[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]



 
             BIOWATCH: LESSONS LEARNED AND THE PATH FORWARD

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



                                HEARING

                               before the

                       SUBCOMMITTEE ON EMERGENCY

                        PREPAREDNESS, RESPONSE,

                           AND COMMUNICATIONS

                                 of the

                     COMMITTEE ON HOMELAND SECURITY

                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             JUNE 10, 2014

                               __________

                           Serial No. 113-70

                               __________

       Printed for the use of the Committee on Homeland Security
                                     

[GRAPHIC] [TIFF OMITTED] 



      Available via the World Wide Web: http://www.gpo.gov/fdsys/

                               __________




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                     COMMITTEE ON HOMELAND SECURITY

                   Michael T. McCaul, Texas, Chairman
Lamar Smith, Texas                   Bennie G. Thompson, Mississippi
Peter T. King, New York              Loretta Sanchez, California
Mike Rogers, Alabama                 Sheila Jackson Lee, Texas
Paul C. Broun, Georgia               Yvette D. Clarke, New York
Candice S. Miller, Michigan, Vice    Brian Higgins, New York
    Chair                            Cedric L. Richmond, Louisiana
Patrick Meehan, Pennsylvania         William R. Keating, Massachusetts
Jeff Duncan, South Carolina          Ron Barber, Arizona
Tom Marino, Pennsylvania             Dondald M. Payne, Jr., New Jersey
Jason Chaffetz, Utah                 Beto O'Rourke, Texas
Steven M. Palazzo, Mississippi       Filemon Vela, Texas
Lou Barletta, Pennsylvania           Eric Swalwell, California
Richard Hudson, North Carolina       Vacancy
Steve Daines, Montana                Vacancy
Susan W. Brooks, Indiana
Scott Perry, Pennsylvania
Mark Sanford, South Carolina
Vacancy
                   Brendan P. Shields, Staff Director
          Michael Geffroy, Deputy Staff Director/Chief Counsel
                    Michael S. Twinchek, Chief Clerk
                I. Lanier Avant, Minority Staff Director
                                 ------                                

  SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND COMMUNICATIONS

                  Susan W. Brooks, Indiana, Chairwoman
Peter T. King, New York              Donald M. Payne, Jr., New Jersey
Steven M. Palazzo, Mississippi,      Yvette D. Clarke, New York
    Vice Chair                       Brian Higgins, New York
Scott Perry, Pennsylvania            Bennie G. Thompson, Mississippi 
Mark Sanford, South Carolina             (ex officio)
Michael T. McCaul, Texas (ex 
    officio)
            Eric B. Heighberger, Subcommittee Staff Director
                   Deborah Jordan, Subcommittee Clerk


                            C O N T E N T S

                              ----------                              
                                                                   Page

                               Statements

The Honorable Susan W. Brooks, a Representative in Congress From 
  the State of Indiana, and Chairwoman, Subcommittee on Emergency 
  Preparedness, Response, and Communications:
  Oral Statement.................................................     1
  Prepared Statement.............................................     2
The Honorable Donald M. Payne, Jr., a Representative in Congress 
  From the State of New Jersey, and Ranking Member, Subcommittee 
  on Emergency Preparedness, Response, and Communications:
  Oral Statement.................................................     3
  Prepared Statement.............................................     4
The Honorable Bennie G. Thompson, a Representative in Congress 
  From the State of Mississippi, and Ranking Member, Committee on 
  Homeland Security:
  Prepared Statement.............................................     4

                               Witnesses

Dr. Kathryn Brinsfield, Acting Assistant Secretary, Office of 
  Health Affairs, U.S. Department of Homeland Security:
  Oral Statement.................................................     7
  Joint Prepared Statement.......................................     9
Dr. Reginald Brothers, Under Secretary, Science and Technology 
  Directorate, U.S. Department of Homeland Security:
  Oral Statement.................................................    12
  Joint Prepared Statement.......................................     9
Mr. Chris Cummiskey, Acting Under Secretary, Management 
  Directorate, U.S. Department of Homeland Security:
  Oral Statement.................................................    14
  Prepared Statement.............................................    15
Mr. Chris Currie, Acting Director, Homeland Security and Justice 
  Issues, U.S. Government Accountability Office:
  Oral Statement.................................................    18
  Prepared Statement.............................................    19
Dr. Deena S. Disraelly, Research Staff, Strategy, Forces, and 
  Resources Division, Institute for Defense Analyses:
  Oral Statement.................................................    27
  Prepared Statement.............................................    29

                                Appendix

Questions From Chairwoman Susan W. Brooks for Kathryn Brinsfield 
  and Reginald Brothers..........................................    55
Questions From Chairwoman Susan W. Brooks for Kathryn Brinsfield.    57
Questions From Chairwoman Susan W. Brooks for Chris Cummiskey....    59


             BIOWATCH: LESSONS LEARNED AND THE PATH FORWARD

                              ----------                              


                         Tuesday, June 10, 2014

             U.S. House of Representatives,
 Subcommittee on Emergency Preparedness, Response, 
                                and Communications,
                            Committee on Homeland Security,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:03 a.m., in 
Room 311, Cannon House Office Building, Hon. Susan W. Brooks 
[Chairwoman of the subcommittee] presiding.
    Present: Representatives Brooks, Palazzo, Sanford, and 
Payne.
    Mrs. Brooks. Good morning. The Subcommittee on Emergency 
Preparedness, Response, and Communications will come to order. 
The subcommittee is meeting today to receive testimony 
regarding the Department of Homeland Security's BioWatch 
program.
    The BioWatch program was established in 2003 in the 
aftermath of the anthrax attacks that killed 5 people and 
sickened more than 20 others. The program is a system of 
detectors deployed to more than 30 U.S. cities to scan for a 
number of aerosolized biothreat agents.
    Recognizing the limitations of the current system, in 2008 
the Department's Office of Health Affairs began the process to 
acquire a next-generation detector known as Gen-3. After a 
series of missteps spanning two administrations, 6 years, and 
millions of dollars later, Secretary Johnson recently canceled 
that acquisition on April 29, 2014.
    We know through the subcommittee's biothreat hearing in 
February and a subsequent Classified briefing that the threat 
of bioterrorism is real. In fact, in its BioWatch analysis of 
alternatives performed for the Department, the Institute for 
Defense Analyses noted that the bioterrorism threat has not 
changed since 2001.
    With that in mind, robust biosurveillance and biodetection 
capabilities are vital to our country's security. I am 
interested in hearing from Dr. Brinsfield and Dr. Brothers 
about their efforts to work together going forward to develop, 
test, and deploy a next-generation technology.
    I am also interested in learning more about efforts to 
enhance the currently deployed system to make it more effective 
as we await new technology, and about the Department's overall 
biosecurity strategy.
    In July 2012, the administration released its National 
Strategy for Biosurveillance. This strategy was supposed to be 
followed 120 days later by an implementation plan. However, 
nearly 2 years later, that plan has still not yet been 
completed.
    This is simply unacceptable. I hope our witnesses will be 
able to shed some light on the administration's strategy and 
when that implementation plan will be complete.
    As we consider what is next for BioWatch, we must be 
mindful of what went wrong with Gen-3 so we learn from those 
mistakes. Unfortunately, this is not the first failed 
acquisition in the Department's history.
    SBInet and others have suffered from management 
shortcomings, be they requirement settings or a failure to 
follow proper acquisition protocols, such as the completion of 
alternatives analyses or cost-benefit analyses.
    We can't afford to waste a single dollar of Homeland 
Security funding. I am interested in hearing from Secretary 
Cummiskey on the Department's efforts to mature its acquisition 
system and oversight of large-scale acquisitions, such as Gen-
3.
    It is my hope that the acquisition legislation introduced 
by my colleague, Mr. Duncan of South Carolina, which the House 
just passed yesterday, will help to strengthen the Department's 
acquisitions management capabilities.
    With that, I look forward to hearing from our distinguished 
panel of witnesses and to continuing the subcommittee's 
examination of the bioterrorism threat facing our country, and 
our programs and capabilities to address that threat.
    The Chairman now recognizes the gentleman from New Jersey, 
Mr. Payne, for any opening statement he may have.
    [The statement of Chairwoman Brooks follows:]
                             June 10, 2014
                Statement of Chairwoman Susan W. Brooks
    The BioWatch program was established in 2003 in the aftermath of 
the anthrax attacks that killed 5 people and sickened more than 20 
others. The program is a system of detectors deployed to more than 30 
U.S. cities to scan for a number of aerosolized biothreat agents.
    Recognizing the limitations of the current system, in 2008 the 
Department's Office of Health Affairs began the process to acquire a 
next generation detector, known as Gen-3. After a series of missteps 
spanning two administrations, 6 years, and millions of dollars later, 
Secretary Johnson cancelled that acquisition on April 29, 2014.
    We know, through this subcommittee's biothreat hearing in February 
and a subsequent Classified briefing, that the threat of bioterrorism 
is real. In fact, in its BioWatch analysis of alternatives performed 
for the Department, the Institute for Defense Analysis noted that the 
bioterrorism threat has not changed since 2001.
    With that in mind, robust biosurveillance and biodetection 
capabilities are vital to our security. I am interested in hearing from 
Dr. Brinsfield and Dr. Brothers about their efforts to work together 
going forward to develop, test, and deploy a next generation 
technology.
    I am also interested in learning more about efforts to enhance the 
currently deployed system to make it more effective as we await new 
technology and about the Department's overall biosecurity strategy.
    In July 2012, the administration released its National Strategy for 
Biosurveillance. This strategy was supposed to be followed, 120 days 
later, by an implementation plan. Nearly 2 years later, that plan has 
still not been completed. This is simply unacceptable. I hope our 
witnesses will be able to shed some light on the administration's 
strategy and when that implementation plan will be complete.
    As we consider what is next for BioWatch, we must be mindful of 
what went wrong with Gen-3 so we learn from those mistakes. 
Unfortunately, this is not the first failed acquisition in the 
Department's history. SBI-Net, the A-S-P program, e-Merge, and TASC all 
suffered from management shortcomings, be it requirements setting, or a 
failure to follow proper acquisition protocols, such as the completion 
of alternatives analyses or cost benefit analyses.
    We cannot afford to waste a single dollar of security funding. I am 
interested in hearing from Secretary Cummiskey about the Department's 
efforts to mature its acquisitions system and oversight of large-scale 
acquisitions, such as Gen-3. It is my hope that the acquisitions 
legislation introduced by my colleague, Mr. Duncan of South Carolina, 
which the House passed just last night, will help to strengthen the 
Department's acquisitions management capabilities.
    With that, I look forward hearing from our distinguished panel of 
witnesses and to continuing the subcommittee's examination of the 
bioterrorism threat and our programs and capabilities to address it.

    Mr. Payne. Good morning. I would like to thank Chairwoman 
Brooks for holding today's hearing on the cancellation of 
BioWatch Gen-3 acquisition and the future of biosurveillance 
and detection.
    The Department of Homeland Security's decision to cancel 
the BioWatch Gen-3 acquisition raises several questions, but I 
think they can be boiled down to two.
    First, if Gen-3 is canceled, what are we going to do 
instead? Second, with about $100 million already appropriated 
to the canceled Gen-3 acquisition, what efforts is DHS 
undertaking to make sure that acquisition decisions are made 
more responsibly in the future?
    To the first question, I understand that the current 
budgetary constraints contributed significantly to the 
Department's decision to cancel the Gen-3 acquisition. I 
appreciate DHS's efforts to reconcile the findings of the 
analysis of alternatives, BioWatch detection goals, and 
existing fiscal limitations.
    I trust that the Secretary's decision, though difficult, 
was informed, thoughtful, and deliberate.
    But the threat posed by biological weapons remains.
    In February, as stated, this subcommittee held a hearing on 
bioterrorism and each witness had the same message--the threat 
posed by biological weapons still exists, and the consequences 
of such an attack would be devastating if we could not identify 
and quickly respond.
    Accordingly, I would be interested to know what and how DHS 
will ensure that it is maximizing the limited resources to 
ensure that our biodetection and surveillance capabilities 
address the threats identified by the intelligence community.
    Turning to the broader acquisition issue, I note that in 
addition to serving as Ranking Member on this panel, I sit on 
the Subcommittee on Oversight and Management Efficiency. Over 
the past year-and-a-half, that panel has devoted a significant 
amount of time to overseeing DHS's efforts to improve 
acquisition management, which has been on the Government 
Accountability Office's high-risk list since 2005.
    Although I understand that some progress has been made to 
get acquisition management off the high-risk list, it continues 
to remain to be a challenge.
    Indeed, the acquisition process for BioWatch Gen-3 embodied 
many of the problems that plagued previous acquisitions--cost 
overruns, delayed deployment, and insufficient documentation to 
support the investment.
    I commend DHS for obtaining a thorough analysis of 
alternatives and other preliminary acquisition documents, and 
for using those documents to assess the future of Gen-3.
    That said, I am concerned that those foundational documents 
were not completed until 7 years after the BioWatch Gen-3 
acquisition process began.
    I would be interested to learn from the Department how it 
will use the lessons learned from the BioWatch Gen-3 
acquisition to strengthen its acquisition policies.
    I thank the witnesses for being here today and I look 
forward to your testimony. With that, Madam Chairwoman, I yield 
back the balance of my time.
    [The statement of Ranking Member Payne follows:]
            Statement of Ranking Member Donald M. Payne, Jr.
                             June 10, 2014
    The Department of Homeland Security's decision to cancel the 
BioWatch Gen-3 acquisition raises several questions, but I think that 
they can be boiled down to two. First, if Gen-3 is canceled, what are 
we going to do instead? Second, with about $100 million already 
appropriated to the cancelled Gen-3 acquisition, what efforts is DHS 
undertaking to make sure that acquisition decisions are made more 
responsibly in the future?
    To the first question, I understand that current budgetary 
constraints contributed significantly to the Department's decision to 
cancel the Gen-3 acquisition. I appreciate DHS's efforts to reconcile 
the findings of the Analysis of Alternatives, biodetection goals, and 
existing fiscal limitations. And I trust that the Secretary's 
decision--though difficult--was informed, thoughtful, and deliberate.
    But the threat posed by biological weapons remains. In February, 
this subcommittee held a hearing on bioterrorism. Each witness had the 
same message: The threat posed by biological weapons still exists and 
the consequences of such an attack would be devastating if we cannot 
identify it quickly and respond.
    Accordingly, I will be interested to know what how DHS will ensure 
that it is maximizing limited resources to ensure that our biodetection 
and surveillance capabilities address the threats identified by the 
intelligence community.
    Turning to the broader acquisition issue, I note that in addition 
to serving as Ranking Member on this panel, I sit on the Subcommittee 
on Oversight and Management Efficiency. Over the past year-and-a-half, 
that panel has devoted a significant amount of time to overseeing DHS' 
efforts to improve acquisition management, which has been on the 
Government Accountability Office's High-Risk List since 2005. Although 
I understand that some progress has been made to get acquisition 
management off the High-Risk List, it continues to remain a challenge.
    Indeed, the acquisition process for BioWatch Gen-3 embodied many of 
the problems that plagued previous acquisitions: Cost overruns, delayed 
deployment, and insufficient documentation to support the investment. I 
commend DHS for obtaining a thorough Analysis of Alternatives and other 
preliminary acquisition documents and for using those documents to 
inform the future of Gen-3.
    That said, I am concerned that those foundational documents were 
not completed until nearly 7 years after the BioWatch Gen-3 acquisition 
process began. I will be interested to learn from the Department how it 
will use the lessons learned from the BioWatch Gen-3 acquisition to 
strengthen its acquisition policies.

    Mrs. Brooks. Thank you.
    Other Members are reminded that statements may be submitted 
for the record.
    [The statement of Ranking Member Thompson follows:]
             Statement of Ranking Member Bennie G. Thompson
                             June 10, 2014
    Nearly 2 years ago, this subcommittee held a hearing on acquisition 
failures that occurred as the Department of Homeland Security pursued 
BioWatch Gen-3. In addition to the problems with acquisition practices, 
Gen-3 was wrought with cost-overruns and technical challenges at the 
time.
    Accordingly, at that hearing, Members of this panel urged DHS to 
suspend acquisition activities until it completed and assessed 
foundational acquisition documents per the recommendations of the 
Government Accountability Office.
    I am pleased that the Department heeded the advice of the GAO and 
our Members. The Department's action resulted in the completion of a 
thorough Analysis of Alternatives, and the time necessary to process 
the findings and determine the best path forward. Given the challenges 
the Department has experienced with acquisitions in the past, I have 
consistently urged it to suspend acquisition immediately when problems 
exist so it can re-evaluate.
    I commend the Department for doing that here. Although nearly $100 
million has already been appropriated to Gen-3, the Department's 
decision to slow down and act deliberately will save taxpayer dollars 
in the long-run.
    That said, I echo concerns made by other members of this panel 
about the timing of the Analysis of Alternatives. I was also troubled 
to learn that there may have been alternative biodetection technologies 
used by other Federal agencies at the time acquisition for Gen-3 began, 
but it does not appear that DHS considered adapting those technologies 
instead of spending millions to develop its own.
    I will be interested in learning whether DHS will consider 
biodetection technology currently used by other Federal agencies or 
other off-the-shelf technologies.
    I am also interested in learning more about the status of 
currently-deployed BioWatch technology, and any challenges it faces. 
For example, I understand that much of the air sample and laboratory 
equipment may be reaching the end of their life cycle, and that some of 
the diagnostic technology is outdated.
    How will DHS address those issues, and does it have the resources 
to carry out the system upgrades necessary to keep existing BioWatch 
technology working?
    Finally, I understand that the Department is contemplating changes 
to the Bioterrorism Risk Assessment (BTRA). I am interested in 
understanding more about the changes to the BTRA, and how the 
Department will make sure that whatever biodetection technology is 
deployed addresses the threat posed.

    Mrs. Brooks. We are very pleased to have a very 
distinguished panel before us today and want to thank you all 
for your time in preparing your written testimony and for your 
time before us today on this very important topic.
    To our left, on the panel, is Dr. Kathryn Brinsfield, 
serving as the acting assistant secretary of health affairs and 
chief medical officer for the Department of Homeland Security's 
Office of Health Affairs.
    She began her service with DHS in July 2008, and previously 
served as associate chief medical officer and director of the 
division of workforce health and medical support within OHA.
    Prior to serving as acting assistant secretary and chief 
medical officer, she served on a detail to the National 
security staff as the director of medical preparedness policy.
    Before joining DHS, Dr. Brinsfield worked for various 
organizations, including Boston's Emergency Services, Boston 
Metropolitan Medical Response System, and the DelValle 
Emergency Preparedness Training Institute.
    She graduated with honors from Brown University and 
received her M.D. from Tufts School of Medicine and her 
master's in public health from Boston University. She completed 
her residency in emergency medicine at Cook County Hospital in 
Chicago and her EMS fellowship at Boston EMS.
    Our next witness is Dr. Reginald Brothers. Dr. Brothers was 
confirmed by the U.S. Senate on April 7, 2014, for the position 
of under secretary for science and technology at the U.S. 
Department of Homeland Security.
    Prior to joining DHS, Dr. Brothers served in the U.S. 
Department of Defense's office of the assistant secretary of 
defense for research and engineering as the deputy assistant 
secretary of defense for research.
    Dr. Brothers received a B.S. in electrical engineering from 
Tufts University, an M.S. in electrical engineering from 
Southern Methodist University, and a Ph.D. in electrical 
engineering and computer science from MIT.
    Next is Mr. Chris Cummiskey, who was appointed acting under 
secretary for management at DHS in February 2014.
    Prior to assuming this position, Mr. Cummiskey served as 
the deputy under secretary for management from May 2010 to 
September 2013 and earlier as the chief of staff for the 
Management Directorate from March 2009 until May 2010.
    Prior to joining DHS, Mr. Cummiskey served as the chief 
information officer for the State of Arizona.
    Mr. Chris Currie is an acting director in GAO's homeland 
security and justice team where he leads the agency's work on 
emergency management and National preparedness issues.
    Prior to this assignment, Mr. Currie was an acting director 
in GAO's defense capabilities and management team where he led 
reviews of DOD programs.
    In the decade since DHS was created, Mr. Currie has led 
numerous audits and assessments of DHS programs including those 
related to transportation security, research, and development 
of new technologies and the Department's efforts to test and 
evaluate large acquisition programs and technologies.
    Mr. Currie joined GAO in 2002 and has a master's in public 
administration from Georgia State and a B.A. in history from 
the University of Georgia.
    Dr. Deena Disraelly--did I pronounce that correctly--is a 
research staff member at the Institute for Defense Analyses. 
She has more than 17 years' experience conducting analysis in 
the chemical, biological, radiological, and nuclear realm and 
working in and training others to support emergency response.
    Her work has focused on the policy, technological, 
operational, and organizational aspects of preparedness, 
emergency response, and consequence management, particularly as 
related to CBRN.
    Most recently, she has been focused on working with all 
levels of government to develop and evaluate biological 
preparedness plans, technologies and activities, improving 
interagency collaborations, developing new CBRN medical 
modelling methodologies, and studying potential methods for 
improving emergency response and disaster management.
    Dr. Disraelly joined IDA after 8 years in the Navy as a 
surface worker officer and Naval nuclear engineering officer. 
Additionally she served as a researcher for 2 years at MIT's 
Center for Transportation and Logistics.
    I must say, this is one of the most incredible panels that 
we have had to address the subject at hand and we are very, 
very pleased that you all could be with us today.
    Your full written statements will appear in the record, and 
I will now recognize Dr. Brinsfield for 5 minutes.
    As you know, the light is green, it will become yellow when 
you have 1 minute and if you--when the light becomes red, if 
you could please come close to wrapping up, we would appreciate 
it so we can make sure we hear from everyone.
    As you also may know, other Members will be coming in and 
out before the panel due to other commitments with other 
hearings.
    So with that, Dr. Brinsfield for 5 minutes.

 STATEMENT OF KATHRYN BRINSFIELD, ACTING ASSISTANT SECRETARY, 
 OFFICE OF HEALTH AFFAIRS, U.S. DEPARTMENT OF HOMELAND SECURITY

    Dr. Brinsfield. Thank you, ma'am.
    Chairman Brooks, Ranking Member Payne, and distinguished 
Members of the subcommittee, thank you for inviting me to speak 
today. I appreciate the opportunity to testify on biological 
defense and specifically the BioWatch Program.
    I am honored to testify alongside my colleagues, Dr. 
Brothers and Mr. Cummiskey, as well as our colleagues from the 
GAO and IDA.
    As this is my first appearance before this subcommittee, 
please allow me to provide an overview of the Office of Health 
Affairs and the responsibilities of the chief medical officer 
of the Department of Homeland Security.
    OHA provides health and medical expertise in support of the 
DHA mission to prepare for, respond to, and recover from all 
threats. Our mission is to advise, promote, integrate, and 
enable a safe and secure workforce and Nation in pursuit of 
National health security.
    The chief medical officer is the principle medical adviser 
to the Secretary and to DHA components for all health security 
matters, including those having a CBRN nexus, and has a 
statutory responsibility to lead coordination of the 
Department's biodefense activities.
    To that end, OHA conducts policy, planning, and operations 
related to preparing for and ensuring rapid response to 
biological events whether naturally-occurring, such as a 
pandemic, or man-made, such as an intentional release of 
aerosolized anthrax.
    Effective management of risks from biological threats and 
hazards depends on early warning and shared situational 
awareness. So critical decisions surrounding response and 
recovery are timely, well-informed, and ultimately save lives.
    The National Biosurveillance Integration Center, or NBIC, 
is housed with OHA and has the key responsibility to integrate, 
analyze, and share the Nation's biosurveillance information to 
advance the safety, security, and resilience of the Nation. As 
a 24/7 operation, NBIC uses information technology tools that 
assist the collaborative process of integrating information and 
expertise bound to cross its biosurveillance partners at all 
levels of government.
    Just as surveillance is critical, detecting a biological 
attack early and identifying the biological agent is an 
essential part of our multi-layered approach to biodefense. The 
BioWatch Program was initially fielded in 2003 within 33 days 
of its announcement at President Bush's State of the Union 
address and has been operational 24 hours a day, 365 days a 
year for more than 10 years.
    The program is a Nation-wide biosurveillance and detection 
system intended to partner with State and local public health 
and responder communities to enhance our Nation's ability to 
respond to a bioterrorism event.
    The sampling technology used by the BioWatch Program is 
designed to detect the intentional catastrophic release of 
select aerosolized biological agents and has a robust quality 
assurance element that includes laboratory and field audits to 
ensure accuracy.
    BioWatch has proven itself a key component of the Nation's 
biodefense architecture. However this technology must be 
improved in response to the evolving threat in a cost-effective 
manner.
    In 2008, the BioWatch Program began examining new 
technologies to streamline operational timeliness, increase 
coverage and decrease costs. BioWatch began a technology 
acquisition known as Gen-3 to provide autonomous detection 
capability generating results as soon as 4 to 6 hours after the 
release of a biological agent rather than 12 to 36 hours needed 
by current operations.
    In 2012, the Government Accountability Office conducted a 
review of the acquisition and recommended that BioWatch perform 
an analysis of alternatives or AOA to ensure that BioWatch 
pursue an optimal solution.
    Using this recommendation, OHA requested that the Institute 
of Defense Analysis conduct an independent AOA to include a 
market survey of available biodetection technologies and a 
cost-benefit analysis. The purpose of the AOA in this process 
was not to issue a specific recommendation but to help inform 
DHS's decision to proceed with any acquisition of biodetection 
technology.
    It was our assessment that the AOA suggested that an 
autonomous detection capability would be a valuable addition to 
current BioWatch operations in certain circumstances. However 
it did not find an overwhelming benefit to justify the cost of 
a full technology switch including one-to-one replacement and 
expanded coverage within and to new jurisdictions.
    Following a thorough review of the acquisition of record, 
the AOA and other studies on the future of biodetection 
capabilities, OHA, in consultation with our DHS colleagues, 
concluded that the autonomous detection system under 
consideration would not meet program objectives and recommend 
that the DHS leadership cancel its acquisition. This decision 
was formalized in an acquisition decision memo on April 29, 
2014.
    Cancellation of the Gen-3 acquisition in no way lessens the 
importance of BioWatch current operations or the need to 
explore advancement in biodetection capabilities. OHA and S&T 
are now completing a plan to both test currently-available 
technology solutions and to look at indoor and outdoor 
applications.
    I want to emphasize that the Secretary, the Department, and 
our offices remain committed to the BioWatch program, its role 
in a layered-approach biodefense, and the advancement of its 
technological capabilities.
    Thank you, and I look forward to answering your questions.
    [The joint prepared statement of Dr. Brinsfield and Mr. 
Brothers follows:]
  Joint Prepared Statement of Kathryn Brinsfield and Reginald Brothers
                             June 10, 2014
    Chairman Brooks, Ranking Member Payne, and distinguished Members of 
the subcommittee, thank you for inviting us to speak with you today. We 
appreciate the opportunity to testify on biological defense and 
specifically the Department of Homeland Security's BioWatch program. 
We're honored to testify alongside Acting Under Secretary Cummiskey as 
well as our colleagues from the Government Accountability Office (GAO) 
and the Institute for Defense Analysis (IDA).
                          the bioterror threat
    More than a decade after anthrax was mailed to Members of Congress 
and to media organizations, dozens of policy, intelligence, and 
technical reports have affirmed the viability of terrorist groups and 
violent extremists using biological weapons to cause death, suffering, 
and socio-economic disruption on a calamitous scale. In 2008, the 
Congressional Commission on the Prevention of Weapons of Mass 
Destruction Proliferation and Terrorism stressed the near-term and 
growing threat that terrorist use of biological weapons pose. The DHS 
Office of Health Affairs (OHA) and the Science and Technology 
Directorate (S&T) have worked diligently to increase understanding of 
the full spectrum of potential threats and their consequences as well 
as countermeasures and means of prevention.
    In 2001, the Defense Science Board affirmed that ``there are no 
technical barriers to a large-scale bioattack.'' We are living in the 
midst of a biotechnology revolution in which the knowledge and tools 
needed to acquire and disseminate a biological weapon are increasingly 
accessible. It is possible today to manipulate pathogens' 
characteristics (e.g., virulence, antibiotic resistance) and even to 
synthesize viruses from scratch. These procedures will inexorably 
become simpler and more available across the globe as technology 
continues to mature. Thankfully, the combination of technical expertise 
required and the restrictions limiting the acquisition of the materials 
necessary for production still make this a challenging task.
    Even small-scale attacks, however, could be highly lethal and 
disruptive, and as has been noted, there is a real possibility of a 
campaign of bioattacks on multiple targets (the ``reload'' 
phenomenon)--because some of these weapons are self-replicating 
organisms. Moreover, it is not necessary for a nation-state to maintain 
a large stockpile of bioweapons as the development of a significant 
offensive bioattack capability could occur within weeks or months.
    Biological threats, including bioterrorism, pandemics, emerging 
infectious diseases, and animal and plant diseases, remain a top 
homeland security risk. A biological attack could impact any sector of 
our society and would place enormous burdens on our Nation's public 
health, security, and critical infrastructures. The 2014 Quadrennial 
Homeland Security Review includes a review of the biological threat 
landscape and the Department's strategy to counter these threats. One 
aspect of our overarching strategy includes robust biosurveillance 
capabilities that provide situational awareness and early detection. 
These capabilities are important because in a biological event, every 
moment counts. The faster we detect an event, the faster we can take 
life-saving steps such as providing medical countermeasures and 
containing the threat.
                            biosurveillance
    It is challenging to recognize early indications of a biological 
attack because its release is invisible, and because of the global 
availability of pathogenic organisms, the dual-use nature of the 
required materials, and the small operational footprint necessary to 
produce the agents. Advance detection and disruption of a bio-weapons 
program will continue to be difficult and, as such, cannot be relied 
upon as the main focus of U.S. defenses against biological attacks. 
Instead, the United States has made a deliberate strategic choice to 
detect an attack through bio-agent release detection technology 
programs such as BioWatch and mitigate its affects by enhancing the 
capabilities of first responders and public health professionals to 
detect bioagents in the field and conduct reliable lab analyses. Other 
investments to improve our early detection capability include working 
to create sensors capable of automatically initiating protective 
actions (e.g., altering a building's airflow patterns) and developing 
rapid diagnostic capabilities to guide our response.
    Effective management of biological threats and hazards depends on 
early warning and shared situational awareness, which in turn support 
response and recovery decision making that is timely, well-informed, 
and ultimately saves lives. The United States has numerous 
biosurveillance capabilities across human health, plant, animal, food, 
water, and environmental domains distributed broadly across Federal, 
State, Tribal, territorial, and local government and the private 
sector. The National Biosurveillance Integration Center (NBIC), 
operated through the DHS Office of Health Affairs (OHA), is the 
designated Government entity charged with integration, analysis, and 
dissemination of the Nation's biosurveillance information in order to 
advance National safety, security, and resilience.
    NBIC is a 24/7 operation that collaborates daily with the BioWatch 
program as well as other National Biosurveillance Integration System 
(NBIS) Federal department and agency partners and State, local, Tribal, 
and territorial entities. At this time, NBIC is monitoring and 
reporting on, among other biological events, avian influenza H7N9 in 
China; Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in a 
number of countries now including the United States; Chikungunya Fever 
in the Caribbean; Ebola Virus Disease in West Africa; and the highly 
pathogenic avian influenza H5N1 world-wide.
             biological detection and the biowatch program
    Early detection of a biological attack and identification of the 
biological agent involved are critical to containing the spread of the 
agent as well as the successful treatment of affected populations. 
Early detection is part of a multi-layered approach to providing public 
health decision makers more time--and thereby more options--in 
responding to, mitigating, and recovering from a bioterrorist event or 
other threat to public health. If release of a bioagent is detected and 
assessed in a timely fashion, an appropriate prophylactic treatment can 
be started prior to the wide-spread onset of symptoms resulting in more 
lives saved.
    BioWatch is the only civilian-managed, Nation-wide surveillance and 
detection system for aerosol biological releases, and it is intended as 
an interface for State and local public health and responder 
communities to jointly respond to a bioterrorism event. The sampling 
technology used by the BioWatch program is designed to detect the 
intentional catastrophic release of the most threatening aerosolized 
biological agents. The BioWatch system consists of units that collect 
air samples in more than 30 cities and a network of local, State, and 
Federal laboratories that analyze samples on a daily basis with a goal 
of providing warning of possible biological attacks within 12 to 36 
hours of an agent's release. The BioWatch program has a robust quality 
assurance element that includes laboratory and field audits to ensure 
accuracy. BioWatch has conducted 37 laboratory and 20 field audits to 
date. For more than 10 years, BioWatch has operated 24 hours a day, 365 
days a year. It is a proven asset to the Nation's overarching 
biodefense architecture.
    The initial deployment of BioWatch in 2003 was intended to provide 
the most comprehensive detection network possible within budgetary, 
time, logistical, operational, and technical constraints. The complex 
coordination required to achieve the successful rollout of BioWatch 
across a broad range of Government and private entities was a difficult 
and hard-earned achievement. The BioWatch program was designed to be 
able to advance its technological capabilities to meet an evolving 
threat. Although technology can always be improved, the challenge is to 
do so cost-effectively and in pace with the evolving threat.
              autonomous detection acquisition activities
    As the National Strategy for Biosurveillance states, we must foster 
innovation and facilitate new biosurveillance activities--including new 
detection technologies. In 2008, as directed by Congress, the BioWatch 
program began examining new technologies to shorten operational 
timelines, increase coverage, and decrease costs. Acknowledging the 
benefit of early warning of a biological attack and the prompt 
distribution of medical countermeasures, the program began exploring 
technologies that could reduce detection and response times in a cost-
effective manner.
    For this reason, BioWatch began a technology acquisition process--
known as Generation 3, or Gen-3--to provide autonomous detection 
capability that would eliminate the time-consuming steps of collecting 
filters by hand and transporting them to a laboratory for analysis. An 
autonomous detector is designed to be a ``lab-in-a-box'' where the 
sampling and analysis processes will take place within the device, 
generating results as soon as 4 to 6 hours after the release of a 
biological agent, rather than the 12 to 36 hours needed by current 
operations. The BioWatch program began a phased acquisition for 
automated detection technology. Phase I was completed in June 2011 and 
assessed the maturity and technical capability of the biodetection 
technology market against a robust set of system requirements. These 
requirements included technical assay/characterization testing of two 
candidate systems and limited field testing of one vendor's candidate 
autonomous detection system.
    In September 2012, the Government Accountability Office (GAO) 
recommended that BioWatch perform an Analysis of Alternatives (AoA) as 
well as re-evaluate its mission needs statement to ensure acquisition 
requirements were well-grounded and that the BioWatch program was 
pursuing an optimal and cost-effective solution. In an Acquisition 
Decision Memorandum issued September 7, 2012, the Acquisition Decision 
Authority (ADA) directed the BioWatch program to prepare a 
solicitation/request for proposal (RFP) for an AoA study, consistent 
with GAO's recommendation.
    The AoA study, conducted by the Institute for Defense Analysis, was 
concluded on August 30, 2013, and the final report was released on 
December 20, 2013. Following an exhaustive market survey, the AoA 
report analyzed four different methodologies, not favoring one over 
another. The intent of the AoA was not to issue a recommendation but to 
help inform DHS's decision to proceed with any acquisition of BioWatch 
technology.
                   cancellation of gen-3 acquisition
    The AoA determined that an autonomous detection capability would be 
a valuable addition to current BioWatch operations. However, it did not 
find an overwhelming benefit to justify the cost of a full technology 
switch (one-to-one replacement and expanded coverage within 
jurisdictions). Following a thorough review of the Gen-3 acquisition of 
record, the AoA and other studies on future biodetection technology, 
OHA, in consultation with S&T, the Management Directorate, and the 
Office of Policy, concluded that the autonomous detection system under 
consideration would not meet program objectives at a reasonable cost 
and recommended that DHS leadership cancel its acquisition. Secretary 
Johnson then directed Acting Under Secretary for Management Cummiskey 
to cancel the BioWatch Gen-3 technology acquisition. In accordance with 
this guidance, and per the Department's Management Directive 102 on 
acquisition procedures and processes, Acting Under Secretary Cummiskey 
convened the Acquisition Review Board for the BioWatch Gen-3 
acquisition to formally cancel the acquisition of record on April 24, 
2014. This cancellation reflects the need to implement cost-effective 
solutions, as it is critical that any upgrades to the technology be 
acquired and deployed in a staged manner and in parallel--not in place 
of--the current operational program.
                            the path forward
    Cancellation of the Gen-3 acquisition of record in no way reduces 
the capability of existing BioWatch operations or the need to 
investigate potential advancements in biodetection capabilities. OHA 
and S&T are working closely on the development of a systems approach to 
next-generation biodetection, including joint development of 
requirements moving forward. Evaluation of the existing operational 
BioWatch system is underway and will guide near- and long-term 
investments in new or updated capabilities. A full range of potential 
investments is under consideration from near-term incremental 
improvements to longer-term shifts such as a distributed, networked, 
sensor-agnostic biosurveillance architecture currently under 
development at S&T with potential for capability well beyond what the 
Department initially envisioned for Gen-3.
    Using newly-delegated prize authority,\1\ S&T and OHA have a 
platform for engaging and harvesting non-traditional Government 
performers through a biosurveillance grand challenge on this issue of 
National importance. S&T is also exploring a ``Beyond BioWatch'' Apex 
Lite \2\ program that will, in partnership with OHA and other National 
biodefense stakeholders, work toward implementation of an integrated 
National systems approach to biodetection. We would be happy to share 
this vision and strategic approach to biosurveillance research with the 
subcommittee as it takes shape in the near future.
---------------------------------------------------------------------------
    \1\ The America Creating Opportunities to Meaningfully Promote 
Excellence in Technology, Education, and Science Reauthorization Act of 
2010 (America COMPETES Reauthorization Act Pub. L. 111-358) outlines 
authorities for all Federal agencies to conduct prize competitions to 
engage broadly the American public to stimulate innovation that may 
potentially advance their agency mission.
    \2\ Apex projects are cross-cutting, multi-disciplinary efforts 
requested by DHS components that are high-priority, high-value, and 
short turn-around in nature. They are intended to solve problems of 
strategic operational importance identified by a component leader. Apex 
Lite projects will be a middle ground between traditionally-managed 
projects and Apex efforts, building off lessons learned from previous 
Apex projects and scaling critical Apex elements to different time 
lines, scopes, and foci.
---------------------------------------------------------------------------
                               conclusion
    We want to emphasize that the Secretary, the Department, and our 
offices remain committed to the operational BioWatch Program, the role 
of vigilant biosurveillance as part of the layered approach to the 
Nation's biodefense, and the advancement of innovative technological 
capability as part of an integrated systems approach to surveillance. 
In the coming years, we intend to focus our limited developmental 
resources on capacities to detect bioattacks in near-real time in order 
to enhance protective response actions. However, we will also have to 
consider future needs for detection of a wider range of potential 
threat agents, including genetically-altered, synthetic, or 
unanticipated agents, and possibly to enable detection of food and 
surface contamination. Faster, more detailed, and more reliable 
characterization of bioevents will be necessary to improve situational 
awareness and inform response. We must continue to develop an agile 
approach that accommodates possible epidemics of emerging disease or 
attacks using unforeseen bioagents or agents not addressed by 
stockpiled countermeasures. Strategies for coping with and stopping 
bioterror campaigns must be developed. Mechanisms of international 
cooperation in dealing with infectious disease outbreaks and 
collaborative approaches to financing and refining needed biodefense 
technologies and countermeasures must evolve.
    OHA and S&T are committed to working together with our colleagues 
across the interagency to address these challenges. We are deeply 
appreciative for this subcommittee's continued support for our shared 
goals of health and homeland security.

    Mrs. Brooks. Thank you. The Chairwoman will now recognize 
Dr. Brothers for 5 minutes.

 STATEMENT OF REGINALD BROTHERS, UNDER SECRETARY, SCIENCE AND 
  TECHNOLOGY DIRECTORATE, U.S. DEPARTMENT OF HOMELAND SECURITY

    Mr. Brothers. Thank you, Chairman Brooks, Ranking Member 
Payne, and distinguished Members of the subcommittee. Thank you 
for the opportunity to join you today to discuss the Science 
and Technology Directorate, lessons learned from the BioWatch 
acquisition and the Department's unified approach to 
biosurveillance moving forward.
    It is a privilege to appear before you today, along with my 
DHS colleagues from health affairs and the management 
directorate, as well as distinguished experts from the GAO and 
IDA.
    Today, science and technology were once drivers of threats 
and sources of solutions for those threats have also improved 
the lives of countless people. Take the internet, for one 
example. By connecting people and facilitating the flow of 
information, it is a central driver of the modern economy. It 
is also, among other things, a platform of choice for 
distributing IED recipes, has made communities around the world 
vulnerable to potentially devastating cyber attacks.
    With numerous potential industrial, environmental, and 
human impacts, biotechnology and the evolution of modern 
biosciences have a potential to be the next major disruptive 
force along the lines of the information technology revolution.
    Already, the availability of equipment and information has 
broken down barriers previously insurmountable to individuals 
outside State-funded biological programs. That means that the 
risk of groups or individuals creating and using a powerful 
bioweapon is real.
    Since becoming under secretary for science and technology, 
I have seen first-hand a passion at S&T for work on these types 
of tough problems. It really is a passion. Walking the halls of 
the directorate, I hear how excited people are to get up in the 
morning and put their shoulder into tough homeland security 
problems.
    For addressing biological risks to homeland security, we 
work hand-in-hand with a broadly-based community of biodefense 
professionals and stakeholders, to develop technology that 
enables better preparation for and more effective response to 
biological attacks.
    At S&T, our National Biodefense Analysis and 
Countermeasures Center in Fort Detrick, Maryland is a fully 
integrated element of our Nation's biodefense and National 
resource retribution and analysis during bioterrorism or 
biocrime events. Our chemical and biological defense division 
is dedicated to providing comprehensive biological threat 
characterization, as well as development of capabilities for 
pre-event assessment, discovery, and interdiction and for 
warning, notification, and analysis during incidents.
    As you know, the BioWatch program was once a part of the 
directorate. S&T has a long history of research and development 
support to the BioWatch program from before DHS's Office of 
Health Affairs or OHA was created through the present time.
    In my time at S&T, I have seen a very functional, a very 
positive working relationship with OHA. We are unified in 
pursuit of the shared goal of development and implementation 
from an effective and efficient National biosurveillance 
framework. That is encouraging to me. Because now more than 
ever, S&T and OHA must be totally synchronized. The 
cancellation of BioWatch Gen-3 acquisition gives us at DHS an 
opportunity to jointly evaluate the current operational 
BioWatch program and to offer systems approach to next-
generation biodetection.
    Numerous lessons learned by S&T, OHA and management 
directorate, are already guiding our unified path forward; for 
that reason, creating positive relationships between all three 
of our organizations. I am confident that we won't repeat past 
mistakes.
    Moving forward, S&T and OHA will evaluate the full range of 
near- and long-term investments in new or updated capabilities. 
This includes potential for short-term, incremental 
improvements to the existing BioWatch system. This also 
includes longer-term shifts toward a distributed, networked, 
sensor-agnostic architecture with potential capability well 
beyond what the Department initially envisioned for the Gen-3 
acquisition.
    At S&T, we are considering a potential BioWatch Apex 
program, Beyond BioWatch Apex program. Like other Apexes, this 
would be cross-cutting multidisciplinary effort and be focused 
on high-priority problems and would have a leadership buy-in in 
robust partnership between organizations.
    It would, in partnership with OHA and other National buyer 
defense stakeholders, work toward implementation of integrated 
National systems approach to biodetection. As part of this 
effort, we also look forward to using newly available tools 
like prize authority. These have potentials of platform for 
biosurveillance grand challenge that would allow S&T and OHA to 
access untapped energy, enthusiasm, expertise from the broader 
community of Government performance.
    As I am sure my colleagues will all agree, I believe all 
the ingredients necessary for a unified path forward for 
joining implementation of long-term vision for biosurveillance 
will make Americans safe at a reasonable cost are in place at 
DHS. Working together, S&T and OHS, OHA's energetic workforces 
have the expertise and experience necessary to successfully 
develop a technology that will be a pillar for our Nation's 
next-generation biodefense.
    We certainly learned from lessons in the past, but we are 
focused right now on the opportunity before us to make a 
lasting impact on the Nation's long-term biodefense and the 
opportunity to safeguard the country against current emerging 
biological threats.
    To close, I want to thank you again for the opportunity to 
join today's discussion. The ingredients for success are in 
place, and we at DHS are unified in our path forward.
    I look forward to your questions.
    Mrs. Brooks. Thank you. The Chairwoman now recognizes Mr. 
Cummiskey for 5 minutes.

     STATEMENT OF CHRIS CUMMISKEY, ACTING UNDER SECRETARY, 
  MANAGEMENT DIRECTORATE, U.S. DEPARTMENT OF HOMELAND SECURITY

    Mr. Cummiskey. Thank you.
    Good morning, Chairman Brooks, Ranking Member Payne, 
Congressman Palazzo. Thank you for the opportunity to appear 
before you today to discuss lessons learned from the BioWatch 
program, as well as specifically discussing the acquisition of 
Generation-3. I also want to thank my fellow colleagues, the 
DHS, as well as the GAO, and the Institute for Defense Analysis 
for their dedicated work in this important area.
    As you understand the under secretary for management is 
also the chief acquisition officer for the Department. I 
oversee the policies 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.
    During the past 5 years, DHS has continued to focus on 
strengthening our acquisition oversight policies to ensure our 
major programs are steeped in established management 
principles. As indicated by GAO, we have made substantial 
progress in building an oversight process with clear and 
logical approval of gateposts backed by business intelligence 
that flags programs that are off-track.
    I am pleased to report that in the past 3 years, no program 
has been authorized to proceed to the next Acquisition 
gatepost, unless they have followed the rigor prescribed in our 
governing policy, Management Directive 102, which was put into 
place in 2010.
    The BioWatch program has played an important role in the 
Department's layered approach to mitigate new and evolving 
threats in providing Nation-wide biosurveillance capability. 
BioWatch Gen-2 has successfully monitored selected aerosolized 
biothreat agents in highly-populated areas.
    I want to reaffirm the Secretary's commitment to 
Generation-2 as the Department's program of record for aerosol 
biological threat detection. In 2009, Congress authorized the 
Department to begin the development and testing of Generation-3 
and noted that DHS must strike a careful balance between 
expediting the deployment of new technologies and ensuring that 
such technologies be fully validated.
    The Department, now through MD-102 requires clear and 
cogent planning documents that are closely tracked throughout 
the acquisition life cycle.
    In September 2012, GAO concluded that the performance, 
schedule, and cost expectations presented in the early 
estimates were not developed with the rigor required in MD-102. 
As a result, significant adjustments were made to both schedule 
and cost estimates.
    GAO further recommended that BioWatch perform an analysis 
of alternatives or AOA, as well as reevaluate the mission needs 
statement to ensure acquisition requirements were well-
grounded.
    In an acquisitions decision memorandum issued in September 
of that same month, then-Under Secretary for Management Rafael 
Borras, as the chief acquisition officer, paused further 
development of the BioWatch Gen-3 program pending the findings 
of the AOA.
    In December 2013, the AOA was published and found that 
while an autonomous detection capability would be a valuable 
addition to current BioWatch operations, there was not an 
overwhelming benefit to justify the cost of a full 
technological replacement estimated at $5.7 billion.
    Following a thorough review of the Generation-3 acquisition 
of record, the AOA and other studies of future biotechnology 
detection, Department officials concluded that the autonomous 
detection system under consideration would not meet the 
program's objectives.
    Based on this information, Secretary Johnson tasked me to 
take the appropriate actions to cancel all acquisition-related 
activities associated with BioWatch Gen-3.
    On April 24, I convened an acquisition review board and 
directed that the Science and Technology Directorate work in 
concert with the Office of Health Affairs BioWatch program 
office to explore the development of an effective and 
affordable automated aerosol biodetection capability going 
forward.
    In conclusion, DHS has worked diligently to improve its 
acquisition processes and these efforts have produced more 
effective governance to current and future acquisitions.
    BioWatch is an example of the relevant application of the 
Department's improved acquisition oversight process.
    As the Department's chief acquisition officer, I can assure 
you this morning that I will continue to evaluate the risks of 
this program and will only provide authorization to proceed 
when well-established criteria are met.
    Thank you, Madam Chairwoman.
    [The prepared statement of Mr. Cummiskey follows:]
                 Prepared Statement of Chris Cummiskey
                             June 10, 2014
    Chairwoman Brooks, Ranking Member Payne, and other distinguished 
Members of the subcommittee, I thank you for the opportunity to appear 
before you today to discuss lessons learned from the BioWatch program, 
specifically with regard to acquisition of Generation-3.
    I wish to express appreciation to my colleagues from the Government 
Accountability Office (GAO) for their long-standing and dedicated work 
to support the transformation of management at DHS. Over the past 4 
years, we have forged an excellent working relationship and reached 
common ground on many issues. I am gratified by their recent comments 
that recognized the substantial progress the Department has made to 
address its high-risk areas. We are committed to sustaining that 
progress given the concrete changes we've made to solidify our 
acquisition management infrastructure, which includes policies, 
delegations, business intelligence, and governance.
    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 
greater vigor in the detailed analysis required before authorizing 
programs to proceed to the next phase of the life cycle.
    When I arrived at DHS nearly 5 years ago, the Management 
Directorate was in the process of strengthening acquisition policies 
and procedures. Former Under Secretary Rafael Borras and I directed our 
program management oversight function to ensure that any new procedures 
adhered to established management principles, and balanced risk 
mitigation with the need for rapid deployment. Our goal was to build an 
oversight process with clear and logical approval ``gate posts'' and 
business intelligence that could ``flag'' programs that were off-track. 
Finally, we wanted risk to be a significant factor considered during 
all acquisition decision events especially at the planning phase when 
strategies are developed. While the preference is to seek ``existing'' 
technologies, I understand that the Department's mission may sometimes 
require development of higher-risk, emerging technology.
    I am pleased to report that in the past 3 years, no program has 
been authorized by the Acquisition Review Board (ARB) to proceed to the 
next acquisition phase unless it has completed the required reviews and 
documentation.
                               background
    In 2011, Under Secretary Borras and I created the Office of Program 
Accountability and Risk Management (PARM) to serve as the Department's 
central oversight body for major acquisition programs. A few of PARM's 
principal oversight responsibilities is to standardize policy, conduct 
independent assessments of major programs at each stage of the life 
cycle, and ensure those programs have sufficient documentation before 
requesting authorization from the ARB to proceed to the next phase.
    To further drive common processes and procedures, Management 
Directive (MD) 102-01 was issued to serve as the Department-wide policy 
for acquisition programs and is recognized by all component executives 
as the road map to document and manage their programs. In recent years, 
the ARB has increased its oversight reach and has taken action to 
cancel or pause several poor-performing/higher-risk programs that were 
not achieving the pre-established cost, schedule, and performance 
goals. When a program is paused, the DHS chief acquisition officer 
conducts an assessment and if the program should continue forward with 
development, the lead program manager develops the appropriate 
acquisition strategy and path forward. The program will remain in 
paused status until the chief acquisition officer approves the 
acquisition strategy and path forward.
    In accordance with this directive, acquisition decisions are made 
throughout a program's life cycle based on valid cost estimates and 
planning documents, such as Mission Needs Statements and Operational 
Requirements Documents. In the past 4 years, the Department has made 
great strides to improve the governance and oversight of acquisition 
programs. The oversight framework has been further strengthened through 
the establishment of a Component Acquisition Executive structure that 
serves as the single point of accountability for programs within the 
components. I rely heavily on the CAEs to support PARM by providing 
day-to-day oversight of major programs within their components.
    Since 2009, not only have we have forged a comprehensive 
integration strategy, we have also demonstrated substantial progress, 
which led GAO to acknowledge in their 2013 High-Risk report that, 
``Significant progress has been made to transform and integrate the 
Department into a more cohesive unit.'' In fact, they stated in 
December 2012 that, ``the Department has made substantial progress in 
many areas and if their Integrated Strategy is fully implemented, they 
are on a path to be removed from the High-Risk List.'' Any progress we 
have made is the direct result of an across-the-board commitment by 
operational components and support components to follow a clear and 
logical strategy. This progress has been reinforced by the willingness 
of our components and line-of-business chiefs to leverage best 
practices in both the procurement and program management disciplines.
    In April of this year, Secretary Johnson issued a memorandum 
directing the Department to further unify its efforts in the way we 
plan, program, budget, and execute our investments. One of the 
principal focus areas of the Unity of Effort initiative is the 
continued refinement of our acquisition oversight framework, especially 
in the earliest stages where acquisition requirements are developed.
                            biowatch program
    The BioWatch program plays an important role in the Department's 
layered approach to mitigate new and evolving threats by providing 
Nation-wide biosurveillance capability. BioWatch Generation-2 (Gen-2) 
is successfully monitoring for select aerosolized biothreat agents in 
highly-populated areas. I want to reaffirm the Secretary's commitment 
to Gen-2 as the Department's program of record for aerosolized 
biological agent threat detection.
    In 2009, Congress authorized the Department to begin the 
acquisition of a next generation (Generation-3, or Gen-3) BioWatch 
system that would be able to respond autonomously to the aerosol 
release of certain biothreat agents, providing significantly earlier 
detection than Gen-2 and enabling quicker deployment of life-saving 
medical countermeasures. Congress noted that DHS must ``strike a 
careful balance between expediting the deployment of new technologies 
and ensuring that such technologies have been fully validated.'' 
Congress appropriated $34.5 million for field testing of systems beyond 
Gen-2 and requested that any resulting contracts be awarded 
competitively. It is important to note that acquisitions of new or 
emerging technology pose a higher risk than traditional acquisitions 
given the need to field cost-effective solutions at a pace that matches 
the evolving threat. As such, the Department requires clear and cogent 
planning documents that are closely tracked and followed throughout the 
development life cycle.
    In September 2012, GAO concluded that the performance, schedule, 
and cost expectations for the Gen-3 acquisition, which predated the 
issuance of MD-102, were not developed with the rigor required in that 
document. As a result, significant adjustments were made over time to 
both schedule and cost estimates. GAO further recommended that BioWatch 
perform an Analysis of Alternatives (AoA), as well as re-evaluate its 
mission needs statement to ensure acquisition requirements were well-
grounded and that BioWatch pursued an optimal solution. In an 
Acquisition Decision Memorandum issued September 7, 2012, the Under 
Secretary for Management, as the Acquisition Decision Authority, 
directed the BioWatch program to develop requirements and conduct an 
AoA.
    In December 2013, the AoA was published and found that an 
autonomous detection capability would be a valuable addition to current 
BioWatch operations. However, it did not find an overwhelming benefit 
to justify the cost of a full technology replacement. Following a 
thorough review of the Gen-3 acquisition of record, the AoA, and other 
studies on the future biodetection technology, the Office of Health 
Affairs, in consultation with the Science & Technology Directorate, 
Office of Policy, and Management Directorate, concluded that the 
autonomous detection system under consideration would not meet program 
objectives and recommended that DHS leadership cancel its acquisition.
    Based on this information, Secretary Johnson directed me to cancel 
all acquisition-related activities associated with BioWatch Gen-3. On 
April 24, 2014, I convened an ARB and requested that the Science & 
Technology Directorate work with the BioWatch program office to improve 
our biodetection capability by exploring the development and maturation 
of an effective and affordable automated aerosol biodetection system.
                               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 Gen-3 
program is an example of the successful application of the Department's 
improved acquisition oversight process because it ultimately led to the 
correct decision that the level of maturity of the technology was not 
sufficient at this date to justify proceeding. As the Department's 
Chief Acquisition Officer, I will continue to evaluate the risk of this 
and other programs, 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 in improving acquisition and investment management 
for the Department's portfolio of major programs. I believe we are 
making progress in 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.

    Mrs. Brooks. Thank you, Mr. Cummiskey.
    The Chairman now recognizes Mr. Currie for 5 minutes. Thank 
you.

 STATEMENT OF CHRIS CURRIE, ACTING DIRECTOR, HOMELAND SECURITY 
   AND JUSTICE ISSUES, U.S. GOVERNMENT ACCOUNTABILITY OFFICE

    Mr. Currie. Thank you, Chairman Brooks and Ranking Member 
Payne, other Members of the subcommittee. I appreciate the 
opportunity to be here today.
    Today I would like to focus on the past, present, and the 
future of the BioWatch program. There are three areas I would 
like to discuss.
    First are lessons learned from the Generation-3 
acquisition. Second, are concerns our work has raised about DHS 
research and development efforts. Third are observations we 
have and questions that should be answered as the BioWatch 
program moves ahead.
    Regarding the Gen-3 acquisition, lessons can definitely be 
learned. We reported that DHS pursued the Gen-3 technology 
without always following its acquisition policies. For example, 
we previously recommended that DHS conduct a robust analysis of 
program alternatives, the AOA, and cost estimate for Gen-3.
    Prior program decisions were made without this information.
    DHS listened. The more robust AOA they completed last year 
and updated cost estimate provided better information to make a 
cost-benefit decision about the program. DHS ultimately decided 
to cancel Gen-3 based on that information.
    While opinions will differ on whether Gen-3 was a failure 
or not, what is clear is that DHS made the decision to cancel 
by following its acquisition processes.
    This is encouraging progress because as this committee 
knows, and as you mentioned in your opening statement, Madam 
Chairwoman, failure to follow its acquisition policies is a 
major reason that DHS management is still on GAO's high-risk 
list.
    My second point today pertains more specifically to the 
Science and Technology Directorate. Our body of work on DHS 
research and development, or R&D, raises management concerns 
that could impact S&T's efforts to develop future biodetection 
technologies.
    More specifically, we reported in 2012 that DHS had no 
policies at the time for defining, overseeing, or coordinating 
R&D across the whole Department. As a result, R&D efforts were 
fragmented and overlapping, which could lead to unnecessary 
duplication.
    Further, while S&T had agreements in place to transfer 
technologies to other DHS components, none of these at the time 
had resulted in a technology actually being transitioned to 
implementation. Also, some DHS component officials did not view 
coordination with S&T positively.
    We made a number of recommendations to address these 
issues. DHS agreed, and they are making progress in addressing 
them. However, efforts are early and it is too soon to tell 
what impact these efforts are going to have.
    The third area I would like to discuss are observations to 
consider as the BioWatch program moves ahead. For years, the 
focus has been on developing the Gen-3 system. Now that there 
is no Gen-3 to replace it, there are new questions about the 
performance and maintainability of the current system that need 
to be answered.
    For example, DHS officials told us that some Gen-2 
equipment is nearing the end of its useful life and will need 
to be replaced as early as next year. But it is not yet clear 
how the current system will be replaced or upgraded.
    Also while Gen-2 has been used in the field for more than a 
decade now, information about its technical capabilities, 
including the limits of detection, is actually pretty limited.
    For example, in 2011 the National Academy of Sciences 
reported that rapid initial deployment of BioWatch did not 
allow for sufficient testing and evaluation.
    I would like to close with one last broader point today. 
This February, as you noted, your committee held a hearing on 
the overall bioterror threat. With the Gen-3 cancellation and 
Gen-2 system nearing the end of its life, DHS and its partners 
have an opportunity right now to assess the overall strategy 
for biosurveillance and how technology fits into it.
    In July 2012, the White House issued the National Strategy 
for Biosurveillance. However, it didn't include a way to 
identify investment priorities among various biosurveillance 
efforts, such as how much do we invest in detection 
technologies?
    These details were to be part of an implementation plan to 
follow, as you noted, the National strategy, but it has not 
been issued yet. We think these details will be very important 
to inform DHS decisions moving ahead.
    This completes my prepared remarks. I would be pleased to 
answer any questions you have.
    [The prepared statement of Mr. Currie follows:]
                   Prepared Statement of Chris Currie
                             June 10, 2014
                             gao highlights
    Highlights of GAO-14-267T, a testimony before the Subcommittee on 
Emergency Preparedness, Response, and Communications, Committee on 
Homeland Security, House of Representatives.
Why GAO Did This Study
    DHS's BioWatch program aims to detect the presence of biological 
agents considered to be at a high risk for weaponized attack in major 
U.S. cities. Initially, development of a next generation technology 
(Gen-3) was led by DHS S&T, with the goal of improving upon currently-
deployed technology (Gen-2). Gen-3 would have potentially enabled 
collection and analysis of air samples in less than 6 hours, unlike 
Gen-2 which can take up to 36 hours to detect and confirm the presence 
of biological pathogens. Since fiscal year 2007, OHA has been 
responsible for overseeing the acquisition of this technology. GAO has 
published a series of reports on biosurveillance efforts, including a 
report on DHS's Gen-3 acquisition.
    In April 2014, DHS canceled the acquisition of Gen-3 and plans to 
move development efforts of an affordable automated aerosol 
biodetection capability, or other enhancements to the BioWatch system 
to DHS S&T. This statement addresses: (1) Observations from GAO's prior 
work on the acquisition processes for Gen-3, and the current status of 
the program; (2) observations from GAO's prior work related to DHS S&T 
and the impact it could have on the BioWatch program; and (3) future 
considerations for the currently deployed Gen-2 system.
    This testimony is based on previous GAO reports issued from 2010 
through 2014 related to biosurveillance and research and development, 
and selected updates obtained from January to June 2014. For these 
updates, GAO reviewed studies and documents and interviewed officials 
from DHS and the National labs, which have performed studies for DHS.
 biosurveillance.--observations on the cancellation of biowatch gen-3 
               and future considerations for the program
What GAO Found
    In September 2012, GAO reported that the Department of Homeland 
Security (DHS) approved the Office of Health Affairs (OHA) acquisition 
of a next generation biosurveillance technology (Gen-3) in October 2009 
without fully following its acquisition processes. For example, the 
analysis of alternatives (AoA) prepared for the Gen-3 acquisition did 
not fully explore costs or consider benefits and risk information in 
accordance with DHS's Acquisition Life-cycle Framework. To help ensure 
DHS based its acquisition decisions on reliable performance, cost, and 
schedule information, GAO recommended that before continuing the Gen-3 
acquisition, DHS reevaluate the mission need and alternatives. DHS 
concurred with the recommendation and in 2012 decided to reassess 
mission needs and conduct a more robust AoA. Following the issuance of 
the AoA in December 2013, DHS decided in April 2014 to cancel Gen-3 
acquisition and move the technology development back to the Science and 
Technology Directorate (S&T). According to DHS's acquisition decisions 
memorandum, the AoA did not confirm an overwhelming benefit to justify 
the cost of a full technology switch to Gen-3. Moreover, DHS officials 
said the decision to cancel the Gen-3 acquisition was a cost-
effectiveness measure, because the system was going to be too costly to 
develop and maintain in its current form.
    GAO's prior work on DHS research and development (R&D) highlights 
challenges DHS may face in shifting efforts back to S&T and acquiring 
another biodetection technology. In September 2012, GAO reported that 
while S&T had dozens of technology transition agreements with DHS 
components, none of these had yet resulted in a technology developed by 
S&T being used by a component. At the same time, other DHS component 
officials GAO interviewed did not view S&T's coordination practices 
positively. GAO recommended that DHS develop and implement policies and 
guidance for defining and overseeing R&D at the Department that 
includes a well-understood definition of R&D that provides reasonable 
assurance that reliable accounting and reporting of R&D resources and 
activities for internal and external use are achieved. S&T agreed with 
GAO's recommendations and efforts to address them are on-going. 
Addressing these coordination challenges could help to ensure that 
S&T's technology development efforts meet the operational needs of OHA.
    Cancellation of the Gen-3 acquisition also raises potential 
challenges that the currently deployed Gen-2 system could face going 
forward. According to DHS officials, DHS will continue to rely on its 
Gen-2 system as an early indicator of an aerosolized biological attack. 
However, in 2011, National Academy of Sciences raised questions about 
the effectiveness of the currently deployed Gen-2 system. While Gen-2 
has been used in the field for over a decade, the National Academy of 
Sciences reported that information about the technical capabilities of 
the system, including the limits of detection, is limited. In April 
2014, DHS officials also indicated that they will soon need to replace 
laboratory equipment of the currently-deployed Gen-2 system and 
readjust life-cycle costs since there will be no Gen-3 technology to 
replace it.
    Chairman Brooks, Ranking Member Payne, and Members of the 
subcommittee: I am pleased to be here today to discuss our observations 
on the Department of Homeland Security's (DHS) BioWatch program, with 
particular focus on the cancellation of BioWatch Generation-3 (Gen-3) 
and future considerations for the program. In recent years, there has 
been an increasing awareness of the potential for biological agents to 
be used as weapons of mass destruction. Experts and practitioners, 
reacting to an increasing awareness of the speed and intensity with 
which a biological weapon of mass destruction could affect the Nation, 
have sought to augment traditional surveillance activities with 
biosurveillance programs and systems.\1\ DHS's BioWatch program is an 
example of such an effort. BioWatch 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.
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    \1\ 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. 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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    DHS's Office of Health Affairs (OHA) oversees the currently-
deployed BioWatch technology--Generation-2 (Gen-2)--which can take 12 
to 36 hours to confirm the presence of pathogens. Until recently, DHS 
had been pursuing a next-generation technology (Gen-3) with the goal of 
improving upon existing technology by enabling autonomous collection 
and analysis of air samples using the same laboratory science that is 
carried out in manual processes to operate the current system (e.g., 
lab-in-a-box). The new technology would have reduced detection time, 
potentially generating a result in under 6 hours, and eliminated 
certain labor costs.
    This statement includes observations from our prior work: (1) On 
DHS's acquisition processes for Gen-3, and the current status of the 
program; (2) related to DHS's Science and Technology Directorate (S&T) 
and the impact it could have on the BioWatch program; and (3) future 
considerations for the currently-deployed Gen-2 system.
    This testimony is based on our previous reports issued from 2010 
through 2014 related to biosurveillance, research and development, and 
acquisitions.\2\ For this work, 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. We also interviewed S&T leadership, technical 
division directors, and DHS component officials to discuss S&T and 
DHS's research and development (R&D) coordination processes. More 
detailed information on our scope and methodology appears in the 
published reports. This statement is also based in part on selected 
updates we conducted in June 2013 and July 2013 related to DHS's R&D 
efforts and its oversight of R&D efforts across the Department and on 
selected updates related to the BioWatch program conducted from January 
to June 2014.\3\ For updates on the BioWatch program, we analyzed 
studies and documents and interviewed knowledgeable officials at DHS 
and the National laboratories, which have performed testing and studies 
for DHS.
---------------------------------------------------------------------------
    \2\ GAO, Biosurveillance: Efforts to Develop a National 
Biosurveillance Capability Need a National Strategy and a Designated 
Leader, GAO-10-645 (Washington, DC: June 30, 2010). GAO, Department of 
Homeland Security: Oversight and Coordination of Research and 
Development Should Be Strengthened, GAO-12-837 (Washington, DC: Sept. 
12, 2012). GAO, Biosurveillance: Observations on BioWatch Generation-3 
and Other Federal Efforts. GAO-12-994T (Washington, DC, Sept. 2012). 
GAO-13-279SP. GAO, Biosurveillance: DHS Should Reevaluate Mission Need 
and Alternatives before Proceeding with BioWatch Generation-3 
Acquisition, GAO-12-810 (Washington, DC: Sept. 10, 2012). GAO, 
Department of Homeland Security: Opportunities Exist to Strengthen 
Efficiency and Effectiveness, Achieve Cost Savings, and Improve 
Management Functions, GAO-13-547T (Washington, DC: April 26, 2013). 
GAO, Department of Homeland Security: Oversight and Coordination of 
Research and Development Efforts Could Be Strengthened, GAO-13-766T 
(Washington, DC, July 17, 2013). GAO, Canceled DOD Programs: DOD Needs 
to Better Use Available Guidance and Manage Reusable Assets, GAO-14-77 
(Washington, DC: Mar. 27, 2014). GAO, Homeland Security: Acquisitions: 
DHS Could Better Manage Its Portfolio To Address Funding Gaps and 
Improve Communications With Congress, GAO-14-332, (Washington, DC, 
April 2014).
    \3\ GAO-13-766T.
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    We conducted the work upon which this statement is based and the 
selected updates 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. 
Additional details on our scope and methodology can be found in the 
individual products cited throughout this statement.
                               background
DHS Acquisitions and the Cancellation of Gen-3
    We have highlighted DHS acquisition management issues in our high-
risk list since 2005.\4\ Over the past several years, our work has 
identified significant shortcomings in the Department's ability to 
manage an expanding portfolio of major acquisitions.\5\ We have also 
reported that while DHS acquisition policy reflects many key program 
management practices intended to mitigate the risks of cost growth and 
schedule slips, the Department did not implement the policy 
consistently.\6\ In 2011, expressing concerns about whether DHS had 
undertaken a rigorous effort to help guide its Gen-3 decision making, 
Members of Congress asked us to examine issues related to the Gen-3 
acquisition. We released a report that evaluated the acquisition 
decision-making process for Gen-3 in September 2012.\7\ As discussed 
later in the statement, we recommended that before continuing the Gen-3 
acquisition, DHS should carry out key acquisition steps, including 
reevaluating the mission need and systematically analyzing alternatives 
based on cost-benefit and risk information.\8\
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    \4\ GAO, High-Risk Series: An Update, GAO-05-207 (Washington, DC: 
January 2005).
    \5\ For examples, see GAO, Homeland Security: DHS Requires More 
Disciplined Investment Management to Help Meet Mission Needs, GAO-12-
833 (Washington, DC: Sept. 18, 2012); Department of Homeland Security: 
Assessments of Selected Complex Acquisitions, GAO-10-588SP (Washington, 
DC: June 30, 2010); and Department of Homeland Security: Billions 
Invested in Major Programs Lack Appropriate Oversight, GAO-09-29 
(Washington, DC: Nov. 18, 2008).
    \6\ GAO, Department of Homeland Security: Progress Made; 
Significant Work Remains in Addressing High-Risk Areas, GAO-14-532T 
(Washington, DC: May 7, 2014). The reference to DHS acquisition policy, 
for purposes of this testimony, consists of Management Directive (ADM) 
102-01, and an associated guidebook. The overall policy and structure 
for acquisition management outlined in DHS's AMD 102-01 includes the 
Department's Acquisition Life-cycle Framework--a template for planning 
and executing acquisitions. DHS's Acquisition Life-cycle Framework 
includes four acquisition phases through which DHS determines whether 
it is sensible to proceed with a proposed acquisition: (1) Identify a 
capability need; (2) analyze and select the optimal solution to meet 
that need; (3) obtain the solution; and (4) produce, deploy, and 
support the solution.
    \7\ GAO-12-810.
    \8\ The Gen-3 acquisition was in the early stages of Phase 3 
(obtain the solution) when the acquisition was placed on hold.
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    On April 24, 2014, DHS issued an Acquisition Decision Memo (ADM) 
announcing the cancellation of the acquisition of Gen-3.\9\ The ADM 
also announced that S&T will explore development and maturation of an 
effective and affordable automated aerosol biodetection capability, or 
other operational enhancements, that meet the operational requirements 
of the BioWatch system.\10\ DHS's S&T conducts research, development, 
testing, and evaluation of new technologies that are intended to 
strengthen the United States' ability to prevent and respond to 
nuclear, biological, explosive, and other types of attacks within the 
United States. S&T has six technical divisions responsible for managing 
S&T's research R&D portfolio and coordinating with other DHS components 
to identify R&D priorities and needs.\11\ Most of S&T's R&D portfolio 
consists of applied research and development projects for its DHS 
customers.
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    \9\ An Acquisition Decision Memo (ADM) is the official record of 
the Acquisition Decision Event and describes the decisions made and any 
action items to be satisfied as conditions of the decision made by the 
Acquisition Review Board.
    \10\ DHS began to develop autonomous detection technology in 2003. 
Initially, development of technologies to support autonomous detection 
was led by DHS's S&T, which partnered with industry. Since fiscal year 
2007, DHS's OHA has been responsible for overseeing the acquisition of 
this technology.
    \11\ These divisions are the Borders and Maritime Division, 
Chemical/Biological Defense Division, Cyber Security Division, 
Explosives Division, Human Factors/Behavioral Sciences Division, and 
the Infrastructure Protection and Disaster Management Division. In 
addition, S&T's First Responder Group (FRG) identifies, validates, and 
facilitates the fulfillment of first responder requirements through the 
use of existing and emerging technologies, knowledge products, and the 
development of technical standards, according to S&T FRG officials.
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BioWatch in Action
    The BioWatch program collaborates with 30 BioWatch jurisdictions 
throughout the Nation to operate approximately 600 Gen-2 collectors. 
These detectors rely on a vacuum-based collection system that draws air 
samples through a filter. These filters must be manually collected and 
transported to State and local public health laboratories for analysis 
using a process called Polymerase Chain Reaction (PCR). During this 
process, the sample is evaluated for the presence of genetic material 
from five different biological agents. If genetic material is detected, 
a BioWatch Actionable Result (BAR) is declared. Figure 1 shows the 
process that local BioWatch jurisdictions are to follow when deciding 
how to respond to a BAR.\12\
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    \12\ The BioWatch program defines a BAR as one or more Polymerase 
Chain Reaction (PCR)-verified positive results from a single BioWatch 
collector. A positive result requires multiple strands of the PCR-
amplified DNA to match an algorithm that has been designed to indicate 
the presence of genetic material from one or more of the agents in 
question. 


 our prior work on the gen-3 acquisition identified challenges and dhs 
                     has since canceled the program
    Our prior findings and recommendations related to the Gen-3 
acquisition provide DHS with lessons learned for future decision 
making. In September 2012, we found that 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, we found that 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.\13\ 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, we 
concluded that the utility of the Mission Needs Statement as a 
foundation for subsequent acquisition efforts was limited.
---------------------------------------------------------------------------
    \13\ 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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    Additionally, in September 2012, we found that 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 (AoA) 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, we found that the 
AoA 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 a predetermined solution from the Mission 
Needs Statement, the AoA did not fully explore costs or consider 
benefits and risk information as part of the analysis. Instead, the AoA 
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 further informed 
decision makers.\14\ Additionally, we found that the AoA 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.
---------------------------------------------------------------------------
    \14\ 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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    As we reported in September 2012, BioWatch program officials 
acknowledged that other options--including but not limited to deploying 
some combination of both technologies (the currently-deployed system 
and an autonomous detection system), 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 AoA would not be necessary because there was already 
Departmental consensus that autonomous detection was the optimal 
solution. Because the Gen-3 AoA did not: Evaluate a complete solution 
set; consider complete information on cost and benefits; and include a 
cost-benefit analysis, we concluded that it did not provide information 
on which to base trade-off decisions.
    To help ensure DHS based its acquisition decisions on reliable 
performance, cost, and schedule information developed in accordance 
with guidance and good practices, in our September 2012 report, we 
recommended that before continuing the Gen-3 acquisition, DHS 
reevaluate the mission need and possible alternatives based on cost-
benefit and risk information. DHS concurred with the recommendation and 
in 2012, DHS directed the BioWatch program to complete an updated 
AoA.\15\
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    \15\ According to DHS's Acquisition Life-cycle Framework, an 
Analysis of Alternatives 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.
---------------------------------------------------------------------------
    DHS contracted with the Institute for Defense Analyses (IDA) to 
conduct the updated AoA, which they issued in December 2013. In January 
2014, as part of recommendation follow-up, we reviewed the completed 
analysis. IDA cited the DHS Acquisition Management Instruction/
Guidebook and its appendix on conducting an AoA as the criteria for 
their study. The management directive lays out a sample framework that 
details the specific steps to take in evaluating acquisition 
alternatives, which the contractor used for completing its study. On 
the basis of our review, we concluded that the IDA-conducted AoA 
followed the DHS guidance and resulted in a more robust exploration of 
alternatives than the previous effort. The AoA was not intended to 
identify a specific solution to address DHS's requirements for earlier 
warning and detection capabilities. According to IDA, the AoA does not 
claim to select a solution, but rather to present alternatives and the 
information required to select an alternative based on cost and 
effectiveness trade-offs.
    On April 24, 2014, the DHS Acquisition Review Board reviewed the 
BioWatch Gen-3 acquisition with OHA and issued an ADM announcing the 
cancellation of the acquisition of Gen-3. According to the DHS ADM, the 
AoA ``did not confirm an overwhelming benefit to justify the cost of a 
full technology switch'' to Gen-3. The ADM also announced that S&T will 
explore development and maturation of an effective and affordable 
automated aerosol biodetection capability, or other operational 
enhancements, that meet the operational requirements of the BioWatch 
system.
    In April 2014, BioWatch Program officials said multiple factors 
influenced the decision to end the Gen-3 acquisition, including budget 
considerations, considerations regarding the readiness level of the 
technology, and the cost to field and maintain the technology. BioWatch 
Program officials said that the Homeland Security Studies and Analysis 
Institute's and our recommendations to complete a robust AoA, which 
resulted in not identifying a clear path forward for a single 
technology type for the Gen-3 acquisition, was also a contributing 
factor. According to BioWatch Program officials, DHS has not ruled out 
the possibility of pursuing autonomous detection for the BioWatch 
program, but officials said the technology would have to cost less to 
develop and maintain than was estimated for the Gen-3 system.
    Earlier this year, we reported that when programs have been 
canceled, cost, schedule, and performance problems have often been 
cited as reasons for this decision, and cancellation can be perceived 
as failure.\16\ However, in some circumstances, program cancellation 
may be the best choice. In an April 2014 interview, BioWatch Program 
officials said the Gen-3 acquisitions process yielded many benefits, 
despite its cancellation. BioWatch Program officials said the program 
office has learned and gained much from this experience, including 
engaging State and local stakeholders to help ensure confidence in the 
system and BioWatch program; finding better ways to test technologies 
and refine the Testing and Evaluation guidance; and developing robust 
acquisition documentation for the Department. BioWatch program 
officials said the decision to cancel the Gen-3 acquisition was a cost-
effectiveness measure, because the system was going to be too costly to 
develop and maintain in its current form. We reported in 2012 that 
while the DHS June 2011 life-cycle cost estimate reported $104 million 
in actual and estimated costs from fiscal year 2008 through fiscal year 
2011, it also indicated that Gen-3 was expected to cost $5.8 billion 
(80 percent confidence) from fiscal year 2012 through June 2028. 
However, the original life-cycle cost estimate for the 2009 decision--a 
point estimate unadjusted for risk--was $2.1 billion.\17\
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    \16\ GAO-14-77.
    \17\ We reported in 2012 that this point estimate was not completed 
in accordance with the GAO Cost Estimating Guide, which DHS uses for 
cost estimating to help ensure the reliability of its cost estimates. 
According to the Guide, a point estimate, by itself, provides no 
information about the underlying uncertainty other than that it is the 
value chosen as most likely. A confidence interval, in contrast, 
provides a range of possible costs, based on a specified probability 
level. See, GAO, Cost Estimating and Assessment Guide, GAO-09-3SP 
(Washington, DC: Mar. 2, 2009).
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  dhs r&d efforts also face challenges that could impact the biowatch 
                                program
    DHS has taken positive steps as we recommended to complete a robust 
assessment of the available biodetection technology alternatives and 
has taken into consideration the cost and readiness level of the 
current technology. However, our prior work reviewing DHS research and 
development efforts highlights challenges DHS may face in transitioning 
the future biodetection development efforts S&T is now charged with 
exploring back to the program office, OHA. For example, S&T works with 
DHS components to ensure that it meets their R&D needs by signing 
technology transition agreements (TTA) to ensure that components use 
the technologies S&T develops. However, we previously reported in 
September 2012 that while S&T had 42 TTAs with DHS components, none of 
these TTAs has yet resulted in a technology being transitioned from S&T 
to a component.\18\ In that review we also found that other DHS 
component officials we interviewed did not view S&T's coordination 
practices positively. Specifically, we interviewed officials in six 
components to discuss the extent to which they coordinated with S&T on 
R&D activities. Officials in four components stated that S&T did not 
have an established process that detailed how S&T would work with its 
customers or for coordinating all activities at DHS. For example, 
officials in one component stated that S&T has conducted R&D that it 
thought would address the component's operational need but, when work 
was completed, the R&D project did not fit into the operational 
environment to meet the component's needs.
---------------------------------------------------------------------------
    \18\ GAO-12-837.
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    We also reported in 2012 that OHA, which oversees operation of the 
BioWatch program, and S&T already had a history of working together on 
advancing the technology used by the BioWatch program.\19\ However, 
differences of opinion on key performance measures had created a 
challenge for these two offices related to future biodetection 
technologies. For example, during our 2012 review of the Gen-3 
acquisition, officials from OHA said both OHA and S&T commissioned the 
Sandia National Laboratory to conduct similar studies on the 
performance characteristics of the Gen-3 autonomous detection system, 
but the two offices requested the use of different performance metrics 
to evaluate Gen-3's detection capability. OHA officials said they 
supported using the fraction of the population covered as the metric 
because it is directly related to public health outcomes, while S&T 
preferred to use the probability of detection. While we recognize there 
are advantages and disadvantages for choosing different performance 
metrics, technology transition of the R&D project developed by S&T 
could prove challenging in the future if fundamental differences like 
this are not resolved early to help ensure the technology meets the 
operational needs of the program office.
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    \19\ GAO-12-810.
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    In our September 2012 report, we concluded that DHS and S&T could 
be in a better position to coordinate the Department's R&D efforts by 
implementing a specific policy outlining R&D roles, responsibilities, 
and processes for coordinating R&D. As a result, we recommended that 
DHS develop and implement policies and guidance for defining and 
overseeing R&D at the Department-level that includes a well-understood 
definition of R&D that provides reasonable assurance that reliable 
accounting and reporting of R&D resources and activities for internal 
and external use are achieved. DHS agreed with our recommendation, and 
in April 2014, updated its guidance to include a definition of R&D, but 
efforts to develop a specific policy outlining R&D roles and 
responsibilities and a process for coordinating R&D with other offices 
remain on-going and have not yet been completed.\20\
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    \20\ The DHS Delegation to the Under Secretary for Science and 
Technology, DHS Delegation Number: 10001, Revision Number: 01, Annex A 
includes the definition for research and development.
---------------------------------------------------------------------------
     future considerations for the currently-deployed gen-2 system
    With the cancellation of the Gen-3 acquisition, DHS will continue 
to rely on its currently deployed Gen-2 system as an early indicator of 
an aerosolized biological attack. Cancellation of the Gen-3 system also 
raises questions that need to be answered about the future maintenance 
of the Gen-2 system, since it will no longer be replaced, as planned. 
According to program officials that we recently contacted, DHS is 
considering multiple options to upgrade the current technology to 
improve detection capabilities in the wake of the Gen-3 acquisition 
cancellation. In April 2014, program officials described some of the 
options they are considering to upgrade the currently deployed system, 
including:
   The addition of a trigger to the current system to enhance 
        performance indoors. These are generally systems that provide 
        very fast but nonspecific warnings of a potential agent 
        release, because they do not identify the type of biological 
        material detected. However, DHS is exploring how to use a 
        trigger to indicate when an air sample should be collected and 
        taken to the laboratory for analysis.
   Use of a wet or liquid filter system rather than the current 
        dry filter system. Collecting samples directly into a liquid 
        could also increase the odds that any microorganisms would 
        remain alive for subsequent testing.
   Increased frequency of manual filter collection and testing, 
        which would likely increase costs.
   Other options for hand-held or portable detection devices.
    While OHA officials determine the next steps with S&T for the 
BioWatch program to try and address the capability gap that Gen-3 
intended to fill, there are other considerations for the currently-
deployed system, such as maintainability of the current technology and 
equipment and the costs associated with any upgrades to extend the life 
of the existing system. For example, BioWatch program officials 
indicated they will need to replace the laboratory equipment for the 
currently-deployed system, as early as 2015, and readjust life-cycle 
costs.\21\
---------------------------------------------------------------------------
    \21\ The Consolidated Appropriations Act, 2014, appropriated the 
Office of Health Affairs $85 million for BioWatch operations. Pub. L. 
No. 113-76, 128 Stat. 5, 260.
---------------------------------------------------------------------------
    Further, while Gen-2 has been used in the field for over a decade, 
information about the technical capabilities for the Gen-2 system, 
including the limits of detection, is limited. In 2011, the National 
Academy of Sciences stated that the rapid initial deployment of 
BioWatch did not allow for sufficient testing, validation, and 
evaluation of the system and its components.\22\ The 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. Further, the 
report also stated that to achieve its health protection goals, the 
BioWatch system should be better linked to a broader and more effective 
National biosurveillance framework that will help provide State and 
local public health authorities, in collaboration with the health care 
system, with the information they need to determine the appropriate 
response to a possible or confirmed attack or disease outbreak.
---------------------------------------------------------------------------
    \22\ See Institute of Medicine and National Research Council, 
BioWatch and Public Health Surveillance, 2011.
---------------------------------------------------------------------------
    Our prior work has also highlighted the uncertainty about the 
incremental benefit of this kind of environmental monitoring as a risk 
mitigation activity because of its relatively limited scope and the 
challenges agencies face in making these investment decisions. In our 
June 2010 report on Federal biosurveillance efforts, we recommended the 
Homeland Security Council direct the National Security Staff to 
identify a focal point to lead the development of a National 
biosurveillance strategy. We made this recommendation because 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.\23\ In July 2012, the White 
House released the National Strategy for Biosurveillance to describe 
the U.S. Government's approach to strengthening biosurveillance, but it 
does not fully meet the intent of our prior recommendations, because it 
does not yet offer a mechanism to identify resource and investment 
needs, including investment priorities among various biosurveillance 
efforts. We remain hopeful that the forthcoming strategic 
implementation plan which was supposed to be issued in October 2012 and 
promised 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 that will help 
prioritize resource allocation. However, as of March 14, 2014 the 
implementation plan had not been released.
---------------------------------------------------------------------------
    \23\ GAO-10-645.
---------------------------------------------------------------------------
    Chairman Brooks, Ranking Member Payne, and Members of the 
subcommittee, this concludes my prepared statement. I would be happy to 
respond to any questions you may have.

    Mrs. Brooks. Thank you, Mr. Currie.
    The Chairwoman now recognizes Dr. Disraelly for 5 minutes.

  STATEMENT OF DEENA S. DISRAELLY, RESEARCH STAFF, STRATEGY, 
 FORCES, AND RESOURCES DIVISION, INSTITUTE FOR DEFENSE ANALYSES

    Ms. Disraelly. Thank you, Chairman Brooks, Ranking Member 
Payne, and distinguished Members of the subcommittee for 
inviting me to speak with you today. My name is Dr. Deena 
Disraelly and I am a research staff member at the Institute for 
Defense Analyses and the team leader on the BioWatch Analysis 
of Alternatives. I am honored to be here today to discuss our 
work with you.
    The Institute for Defense Analyses is a Federally-funded 
research and development center assisting the Department of 
Defense and other Federal agencies in addressing important 
National security issues, particularly those requiring 
scientific and technical expertise.
    We were tasked by the BioWatch program office within the 
Department of Homeland Security to conduct an Analysis of 
Alternatives subsequent to the Government Accountability Office 
report on biosurveillance and the BioWatch Gen-3 acquisition.
    Our study is documented in the BioWatch Analysis of 
Alternatives, which is summarized very briefly in the written 
testimony we submitted.
    Based on the Department's guidance, an Analysis of 
Alternatives provides the systematic, analytic, and decision-
making process to facilitate identification of an optimal 
solution for an identified capability gap.
    In this case, the capability gap was established in 
Homeland Security Presidential Directive-10, which called for 
early warning, detection, or recognition of biological weapons 
attacks to permit a timely response to mitigate their 
consequences.
    The intent of the Analysis of Alternatives was to identify 
material and non-material biological surveillance capabilities, 
with the potential to reduce casualties resulting from the 
release of an aerosolized pathogen, and to conduct our study in 
accordance with the Department's guidance documents on 
established metrics and methodologies.
    It was not within the scope of our study to provide a 
recommendation about the disposition of the BioWatch Gen-3 
system.
    Following a review of approximately 500 biological 
surveillance capabilities, we identified four candidate 
alternatives, each with an anticipated operational capability 
to perform the BioWatch mission and concepts of operation to 
detect an aerosolized biological event.
    Autonomous identification systems are labs in a box that 
collect and test environmental samples on site. Environmental 
collection systems collect environmental samples that are then 
picked up and transported to an off-site laboratory for 
analysis.
    The Sentinel population alternative involves police 
officers carrying lightweight portable collectors for 
subsequent laboratory sample analysis.
    Clinical diagnosis and diagnostics are a combination of 
technologies and activities used to identify disease in 
symptomatic individuals and notify the appropriate public 
health authorities.
    The Analysis of Alternatives provides the Government 
decision-makers a framework for thinking about the trade-offs 
among the alternatives examined. Our findings can be summarized 
as follows.
    Clinical diagnosis and diagnostics is the least expensive 
alternative, and was assumed to have a probability of detection 
of 100 percent because every disease is eventually diagnosed. 
However, diagnosis takes time and detection of an event 
requires some number of diagnosed cases. Therefore this 
alternative also had the highest number of casualties.
    The Sentinel population alternative had a high probability 
of detection, and those detections happened relatively quickly, 
resulting in lower numbers of casualties. That probability of 
detection is achieved with a large number of roving detectors, 
meaning a large number of samples processed several times a 
day.
    The result is a life-cycle cost estimate four times that of 
environmental collection and autonomous identification.
    Environmental collection is currently deployed, as has been 
noted, and is less expensive than autonomous identification. 
However, it also takes longer to identify agents, which may 
lead to an increase in casualties for detected attacks.
    Autonomous identification has a slightly higher life-cycle 
cost estimate than environmental collection. Additionally, 
while it achieves the fastest detections, when it detects, it 
only detects on average approximately half the number of 
attacks detected by environmental collection, resulting in 
increased numbers of casualties due to large numbers of missed 
attacks.
    HSPD-10 is still in effect and, as such, the imperative 
remains for an early warning and detection system to identify 
biological events and trigger a response to mitigate their 
consequences. Our Analysis of Alternatives provided objective, 
analytical information to support DHS's decision-making with 
regard to that directive.
    This concludes my opening remarks. Thank you.
    [The prepared statement of Ms. Disraelly follows:]
                Prepared Statement of Deena S. Disraelly
                               June 2014
                            a. introduction
    Good morning Chairman Brooks, Ranking Member Payne, and 
distinguished Members of the House Subcommittee on Emergency 
Preparedness, Response, and Communication. My name is Dr. Deena 
Disraelly. I am a research staff member at the Institute for Defense 
Analyses (IDA) and the project lead for the BioWatch Analysis of 
Alternatives (AoA). I am honored to appear before you today to discuss 
this study and its results.
    In October 2012, the BioWatch Program Office asked IDA, a 
Federally-Funded Research and Development Center (FFRDC) assisting the 
Department of Defense and other Federal agencies in addressing issues 
of National security, to conduct an AoA of capabilities to meet the 
biosurveillance mission. According to U.S. Department of Homeland 
Security (DHS) guidance, an AoA provides ``a systematic analytic and 
decision-making process to identify and document an optimal solution 
for an identified mission capability gap.''\1\ The BioWatch AoA 
addresses a capability gap identified in Homeland Security Presidential 
Directive (HSPD)-10 Biodefense for the 21st Century, namely the 
requirement for an ``early warning, detection, or recognition of 
biological weapons attacks to permit a timely response to mitigate 
their consequences.''\2\ This AoA identified material (technology) and 
non-material (activity) biological surveillance capabilities--comprised 
of one or more technologies or related activities--with the potential 
to reduce mortality and morbidity from an aerosolized release of a 
pathogen. Specifically, the AoA focused on four candidate alternatives 
that will be defined later in this presentation.
---------------------------------------------------------------------------
    \1\ U.S. Department of Homeland Security (DHS), Acquisition 
Management Instruction/Guidebook, DHS Instruction Manual 102-01-001, 
Appendix G (Washington, DC: DHS, 2011), G-3.
    \2\ President George W. Bush, Biodefense for the 21st Century 
(hereafter: HSPD-10), Homeland Security Presidential Directive HSPD-10 
(Washington, DC: The White House, 2004).
---------------------------------------------------------------------------
    While the objective of this study was to identify and compare 
capabilities, IDA was not asked to provide DHS with any recommendations 
about the disposition of the BioWatch Generation-3 (Gen-3) system.
    The IDA team's BioWatch Analysis of Alternatives \3\ was delivered 
to the BioWatch Program Office in December 2013. What follows is a 
brief discussion of the AoA objectives, methodology, and findings 
extracted from the more detailed discussion in that paper.
---------------------------------------------------------------------------
    \3\ Deena Disraelly et al., BioWatch Analysis of Alternatives, 
Institute for Defense Analyses (IDA), Paper P-5083 (Alexandria, VA: 
IDA, 2013).
---------------------------------------------------------------------------
      b. analysis of alternatives (aoa) background and objectives
    In accordance with HSPD-10, the DHS BioWatch Program is intended to 
provide ``a Nation-wide biosurveillance capability to monitor for 
select aerosolized biothreat agents in highly populated areas . . . and 
is a partnership between Federal, State, and local governments for the 
purpose of ensuring the protection of the Nation's population against 
biological threats.''\4\ The objective of the BioWatch collectors is to 
monitor the air continuously for agents of concern and provide regular 
analyses of the results. The goal is to field a system that is 
operational 24 hours per day, 365 days per year and able to signal an 
attack early enough to promote quick response.\5\
---------------------------------------------------------------------------
    \4\ DHS, Office of Health Affairs (DHS/OHA), Gen-3 [Generation-3] 
Autonomous Detection System, Operational Requirements Document (ORD) v 
2.2 (hereafter: Gen-3 ORD) (Washington, DC: DHS, 2012), ES-1, For 
Official Use Only (FOUO).
    \5\ DHS/OHA, Gen-3 ORD, FOUO; Bush, HSPD-10.
---------------------------------------------------------------------------
    The BioWatch Program was created in 2003 ``to provide early 
warning, detection, or recognition of biological attack.''\6\ The first 
environmental collectors (Generation-1) were deployed in March of 2003, 
with deployment eventually reaching 20 major metropolitan areas. The 
program began a second deployment (Generation-2) immediately in the 
wake of the previous deployment, adding ten jurisdictions and ``indoor 
monitoring capabilities in three high-threat jurisdictions and provided 
additional capacity for events of national significance, such as major 
sporting events and political conventions.''\7\ Generation-1 and 
Generation-2 collectors are predominantly located in outdoor 
environments and the overall system, as currently implemented, relies 
on both the collectors and teams of field and laboratory personnel. The 
2009 DHS Appropriations Act established the appropriations for an 
improved biodetection capability.
---------------------------------------------------------------------------
    \6\ U.S. Government Accountability Office (GAO), BioSurveillance: 
DHS Should Reevaluate Mission Need and Alternatives before Proceeding 
with BioWatch Generation-3 Acquisition (hereafter: BioSurveillance--
Reevaluate Mission Need), GAO-12-810 (Washington, DC: GAO, 2012), 9.
    \7\ Ibid.
---------------------------------------------------------------------------
    In 2010, DHS published its first Acquisition Directive (DHS 
Directive 102-01),\8\ which requires DHS components pursuing 
acquisition programs to perform an AoA or Alternatives Analysis \9\ 
during procurement. Two years later, the Homeland Security Studies and 
Analysis Institute published the BioWatch Gen-3 Program Acquisition 
Assessment. Soon after, the U.S. Government Accountability Office (GAO) 
published GAO-12-810, BioSurveillance: DHS Should Reevaluate Mission 
Need and Alternatives Before Proceeding with BioWatch Gen-3 
Acquisition. Both reports recommended that the BioWatch Program Office 
perform an AoA for the BioWatch Program. Subsequently, the BioWatch 
Program Office asked IDA to conduct an AoA of biosurveillance 
capabilities in accordance with applicable DHS guidance.
---------------------------------------------------------------------------
    \8\ DHS published an interim Acquisition Directive 102-01 in 
November 2008; this document includes the requirement for a capability 
development plan ``including the initial ground rules for the Analysis 
of Alternatives (AoA) or Alternatives Analysis (AA) . . . to begin the 
Analyze/Select phase'' once the Mission Needs Statement (MNS) is 
approved. DHS, Acquisition Directive 102-01, version 1.9, Interim 
(Washington, DC: DHS, 2008), 14.
    \9\ DHS, Acquisition Management Directive 102-01 (hereafter: AMD 
102-01) (Washington, DC: DHS, 2010), 6; this document has since been 
supplemented and collated into DHS, Acquisition Management Directive 
102-01, Revision 2 (hereafter: AMD 102-01 Rev. 2) (Washington, DC: DHS, 
2013).
---------------------------------------------------------------------------
                       c. aoa project methodology
1. Methodology Overview
    The first step in the AoA process was to consult relevant studies 
and literature on biosurveillance and conduct a market survey of all 
biosurveillance capabilities and their component technologies/
activities (hereafter referred to simply as capabilities). During the 
course of the market survey, the IDA team identified approximately 500 
biosurveillance capabilities that are either readily deployable or in 
development. Constraints were defined then used to identify selected 
candidate alternatives that could fulfill the BioWatch mission need and 
requirements.\10\ Specifically, the selected candidate alternatives met 
the following constraints:
---------------------------------------------------------------------------
    \10\ DHS, Mission Needs Statement for BioWatch Gen-3 Autonomous 
Detection System (hereafter: Mission Needs Statement v.2.0), Version 
2.0, DRAFT (Washington, DC: DHS, 2012), FOUO.
---------------------------------------------------------------------------
    1. Include technologies and activities at, or equivalent to, 
        technology readiness level (TRL) 6.\11\
---------------------------------------------------------------------------
    \11\ ``Department of Homeland Security Research & Development 
Partnerships Group: Product Realization Guide,'' DHS, accessed January 
7, 2013, https://www.dhs.gov/sites/default/files/publications/product-
realization-guide-partnership-focus-508-1.pdf. Technology readiness 
level 6 indicates that the capability of a representative model or 
prototype system has been tested in a relevant environment, including a 
laboratory or simulated operational environment. Taken from: Homeland 
Security Institute, Department of Homeland Security Science and 
Technology Readiness Level Calculator, Version 1.1 (Washington, DC: 
Homeland Security Institute, 2009), B-23.
---------------------------------------------------------------------------
    2. Be available to deploy within 2 to 3 years and be fully 
        fieldable within 2 to 5 years of the completion of the AoA.\12\
---------------------------------------------------------------------------
    \12\ This is based on the stated assumption that a BioWatch Gen-3 
detector will be available and fielded within 2 to 5 years.
---------------------------------------------------------------------------
    3. Be able to detect an aerosolized biological attack for, at 
        least, the same five threshold biological agents as required 
        for Gen-3.\13\
---------------------------------------------------------------------------
    \13\ DHS, BioWatch Gen-3 Systems Engineering Life Cycle Tailoring 
(SELCT) Plan for the BioWatch Generation-3 Program, Version 1.1 
(Washington, DC: DHS/OHA, 2012), A-1, FOUO; and DHS/OHA, Gen-3 ORD, 3-
1, FOUO.
---------------------------------------------------------------------------
    4. Are anticipated to be fully fieldable and sustainable within the 
        budget already allocated for BioWatch over the next 5 years 
        (the budget figure is in fiscal year 2013 dollars and is not 
        adjusted for inflation or other time-dependent increases).\14\
---------------------------------------------------------------------------
    \14\ In the final evaluation of alternatives, budget should be a 
constraint and is, therefore, listed here. Budget, however, is not used 
as a hard boundary in this AoA because the exact BioWatch budget is not 
known. GAO, BioSurveillance--Reevaluate Mission Need, 26, 30-31; and, 
DHS, ``BioWatch Gen-3 Phase II Industry Day,'' briefing, Washington, 
DC, September 12, 2011.
---------------------------------------------------------------------------
    5. Fill a capability gap as defined in the BioWatch Gen-3 Mission 
        Needs Statement and align with (or have) a viable concept of 
        operations.
    Based on these criteria, the IDA team proposed four alternatives 
for additional analyses. Additional analyses included casualty 
modeling, life-cycle cost estimates, and evaluation of the Net Present 
Value and Return on Investment.
2. Selected Alternative Biosurveillance Candidates
    The four selected candidate alternatives identified through the AoA 
process and approved as reasonable capability representatives by the 
DHS Acting Principal Deputy Assistant Secretary of Health Affairs \15\ 
are (in alphabetical order):
---------------------------------------------------------------------------
    \15\ Sally Phillips, ``DHS Office of Health Affairs (OHA) Review of 
Candidates Selected for BioWatch Analysis of Alternatives (AoA),'' 
memorandum to Deena Disraelly, May 24, 2013.
---------------------------------------------------------------------------
    1. Autonomous Identification:\16\ Autonomous and integrated multi-
        component systems that perform all environmental sampling and 
        on-site testing without human intervention or control.
---------------------------------------------------------------------------
    \16\ Proposed as an autonomous detection platform, BioWatch Gen-3 
would be an example of an autonomous identification capability.
---------------------------------------------------------------------------
    2. Clinical diagnosis/diagnostics with mandatory U.S. Centers for 
        Disease Control and Prevention (CDC)/local public health 
        disease reporting (hereafter Clinical Diagnosis/Diagnostics): 
        Technologies and activities used in combination to evaluate and 
        assess the disease manifesting in symptomatic individuals, 
        combined with notification to the CDC regarding the detection 
        of specific diseases in a timely manner.
    3. Environmental collection with manual sample retrieval with 
        analytical laboratory (hereafter Environmental Collection\17\): 
        Technologies that collect aerosol samples that are manually 
        retrieved and transported to an analytical laboratory for 
        analysis.
---------------------------------------------------------------------------
    \17\ Environmental Collection simulates the current BioWatch 
Generation-2 system.
---------------------------------------------------------------------------
    4. Sentinel population with technological collectors with 
        analytical laboratory (hereafter Sentinel Population): A 
        limited portion of the population (e.g., law enforcement 
        officers) wearing lightweight, portable, personal air samplers 
        to collect samples for detection/identification of biological 
        agents with subsequent laboratory analysis.
3. Metrics, Scenarios, and Assumptions
            a. Mission Tasks, Measures of Effectiveness (MOE), and 
                    Measures of Performance (MOP)
    Upon the selection of the four alternatives, the next step in the 
AoA process was to formulate a hierarchy of metrics including mission 
tasks, measures of effectiveness, and measures of performance.
    Per HSPD-10 and the BioWatch documentation, a BioWatch system has 
four specific mission tasks:\18\
---------------------------------------------------------------------------
    \18\ Bush, HSPD-10, 6; DHS, Mission Needs Statement v.2.0, C-5, 
FOUO; and DHS/OHA, SELCT Plan, 3-4, FOUO.
---------------------------------------------------------------------------
   Early warning: Detect an aerosolized biological agent attack 
        24 hours per day, 365 days per year;
   Reinforce existing systems: Utilize concept of operations, 
        processes, and other biosurveillance activities that have been 
        accepted by Federal, State, and local authorities to evaluate a 
        BioWatch Actionable Result (BAR);\19\
---------------------------------------------------------------------------
    \19\ In this instance, the term BioWatch Actionable Result (BAR) 
denotes the positive presence of a biological threat agent in an 
environmental or clinical sample; for the purposes of this study, the 
BioWatch actionable result triggers a response in the form of a 
stakeholder meeting/teleconference to discern if a threat exists and 
determine what, if any, public health intervention is required.
---------------------------------------------------------------------------
   Timely response: Identify a BioWatch actionable result and 
        initiate an appropriate public health intervention in a timely 
        manner; and
   Operate in Multiple Environments: Operate in outdoor, 
        indoor, and mixed (indoor and outdoor) environments.
    Based on the mission tasks, three measures of effectiveness were 
identified: (1) Availability--degree that a system or group of systems 
are operationally capable of performing an assigned mission;\20\ (2) 
casualties--number of exposed and infected individuals who eventually 
manifest disease symptoms following a BioWatch actionable result and a 
subsequent trigger of a public health intervention,\21\ estimated as a 
function of the systems' ability to respond within an allotted time and 
the speed or delay between steps in a biosurveillance system;\22\ and 
(3) probability of detection--effectiveness of the alternative at 
detecting aerosolized biological weapons attacks, measured using the 
probability of detection calculation as a proxy as described below.\23\
---------------------------------------------------------------------------
    \20\ Defense Acquisition University, ``Operational Availability,'' 
in Glossary of Defense Acquisition Acronyms and Terms, 15th ed., 
December 2012, accessed July 30, 2013, https://dap.dau.mil/glossary/
Pages/2331.aspx.
    \21\ For each candidate alternative, casualties are calculated 
following a BioWatch actionable result, which triggers a public health 
intervention.
    \22\ Douglas N. Klaucke et al., ``Guidelines for Evaluating 
Surveillance Systems,'' Morbidity and Mortality Weekly Report (MMWR) 
37, no. S-5 (1988): 1-18; and Ruth A. Jajosky and Samuel L. Groseclose, 
``Evaluation of Reporting Timeliness of Public Health Surveillance 
Systems for Infectious Diseases,'' BioMed Central (BMC) Public Health 
4, no. 29 (2004): 1-9.
    \23\ Nerayo P. Teclemariam et al., BioWatch Technical Analysis of 
Biodetection Architecture Performance, Sandia Report, SAND2012-0125 
(Livermore, CA: Sandia National Laboratories, 2012), 16, FOUO.
---------------------------------------------------------------------------
    The IDA team then identified five measures of performance that were 
mapped to the measures of effectiveness (see Figure 1). These measures 
of performance included coverage, number of detectable and identifiable 
agents, operational environment, probability of detection, and time to 
detect/identify.
            b. Operational and Modeling Scenarios
    The four selected candidate alternatives were evaluated against 
three operational scenarios each with its own operational setting--
outdoors (represented by metropolitan Chicago), indoors (represented by 
O'Hare International Airport, Chicago), and inside a transportation 
center (represented by Grand Central Terminal, New York). These 
scenarios were intended to replicate the scenarios outlined for 
BioWatch Gen-3 in its concept of operations document.\24\ This 
evaluation used results derived from earlier modeling efforts conducted 
by Sandia National Laboratories (SNL) and Los Alamos National 
Laboratories (LANL), which represented attacks with three biothreat 
agents (Bacillus anthracis, Yersinia pestis, and Francisella 
tularensis)\25\ and variable attack sizes, locations, and times of day.
---------------------------------------------------------------------------
    \24\ DHS, Acquisition Concept of Operations (CONOPS) for BioWatch 
Gen-3 (Hereafter: Acquisition CONOPS for Gen-3), version 0.1 
(Washington, DC: DHS, 2012), FOUO.
    \25\ Due to the diversity of these agents with regard to contagion, 
lethality, and long-term care requirements, these three diseases were 
considered representative of the diseases resulting from aerosolized 
exposure to the five threshold biological agents required for Gen-3.
---------------------------------------------------------------------------
    The operational scenarios were modeled to determine the amount of 
time required to detect and identify an agent, the time to establish a 
point of distribution (POD) to begin dissemination of prophylaxis, the 
probability that a given alternative would detect an attack, and the 
number of casualties resulting from the attack. Figure 2 illustrates 
the modeling process used in this AoA. Life-cycle cost estimates were 
constructed independently for the four alternatives. Next, modeling and 
life-cycle cost estimates results were combined to evaluate Net Present 
Value and Return on Investment.\26\
---------------------------------------------------------------------------
    \26\ Net Present Value is the present value of calculated benefits 
and costs over a defined number of time periods--for the purpose of 
IDA's study, 20 years. Return on Investment is the net benefit 
expressed as a percentage of the investment amount. Net Present Value 
and Return on Investment may also be negative depending on perceived 
risk of attack and value of human life for three of the four 
alternatives. Clinical Diagnosis/Diagnostics always has a positive Net 
Present Value and Return on Investment.
---------------------------------------------------------------------------
            c. Assumptions
    Several assumptions were included in the modeling process. They are 
as follows:
    1. Each biological surveillance alternative capability can be 
        assessed independently or in combination with other 
        capabilities.
    2. Three diseases--anthrax, plague, and tularemia--are assumed to 
        be representative of the diseases in the BioWatch Gen-3 
        operational requirements document (ORD).
    3. Biological exposure and contagious spread (if any) are 
        restricted and limited to specific geographical location/region 
        where the release occurred.
    4. A BioWatch Gen-3 autonomous biological agent detector would be 
        available for deployment in 2 to 5 years.
    5. One biological identification is a BioWatch actionable result.
    6. Casualty estimates are given in days (rather than hours) to 
        avoid implying a higher level of precision than is supported by 
        the relevant literature.
    7. Notional classes of capabilities are an appropriate 
        representation of alternatives.
    8. Timeliness of the response is a function of when the public 
        health intervention occurs as defined by the antibiotic 
        prophylaxis points of distribution being opened to the public.
    9. Twenty-four hours is required from the decision to deploy the 
        strategic National stockpile for antibiotic prophylaxis to the 
        opening of the points of distribution with an additional 24 
        hours to distribute the prophylaxis \27\ for all candidate 
        alternatives and excursions.
---------------------------------------------------------------------------
    \27\ Mark Whitworth, RSS Analysis Project Final Report (Cambridge, 
MA: Center for Emergency Response Analytics, 2009), 7.
---------------------------------------------------------------------------
    10. The study assumes that antibiotic prophylaxis is distributed to 
        the entire population on the day the points of distribution 
        open; prophylaxis is effective 1 day later.
    11. The population is assumed to be 100% compliant in taking the 
        directed course of antibiotic prophylaxis.
    12. For the outdoor release, all individuals with a given 
        aerosolized agent concentration at a given latitude and 
        longitude receive the same exposure.\28\
---------------------------------------------------------------------------
    \28\ Roebert L. Stearman, Protection Against Chemical Attack 
Provided by Buildings, Technical Report DPG-S-TA-85-05 (Dugway, UT: 
U.S. Army Dugway Proving Ground, 1985).
---------------------------------------------------------------------------
    13. Detections in a scenario are independent of any other nearby 
        alternative employments (e.g., there are no outdoor detections 
        for an indoor scenario).\29\
---------------------------------------------------------------------------
    \29\ The versions of the outdoor and indoor transport and 
dispersions models employed in this study to estimate agent 
concentrations were unable to exchange data between one another, making 
it very difficult to transfer agent concentrations from one domain to 
another.
---------------------------------------------------------------------------
    14. Casualties are evaluated as a function of exposure to a 
        biological agent and the resulting symptomatic illness; mass 
        casualty medical interventions are not included in the 
        modeling.
    15. Life-cycle cost estimate calculations are made in U.S. 
        Government fiscal year 2013 dollars, with results presented at 
        the 50% confidence level.\30\
---------------------------------------------------------------------------
    \30\ See footnote 1 in ``Certification of Acquisition Funding'' 
(memorandum from Peggy Sherry, Chief Financial Officer, to Component 
Senior Financial Officers, Department of Homeland Security, December 2, 
2012).
---------------------------------------------------------------------------
    16. Each year in the life-cycle cost estimate is based on the 
        fiscal year, which runs from October 1 to September 30 and 
        program costs are incurred beginning on October 1, 2013.
    17. Estimates assume a 20-year operational life span beginning in 
        fiscal year 2014 and ending in fiscal year 2033, with full 
        implementation of material solutions by fiscal year 2018.
    18. Material solutions were assumed to be deployed to 50 cities per 
        the concept of operations for BioWatch Gen-3.\31\
---------------------------------------------------------------------------
    \31\ DHS, Acquisition CONOPS for Gen-3, 45-47, FOUO.
---------------------------------------------------------------------------
    19. The IDA team excluded the costs of construction/base operation 
        of certain public health infrastructure, notably hospitals and 
        analytical or clinical laboratory facilities.
    20. Estimates do not include either the cost of patient treatment 
        once a decision has been made to establish points of 
        distribution for prophylaxis or the cost of remediation (e.g., 
        facility decontamination).
    21. Estimates include an information management system (IMS) that 
        was developed and costed independent of each alternative.
    22. The cost of decommissioning hardware is assumed to be similar 
        for all material systems.
    23. Unless otherwise noted, life-cycle cost estimates do not 
        include the cost of equipment being further designed and 
        developed using Government funds, assuming that solutions are 
        fully developed and could be purchased from a vendor. 
        Additionally, unless otherwise noted, test and evaluation costs 
        are not included. Both these assumptions could increase life-
        cycle cost estimates.
                        d. aoa project findings
1. Modeling Findings
    The biosensor alternatives--specifically Autonomous Identification, 
Environmental Collection, and the Sentinel Population alternative--
would benefit from improved probability of detection. Probability of 
detection can be improved by either increasing the number of systems 
deployed (for the Autonomous Identification and Environmental 
Collection systems) or by increasing the sensitivity \32\ of these 
systems. Improved probability of detection, however, may also increase 
system costs.
---------------------------------------------------------------------------
    \32\ System sensitivity is the amount of mass of agent required to 
be present in a sample for it to be identified by a detector or in a 
laboratory process.
---------------------------------------------------------------------------
    For the biosensor alternatives in an outdoor attack, probability of 
detection is approximately 50% or less for attacks that cause 100 or 
more casualties and 65% or less for 10,000 casualties. Indoors, 
probability of detection is greater, approaching 100% in those cases in 
which there are upwards of 10,000 casualties, resulting in less 
reliance on clinical diagnostics/diagnoses to trigger the distribution 
of prophylaxis.
    In general, for attack scenarios modeled in this AoA:
   All four alternatives demonstrated approximately equivalent 
        availability for aerosolized biological agent events: i.e., 
        equivalent coverage of 50 (or more) cities; ability to detect 
        the five threshold BioWatch agents or more; and capability to 
        operate in a variety of environments.
   Autonomous Identification was consistently the quickest 
        alternative to identify any of the three agents (at 6 hours), 
        followed by the Sentinel Population alternative (generally at 
        18 hours), Environmental Collection (at 34 hours), and Clinical 
        Diagnosis/Diagnostics (at 4-13 days, depending on the agent). 
        Timeliness is illustrated in Figure 3.
   Clinical Diagnosis/Diagnostics has the highest probability 
        of detection (i.e., all agents will ultimately be detected) for 
        both indoor and outdoor scenarios.
     Environmental Collection and the Sentinel Population 
            alternative approach 99% detection indoors depending on the 
            scenario.
     The probability of detection for Environmental Collection 
            and the Sentinel Population alternatives is less than 50% 
            for the outdoor scenario; for Autonomous Identification, it 
            is less than 25%.
     More detail on the probability of detection results are in 
            Figure 4.
   For detected attacks, Autonomous Identification and Sentinel 
        Population alternatives lead to the fewest casualties, followed 
        by Environmental Collection and Clinical Diagnosis/Diagnostics, 
        though the magnitude of differences between alternatives tends 
        to be agent-dependent. Given the high concentrations found in 
        the indoor scenarios, resulting in the more rapid onset of 
        severe disease symptoms, the biosensor alternatives were less 
        effective at reducing casualties for the indoor scenarios.
   These casualty results are illustrated for anthrax and 
        plague in Figure 5.
    Several factors have the potential to change these findings. They 
include sensor sensitivity, number of sensors deployed, number of 
detections required to initiate a public health intervention, frequency 
of sampling, new diagnostic protocols/tools, leadership's willingness 
to act, different concept of operations and employment, and human 
behavior. There are also several non-quantified considerations that 
should be kept in mind, including false positive rates, situational 
awareness and characterization, rapidly confirmable information, 
possibility of exposure limitation through facility closure (indoor 
scenario), and the availability of forensic samples (wet or dry).
2. Cost Findings
    Life-cycle cost estimates were developed based on the major cost 
drivers for selected candidate alternatives over the 20-year life span. 
The Sentinel Population alternative has the highest life-cycle costs, 
roughly an order of magnitude higher than Autonomous Identification and 
Environmental Collection, which are approximately equivalent. Clinical 
Diagnosis/Diagnostics, which assumes a pre-existing public health 
infrastructure and includes only the costs of testing (not treating) a 
small population of patients and the deployment of an information 
management system, is the lowest-cost alternative. The life-cycle cost 
estimates are illustrated in Figure 6, with Clinical Diagnosis/
Diagnostics as the least expensive option at approximately $43 million. 
Sentinel Population was the most expensive option ($16.4 billion). 
Environmental Collection and Autonomous Identification were estimated 
at $3.7 and $4.2 billion respectively.
    Cost-effectiveness was evaluated by comparing cost against a 
variety of effectiveness measures. Life-cycle cost estimates were 
compared to the probability of detection, the casualties for a number 
of representative attacks, and the detection-adjusted casualties.\33\ 
The Sentinel Population alternative often achieves the lowest detection 
adjusted casualties value, owing to its high probability of rapid 
detection and high cost due to its large number of samples. Conversely, 
although Clinical Diagnosis/Diagnostics has the highest probability of 
detection, the relatively long time before a detection can be obtained 
(and therefore extended time before antibiotic prophylaxis can be 
administered), results in the highest detection adjusted casualties 
value. Environmental Collection and Autonomous Identification are 
roughly equivalent in terms of cost and detection adjusted casualties 
for most scenarios.
---------------------------------------------------------------------------
    \33\ Detection-adjusted casualties estimates the expected number of 
casualties as a function of the probability of detection. It is a 
weighted average of casualties that occur when there is a detection and 
when there is no detection.
---------------------------------------------------------------------------
                         e. concluding remarks
    The principal BioWatch AoA findings are:
   Any biosurveillance solution involves a combination of 
        material and non-material capabilities as well as defined 
        doctrine and procedures to facilitate decisions by local and 
        State leadership, and public health, law enforcement, emergency 
        management, public works, transportation, and other public and 
        private stakeholders.
   Improved probability of detection for the biosensor 
        alternatives options will result in earlier detection and 
        decreased casualties and, therefore, lower detection-adjusted 
        casualties.
   Autonomous Identification, Clinical Diagnosis/Diagnostics, 
        and Environmental Collection were all below the life-cycle cost 
        constraint of $5.8 billion (as cited by the GAO).\34\ The 
        Sentinel Population alternative exceeds the constraint due to 
        the high number of deployed collectors and the associated 
        laboratory and processing requirements.
---------------------------------------------------------------------------
    \34\ ``In June 2011, DHS provided a risk-adjusted estimate at the 
80 percent confidence level of $5.8 billion [2010 dollars];'' GAO, 
BioSurveillance--Reevaluate Mission Need, 3.
---------------------------------------------------------------------------
   The selected candidate alternatives were evaluated against a 
        variety of metrics. These findings, as summarized in Figure 7, 
        present a number of criteria which could, independently or in 
        combination, inform future BioWatch discussions.
    The choice of alternative (whether Autonomous Identification, 
Clinical Diagnosis/Diagnostics, Environmental Collection or a 
combination) depends on a variety of system factors, as well as factors 
with the potential to assist and influence decision makers using 
BioWatch system information. Table 1 shows several criteria that DHS 
might consider, independently or in combination, when selecting a 
BioWatch alternative and the corresponding system potentially best 
suited (given each criteria) for systems deployed outdoors, indoors, 
and in combined environments.
    There is a positive Net Present Value and Return on Investment for 
each of the four alternatives, depending on the perceived risk of 
attack and value associated with a human life. Clinical Diagnosis/
Diagnostics is the least expensive alternative with the highest 
probability of detection but also is likely to result in the highest 
number of casualties due to delays in disease detection and 
identification. Indoors, both Autonomous Identification and 
Environmental Collection have roughly equivalent detection adjusted 
casualties values. Autonomous Identification shows reductions in 
casualties as compared with Clinical Diagnosis/Diagnostics for detected 
attacks due to the system's timeliness of warning, while delays in 
warning for Environmental Collection are ameliorated by its higher 
probability of detection.\35\ Outdoors, Environmental Collection has 
the lowest detection adjusted casualties due to its higher probability 
of detection as compared to Autonomous Identification and its 
timeliness as compared to Clinical Diagnosis/Diagnostics.
---------------------------------------------------------------------------
    \35\ It is important to remember that the AoA used Gen-3 ORD values 
for Autonomous Identification sensitivity rather than a specific system 
data as no representative system has yet been selected. Demonstrated 
improvements in system sensitivity beyond those required in the Gen-3 
ORD improve the system probability of detection and detection adjusted 
casualties as discussed in Section 6.
---------------------------------------------------------------------------
    Insofar as there is a requirement for earlier warning and 
detection, employing a biosensor system according to a planned concept 
of operations--with appropriate response by decision-making authorities 
and timely engagement by public health officials--would yield fewer 
casualties and potentially non-quantifiable benefits, including 
forensic samples, rapidly confirmable information, situational 
awareness and characterization, and improved planning and preparedness.
    Homeland Security Presidential Directive (HSPD)-10, BioDefense for 
the 21st Century states:

``Early warning, detection, or recognition of biological weapons 
attacks to permit a timely response to mitigate their consequences is 
an essential component of biodefense . . . creating a national 
bioawareness system will permit the recognition of a biological attack 
at the earliest possible moment and permit initiation of a robust 
response to prevent unnecessary loss of life, economic losses, and 
social disruption.''\36\
---------------------------------------------------------------------------
    \36\ Bush, HSPD-10, 6.

    HSPD-10 is still in effect. This directive requires DHS to maintain 
a detection and early warning system. This Analysis of Alternatives 
provided DHS with information with which to evaluate alternate 
approaches to providing that capability.
                     Referenced Figures and Tables









    Mrs. Brooks. Thank you, Dr. Disraelly.
    The Chairwoman will now recognize myself for 5 minutes of 
questioning. I will recognize other Members of the subcommittee 
for questions they may wish to ask the witnesses.
    In accordance with our committee rules, I plan to recognize 
Members who were present at the start of the hearing by 
seniority on the subcommittee. Those coming in later will be 
recognized in the order of their arrival.
    I would like to just confirm with everyone, or 
particularly, actually, with Dr. Brinsfield, Dr. Brothers, and 
Dr. Disraelly, do you think--simple yes or no--that 
bioterrorism continues to be a significant threat about which 
this Nation needs to be concerned? Yes or no? That is all I 
want to know. Dr. Brinsfield.
    Dr. Brinsfield. Yes, we continue to be concerned.
    Mrs. Brooks. Dr. Brothers.
    Mr. Brothers. Yes.
    Mrs. Brooks. Dr. Disraelly.
    Ms. Disraelly. Yes.
    Mrs. Brooks. With a yes or no, do you believe, what you 
know now, that the Gen-2 system is sufficient? Yes or no? Dr. 
Brinsfield.
    Dr. Brinsfield. We believe the Gen-2 system works. We 
believe that a Gen-3 system would--or another system that did 
autonomous detection could be an improvement in the future.
    Mrs. Brooks. Okay. Dr. Brothers.
    Mr. Brothers. Agree. I believe we get effectiveness from 
the Gen-2 system and believe we could have some improved 
capabilities with a Gen-3 system.
    Mrs. Brooks. Dr. Disraelly.
    Ms. Disraelly. We believe that environmental collection is 
a viable alternative and that with improvements autonomous 
identification may be, as well.
    Mrs. Brooks. Okay. Thank you. As I noted in my opening 
statement, the administration did release its National 
Biosurveillance Survey--Strategy rather in July 2012, and we 
are now coming up on 2 years and we have yet, as Mr. Currie 
noted, the plan for implementation of this important strategy 
was to be completed in the fall 2012.
    To date that plan has yet to be completed. It seems as if 
we have a National strategy but yet we have no implementation 
plan as to how to implement the strategy, that there has not 
been sufficient attention being driven to this problem.
    Dr. Brinsfield, can you share with us, having served on 
National Security Staff and now in your capacity, can you shed 
any light when this plan will be completed? If you could, 
please share with us what has caused this delay.
    Dr. Brinsfield. I think this plan--it would be honest to 
say that our staff is working diligently with the staff at the 
NSC right now. There is a rapid pace to this implementation 
plan's development, and I have good faith that when it is 
released it will be a good plan and incorporate all the 
necessary elements.
    Mrs. Brooks. What has taken 2 years?
    Dr. Brinsfield. I don't think you could really say any one 
particular issue. I think it is important to make sure that you 
get all the different partners and agencies to the table and 
make sure that we have the right expertise and look at this 
data, the science. So I am very pleased with the progress it is 
making.
    Mrs. Brooks. How many people are working on the plan?
    Dr. Brinsfield. On a regular basis in meetings, the 
meetings tend to be 10 to 20 people big. It depends. There are 
a lot of departments and agencies that participate. We have 
staff members that participate on a regular basis.
    Mrs. Brooks. When can we anticipate the completion of the 
plan? In 2014?
    Dr. Brinsfield. Ma'am, I can't answer that question, but I 
will be glad to work to get back to you.
    Mrs. Brooks. Who is in charge of it?
    Dr. Brinsfield. That would be at the National Security 
Staff for final release.
    Mrs. Brooks. So who is in charge of it? Who is in charge?
    Dr. Brinsfield. Of the National Security Staff?
    Mrs. Brooks. No, of the--who is responsible for ensuring 
there is an implementation plan that is developed?
    Dr. Brinsfield. Ma'am, I will get back to you. I don't want 
to speak to their activities. I will get back to you with an 
answer, if I may.
    Mrs. Brooks. Dr. Brothers, do you know?
    Mr. Brothers. I do not have an answer for that. Glad to 
work with Dr. Brinsfield to come up with an answer.
    Mrs. Brooks. With respect to the Quadrennial Homeland 
Security Review--and this is for Dr. Brinsfield and Dr. 
Brothers--the 2014 Homeland Security review includes a review 
of the biological threat landscape that we have reviewed and 
the Department's strategy to counter these threats. It was--the 
Quadrennial Review was due to Congress by December 21, 2013. Do 
we have any idea when that will be submitted to Congress, Dr. 
Brinsfield or Dr. Brothers?
    Dr. Brinsfield. I am sorry, ma'am. Can you repeat the last 
part of the question?
    Mrs. Brooks. When the 2014 Quadrennial Homeland Security 
Review, it was due to Congress end of 2013, but we have yet to 
see it. Are you familiar with this report?
    Dr. Brinsfield. Very familiar, ma'am, and that is why I was 
trying to make sure I understood correctly. Maybe Mr. Cummiskey 
can answer to the exact date of its release, but very familiar 
with the report and its finding.
    Mr. Cummiskey. Chairwoman Brooks, I understand that the 
QHSR is forthcoming. It should be here shortly in the not-too-
distant future. I can't give you a precise day, but it is 
intended to be here in the next 7 to 10 days.
    Mrs. Brooks. Thank you. Will it address biothreats in the 
report? Do we anticipate that biothreats will be addressed in 
the report?
    Dr. Brinsfield. Yes ma'am, it does.
    Mrs. Brooks. Okay. Thank you. We look forward to that. My 
time is up.
    Mr. Payne. Thank you, Madam Chairwoman. Excuse me.
    This question is for Dr. Brinsfield and Dr. Brothers as 
well. You know, after DHS canceled the Gen-3 acquisition, the 
Secretary directed the Office of Health Affairs and Science and 
Technology Directorate to complete two reports within 2 weeks 
of the April 2014 ADM.
    One report is to address lessons learned and the other is 
to lay out a strategy moving forward. It has been a month-and-
a-half since the decision to discontinue Gen-3 was announced. 
What is the status of those reports requested by the Secretary 
and why have the documents been delayed?
    Dr. Brinsfield. We have been working very closely on those 
documents. We have actually submitted those documents for 
Department review.
    Mr. Payne. Okay. Can you give us an idea or sense of the 
major findings or strategies that will be included?
    Dr. Brinsfield. I think in the first report that looked at 
history, I would concur with much of what has been discussed 
here today. We looked at how information is generated, 
requirements are generated, looking forward to a coordinated 
process in that effect.
    Also looked at how the acquisition process moves forward 
and how we can make sure that the best decisions are being 
made. In the second report, I will defer in a second to Dr. 
Brothers, but I think what we have agreed to is looking 
together in a collaborative fashion at how we can move forward 
in the technology space.
    Mr. Brothers. Yes. I think we have talked to kind-of a 
near-term and a far-term look at this. Where in near-term we 
are looking at what we can do to augment the current system. 
Then in the far-term what we can do to look at increased 
capabilities, maybe distributed, a sensor-agnostic type-of 
system. So we are working together to try to flesh those things 
out.
    Mr. Payne. Okay. Dr. Disraelly, in your testimony you note 
that the IDA team identified about 500 technologies that are 
either readily-deployable or in development, and that 
ultimately you narrowed it down, the available technologies, to 
four for purposes of the AOA. Can you talk about some of the 
technologies that were not selected to be considered for the 
AOA and why?
    Ms. Disraelly. The 500 technologies and capabilities that 
we included, or that we mentioned, included activities, 
programs, and technologies themselves. We sorted those into 29 
classes of capabilities. So basically like was sorted with 
like.
    One example of a technology, for example, that was not 
included was social media. Social media gets a lot of attention 
right now as an epidemiological tool and a tracking tool in the 
public health sector.
    However, people aren't reporting on social media until 
after they have actually been diagnosed with a disease, and 
therefore it doesn't have the timeliness factor that clinical 
diagnosis and diagnostics does because we would already know 
that the disease was present, before social media actually was 
able find it. Does that give you an answer?
    Mr. Payne. Okay. Let's see. In terms of the GAO, Dr. 
Brinsfield, they observed that the National Academy of Sciences 
has raised questions about the effectiveness of the currently 
deployed Gen-2 BioWatch system. You know, other critics have 
raised concerns regarding whether Gen-2 addresses the threats 
raised by our intelligence community. Members of this panel 
have historically raised similar concerns.
    What efforts will you take to examine and reevaluate the 
concerns as you consider replacing Gen-2 equipment? We know 
that it was stated this morning already that some of that 
equipment is coming to the end of its life cycle or its 
usefulness. I think technology has moved dramatically in terms 
of what is possible in this area since Gen-2 was implemented. 
So could you speak to that?
    Dr. Brinsfield. Sure. I will speak briefly and then turn it 
over again. First, to the question of does the current system 
work, we have data analyzing its current effectiveness that we 
would be happy to share with the committee environment, if you 
would like us to come back.
    In terms of future threats, I think exactly as Dr. Brothers 
was saying, as we look at the future technology we want to make 
sure that it covers a broader array and that we think broadly 
about what the current risks are.
    Mr. Brothers. Yes. I mean, I think some of the fundamental 
things we are looking at going forward are getting greater 
confidence in our systems so that the leadership has to make 
decisions of what to do when these events happen that they have 
greater confidence in the answers. A shorter time frame, 
because I think we were talking earlier about casualty rates 
and the importance of early detection.
    So those are some of the things we are looking at. Whether 
we go from signature detection to more anomaly detection, there 
are different ways of thinking about the problem and we will be 
looking at all of those.
    Mr. Payne. From what I understand is that you would need a 
large aerosol pathogen to go through the system in order to 
detect it. What if you had a lone wolf-type situation? Would 
the system be able to capture that? Then the collection time is 
something that we need to consider, 24 to 36 hours before we 
could collect and identify that there is an issue. That is a 
pretty lengthy amount of time.
    Dr. Brinsfield. Yes. I think we are going to look at all 
those issues as we move forward, both shortening the collection 
time, increasing the number of agents, and looking at different 
environments, whether it is just a broad aerosol environment, 
an indoor environment or other types of environments. We might 
want to do a collection. All of these are questions that have 
been looked at and raised and will be good questions to work 
together on going forward.
    Mr. Payne. Okay. Well I hope, you know, based on where we 
are and the technology that we can--you know, we are starting 
all over. We have been working on I guess the Gen-3 really 
since 2003 maybe. So it is about a decade, and now we are going 
back to the drawing board.
    It is very disturbing to have that situation arise now and 
knowing that the technology that we are using--I mean, if we 
started looking at Gen-3 a decade ago, then, you know, what 
does it say of Gen-2 and where it started? You know, we need to 
really find a way to get moving in terms of the technology 
before we have a calamity occur.
    I will yield back. Sorry.
    Mrs. Brooks. Thank you.
    At this time the Chairwoman now recognizes Vice Chair of 
the committee, the gentleman from Mississippi, Mr. Palazzo, for 
5 minutes of questioning.
    Mr. Palazzo. Thank you, Madam Chairwoman.
    Secretary Cummiskey, the Department has had a number of 
failed acquisitions over the course of its relatively short 
existence, SBInet, Emerge, and the ASP program, and now Gen-3. 
I applaud the Secretary for canceling a program that was not 
working.
    What have we learned from each of these failed acquisitions 
that will help us avoid similar mistakes in the future, and 
what policies have you put in place to ensure more robust 
acquisition oversight?
    Mr. Cummiskey. Thank you, Congressman.
    We have taken a number of steps over the last several years 
to strengthen the entire life-cycle continuum. We started with 
oversight because that the area where we are already working 
with 123 other major acquisitions in the Department.
    So what we have tried to do is strengthen that by creating 
the program acquisition and risk management entity within 
management, which is the acquisition oversight arm. We created 
the chief acquisition executive process in each of the 
components in order to make sure that they are invested in this 
or working in concert with the folks that are actually 
operators on the ground that are deploying these systems.
    We have also worked closely on strengthening life-cycle 
cost estimating by shifting that function out of harm, the 
program accountability group, into the chief finance office of 
the Department so that we can get stronger life-cycle cost 
estimates in that oversight bucket.
    The Secretary has called for a Unity of Effort in this area 
and so what we are doing is we are shifting our focus now to 
strategies and plans as well as joint capabilities and 
requirements development so that when you are feeding the 
oversight piece, we have got stronger pieces of the continuum, 
which we are going to reduce the likelihood that would be less 
successful.
    Mr. Palazzo. Okay. So you said you are going to continue to 
refine your acquisition oversight framework as a part of the 
Unity of Effort.
    Can you elaborate on some of the things that you are 
refining now?
    Mr. Cummiskey. Absolutely.
    Congressman, first of all, let me thank the entire House 
and particularly the committee for the leadership on 4228. That 
piece of legislation will go a long way in codifying many of 
the things that we have tried to put into place in the 
oversight function.
    What the Secretary is saying is that in terms of looking at 
the requirements, we have got to take a joint requirements 
perspective on this and not just have one component or office, 
you know, trying to develop that. So what he has called for is 
the development of a joint requirements council, which, again, 
I think the full committee has called for in the past, which 
would give us an opportunity to sit together and look at best 
practices in the space, strengthen the joint requirements so 
that when we are feeding the resourcing piece, we will have a 
better sense of what we are actually buying and increase the 
likelihood of success.
    Mr. Palazzo. Now both DOD and DHS S&T have been studying 
and developing environmental detection systems for some time.
    Before deciding to begin the development of Gen-3 systems, 
did the BioWatch Program look at these existing systems and if 
so, what type of analysis was done to determine that BioWatch 
needed to develop its own technology? Can any of these systems 
be leveraged now to make improvements to the current system?
    That is for Dr. Brinsfield, Dr. Brothers, and Mr. 
Cummiskey.
    Dr. Brinsfield. So there was an integrated planning team 
that did meet in the early stages of this that included other 
departments and agencies providing input.
    I will note that as of now, the Department of Defense is 
actually using some of the current Gen-3 equipment to test 
against their current system so we hope to have that 
information.
    Mr. Brothers. I think that we have a good relationship with 
the Department of Defense. I think we look forward to 
leveraging those to work together in fielding the best system 
possible.
    Mr. Cummiskey. Congressman, to be candid with you, we went 
back into some of the documentation that was essential to 
launch this successfully. It was not there. We had to go back 
and do the AOA, the other documentation around operational 
requirements and things of that nature.
    So what we have done now is for the last 3 years, no 
program has advanced without making sure we are hitting those 
gates in concurrence with what the GAO has called for. So we 
are in a better position. We would anticipate going forward 
that all of that will be in place for Gen-3.
    Mr. Palazzo. Thank you.
    I yield back.
    Mrs. Brooks. Thank you.
    At this time, the Chairwoman now recognizes the gentleman 
from South Carolina, Mr. Sanford, for 5 minutes' questioning.
    Mr. Sanford. Thank you.
    It strikes me that you could have the greatest technology 
in the world but if you didn't have appropriate and proper 
human infrastructure to manage that technology, you would still 
have a very, very serious, even gaping security hole.
    So with that in mind, I listen to your answers to the 
Chairwoman's questions, simple questions on implementation and 
your answer, Dr. Brinsfield, your answer, Dr. Brothers, was ``I 
don't know, and I don't know.''
    It just strikes me that that is the kind of mismatch 
between technology whether talking Gen-2 or Gen-3 that is 
quantitative, real, in some cases, proven, in some cases, not 
proven with a human infrastructure, which I think has been a 
lot of people's beef with homeland security as you look at 
different GAO reports and what-not.
    Let me just go back to that question one more time because 
the Chairwoman asked, I thought, a fairly basic question on 
implementation. Why wouldn't you know?
    Dr. Brinsfield. So, sir, I think we do a lot of work and 
work very hard with our State and local partners to make sure 
that both the BioWatch Program and the NBIC are very well-
integrated with their strategies and where they are moving 
forward. I think the important thing to focus on here is the 
amount of time and effort we give to supporting the boots on 
the ground and the people that have to actually do the 
response, the first responders----
    Mr. Sanford. If I could respectfully interject, I have 
actually sat in that role and at a State level. A lot of times, 
we were driven by Federal mandates in terms of different 
benchmarks that they had laid out with regard to level of 
implementation.
    So I mean, I had 8 years of experience in that particular 
regard. So respectfully I would disagree.
    Is there integration? Absolutely. But in many cases, we 
were responding at the State level to what the Feds had laid 
out in terms of benchmarks. I don't understand why there 
wouldn't be, at least, benchmarks, at a minimum, benchmarks 
with regard to implementation to the Chairwoman's question.
    Dr. Brinsfield. So I am very interested in hearing your 
perspective, and I would like to offer to get together and 
discuss this with you in the future. I think anything we could 
do to improve those relationships would be a good thing.
    Mr. Sanford. But that is still not answering the question 
on implementation.
    Dr. Brinsfield. For implementation in terms of the strategy 
to move antibiotics into an area after release, there is a 
program within the CDC that measures that and does a very good 
job working with States and locals to provide benchmarks and 
measure that.
    In terms of BioWatch, we have a very active group that is 
working on CONOPS with the State and locals both for outdoor 
and indoor monitoring to provide those benchmarks.
    Mr. Sanford. Again, respectfully, one of the things I often 
times say to my staff is, look, fewer words, more facts.
    I guess I would put this in the same category. I am getting 
a lot of process but still no benchmarks in terms of the 
question the Chairwoman asked, which was, ``Is there not any 
date specific in terms of the implementation''?
    Dr. Brinsfield. You are asking on an implementation plan 
date release, which is an interagency process. Sir, I apologize 
but I can't give you a hard date on an interagency document.
    Mr. Sanford. But a ballpark?
    Dr. Brinsfield. I would hope it would be released in the 
near future, sir. I know we are working very hard towards that 
end.
    Mr. Sanford. Any further illumination from your--do you 
understand my frustration? It just seems like it is what people 
hate most about Government, which is process, process, process, 
and process, with no sort of--okay.
    I mean, I think that one of the things that people really 
admire about the military and the disjunction between the times 
where the military is perceived and where Homeland Security is 
perceived is that they will flat out give you a target. This is 
what we hope to do by this date. This is what we hope to do by 
this date. This is what we hope to do by this date.
    They may or may not hit those benchmarks, but they will 
give you at least what they are shooting for. What I am hearing 
from your end is it is a process, and we are in that process. I 
think people find that very, very frustrating.
    With that, I yield back.
    Mrs. Brooks. Thank you. Kind of building on that a little 
bit, I would like to--Mr. Currie, you talked about the fact 
that GAO found that, at least in 2012, DHS had no policies for 
defining and coordinating R&D. There are a lot of different 
groups within Homeland Security, and we have some new leaders 
here in Dr. Brinsfield and Dr. Brothers.
    Can you share with us what GAO's recommendations were with 
respect to coordinating and the fact that all the technology, 
and I know it takes a lot to develop technology, but then to 
transfer it into implementation, but S&T had had no tech 
transfer that was successful. So what would we say should be 
happening within DHS?
    Then I would like to go to Dr. Brinsfield and Dr. Brothers 
for more clarification about how you now are going to 
coordinate this plan so that we, as a country, and we as 
Congress can have more comfort than we do right now, that there 
is real technology R&D discussions and real implementation with 
respect to bioterrorism, which is very real and we have very 
great concerns about what is not happening.
    Mr. Currie.
    Mr. Currie. Thank you, Chairwoman Brooks.
    You are correct. In 2012, we reported that DHS had no 
policies for coordinating or really managing its R&D 
investments, not just within S&T but across all the components. 
I liken the R&D situation at DHS to what the acquisition 
situation was at DHS probably 8 or 10 years ago when there were 
no acquisition policies.
    The Department, as Mr. Cummiskey has outlined, has taken 
many steps to outline that they have new policies and practices 
for following those.
    In R&D they have gotten a little bit of a late start on 
that. It is very similar. So let me give you an example of 
that. For example, a couple of years ago DHS had no definition 
for what R&D at the Department was. Other agencies like DOD or 
NASA use technology readiness levels and other things to define 
R&D. DHS did not have a common definition.
    So----
    Mrs. Brooks. Would you agree--just to interrupt briefly--
that in any development of anything new, the R&D costs, thereby 
the costs to the taxpayers, are often the highest in the R&D 
process?
    Mr. Currie. Well, it is true. It costs a lot to research 
and develop technologies. But it is why we think it is very 
important and what we recommended is that they develop these 
policies for what R&D is going to look like through the life 
cycle, what S&T is going to do, but more importantly, what is 
going to happen when they transfer it to the components, and 
when is that going to happen?
    I think on this issue we are talking about today, on 
BioWatch and biodetection, it is going to be very important 
that very early on S&T and NAFSA health affairs agree very 
early what is going to actually happen, what both parties are 
going to do, and when that transfer is going to occur.
    Mrs. Brooks. Thank you.
    So, with that, Dr. Brinsfield and Dr. Brothers, I have 
tremendous respect for your qualifications for the offices that 
you are both holding and with your experience. So can you 
please share with us--and I applaud the Secretary's unity of 
effort charge--how is it going to work?
    Mr. Brothers. So let me start off with one of the comments 
that was just made. We do actually have an R&D definition now. 
So I think that is very helpful. Because as you mentioned, 
without having that kind of definition, it is very difficult to 
try to understand what we are talking about, right?
    But we now do have a definition. You mentioned the NASA and 
DOD TRL, technology readiness level, way of looking at it. That 
is exactly the type of thing we have adopted. So we have the 
same kind of 6-1 to 6-7 type-of designation the Department of 
Defense does.
    So that is going to be very helpful in us actually 
understanding what is going on across the Department.
    The other piece here that is important to think about is in 
the 6 weeks that I have been there, I have made a point to 
actually--meeting with the component leads to try to understand 
what their needs are and also what is going on. I am in the 
process of that right now.
    Part of this process of working with Dr. Brinsfield is 
understanding exactly the types of activities we have going on 
and what we should be doing going forward, as well.
    So I think I mentioned earlier that there is this emphasis 
on near-term versus far-term. So particular to BioWatch is 
there will be a near-term effort that we will be looking at, 
trying to understand what we can do with existing capabilities, 
how we are going to augment those. There is a longer-term 
effort, as well.
    I think I also mentioned that from an S&T perspective we 
are looking at doing a potential apex program to really try to 
figure out how we can push this technology.
    But I think going back to this point of coordinating S&T, I 
think the roots--the basis of being able to do that is this 
definition and communication and collaboration with the 
component heads. That is part of what the Secretary's Unity of 
Effort call to action is all about.
    So I am very confident that we can do this going forward.
    Mrs. Brooks. Dr. Brinsfield.
    Dr. Brinsfield. We have already had numerous conversations 
about sort-of the big picture where we see this going forward. 
I think it is a good relationship. We are working well 
together. The staffs are working well together. I look forward 
to a structured joint requirements process. I think this will 
help to answer much of the issues.
    Mrs. Brooks. Dr. Disraelly, have you been consulted in--
with respect to your report by OHA and by S&T on what your 
analysis was and what the alternatives were that your Institute 
has presented?
    Ms. Disraelly. At several points during the study, all the 
way from its inception, all the way through its conclusion, we 
briefed several members of the Department of Homeland Security.
    We had a stakeholder team that included nine organizations 
within the Department who were given the opportunity to 
participate in the briefings as well as comment on the 
documents as we went through.
    Mrs. Brooks. Did you feel that they were high-level 
individuals within DHS that participated? Or do there need to 
be additional meetings with respect to all of the work that 
your organization did?
    Have you met with Dr. Brothers?
    Ms. Disraelly. We have met with Dr. Brinsfield. The study 
was concluded before Dr. Brothers came to the Department, and 
so we have not briefed with him.
    Mrs. Brooks. Okay. I am certainly hopeful that all the work 
and I appreciate that you are new, but that collaboration can--
with the analysis that has already been done, because it seems 
as though you are stepping into an organization that has not 
had much success in its tech transfer and in its implementation 
of the technologies it studied, if Mr. Currie's analysis of 
past work from S&T is correct.
    So, I certainly hope that those discussions will happen 
very, very quickly. We look forward to your near-term goals 
being set as well as future goals.
    With that, my time is up and I would turn it over to 
Ranking Member Payne for 5 minutes.
    Mr. Payne. Yes, thank you, Madam Chairwoman. I was going to 
mention that Dr. Brothers, I am concerned that you haven't been 
able to straighten all this out in 6 weeks.
    [Laughter.]
    Just to that point.
    But Under Secretary Cummiskey, I am concerned that the 
Department did not engage in a thorough Analysis of 
Alternatives until the acquisition of Gen-3 was well underway. 
I am glad that it has suspended the acquisition to reevaluate 
when GAO raised the red flags in 2012.
    Can you tell the subcommittee how much money has been 
appropriated to Gen-3 and how much of the funding that has 
already been obligated and what the Department plans to do with 
the funds appropriated to Gen-3 that have not already been 
obligated?
    Mr. Cummiskey. Thank you, Ranking Member Payne.
    With regard to the expenditures, I checked with the CFO's 
office. The amount that has been spent on Generation-3 since 
2009 is $61 million. Of that, it was spent primarily on 
evaluation and testing capabilities. There was some money spent 
prior to 2009 on other aspects of BioWatch. But as to the 
question of Gen-3, it is $61 million.
    Mr. Payne. Okay. And the dollars for Gen-3 that haven't 
been obligated?
    Mr. Cummiskey. There were $16 million that were unspent as 
part of the appropriations and were routed to the Treasury.
    Mr. Payne. Back to Treasury?
    Mr. Cummiskey. Yes.
    Mr. Payne. Okay. All right. Let's see. Also, this is a 
little bit off-topic, but since I have a captive audience I 
will take the opportunity.
    As you know, I have introduced legislation to resolve 
inter-operability communication problems within DHS, first 
identified by the inspector general in November 2012.
    This legislation is H.R. 4289 and will be marked up by the 
full committee tomorrow, as a matter of fact.
    Have you seen this or reviewed this legislation? Can I 
count on you to work with me to address this important issue? 
Because any time I am involved in crafting legislation, I try 
to get as many people involved to help it be good legislation, 
so when it is finally presented all sides have had an 
opportunity to weigh in on it.
    Your thoughts?
    Mr. Cummiskey. Sure. Congressman, I had an opportunity to 
review 4289 last evening. Just on a personal note as a former 
State Senator who spent a lot of time on inter-operability 
issues, I really applaud and appreciate your efforts. We look 
forward to working with you to advance what is really an 
essential role for the Department.
    Mr. Payne. Absolutely. I mean, based on the information 
that I have learned and gathered since coming to this committee 
and the Congress that the whole question around inter-
operability throughout agencies and to the States and locals is 
crucial in order for continuity in addressing the safety of the 
homeland.
    So I thank you for that.
    Also, it seems that one of the problems--okay. Never mind.
    Dr. Brinsfield, the BioWatch is currently deployed in 30 
cities. Under Gen-3 the program was expanded to 50 cities. What 
was the rationale behind expanding the program to 50 cities, 
and was it based on specific intelligence suggested that such 
an expansion was necessary?
    Dr. Brinsfield. Sir, when the program was proposed to be 
expanded, it was working off lists provided by the FEMA grants 
initiative as to cities that would be possibly at risk and 
covered under that program.
    That list has since been moved back.
    Mr. Payne. Okay, so expanding to the 50 cities is not a 
priority or will it continue to be a priority?
    Dr. Brinsfield. Sir, we don't currently have funding to 
expand in that area.
    Mr. Payne. Okay.
    Okay, Madam Chairwoman. I yield back. Thank you.
    Mrs. Brooks. Thank you.
    With respect to--because it sounds as if the current 
system, Gen-2 is going to be in place for some time with no 
really new systems having been identified on the horizon or 
certainly submitted in any budget request, speaking of funding, 
which might also be, in part, because the administration has 
yet to produce the plan. But with that said and to ensure that 
Gen-2, the GAO do make any recommendations with respect to 
improvements to Gen-2, Mr. Currie?
    Mr. Currie. No, ma'am. Actually, most of our focus has been 
on the Gen-3 acquisition----
    Mrs. Brooks. Do you have any recommendations for Gen-2 at 
this point? Are you prepared to make any recommendations with 
respect to Gen-2, which is what we have in 30 cities?
    Mr. Currie. Currently, we have work on-going looking at the 
technical capabilities of Gen-2, which may result in 
recommendations. But at this point, we don't have any specific 
reported recommendations. As I laid out in my testimony, we 
have many questions and concerns about what is going to happen 
with the program, but this has all happened so recently that it 
is very unclear what is going to transpire at this point.
    Mrs. Brooks. Dr. Disraelly, do you have any recommendations 
with respect to the current system improvements?
    Mr. Currie. No, ma'am. That was outside the scope of our 
study.
    Mrs. Brooks. Okay. So, Dr. Brinsfield, Dr. Brothers, and I 
do appreciate our recent visit to the NBIC, which was very 
enlightening and I want to thank you and your staff for putting 
on a very--you know, a wonderful presentation about NBIC. But 
what improvements might you have or suggestions that should be 
made to the Gen-2 system, in order to make it the most 
efficient and best system, if that is what we have got right 
now?
    Dr. Brinsfield. Thank you, ma'am, and Mr. Payne for your 
visits. We greatly appreciated you coming to the NBIC. We are 
looking at a number of issues that we will be coordinating with 
Dr. Brothers staff as well. Some of them are about how we 
collect the samples. Some of them are about the form that the 
samples are collected in, so that might provide more 
information. Some of them are about giving us a warning, if 
something might have been released early so that we could go 
and take a look at the sample earlier.
    All those--there are about seven of those different 
potential incremental improvements to the current system and we 
are looking at them as we speak to see which we could field in 
the near-near-term. By that I mean, within the year or so and 
others that we might be able to implement in the near-term.
    Mrs. Brooks. Might you be considering detectors and use by 
other Federal agencies as well to supplement the current Gen-2 
system?
    Dr. Brinsfield. There are different types of detectors that 
we have looked at in different Federal agencies. As you know, 
we have looked at studies done by a number of different groups 
to look at what is currently in place and using the technology 
readiness levels, you know, what could be fielded now. There 
isn't a start-to-finish detector in another agency that would 
be better than our current system. So that is where we are at 
looking at improvements to the current system.
    Mrs. Brooks. Dr. Brothers, I do appreciate that you would 
only been there 6 weeks. But in your--and having been in new 
positions in the past in kind of order of priority, where does 
the Gen-2 and the BioWatch program, you know, fall in S&T?
    Mr. Brothers. You understand, it is clear to me the 
importance of this capability, the threat that bio poses to the 
country. You know, right now about 25 percent of our budget is 
spent in chem-bio. So I think just based on that alone, you can 
see, it is a large priority for us.
    So yes, it is important. I think it is also to consider the 
near-term. I think the comment came up earlier about, you know, 
how this is used. I think, you know, taking a system-to-system 
approach both near-term and far-term is important.
    Mrs. Brooks. Dr. Brinsfield, can you share with us briefly, 
how is BioWatch and NBIC working together?
    Dr. Brinsfield. Yes, ma'am.
    I know we discussed this when you came to visit and for us, 
it is a high priority to make sure that the two are working 
together.
    BioWatch is a tool, a very useful tool that gives us a 
data-point in which we can look at to see if there has been a 
biological event. NBIC or the National Biosurveillance 
Integration Center looks at this from the continuum, from early 
through, with the departments and agencies collecting all 
information available.
    It is our role in this next bit of time to see how we can 
make the two, use the two more efficiently to work together. We 
already use the two on a daily basis to provide information to 
both States and locals to the White House and we are looking at 
how we can sort of institutionalize that coordination.
    Mrs. Brooks. Didn't you indicate at that time that the 
personnel over--with responsibility for BioWatch were moving to 
NBIC's site?
    Dr. Brinsfield. Yes, ma'am.
    One of the ways we are going to work on that collaboration 
issue is to make sure that all personnel are housed in the same 
area so they can have those day-to-day conversations more 
easily.
    Mrs. Brooks. Then also can you--the current BioWatch 
detectors that are currently deployed, how is that information 
provided to NBIC so that it can be disseminated to State and 
local authorities?
    How does that work from the BioWatch collection to NBIC to 
State and locals?
    Dr. Brinsfield. So speaking to the BioWatch CONOPS as was 
previously mentioned, there is a way that the States, locals, 
Federal agencies, all of which have a role, including NBIC and 
NBIC's partners, can participate in an information call when 
you have positive results from one of the BioWatch.
    It is meant to set it up so that you can put it in 
perspective of what else people are seeing, what is going on 
and make sort-of a collaborative decision on the path forward. 
That process has been in place for a number of years and has 
been tested numerous times. It is something that we work very 
hard to make sure we are doing this in collaboration all the 
way through our health and human services partners, USDA and 
others back to the field and States and locals.
    Mrs. Brooks. Thank you.
    My time is now up--for 5 minutes of questioning from the 
Ranking Member. Okay.
    If I might have one moment, please?
    At this time, we have no further questions.
    I do want to thank all of the witnesses for their valuable 
testimony, both that was written and your answers to our 
questions today.
    Members of the subcommittee may have some additional 
questions for the witnesses. We will ask you to respond to 
those in writing.
    I just would like to close by reiterating as I began, the 
importance of the administration providing the implementation 
plan for the National Biosurveillance Strategy.
    Additionally, it is very difficult. Congress wants to be a 
strong partner in ensuring that our country is safe from 
bioterrorism threats and I believe that from this committee, in 
a bipartisan way, we are very concerned that we don't have the 
plan from the administration forward.
    We are in the dark as to what the administration wants 
funded and what the needs are in the country. We don't believe 
that the threat is diminishing around the world and we look 
forward to receiving those plans and also look forward to 
continuing discussions in the Classified manner in which you 
suggested.
    So at this time, pursuant to committee rule 7(e), the 
hearing record will be open for 10 days.
    Without objection, the subcommittee stands adjourned.
    Thank you.
    [Whereupon, at 11:20 a.m., the subcommittee was adjourned.]


                            A P P E N D I X

                              ----------                              

 Questions From Chairwoman Susan W. Brooks for Kathryn Brinsfield and 
                           Reginald Brothers
    Question 1a. On November 22 of last year, several Members of the 
committee wrote a letter to DHS to ask about progress made in looking 
at the coordination of programs and activities with Weapons of Mass 
Destruction, Chemical, Biological, Radiological, and Nuclear 
responsibilities. This letter cited the fiscal year 2013 DHS 
appropriations bill report language that requested DHS to submit a 
consolidation plan to merge the Domestic Nuclear Detection Office 
(DNDO) and the Office of Health Affairs (OHA). We received a response 
from Secretary Johnson stating that ``I have directed my staff to begin 
working on several initial focus areas that are intended to build 
organizational capacity in support of our primary objective: the 
effective and efficient execution of our mission.''
    Can you please provide us an update on that progress?
    Answer. The Department of Homeland Security (DHS) continues to 
explore alternatives to re-orient and re-invigorate several 
headquarters functions and organizations to meet the intent of the 
Secretary's Unity of Effort initiative and its ultimate objective: 
Empowering DHS components to effectively execute their operations. 
Science and Technology (S&T), OHA, DNDO, and the rest of the Department 
have been working together closely to analyze a range of possibilities 
for closer coordination of chemical, biological, radiological, and 
nuclear (CBRN) responsibilities. DHS is considering a number of viable 
options, but we are not prepared to suggest one particular path forward 
at this time.
    Question 1b. Do you believe that the Weapons of Mass Destruction 
(WMD) functions of DHS would be better consolidated than in separate 
offices?
    Answer. There are advantages and disadvantages to both options, and 
those will be articulated to the Secretary to inform his decision on 
organizational changes. In the mean time, the offices with WMD 
responsibilities will continue to coordinate closely on matters of 
mutual interest, whether related to policy, budget, acquisition, plans, 
or operations.
    Question 2a. Your testimony refers to the business model used by 
the BioWatch program. This model, as you described it, uses the 
BioWatch units that are provided by the Federal Government and then ``a 
network of local, State, and Federal laboratories.'' Much focus has 
been placed on the acquisition and technology of BioWatch but I am also 
interested in hearing about challenges in using this type of approach.
    Do you think that this model still works today?
    Question 2b. What challenges exist in using this model?
    Question 2c. Do you plan on looking at alternatives to this model 
moving forward?
    Answer. BioWatch is a tool of the public health and first/emergency 
response communities. The network of local, State, and Federal 
laboratories and stakeholders is an essential element of the program. 
These partnerships include public health, emergency management, first 
responders, law enforcement, and laboratory officials. This model has 
proven to be a successful integration of a Federal program operating at 
a State/local level that allows all partners access to the information 
and tools they need to make informed and timely decisions, while 
staying consistent with local response operations. We work in 
partnership with transit agencies, local police departments, health 
departments, etc. to build effective networks within each jurisdiction. 
The communications and exercises conducted with these networks through 
the BioWatch program build personal and professional relationships 
within this community and improve the ability at all levels of 
government to respond to a large-scale bioterrorism attack. Each 
jurisdiction has a multi-agency group that coordinates the 
implementation, routine operations, and enhancement of their 
jurisdictional BioWatch program. Recent reductions in State and local 
funding have led to challenges for public health departments, who have 
to carefully balance their resources among competing priorities, and 
have prevented some communities currently outside the network from 
joining the program. Additionally, each jurisdiction has specific needs 
and protocols that make it difficult to adopt a standardized approach 
across the entire BioWatch network.
    Potential technology changes may alter the current program 
processes. In cooperation with S&T, the BioWatch program is examining 
as a near-term strategy several technology approaches which essentially 
keep the current collector-laboratory approach, but upgrade the 
technology used in aerosol collection, the laboratory identification 
methods, or both. Any improvements would be predicated on efficiency, 
timeliness, and cost considerations. As longer-term alternatives are 
developed, alterations to the current model may be considered that 
would be contingent on improving efficiency, timeliness, and/or 
decreasing costs before being deployed.
    Question 3a. As you work to identify and develop alternatives to 
the Gen-2 system, and appreciating the critical role technology 
providers in industry can play in advancing this technology, what are 
you doing to communicate with the private sector regarding the way 
ahead for the advancement of detection systems so they can participate 
in this effort?
    Answer. Any new acquisition of technology will be conducted in 
accordance with the DHS Acquisition Management Directive 102-01 (MD 
102-01) acquisition process to emphasize transparent, full, and open 
competition. The BioWatch program has discussed potential technology 
approaches with the commercial sector and has met with industry 
representatives, when appropriate, to discuss needs and available 
technologies for potential implementation. Potential Gen-2 enhancement 
efforts will largely be executed through traditional acquisition 
instruments such as Requests for Information, Broad Agency 
Announcements (BAAs), and scheduled ``Industry Days'' that allow direct 
discussion of BioWatch technical needs with multiple industry 
representatives. As one example, S&T's recently initiated investigation 
of detection networking architectures began with an Industry Day to 
allow discussion of concepts with industry, and a BAA-enabled industry 
to describe concepts for funding consideration. In addition to these 
traditional mechanisms, S&T looks forward to taking advantage of its 
newly-delegated prize authority to engage and harvest performers 
through a potential biosurveillance grand challenge.
    Under the new leadership of Dr. Brothers, a priority for S&T has 
been finding more effective ways to harness the energy and expertise of 
the Homeland Security Industrial Base. Working better with industry is 
essential to developing near- and long-term solutions to homeland 
security problems. Part of this effort over the last 2 months has 
involved development of a homeland security science and technology 
strategic document that lays out visionary near- and long-term Research 
and Development (R&D) goals that will, among other purposes, serve as 
hooks for engaging industry. The strategy is also supported by on-going 
development of technology road maps by S&T's research divisions in 
S&T's major investment areas. When completed, the strategy and road 
maps will be valuable tools for communicating S&T's investments and 
vision, including where perceived gaps and opportunities may lie, and 
driving complementary investment by industry stakeholders.
    Question 3b. How are you communicating with State and local 
officials to discuss their needs going forward?
    Answer. The BioWatch Program is communicating with State and local 
partners on the status of technology upgrades within BioWatch and 
working with them to assess their needs through a number of channels. 
These include webinars and program updates to inform all BioWatch 
jurisdictions as well as Federal partners of the current status of the 
BioWatch program and the cancellation of the Gen-3 acquisition. Daily 
interactions by the jurisdictional coordinators who serve as liaisons 
in each BioWatch Jurisdiction and the implementation of new 
technologies under consideration will be discussed at length as part of 
the National BioWatch Workshop in October 2014. In addition, the 
BioWatch program staff attend and discuss needs with BioWatch Advisory 
Committees (BACs are multi-agency groups that coordinate the 
implementation, routine operations, and enhancement of their 
jurisdictional BioWatch program) during regularly-scheduled BAC 
meetings throughout the year and will also discuss jurisdictional needs 
while attending exercises held within the BioWatch jurisdictions. The 
BioWatch program has also requested input from local laboratory and 
public health representatives on the selection criteria used to inform 
the evaluation of laboratory instrumentation to ensure end-user needs 
are being met. The contact information of the BioWatch Program and 
Deputy Program Manager are well-advertised, and all members of BioWatch 
operations at all levels of government have been encouraged to call and 
discuss their needs and concerns directly with Program leadership.
    Question 4. A 2008 National Center for Risk and Economic Analysis 
of Terrorism Events report estimated the impact of a bioterror attack 
on a major league sports stadium would cost between $62 and $73 
billion. In light of this estimate and the Gen-3 cancellation, how does 
the Department plan to address this threat? Has the Post-Implementation 
Plan been completed? If not, what is the time line for its completion?
    Answer. OHA concurs with the severity of the estimate offered by 
CREATE. Further, BioWatch has consulted independent research within the 
scientific community that validates the significance and severity of 
such an event.
    The operational BioWatch system will continue its normal operations 
as a fundamental part of the Nation's biodefense. Moving forward, OHA 
and S&T are working closely on development of a systems approach to 
next-generation biodetection including joint development of 
requirements. The systems approach will also look carefully at the 
results of an evaluation, completed by the BioWatch program earlier 
this year, of the existing operational BioWatch system. As the path 
forward is finalized, a full range of potential investments will be 
under consideration from near-term incremental improvements to longer-
term shifts to a distributed, networked, sensor-agnostic 
biosurveillance architecture with potential for capability beyond what 
the Department initially envisioned for Gen-3.
    The Post-Implementation Review along with its accompanying briefing 
is currently under DHS review.
    Questions From Chairwoman Susan W. Brooks for Kathryn Brinsfield
    Question 1. Dr. Polk testified before this subcommittee in April 
2012 that OHA and the CDC were in the process of developing a pilot 
program for the voluntary, pre-event vaccination of first responders. 
However, more than 2 years later, little progress has been made.
    What is the status of this important pilot program to protect our 
protectors?
    Answer. The Department of Homeland Security (DHS), in coordination 
with the Centers for Disease Control and Prevention (CDC), is 
developing the Anthrax preparedness and Protection Pilot to provide 
responders with a voluntary and comprehensive approach for preparing 
and protecting themselves consistent with broader anthrax preparedness 
guidance. Enhancing the ability of our Nation's responders to conduct 
life-saving activities more safely and efficiently is a goal of this 
Department, as responders face a number of real and potential threats, 
including anthrax.
    DHS's Office of Health Affairs (OHA) has been assessing the demand 
for and acceptance of pre-event anthrax vaccination for responders 
through a proposed Anthrax Preparedness and Protection Pilot. The goal 
of such a pilot is to assess the demand by responders and communities 
for the anthrax vaccine and the capability of Federal, State, local, 
Tribal, and territorial governments and organizations to deliver this 
program with the ultimate goal of better protecting responders and 
communities.
    Past biodefense vaccine efforts, such as the 2003 effort to 
encourage vaccination of health care workers and first responders 
against smallpox, encountered challenges in meeting the needs of the 
response community. Actively engaging the responder and public health 
communities will be the backbone on which this effort will be built. 
OHA has conducted outreach activities with 243 individuals representing 
public health, occupational health, emergency management, and responder 
communities and has increased awareness among many more stakeholders. 
Through this effort, stakeholders have expressed concerns such as their 
need to have increased awareness of the threat, education about 
comprehensive personal health protection, vaccine safety, liability 
protection, logistical implementation, and a strategic plan to protect 
unvaccinated families and communities. DHS and the CDC have redefined 
core program elements which are responsive to stakeholder requirements 
and are critical as we consider actions to the design and build-out 
pilot promotion and coordination of this effort. OHA is actively 
conferring with partners both inside and outside of the Department to 
capitalize on existing programs to implement this pilot. As pilot 
elements are developed, DHS will solicit community applications for two 
States to participate in the pilot through the Federal Register, making 
the process both open and transparent process. Successful applicants 
will be well-positioned to deliver a safe and quality program through 
demonstration of a qualified occupational health and safety program, 
accessible education platforms and the necessary infrastructure to 
handle the complete chain of receipt through delivery and monitoring of 
recipients of the vaccine.
    Question 2. In addition to reducing detection time, one of the 
goals of Gen-3 was to increase indoor detection. With the cancellation 
of Gen-3, what is the plan now for indoor detection?
    Answer. The technology currently used in BioWatch is employed 
indoors in limited locations; however its use requires multiple 
sampling events that increase costs to the Program. OHA, in cooperation 
with S&T, is examining a number of alternative approaches to improve 
indoor detection including, but not limited to, the use of air 
monitoring systems that continuously sample indoor air spaces for 
irregularities (unusually high particle counts, fluorescence 
signatures, etc.) and provide a warning within minutes of a suspicious 
aerosol event to trigger and direct response, upgrading collectors 
using a collection medium that is able to preserve the viability of the 
collected organisms (e.g., liquid-based), and portable identification 
technology that allows for the rapid field identification of potential 
agents. Through S&T, DHS is also investigating alternative 
architectures for networked systems of sensors equipped with analytic 
capability for rapid determination of unusual and potentially hazardous 
biological and chemical contamination in the air, both for indoor and 
outdoor environments.
    Question 3. The value and effectiveness of BioWatch early detection 
is premised on the capability of State and local public health 
authorities to respond, for example, by directing the mass dispensing 
of medications or establishing mass treatment centers. Without the 
capability to respond with an appropriate public health and medical 
measures to minimize illness and death, the BioWatch warning will not 
produce a benefit.
    Please discuss what actions DHS takes (in partnership with the 
appropriate Federal, State, and local authorities) to ensure that 
sufficient medical countermeasures are in place to respond to an attack 
with any of the agents Gen-2 is designed.
    Answer. The BioWatch program not only provides the critical first 
laboratory detection of an aerosolized threat, it also supports the 
infrastructure that coordinates the initial awareness for response 
officials, including within the medical and public health community, 
that will initiate protective actions such as dispensing medical 
countermeasures (MCMs). The BioWatch Exercise Program provides BioWatch 
jurisdictions up to 7 exercises per year to improve local, State, and 
Federal preparedness for a large-scale bioterrorism attack. These 
exercises are tailored to each jurisdiction's needs, are multi-
disciplinary in nature, provide specific subject-matter expertise as 
needed, and are tightly focused on the initial BioWatch Actionable 
Result (BAR) assessment phase. In each jurisdiction, the BioWatch 
program has formalized partnerships with local and State agencies that 
include public health officials, emergency management, first 
responders, law enforcement, and laboratory officials. These local and 
State officials have designated points of contact at Federal agencies 
to aid in coordination.
    The Department of Health and Human Services (HHS) manages the 
Strategic National Stockpile (SNS) of MCMs as well as the Cities 
Readiness Initiative (CRI). Through CRI, State and large metropolitan 
public health departments have developed plans to respond to a large-
scale bioterrorist event by dispensing antibiotics to the entire 
population of an identified metropolitan statistical area within 48 
hours. Further, Executive Order (EO) 13527 (December 20, 2009), 
``Establishing Federal Capability for the Timely Provision of Medical 
Countermeasures Following a Biological Attack,'' Section 3, explicitly 
calls for the Secretaries of Homeland Security, Health and Human 
Services, and Defense, along with the Attorney General, to develop a 
Federal capability to immediately supplement the capabilities of 
affected jurisdictions to rapidly distribute MCM following a biological 
attack. On September 9, 2010, the Secretaries of the Departments of 
Homeland Security (DHS) and Health and Human Services (HHS), endorsed 
and forwarded to the White House National Security Staff, The Federal 
Interagency Concept of Operational Plan-Rapid Medical Countermeasures 
Dispensing (FICOP-MCM). The FICOP-MCM delineates options for the rapid 
and coordinated deployment of Federal resources to supplement State and 
local governments' abilities to dispense MCM. This Federal capability 
resource is intended to be an initial rapid response to stabilize the 
situation in partnership with State and local authorities.
    FEMA is supporting this regional MCM planning initiative in concert 
with local CRI planning supported by the Centers for Disease Control 
and Prevention (CDC). This joint effort includes HHS regional 
representation; the CDC SNS senior official; as well as appropriate 
State, county, and city public health and emergency management 
officials. This initiative will result in a Regional MCM support annex 
to the Regions' All Hazards Plan that is consistent with the scope, 
mission essential tasks, and concept of operations outlined in the 
FICOP-MCM. Each Regional MCM annex will, in turn, describe the Federal 
supporting concept of operations to support and complement the local 
CRI plan of the metropolitan area.
    Efficient delivery of medical countermeasures requires that 
critical decisions affecting how MCMs are dispensed be determined 
before we face such an incident. Towards this goal, DHS has worked with 
Federal partners, to include CDC, on guidance documents such as 
prioritization for anthrax vaccine in affected communities that 
addresses the need of those most at risk as well as the response 
community that we will rely on in such an incident. To further enable a 
rapid response, DHS and its partners issued ``Guidance for Protecting 
Responders' Health During the First Week Following A Wide-Area Aerosol 
Anthrax Attack.''
     Questions From Chairwoman Susan W. Brooks for Chris Cummiskey
    Question 1. Setting requirements for large-scale acquisitions has 
been a challenge for the Department since its inception.
    What are you doing to work with program offices to ensure that 
well-developed requirements are put in place prior to the start of an 
acquisition?
    Answer. One of the principal focus areas of Secretary Johnson's 
Unity of Effort initiative, as outlined in his April 22, 2014, 
memorandum entitled, ``Strengthening Departmental Unity of Effort'' is 
to continue to refine our acquisition oversight framework, especially 
in the earliest stages where acquisition requirements are developed. As 
part of this initiative, a component-composed and component-chaired 
Joint Requirements Council (JRC) has been established to review cross-
component requirements and develop recommendations for investment, as 
well as changes to training, organization, and operational processes 
and procedures. The Department continues to enhance its acquisition 
governance and oversight structures to support and oversee programs 
after requirements are reviewed and approved by the JRC and DHS 
leadership. Additionally, the Department, working with its components, 
has in recent years established robust training and certification 
programs at the Homeland Security Acquisition Institute for program 
managers, systems engineers, cost estimators, and contracting 
specialists. Combined, these efforts will enable components to 
thoroughly develop organizational requirements on which acquisitions 
programs may be established.
    Question 2. DHS reported to Congress that the original life-cycle 
cost estimate for the 2009 decision--a point estimate unadjusted for 
risk--was $2.1 billion. Two years later, in 2011, DHS estimated that 
Gen-3 was expected to cost $5.8 billion (80 percent confidence) from 
fiscal year 2012 through June 2028.
    What specific steps does DHS plan to take to control costs and 
provide accurate reports to Congress that accurately describe the life-
cycle costs of any follow-on systems or upgrades to Gen-2?
    Answer. Over the past 5 years, we have improved acquisition 
oversight, ensuring full consideration of the investment life cycle in 
cost estimates. Before any follow-on systems or upgrades to Gen-2, the 
current operationally-deployed system, are approved to proceed, they 
must get Acquisition Review Board approval, which includes full review 
and approval of planned life-cycle costs.
    As the Department's Science and Technology Directorate, in 
partnership with OHA, explores the capability gaps and the capability 
needs of automated aerosol biodetection capabilities, any proposed 
follow-on systems or upgrades to Gen-2 will be under the management 
practices of the Department's acquisition oversight policy, Management 
Directive 102-01. This management process controls the cost of 
acquisition programs in two ways. First, programs are required to 
develop accurate, credible, comprehensive, and well-documented Life-
Cycle Cost Estimates at major acquisition decision event milestones to 
ensure that the costs are accurate for the life cycle of the program. 
Second, any future follow-on systems or upgrades to BioWatch Gen-2 are 
required by the DHS Chief Financial Officer to have met affordability 
requirements before proceeding through acquisition phases.
    Question 3. Will DHS continue to use the 80 percent confidence 
factor to ensure Congress has more reliable cost estimates in the 
future?
    Answer. While DHS policy requires acquisition programs be resourced 
to at least a 50% confidence level of the cost estimate, estimates are 
conducted at each confidence interval, and the ARB then discusses the 
appropriate estimate to use for budgeting based on the investment and 
program risk.

                                 
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