule estimating could help ensure that more 
reliable performance, cost, and schedule information is available for 
future acquisition decision making.
    We recommended that before continuing the acquisition, DHS 
reevaluate the mission need and alternatives and develop performance, 
cost, and schedule information in accordance with guidance and good 
acquisition practices. DHS concurred with the recommendations but plans 
to proceed with the next step in the acquisition--performance testing--
while implementing them. We are pleased that DHS plans to implement the 
recommendation but are concerned by DHS's intention to continue the 
acquisition efforts before ensuring that it has fully developed the 
critical knowledge a comprehensive Acquisition Life-cycle Framework 
effort is designed to provide.
Several Steps Remain before Gen-3 Is Ready for Deployment
    The BioWatch program completed initial testing and evaluation on a 
Gen-3 prototype technology in June 2011, but several steps remain 
before Gen-3 can be deployed and operational.\9\ For example, the 
BioWatch program must complete additional testing. The characterization 
testing conducted in 2010 and 2011 was intended to assess the state of 
available technology. This testing sought to demonstrate the 
performance of available candidate Gen-3 technologies against the 
requirements established by the BioWatch program, and consisted 
primarily of laboratory testing of individual system components. This 
testing did not demonstrate the performance of the full system in 
detecting live pathogens in the operational environment. It also did 
not test the information technology network that will transmit results 
for public health officials. Now the program plans to conduct the next 
phase of testing--performance testing in three independent laboratories 
and operational test and evaluation in four BioWatch jurisdictions. On 
the basis of the June 2011 Life-Cycle Cost Estimate, the BioWatch 
program estimates this testing will take approximately 3 years and cost 
approximately $89 million (risk adjusted at the 80 percent confidence 
level).
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    \9\ A second candidate technology participated in two test events--
aerosol collection subsystem testing and assay evaluation--but did not 
complete all testing because the candidate system did not meet program 
requirements during the assay evaluation. Specifically, the second 
candidate technology yielded both false positives--detecting a BioWatch 
agent when none was present--and false negatives--not detecting an 
agent when one was present.
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    The Deputy Secretary of Homeland Security and other senior 
officials met on August 16, 2012 for an Acquisition Review Board, 
during which the BioWatch program was seeking approval to initiate the 
next phase of the acquisition. DHS did not make a final decision, but 
authorized release of a solicitation for performance testing under the 
next testing phase. In response to the recommendations we made in the 
Gen-3 report, DHS officials stated that before awarding a performance 
testing contract--which would allow the program to acquire a small 
number of test units--the program office is directed to return to the 
Acquisition Review Board for approval.
    Before undertaking the remaining steps in the acquisition, the 
program office is directed to return for Acquisition Decision Event-2B 
(ADE-2B)--the next formal decision point in DHS's Acquisition Life-
cycle Framework--with updated information, including an Analysis of 
Alternatives and Concept of Operations, as we recommended. No time 
frame for completing these actions has been specified, but according to 
DHS officials, it may take up to 1 year to update the Analysis of 
Alternatives. In preparation for the August 16, 2012, meeting, the 
BioWatch program had updated key acquisition documents--including the 
Life-cycle Cost Estimate and Acquisition Program Baseline--as required 
by the Acquisition Decision Authority in a February 2012 memo. However, 
in order to inform the ADE-2B decision, these documents must accurately 
reflect changes to Gen-3 performance requirements and updated cost and 
schedule estimates for the acquisition and therefore may require 
further revisions.
    If approved at ADE-2B, the BioWatch program plans to conduct 
operational testing of Gen-3 units in four BioWatch jurisdictions. 
Following operational testing, DHS intends to decide whether to 
authorize the production and deployment of Gen-3. If Gen-3 is approved, 
the BioWatch program plans to prepare for deployment by working with 
BioWatch jurisdictions to develop location-specific plans to guide Gen-
3 operations. DHS estimates based on the June 2011 Life-Cycle Cost 
Estimate show that about $5.7 billion of the $5.8 billion life-cycle 
cost (risk adjusted at the 80 percent confidence level) remains to be 
spent to test, produce, deploy, and operate 
Gen-3 through fiscal year 2028.
  observations about prior strategy recommendations and the july 2012 
                 national strategy for biosurveillance
    In the report on Gen-3 released today, we noted that beyond the 
uncertainty related to the costs and benefits of the planned Gen-3 
approach, there is additional uncertainty about the incremental benefit 
of this kind of environmental monitoring as a risk mitigation activity 
because of its relatively limited scope. As the study committee for a 
2011 National Academies evaluation of BioWatch noted, there is 
considerable uncertainty about the likelihood and magnitude of a 
biological attack, and how the risk of a release of an aerosolized 
pathogen compares with risks from other potential forms of terrorism or 
from natural diseases. The National Academies report also notes that 
while the BioWatch program is designed to detect certain biological 
agents (currently five agents) that could be intentionally released in 
aerosolized form, detecting a bioterrorism event involving other 
pathogens or routes of exposure requires other approaches.\10\
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    \10\ Institute of Medicine and National Research Council of the 
National Academies, Committee on Effectiveness of National 
Biosurveillance Systems, BioWatch and the Public Health System, 
BioWatch and Public Health Surveillance: Evaluating Systems for the 
Early Detection of Biological Threats (Washington, DC: 2011).
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    In the report we released today, we stated that given the total 
estimated operating cost for the Gen-3 program, it is important, 
especially in an increasingly resource-constrained environment, to 
consider the benefit--in terms of its ability to mitigate the 
consequences of a potentially catastrophic biological attack--that the 
investment provides. We noted that the scope limitations of this kind 
of environmental monitoring provide context in both the consideration 
of mission need and in analyzing cost-effectiveness.\11\
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    \11\ GAO-12-810.
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    However, it was not within the scope of our BioWatch Gen-3 study 
nor was it our intention to reach a firm conclusion about the value of 
this kind of activity as part of a layered biosurveillance strategy. 
Rather, we believe the need to consider value within the larger 
biosurveillance enterprise as part of an effort to define mission need 
for a single Federal program like Gen-3 provides a timely and concrete 
illustration of the kind of issues we sought to address with our June 
2010 recommendation. The recommendation for the Homeland Security 
Council to direct the National Security Staff to identify a focal point 
to lead the development of a National biosurveillance strategy was 
grounded in previous work on desirable strategy characteristics for 
complex homeland security missions. We recognized the difficulty that 
decision makers and program managers in individual Federal agencies 
face prioritizing resources to help ensure a coherent effort across a 
vast and dispersed interagency, intergovernmental, and intersectoral 
network. Therefore, we called for a strategy that would, among other 
things: (1) Define the scope and purpose of a National capability; (2) 
provide goals, objectives and activities, priorities, milestones, and 
performance measures; and (3) assess the costs and benefits and 
identify resource and investment needs, including investment 
priorities.\12\
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    \12\ GAO-10-645.
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    We stated that one of the aims of a National biosurveillance 
strategy should be to help prioritize where resources and investments 
should be targeted and guide agencies to allocate resources 
accordingly. Further, we reported that a National strategy could begin 
to address the difficult but critical issues of who pays and how 
funding for biosurveillance will be sustained in the future. Finally, 
we noted that in an environment with competing priorities, a strategy 
could help address situations where investments must be carefully 
weighed and sound judgments made about the most cost-effective 
approaches, but doing so would require information about the cost, 
benefits, and risks associated with the whole biosurveillance 
enterprise.\13\
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    \13\ GAO-10-645.
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    The National Strategy for Biosurveillance includes four guiding 
principles that are designed to serve as a foundation for enterprise-
wide efforts, four core functions that are designed to promote a 
deliberate and shared approach, and four enabling capabilities that are 
designed to represent areas for on-going focus.\14\ These planks of the 
strategy align with our call for a strategy that would help to clarify 
the scope and purpose of a National biosurveillance capability and the 
goals of that capability. Our June 2010 report described several 
categories of Federal efforts to improve the personnel, training, and 
systems and equipment that support a National capability. These 
included responding to workforce needs, facilitating information 
sharing, and applying technologies to enhance surveillance. Among the 
planks of the National Strategy for Biosurveillance, it is possible to 
discern support for each these categories. For example, the enabling 
capability called build capacity, discusses both workforce and 
information-sharing issues. The four guiding principles that serve as 
the strategy's foundation encourage broad-based and cross-cutting 
actions to leverage constrained resources, responding, in part, to our 
call for the strategy to help identify the resources currently being 
used, additional resources that may be needed, and opportunities for 
leveraging resources.
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    \14\ The guiding principles articulated in the strategy are to: (1) 
Leverage existing capabilities, (2) embrace an all-of-Nation approach, 
(3) add value for all participants, and (4) maintain a global health 
perspective. The core functions are to: (1) Scan and discern the 
environment, (2) identify and integrate essential information, (3) 
inform and alert decision makers, and (4) forecast and advise about 
potential impacts. The enablers are to: (1) Integrate capabilities, (2) 
build capacity, (3) foster innovation, and (4) strengthen partnerships.
---------------------------------------------------------------------------
    However, the strategy does not yet offer a mechanism to identify 
resource and investment needs, including investment priorities among 
these various efforts. Accordingly, the enterprise is still without a 
framework to guide the systematic identification of risk, assessment of 
resources needed to address those risks, and the prioritization and 
allocation of investment across the entire biosurveillance enterprise, 
as we recommended in June 2010. For example, in the case of the broader 
contextual information needed to inform the BioWatch Gen-3 mission 
need, the strategy has language indicating that advances in science and 
technology are a priority. In fact, the capability enabler called 
fostering innovation specifically calls for science and technology 
capabilities, including new detection approaches. However, the strategy 
does not facilitate analysis or provide tools to assess the risks to be 
addressed--in the context of enterprise-wide goals--by such science and 
technology approaches or the value they should offer the enterprise 
relative to their costs. Without such a framework and tool set, it 
remains difficult for decision makers--in both the Executive and 
Legislative branches--to help ensure that their resource allocation 
decisions contribute to a coherent enterprise-wide approach.
    We are encouraged by the National Strategy for Biosurveillance and 
the work the White House has done to date to provide a platform for 
achieving a well-integrated National biosurveillance enterprise. We are 
hopeful that the forthcoming strategic implementation plan which 
promises to include specific actions and activity scope, designated 
roles and responsibilities, and a mechanism for evaluating progress 
will help to address the on-going need for mechanisms to help 
prioritize resource allocation.
    Chairmen Bilirakis and Lungren, this concludes my prepared 
statement.
    I would be happy to respond to any questions you or the other 
committee Members may have.

    Mr. Bilirakis. Thank you very much.
    Now we will recognize Ms. Phillips for 5 minutes.

STATEMENT OF FRANCES PHILLIPS, DEPUTY SECRETARY, PUBLIC HEALTH 
  SERVICES, DEPARTMENT OF HEALTH AND MENTAL HYGIENE, STATE OF 
                            MARYLAND

    Ms. Phillips. Good afternoon, Chairmen Bilirakis and 
Lungren, Ranking Members Clarke and Richardson, and also 
distinguished Members of the subcommittee. My name is Frances 
Phillips, and I am the deputy secretary for public health from 
Maryland's Department of Health and Mental Hygiene. In that 
role I oversee public health, our public health lab, as well as 
our public health preparedness.
    I do thank you for the opportunity to speak with you on 
this important subject, which I would like to do in connection 
with Maryland's experience with regard to both the challenges 
and the benefits that we have experienced in our participation 
in the BioWatch program.
    First, I would like to express Maryland's continued support 
for the BioWatch program as an important and useful addition to 
our existing biosurveillance programs. BioWatch is still 
evolving and will continue to drive improved communications and 
foster more robust relationships as the technology develops.
    Public health, as it has been stated, has a vital role in 
the detection, response to and recovery from bioterrorism and 
emerging infectious diseases. Public health has been in the 
business of monitoring population health, detecting diseases, 
and designing and implementing interventions to mitigate 
against diseases for generations.
    With the events of September 11, 2001, and the anthrax 
attack of that year, it became clear that new tools and systems 
were needed to detect previously unimaginable events. Governor 
Martin O'Malley has been a strong supporter of expanding 
biosurveillance capabilities in Maryland. In his first 
administration he published the strategic goals for homeland 
security, and goal No. 5 sets out a vision for a State-wide 
biosurveillance system that integrates new technologies along 
with our traditional public health disease surveillance 
monitoring.
    BioWatch is one of several tools in the public health 
toolbox. In Maryland, another important tool is the electronic 
surveillance system for early notification of community-based 
epidemics. That is a mouthful; we call it ``ESSENCE.'' ESSENCE 
captures, integrates, and interprets on a daily basis 
electronic data from all of Maryland's emergency room 
departments, from over 300 pharmacies with regard to 
prescription and over-the-counter pharmaceutical sales, from 
all of our school districts with regard to student absenteeism, 
as well as the nature and volume of all calls to our poison 
control center.
    BioWatch, even with the limitations that I will mention, 
has provided benefits to the overall biosurveillance capability 
and complements tools such as ESSENCE.
    Maryland has worked with our local jurisdictions, with our 
neighboring States and various Federal agencies to collaborate 
and continuously improve on the management of BioWatch alerts. 
This collaboration has improved the evaluation of the alerts, 
has identified gaps in coordination, and resulted in enhanced 
communication and response capabilities across our region.
    In addition, the internal notification protocols at the 
State and local level have been strengthened as a result of 
evaluations after each BioWatch alert. The benefit of these 
enhanced protocols has reached across the all-hazards spectrum 
in Maryland.
    From the department's perspective, there have been 
challenges with BioWatch program. This is a program designed to 
be an early warning system. So in the instances when the 
technology produces an alert, a diverse and very expert team 
must be promptly convened in real time for interpretation and 
decision making.
    Our BioWatch response decision making requires the 
integration of our all of our biosurveillance systems along 
with environmental and seasonal data, technical considerations, 
and coordinated threat assessment input from State and local 
enforcement, law enforcement, security, and our fusion center 
partners.
    You have heard about false positives. I would like to 
mention the issue of false positives, which is a familiar 
challenge to the BioWatch program. On a few occasions in 
Maryland, we had detected--the program, the lab has detected 
gene targets from naturally-occurring microorganisms. These 
alerts are true positives in that the technology correctly 
detected presence of a select organism, but were false 
positives in that the organism was later determined to be 
naturally occurring and not a public health threat. None of 
these alerts resulted in the activation of public response; 
however, the multi-agency collaboration and applied data 
integration associated with these BioWatch alerts has enhanced 
our overall capability to respond to all manner of public 
health emergencies.
    We are maintaining an effective working relationship with 
the Department's Office of Health Affairs, and every week our 
State lab conducts hundreds--I am sorry--daily conducts 
regulated and highly-tested BioWatch filter samples. Our State 
lab has been supported in that regard by the Department with 
regard to salaries, supplies and, just recently, administrative 
expenses.
    So to conclude, biosurveillance is a core competency of 
preparedness. Using and exercising multiple systems has helped 
Maryland enhance its ability to identify and respond to a wide 
range of threats. We support continued improvement in BioWatch 
and other components of surveillance.
    Thank you for the opportunity to provide one State's 
perspective on this important issue. I would be happy to answer 
any questions you may have.
    [The prepared statement of Ms. Phillips follows:]
                 Prepared Statement of Frances Phillips
                           September 13, 2012
    Good afternoon, Chairman Bilirakis, Chairman Lungren, and 
subcommittee Members: My name is Frances Phillips. I am the Deputy 
Secretary for Public Health Services in the Maryland Department of 
Health and Mental Hygiene. In that role I oversee Public Health 
Emergency Preparedness for the Department. Thank you for giving me the 
opportunity to speak with you on this important topic. There are 
several points that I plan to speak about today, based on the 
experience that Maryland has had with the BioWatch program. I want to 
address our overall experience with BioWatch in Maryland, tell you 
about the benefits that have resulted from our participation in the 
program, and discuss some of the challenges inherent in the program.
    First, I want to express Maryland's continued support of the 
BioWatch program as an important and useful addition to existing 
biosurveillance programs. BioWatch is still evolving and will continue 
to drive improved communications and foster more robust relationships 
as the technology advances.
    Public health has a vital role in the detection, response to, and 
recovery from bioterrorism and emerging infectious diseases. Public 
health has been in the business of monitoring population health, 
detecting diseases, and designing and implementing interventions to 
mitigate the impact of resulting diseases for generations. With the 
events of September 11, 2011 and the anthrax attack of that year, it 
became clear that new tools and systems needed to be developed to 
detect previously unimagined threats. Governor Martin O'Malley has been 
a strong supporter of expanding biosurveillance capabilities within 
Maryland. In his first administration he published the Strategic Goals 
and Objectives for Homeland Security. Goal No. 5 sets out a vision for 
a State-wide biosurveillance system that integrates new technology and 
traditional public health disease surveillance systems to monitor human 
illness and sensor-based monitoring for chemical and radiological 
threats.
    BioWatch is one of the several tools in the Public Health ``tool 
box.'' Other tools include the Electronic Surveillance System for the 
Early Notification of Community-based Epidemics (ESSENCE), Maryland's 
syndromic surveillance system. ESSENCE captures, aggregates, and 
interprets electronic data reported daily by all Maryland hospitals on 
the nature and volume of emergency department visits, by over 300 
pharmacies on prescription and over-the-counter pharmaceutical sales, 
by all Maryland school districts on student absenteeism, and by the 
Maryland Poison Control Center on the nature and volume of calls.
    BioWatch, even with limitations that will be discussed later, has 
provided benefits to overall biosurveillance capability and complements 
tools such as ESSENCE. BioWatch is intended to reduce the time needed 
to identify potential incidents of covert bioterrorism. The sooner that 
exposures to dangerous pathogens are identified, the sooner 
interventions can be implemented and the rates of morbidity and 
mortality reduced. Another benefit of BioWatch is the standardization 
of sampling and testing protocols across all BioWatch areas. This 
allows for a common operating picture and ensures that National 
discussions of potential incidents are based on a shared analytical 
protocol and have a common terminology.
    Maryland has worked with local jurisdictions, neighboring States, 
and various Federal agencies to collaborate on and continuously improve 
the management of BioWatch alerts. This collaboration has improved the 
evaluation of the alerts, identified gaps in coordination, and resulted 
in enhanced communication and response capabilities across the region. 
In addition, the internal notification protocols at the State and local 
level have been strengthened as a result of evaluations after each 
BioWatch alert. The benefit of these enhanced protocols has reached 
across the all-hazards spectrum for Maryland.
    From the Department's perspective, there are also challenges with 
the BioWatch program. This program is designed to be an ``early 
warning'' system. In instances when the technology produces an alert, a 
diverse and very expert team must be promptly convened for real-time 
interpretation and response decision-making. The ensuing situational 
analysis is based on relevant data drawn from clinical, environmental, 
technical, and security intelligence. Clinical reporting systems 
include routine data reporting from sentinel laboratories as well as 
from ESSENCE. All of this data is needed to bring context to a Biowatch 
alert.
    Our BioWatch response decision-making also requires integration of 
pertinent environmental and seasonal conditions, technical 
considerations regarding signal strength, and coordinated threat 
assessment input from State and Federal law enforcement, security, and 
fusion center partners.
    Certainly, when confirmatory testing is positive, a BioWatch alert 
triggers action. Interdisciplinary consultation among a team of experts 
representing State, local, and Federal laboratorians, public health 
professionals, environmental experts, law enforcement officials, and 
emergency management officials is needed to fully assess the risk and 
to determine the appropriate protective response. Rigorous 
communication protocols have been developed and refined to direct a 
hierarchy of response communications.
    The issue of ``false positives'' is a familiar challenge to the 
BioWatch program. On a few occasions in Maryland the BioWatch system 
detected gene targets from naturally occurring microorganisms. These 
alerts were ``true positives'' in that the technology correctly 
detected the presence of a select organism, but were ``false 
positives'' in that the organism was later determined to be naturally-
occurring and not a public health threat. None of these alerts resulted 
in the activation of a public response. However, the multi-agency 
collaboration and applied data integration associated with Biowatch 
alerts and exercises enhances our overall capability to respond to all 
manner of public health emergencies.
    Maryland's Department of Health and Mental Hygiene maintains an 
effective working close relationship with the BioWatch Systems Program 
Office within the U.S. Department of Homeland Security Office of Health 
Affairs. This relationship has improved markedly over the years from 
what initially had been a very closed and top-down Federal approach to 
what is now a far more collaborative partnership. This strong State-
Federal relationship is essential to the success of BioWatch since both 
routine laboratory operations and infrequent alerts require State and 
Federal partners assume interdependent roles and responsibilities.
    Every day of the week, the Maryland State Public Health Laboratory 
conducts highly-regulated testing on filter samples delivered from 
various locations in the State. The Federal BioWatch Office has 
supported our lab's work through grants to cover a full-time lab 
scientist salary, supplies, and equipment and administrative expenses. 
This has helped us upgrade our preparedness for a wide range of 
threats.
    Our department actively participates in the Baltimore/Washington/
Richmond BioWatch Core Work Group which meets quarterly to coordinate 
planning, communications, and exercises across the greater National 
Capital Area region.
    Biosurveillance is a core component of preparedness. Using and 
exercising multiple systems has helped Maryland enhance its ability to 
identify and respond to a wide range of threats. We support continued 
improvement in BioWatch and other components of biosurveillance.
    Thank you again for the opportunity to provide one State's 
perspective on these important issues.
    That concludes my remarks. I would be happy to answer any questions 
you may have.

    Mr. Bilirakis. Thank you very much for your testimony.
    The entire panel: Thanks for your patience as well, and 
thanks for sticking to the time allotted.
    I am going to go ahead and recognize Chairman Lungren first 
for any questions he might have. You are recognized, sir, for 5 
minutes.
    Mr. Lungren. Thank you very much, Mr. Chairman, and thank 
you for that courtesy.
    Dr. Garza, you heard from Mr. Jenkins and the suggestion 
that your operation is receptive to reviewing the mission needs 
statement and doing the more vigorous approach to the 
alternatives to Gen-3, but Mr. Jenkins stated that it seemed to 
be contradictory that you would be going forward in as 
aggressive a way with letting a contract at the same time those 
two things remain in question. How would you directly respond 
to that, please?
    Dr. Garza. Yes. Thank you, Mr. Chairman. That is a very 
good question.
    So the approach that we are taking, and I will let Under 
Secretary Borras chime in on this as well, is you are 
absolutely right that we are doing all the required 
documentation for acquisitions, which is doing an effective 
AOA, a cost-benefit analysis, a mission needs statement. All of 
those things take time, and during that time period, we do not 
want to delay the performance side or the technology side as 
well.
    So the issuance of an intent to release an RFP also takes 
time. So there is not going to be any contracts being let; 
there is not going to be any performance testing that is being 
done during that time period. So, in essence, we are actually 
going to be--when you come at the end of the day, we are going 
to be aligned with exactly what GAO is saying, with completing 
these documents before we start performance testing.
    Under Secretary Borras informed you that we are going to 
have to come back to the ARB in order to get approval to do any 
performance contracting. So the release of the RFP does not 
necessarily guarantee the release of any performance 
contracting for testing.
    So, in essence, we are following the same paradigm, it is 
just the timing is a little bit----
    Mr. Lungren. So if I were one of those that were pursuing 
one of the alternatives, would I be encouraged or discouraged 
by that approach with respect to me pursuing my approach and 
the receptivity with which I would be received by your 
operation?
    Dr. Garza. Sure. That is an excellent question.
    So the requirements for the request for proposals is a full 
and open competition. It is not wed to any technology 
whatsoever. We will put out the requirements that the 
Department is going to need. But just because we have used PCR-
based technology in the past does not mean that any other 
technology cannot come forward.
    Mr. Lungren. Let me ask you this: Now, you got to 
understand my dad was a doctor, I wanted to be a doctor at one 
time, I have great respect for doctors. I have a rich and long-
standing experience with the L.A. Times, so I think you know 
where my--where my loyalties would lie. But with regard to 
certain press claims about the false positives, and if such 
claims are inaccurate, as I understand you have stated, and 
that they are all true positives--I love science, I respect 
science. I am always a little worried when I hear that they are 
all perfect, we have no false positives.
    Now, Ms. Phillips gave us a view of the false positive from 
her perspective. Could you elaborate a little bit more on that? 
Because it is difficult for me to go to my colleagues and say, 
don't worry about the program, we have been assured by Dr. 
Garza that there are never and--there are no false positives, 
there never have been. I just have to tell you that is 
difficult for people to accept. So would you try and enlighten 
us on that?
    Dr. Garza. Yes, sir, and thank you again for the question 
and bringing that up, because I think it has caused an immense 
amount of confusion out in the community.
    I believe what Ms. Phillips said is absolutely right. We 
have had true positives on our tests, which means I ask the 
machine to go out and look for targeted DNA, and it has done 
that every single time. Now, I also agree with you that no test 
is perfect, but every time that we have looked at any of these 
organisms that we have had a detection on, it has always been a 
true positive.
    Now, where the confusion comes in is with the term 
``BioWatch Actionable Result,'' or the BAR, and this was 
something that was brought up again in the National Academy of 
Sciences report as well, where some people will interpret that 
as an indication of bioterrorism, which it is not. It is an 
indication that we have found some bacteria that is of 
interest, and that we need to come together and discuss what it 
actually means.
    So what does that mean? That means we get together with our 
State and local partners and with our Federal partners, and it 
is not just public health. It is our security people, it is our 
intelligence folks, it is many different people from many 
different disciplines that come together to look at the results 
and say, first of all, is this bioterrorism, yes or no. The 
people make that decision, not the machine and not BioWatch.
    The second question is--equally important--is this a threat 
to public health? So it could be a naturally occurring organism 
and still be a threat to public health. I think that sometimes 
gets lost in the conversation.
    But I appreciate your concern over stories that come out, 
and I think some misconceptions about what false positives and 
what true positives actually are.
    Mr. Lungren. Mr. Chairman, can I just follow up on that?
    Mr. Bilirakis. You are recognized, sir.
    Mr. Lungren. So would that suggest that the hits have been 
on close cousins of what you were looking for, not the actual 
bad bacteria? Is that what you are telling me, or is it 
something different than that? I am trying to figure this out.
    Dr. Garza. Right. So without going too much into the 
organisms that we look for, for a particular organism there is 
what is considered a subspecies of the organism, very, very 
closely linked, so closely linked that when BioWatch was rolled 
out in 2003, there was not a test to distinguish between the 
different subspecies of organisms. So by and large what we find 
is that very low-level subspecies of that organism.
    Now, since that time we have learned that--and, frankly, 
many people didn't know this even existed in the environment in 
some of the cities that we are in, so it was a surprise to them 
when we were finding this there. So, you know, we rewrote the 
book on where bacteria live. But the question is what are we 
doing about it? So what we did do about it is after we 
discovered, hey, we are finding these things, but this is of no 
consequential public health or terrorism event is looking at 
ways to improve our detection technology. We have done that.
    So we have been partnering with the DOD to build more 
specific assays. I believe we are going to be rolling out some 
of these assays in the fall time frame, but, again, we have to 
make sure this is in concert with our State and local partners.
    Mr. Lungren. Thank you very much.
    Thank you, Mr. Chairman.
    Mr. Bilirakis. You are welcome.
    Now I recognize the gentle lady from California, our 
Ranking Member Ms. Richardson. You are recognized 5 minutes.
    Ms. Richardson. Thank you, Mr. Chairman.
    Dr. Garza, you might recall that when you were last here, I 
asked you a question regarding the first responders, and I 
wanted to get an update on the pilot project to voluntarily 
administer the anthrax vaccine to first responders.
    Dr. Garza. Sure. I know that it is in the works right now, 
and let me find my notes here on that. But I will tell you 
where it is right now. We have been working on this very 
diligently with a lot of different people, and that includes 
our State and locals, with NGOs, and with our Federal suite of 
families including the CDC.
    Now, as you can imagine, this is a very complex endeavor. 
This is delivering anthrax vaccine, I have been in the 
military, I have been vaccinated, and I know how much of a 
challenge it is for the military to get this done, and so it is 
no small feat get this done.
    Be that as it may, it has been a been a very collaborative 
effort. There has been a lot of good work that has been done on 
this, and where we are right now is I think the last time I was 
briefed on this is we are starting to put the final touches on 
it so that we can start reaching out to our State and locals 
and soliciting who would be interested in participating in 
these pilot projects.
    As you can imagine, there are a lot of questions out there 
with State and locals, as there should be, and so this takes a 
lot of discussion. It takes a lot of communication back and 
forth before we roll this out. We want it to be an instrument 
of success, and so we are being very deliberate in how we 
approach this problem.
    So the time frame I can't give you right now, but I can say 
that it is--we are fairly close to having this rolled out.
    Ms. Richardson. Could you at least give us--do you 
anticipate by the end of the year, midyear, next year? What is 
your general----
    Dr. Garza. Right. So in addition to working through the 
communications strategy and all those other things, there are 
certain bureaucratic mechanisms we need to go through as well, 
and some of that will depend on some of those mechanisms. You 
know as well as I do that it is difficult to put a time line on 
some of those.
    If pressed I would say, you know, I don't know, early next 
year would probably be an end date.
    Ms. Richardson. Okay. So have you decided how you are going 
to--are you going to reach out to certain particular agencies 
in an area or a particular--you know, meaning are you looking 
at doing geographic areas, or areas by professions, or all in 
general, or have you had any thought about that, or do you have 
members of these organizations who are involved in these 
discussions?
    Dr. Garza. Yes, ma'am. So we want the pilot projects to be 
instruments of success, and so we want to make sure that they 
are geared towards first it has to be an at-risk place, so it 
doesn't make as much sense to roll these programs out where we 
don't feel that the population is at risk. But also it has to 
have a pretty robust infrastructure to handle this type of 
program, whether that be with occupational health, being able 
to track who has received vaccines, things like that.
    So right now we have been--people have come to us and 
talked about participating in the program, and some, I think, 
are much further along in setting up that sort of 
infrastructure than others are. But certainly those are the two 
factors that I think that we are really keying on is at-risk 
cities, and do you have the infrastructure to support this?
    Ms. Richardson. So but what you didn't answer is will you 
be determining like, let us say, only police, or only fire, or 
a combination of the two?
    Dr. Garza. Right. Yes, ma'am. So if I remember correctly, 
and I will make sure that we get you the information that you 
need on this, we are not limiting it to any particular 
demographic or any particular profession. It is really up to 
the municipality. So we view ourselves more as a pass-through. 
So remember, we don't own the vaccine. We are merely assisting 
State and locals to have access to it. So we are leaving as 
much as possible to the State and locals to determine what 
their needs are.
    Ms. Richardson. Okay. If and when Gen-3 is fully 
implemented, what percentage of the OHA's budget do you expect 
the program will represent?
    Dr. Garza. If and when it is fully implemented, assuming 
full deployment, issues like that, I am guessing probably 
around 90 percent of the budget.
    Ms. Richardson. So what reassurance could you give to this 
committee that the other aspects of the work that you do would 
not lose sight and priority of their need?
    Dr. Garza. Right. So regardless of what the budget size is, 
so that budget pays for a lot of other things, right? So it 
pays for assistance to our State and locals to run local 
BioWatch programs. A portion of it is run here at headquarters. 
It is a Federally-managed program. But that does not diminish 
the mission that we have to DHS for occupational and 
operational medicine, for biosurveillance, for food, ag and vet 
defense. So in that sense it is all on equal footing with that.
    Ms. Richardson. Thank you.
    Mr. Bilirakis. Thank you very much.
    I will now recognize myself for 5 minutes. The first 
question is for Mr. Jenkins.
    Your report recommends that DHS reevaluate the mission need 
for BioWatch Generation 3. You wrote that this document was 
essentially prepared after the fact in order to justify a 
predetermined solution.
    Was DHS ignoring its own best practices when it began to 
pursue autonomous detection prior to establishing the mission 
need, and was this reassessed at any point in the last 3 years 
to ensure that the acquisition was on track to meet a specific 
mission need?
    Mr. Jenkins. Well, the current acquisition process wasn't--
hadn't been in place, but the basic requirement of a mission 
need statement was in place in the prior acquisition process. 
So from our perspective, the mission needs statement that 
should have been provided under the new process should also 
have been provided under the old process.
    In general what we found was that there had been sort of an 
assumption that this--from very early on, even before the 
Secretary's guidance in 2008, that automating Gen-2 was the way 
to go. So all of the decisions basically sort of flowed from 
that assumption, and what was--what we were told was a 
consensus within the Department, and that this was the way to 
go. So it never was a real refreshing new look at the mission 
needs statement, as far as we know.
    Mr. Bilirakis. Thank you.
    Next question for Dr. Garza. The President's fiscal year 
2013 budget request included an increase of almost $40 million 
to fund continuing testing of Gen-3. I believe Chairman Lungren 
referred to this. The House bill did not provide an increase.
    What strikes me as the most troublesome about this kind of 
expenditure is that GAO has confirmed for us there has been no 
comprehensive cost-benefit analysis done to ensure that all of 
these millions, specifically $5.9 billion, incredible, over the 
project life cycle will buy down risks sufficient to justify 
the expenditure. Despite this estimate we still do not know 
just how much of an improvement Gen-3 would be over Gen-2.
    Where is the cost-benefit analysis? How much more certainty 
do we get with these machines? What is the decrease in human 
morbidity or mortality? How much are we helping people; and if 
we are not, shouldn't these millions be spent on other 
biosurveillance programs showing promise, like the integration 
and information-sharing initiatives that Congress has funded?
    Dr. Garza. Thank you, Mr. Chairman. Allow me to entertain 
some of the points that you made.
    First off, you are absolutely right. The President's budget 
was around $40 million, and I agree with you that we do need to 
have a thorough analysis of alternatives as well as a mission 
needs statement and a cost-benefit study done. As I mentioned 
in my opening remarks, and I am sure that Under Secretary 
Borras supports this as part of our acquisition program, and it 
is documents that we are in the midst of completing. So I don't 
think there is any disagreement that we do need to have this 
thorough look at the BioWatch program.
    Let me address, though, the costs that you were putting out 
there, the $5.9 billion----
    Mr. Bilirakis. Please, please.
    Dr. Garza [continuing]. Over a 20-year life cycle. So I 
want to make sure that everybody understands that is a 20-year 
life-cycle cost. This isn't--we haven't spent any money on 
procuring anything right now. We have taken--and I think the 
management of DHS has been--should be commended for this. It is 
setting up several gates to make sure that we are meeting all 
of the required documentation, as well as doing all of our due 
diligence in evaluating the technology so that the Secretary 
and the Department can make a very effective, robust, and 
minimize risk to the Department on the decision that they plan 
on making.
    As far as the capabilities that we bring, I highlighted 
some of those in my opening statement. The true benefit that it 
brings to the Department, to the Nation is decreasing that time 
to detection from 12 to 36 hours to 4 to 6. If you look at the 
mortality curve for bacillus anthracis, there is a certain 
amount of time that people are exposed, it is incubated, they 
become sick, and then you get the steep curve on the mortality 
side. Any time you can move that curve to the left where you 
are able to detect, decide, deploy, and treat medical 
countermeasures, you will save lives.
    Really, time is the currency that we barter with when it 
comes to bioterrorism. The quicker that we can get pills in 
mouths, the more lives we are going to save.
    Mr. Bilirakis. Let me follow up with one last question. We 
know that Gen-2, the currently developed version of BioWatch, 
could use some relatively simple upgrades to its assays that 
could make it substantially less likely to alarm on bacteria 
that are close cousins to ones we actually care about. Might it 
be better to balance costs and mission needs to spend a little 
to improve Gen-2 and to send a ``lab in a box'' notion back to 
S&T for research? I know, again, Chairman Lungren agreed. Why 
not improve Gen-2 as opposed to spending more money on Gen-3?
    Dr. Garza. Thank you, sir.
    Regardless of what happens with our acquisition program in 
Gen-3, we are already moving forward with improving Gen-2 in 
just the issues that you discussed, with improving the assays 
so that we can differentiate between close cousins of the 
different bacterias. That is already in the works. The issue 
with that is making sure that we have good communication with 
our State and locals, because, again, this is going to change 
the way that we do business. So the only thing that this is 
waiting on is making sure that we have firm concepts of 
operations on how we are going to roll this assay out.
    So there is no question that we are improving Gen-2. You 
talked or you asked about whether optimizing Gen-2 versus Gen-3 
would be--would that fit the bill. I think the answer is I 
think that will be part of our analysis of alternatives is 
would it be possible to just optimize Gen-2, and would that be 
sufficient to replace or to forego Gen-3.
    So I am happy to take a look at that question, but be that 
as it may, the most important aspect as well is that reduction 
in time from the 12 to 36 hours to the 4 to 6.
    Don't forget that the Gen-3 technology is also slated to go 
indoors, where Gen-2 is not now, which is an important part 
that sometimes gets lost in the conversation; that not only are 
we going to be improving the timeliness, we are going to be 
able to move this inside where we think some of the threat will 
be emanating from.
    Mr. Bilirakis. Thank you very much.
    Now I will yield and give 5 minutes or so to the ranking 
gentle lady from New York, Ms. Clarke. You are recognized, 
ma'am.
    Ms. Clarke of New York. Thank you very much, Mr. Chairman.
    Dr. Garza, I understand from the GAO report that the annual 
cost to operate Gen-3 is estimated to be about four times more 
than the cost of current Gen-2 deployment, and that Gen-3 will 
involve the deployment of 2,322 detectors, a marked increase 
from the 594 detectors currently deployed.
    What is the rationale behind this deep increase in the 
number of detectors deployed, and where are these additional 
detectors going? Can you explain why Gen-3 will be so much more 
expensive to operate?
    Dr. Garza. Thank you for that question, and I think this 
brings up a very good point. This, again, I think it gets a 
little confusing because you are not comparing apples to apples 
anymore. The slogan that I use to my office is you are not even 
comparing apples to oranges; you are comparing apples to 
elephants.
    Gen-2 was designed to be an outdoor collector. It was 
designed to take 12 to 36 hours to cycle. Typical 
municipalities will collect the filter once a day. The moved--
or the plans for Gen-3 are to move it indoors into high-
concentration areas. So these would be places like shopping 
malls, football stadiums, you know, subways, things like that, 
where there is a high concentration of people where there could 
be a possibility of high levels of infectivity in a short 
amount of time. So that was a goal as well.
    The difference in the cost is if we were going to collect 
Gen-2 three times a day, you would absolutely see an increase 
in cost, and then you would start approximating where we are at 
with Gen-3, because that would include people to go pick up the 
filter to run the PCR analysis and be able to report out. So 
for Gen-3 it cycles, again, three times more than Gen-1/2. We 
will be going into many more locations, and frankly, the 
original plans were to expand it to over 50 cities, where it is 
currently at 30.
    So comparing just bottom-line numbers between the two is 
not a--it is not really a fair comparison. When you get down to 
the cost of--and Mr. Jenkins mentioned this as well--the cost 
of running that sample drops tremendously from the Gen-2 to the 
Gen-3 side because of the efficiencies that are built into the 
automation. I did--and I hope that answers your question, Ms. 
Clarke.
    Ms. Clarke of New York. Just a little clarification. So are 
you saying that there are components of Gen-2 that will not be 
utilized in Gen-3 because of the apples to elephants, or----
    Dr. Garza. Right. So what I am saying is when you look at 
the entire system. So the entire system when it was first 
developed back in, gosh, probably 2007, 2008, before my time--
--
    Ms. Clarke of New York. Uh-huh.
    Dr. Garza [continuing]. It was pictured as expanding across 
the country to over 50 cities, going indoor to all of these 
locations. This is the number of machines that we think we are 
going to need. So that is what generates your life-cycle cost.
    We haven't bought machine one, frankly, and I think as 
Under Secretary Borras said, look, we are going to have to take 
a look at this program as well when it comes to procurement and 
say, do we really need to be in over 50 cities? Do we really 
need to be in all of these locations? I think that is 
appropriate given our financial constraints. So we have to come 
up with the proper sizing of the system.
    Now, in reference to your question with Generation 2, 
though, I don't think anybody can sit here and tell you today 
what the optimal system looks like. So whether that is going to 
be all Gen-3, whether that is going to be all Gen-2, or whether 
it is going to be some sort of combination of the two, nobody 
can tell you that right now until we have gone through all of 
the acquisition documents that we need to complete as well as 
finish our performance testing so we have an understanding of 
what this technology can do for us.
    Ms. Clarke of New York. Well, is there, I guess, a vision 
of Gen-3 being an overlay on top of Gen-2, or that a new system 
would be created that would make Gen-2 obsolete?
    Dr. Garza. So if I recall correctly, when I first came into 
the office, I believe that the vision when it was started was 
Gen-3 would eventually take over for Gen-1/2.
    Ms. Clarke of New York. Uh-huh.
    Dr. Garza. But I believe that since that time there has 
been a lot of discussion about really what is the optimal 
solution. I think that is where the appropriate acquisition 
documents come into play is what can be an optimal solution?
    So I would say right now, you know, although we have to 
develop our documents based on something, which is where our 
life cycle cost estimates come from, there is still, I think, 
going to be plenty of discussion on what that optimal system 
looks likes.
    If I may, though, I want to come back to a comment that 
Chairman Bilirakis said, and that was in regard to R&D and S&T. 
So OHA does not do basic research and development. S&T clearly 
has that responsibility. What we do is we do operational 
testing on technology that we think is beneficial to the 
Nation. We have had the prototyping that is evaluated by two 
different independent groups on where this is in the technology 
scheme. Both of them independently came back with this is a 
mature technology. It is not in the development stage; it is in 
the operational evaluation stage. That is a big difference.
    The requirements that we put on our machines are much 
different than the requirements that are put onto basic design. 
We have to make sure these machines can operate in many 
different environments, whether it is hot, cold, raining, 
snowing. We have to make sure they can operate in train 
tunnels, or in football stadiums, or on a street corner, which 
is much different than developing something in a lab or in a 
building.
    So I just wanted to make that point clear, that we are not 
doing basic research and development. What we are doing is 
evaluating technology.
    Ms. Clarke of New York. Thank you very much.
    Mr. Chairman, I yield back.
    Mr. Bilirakis. Thank you. Thank you.
    One last question for Mr. Philips. What outreach, if any, 
has DHS done with the BioWatch practitioner such as yourself in 
developing the next-generation detector?
    Ms. Phillips. Thank you very much, Mr. Chairman. The on-
going relationship and communication enhancement that the 
department--that our department has with OHA is largely in the 
context of a working group. We have a BioWatch core working 
group that includes representatives from Maryland, from the 
District of Columbia, and from Virginia. It is the Baltimore, 
Washington, Richmond Working Group, and it is in that context 
that we review communication protocols.
    We--on the occasion when there is an alert, we conduct a 
hot wash and after-action review. We have discussed 
improvements on communications and other protocols. So it is 
within that context. I will point out that that is clearly an 
improved and much closer working relationship that our State 
has had, has benefited with the Department in the past. I will 
say that in my past experience prior to coming to the State, I 
was a local health officer in Maryland and had the opportunity 
to be connected with BioWatch, and it was a very different 
culture, and it was a very different connection with State and 
local officials than what we are experiencing now.
    Mr. Bilirakis. Thank you.
    Do you see value in the type of system envisioned in 
Generation 3?
    Ms. Phillips. Well, Mr. Chairman, the comments that you 
have heard have to do with the acceleration or the 
decompression of the time from what we currently have in Gen-2, 
which can be up to 36 hours, to reduce that down to something 
that is much quicker in terms of an alert. As I mentioned in my 
testimony, when we get an alert, there are oftentimes now that 
that alert is as a result of a specimen that was brought into 
our lab, and the material could be up to 36 hours old. So what 
we are not getting is we are not getting that near-real-time 
alert that would be an advance to what we get in rather robust 
systems from our labs and from our emergency rooms.
    So right now we see a near-real-time what goes on every day 
in Maryland's emergency rooms and gives us chief complaints, 
the leading edge. But I think what is being described with this 
new technology is an opportunity to get ahead of that by 
several hours, which would then really be an advance in terms 
of our ability to muster a response.
    Mr. Bilirakis. Very good. Thank you very much.
    Anything further from the panel?
    Well, thank you so much. Thanks for your patience. I want 
to thank the witnesses for your valuable testimony; of course, 
the Members for their questions. The Members of the 
subcommittee may have some additional questions, and we ask 
that you respond in writing, please. The hearing record will be 
open for 10 days.
    Without objection, the subcommittee stands adjourned. 
Thanks so much.
    [Whereupon, at 4:28 p.m., the subcommittees were 
adjourned.]


                            A P P E N D I X

                              ----------                              

    Questions From Chairman Gus M. Bilirakis for Alexander G. Garza
    Question 1. Please provide the amount of funding spent on BioWatch 
Generation 1/2 since its inception. Please include all relevant costs, 
such as research and development, unit costs, operational and 
maintenance costs, etc.
    Answer. Response was not received at the time of publication.
    Question 2. Please provide the amount of funds spent on the 
development of the Autonomous Pathogen Detection System (APDS).
    Answer. Response was not received at the time of publication.
    Question 3. Please provide all data, and a detailed description of 
the experimental methods used to generate these data, pertaining to 
system sensitivity for Generation 1/2. Please indicate when these tests 
were undertaken.
    Answer. Response was not received at the time of publication.
    Question 4. Please provide a list of all BioWatch Actionable 
Results since the deployment of BioWatch, to include which agents were 
detected, the method of testing performed to confirm the findings, and 
any other data and supporting evidence utilized to determine whether a 
positive result was due to an attack versus natural persistence of the 
organism in the environment.
    Answer. Response was not received at the time of publication.
    Question 5. You mentioned in your testimony that you are working on 
improving the Generation 2 assays. Please describe in detail what steps 
are being undertaken to ensure that deployed assays are meeting the 
mission need, where the work is occurring, when it was initiated, how 
much it is costing, what the end goal is, and when you expect to have 
the improved assays finished and fielded.
    Answer. Response was not received at the time of publication.
    Question 6. Please provide all of the data associated with BioWatch 
Generation 3 systems in development to date, including those for the 
Chicago field test.
    Answer. Response was not received at the time of publication.
    Question 7. Please provide all supporting documentation provided to 
Department of Homeland Security management (including for Acquisition 
Review Board decisions) pertaining to the Generation 3 system test, 
evaluation, and acquisition activities.
    Answer. Response was not received at the time of publication.
    Question 8. Please indicate how much money has been spent to date 
on Generation 3, and how much remains unspent from prior year funds.
    Answer. Response was not received at the time of publication.
    Question 9. Please explain what the difference is between the 
Autonomous Pathogen Detection System (APDS), which was pulled from 
indoor testing in New York City, and the more recent Automated 
Detection System that has undergone testing by the Office of Health 
Affairs. Are there any differences in the assay chemistry, sample 
capture process, sample processing process, or sample analysis process? 
Please provide details.
    Answer. Response was not received at the time of publication.
    Question 10. Please provide funding levels and rationale for such 
funding provided to performers to upgrade Generation 3/advanced systems 
to fulfill Generation 3 requirements.
    Answer. Response was not received at the time of publication.
    Question 11. Is the Department of Homeland Security Science and 
Technology Directorate undertaking any activities to support or 
optimize a BioWatch Generation 3 system at the current time? If so, 
what are they? What is the funding associated with the project to date, 
which system is it for, and what is the time line for the deliverable?
    Answer. Response was not received at the time of publication.
    Question 12. When do you plan to complete the new Analysis of 
Alternatives?
    Answer. Response was not received at the time of publication.
    Questions From Chairman Daniel E. Lungren for Alexander G. Garza
    Question 1. In your testimony you mentioned that two independent 
studies have supported your claim that the work you are doing on 
BioWatch Generation 3 is not research and development. Please provide 
these studies.
    Answer. Response was not received at the time of publication.
    Question 2a. The Department of Homeland Security Science and 
Technology (S&T) Directorate is working on a number of advanced 
biodetection efforts. One of these, Detect to Protect, a ``triggers and 
confirmers'' type of system, is undergoing testing in the Boston subway 
system.
    What is the difference between Detect to Protect and BioWatch 
Generation 3?
    Answer. Response was not received at the time of publication.
    Question 2b. When was the Detect to Protect project initiated, and 
how much has been spent on it? How do the anticipated procurement, 
operations, and maintenance costs compare to BioWatch Generation 3?
    Answer. Response was not received at the time of publication.
    Question 2c. What testing, evaluation, and validation have been 
conducted to date? What have these tests told us about the system 
sensitivity, specificity, and reproducibility?
    Answer. Response was not received at the time of publication.
    Question 2d. When will this project be completed and transition to 
the Office of Health Affairs (OHA), and how will OHA use this 
technology?
    Answer. Response was not received at the time of publication.
    Question 3. Please describe the ways in which you coordinate with 
Under Secretary O'Toole on the S&T biodetection portfolio generally, to 
ensure prevention of redundancy and optimization of acquisition of 
biodetection technology that will be most useful for end users.
    Answer. Response was not received at the time of publication.
    Question 4a. Your position with regard to recent press claims about 
false positives in the BioWatch Generation 1/2 system is that such 
claims are inaccurate and that, in fact, any hits have always been true 
positives. You have also argued that the BioWatch program has never had 
any false positives and all positives are associated with background 
environmental persistence of the organisms, not actual attacks.
    Can you please tell us how these were confirmed to be true 
positives? What gold standard test was performed to reach this 
conclusion in each case?
    Answer. Response was not received at the time of publication.
    Question 4b. Were the hits on the DNA of bacteria that were very 
closely related to those we were looking for? But they weren't actually 
what we were looking for?
    Answer. Response was not received at the time of publication.
    Question 4c. If these bacteria are setting off the sensors, why 
hasn't anyone gotten sick from them?
    Answer. Response was not received at the time of publication.
    Question 5. Many agencies employ some form of biodetection. Who is 
designated to look across the board at all of these different programs, 
and assess them for redundancy, overlap, gaps, and potential for cost-
savings?
    Answer. Response was not received at the time of publication.
       Question From Chairman Gus M. Bilirakis for Rafael Borras
    Question. Your testimony states that the Department of Homeland 
Security Science and Technology Directorate is working closely with the 
Office of Health Affairs on the technical strategy for Generation 3. 
Please provide evidence of this.
    Answer. Response was not received at the time of pulication.