[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
BIOWATCH: LESSONS LEARNED AND THE PATH FORWARD
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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
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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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90-880 WASHINGTON : 2014
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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
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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
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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
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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.
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\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.
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\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.
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\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.
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\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.
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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.
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\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.
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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.
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\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.
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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.
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\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.
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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\
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\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.