[House Hearing, 112 Congress]
[From the U.S. Government Printing Office]
BIOWATCH PRESENT AND FUTURE: MEETING
MISSION NEEDS FOR EFFECTIVE BIOSURVEILLANCE?
=======================================================================
JOINT HEARING
before the
SUBCOMMITTEE ON EMERGENCY PREPAREDNESS,
RESPONSE, AND COMMUNICATIONS
and the
SUBCOMMITTEE ON CYBERSECURITY,
INFRASTRUCTURE PROTECTION,
AND SECURITY TECHNOLOGIES
of the
COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TWELFTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 13, 2012
__________
Serial No. 112-117
__________
Printed for the use of the Committee on Homeland Security
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Available via the World Wide Web: http://www.gpo.gov/fdsys/
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COMMITTEE ON HOMELAND SECURITY
Peter T. King, New York, Chairman
Lamar Smith, Texas Bennie G. Thompson, Mississippi
Daniel E. Lungren, California Loretta Sanchez, California
Mike Rogers, Alabama Sheila Jackson Lee, Texas
Michael T. McCaul, Texas Henry Cuellar, Texas
Gus M. Bilirakis, Florida Yvette D. Clarke, New York
Paul C. Broun, Georgia Laura Richardson, California
Candice S. Miller, Michigan Danny K. Davis, Illinois
Tim Walberg, Michigan Brian Higgins, New York
Chip Cravaack, Minnesota Cedric L. Richmond, Louisiana
Joe Walsh, Illinois Hansen Clarke, Michigan
Patrick Meehan, Pennsylvania William R. Keating, Massachusetts
Ben Quayle, Arizona Kathleen C. Hochul, New York
Scott Rigell, Virginia Janice Hahn, California
Billy Long, Missouri Ron Barber, Arizona
Jeff Duncan, South Carolina
Tom Marino, Pennsylvania
Blake Farenthold, Texas
Robert L. Turner, New York
Michael J. Russell, Staff Director/Chief Counsel
Kerry Ann Watkins, Senior Policy Director
Michael S. Twinchek, Chief Clerk
I. Lanier Avant, Minority Staff Director
SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND COMMUNICATIONS
Gus M. Bilirakis, Florida, Chairman
Laura Richardson, California
Scott Rigell, Virginia Hansen Clarke, Michigan
Tom Marino, Pennsylvania, Vice Kathleen C. Hochul, New York
Chair Bennie G. Thompson, Mississippi
Blake Farenthold, Texas (Ex Officio)
Robert L. Turner, New York
Peter T. King, New York (Ex
Officio)
Kerry A. Kinirons, Staff Director
Natalie Nixon, Deputy Chief Clerk
Vacant, Minority Professional Staff Member
------
SUBCOMMITTEE ON CYBERSECURITY, INFRASTRUCTURE PROTECTION, AND SECURITY
TECHNOLOGIES
Daniel E. Lungren, California, Chairman
Michael T. McCaul, Texas Yvette D. Clarke, New York
Tim Walberg, Michigan, Vice Chair Laura Richardson, California
Patrick Meehan, Pennsylvania Cedric L. Richmond, Louisiana
Billy Long, Missouri William R. Keating, Massachusetts
Tom Marino, Pennsylvania Bennie G. Thompson, Mississippi
Peter T. King, New York (Ex (Ex Officio)
Officio)
Coley C. O'Brien, Staff Director
Zachary D. Harris, Subcommittee Clerk
Chris Schepis, Minority Senior Professional Staff Member
C O N T E N T S
----------
Page
Statements
The Honorable Gus M. Bilirakis, a Representative in Congress From
the State of Florida, and Chairman, Subcommittee on Emergency
Preparedness, Response, and Communications..................... 1
The Honorable Laura Richardson, a Representative in Congress From
the State of California, and Ranking Member, Subcommittee on
Emergency Preparedness, Response, and Communications........... 3
The Honorable Daniel E. Lungren, a Representative in Congress
From the State of California, and Chairman, Subcommittee on
Cybersecurity, Infrastructure Protection, and Security
Technologies................................................... 4
The Honorable Yvette D. Clarke, a Representative in Congress From
the State of New York, and Ranking Member, Subcommittee on
Cybersecurity, Infrastructure Protection, and Security
Technologies................................................... 6
The Honorable Bennie G. Thompson, a Representative in Congress
From the State of Mississippi, and Ranking Member, Committee on
Homeland Security:
Prepared Statement............................................. 8
Witnesses
Dr. Alexander G. Garza, M.D., MPH, Assistant Secretary for Health
Affairs, Chief Medical Officer, U.S. Department of Homeland
Security:
Oral Statement................................................. 9
Prepared Statement............................................. 10
Mr. Rafael Borras, Under Secretary for Management, U.S.
Department of Homeland Security:
Oral Statement................................................. 12
Prepared Statement............................................. 14
Mr. William O. Jenkins, Jr., Director, Homeland Security and
Justice Issues, Government Accountability Office:
Oral Statement................................................. 15
Prepared Statement............................................. 17
Ms. Frances Phillips, Deputy Secretary, Public Health Services,
Department of Health and Mental Hygiene, State of Maryland:
Oral Statement................................................. 25
Prepared Statement............................................. 27
Appendix
Questions From Chairman Gus M. Bilirakis for Alexander G. Garza.. 39
Questions From Chairman Daniel E. Lungren for Alexander G. Garza. 40
Questions From Chairman Gus M. Bilirakis for Rafael Borras....... 40
BIOWATCH PRESENT AND FUTURE: MEETING MISSION NEEDS FOR EFFECTIVE
BIOSURVEILLANCE?
----------
Thursday, September 13, 2012
U.S. House of Representatives,
Committee on Homeland Security,
Subcommittee on Emergency Preparedness,
Response, and Communications, and
Subcommittee on Cybersecurity, Infrastructure
Protection, and Security Technologies,
Washington, DC.
The subcommittees met, pursuant to call, at 3:14 p.m., in
Room 311, Cannon House Office Building, Hon. Gus M. Bilirakis
[Chairman of the Subcommittee on Emergency Preparedness,
Response, and Communications] presiding.
Present: Representatives Bilirakis, Lungren, Marino, Clarke
of New York, and Richardson.
Mr. Bilirakis. Good afternoon. The joint hearing of the
Committee on Homeland Security Subcommittee on Emergency
Preparedness, Response, and Communications and the Subcommittee
on Cybersecurity, Infrastructure Protection, and Security
Technologies will come to order.
The subcommittees are meeting today to receive testimony on
the Department of Homeland Security's biosurveillance efforts
and particularly the BioWatch program.
I now recognize myself for my own statement.
Established in 2003 in the wake of the anthrax attacks that
killed five people, the BioWatch program was the first
Nationally-deployed system designed to detect an aerosol attack
with anthrax and other agents of bioterrorism. Now very near
the 11th, of course the 11th anniversary of the attacks that
prompted the program's development, it is time to take a step
back and ask what Gen-2 has accomplished for us, what it has
not achieved, and how we can better understand its relevancy to
an overall biodetection architecture that must be dynamic and
capable of meeting evolving threats.
BioWatch is currently in its second generation known as
Gen-2, and accounts for the vast majority of the budget at the
Office of Health Affairs.
The Department of Homeland Security is currently in the
process of testing technology for a third generation of
BioWatch known as Gen-3. Gen-3 would be a lab in the box,
eliminating the need for daily collection of samples, and, if
successfully implemented, the detection time could be reduced
from the current 12 to 36 hours down to 4 to 6 hours. This goal
is certainly laudable; however, Chairman Lungren and I have
expressed serious concerns about the status of this
acquisition.
One of the many important functions of the Congress is to
ensure we avoid and eliminate wasteful spending. This becomes
even more vital in the difficult times, of course, that we are
currently facing. Yet I am concerned that without corrective
action, we may be heading down a path at DHS with a Gen-3
procurement that we have been down before, and with the
potential life-cycle costs of $5.8 billion, among the most
costly DHS acquisitions; we cannot afford to fail.
Over the course of its existence, DHS has seen a number of
failed large-scale acquisitions, be it through a failure to
conduct an analysis of alternative or cost-benefit analysis or
to adequately define requirements. We must ensure that BioWatch
does not go down the way of SBInet or the ASP program. However,
I am concerned that DHS is not taking appropriate steps to
ensure the success of
Gen-3. As the GAO notes in its report, without a systematic
effort to justify the need for the acquisition and the control
of its costs, benefits, and risks, DHS has pursued goals and
requirements for
Gen-3 with limited assurance that they represent an optimal
solution.
I am pleased our subcommittees could convene today to
consider the future of BioWatch, and particularly the findings
of GAO's report as it pertains to Gen-3.
Chairman Lungren and I have posed numerous questions to the
Department about the Gen-3 procurement, but have not received
satisfactory responses. How can we proceed with procurement of
a new system when we don't fully understand the capabilities of
the current system? Where is the cost-benefit analysis that
proves that this generation system will be sufficient--would be
of sufficient improvement over the existing system? Where is
the analysis of alternatives that says that BioWatch 3 is the
answer versus improving the Gen-2 system or investing in
improved performance and data integration? How is it possible
that the Department is down to only one single competitor when
we know, without a doubt, that many engineering and
biotechnology companies are making biodetectors for the
Department of Defense and even for DHS itself?
I am hopeful that our witnesses will provide us with
answers to these and other important questions about the future
of this program today.
It is also important to recognize that BioWatch is one
component of an overall biosurveillance architecture which must
be multifaceted in order to be successful. I look forward to
hearing from Dr. Garza on recent developments with OHA's other
biosurveillance initiatives and how they will help us achieve
true situational awareness to the greatest extent possible.
We all want to ensure our Nation has a comprehensive
biosurveillance capability in place; however, we must be smart
about how we accomplish this goal. We must ensure that the
development and procurement of the next generation of BioWatch
is based on sound science, we are getting an appropriate return
on our investment, and that we do not lose sight of the greater
goal by harnessing all our resources toward one single and
static technology.
With that, I welcome our witnesses, and I look forward to
your testimony and working with you to ensure we have an
effective program in place.
The Chairman now recognizes the Ranking Member on the
Subcommittee on Emergency Preparedness, Response, and
Communications, the gentle lady from California, Ms.
Richardson. You are recognized for your statement.
Ms. Richardson. Thank you. Good afternoon, our witnesses
here today, and thank you Chairman Bilirakis and Mr. Lungren
and Ranking Member Clarke for us all coming together on this
very important joint hearing.
As Ranking Member on the Subcommittee on Emergency
Preparedness, Response, and Communications, I am committed to
ensuring that the money allocated to make our communities safer
and that mitigate the devastation that follows a major incident
is carefully targeted to develop the best solutions to pressing
capability gaps. We must ask whether, however, it is
appropriate to invest in the potential of technologies when
simple cost-effective solutions might suffice as well.
In March 2008, DHS advanced its integrated planning
guidance for year 2012 through 2014, which included specific
criteria for the generation of the BioWatch, although the
Department has not engaged in the process of identifying the
capability and determining whether addressing it is worth the
cost.
One of the trends that has been reported that we need to
bring clarification to today is the GAO's report, and in that
report it appears that it has been a foregone conclusion that
automated biodetection was the only way to make BioWatch
technology cheaper and faster. The momentum of this acquisition
process appears to have been driven potentially by individuals
who were wedded to the concepts of deploying an automated
biodetection system regardless of the increasing costs, the
questionable benefits and the repeated delays.
At this point we are all looking at the fact of spending
$104 million that we have invested in developing Gen-3 that
could have been potentially spent on local and State
governments that could have invested the money in a very
effective way to protect the citizens.
It is unfortunate that we do not know who made these
decisions or why at the time; however, continuing on a faulty
procurement process does not seem to be most prudent for us.
Steps in the acquisition process designed to inject thought
and analysis into the process were completed in a cursory
manner to speed along the process. Although I am pleased that
the Department has agreed to partially adopt the GAO's
recommendations and to reevaluate the mission need, and the
alternatives and the update associated with the cost and the
scheduled information, I am concerned that this will occur
simultaneously while the
Gen-3 is in the performance testing phase. Simultaneously
conducting an analysis of alternatives while performance
testing will allow payment for a product that the Government
may never use.
Finally, I am concerned that the performance testing that
sets stage for a predetermined outcome. Now, I come from
California, and the Los Angeles Times has been covering this
issue pretty heavily and reported, released yesterday, marked
an opportunity to stop and reevaluate Gen-3 and assess where
BioWatch fits into our Federal biosurveillance efforts.
For almost a decade now many have believed that BioWatch is
the answer that we have sought. The Los Angeles Times has also
reported that there have been 56 BioWatch actionable alerts
since the program's inception; however, no jurisdiction has
ever initiated the distribution of the countermeasures as a
result.
Although I understand that the BioWatch program office has
improved with its guidance, and I want to commend Dr. Garza for
your work, and you have always been here, and have faced the
music, and answered the questions and made the commitments to
address the concerns of this committee, so that has been a part
of the process that we have witnessed, although we are still
concerned and remain concerned of the continuation of this
program.
I look forward to the testimony of all the witnesses today,
and above all we have to remember in all times, even these
tough times, that it is our ultimate responsibility to make
sure that the scarce resources that we have available are spent
appropriately.
With that I yield back the balance of my time.
Mr. Bilirakis. Thank you very much.
The Chairman now recognizes the Chairman of the
Subcommittee on Cybersecurity, Infrastructure Protection, and
Security Technology, the gentleman from California, Mr.
Lungren.
Mr. Lungren. Thank you very much, Mr. Chairman.
In just a few weeks, as you suggested, we do mark the 11th
anniversary of the anthrax attacks. Since that difficult time,
initiatives ranging from screening the mail to monitoring the
environment, to integrating National biosurveillance efforts
have been undertaken in a vigorous effort to identify the
presence of harmful infectious agents. But after 11 years of
refining our detection technology and fostering information-
sharing partnerships, the question remains: Have we improved
our capability substantially to identify and respond to a
biological attack?
Today it is our purpose to examine the Department of
Homeland Security's BioWatch program and how effective it has
been in countering the biothreat. As my colleague Chairman
Bilirakis has indicated, we need to put this program in proper
perspective. We know from our oversight and from lots of good
work from the GAO, the DHS, other Federal agencies, and States
and localities have taken many steps to improve
biosurveillance. But truly integrated surveillance remains to
be achieved.
Efforts to establish a working National biosurveillance and
integration center, while not without flaws, however, have at
least demonstrated where some of our capability gaps remain.
The problems are not intractable, nor do I suggest that they
are.
What is necessary is a well-thought-out architecture that
balances the contributions of static and dynamic sensors. Many
good ideas, some in the research phase, some being piloted,
some operational, are already making positive contributions.
Astute physicians and advanced patient-side diagnostics may
play an important role far earlier in the wake of an attack
than that for which they are commonly given credit.
The DHS Science and Technology Directorate is working on a
number of advanced biodetection efforts, and we hope to hear
from our witnesses how these might complement our efforts to
automate BioWatch. We have heard over the years from many
constituencies about the successes and challenges of the
deployed BioWatch system Generation 2. The good news is that
through this program, many U.S. localities have been able to
partner with their Federal Government and with each other to
enhance their biosurveillance capabilities.
BioWatch, in fact, depends on the very important
contributions from State and local public health laboratories,
and their service to this program is essential, and for that
and we thank them. But the Gen-2 system has its deficiencies,
and I look forward to hearing from Dr. Garza about the
Department's plan to mitigate them.
To meet some of Gen-2's lack of capacity, OHA has proposed
BioWatch Generation 3, an advanced automated detection system
undergoing DHS acquisition.
The GAO, at least from the written testimony that I have
perused, will tell us today that DHS did not fully develop
critical information for decision making on this major
acquisition, with life-cycle cost estimates now approaching $6
billion.
As has been mentioned, delays now put full deployment, if
approved, as I understand it, at the year 2022. If
biosurveillance is such an urgent need, do we need more to
ensure that we are not going to wait for 10 more years to
improve the program?
Those are some of the questions I have got. I look forward
to hearing from our witnesses as to what we can do now to make
us more secure from the biothreat.
GAO has offered several recommendations for how DHS can
self-correct this acquisition. DHS agreed with GAO's
recommendations and plans to implement them, but is
nevertheless pushing forward with the acquisition process to
avoid further delays. I understand both sides of that equation,
but it will be interesting to see how you address those. My
concern is not the delays, but whether multiple acquisition
weaknesses identified by our committee's oversight hearings
have been addressed, and whether this very expensive
acquisition will be properly handled.
We have already spent $100 million on Gen-3, and even in
Washington that is a lot of money. The House has not provided
funds for fiscal year 2013. If we support this program, we have
to just justify to our colleagues as to why we should continue
to fund it in substantial ways. Shouldn't an acquisition of
this size have a cost-benefit analysis at the very least to
justify in our minds going forward? But we also have the burden
as this committee to convince our colleagues that there is a
cost-benefit analysis that justifies it.
We also need to understand all the opportunities to protect
human life from bioattack before we adopt a specific path
forward. We can only do this with a thorough analysis of
alternatives, which should include proposals to refine and
improve the Gen-2 system--as least this is my thought--before
pushing forward to the next generation.
Rapid post-event detection is unquestionably critical, but
clearly we need to refine our focus on defining the problem and
then determining the total architecture, from hardware to
software to the human element, that can best meet the
challenge. I would like to see a truly open competition where
all the bright minds in small business, big industry, our
National labs, all of them come together to meet the challenge.
So I look forward to the testimony. We were going to start
at 3 o'clock. We were interrupted by votes. Unfortunately for
me I have other things that I have got to meet as well, so I
will remain here as long as possible, but I will assure you
that we will go over with a fine-tooth comb your written and
your oral presentation. So I thank you.
Mr. Bilirakis. The Chairman now recognizes the Ranking
Member of the Subcommittee on Cybersecurity, Infrastructure
Protection, and Security Technologies, the gentlewoman from New
York Ms. Clarke. You are recognized for your statement.
Ms. Clarke of New York. Thank you very much, Mr. Chairman,
and good afternoon to you, Ranking Member Richardson, and of
course to Chairman Lungren, and thank you for holding this
hearing on our efforts to assess the BioWatch program.
I would like to also acknowledge and thank today's
witnesses for being here to testify before us today.
The Nation's capacity to respond to bioterrorism depends in
part on the ability of clinicians and public health officials
to detect, manage, and communicate during a bioterrorism event.
Information technologies and decision support systems have the
potential to aid clinicians and public health officials to
respond effectively to a bioterrorist attack. The information
that public health officials require to prepare for and respond
to a bioterrorism event can be considered in relation to the
decisions they must make, the interpretation of the
surveillance data, the investigation of outbreaks, the
institution of epidemiologic control measures, and the issuance
of surveillance alerts.
If we are going to do detection systems right, there are
capabilities we must have: Portability, a large number of
samples that can be run simultaneously, a large number of
biothreat agents that can be identified, and whether both
toxins or organisms can be identified. As we have seen from
previous efforts, these capabilities are not easy to achieve.
It seems clear that the private sector does not yet assess
or possess the technological expertise necessary to produce
next and future generation versions of BioWatch. I believe it
makes sense that DHS S&T should resume responsibilities for the
R&D required. It has become clear that OHA is not, nor was it
ever, envisioned by Congress to be an R&D organization.
BioWatch contract management has historically been
problematic, but it has been difficult determining exactly why.
What is clear is that OHA has had to put a stop to Gen-2.5 and
now Gen-3.0, but well after a lot of money has been spent. Too
much money being spent should be an indicator to managers that
there is something wrong. It is also not clear to me why the
management directorate did not step in earlier.
Let me put a little historical perspective on this issue.
Years ago OHA handled the interface with the State and local
public health labs that house BioWatch-related activities
poorly. OHA leadership recognized this and made some positive
changes. The relationships have improved since then, with money
going into the States and locals just recently. However, as
recent media stories and previous testimony have indicated, no
one has very much faith in the BioWatch system even as it
stands right now, including the public health lab directors.
There is a question as to whether OHA or S&T have been
keeping up with the technology changes used by other agencies.
For example, why is the Secret Service using different
biological-sensor technology than BioWatch? Where is DOD with
their continued development of biological sensors, and how, if
at all, is that information being shared with DHS or anyone
else?
Importantly, the majority of OHA's budget goes to NBIC and
BioWatch. If funding were to be cut for NBIC and BioWatch, and
funds for R&D were to be given back to S&T, then there wouldn't
be that much left for whatever else OHA does.
From an oversight perspective, one has to ask whether what
is left at OHA would constitute an entire office at DHS with
its own assistant secretary and staff. As I remember, the
original model for OHA was just the chief medical officer, one
person, with two other people assisting. GAO has noted on a
number of occasions in assessing contractors in the workforce
and DHS that use of contractors to perform certain functions
can place the Government at risk of transferring Government
responsibilities to contractors, and potentially results in the
loss of Government control over and accountability for policy
and program decisions.
In its latest findings, GAO told DHS to stop BioWatch in
its tracks, and reevaluate the mission need and alternatives,
and develop performance schedule and cost information in
accordance with guidance and good acquisition practices. That
is about as blunt as you can get.
Is it true that DHS plans to proceed with the acquisition
of
Gen-3 while implementing acquisition and performance guidelines
to avoid further delay? I hope we will find out today.
GAO believes the recommendation should be enacted before
DHS proceeds with the acquisition as discussed in this report,
and I agree with GAO.
The Secretary should be more involved in this problem.
There are substantial sums of taxpayer money, over $5 billion,
at stake here, and a huge amount of the money already spent to
no productive end. My colleagues on our two subcommittees have
written the Secretary in detail about our concerns with this
program. DHS should act now, follow GAO's recommendations, and
with haste.
With that, Mr. Chairman, I yield back.
Mr. Bilirakis. Thank you, Ms. Clarke. I appreciate it very
much.
I am pleased to welcome our distinguished panel of
witnesses at this time. Our first witness is Dr. Alexander
Garza. Dr. Garza is the assistant secretary for health
affairs----
Ms. Clarke of New York. Excuse me. I am sorry, Mr.
Chairman.
Mr. Bilirakis. You are recognized.
Ms. Clarke of New York. Thank you so much, Mr. Chairman.
I wanted to ask unanimous consent to submit for the record
the testimony statement of Ranking Member Thompson.
Mr. Bilirakis. Without objection, so ordered.
Ms. Clarke of New York. Thank you, Mr. Chairman.
[The statement of Mr. Thompson follows:]
Statement of Ranking Member Bennie G. Thompson
September 13, 2012
As many of us remember, one week after the September 11 attacks,
the Nation was subjected to anthrax attacks. Envelopes containing a
powder laced with anthrax spores were delivered in the mail and were
directed at Capitol Hill offices and various media outlets. These
poisoned envelopes killed 5 people and infected 17 others. According to
the FBI, the ensuing investigation became ``one of the largest and most
complex in the history of law enforcement.''
The legislative response to these attacks was to enact a measure
that would provide an early warning system to detect the release of
harmful biological or chemical compounds in our major cities. We called
the program BioShield. Eleven years and $800 million dollars later, the
program is called BioWatch. Eleven years and $800 million dollars
later, we still do not have an early warning system that can quickly
and efficiently detect the release of a harmful biological or chemical
compound in our major cities. Eleven years and $800 million dollars
later, it is time to reconsider the likelihood of the risk and adjust
our priorities.
Although today's hearing is about Generation 3 of BioWatch, I
wanted to provide the historical context of this program because we
must understand that we are on Generation 3 because Generations 1 and 2
did not work. The technological component of this program, which
originally began in 2003, has suffered from poor planning, poor
execution, and poor performance throughout its life cycle.
We should seriously consider whether the technology Congress
envisioned is capable of being produced. It seems that the answer is--
not yet. GAO recommends that before continuing with the acquisition,
DHS reevaluate the mission need, investigate alternatives and develop
performance, schedule, and cost information. Given the history of this
program and the $800 million that has been spent, GAO's recommendations
seem reasonable and sound.
I urge DHS to reconsider its plan to proceed with the acquisition.
Before yielding back, I want to make note that not all of BioWatch
should be reconsidered. It is my understanding that the program has
strengthened interactions and partnerships between the Federal, State,
and local public health community. The increased interaction and
information sharing that has come about as a result of those
relationships will serve this Nation well. We know that those
relationships were important a few years ago when we were concerned
about a flu pandemic.
The interaction among the public health sector helped this Nation
quickly mobilize, take preventive action, and provide precautionary
vaccines to millions of people. So Mr. Chairman, whatever the fate of
Biowatch, I think we all benefit by continuing to provide grants and
other incentives for the public health community to work together.
Mr. Bilirakis. Dr. Garza is the assistant secretary for
health affairs and chief medical officer of the Department of
Homeland Security.
Following Dr. Garza we will hear from Mr. Rafael Borras,
and he is the under secretary for management at the Department
of Homeland Security, a position he has held since April 2010.
Next we will hear the testimony from Mr. William Jenkins.
Mr. Jenkins is director of homeland security and justice issues
at the United States Government Accountability Office.
Finally, we will hear--we will receive testimony from Ms.
Frances Phillips. Ms. Phillips is the deputy secretary for
public health services for the Maryland Department of Health
and Mental Hygiene, a position she has held since December
2008.
I want to welcome the witnesses. Your entire written
statements will appear in the record. I ask that you summarize
your testimony for 5 minutes. We will begin with Dr. Garza.
Welcome, sir. Thank you. You are recognized.
STATEMENT OF ALEXANDER G. GARZA, M.D., MPH, ASSISTANT SECRETARY
FOR HEALTH AFFAIRS, CHIEF MEDICAL OFFICER, U.S. DEPARTMENT OF
HOMELAND SECURITY
Dr. Garza. Thank you, Chairmen Bilirakis, Lungren, Ranking
Members Richardson and Clarke, and distinguished Members, thank
you for inviting me to speak with you today. I appreciate the
opportunity to update you on the Office of Health Affairs
BioWatch program, and I am honored to testify with Under
Secretary Borras, Director Jenkins, and Ms. Phillips.
Terrorism continues to be a threat to our Nation, including
the use of biological organisms as a means. In fact, in a
recent publication by a known terrorist organization, it was
stated that the use of poisons or chemical-biological weapons
against population centers is allowed and is strongly
recommended due to its great effect on the enemy.
Recent events also demonstrate the potential lethality and
complexities of response to biological agents. Just last month
in a small village in Russia, 14 people were hospitalized and 1
person died from an outbreak of anthrax. Local authorities
declared a state of emergency, quarantined the area, and began
vaccinating people and animals, but only after people were sick
and dead.
We also know that with rapid advances in biotechnology and
life sciences, the barrier to successfully using biological
agents as a method of terrorism has never been lower.
Though the risk of using biological agents is constantly
shifting and evolving, one thing is clear: BioWatch has the
potential to provide early warning to public health officials
before sick and dying people show up in the emergency
department. It complements public health surveillance systems
and ultimately can save lives.
As you know, BioWatch is the Nation's only Federally-
managed, locally-operated Nation-wide biosurveillance system
designed to detect select aerosolized biological agents. The
system is collaborative. It is an effort across all levels of
government, supported by a Nation-wide network of lab
personnel, local public health officials, responders, and
Federal partners.
The program's current capabilities consist of air
collectors with a filter that requires manual retrieval and
analysis at a local public health lab. If the analysis
indicates that a filter contains DNA from an organism of
concern, the local lab director declares a BioWatch Actionable
Result, or a BAR.
Now, allow me to clarify some misconceptions about what a
BAR means. It is a detection of targeted DNA. It has never been
promoted nor described as a declaration of a bioterrorist
attack. Humans decide what is an act of terrorism, not
machines. Furthermore, a BAR does not dictate any public
action. It is a piece of data.
While the current BioWatch system is extremely beneficial,
as you mentioned, it is resource-intensive, and the results may
not be readily available. This is time that is required to
deploy medical countermeasures. It is clear that technology
needs to improve if we are ever to defeat the tyranny of time
imposed by these agents. This is consistent with the
President's National Strategy For Biosurveillance, which
states, ``Rapid detection and enhanced situational awareness
are critical to saving lives and improving incident outcome.''
Automated biodetection eliminates the need for manual
filter retrieval, can provide continuous sample collection and
analysis, and have results transmitted virtually to public
health officials. These capability improvements are encompassed
in the next generation of biological detectors known as
Generation 3, or Gen-3. All told, this automated detection
technology holds the promise of reducing the detection from the
current 12 to 36 hours to 4 to 6.
What I am describing here is a game-changer. Moving from
manual retrieval and analysis to essentially a lab in a box
would bring DHS and National security to the leading edge of
detection technology. This type of leading-edge technology
demands a complex and agile strategy that can accommodate
iterative improvements while ensuring that rigorous performance
standards are met. This is exactly how we approach this
acquisition.
Phase 1 testing for Gen-3 acquisition was completed in June
2011 and assessed the maturity and technical capability of the
biotechnology market, including assay and field testing.
Besides the technical work, BioWatch continues to make
certain that Generation 3 acquisition is consistent with
Department directives. DHS concurs with the two GAO
recommendations, and we are moving forward in a manner that
ensures best practice compliance. Where we differ on is the
execution. To that end, Under Secretary Borras chaired a
meeting of the Acquisition Review Board for Generation 3
acquisition on August 16, where the release of solicitation for
an analysis of alternatives including a cost-benefit study and
a request for proposals for performance testing was
conditionally approved.
In addition, OHA will deliver required acquisition
documents for approval and meet again with the ARB before
awarding of performance contracts.
I appreciate this subcommittee's interest in BioWatch and
Generation 3 acquisition and your continued partnership as we
work to improve the Nation's biosurveillance.
Thank you for the opportunity to appear before you today,
and I look forward to answering any questions.
[The prepared statement of Dr. Garza follows:]
Prepared Statement of Alexander G. Garza
September 13, 2012
Chairmen Bilirakis & Lungren, and distinguished Members of the
subcommittees: Thank you for inviting me to speak with you today. I
appreciate the opportunity to update you on the Office of Health
Affairs' (OHA) BioWatch Program and I'm honored to testify with Under
Secretary Borras and my distinguished colleague from the Government
Accountability Office.
Bioterrorism remains a continuing threat to the security of our
Nation. We know that terrorist organizations continue to call for
chemical, biological, radiological, nuclear, and explosive (CBRNE)
attacks targeting the West.
At the same time, the rapid global development of biotechnology,
which provides important new capabilities for industry, medicine, and
scientific research, is also making the capability to develop
biological weapons increasingly accessible. The threat environment is
constantly evolving and the early detection of a biological attack, as
supported by the BioWatch Program, is an essential part of an effective
biodefense posture.
As you know, the BioWatch Program is the Nation's only Federally-
managed, locally-operated Nation-wide biosurveillance system designed
to detect the intentional release of select aerosolized biological
agents. Deployed in more than 30 metropolitan areas throughout the
country, the system is a collaborative effort of health personnel at
all levels of government.
In accordance with the President's July 2012 National Strategy for
Biosurveillance, the BioWatch Program is strengthening local
partnerships and building capacity to improve biosurvelliance, enabling
rapid, well-informed decision-making. BioWatch is supported by a
network of laboratory personnel, local public health and responder
personnel, and Federal partners including the Centers for Disease
Control and Prevention (CDC), the Federal Bureau of Investigation, the
Department of Defense and the Environmental Protection Agency.
The current detection capabilities used by the BioWatch Program
consist of outdoor aerosol collectors whose filters are manually
retrieved for subsequent analysis in a State or county public health
laboratory that is a member of the CDC Laboratory Response Network
(LRN). The results are generally received 8-10 hours after sample
delivery to the laboratory. If the analysis indicates the filter
contains genetic material from an organism of concern, a BioWatch
Actionable Result (BAR) is declared by the director of that public
health laboratory or their designee. To be clear, a BAR does not mean a
terrorist attack has occurred, a viable agent has been released, or
that people have been exposed. Additional information is needed to
determine if an attack has occurred and if there is a risk to public
health. A BAR simply means that targeted DNA is present.
Each BioWatch jurisdiction has a BioWatch Advisory Committee (BAC)
made up of State, local, and Federal partners who operate the program
and are responsible for leading response efforts. When a BAR has been
declared, the BAC is informed within 1 hour and a National conference
call is generally conducted within 2 hours. The National conference
call brings together all the necessary State, local, and Federal
response partners, allowing for rapid characterization of the public
health threat, if any, and can put into motion the actions necessary to
save lives. These actions may include deploying medical countermeasures
or notifying hospitals to be aware of certain symptoms. An early
warning of an attack allows exposed populations to protect themselves
before they become acutely and critically sick, reducing symptomatic
cases and casualties. By providing such warning for certain biological
threat agents, the BioWatch Program complements and strengthens the
existing public health surveillance system and allows information to be
rapidly shared with health care providers. Such early warning may also
empower the U.S. Government to take actions to further protect the
country from follow-on attacks.
Fostering preparedness is a key part of BioWatch operations. To
this end, the BioWatch Program provides guidance documents to assist
jurisdictions in preparing response plans and conducts exercises of the
notification and response processes. Additionally, the BioWatch Program
manages the National notification process and offers laboratory
support, environmental sampling, and event modeling.
While the current BioWatch system is extremely beneficial, it is
labor-intensive and results may not be available until 12-36 hours
after the release of a biological agent has occurred. In the event of a
bioterrorism attack, a shorter time to detect could mean thousands of
additional lives saved. The incubation periods of biological agents
vary, but in general, the rapid deployment of medical countermeasures
is critical to saving as many lives as possible.
As the National Strategy for Biosurveillance states, we must foster
innovation to facilitate new biosurveillance activities--including new
detection technologies. To give public health officials the timeliest
information possible to help them make these high-consequence
decisions, the Department of Homeland Security (DHS) determined that it
should test the viability of developed autonomous biodetection
technology. Congress supported this approach in the 2009 DHS
Appropriations Act, by calling for a competitive bid process for Phase
I of the BioWatch Generation 3 (Gen-3) acquisition.\1\ DHS implemented
the Gen-3 acquisition, which aims to reduce the time between potential
exposure and confirmation of a potential biological attack through
automated detection.
---------------------------------------------------------------------------
\1\ See pages 655-656 of the House Appropriations committee print,
H.R. 2638; Pub. L. 110-329, which presents the final legislative text
and explanatory statement.
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Automated detection will eliminate the need for manual filter
retrieval and is intended to provide continuous collection and analysis
of samples within the unit. The results of this automated analysis
would be transmitted electronically to public health officials. With
Gen-3, the time to detect could be reduced to 4-6 hours, handing back
precious time to public health officials faced with responding to a
potential bioterrorism event.
Moving from the manual analysis of a filter towards what would
essentially be a ``laboratory in a box,'' marks a true sea change,
bringing DHS to the forefront of state-of-the-art biological detection
technology. However, acquiring a first-of-kind technology requires a
robust and agile acquisition strategy that can accommodate iterative
improvements and open competition, while ensuring rigorous performance
standards are met.
Phase I testing for the Gen-3 acquisition, which was completed in
June 2011, assessed the maturity and technical capability of the
biodetection technology market against a robust set of system
requirements. To accomplish this goal, Phase I included assay/
characterization testing and field testing of candidate Gen-3
detectors. We are currently preparing to enter Phase II, which will
allow us to test a small number of production-level units to ensure
they meet performance standards. Once they do, the remainder of the
Phase II acquisition will be a full and open competition, and vendors
will be evaluated equally in accordance with the terms of the Request
for Proposal (RFP).
At the outset of the Gen-3 acquisition, OHA followed prior existing
guidance which has since been revised as the Department has matured its
acquisition process. I appreciate the Government Accountability
Office's (GAO) draft report on the status of the Gen-3 acquisition and
we are currently working to develop, revise, and update the requisite
acquisition documentation as appropriate and in line with current
Departmental acquisition directives. I will continue to partner with
Under Secretary Borras to ensure we meet the rigorous standards called
out in the Department's acquisitions directives.
To that end, Under Secretary Borras chaired an Investment Review
Board (IRB) meeting for the Gen-3 acquisition on August 16, 2012. The
Acquisition Decision Authority (ADA) gave contingent approval for the
BioWatch Program to release the solicitation for an analysis of
alternatives (AoA) and the RFP for Gen-3 Phase II Stage 1, which
provides for performance testing of a small number of detector units
from each competitively-selected vendor. These next steps are
contingent upon the BioWatch Program updating and receiving approval of
the system's Operational Requirements Document and several other
acquisition documents. OHA will return to the IRB prior to awarding a
Phase II performance testing contract.
This course of action addresses the core of GAO's recommendations
which call for a re-evaluation of the mission need and an AoA based on
cost-benefit and risk information, as well as updates to acquisition
documents to consider cost-benefit and risk information. As a result of
the guidance provided in the last IRB, we are in the process of
updating the Mission Need Statement, commissioning an independent
organization to conduct the AoA, which will include a cost-benefit
analysis, and updating all the required documents to ensure they comply
with the current Departmental guidance for acquisitions as outlined in
Management Directive 102-01.
I appreciate the subcommittees' oversight of the BioWatch Program
and the
Gen-3 acquisition as well as your continued partnership as we work to
improve our Nation's biosurveillance. Thank you for the opportunity to
appear before you today. I look forward to your questions.
Mr. Bilirakis. Thank you, Dr. Garza.
Now we will call on Secretary Borras. You are recognized
for 5 minutes, sir.
STATEMENT OF RAFAEL BORRAS, UNDER SECRETARY FOR MANAGEMENT,
U.S. DEPARTMENT OF HOMELAND SECURITY
Mr. Borras. Thank you, Chairman Bilirakis, Chairman
Lungren, Ranking Member Richardson, and Ranking Member Clarke,
and other distinguished Members of the committee, I appreciate
the opportunity to appear here today.
I am pleased to be here with Dr. Alexander Garza, along
with my other distinguished colleagues on this panel. While Dr.
Garza described the history and the objectives of the BioWatch
program, I would like to discuss with you very briefly how we
have been maturing our acquisition and oversight procedures to
help minimize the risk for important Department of Homeland
Security programs, in this case specifically BioWatch Gen-3.
As Chief Acquisition Officer for DHS, I oversee the
policies, processes, and procedures used to acquire and oversee
more than $18 billion of goods and services each year. I have
focused significant attention on improving the analysis and the
rigor for all phases of acquisition life cycle during my tenure
from the requirements development phase through implementation.
This includes applying a more disciplined approach and
requiring more detail analysis before authorizing programs to
proceed to the next phase of development and life cycle.
The technical requirements for the BioWatch and Gen-3
technology are highly specialized and complex. I am pleased
that our Science and Technology Directorate is working closely
with the Office of Health Affairs on the technical strategy for
the third generation of BioWatch.
The Office of Program Accountability and Risk Management,
which reports directly to me, is also working closely with S&T
and OHA to provide high-quality acquisition management support.
The record of the Department's acquisition oversight for
BioWatch
Gen-3 is clear. Since 2009, BioWatch Gen-3 program has been
reviewed by the Department's Acquisition Review Board five
times. Most recently I directed the BioWatch Gen-3 program to
refine the developmental and operational test and evaluation
subphases based on the findings from the study conducted by the
Government Accountability Office and an independent assessment
commissioned by the Secretary and carried out with the Homeland
Security Studies and Analysis Institute.
I also gave contingent approval to release two competitive
procurements. The first is to conduct analysis of alternatives
to identify and document an optimal solution for the identified
mission capability gap, and the second is to conduct a system
performance testing that verifies attainment of technical
performance and validates required operational effectiveness
and suitability.
Prior to any award of Gen-3 performance testing contract,
the program must be reviewed again by the Acquisition Review
Board to evaluate the results of the testing and to determine
if the program is able to meet the revised targets of the
program plan.
Regarding costs, I, too, have concerns regarding the life-
cycle costs of this program and have directed the program
leadership to develop a more credible cost estimate which
provides an exhaustive and structured accounting of all the
resources and associated cost elements.
At DHS we have worked diligently to improve our acquisition
processes, and these efforts have produced more effective
governance and significant improvements to the future of our
current acquisitions. The BioWatch Gen-3 program is an example
of the application of these improved processes. I will continue
to evaluate the risk of this program in my role as the
Department's Chief Acquisition Officer and as the chair of the
Acquisition Review Board, and will only provide authorization
to proceed when pre-established criteria are met.
While there is still much work to do, the Department has
made significant strides to improve our acquisition and
investment management. We are making progress. Our investment
decisions are now more empirically driven, and qualified
technical expertise is available to support program managers at
each phase of the life cycle.
Thank you again for the opportunity to testify regarding
the improvements in our acquisition investment, and
specifically the BioWatch Gen-3 program.
[The prepared statement of Mr. Borras follows:]
Prepared Statement of Rafael Borras
September 13, 2012
Chairman Bilirakis, Chairman Lungren, Ranking Member Richardson,
Ranking Member Clarke, and other distinguished Members of the
committees, I thank you for the opportunity to appear before you today.
As Chief Acquisition Officer, I oversee the policies, processes,
and procedures used to acquire and oversee over $18 billion in goods
and services each year. During my tenure, I have focused significant
attention on improving the analysis and rigor for all phases of the
acquisition life cycle, from the requirements-development phase through
implementation. This includes applying a more disciplined approach and
requiring more detailed analysis before authorizing programs to proceed
to the next phase of the life cycle. Historically, we have sometimes
let urgency outweigh prudence when making investment decisions. This
has sometimes resulted in well-documented programmatic failures.
When I first arrived at DHS over 2 years ago, the organization was
in the process of strengthening its acquisition policies and
procedures. I directed our program management function to ensure any
new procedures be steeped in established management principles and
balance risk mitigation with the need for rapid deployment. I wanted an
oversight process with clear and logical approval ``gateposts'' and
business intelligence which could ``flag'' programs that were off
track. Finally, I asked that risk be a significant factor at all
acquisition decision events, especially at the planning phase when
strategies are developed. While the preference is to seek ``existing''
technologies, I understand the Department's mission may sometimes
require development of higher-risk, emerging technology.
In the past year, we have solidified a vast majority of our
policies and procedures and worked with each component so they
understand the rigor expected for all new programs. For some existing
programs that were not subject to the rigors of our new policies and
procedures, we asked that they provide additional documentation before
they could proceed to the next phase of implementation.
Today, I am here to discuss how the Management Directorate is
supporting the success of the BioWatch program and how our maturing
acquisition and oversight procedures are minimizing risk.
biowatch gen-3 investment and acquisition oversight activities
Dr. Garza provides a detailed description of the history and
objectives for the BioWatch program. I will, therefore, not repeat this
information to the committee. It is clear that the program has a long
history and its opportunity for success relies both on emerging
technology and well-coordinated partnerships with industry, other
Federal agencies and State/local governments. The technical
requirements for this technology are complex and I am pleased that our
Science and Technology (S&T) Directorate is working closely with the
Office of Health Affairs (OHA) on the technical strategy for the third
generation (Gen-3).
As indicated by Dr. Garza, there have been some schedule delays in
the acquisition of Gen-3 technology for the BioWatch program because
earlier generations were governed by outdated, less rigorous standards.
I am confident that our technical, acquisition, and oversight
environments are sufficiently settled so future generations of BioWatch
equipment will be well-supported.
S&T is in a unique position to evaluate new and emerging
technologies against capability gaps, which will increase technological
expertise and assist the Department in making better technology ``buy''
decisions. S&T and OHA are working closely to pursue this highly
specialized detection technology while the Office of Program
Accountability and Risk Management (PARM), which reports directly to
me, is positioned to offer high-quality acquisition management support.
In October 2009, the Deputy Secretary led an Acquisition Review
Board to review its Phase 1 testing, which resulted in authorization
for the program to proceed; however, OHA was required to provide a
quarterly report to the Deputy Secretary and to my predecessor. The
July 2010, program review examined initial performance of the BioWatch
Gen-3 Assay Evaluation Test and resulted in the authorization to
execute the remainder of the BioWatch Gen-3 Phase 1 test events.
I conducted program reviews of BioWatch in December 2010, April
2011, and August 2012. The first Acquisition Review Board was a program
review focused on challenges with BioWatch Gen-3 testing, which
highlighted vendor failure during Phase I testing. The April 2011
review focused on the constraints of testing due to the testing
environment in Chicago. All work under the BioWatch Gen-3 Phase I
testing contract was completed at a cost of about $50 million. These
reviews resulted in additional requirements for the BioWatch Gen-3
Program, including: The development of an acquisition plan; the
completion of program planning through development of a life-cycle cost
estimate; the creation of a concept of operations; and the creation of
an integrated logistics support plan. All of these requirements were
conditions precedent to the program progressing to its next acquisition
milestone.
In February 2012, the program requested I convene an ARB to obtain
approval to release the BioWatch Gen-3 Phase II performance testing
solicitation. Since the program had not completed the conditions set
forth in prior program reviews, the BioWatch Gen-3 request was denied.
Both the Program Management and Cost Estimating COEs worked with
BioWatch Gen-3 on program and cost challenges to assist them in getting
ready for this milestone. OHA submitted the required acquisition
documentation for the program to the Department for review in July
2012.
The BioWatch program presents challenging acquisition issues under
the most optimal circumstances, but this form of acquisition is not
unique. There are no current, active procurements for BioWatch Gen-3.
The first and second generations are in the operations and maintenance
phase--and were prior to my tenure--while third generation technology
is within the acquisition life cycle and is currently working through
technology demonstration and planning. As chair of the Acquisition
Review Board, I will continue to monitor the progress of the program
and will not allow Gen-3 to proceed unless it is meeting actions from
the ADM.
I directed the BioWatch program to refine the developmental and
operational test and evaluation sub-phases earlier this month based
partially on the findings from a study conducted by the Government
Accountability Office (GAO) and an independent assessment commissioned
by the Secretary and carried out by the Homeland Security Studies and
Analysis Institute (HSSAI). I granted contingent approval to release
two competitive solicitations. The first is to conduct an Analysis of
Alternatives (AoA) and the second to conduct system performance
testing. This is contingent upon the Chief Procurement Officer's
approval of the Acquisition Plan and the Acquisition Review Board's
approval of a Gen-3 Integrated Master Schedule. Prior to the award of
the BioWatch Gen-3 performance testing contract, the program must be
reviewed again by the ARB to determine if the program is able to meet
the revised targets in the program plan.
conclusion
DHS has worked diligently to improve its acquisition processes and
these efforts have produced more effective governance and significant
improvements to future and current acquisitions. The BioWatch program
is an example of the successful application of the Department's
improved acquisition oversight process. The program has accepted
feedback from the Department and been open to revising strategies to
ensure that risk is balanced against benefits. I will continue to
evaluate the risk of this program in my role as the Department's Chief
Acquisition Officer and will only provide authorization to proceed when
pre-established criteria are met.
While there is still much work to do, the Department has made
significant strides to improve acquisition and investment management
for the Department's portfolio of major programs. I believe we are
making progress to shifting the paradigm so investment decisions are
more empirically driven and there is qualified technical expertise to
support program managers at each phase of the life cycle.
Mr. Bilirakis. Thank you, Secretary Borras.
Now we will recognize Mr. Jenkins for 5 minutes.
STATEMENT OF WILLIAM O. JENKINS, JR., DIRECTOR, HOMELAND
SECURITY AND JUSTICE ISSUES, GOVERNMENT ACCOUNTABILITY OFFICE
Mr. Jenkins. Chairmen Bilirakis and Lungren, Ranking
Members Richardson and Clarke, and other distinguished Members
of the subcommittee, I appreciate the opportunity to be here
today to discuss our work on biosurveillance generally and
specifically on our report on BioWatch released yesterday.
A large-scale biological event, such as a terrorist attack
with a deadly pathogen or a naturally-occurring pandemic, could
result in hundreds of thousands of casualties and have
devastating effects on the Nation. Recognizing that a
bioterrorist attack could be difficult to prevent, attention
has been focused on biosurveillance; that is, the ability to
quickly detect and characterize a biological attack or the
emergence and spread of a deadly infectious disease.
The new National Biosurveillance Strategy states that the
goal of biosurveillance is to achieve a well-integrated
National enterprise that saves lives by providing essential
information for better decision making at all levels. Reliable
early detection is a key component of effective
biosurveillance, which includes a wide variety of programs and
activities by Federal, State, and local governments, hospitals,
doctors, and others.
Determining how much to invest in what program requires an
objective assessment of the key capabilities each activity or
program is intended to address. Gen-3's estimated life-cycle
costs, some $5.8 billion, makes it one of the largest DHS
acquisitions, and the question is whether it justifies that
level of investment.
DHS has developed a sound formal acquisition process, but
the BioWatch program has not fulfilled some of the key
requirements of the first two phases of the process. These two
phases are intended to: No. 1, conduct an analysis that
identifies the capability gap or other mission need and why
that need warrants the investment of resources. This results in
a mission needs statement; No. 2, select an optimal solution to
meet the mission need by evaluating viable alternatives based
on cost, benefits, and risk. The result is an analysis
alternatives document.
Abbreviated forms of both these analyses were completed on
an expedited basis in 2009, but neither met the requirements of
the DHS acquisition life cycle framework.
First, the mission needs analysis. The purpose of the
mission needs statement is to identify a need, not to specify a
solution for meeting that need. In March 2008, the Secretary of
DHS issued the DHS Integrated Planning Guidance, which sets
specific goals for BioWatch that are still the basic Gen-3
goals: Develop a lab in a box, reduce costs by more than 50
percent, and shorten notification times to 6 hours or less. The
October 2009 mission needs statement basically reiterated those
specific goals. We interviewed multiple officials in various
DHS offices who had knowledge of the process used to justify
the need for Gen-3. None could describe the processes, if any,
DHS followed to determine that need. Rather, we were told that
there was a departmental consensus that automated detection was
needed and could save lives.
Second, the analysis of alternatives is intended to
identify the best solutions to meet the approved need. The 2009
analysis for BioWatch did not reflect a systematic effort to
identify an optimal solution based on cost-benefit and risk
information. It fell short in three areas.
No. 1, it considered only two alternatives, Gen-2 with more
frequent filter collection and Gen-3. The DHS guidance calls
for a minimum of three alternatives.
No. 2, it used only one cost metric, cost per detection
cycle, that favored Gen-3.
No. 3, it contained no analysis of benefits. Rather, it
assumed that earlier detection would save lives and limit
economic losses, a basic benefit of all biosurveillance efforts
worthy of investment.
The Gen-3 program is pushing the frontiers of technology,
and experience has shown that such programs often encounter
unexpected difficulties, delays, and cost increases. Given the
growing cost of BioWatch and the fact that estimated full
deployment is almost a decade away, it would be prudent to step
back and conduct a careful mission needs analysis and an
independent analysis of alternatives to meet the defined need.
The results of those analyses may still lead to Gen-3, but they
may not.
Because the current 2000 missions needs statement
presupposes the need for Gen-3, we are concerned that an
analysis of alternatives based on that needs statement would be
unlikely to foster alternatives much different from Gen-3. We
appreciate that DHS, in its response to our recommendations, is
willing to reevaluate Gen-3, but it appears somewhat
contradictory to us to do so at the same time it is issuing a
contract solicitation and considering proposals to move to the
next phase of Gen-3 testing.
That concludes my statement, Mr. Chairman. I would be
pleased to respond to any questions you or other Members of the
subcommittees may have.
[The prepared statement of Mr. Jenkins follows:]
Prepared Statement of William O. Jenkins, Jr.
September 13, 2012
gao highlights
Highlights of GAO-12-994T, a testimony before the Subcommittees on
Emergency Preparedness, Response, and Communications and Cybersecurity,
Infrastructure Protection, and Security Technologies, Committee on
Homeland Security, House of Representatives.
Why GAO Did This Study
A catastrophic biological event could have devastating
consequences. The U.S. Government has efforts to provide early
detection and warning of biological threats. DHS's BioWatch, which aims
to detect certain pathogens in the air, is one such program. DHS has
been pursuing a third generation of BioWatch technology (Gen-3) to
further enhance detection. GAO has published a series of reports on
National biosurveillance efforts, including a report released today on
DHS's efforts to acquire Gen-3. This statement discusses: (1) Prior
biosurveillance work and related Federal efforts, (2) today's report on
the Gen-3 acquisition, and (3) prior strategy recommendations and the
White House's July 2012 National Strategy for Biosurveillance. This
statement is based on GAO reports published from December 2009 to
September 2012 and GAO's review of the National Strategy for
Biosurveillance in relation to prior GAO recommendations for a National
biosurveillance strategy.
What GAO Recommends
In prior reports, GAO made biosurveillance recommendations to DHS
and the White House Homeland Security Council. DHS concurred with prior
recommendations. The White House did not comment. In today's report,
GAO recommended that before continuing the Gen-3 acquisition, DHS
reevaluate the mission need and alternatives and update associated
performance, schedule, and cost information. DHS concurred but stated
it plans to reevaluate the acquisition and pursue performance testing
concurrently. We believe DHS should first develop the critical
information we recommended.
biosurveillance.--observations on biowatch generation-3 and other
federal efforts
What GAO Found
The Department of Homeland Security (DHS) and the White House have
acted to strengthen biosurveillance consistent with prior GAO
recommendations made from December 2009 through October 2011. In August
2012, DHS issued a strategic plan for its National Biosurveillance
Integration Center (NBIC) that officials say was written in
coordination with Federal partners and designed to respond to GAO's
December 2009 findings that NBIC did not have key resources to carry
out its mission, in part due to collaboration issues it faced. In July
2012, the White House released the National Strategy for
Biosurveillance, which describes guiding principles, core functions,
and enablers for strengthening biosurveillance. In June 2010, GAO
recommended a National biosurveillance strategy to provide a unifying
framework for building and maintaining a National biosurveillance
capability. In October 2011, GAO also recommended the strategy account
for the need to leverage resources and respond to challenges while
partnering with non-Federal entities. The July 2012 strategy partially
responds to the issues GAO called for such a strategy to address, but
does not fully address them, as discussed below. A strategic
implementation plan is to be published within 120 days of strategy
issuance (October 2012), and may align the strategy more fully with the
array of issues GAO identified.
DHS approved the Generation-3 (Gen-3) acquisition in October 2009,
but it did not fully engage its acquisition framework to ensure that
the acquisition was grounded in a justified mission need and that it
pursued an optimal solution. The performance, schedule, and cost
expectations presented in required documents when DHS approved the
acquisition were not developed in accordance with DHS guidance and good
acquisition practices--like accounting for risk in schedule and cost
estimates. Since October 2009, the estimated date for full deployment
has been delayed from fiscal year 2016 to fiscal year 2022. The 2009
life-cycle cost estimate--a point estimate unadjusted for risk--was
$2.1 billion. In June 2011, DHS provided a risk-adjusted estimate at
the 80 percent confidence level of $5.8 billion. Several steps remain
before DHS can fully deploy Gen-3 including additional performance
testing, operational testing, and developing location-specific
deployment plans.
The White House's National Strategy for Biosurveillance serves as a
foundation for enterprise-wide efforts and begins to define mission,
goals, and objectives, as we called for in making the June 2010
strategy recommendation; however, the strategy does not yet offer the
mechanism GAO recommended to identify resource and investment needs,
including investment priorities. Accordingly, the biosurveillance
enterprise remains without a framework to guide the systematic
identification of risk, assessment of resources needed to address those
risks, and the prioritization and allocation of investment across the
entire enterprise. In recommending a National strategy, GAO recognized
the challenges individual Federal programs and agencies face
prioritizing resources to help ensure a coherent effort across the
dispersed biosurveillance enterprise. Today's report on Gen-3 offers a
timely and concrete example of this challenge--to assess the extent to
which Gen-3 warrants the investment of scarce resources when the
incremental value of the environmental monitoring Gen-3 offers is
considered as part of a layered biosurveillance strategy.
Chairmen Bilirakis and Lungren and Members of the subcommittees: I
am pleased to have the opportunity to be here today to discuss our
biosurveillance work, with particular focus on the Department of
Homeland Security's (DHS) BioWatch Generation-3 (Gen-3) program.\1\ A
catastrophic biological event, such as a terrorist attack with a weapon
of mass destruction or a naturally-occurring pandemic, could cause
thousands of casualties or more, weaken the economy, damage public
morale and confidence, and threaten National security. In recent years,
there has been an increasing awareness of the potential for biological
agents to be used as weapons of mass destruction and of the threat of
catastrophic effects arising from emerging strains of infectious
disease. For example, events like the 2001 Amerithrax incident, which
killed 5 people and sickened 17, and the global pandemic resulting from
emergence of a novel strain of influenza in 2009, have brought
increased attention to intentional and naturally-occurring biological
threats.
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\1\ The National Strategy for Biosurveillance defines
``biosurveillance'' as the process of gathering, integrating,
interpreting, and communicating essential information related to all-
hazards threats or disease activity affecting human, animal, or plant
health to achieve early detection and warning, contribute to overall
situational awareness of the health aspects of an incident, and enable
better decision-making at all levels.
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The U.S. Government has a long history of employing disease
surveillance activities to help limit malady, loss of life, and
economic impact. Traditional disease surveillance activities involve
trained professionals engaged in monitoring, investigating, confirming,
and reporting in an effort to further various missions including, but
not limited to, detecting signs of pathogens in humans, animals,
plants, food, and the environment. However, in recent years, experts
and practitioners, reacting to an increasing awareness of the speed and
intensity with which a biological weapon of mass destruction or highly
pathogenic strain of emerging infectious disease could affect the
Nation, have sought to augment traditional surveillance activities with
biosurveillance programs and systems. DHS's BioWatch program is an
example of such an effort. It aims to reduce the time required to
recognize and characterize potentially catastrophic aerosolized attacks
by detecting the presence of five biological agents--considered to be
at a high risk for weaponized attack--in the air.
The currently deployed BioWatch technology--Generation-2 (Gen-2)--
can take 12 to 36 hours to confirm the presence of pathogens. DHS has
been pursuing Gen-3 with the goal of implementing a system that will
perform automated testing, potentially generating a result in under 6
hours and eliminating certain labor costs. Expressing questions about
whether DHS had undertaken a rigorous effort to help guide its Gen-3
decision making, two subcommittees of this committee asked us to
examine issues related to the Gen-3 acquisition. Today, we released a
report that evaluates the acquisition decision-making process for Gen-
3.\2\ In addition, since December 2009, we have published three other
reports about efforts across the Federal Government and with non-
Federal partners to enhance the Nation's biosurveillance
capabilities.\3\ This statement: (1) Describes recent Federal efforts
that align with our biosurveillance work published from December 2009
through October 2011, (2) discusses our Gen-3 acquisition findings, and
(3) makes observations about our prior strategy recommendations and the
White House's recently released National Strategy for Biosurveillance.
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\2\ GAO, Biosurveillance: DHS Should Reevaluate Mission Need and
Alternatives Before Proceeding With BioWatch Generation-3 Acquisition,
GAO-12-810 (Washington, DC: Sept. 10, 2012).
\3\ GAO, Biosurveillance: Developing a Collaboration Strategy Is
Essential to Fostering Interagency Data and Resource Sharing, GAO-10-
171 (Washington, DC: Dec. 18, 2009); Biosurveillance: Efforts to
Develop a National Biosurveillance Capability Need a National Strategy
and a Designated Leader, GAO-10-645 (Washington, DC: June 30, 2010);
and Biosurveillance: Nonfederal Capabilities Should Be Considered in
Creating a National Biosurveillance Strategy, GAO-12-55 (Washington,
DC: Oct. 31, 2011).
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To describe recent Federal efforts that align with our work
published from December 2009 through October 2011, we reviewed the
National Biosurveillance Integration Center Strategic Plan and the
National Strategy for Biosurveillance, and obtained information from
DHS officials. To develop findings in the report released today about
Gen-3, which this statement is largely based on, we reviewed DHS's
acquisition guidance, including Acquisition Management Directive 102-
01. Additionally, we reviewed acquisition documentation and interviewed
agency officials from the BioWatch program and other DHS offices with
development, policy, and acquisition responsibilities. We then compared
the information developed from our documentation review and interviews
against the guidance. More detailed information on our scope and
methodology appears in our published work. To make observations about
the National Strategy for Biosurveillance, we analyzed the strategy and
assessed its alignment with findings and recommendations about a the
need for a National biosurveillance strategy in prior work. We
conducted this work from August 2012 to September 2012 in accordance
with generally accepted Government auditing standards. Those standards
require that we plan and perform the audit to obtain sufficient,
appropriate evidence to provide a reasonable basis for our findings and
conclusions based on our audit objectives. We believe that the evidence
obtained provides a reasonable basis for our findings and conclusions
based on our audit objectives.
dhs and the white house have taken action to enhance biosurveillance
In December 2009, we published a report assessing DHS's efforts to
establish the National Biosurveillance Integration Center (NBIC). We
reported that NBIC was not fully equipped to carry out its mission
because it lacked key resources--data and personnel--from its partner
agencies, a situation that could be at least partially attributed to
collaboration challenges NBIC faced. We recommended that NBIC work with
its Federal partners to develop a strategy to enhance collaboration--
including sharing data, personnel, and other resources--and to
establish effectiveness measures for that collaboration. DHS generally
concurred with our findings and recommendations and stated that NBIC
would work with its partners to develop a collaboration strategy to
clarify both the mission space and roles and responsibilities for all
partners.\4\ In August 2012, DHS issued the National Biosurveillance
Integration Center Strategic Plan. According to DHS officials, the plan
articulates a clear approach with a series of measurable steps and
initiatives to enhance the Nation's biosurveillance capability. In late
August 2012, when providing us with a copy of the strategy, officials
stated that they believe it satisfies the intent of our
recommendations. Officials said the plan was written in coordination
with NBIC's Federal partners and is the result of a deliberative
process examining NBIC's current capabilities and capability gaps. We
are currently assessing the extent to which the plan fully responds to
the recommendations.
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\4\ GAO-10-171.
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In June 2010, we reported on Federal efforts that support a
National biosurveillance capability and the extent to which mechanisms
were in place to guide the development of a National biosurveillance
capability. We reported that a National biosurveillance capability
would largely rely on an interagency effort because the activities and
accompanying resources that support the capability--personnel,
training, equipment, and systems--are dispersed across a number of
Federal agencies. However, we found that the Federal Government did not
have a unifying framework and structure for integrating dispersed
capabilities and responsibilities and no Federal agency had authority
to guide and oversee the development and implementation of a National
effort that encompassed all stakeholders with biosurveillance
responsibilities. We concluded that without such a framework and an
entity with the authority, resources, time, and responsibility for
guiding its implementation, it would be very difficult to create an
integrated approach to building and sustaining a National
biosurveillance capability. We recommended that the Homeland Security
Council within the White House direct the National Security Staff to
identify, in consultation with relevant Federal agencies, a focal point
to lead the development of such a strategy.
Our June 2010 report also noted that a National biosurveillance
capability depends upon participation from State, local, and Tribal
governments, because few of the resources required to support the
capability are wholly owned by the Federal Government. In October 2011,
we reported on how the Federal Government worked with its non-Federal
partners to support biosurveillance, activities those partners
identified as essential to their biosurveillance efforts, and
particular challenges those partners faced. We recommended that the
strategy we called for in June 2010 incorporate a means to leverage
existing efforts that support non-Federal biosurveillance capabilities,
consider challenges that non-Federal jurisdictions face, and include a
framework to develop a baseline and gap assessment of non-Federal
jurisdictions' biosurveillance capabilities.\5\ The White House did not
comment on these recommendations.
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\5\ GAO-12-55.
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In July 2012, the White House released the National Strategy for
Biosurveillance to describe the U.S. Government's approach to
strengthening biosurveillance. The strategy describes guiding
principles, core functions, and enablers for strengthening
biosurveillance. The strategy states that its approach emphasized
teamwork between and within Federal departments, across all layers of
government, and with private-sector partners. A strategic
implementation plan is to be completed within 120 days of the strategy
issuance. The strategy does not fully meet the intent of our June 2010
and October 2011 recommendations, as discussed later in this statement,
but it is possible that it will when the implementation plan is
complete.
dhs did not develop critical knowledge before proceeding with the gen-3
acquisition
DHS Proceeded With the Gen-3 Acquisition Before Establishing a Mission
Need
DHS approved the Gen-3 acquisition in October 2009 without fully
developing critical knowledge that would help ensure sound investment
decision making, pursuit of optimal solutions, and reliable
performance, cost, and schedule information. Specifically, DHS did not
engage the initial phase of its Acquisition Life-cycle Framework, which
is designed to help ensure that the mission need driving the
acquisition warrants investment of limited resources.\6\ In the
Acquisition Life-Cycle Framework design, it is not the purpose of the
Mission Needs Statement to specify a technical solution. Rather it is
to serve as a touchstone for subsequent acquisition efforts by focusing
on the capability gap to help articulate and build consensus around the
goals and objectives for a program.
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\6\ According to DHS officials, the Gen-3 acquisition was on-going
when Acquisition Management Directive 102-01 was issued. The officials
said that many DHS programs that were on-going in 2009 faced similar
challenges. Nevertheless, DHS Management Directive 1400, which preceded
Acquisition Management Directive 102-01, was similarly designed to,
among other things, ensure that investments directly support and
further DHS's missions. Like Acquisition Management Directive 102-01,
Management Directive 1400 describes a phased life-cycle investment
construct in which the first step is defining the mission need in a
Mission Needs Statement. As with the Mission Need Statement called for
in Acquisition Management Directive 102-01, the statement in Management
Directive 1400 was to be a high-level description of a capability gap
rather than a specific solution.
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However, DHS began to pursue a specific autonomous detection
solution well before completing a Mission Needs Statement.
Specifically, DHS's Integrated Planning Guidance (IPG) for fiscal years
2010-2014, which was finalized in March 2008, included specific goals
for the next generation of BioWatch--to deploy in all major cities an
autonomous BioWatch detection device reducing the operating cost per
site by more than 50 percent and warning time to less than 6 hours. The
purpose of DHS's IPG is to communicate the Secretary's policy and
planning goals to component-level decision makers to inform their
programming, budgeting, and execution activities. As such, this
specific set of goals for BioWatch Gen-3 demonstrates that DHS
leadership had established a course for the acquisition by March 2008,
in advance of efforts to define the mission need through the Mission
Needs Statement process, which was finalized more than a year and a
half later.
DHS officials in multiple departments described a climate, in the
wake of the September 11, 2001, terrorist attacks and the subsequent
Amerithrax attacks, in which the highest levels of the administration
expressed interest in quickly deploying the early generation BioWatch
detectors and improving their functionality--as quickly as possible--to
allow for faster detection and an indoor capability. BioWatch officials
stated that they were aware that the Mission Needs Statement prepared
in October 2009 did not reflect a systematic effort to justify a
capability need, but stated that the department directed them to
proceed because there was already departmental consensus around the
solution. Accordingly, the utility of the Mission Needs Statement as a
foundation for subsequent acquisition efforts was limited.
DHS Did Not Systematically Analyze Alternatives
Additionally, DHS did not use the processes established by its
Acquisition Life-cycle Framework to systematically ensure that it was
pursuing the optimal solution--based on cost, benefit, and risk--to
mitigate the capability gap identified in the Mission Needs Statement.
The DHS Acquisition Life-cycle Framework calls for the program office
to develop an Analysis of Alternatives that systematically identifies
possible alternative solutions that could satisfy the identified need,
considers cost-benefit and risk information for each alternative, and
finally selects the best option from among the alternatives.
However, the Analysis of Alternatives prepared for the Gen-3
acquisition did not reflect a systematic decision-making process. For
example, in addition to--or perhaps reflecting--its origin in the
predetermined solution from the Mission Needs Statement, the Analysis
of Alternatives did not fully explore costs or consider benefits and
risk information as part of the analysis. Instead, the Analysis of
Alternatives focused on just one cost metric that justified the
decision to pursue autonomous detection--cost per detection cycle--to
the exclusion of other cost and benefit considerations that might have
informed decision makers.\7\ Additionally, the Analysis of Alternatives
examined only two alternatives, though the guidance calls for at least
three. The first alternative was the currently deployed Gen-2
technology with a modified operational model (which by definition was
unable to meet the established goals). The second alternative was the
complete replacement of the deployed Gen-2 program with an autonomous
detection technology and expanded deployment.
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\7\ Cost per detection cycle is the cost each time an autonomous
detector tests the air for pathogens or the cost each time a Gen-2
filter is manually collected and tested in a laboratory.
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BioWatch program officials acknowledged that other options--
including but not limited to deploying some combination of both
technologies, based on risk and logistical considerations--may be more
cost-effective. As with the Mission Needs Statement, program officials
told us that they were advised that a comprehensive Analysis of
Alternatives would not be necessary because there was already
departmental consensus that autonomous detection was the optimal
solution.
Because the Gen-3 Analysis of Alternatives did not evaluate a
complete solution set, did not consider complete cost information, did
not consider benefits, and did not include a cost-benefit analysis, it
does not provide information on which to base trade-off decisions. For
example, it does not provide information about the extent to which
various aspects of the solution--such as the number of participating
jurisdictions--results in a reduction of risk and at what cost. Given
the uncertainty related to Gen-3's costs, benefits, and risk mitigation
potential, DHS does not have reasonable assurance that the strategy of
expanding and completely replacing the existing Gen-2 program with
autonomous detection technology is the most cost-effective solution.
DHS Did Not Fully Develop Performance, Cost, and Schedule Information
In October 2009, DHS approved the Gen-3 acquisition at Acquisition
Decision Event (ADE) 2A--one of the key formal decision points in DHS's
Acquisition Life-cycle Framework--based on information contained in
acquisition documents provided by the BioWatch program. One critical
purpose of the ADE-2A documentation set required by DHS's acquisition
guidance is to describe the expected performance, cost, and schedule
parameters for an acquisition. However, the ADE-2A Acquisition Decision
Memorandum stated that significant data necessary for the proper
adjudication of an ADE-2A decision were missing. Further, we reported
that some performance, cost, and schedule expectations presented at
ADE-2A were not developed in accordance with DHS guidance and good
acquisition practices--like accounting for risk in schedule and cost
estimates.
On the basis of the Gen-3 documentation submitted at ADE-2A, DHS
expected to acquire a system that would cost $2.1 billion, be fully
deployed by fiscal year 2016, and meet certain performance
requirements. However, the performance, cost, and schedule parameters
for the Gen-3 acquisition have changed. Specifically, certain
performance requirements have been revised, the estimated date for full
deployment has been delayed from fiscal year 2016 to fiscal year 2022,
and the expected life-cycle cost has changed from the $2.1 billion
point estimate prepared for ADE-2A to a risk-adjusted $5.8 billion
estimate, calculated at the 80 percent confidence level.\8\
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\8\ The $2.1 billion life-cycle cost estimate (a point estimate)
submitted at ADE-2A was the estimate used for planning purposes at the
time. In the June 2011 Life-cycle Cost Estimate, the BioWatch program
recommended the 80 percent confidence level for planning purposes. We
present these estimates here in comparison because they are the two
estimates used for planning purposes. However, it is important to note
that June 2011 estimates at the 28 percent and 80 percent confidence
level are risk adjusted and the 2009 point estimate is not. The point
estimate at the 28 percent confidence level in the June 2011 Life-Cycle
Cost Estimate was $3.8 billion. The confidence level indicates the
probability that the actual cost will be at or below the estimate. For
example, the June 2011 estimate of $5.8 billion conveys that (at the
time of that estimate) the program anticipated 80 percent probability
that the cost would be $5.8 billion or less.
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BioWatch program officials told us that they had to prepare ADE-2A
documentation quickly because ADE-2A had been accelerated by more than
a year. Additionally, DHS officials from multiple offices described a
climate around the time of ADE-2A in which the department's business
processes--including acquisition practices--were maturing and thus were
less rigorous in their adherence to best practices for cost and
schedule estimating. However, in the absence of complete and reliable
information, DHS had limited assurance that the acquisition would
successfully deliver the intended capability within cost and on
schedule. Comprehensive and systematic information developed using good
practices for cost and schedule estimating could help ensure that more
reliable performance, cost, and schedule information is available for
future acquisition decision making.
We recommended that before continuing the acquisition, DHS
reevaluate the mission need and alternatives and develop performance,
cost, and schedule information in accordance with guidance and good
acquisition practices. DHS concurred with the recommendations but plans
to proceed with the next step in the acquisition--performance testing--
while implementing them. We are pleased that DHS plans to implement the
recommendation but are concerned by DHS's intention to continue the
acquisition efforts before ensuring that it has fully developed the
critical knowledge a comprehensive Acquisition Life-cycle Framework
effort is designed to provide.
Several Steps Remain before Gen-3 Is Ready for Deployment
The BioWatch program completed initial testing and evaluation on a
Gen-3 prototype technology in June 2011, but several steps remain
before Gen-3 can be deployed and operational.\9\ For example, the
BioWatch program must complete additional testing. The characterization
testing conducted in 2010 and 2011 was intended to assess the state of
available technology. This testing sought to demonstrate the
performance of available candidate Gen-3 technologies against the
requirements established by the BioWatch program, and consisted
primarily of laboratory testing of individual system components. This
testing did not demonstrate the performance of the full system in
detecting live pathogens in the operational environment. It also did
not test the information technology network that will transmit results
for public health officials. Now the program plans to conduct the next
phase of testing--performance testing in three independent laboratories
and operational test and evaluation in four BioWatch jurisdictions. On
the basis of the June 2011 Life-Cycle Cost Estimate, the BioWatch
program estimates this testing will take approximately 3 years and cost
approximately $89 million (risk adjusted at the 80 percent confidence
level).
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\9\ A second candidate technology participated in two test events--
aerosol collection subsystem testing and assay evaluation--but did not
complete all testing because the candidate system did not meet program
requirements during the assay evaluation. Specifically, the second
candidate technology yielded both false positives--detecting a BioWatch
agent when none was present--and false negatives--not detecting an
agent when one was present.
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The Deputy Secretary of Homeland Security and other senior
officials met on August 16, 2012 for an Acquisition Review Board,
during which the BioWatch program was seeking approval to initiate the
next phase of the acquisition. DHS did not make a final decision, but
authorized release of a solicitation for performance testing under the
next testing phase. In response to the recommendations we made in the
Gen-3 report, DHS officials stated that before awarding a performance
testing contract--which would allow the program to acquire a small
number of test units--the program office is directed to return to the
Acquisition Review Board for approval.
Before undertaking the remaining steps in the acquisition, the
program office is directed to return for Acquisition Decision Event-2B
(ADE-2B)--the next formal decision point in DHS's Acquisition Life-
cycle Framework--with updated information, including an Analysis of
Alternatives and Concept of Operations, as we recommended. No time
frame for completing these actions has been specified, but according to
DHS officials, it may take up to 1 year to update the Analysis of
Alternatives. In preparation for the August 16, 2012, meeting, the
BioWatch program had updated key acquisition documents--including the
Life-cycle Cost Estimate and Acquisition Program Baseline--as required
by the Acquisition Decision Authority in a February 2012 memo. However,
in order to inform the ADE-2B decision, these documents must accurately
reflect changes to Gen-3 performance requirements and updated cost and
schedule estimates for the acquisition and therefore may require
further revisions.
If approved at ADE-2B, the BioWatch program plans to conduct
operational testing of Gen-3 units in four BioWatch jurisdictions.
Following operational testing, DHS intends to decide whether to
authorize the production and deployment of Gen-3. If Gen-3 is approved,
the BioWatch program plans to prepare for deployment by working with
BioWatch jurisdictions to develop location-specific plans to guide Gen-
3 operations. DHS estimates based on the June 2011 Life-Cycle Cost
Estimate show that about $5.7 billion of the $5.8 billion life-cycle
cost (risk adjusted at the 80 percent confidence level) remains to be
spent to test, produce, deploy, and operate
Gen-3 through fiscal year 2028.
observations about prior strategy recommendations and the july 2012
national strategy for biosurveillance
In the report on Gen-3 released today, we noted that beyond the
uncertainty related to the costs and benefits of the planned Gen-3
approach, there is additional uncertainty about the incremental benefit
of this kind of environmental monitoring as a risk mitigation activity
because of its relatively limited scope. As the study committee for a
2011 National Academies evaluation of BioWatch noted, there is
considerable uncertainty about the likelihood and magnitude of a
biological attack, and how the risk of a release of an aerosolized
pathogen compares with risks from other potential forms of terrorism or
from natural diseases. The National Academies report also notes that
while the BioWatch program is designed to detect certain biological
agents (currently five agents) that could be intentionally released in
aerosolized form, detecting a bioterrorism event involving other
pathogens or routes of exposure requires other approaches.\10\
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\10\ Institute of Medicine and National Research Council of the
National Academies, Committee on Effectiveness of National
Biosurveillance Systems, BioWatch and the Public Health System,
BioWatch and Public Health Surveillance: Evaluating Systems for the
Early Detection of Biological Threats (Washington, DC: 2011).
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In the report we released today, we stated that given the total
estimated operating cost for the Gen-3 program, it is important,
especially in an increasingly resource-constrained environment, to
consider the benefit--in terms of its ability to mitigate the
consequences of a potentially catastrophic biological attack--that the
investment provides. We noted that the scope limitations of this kind
of environmental monitoring provide context in both the consideration
of mission need and in analyzing cost-effectiveness.\11\
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\11\ GAO-12-810.
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However, it was not within the scope of our BioWatch Gen-3 study
nor was it our intention to reach a firm conclusion about the value of
this kind of activity as part of a layered biosurveillance strategy.
Rather, we believe the need to consider value within the larger
biosurveillance enterprise as part of an effort to define mission need
for a single Federal program like Gen-3 provides a timely and concrete
illustration of the kind of issues we sought to address with our June
2010 recommendation. The recommendation for the Homeland Security
Council to direct the National Security Staff to identify a focal point
to lead the development of a National biosurveillance strategy was
grounded in previous work on desirable strategy characteristics for
complex homeland security missions. We recognized the difficulty that
decision makers and program managers in individual Federal agencies
face prioritizing resources to help ensure a coherent effort across a
vast and dispersed interagency, intergovernmental, and intersectoral
network. Therefore, we called for a strategy that would, among other
things: (1) Define the scope and purpose of a National capability; (2)
provide goals, objectives and activities, priorities, milestones, and
performance measures; and (3) assess the costs and benefits and
identify resource and investment needs, including investment
priorities.\12\
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\12\ GAO-10-645.
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We stated that one of the aims of a National biosurveillance
strategy should be to help prioritize where resources and investments
should be targeted and guide agencies to allocate resources
accordingly. Further, we reported that a National strategy could begin
to address the difficult but critical issues of who pays and how
funding for biosurveillance will be sustained in the future. Finally,
we noted that in an environment with competing priorities, a strategy
could help address situations where investments must be carefully
weighed and sound judgments made about the most cost-effective
approaches, but doing so would require information about the cost,
benefits, and risks associated with the whole biosurveillance
enterprise.\13\
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\13\ GAO-10-645.
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The National Strategy for Biosurveillance includes four guiding
principles that are designed to serve as a foundation for enterprise-
wide efforts, four core functions that are designed to promote a
deliberate and shared approach, and four enabling capabilities that are
designed to represent areas for on-going focus.\14\ These planks of the
strategy align with our call for a strategy that would help to clarify
the scope and purpose of a National biosurveillance capability and the
goals of that capability. Our June 2010 report described several
categories of Federal efforts to improve the personnel, training, and
systems and equipment that support a National capability. These
included responding to workforce needs, facilitating information
sharing, and applying technologies to enhance surveillance. Among the
planks of the National Strategy for Biosurveillance, it is possible to
discern support for each these categories. For example, the enabling
capability called build capacity, discusses both workforce and
information-sharing issues. The four guiding principles that serve as
the strategy's foundation encourage broad-based and cross-cutting
actions to leverage constrained resources, responding, in part, to our
call for the strategy to help identify the resources currently being
used, additional resources that may be needed, and opportunities for
leveraging resources.
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\14\ The guiding principles articulated in the strategy are to: (1)
Leverage existing capabilities, (2) embrace an all-of-Nation approach,
(3) add value for all participants, and (4) maintain a global health
perspective. The core functions are to: (1) Scan and discern the
environment, (2) identify and integrate essential information, (3)
inform and alert decision makers, and (4) forecast and advise about
potential impacts. The enablers are to: (1) Integrate capabilities, (2)
build capacity, (3) foster innovation, and (4) strengthen partnerships.
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However, the strategy does not yet offer a mechanism to identify
resource and investment needs, including investment priorities among
these various efforts. Accordingly, the enterprise is still without a
framework to guide the systematic identification of risk, assessment of
resources needed to address those risks, and the prioritization and
allocation of investment across the entire biosurveillance enterprise,
as we recommended in June 2010. For example, in the case of the broader
contextual information needed to inform the BioWatch Gen-3 mission
need, the strategy has language indicating that advances in science and
technology are a priority. In fact, the capability enabler called
fostering innovation specifically calls for science and technology
capabilities, including new detection approaches. However, the strategy
does not facilitate analysis or provide tools to assess the risks to be
addressed--in the context of enterprise-wide goals--by such science and
technology approaches or the value they should offer the enterprise
relative to their costs. Without such a framework and tool set, it
remains difficult for decision makers--in both the Executive and
Legislative branches--to help ensure that their resource allocation
decisions contribute to a coherent enterprise-wide approach.
We are encouraged by the National Strategy for Biosurveillance and
the work the White House has done to date to provide a platform for
achieving a well-integrated National biosurveillance enterprise. We are
hopeful that the forthcoming strategic implementation plan which
promises to include specific actions and activity scope, designated
roles and responsibilities, and a mechanism for evaluating progress
will help to address the on-going need for mechanisms to help
prioritize resource allocation.
Chairmen Bilirakis and Lungren, this concludes my prepared
statement.
I would be happy to respond to any questions you or the other
committee Members may have.
Mr. Bilirakis. Thank you very much.
Now we will recognize Ms. Phillips for 5 minutes.
STATEMENT OF FRANCES PHILLIPS, DEPUTY SECRETARY, PUBLIC HEALTH
SERVICES, DEPARTMENT OF HEALTH AND MENTAL HYGIENE, STATE OF
MARYLAND
Ms. Phillips. Good afternoon, Chairmen Bilirakis and
Lungren, Ranking Members Clarke and Richardson, and also
distinguished Members of the subcommittee. My name is Frances
Phillips, and I am the deputy secretary for public health from
Maryland's Department of Health and Mental Hygiene. In that
role I oversee public health, our public health lab, as well as
our public health preparedness.
I do thank you for the opportunity to speak with you on
this important subject, which I would like to do in connection
with Maryland's experience with regard to both the challenges
and the benefits that we have experienced in our participation
in the BioWatch program.
First, I would like to express Maryland's continued support
for the BioWatch program as an important and useful addition to
our existing biosurveillance programs. BioWatch is still
evolving and will continue to drive improved communications and
foster more robust relationships as the technology develops.
Public health, as it has been stated, has a vital role in
the detection, response to and recovery from bioterrorism and
emerging infectious diseases. Public health has been in the
business of monitoring population health, detecting diseases,
and designing and implementing interventions to mitigate
against diseases for generations.
With the events of September 11, 2001, and the anthrax
attack of that year, it became clear that new tools and systems
were needed to detect previously unimaginable events. Governor
Martin O'Malley has been a strong supporter of expanding
biosurveillance capabilities in Maryland. In his first
administration he published the strategic goals for homeland
security, and goal No. 5 sets out a vision for a State-wide
biosurveillance system that integrates new technologies along
with our traditional public health disease surveillance
monitoring.
BioWatch is one of several tools in the public health
toolbox. In Maryland, another important tool is the electronic
surveillance system for early notification of community-based
epidemics. That is a mouthful; we call it ``ESSENCE.'' ESSENCE
captures, integrates, and interprets on a daily basis
electronic data from all of Maryland's emergency room
departments, from over 300 pharmacies with regard to
prescription and over-the-counter pharmaceutical sales, from
all of our school districts with regard to student absenteeism,
as well as the nature and volume of all calls to our poison
control center.
BioWatch, even with the limitations that I will mention,
has provided benefits to the overall biosurveillance capability
and complements tools such as ESSENCE.
Maryland has worked with our local jurisdictions, with our
neighboring States and various Federal agencies to collaborate
and continuously improve on the management of BioWatch alerts.
This collaboration has improved the evaluation of the alerts,
has identified gaps in coordination, and resulted in enhanced
communication and response capabilities across our region.
In addition, the internal notification protocols at the
State and local level have been strengthened as a result of
evaluations after each BioWatch alert. The benefit of these
enhanced protocols has reached across the all-hazards spectrum
in Maryland.
From the department's perspective, there have been
challenges with BioWatch program. This is a program designed to
be an early warning system. So in the instances when the
technology produces an alert, a diverse and very expert team
must be promptly convened in real time for interpretation and
decision making.
Our BioWatch response decision making requires the
integration of our all of our biosurveillance systems along
with environmental and seasonal data, technical considerations,
and coordinated threat assessment input from State and local
enforcement, law enforcement, security, and our fusion center
partners.
You have heard about false positives. I would like to
mention the issue of false positives, which is a familiar
challenge to the BioWatch program. On a few occasions in
Maryland, we had detected--the program, the lab has detected
gene targets from naturally-occurring microorganisms. These
alerts are true positives in that the technology correctly
detected presence of a select organism, but were false
positives in that the organism was later determined to be
naturally occurring and not a public health threat. None of
these alerts resulted in the activation of public response;
however, the multi-agency collaboration and applied data
integration associated with these BioWatch alerts has enhanced
our overall capability to respond to all manner of public
health emergencies.
We are maintaining an effective working relationship with
the Department's Office of Health Affairs, and every week our
State lab conducts hundreds--I am sorry--daily conducts
regulated and highly-tested BioWatch filter samples. Our State
lab has been supported in that regard by the Department with
regard to salaries, supplies and, just recently, administrative
expenses.
So to conclude, biosurveillance is a core competency of
preparedness. Using and exercising multiple systems has helped
Maryland enhance its ability to identify and respond to a wide
range of threats. We support continued improvement in BioWatch
and other components of surveillance.
Thank you for the opportunity to provide one State's
perspective on this important issue. I would be happy to answer
any questions you may have.
[The prepared statement of Ms. Phillips follows:]
Prepared Statement of Frances Phillips
September 13, 2012
Good afternoon, Chairman Bilirakis, Chairman Lungren, and
subcommittee Members: My name is Frances Phillips. I am the Deputy
Secretary for Public Health Services in the Maryland Department of
Health and Mental Hygiene. In that role I oversee Public Health
Emergency Preparedness for the Department. Thank you for giving me the
opportunity to speak with you on this important topic. There are
several points that I plan to speak about today, based on the
experience that Maryland has had with the BioWatch program. I want to
address our overall experience with BioWatch in Maryland, tell you
about the benefits that have resulted from our participation in the
program, and discuss some of the challenges inherent in the program.
First, I want to express Maryland's continued support of the
BioWatch program as an important and useful addition to existing
biosurveillance programs. BioWatch is still evolving and will continue
to drive improved communications and foster more robust relationships
as the technology advances.
Public health has a vital role in the detection, response to, and
recovery from bioterrorism and emerging infectious diseases. Public
health has been in the business of monitoring population health,
detecting diseases, and designing and implementing interventions to
mitigate the impact of resulting diseases for generations. With the
events of September 11, 2011 and the anthrax attack of that year, it
became clear that new tools and systems needed to be developed to
detect previously unimagined threats. Governor Martin O'Malley has been
a strong supporter of expanding biosurveillance capabilities within
Maryland. In his first administration he published the Strategic Goals
and Objectives for Homeland Security. Goal No. 5 sets out a vision for
a State-wide biosurveillance system that integrates new technology and
traditional public health disease surveillance systems to monitor human
illness and sensor-based monitoring for chemical and radiological
threats.
BioWatch is one of the several tools in the Public Health ``tool
box.'' Other tools include the Electronic Surveillance System for the
Early Notification of Community-based Epidemics (ESSENCE), Maryland's
syndromic surveillance system. ESSENCE captures, aggregates, and
interprets electronic data reported daily by all Maryland hospitals on
the nature and volume of emergency department visits, by over 300
pharmacies on prescription and over-the-counter pharmaceutical sales,
by all Maryland school districts on student absenteeism, and by the
Maryland Poison Control Center on the nature and volume of calls.
BioWatch, even with limitations that will be discussed later, has
provided benefits to overall biosurveillance capability and complements
tools such as ESSENCE. BioWatch is intended to reduce the time needed
to identify potential incidents of covert bioterrorism. The sooner that
exposures to dangerous pathogens are identified, the sooner
interventions can be implemented and the rates of morbidity and
mortality reduced. Another benefit of BioWatch is the standardization
of sampling and testing protocols across all BioWatch areas. This
allows for a common operating picture and ensures that National
discussions of potential incidents are based on a shared analytical
protocol and have a common terminology.
Maryland has worked with local jurisdictions, neighboring States,
and various Federal agencies to collaborate on and continuously improve
the management of BioWatch alerts. This collaboration has improved the
evaluation of the alerts, identified gaps in coordination, and resulted
in enhanced communication and response capabilities across the region.
In addition, the internal notification protocols at the State and local
level have been strengthened as a result of evaluations after each
BioWatch alert. The benefit of these enhanced protocols has reached
across the all-hazards spectrum for Maryland.
From the Department's perspective, there are also challenges with
the BioWatch program. This program is designed to be an ``early
warning'' system. In instances when the technology produces an alert, a
diverse and very expert team must be promptly convened for real-time
interpretation and response decision-making. The ensuing situational
analysis is based on relevant data drawn from clinical, environmental,
technical, and security intelligence. Clinical reporting systems
include routine data reporting from sentinel laboratories as well as
from ESSENCE. All of this data is needed to bring context to a Biowatch
alert.
Our BioWatch response decision-making also requires integration of
pertinent environmental and seasonal conditions, technical
considerations regarding signal strength, and coordinated threat
assessment input from State and Federal law enforcement, security, and
fusion center partners.
Certainly, when confirmatory testing is positive, a BioWatch alert
triggers action. Interdisciplinary consultation among a team of experts
representing State, local, and Federal laboratorians, public health
professionals, environmental experts, law enforcement officials, and
emergency management officials is needed to fully assess the risk and
to determine the appropriate protective response. Rigorous
communication protocols have been developed and refined to direct a
hierarchy of response communications.
The issue of ``false positives'' is a familiar challenge to the
BioWatch program. On a few occasions in Maryland the BioWatch system
detected gene targets from naturally occurring microorganisms. These
alerts were ``true positives'' in that the technology correctly
detected the presence of a select organism, but were ``false
positives'' in that the organism was later determined to be naturally-
occurring and not a public health threat. None of these alerts resulted
in the activation of a public response. However, the multi-agency
collaboration and applied data integration associated with Biowatch
alerts and exercises enhances our overall capability to respond to all
manner of public health emergencies.
Maryland's Department of Health and Mental Hygiene maintains an
effective working close relationship with the BioWatch Systems Program
Office within the U.S. Department of Homeland Security Office of Health
Affairs. This relationship has improved markedly over the years from
what initially had been a very closed and top-down Federal approach to
what is now a far more collaborative partnership. This strong State-
Federal relationship is essential to the success of BioWatch since both
routine laboratory operations and infrequent alerts require State and
Federal partners assume interdependent roles and responsibilities.
Every day of the week, the Maryland State Public Health Laboratory
conducts highly-regulated testing on filter samples delivered from
various locations in the State. The Federal BioWatch Office has
supported our lab's work through grants to cover a full-time lab
scientist salary, supplies, and equipment and administrative expenses.
This has helped us upgrade our preparedness for a wide range of
threats.
Our department actively participates in the Baltimore/Washington/
Richmond BioWatch Core Work Group which meets quarterly to coordinate
planning, communications, and exercises across the greater National
Capital Area region.
Biosurveillance is a core component of preparedness. Using and
exercising multiple systems has helped Maryland enhance its ability to
identify and respond to a wide range of threats. We support continued
improvement in BioWatch and other components of biosurveillance.
Thank you again for the opportunity to provide one State's
perspective on these important issues.
That concludes my remarks. I would be happy to answer any questions
you may have.
Mr. Bilirakis. Thank you very much for your testimony.
The entire panel: Thanks for your patience as well, and
thanks for sticking to the time allotted.
I am going to go ahead and recognize Chairman Lungren first
for any questions he might have. You are recognized, sir, for 5
minutes.
Mr. Lungren. Thank you very much, Mr. Chairman, and thank
you for that courtesy.
Dr. Garza, you heard from Mr. Jenkins and the suggestion
that your operation is receptive to reviewing the mission needs
statement and doing the more vigorous approach to the
alternatives to Gen-3, but Mr. Jenkins stated that it seemed to
be contradictory that you would be going forward in as
aggressive a way with letting a contract at the same time those
two things remain in question. How would you directly respond
to that, please?
Dr. Garza. Yes. Thank you, Mr. Chairman. That is a very
good question.
So the approach that we are taking, and I will let Under
Secretary Borras chime in on this as well, is you are
absolutely right that we are doing all the required
documentation for acquisitions, which is doing an effective
AOA, a cost-benefit analysis, a mission needs statement. All of
those things take time, and during that time period, we do not
want to delay the performance side or the technology side as
well.
So the issuance of an intent to release an RFP also takes
time. So there is not going to be any contracts being let;
there is not going to be any performance testing that is being
done during that time period. So, in essence, we are actually
going to be--when you come at the end of the day, we are going
to be aligned with exactly what GAO is saying, with completing
these documents before we start performance testing.
Under Secretary Borras informed you that we are going to
have to come back to the ARB in order to get approval to do any
performance contracting. So the release of the RFP does not
necessarily guarantee the release of any performance
contracting for testing.
So, in essence, we are following the same paradigm, it is
just the timing is a little bit----
Mr. Lungren. So if I were one of those that were pursuing
one of the alternatives, would I be encouraged or discouraged
by that approach with respect to me pursuing my approach and
the receptivity with which I would be received by your
operation?
Dr. Garza. Sure. That is an excellent question.
So the requirements for the request for proposals is a full
and open competition. It is not wed to any technology
whatsoever. We will put out the requirements that the
Department is going to need. But just because we have used PCR-
based technology in the past does not mean that any other
technology cannot come forward.
Mr. Lungren. Let me ask you this: Now, you got to
understand my dad was a doctor, I wanted to be a doctor at one
time, I have great respect for doctors. I have a rich and long-
standing experience with the L.A. Times, so I think you know
where my--where my loyalties would lie. But with regard to
certain press claims about the false positives, and if such
claims are inaccurate, as I understand you have stated, and
that they are all true positives--I love science, I respect
science. I am always a little worried when I hear that they are
all perfect, we have no false positives.
Now, Ms. Phillips gave us a view of the false positive from
her perspective. Could you elaborate a little bit more on that?
Because it is difficult for me to go to my colleagues and say,
don't worry about the program, we have been assured by Dr.
Garza that there are never and--there are no false positives,
there never have been. I just have to tell you that is
difficult for people to accept. So would you try and enlighten
us on that?
Dr. Garza. Yes, sir, and thank you again for the question
and bringing that up, because I think it has caused an immense
amount of confusion out in the community.
I believe what Ms. Phillips said is absolutely right. We
have had true positives on our tests, which means I ask the
machine to go out and look for targeted DNA, and it has done
that every single time. Now, I also agree with you that no test
is perfect, but every time that we have looked at any of these
organisms that we have had a detection on, it has always been a
true positive.
Now, where the confusion comes in is with the term
``BioWatch Actionable Result,'' or the BAR, and this was
something that was brought up again in the National Academy of
Sciences report as well, where some people will interpret that
as an indication of bioterrorism, which it is not. It is an
indication that we have found some bacteria that is of
interest, and that we need to come together and discuss what it
actually means.
So what does that mean? That means we get together with our
State and local partners and with our Federal partners, and it
is not just public health. It is our security people, it is our
intelligence folks, it is many different people from many
different disciplines that come together to look at the results
and say, first of all, is this bioterrorism, yes or no. The
people make that decision, not the machine and not BioWatch.
The second question is--equally important--is this a threat
to public health? So it could be a naturally occurring organism
and still be a threat to public health. I think that sometimes
gets lost in the conversation.
But I appreciate your concern over stories that come out,
and I think some misconceptions about what false positives and
what true positives actually are.
Mr. Lungren. Mr. Chairman, can I just follow up on that?
Mr. Bilirakis. You are recognized, sir.
Mr. Lungren. So would that suggest that the hits have been
on close cousins of what you were looking for, not the actual
bad bacteria? Is that what you are telling me, or is it
something different than that? I am trying to figure this out.
Dr. Garza. Right. So without going too much into the
organisms that we look for, for a particular organism there is
what is considered a subspecies of the organism, very, very
closely linked, so closely linked that when BioWatch was rolled
out in 2003, there was not a test to distinguish between the
different subspecies of organisms. So by and large what we find
is that very low-level subspecies of that organism.
Now, since that time we have learned that--and, frankly,
many people didn't know this even existed in the environment in
some of the cities that we are in, so it was a surprise to them
when we were finding this there. So, you know, we rewrote the
book on where bacteria live. But the question is what are we
doing about it? So what we did do about it is after we
discovered, hey, we are finding these things, but this is of no
consequential public health or terrorism event is looking at
ways to improve our detection technology. We have done that.
So we have been partnering with the DOD to build more
specific assays. I believe we are going to be rolling out some
of these assays in the fall time frame, but, again, we have to
make sure this is in concert with our State and local partners.
Mr. Lungren. Thank you very much.
Thank you, Mr. Chairman.
Mr. Bilirakis. You are welcome.
Now I recognize the gentle lady from California, our
Ranking Member Ms. Richardson. You are recognized 5 minutes.
Ms. Richardson. Thank you, Mr. Chairman.
Dr. Garza, you might recall that when you were last here, I
asked you a question regarding the first responders, and I
wanted to get an update on the pilot project to voluntarily
administer the anthrax vaccine to first responders.
Dr. Garza. Sure. I know that it is in the works right now,
and let me find my notes here on that. But I will tell you
where it is right now. We have been working on this very
diligently with a lot of different people, and that includes
our State and locals, with NGOs, and with our Federal suite of
families including the CDC.
Now, as you can imagine, this is a very complex endeavor.
This is delivering anthrax vaccine, I have been in the
military, I have been vaccinated, and I know how much of a
challenge it is for the military to get this done, and so it is
no small feat get this done.
Be that as it may, it has been a been a very collaborative
effort. There has been a lot of good work that has been done on
this, and where we are right now is I think the last time I was
briefed on this is we are starting to put the final touches on
it so that we can start reaching out to our State and locals
and soliciting who would be interested in participating in
these pilot projects.
As you can imagine, there are a lot of questions out there
with State and locals, as there should be, and so this takes a
lot of discussion. It takes a lot of communication back and
forth before we roll this out. We want it to be an instrument
of success, and so we are being very deliberate in how we
approach this problem.
So the time frame I can't give you right now, but I can say
that it is--we are fairly close to having this rolled out.
Ms. Richardson. Could you at least give us--do you
anticipate by the end of the year, midyear, next year? What is
your general----
Dr. Garza. Right. So in addition to working through the
communications strategy and all those other things, there are
certain bureaucratic mechanisms we need to go through as well,
and some of that will depend on some of those mechanisms. You
know as well as I do that it is difficult to put a time line on
some of those.
If pressed I would say, you know, I don't know, early next
year would probably be an end date.
Ms. Richardson. Okay. So have you decided how you are going
to--are you going to reach out to certain particular agencies
in an area or a particular--you know, meaning are you looking
at doing geographic areas, or areas by professions, or all in
general, or have you had any thought about that, or do you have
members of these organizations who are involved in these
discussions?
Dr. Garza. Yes, ma'am. So we want the pilot projects to be
instruments of success, and so we want to make sure that they
are geared towards first it has to be an at-risk place, so it
doesn't make as much sense to roll these programs out where we
don't feel that the population is at risk. But also it has to
have a pretty robust infrastructure to handle this type of
program, whether that be with occupational health, being able
to track who has received vaccines, things like that.
So right now we have been--people have come to us and
talked about participating in the program, and some, I think,
are much further along in setting up that sort of
infrastructure than others are. But certainly those are the two
factors that I think that we are really keying on is at-risk
cities, and do you have the infrastructure to support this?
Ms. Richardson. So but what you didn't answer is will you
be determining like, let us say, only police, or only fire, or
a combination of the two?
Dr. Garza. Right. Yes, ma'am. So if I remember correctly,
and I will make sure that we get you the information that you
need on this, we are not limiting it to any particular
demographic or any particular profession. It is really up to
the municipality. So we view ourselves more as a pass-through.
So remember, we don't own the vaccine. We are merely assisting
State and locals to have access to it. So we are leaving as
much as possible to the State and locals to determine what
their needs are.
Ms. Richardson. Okay. If and when Gen-3 is fully
implemented, what percentage of the OHA's budget do you expect
the program will represent?
Dr. Garza. If and when it is fully implemented, assuming
full deployment, issues like that, I am guessing probably
around 90 percent of the budget.
Ms. Richardson. So what reassurance could you give to this
committee that the other aspects of the work that you do would
not lose sight and priority of their need?
Dr. Garza. Right. So regardless of what the budget size is,
so that budget pays for a lot of other things, right? So it
pays for assistance to our State and locals to run local
BioWatch programs. A portion of it is run here at headquarters.
It is a Federally-managed program. But that does not diminish
the mission that we have to DHS for occupational and
operational medicine, for biosurveillance, for food, ag and vet
defense. So in that sense it is all on equal footing with that.
Ms. Richardson. Thank you.
Mr. Bilirakis. Thank you very much.
I will now recognize myself for 5 minutes. The first
question is for Mr. Jenkins.
Your report recommends that DHS reevaluate the mission need
for BioWatch Generation 3. You wrote that this document was
essentially prepared after the fact in order to justify a
predetermined solution.
Was DHS ignoring its own best practices when it began to
pursue autonomous detection prior to establishing the mission
need, and was this reassessed at any point in the last 3 years
to ensure that the acquisition was on track to meet a specific
mission need?
Mr. Jenkins. Well, the current acquisition process wasn't--
hadn't been in place, but the basic requirement of a mission
need statement was in place in the prior acquisition process.
So from our perspective, the mission needs statement that
should have been provided under the new process should also
have been provided under the old process.
In general what we found was that there had been sort of an
assumption that this--from very early on, even before the
Secretary's guidance in 2008, that automating Gen-2 was the way
to go. So all of the decisions basically sort of flowed from
that assumption, and what was--what we were told was a
consensus within the Department, and that this was the way to
go. So it never was a real refreshing new look at the mission
needs statement, as far as we know.
Mr. Bilirakis. Thank you.
Next question for Dr. Garza. The President's fiscal year
2013 budget request included an increase of almost $40 million
to fund continuing testing of Gen-3. I believe Chairman Lungren
referred to this. The House bill did not provide an increase.
What strikes me as the most troublesome about this kind of
expenditure is that GAO has confirmed for us there has been no
comprehensive cost-benefit analysis done to ensure that all of
these millions, specifically $5.9 billion, incredible, over the
project life cycle will buy down risks sufficient to justify
the expenditure. Despite this estimate we still do not know
just how much of an improvement Gen-3 would be over Gen-2.
Where is the cost-benefit analysis? How much more certainty
do we get with these machines? What is the decrease in human
morbidity or mortality? How much are we helping people; and if
we are not, shouldn't these millions be spent on other
biosurveillance programs showing promise, like the integration
and information-sharing initiatives that Congress has funded?
Dr. Garza. Thank you, Mr. Chairman. Allow me to entertain
some of the points that you made.
First off, you are absolutely right. The President's budget
was around $40 million, and I agree with you that we do need to
have a thorough analysis of alternatives as well as a mission
needs statement and a cost-benefit study done. As I mentioned
in my opening remarks, and I am sure that Under Secretary
Borras supports this as part of our acquisition program, and it
is documents that we are in the midst of completing. So I don't
think there is any disagreement that we do need to have this
thorough look at the BioWatch program.
Let me address, though, the costs that you were putting out
there, the $5.9 billion----
Mr. Bilirakis. Please, please.
Dr. Garza [continuing]. Over a 20-year life cycle. So I
want to make sure that everybody understands that is a 20-year
life-cycle cost. This isn't--we haven't spent any money on
procuring anything right now. We have taken--and I think the
management of DHS has been--should be commended for this. It is
setting up several gates to make sure that we are meeting all
of the required documentation, as well as doing all of our due
diligence in evaluating the technology so that the Secretary
and the Department can make a very effective, robust, and
minimize risk to the Department on the decision that they plan
on making.
As far as the capabilities that we bring, I highlighted
some of those in my opening statement. The true benefit that it
brings to the Department, to the Nation is decreasing that time
to detection from 12 to 36 hours to 4 to 6. If you look at the
mortality curve for bacillus anthracis, there is a certain
amount of time that people are exposed, it is incubated, they
become sick, and then you get the steep curve on the mortality
side. Any time you can move that curve to the left where you
are able to detect, decide, deploy, and treat medical
countermeasures, you will save lives.
Really, time is the currency that we barter with when it
comes to bioterrorism. The quicker that we can get pills in
mouths, the more lives we are going to save.
Mr. Bilirakis. Let me follow up with one last question. We
know that Gen-2, the currently developed version of BioWatch,
could use some relatively simple upgrades to its assays that
could make it substantially less likely to alarm on bacteria
that are close cousins to ones we actually care about. Might it
be better to balance costs and mission needs to spend a little
to improve Gen-2 and to send a ``lab in a box'' notion back to
S&T for research? I know, again, Chairman Lungren agreed. Why
not improve Gen-2 as opposed to spending more money on Gen-3?
Dr. Garza. Thank you, sir.
Regardless of what happens with our acquisition program in
Gen-3, we are already moving forward with improving Gen-2 in
just the issues that you discussed, with improving the assays
so that we can differentiate between close cousins of the
different bacterias. That is already in the works. The issue
with that is making sure that we have good communication with
our State and locals, because, again, this is going to change
the way that we do business. So the only thing that this is
waiting on is making sure that we have firm concepts of
operations on how we are going to roll this assay out.
So there is no question that we are improving Gen-2. You
talked or you asked about whether optimizing Gen-2 versus Gen-3
would be--would that fit the bill. I think the answer is I
think that will be part of our analysis of alternatives is
would it be possible to just optimize Gen-2, and would that be
sufficient to replace or to forego Gen-3.
So I am happy to take a look at that question, but be that
as it may, the most important aspect as well is that reduction
in time from the 12 to 36 hours to the 4 to 6.
Don't forget that the Gen-3 technology is also slated to go
indoors, where Gen-2 is not now, which is an important part
that sometimes gets lost in the conversation; that not only are
we going to be improving the timeliness, we are going to be
able to move this inside where we think some of the threat will
be emanating from.
Mr. Bilirakis. Thank you very much.
Now I will yield and give 5 minutes or so to the ranking
gentle lady from New York, Ms. Clarke. You are recognized,
ma'am.
Ms. Clarke of New York. Thank you very much, Mr. Chairman.
Dr. Garza, I understand from the GAO report that the annual
cost to operate Gen-3 is estimated to be about four times more
than the cost of current Gen-2 deployment, and that Gen-3 will
involve the deployment of 2,322 detectors, a marked increase
from the 594 detectors currently deployed.
What is the rationale behind this deep increase in the
number of detectors deployed, and where are these additional
detectors going? Can you explain why Gen-3 will be so much more
expensive to operate?
Dr. Garza. Thank you for that question, and I think this
brings up a very good point. This, again, I think it gets a
little confusing because you are not comparing apples to apples
anymore. The slogan that I use to my office is you are not even
comparing apples to oranges; you are comparing apples to
elephants.
Gen-2 was designed to be an outdoor collector. It was
designed to take 12 to 36 hours to cycle. Typical
municipalities will collect the filter once a day. The moved--
or the plans for Gen-3 are to move it indoors into high-
concentration areas. So these would be places like shopping
malls, football stadiums, you know, subways, things like that,
where there is a high concentration of people where there could
be a possibility of high levels of infectivity in a short
amount of time. So that was a goal as well.
The difference in the cost is if we were going to collect
Gen-2 three times a day, you would absolutely see an increase
in cost, and then you would start approximating where we are at
with Gen-3, because that would include people to go pick up the
filter to run the PCR analysis and be able to report out. So
for Gen-3 it cycles, again, three times more than Gen-1/2. We
will be going into many more locations, and frankly, the
original plans were to expand it to over 50 cities, where it is
currently at 30.
So comparing just bottom-line numbers between the two is
not a--it is not really a fair comparison. When you get down to
the cost of--and Mr. Jenkins mentioned this as well--the cost
of running that sample drops tremendously from the Gen-2 to the
Gen-3 side because of the efficiencies that are built into the
automation. I did--and I hope that answers your question, Ms.
Clarke.
Ms. Clarke of New York. Just a little clarification. So are
you saying that there are components of Gen-2 that will not be
utilized in Gen-3 because of the apples to elephants, or----
Dr. Garza. Right. So what I am saying is when you look at
the entire system. So the entire system when it was first
developed back in, gosh, probably 2007, 2008, before my time--
--
Ms. Clarke of New York. Uh-huh.
Dr. Garza [continuing]. It was pictured as expanding across
the country to over 50 cities, going indoor to all of these
locations. This is the number of machines that we think we are
going to need. So that is what generates your life-cycle cost.
We haven't bought machine one, frankly, and I think as
Under Secretary Borras said, look, we are going to have to take
a look at this program as well when it comes to procurement and
say, do we really need to be in over 50 cities? Do we really
need to be in all of these locations? I think that is
appropriate given our financial constraints. So we have to come
up with the proper sizing of the system.
Now, in reference to your question with Generation 2,
though, I don't think anybody can sit here and tell you today
what the optimal system looks like. So whether that is going to
be all Gen-3, whether that is going to be all Gen-2, or whether
it is going to be some sort of combination of the two, nobody
can tell you that right now until we have gone through all of
the acquisition documents that we need to complete as well as
finish our performance testing so we have an understanding of
what this technology can do for us.
Ms. Clarke of New York. Well, is there, I guess, a vision
of Gen-3 being an overlay on top of Gen-2, or that a new system
would be created that would make Gen-2 obsolete?
Dr. Garza. So if I recall correctly, when I first came into
the office, I believe that the vision when it was started was
Gen-3 would eventually take over for Gen-1/2.
Ms. Clarke of New York. Uh-huh.
Dr. Garza. But I believe that since that time there has
been a lot of discussion about really what is the optimal
solution. I think that is where the appropriate acquisition
documents come into play is what can be an optimal solution?
So I would say right now, you know, although we have to
develop our documents based on something, which is where our
life cycle cost estimates come from, there is still, I think,
going to be plenty of discussion on what that optimal system
looks likes.
If I may, though, I want to come back to a comment that
Chairman Bilirakis said, and that was in regard to R&D and S&T.
So OHA does not do basic research and development. S&T clearly
has that responsibility. What we do is we do operational
testing on technology that we think is beneficial to the
Nation. We have had the prototyping that is evaluated by two
different independent groups on where this is in the technology
scheme. Both of them independently came back with this is a
mature technology. It is not in the development stage; it is in
the operational evaluation stage. That is a big difference.
The requirements that we put on our machines are much
different than the requirements that are put onto basic design.
We have to make sure these machines can operate in many
different environments, whether it is hot, cold, raining,
snowing. We have to make sure they can operate in train
tunnels, or in football stadiums, or on a street corner, which
is much different than developing something in a lab or in a
building.
So I just wanted to make that point clear, that we are not
doing basic research and development. What we are doing is
evaluating technology.
Ms. Clarke of New York. Thank you very much.
Mr. Chairman, I yield back.
Mr. Bilirakis. Thank you. Thank you.
One last question for Mr. Philips. What outreach, if any,
has DHS done with the BioWatch practitioner such as yourself in
developing the next-generation detector?
Ms. Phillips. Thank you very much, Mr. Chairman. The on-
going relationship and communication enhancement that the
department--that our department has with OHA is largely in the
context of a working group. We have a BioWatch core working
group that includes representatives from Maryland, from the
District of Columbia, and from Virginia. It is the Baltimore,
Washington, Richmond Working Group, and it is in that context
that we review communication protocols.
We--on the occasion when there is an alert, we conduct a
hot wash and after-action review. We have discussed
improvements on communications and other protocols. So it is
within that context. I will point out that that is clearly an
improved and much closer working relationship that our State
has had, has benefited with the Department in the past. I will
say that in my past experience prior to coming to the State, I
was a local health officer in Maryland and had the opportunity
to be connected with BioWatch, and it was a very different
culture, and it was a very different connection with State and
local officials than what we are experiencing now.
Mr. Bilirakis. Thank you.
Do you see value in the type of system envisioned in
Generation 3?
Ms. Phillips. Well, Mr. Chairman, the comments that you
have heard have to do with the acceleration or the
decompression of the time from what we currently have in Gen-2,
which can be up to 36 hours, to reduce that down to something
that is much quicker in terms of an alert. As I mentioned in my
testimony, when we get an alert, there are oftentimes now that
that alert is as a result of a specimen that was brought into
our lab, and the material could be up to 36 hours old. So what
we are not getting is we are not getting that near-real-time
alert that would be an advance to what we get in rather robust
systems from our labs and from our emergency rooms.
So right now we see a near-real-time what goes on every day
in Maryland's emergency rooms and gives us chief complaints,
the leading edge. But I think what is being described with this
new technology is an opportunity to get ahead of that by
several hours, which would then really be an advance in terms
of our ability to muster a response.
Mr. Bilirakis. Very good. Thank you very much.
Anything further from the panel?
Well, thank you so much. Thanks for your patience. I want
to thank the witnesses for your valuable testimony; of course,
the Members for their questions. The Members of the
subcommittee may have some additional questions, and we ask
that you respond in writing, please. The hearing record will be
open for 10 days.
Without objection, the subcommittee stands adjourned.
Thanks so much.
[Whereupon, at 4:28 p.m., the subcommittees were
adjourned.]
A P P E N D I X
----------
Questions From Chairman Gus M. Bilirakis for Alexander G. Garza
Question 1. Please provide the amount of funding spent on BioWatch
Generation 1/2 since its inception. Please include all relevant costs,
such as research and development, unit costs, operational and
maintenance costs, etc.
Answer. Response was not received at the time of publication.
Question 2. Please provide the amount of funds spent on the
development of the Autonomous Pathogen Detection System (APDS).
Answer. Response was not received at the time of publication.
Question 3. Please provide all data, and a detailed description of
the experimental methods used to generate these data, pertaining to
system sensitivity for Generation 1/2. Please indicate when these tests
were undertaken.
Answer. Response was not received at the time of publication.
Question 4. Please provide a list of all BioWatch Actionable
Results since the deployment of BioWatch, to include which agents were
detected, the method of testing performed to confirm the findings, and
any other data and supporting evidence utilized to determine whether a
positive result was due to an attack versus natural persistence of the
organism in the environment.
Answer. Response was not received at the time of publication.
Question 5. You mentioned in your testimony that you are working on
improving the Generation 2 assays. Please describe in detail what steps
are being undertaken to ensure that deployed assays are meeting the
mission need, where the work is occurring, when it was initiated, how
much it is costing, what the end goal is, and when you expect to have
the improved assays finished and fielded.
Answer. Response was not received at the time of publication.
Question 6. Please provide all of the data associated with BioWatch
Generation 3 systems in development to date, including those for the
Chicago field test.
Answer. Response was not received at the time of publication.
Question 7. Please provide all supporting documentation provided to
Department of Homeland Security management (including for Acquisition
Review Board decisions) pertaining to the Generation 3 system test,
evaluation, and acquisition activities.
Answer. Response was not received at the time of publication.
Question 8. Please indicate how much money has been spent to date
on Generation 3, and how much remains unspent from prior year funds.
Answer. Response was not received at the time of publication.
Question 9. Please explain what the difference is between the
Autonomous Pathogen Detection System (APDS), which was pulled from
indoor testing in New York City, and the more recent Automated
Detection System that has undergone testing by the Office of Health
Affairs. Are there any differences in the assay chemistry, sample
capture process, sample processing process, or sample analysis process?
Please provide details.
Answer. Response was not received at the time of publication.
Question 10. Please provide funding levels and rationale for such
funding provided to performers to upgrade Generation 3/advanced systems
to fulfill Generation 3 requirements.
Answer. Response was not received at the time of publication.
Question 11. Is the Department of Homeland Security Science and
Technology Directorate undertaking any activities to support or
optimize a BioWatch Generation 3 system at the current time? If so,
what are they? What is the funding associated with the project to date,
which system is it for, and what is the time line for the deliverable?
Answer. Response was not received at the time of publication.
Question 12. When do you plan to complete the new Analysis of
Alternatives?
Answer. Response was not received at the time of publication.
Questions From Chairman Daniel E. Lungren for Alexander G. Garza
Question 1. In your testimony you mentioned that two independent
studies have supported your claim that the work you are doing on
BioWatch Generation 3 is not research and development. Please provide
these studies.
Answer. Response was not received at the time of publication.
Question 2a. The Department of Homeland Security Science and
Technology (S&T) Directorate is working on a number of advanced
biodetection efforts. One of these, Detect to Protect, a ``triggers and
confirmers'' type of system, is undergoing testing in the Boston subway
system.
What is the difference between Detect to Protect and BioWatch
Generation 3?
Answer. Response was not received at the time of publication.
Question 2b. When was the Detect to Protect project initiated, and
how much has been spent on it? How do the anticipated procurement,
operations, and maintenance costs compare to BioWatch Generation 3?
Answer. Response was not received at the time of publication.
Question 2c. What testing, evaluation, and validation have been
conducted to date? What have these tests told us about the system
sensitivity, specificity, and reproducibility?
Answer. Response was not received at the time of publication.
Question 2d. When will this project be completed and transition to
the Office of Health Affairs (OHA), and how will OHA use this
technology?
Answer. Response was not received at the time of publication.
Question 3. Please describe the ways in which you coordinate with
Under Secretary O'Toole on the S&T biodetection portfolio generally, to
ensure prevention of redundancy and optimization of acquisition of
biodetection technology that will be most useful for end users.
Answer. Response was not received at the time of publication.
Question 4a. Your position with regard to recent press claims about
false positives in the BioWatch Generation 1/2 system is that such
claims are inaccurate and that, in fact, any hits have always been true
positives. You have also argued that the BioWatch program has never had
any false positives and all positives are associated with background
environmental persistence of the organisms, not actual attacks.
Can you please tell us how these were confirmed to be true
positives? What gold standard test was performed to reach this
conclusion in each case?
Answer. Response was not received at the time of publication.
Question 4b. Were the hits on the DNA of bacteria that were very
closely related to those we were looking for? But they weren't actually
what we were looking for?
Answer. Response was not received at the time of publication.
Question 4c. If these bacteria are setting off the sensors, why
hasn't anyone gotten sick from them?
Answer. Response was not received at the time of publication.
Question 5. Many agencies employ some form of biodetection. Who is
designated to look across the board at all of these different programs,
and assess them for redundancy, overlap, gaps, and potential for cost-
savings?
Answer. Response was not received at the time of publication.
Question From Chairman Gus M. Bilirakis for Rafael Borras
Question. Your testimony states that the Department of Homeland
Security Science and Technology Directorate is working closely with the
Office of Health Affairs on the technical strategy for Generation 3.
Please provide evidence of this.
Answer. Response was not received at the time of pulication.
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