[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]

IMPROVING THE DEPARTMENT OF HOMELAND SECURITY'S BIOLOGICAL DETECTION
AND SURVEILLANCE PROGRAMS

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

HEARING

BEFORE THE

SUBCOMMITTEE ON
EMERGENCY PREPAREDNESS,
RESPONSE, AND COMMUNICATIONS

OF THE

COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES

ONE HUNDRED FOURTEENTH CONGRESS

SECOND SESSION

__________

FEBRUARY 11, 2016

__________

Serial No. 114-52

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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

Michael T. McCaul, Texas, Chairman
Lamar Smith, Texas Bennie G. Thompson, Mississippi
Peter T. King, New York Loretta Sanchez, California
Mike Rogers, Alabama Sheila Jackson Lee, Texas
Candice S. Miller, Michigan, Vice James R. Langevin, Rhode Island
Chair Brian Higgins, New York
Jeff Duncan, South Carolina Cedric L. Richmond, Louisiana
Tom Marino, Pennsylvania William R. Keating, Massachusetts
Lou Barletta, Pennsylvania Donald M. Payne, Jr., New Jersey
Scott Perry, Pennsylvania Filemon Vela, Texas
Curt Clawson, Florida Bonnie Watson Coleman, New Jersey
John Katko, New York Kathleen M. Rice, New York
Will Hurd, Texas Norma J. Torres, California
Earl L. ``Buddy'' Carter, Georgia
Mark Walker, North Carolina
Barry Loudermilk, Georgia
Martha McSally, Arizona
John Ratcliffe, Texas
Daniel M. Donovan, Jr., New York
Brendan P. Shields, Staff Director
Joan V. O'Hara, General Counsel
Michael S. Twinchek, Chief Clerk
I. Lanier Avant, Minority Staff Director

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SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND COMMUNICATIONS

Martha McSally, Arizona, Chairman
Tom Marino, Pennsylvania Donald M. Payne, Jr., New Jersey
Mark Walker, North Carolina Bonnie Watson Coleman, New Jersey
Barry Loudermilk, Georgia Kathleen M. Rice, New York
Daniel M. Donovan, Jr., New York Bennie G. Thompson, Mississippi
Michael T. McCaul, Texas (ex (ex officio)
officio)
Kerry A. Kinirons, Subcommittee Staff Director
Moira Bergin, Minority Subcommittee Staff Director

C O N T E N T S

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Page

Statements

The Honorable Martha McSally, a Representative in Congress From
the State of Arizona, and Chairman, Subcommittee on Emergency
Preparedness, Response, and Communications:
Oral Statement................................................. 1
Prepared Statement............................................. 2
The Honorable Donald M. Payne, Jr., a Representative in Congress
From the State of New Jersey, and Ranking Member, Subcommittee
on Emergency Preparedness, Response, and Communications:
Prepared Statement............................................. 5
The Honorable Bennie G. Thompson, a Representative in Congress
From the State of Mississippi, and Ranking Member, Committee on
Homeland Security:
Oral Statement................................................. 3
Prepared Statement............................................. 4

Witnesses

Dr. Kathryn Brinsfield, Assistant Secretary, Office of Health
Affairs, U.S. Department of Homeland Security:
Oral Statement................................................. 7
Joint Prepared Statement....................................... 9
Dr. Reginald Brothers, Under Secretary for Science and
Technology, U.S. Department of Homeland Security:
Oral Statement................................................. 13
Joint Prepared Statement....................................... 9
Mr. Chris P. Currie, Director, Emergency Management, National
Preparedness and Critical Infrastructure Protection, Homeland
Security and Justice Team, U.S. Government Accountability
Office:
Oral Statement................................................. 15
Prepared Statement............................................. 16

IMPROVING THE DEPARTMENT OF HOMELAND SECURITY'S BIOLOGICAL DETECTION
AND SURVEILLANCE PROGRAMS

----------

Thursday, February 11, 2016

U.S. House of Representatives,
Subcommittee on Emergency Preparedness, Response,
and Communications,
Committee on Homeland Security,
Washington, DC.
The subcommittee met, pursuant to call, at 2:13 p.m., in
Room 311, Cannon House Office Building, Hon. Martha McSally
[Chairwoman of the subcommittee] presiding.
Present: Representatives McSally, Payne, and Thompson.
Ms. McSally. The Subcommittee on Emergency Preparedness,
Response, and Communications will come to order.
The subcommittee is meeting today to receive testimony
regarding the Department of Homeland Security's detection and
surveillance programs to address the bioterrorism threat.
I now recognize myself for an opening statement.
The Subcommittee on Emergency Preparedness, Response, and
Communications has a long history of oversight on the issue of
bioterrorism. So far this Congress, we have held multiple
hearings and a Classified briefing on this threat. The threat
is real.
We know terrorist groups like ISIS have an interest in
utilizing biological agents in their attacks. In fact, a little
over a year ago, a laptop reportedly retrieved from an ISIS
hideout in Syria contained plans for weaponizing bubonic
plague, in a document discussing the advantages of using
biological weapons. We now know ISIS is intent on conducting
attacks in the United States.
In its 2016 World-wide Threat Assessment provided earlier
this week, the director of national intelligence noted that
weapons of mass destruction continue to be a major threat to
U.S. security. He remarked that biological materials and
technologies as well as personnel with the expertise to design
and use them move easily in the economy.
The DNI also stated that infectious diseases continue to
threaten our security, and that a more crowded and
interconnected world is increasing the opportunities for human
and animal diseases to emerge and spread globally, something we
are seeing right now with the Zika virus.
A bio-attack could cause illness or death in hundreds of
thousands of people, overwhelm our public health capabilities
and have an economic impact of over $1 trillion per incident.
Our Nation's capability to mitigate the impacts of all types of
biological events is a top National security priority.
But we know that our efforts leave room for improvement.
The Blue Ribbon Study Panel on Biodefense's report, which was
released October 2015, highlights shortcomings of the
Department of Homeland Security's biological surveillance and
detection efforts through the National Biosurveillance
Integration System, or NBIS, and the BioWatch program.
In testimony before the full committee, Blue Ribbon co-
chair and former Secretary of Homeland Security Tom Ridge
stated: ``DHS has made only limited progress with BioWatch and
the National biosurveillance integration system--and at great
expense.''
Limited information sharing from Federal and industry
partners has hampered the effectiveness of the National
Biosurveillance Integration Center, or NBIC. BioWatch uses
aging equipment, despite the fact that other agencies have
fielded more advanced detection technology.
He recommended that: ``Either we make these effective tools
or we replace them.''
The GAO also completed reviews of NBIC and BioWatch,
containing a number of similar findings to the Blue Ribbon
Study Panel.
With respect to BioWatch, the review found that DHS did not
conduct sufficient testing to determine that the technology can
effectively meet the program's objectives, which brings us to
today's hearing.
In light of the threats that we face, the Department of
Homeland Security must have biological detection and
surveillance programs in place, which serve to enhance our
security and provide a return on our investment. I am
interested in hearing from Dr. Brinsfield on how the Office of
Health Affairs, OHA, is working to address the findings of
these reviews and chart an effective course for these programs.
I am also interested in learning more about collaborative
efforts between OHA and the Science and Technology Directorate
to determine the next steps for BioWatch.
With that in mind, the Ranking Member and I had a
discussion with industry representatives on this very topic
yesterday. We were concerned to hear that there has been
limited engagement with the innovators who may have interim and
long-term solutions to these problems. If you don't communicate
your plans with industry, they can't plan for how they might be
able to support you.
These are complex problems for sure, and we must work
collaboratively at all levels of Government and with the
private sector to address them.
With that, I welcome our witnesses. I look forward to
hearing your testimony.
[The statement of Chairman McSally follows:]
Statement of Chairman Martha McSally
The Subcommittee on Emergency Preparedness, Response, and
Communications has a long history of oversight on the issue of
bioterrorism. So far this Congress, we have held multiple hearings and
a Classified briefing on this threat.
The threat is real. We know terrorist groups, like ISIS, have an
interest in utilizing biological agents in their attacks. In fact, a
little over a year ago, a laptop reportedly retrieved from an ISIS
hideout in Syria contained plans for weaponizing bubonic plague and a
document discussing the advantages of using biological weapons. And we
know ISIS is intent on conducting attacks in the United States.
In his 2016 Worldwide Threat Assessment provided earlier this week,
the director of national intelligence noted that weapons of mass
destruction continue to be a major threat to U.S. security. He remarked
that biological materials and technologies, as well as personnel with
the expertise to design and use them, move easily in the economy. The
DNI also stated that infectious disease continues to threaten our
security and that a more crowded and interconnected world is increasing
the opportunities for human and animal diseases to emerge and spread
globally--something we're seeing right now with the Zika virus.
A bio attack could cause illness or death in hundreds of thousands
of people, overwhelm our public health capabilities, and have an
economic impact of over 1 trillion dollars per incident.
Our Nation's capacity to mitigate the impacts of all types of
biological events is a top National security priority. But, we know
that our efforts leave room for improvement.
The Blue Ribbon Study Panel on Biodefense's report, which was
released in October, highlights shortcomings of the Department of
Homeland Security's biological surveillance and detection efforts
through the National Biosurveillance Integration System (NBIS) and the
BioWatch Program.
In testimony before the full committee, Blue Ribbon Co-Chair and
former Secretary of Homeland Security Tom Ridge stated, ``DHS has made
only limited progress with BioWatch and the National Biosurveillance
Integration System . . . and at great expense.'' Limited information
sharing from Federal NBIS partners has hampered the effectiveness of
the National Biosurveillance Integration Center (NBIC), and BioWatch
uses aging equipment, despite the fact that other agencies have fielded
more advanced detection technology. He recommended, ``either we make
these effective tools or we replace them.''
The Government Accountability Office also completed reviews of NBIC
and BioWatch, containing a number of similar findings to the Blue
Ribbon Study Panel. With respect to BioWatch, the review found that DHS
did not conduct sufficient testing to determine that the technology can
effectively meet the program's objectives.
Which brings us to today's hearing. In light of the threats we
face, the Department of Homeland Security must have biological
detection and surveillance programs in place, which serve to enhance
our security and provide a return on our investment.
I am interested in hearing from Dr. Brinsfield about how the Office
of Health Affairs (OHA) is working to address the findings of these
reviews and chart an effective course for these programs. I am also
interested in learning more about collaborative efforts between OHA and
the Science and Technology Directorate to determine next steps for
BioWatch.
With that in mind, the Ranking Member and I had a discussion with
industry representatives on this very topic yesterday. We were
concerned to hear that there has been limited engagement with the
innovators who may have interim and long-term solutions to these
problems. If you don't communicate your plans with industry, they can't
plan for how they might be able to support you.
These are complex problems and we must work collaboratively at all
levels of Government and with our private-sector partners to address
them.
With that, I welcome our witnesses. I look forward to your
testimony.

Ms. McSally. The Chair now recognizes the gentleman from
Mississippi, the Ranking Member of the full committee, Mr.
Thompson, for any opening statement he may have.
Mr. Thompson. Thank you very much, Madam Chair.
Let me say at the beginning that Ranking Member Payne is
actually in the House physician's office and I am kind of
pinch-hitting for him today.
Nonetheless, welcome, to our witnesses for this hearing.
I would like to also thank you for holding this hearing.
The Department of Homeland Security's signature programs in
this mission space, BioWatch and the National Biosurveillance
Integration Center, referred to commonly as NBIC, has
historically struggled to meet Congress's expectations.
This committee has conducted exhaustive oversight of the
BioWatch program since it was transferred to the Department and
NBIC since it was authorized with the 9/11 Act.
Let me mention and I appreciate both Mr. Payne and Ms.
McSally's efforts to continue those efforts.
That said, I have grown frustrated, like many, that we seem
to be having the same hearings over and over again. At least
once every Congress, we ask the Department to come to the
committee to respond to the latest criticisms of BioWatch and
NBIC.
In 2012, we asked about reports of false positives with the
currently-deployed BioWatch system, a 2011 National Academy of
Sciences report that found that current BioWatch technology
would work in very limited circumstances, and acquisition
challenges that ultimately proved to be Gen-3's demise.
At the time, we were assured that the currently-deployed
BioWatch system did work and that the Office of Health Affairs
would work closely with the Science and Technology Directorate
to identify new technologies to address shortcomings of the
archaic BioWatch system.
Two years after the Gen-3 acquisition was officially
canceled, it is unclear whether we have made any concrete
progress to identify new biodetection technology. Worse yet,
last fall both the Blue Ribbon Study Panel on Biodefense and
the Government Accountability Office released reports raising
questions about what benefits the current BioWatch program
provides.
The questions raised by the study panel and GAO were many
of the same questions raised by our Members and the National
Academy of Science years ago. Similarly, the GAO has raised
questions about the value of NBIC since 2009.
While I commend the Office of Health Affairs for fully
implementing the recommendations GAO made to improve the NBIC,
it still appears that NBIC struggles to effectively collect,
integrate, and analyze biosurveillance data from across the
Federal Government to identify emerging threats.
Despite laudable efforts, GAO reports NBIC struggles to get
access to the information it needs to do the job. Some
stakeholders say the products NBIC produces are not timely or
useful.
The Blue Ribbon Panel echoed these concerns particularly
regarding stalled progress on identifying innovative data
sources. These are many of the problems we heard about in 2009.
So, Madam Chair, in the interest of time, I think they get
the point.
[Laughter.]
We would like to hear from our witnesses to help us out
with this.
I yield back.
[The statement of Ranking Member Thompson follows:]
Statement of Ranking Member Bennie G. Thompson
The Department of Homeland Security's signature programs in this
mission space--BioWatch and the National Biosurveillance Integration
Center (NBIC)--have historically struggled to meet Congress'
expectations. This committee has conducted exhaustive oversight of the
BioWatch program since it was transferred to the Department and NBIC
since it was authorized in the 9/11 Act. Let me also mention that I
appreciate Mr. Payne and Ms. McSally's efforts to continue those
efforts.
That said, I have grown frustrated that we seem to be having the
same hearing over and over again. At least once every Congress, we ask
the Department to come before the committee to respond to the latest
criticisms of BioWatch and NBIC. In 2012, we asked about reports of
false positives with the currently-deployed BioWatch system, a 2011
National Academy of Sciences report that found that current BioWatch
technology would work in very limited circumstances, and acquisition
challenges that ultimately proved to be Gen-3's demise.
At the time, we were assured that the currently-deployed BioWatch
system did work and that the Office of Health Affairs would work
closely with the Science and Technology directorate to identify new
technology to address shortcomings of the archaic BioWatch system. Two
years after the Gen-3 acquisition was officially canceled, it is
unclear whether we have made any concrete progress in identify new
biodetection technology.
Worse yet, last fall, both the Blue Ribbon Study Panel on
Biodefense and the Government Accountability Office released reports
raising questions about what benefit the current BioWatch program
provides. The questions raised by the Study Panel and GAO were many of
the same questions raised by our Members and the National Academy of
Science years ago. Similarly, the Government Accountability Office has
been raising questions about the value of NBIC since 2009.
While I commend the Office of Health Affairs for fully implementing
the recommendations GAO made to improve the NBIC, it still appears that
NBIC struggles to effectively collect, integrate, and analyze
biosurveillance data from across the Federal Government to identify
emerging threats.
Despite laudable efforts, GAO reports NBIC struggles to get access
to the information it needs to do its job and some stakeholders say the
produce NBIC produces are not timely or useful. The Blue Ribbon Panel
echoed these concerns, particularly regarding stalled progress on
identifying innovative data sources. These are many of the problems we
heard about in 2009. I am frustrated that we are sitting here today
having the same conversations we were having almost 4 years ago, and I
want to understand what it will take to move the ball.
Today, I want to learn what challenges are undermining progress. Is
it a question of insufficient resources for these programs? Is it a
lack of centralized leadership on biodefense issues at the Federal
level guiding prioritization, coordination, and investments? Is it time
to rethink the mission of these programs so they are responsive to the
current threat environment and capability gaps?
Help us understand the challenges you are facing, your vision for
these programs, and what you need from Congress. I look forward to the
testimony today, and I hope that we will hear a concrete strategy for
making concrete improvement on programs that DHS has struggled with for
too long.

Ms. McSally. Thank you, Ranking Member Thompson.
The gentlemen yields back.
Other Members of the subcommittee are reminded that opening
statements may be submitted for the record.
[The statement of Ranking Member Payne follows:]
Statement of Ranking Member Donald M. Payne, Jr.
February 11, 2016
DHS has a critical role to play in the biodefense space. I am glad
that Ms. McSally shares my commitment to ensuring that the Department's
programs are responsive to the current threat environment and make
meaningful contributions to help prevent and protect against a
biological incident.
I joined this committee in January 2013, and have served as Ranking
Member on this subcommittee ever since. At that time, the Office of
Health Affairs was conducting the ``Analysis of Alternatives'' for the
BioWatch Gen-3 ``lab-in-a-box'' and implementing its 2012 Strategic
Plan for the National Biosurveillance Integration Center. The Gen-3
acquisition was ultimately canceled, questions about Gen-2 were on-
going, and we took the ``wait and see'' approach with NBIC, hoping that
with time and a new strategy, it would successfully achieve its
mandate.
I find it remarkable that today I sit here with a new Subcommittee
Chairman asking many of the same questions I was asking 3 years ago. I
have met with both Dr. Brinsfield and Dr. Brothers privately, and
expressed my concern about the lack of progress in identifying
technology to replace the current BioWatch system.
Although I have been assured that progress is under way, the Chair
and I have met with representatives from the private sector and they
did not share that optimism. Further, both the Blue Ribbon Study Panel
on Biodefense and the Government Accountability Office have recently
questioned the benefit of both NBIC and the deployed BioWatch
technology. With respect to NBIC, the Blue Ribbon Panel acknowledged
the challenges that OHA has experienced with respect to gaining access
to information without an enforcement mechanism and urged OHA to
innovate on identifying new data sources.
GAO raised similar concerns with respect to information access and
suggested that NBIC could further clarify its mission to ensure that
its work added to the National biosurveillance capability. That said, I
do not know how OHA can address these challenges or clarify its mission
under its current budget or the reduced resources sought under the
President's fiscal year 2017 budget request. Together, the message from
GAO and the Blue Ribbon Study Panel is that the NBIC cannot carry on
with a ``business as usual'' mentality. I will be interested to learn
how NBIC has internalized this message.
With respect to BioWatch, GAO recently found that DHS lacks a full
understanding of the deployed system's detection capabilities. The Blue
Ribbon Study Panel amplified the system's limitations by outlining a
series of shortcomings, from relying on ``winds blowing in optimal
directions,'' to its inability to distinguish normal background
bacteria from dangerous pathogens, to its inability to detect atypical
threats.
Although the Department is adamant that BioWatch can achieve its
operational objective--to detect a catastrophic biological event that
would cause 10,000 casualties--I am not convinced that that objective
is responsive to the current threat environment.
Before I yield back, I would be remiss if I did not note that the
President's fiscal year 2017 budget request proposes devastating cuts
to terrorism preparedness grants that first responders in my district
rely on. The budget would cut $267 million from the State Homeland
Security Grant Program, $270 million from the Urban Area Security
Initiative, $15 million from Transit Grants, and $7 million from Port
Grants. It is penny-wise and pound-foolish to make such cuts even to
these effective programs. The Federal dollars we spend yield concrete
capabilities at the State and local level.
Getting back to the subject at hand, I have to say that it is hard
to justify funding for programs whose value is questioned year after
year when essential first responder grants are being axed. I am
committed to putting DHS's biodefense efforts on the right track, but I
have a hard time going to bat for programs that appear to be stagnant,
particularly in the current budget environment.

Ms. McSally. We are pleased to have a very distinguished
panel before us today on this important topic.
Dr. Kathy Brinsfield serves as assistant secretary of
health affairs and chief medical officer for the Department of
Homeland Security and leads the DHS Office of Health Affairs.
Dr. Brinsfield is responsible for ensuring the DHS workforce
and the Nation are prepared for the health impacts of all
threats, including biological and chemical terrorism and
emerging infectious diseases.
Prior to her appointment as assistant secretary and chief
medical officer, she served on a detail to the National
security staff as the director of medical preparedness policy.
Before joining DHS, Dr. Brinsfield worked for various
organizations, including Boston EMS, Boston Metropolitan
Medical Response System, and the the del Valle Emergency
Preparedness Training Institute.
Dr. Reggie Brothers serves as under secretary for science
and technology at the U.S. Department of Homeland Security. Dr.
Brothers is responsible for a science and technology portfolio
that includes basic and applied research, development,
demonstration, testing, and evaluation.
Prior to DHS, Dr. Brothers served as the deputy assistant
secretary of defense for research at the Department of Defense
where he was responsible for policy and oversight of the
Department's science and technology programs, from basic
research through advanced technology development.
Chris Currie is the director of GAO's Homeland Security and
Justice Team where he leads the agency's work on emergency
management and National preparedness issues. In this role, he
and his team of GAO auditors evaluate Federal efforts and
programs to prevent, plan for, and respond to natural and man-
made disasters.
Prior to this, Mr. Currie was acting director in the GAO's
Defense Capabilities and Management Team where he led reviews
of DOD programs, including those related to military housing,
aircraft, and the U.S. counter-piracy efforts. In the decade
since DHS was created, Mr. Currie has led numerous audits and
assessments of DHS programs, including those related to
transportation security, research and development of new
technologies, and the Department's effort to test and evaluate
large acquisition programs and technologies.
The witnesses' full written statements will appear in the
record. The Chair now recognizes Dr. Brinsfield, for 5 minutes.

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

Dr. Brinsfield. Chairman McSally, Mr. Thompson and
distinguished Members of the subcommittee, I appreciate the
opportunity to speak to you today alongside my colleague, Dr.
Brothers, and Mr. Currie from the Government Accountability
Office.
Thank you for your continued oversight on this issue and
your commitment to strengthening our Nation's biodefense.
I know you are familiar with the Office of Health Affairs
and our mission and role in biodetection and biosurveillance,
so I will focus my remarks on what we are doing to build better
systems to detect and respond to biological events, whether
man-made or naturally occurring.
We worry about biological attacks and other major
biological incidents because of how wide-reaching the impacts
can be. Within 24 hours, an individual infected with a virulent
contagious pathogen, introduced naturally or intentionally,
could land on our shores and spark an outbreak with far-
reaching National or global consequences.
As noted by the Blue Ribbon Study Panel on Biodefense, our
ability to defend the American public is a whole-of-Government
issue because no single Government agency or even level of
Government has the resources and the mission to handle this
alone.
I continue to believe that this country must have a
layered, early-warning capability for biodefense. Right now,
our BioWatch program and National Biosurveillance Integration
Center, or NBIC, serve to fill that need.
These capabilities aim to provide us with information that
helps decision makers track trends and detect anomalies that
may indicate that an attack has occurred, before sick people
start flooding our hospitals and clinics.
BioWatch has worked over the last 7 years to reinforce the
performance and capabilities of currently-deployed
technologies. The deployed technologies have been tested many
times and further verified through the quality assurance
program. The early-warning capabilities that BioWatch provides
allow responders and communities to make timely decisions and
take actions to protect the American people and save lives.
Can our capabilities go further? Yes. We acknowledge that
even our current BioWatch technology is labor-intensive and not
suitable for every environment in which we need to detect an
attack.
The Department also appreciates the work of the GAO on
BioWatch. GAO clearly recognizes some of the unique challenges
for this system which was rolled out with the best available
technology in 2003 to respond to an urgent threat. So, in
recognition of these challenges, we are looking at a suite of
capabilities that will expand the venues into which BioWatch
collectors can be deployed and provide more rapid detection,
better situational awareness and improve our collective
decision making in response to a bioterror attack.
Dr. Brothers and I share this goal because it is important.
Together, including our interagency partners, such as
Department of Defense, we are assessing various technologies to
integrate into the BioWatch system.
In cooperation with DHS Science and Technology, we are
exploring advanced detection technologies, such as improved DNA
sequencing techniques intended to improve sensitivity and
expand the range of agents of concern that BioWatch is able to
detect.
The Department has a plan and proposed time line to
implement the recommendations of the most recent report. Much
of that effort is currently under way or already complete.
The same goes for biosurveillance. As part of our layered
defense, the NBIC is the Nation's integrator of human health,
animal health, and environmental data to develop a
comprehensive understanding of the biological threat landscape
and emerging incidents to ensure our Nation's decision makers
have timely, accurate, and actionable information. This
includes terrorist incidents and naturally-occurring biological
threats.
For example, since April 2015, NBIC has provided updates to
Federal, State, and local officials on the evolving nature of
the current Zika virus outbreak.
We are cognizant the reports by GAO and the Blue Ribbon
Panel have acknowledged that although NBIC has made progress in
delivering daily situational awareness to our partners, we
still have work to do to fully realize the vision of a
comprehensive biosurveillance integration.
NBIC will continue to advance its capacity to conduct
biosurveillance reporting and analysis by developing new
collaboration tools, pursuing innovative data sources and
methods and fostering greater stakeholder engagement. One such
example is our work with the U.S. Departments of Veterans
Affairs and Defense for data sharing and integration, which we
hope to leverage as a model for future interagency
collaborations.
I wish it was quick, easy, and cheap to improve our
biosurveillance and biodetection capabilities. Unfortunately,
it isn't. It is a constant balance to improve our capabilities
in a fiscally responsible way.
At present, our programs provide and will continue to
provide meaningful and actionable protections for the security
of our homeland. A key part of our system is our engagement
with State and local partners.
In addition to our biodetection and early-warning support,
we continue to seek ways to support our first-responder
communities in their preparation and response to biological
defense. By developing initiatives like the voluntary first-
responder anthrax vaccine program, for which I thank this
committee for its support, we improve our National
preparedness.
We appreciate the legislative attention this committee has
given to these issues.
Thank you.
[The joint prepared statement of Dr. Brinsfield and Dr.
Brothers follows:]
Joint Prepared Statement of Kathryn H. Brinsfield and Reginald Brothers
February 11, 2016
Chairman McSally, Ranking Member Payne, and distinguished Members
of the subcommittee, thank you for inviting us to speak with you today.
We appreciate the opportunity to testify on Department of Homeland
Security's biological detection and surveillance programs. We want to
thank you for your support and commitment to strengthen our Nation's
biodefense.
the changing biological threat
In the 15 years since the U.S. anthrax attacks, we have continued
to face not only the threat of biological attacks but also naturally-
occurring disease outbreaks (e.g., avian influenza, Ebola Virus, Zika
Virus), a global pandemic (e.g., H1N1 influenza), and criminal acts
using biological agents (e.g., ricin). The threats and risks posed by
emerging and re-emerging infectious disease and the potential research,
development, acquisition, and use of biological agents by international
terrorist organizations, home-grown violent extremists, and rogue
states will continue to challenge our ability to warn, prepare, and
protect the homeland.
The Blue Ribbon Study Panel on Biodefense's recent National
Blueprint for Biodefense made it abundantly clear that the threat of
both man-made and natural biological disasters has not waned and, in
fact, continues to grow and evolve. The effects of climate change,
global connectivity, advances in biotechnology, and increased
instability in the Middle East, Africa, and parts of Asia increase the
likelihood of a biological event in the homeland. Synthetic biology and
gene editing offer the promise of great medical breakthroughs; however,
they also offer rogue states, international terrorist organizations,
and violent extremists similar potential to modify organisms for
malicious purposes. In the same vein, naturally-emerging avian
influenza outbreaks and antibiotic-resistant bacteria reflect increased
risk to the United States. Within 24 hours, an individual infected with
a virulent, contagious, potentially man-made pathogen can land on our
shores and spark an outbreak with far-reaching National or global
consequences. These risks and threats have also been highlighted
previously in Congressional testimony from Director of National
Intelligence James Clapper.
In the wake of these growing threats, the Department of Homeland
Security (DHS) remains fully engaged and proactive in attempting to
characterize the threat, providing warning of emerging and imminent
threats, and coordinating whole-of-Government response. During the most
recent Ebola Virus Disease outbreak in West Africa, DHS provided
intelligence analysis to the interagency, State and local governments,
and first responders, and it directed research to better characterize
the threat and fill gaps in public health and operational responses.
Additionally, DHS coordinated and implemented enhanced screening for
more than 38,000 international passengers at 5 airports. The Department
continues to work with State and local governments, intelligence
community partners, and Federal partners to provide predictive analysis
and early warning in addition to longer-term research and development
(R&D) that strengthens preparedness and response capabilities and
fosters resilient communities. We must remain vigilant and innovative
as biological threats continue to evolve and new threats emerge.
department of homeland security's role in biodefense
The DHS Office of Health Affairs (OHA) and the Science and
Technology Directorate (S&T) continue to lead the Department's work
with all biodefense stakeholders, from local to Federal partners, to
understand and meet these threats today and to be ready for the threats
that will emerge tomorrow. With in-house experts including physicians,
scientists, toxicologists, veterinarians, intelligence and data
analysts, and first responders, the Department is positioned to address
natural and man-made biological threats in our population as well as in
our agriculture and wildlife.
Detection and defense against biological threats, be they acts of
terrorism or naturally occurring, remain important mission areas for
DHS. For large-scale biological events, knowledge as early as possible
allows informed decisions that can save American lives. To this end,
the Department's operational biodetection and biosurveillance programs,
the BioWatch Program and the National Biosurveillance Integration
Center, are critical to our Nation's biodefense. The capabilities are
mutually reinforcing--one provides detection of selected threats at
their onset in high-risk areas while the other provides public health
surveillance at a broader level at later stages. Each capability is
supported by a biodefense R&D portfolio in the Department dedicated to
creating technology options that address identified and validated
capability gaps. R&D helps the Department maintain a longer-range view
and ensures operational elements are not caught off-guard by emerging
or new trends and threats.
The Nation's biodefense integrates numerous agencies and levels of
government, and S&T's biodefense R&D portfolio serves the full range of
interagency, intergovernmental stakeholders. In addition to on-going
R&D programs with OHA, S&T's portfolio extends to stakeholders outside
the Department including protection of livestock from foreign animal
diseases, support for acquisition of medical countermeasures, bioassay
and diagnostic development, biological forensics programs, and
biological event remediation. S&T's biodefense R&D portfolio is
grounded in coordination and close working relationships with both DHS
and external partners.
biowatch program
The BioWatch Program is the Nation's only civilian program that
provides early warning in the event of an aerosolized biological
attack. The program consists of planning, preparedness, exercising,
training, and early detection capabilities. Deployed at more than 30
major metropolitan areas throughout the country, the system is a
collaborative effort of health professionals at all levels of
government. The program is operated by a team comprised of field
operators, laboratory technicians, and public health officials from
city, county, State, and Federal organizations. Each hour gained
through early detection and before the onset of medical symptoms,
improves the chances that response efforts will be successful. The
BioWatch Program has succeeded in bringing together State and local
public health, first responders, and law enforcement personnel, along
with locally-deployed Federal officials, resulting in communities that
are better prepared not only for a biological attack, but also for an
all-hazards response.
The current system has been, and will continue to be, extensively
tested, and the program is advancing plans and building capabilities in
early detection and situational awareness. BioWatch builds the
collective capabilities across all levels of government to effectively
and rapidly mobilize in response to an attack, mitigating the impacts
of a catastrophic bioterrorism event. The BioWatch Program is a
critical component of our Nation's response to minimize the impacts of
a biological attack.
The Department appreciates the Government Accountability Office
(GAO) report and recommendations on the path forward for the BioWatch
Program. GAO clearly recognizes the unique challenges for this system
which was rolled out with the best available technology in 2003 to
respond to an urgent threat. The relevant technical capabilities
available to adversaries have only increased since then, as
biotechnologies have continued their global development and
dissemination. So the need for BioWatch persists. In the past 2 years,
the capabilities of the system have been independently tested and
validated. Four independent tests have been conducted over the last 6
years that have tested all components of the BioWatch system. This has
included extensive testing of our identification assays (laboratory
tests that detect selected biological agents), subsystem- and system-
level testing in test chambers using actual threat agents, and open-air
testing of simulated agents in as near an operational environment as
possible. In addition, the BioWatch Quality Assurance Program has
analyzed over 30,400 samples to monitor operations against performance
benchmarks and requirements. The results of these tests reinforce
confidence in the system's ability to achieve its mission: Detecting a
large-scale aerosol release of specific threat agents in our Nation's
most populated areas.
The system's capability to detect biological agents was further
affirmed last year when BioWatch detected the subtype of Francisella
tularensis that is pathogenic to humans during confirmed occurrences of
that strain of Tularemia in Denver, Colorado. Though the agent was not
disseminated by an adversary, these detections took place during a
documented uptick in naturally-occurring disease. By analyzing
available medical surveillance data and discussing the BioWatch
detections through the BioWatch National Conference Call, local, State,
and Federal officials were provided with additional data for decision
support in responding to this occurrence of Tularemia. This shows that
the BioWatch Program is able to detect an airborne biological agent in
the environment.
The BioWatch Program is more than just an environmental detection
system. BioWatch also helps strengthen jurisdictional preparedness in
the event of a bioterrorism event through coordinating exercises and
drills; providing training, guidance and assessments, and standardized
methodologies for response; and by enabling a forum for all levels of
government to share data and information. Over 500 State and local
partners and stakeholders representing a broad cross-section of
Government agencies have participated in BioWatch preparedness
activities in the last year. BioWatch has also coordinated
environmental assessment activities, including developing initial
environmental sampling plans for jurisdictions to help characterize an
attack. All of the program's key elements--including response--are
supported by a number of Federal departments and agencies, such as the
Department of Health and Human Services (HHS) including the Centers for
Disease Control and Prevention (CDC), Department of Defense (DOD),
Environmental Protection Agency, and Federal Bureau of Investigation.
BioWatch also supports major events such as Super Bowls and National
Special Security Events (e.g., 2015 papal visit to 3 U.S. cities).
Since 2014, BioWatch has been working with DHS S&T, DOD, and other
Federal partners to identify technologies that would substantially
improve BioWatch operations. These improvements are intended to advance
the current ``detect to treat'' capability, which will enable us to
deploy medical countermeasures before the affected population is
symptomatic. Additionally, BioWatch and the National Biosurveillance
Integration Center are working together to improve situational
awareness at all levels of Government in the event of a biological
attack.
national biosurveillance integration center (nbic)
Given the evolving threats that our Nation faces, both man-made and
natural, greater coordination among Federal, State, local, Tribal, and
territorial partners is required. NBIC is uniquely situated within DHS
to provide a fusion of human health, animal health, and environmental
data to develop a comprehensive understanding of the biological threat
landscape and emerging incidents to ensure our Nation's decision makers
have timely, accurate, and actionable information.
Established in 2004 and transitioned to OHA in 2007, the NBIC's
mission is to enable early warning and shared situational awareness of
acute biological events and support better decisions through rapid
identification, characterization, localization, and tracking for
biological events of National significance. To accomplish this, NBIC
monitors thousands of data sources and leverages the expertise of 14
Federal departments and agencies, then integrates this array of
information into reports on global and National biological incidents
that could potentially cause economic damage, social disruption, or
loss of life. Over 900 Federal and 1,500 State, local, Tribal, and
territorial offices across this spectrum of human, animal, and
environmental health and response have access to NBIC's reports and
analysis.
We are cognizant that reports by the GAO and the Blue Ribbon Panel
on Biodefense have acknowledged the progress that NBIC has made
delivering daily situational awareness to our partners, but have
pointed out that we still have work to do to fully realize the vision
of comprehensive biosurveillance integration. Towards this end, NBIC is
working with the Department of Veterans Affairs on a data initiative
that will help to create an aggregated National view of disease trends,
while also facilitating understanding of those trends in our veteran
population. Similarly, NBIC is working with DOD's Defense Threat
Reduction Agency to deploy new collaboration and analytic tools that
will enable biosurveillance analysts from across the Government to
collaboratively examine and report on emerging biological threats.
NBIC's efforts are also focused on biosurveillance tools and reporting
for local officials so that they can address the biological incidents
emerging in their own communities, while strengthening National
surveillance as a whole. NBIC will continue to advance its capacity to
conduct biosurveillance reporting and analysis by developing new
collaboration tools, pursuing innovative data sources and methods, and
fostering greater stakeholder engagement.
a coordinated r&d approach for biodefense
S&T's Chemical and Biological Defense Division conducts R&D across
4 primary focus areas benefitting numerous interagency and
intergovernmental biodefense stakeholders and end-users. Threat
awareness R&D informs the Department of Health and Human Services'
medical countermeasure acquisition programs for the Strategic National
Stockpile. Surveillance R&D is examining capabilities that could
support DHS OHA and the Department of Agriculture in improving the
Nation's ability to quickly identify chemical and biological events
threatening human and livestock animal populations. Detection and
Diagnostics is supporting the CDC, Department of Agriculture, and DHS
OHA on the development of new biological sensors for rapid detection of
threat agent releases as well as bioassays for improved identification
of pathogens in clinical and environmental settings. Finally, S&T's
Response and Recovery programs help law enforcement to identify sources
of chemical and biological attack events (forensics and attribution)
and major metropolitan transit authorities and the Environmental
Protection Agency to remediate and decontaminate after a biological
attack.
Within S&T's biodefense portfolio, one reflection of R&D serving
the Department's biodefense mission and specific language was last
year's establishment of the Biosurveillance Apex project. Apex projects
represent some of the S&T's most ambitious, strategically-urgent R&D
investments, and the Biosurveillance Apex will spur short-, medium-,
and long-term development and delivery of technology improvements to
these essential operational programs. The R&D community within DHS
maintains strong links to academia, National laboratories, and other
R&D organizations to allow rapid transition of mature technologies and
identification of further R&D to support promising new systems. S&T
leverages that expertise to address technical gaps and needed
enhancements by DHS components.
Last year, Secretary Johnson directed establishment of Integrated
Product Teams (IPTs) calling for a central mechanism for the Department
to identify and coordinate R&D. Specifically called for in the
Secretary's memo was an IPT on Biological Threat to identify priority
capability gaps in biodefense (e.g., needs for better predictive models
and algorithms for response, decision support tools during events,
better personnel protective equipment) and R&D efforts that address
those gaps. The solutions developed will deliver new and improved
capabilities, such as new bioassays for detection to our public health
partners. The Biological Threat IPT is co-chaired by the Federal
Emergency Management Agency and OHA and serves as a platform to jointly
assess challenges and prioritize solutions, ultimately determining how
we will conduct faster threat detection and response for a greater
proportion of the population as well as predict the path and severity
of emerging disease outbreaks.
state, local, and first responder engagement
Key stakeholders in all our programs are State and local partners.
OHA engages with the Association of State and Territorial Health
Officials, the National Association of County and City Health
Officials, and the Institute of Medicine, to leverage established
working groups and information-sharing mechanisms for direct engagement
with State and local public health officials. This engagement allows
for State and local health officials to maintain awareness of, and
provide expertise, feedback, and support to, OHA activities, including
the BioWatch and NBIC programs.
OHA continues to seek ways to support the first-responder community
in its preparation and response to biological events. One initiative we
are developing is the First Responder Vaccine Initiative (FRVI), which
is developing the infrastructure for an anthrax vaccination pilot to
evaluate the feasibility of a voluntary pre-event anthrax vaccination
program among first responders using anthrax vaccine scheduled to
rotate out of the CDC's Strategic National Stockpile in at least 2
States. DHS is facilitating transfer of the vaccine from CDC to the
States.
conclusion
Since the stand-up of the Department, we have worked hard to
strengthen our Nation's biodefense. We acknowledge and appreciate GAO's
efforts to highlight areas for improvement in the Department's
biodefense programs. We are committed to working with our partners and
look forward to the subcommittee's continuing help building and
refining these robust programs. We appreciate the subcommittee for
keeping this issue at the forefront and for your continued support to
biodefense and homeland security.

Ms. McSally. Thank you, Dr. Brinsfield.
The Chair now recognizes Dr. Brothers, for 5 minutes.

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

Mr. Brothers. Chair McSally, Ranking Member Thompson,
distinguished Members of the subcommittee, good afternoon and
thank you for this opportunity to discuss the role the
Department of Homeland Security and Science and Technology
Directorate in our Nation's biodefense.
I am grateful for the committee's long-standing interest in
and support for the Department and directorate.
As the Blue Ribbon Study Panel on Biodefense's National
blueprint for biodefense recently made clear, the risk of man-
made and naturally-occurring biological events has not waned in
the 15 years since the anthrax attacks. In that time, the
Department has played a pivotal role in characterizing the
biological threat, providing warning of emerging threats and
coordinating Government response during events.
Still, while appreciative of progress made, the blueprint
also emphasizes opportunities for improving and streamlining
the Federal approach to biodefense. As with input from our
colleagues in GAO, we welcome those recommendations and look
forward to discussing them in further detail today.
The mission of the Science and Technology Directorate, or
S&T, is deliver effective and innovative insight, methods, and
solutions for the critical needs of the homeland security
enterprise. As the research and development arm and technical
center of gravity for the Department, S&T's portfolio extends
across diverse homeland security mission areas, a few of which
include borders and maritime, cyber, transportation, first
responders, disaster resilience and, of course, biodefense.
We work hand-in-hand with our operators and end-users to
identify capability gaps, connect them with the right
innovators and solutions from laboratories, small and large
businesses, universities, and international partners.
Last year, as part of a Unity of Effort initiative, the
Secretary directed S&T to launch Departmental integrated
product teams, or IPTs. These represent a formal mechanism for
identifying technology capability gaps across the Department's
mission areas. In the past 6 months, S&T and its operational
partners have served 5 of these teams. Together, they have
validated on-going research and development activities and
prioritized project topics in IPT mission areas.
The ultimate result of the IPT process will be improved
coordination of DHS research and development and assurance that
identified technology solutions address component mission
needs.
The biological threat IPT was 1 of 5 specifically called
for by the Secretary and tasked with identifying priority
capability gaps in biodefense as well as research and
development efforts to address those gaps.
One of S&T's most important partners in this area is Dr.
Brinsfield and the Office of Health Affairs. Our current
collaboration is on an enhancement effort for BioWatch. It will
spur both near- and long-term development and delivery of
technology improvements to essential BioWatch and National
Biosurveillance Integration Center programs.
Another aspect worthy of recognition is demand for
collaboration and cooperation in biodefense work.
Unlike many challenges the Federal Government faces that
tend to isolate with a specific lead agency, biodefense is
almost uniquely interagency and intergovernmental and involves
an addition of State and local public health workers, the
Departments of Agriculture, Defense, Health and Human Services,
Homeland Security, and Justice.
While the agencies have specific equities, holistic success
against biological threats requires a cooperative,
collaborative environment.
Biodefense research and development by its nature also
serves a broad group of stakeholders. In addition to co-
managing a laboratory, S&T works with USDA on programs
dedicated to the protection of livestock from foreign animal
diseases.
In partnership with the intelligence community, we support
acquisition of medical countermeasures by the Department of
Health and Human Services as required by the Bioshield Act of
2004.
We partner with the Centers for Disease Control and
Prevention on bioassay and diagnostic development, detection
and rapid identification of bioagents during a biological
attack.
We jointly run biological forensics programs with the FBI
to enable surveillance, investigation, and prosecution of
criminal elements seeking to harm citizens.
We work with several major city-level transit authorities
and the EPA on remediation technology for public transportation
systems in the event of a large-scale biological attack.
Homeland security in this area involves much more than DHS,
as successful research and development is determined by how
well we work with the entire community. DHS cannot and should
not do this alone. Protecting our Nation from a biological
attack is a joint effort. We are working across Government with
partners like DOD to share information, build upon successes
and lessons learned, and leverage resources whenever possible.
Although civilian and military missions are distinct,
information gained and investment made in each informs and
improves the other.
This rich union of effort, regardless of agency or level of
Government, calls on mission owners to do their part to protect
citizens from biological threats. That is where S&T is focused
in all of our research and development projects in this area.
Thank you for your time time today and I look forward to
your questions.
Ms. McSally. Thank you, Dr. Brothers.
The Chair now recognizes Mr. Currie, for 5 minutes.

STATEMENT OF CHRIS P. CURRIE, DIRECTOR, EMERGENCY MANAGEMENT,
NATIONAL PREPAREDNESS AND CRITICAL INFRASTRUCTURE PROTECTION,
HOMELAND SECURITY AND JUSTICE TEAM, U.S. GOVERNMENT
ACCOUNTABILITY OFFICE

Mr. Currie. Thank you, Chairman McSally and Ranking Member
Thompson. It is an honor to be here.
Today I would like to discuss GAO's work on some of DHS's
most critical biosurveillance programs.
For almost a decade, we have evaluated DHS's efforts to
implement BioWatch and the National Biosurveillance Integration
Center, or NBIC.
Regarding BioWatch, this committee is well aware of the DHS
acquisition challenges in implementing the Next Gen or Gen-3
system, and the decision to cancel the program in 2014.
However, without Gen-3 to replace it, new questions were raised
about how well the current system works.
Our report last October found that 12 years after the
system was first deployed, DHS does not have reliable
information about its capabilities, mainly because it was put
in the field so quickly without performance requirements.
We also found that because the capabilities of the system
were not fully tested, its uncertainties and limitations are
not fully known.
Now, some may ask why this is important now since Gen-3 was
canceled and the system has been in place for over a decade. It
is important because right now DHS is considering improvements
based on unknown capabilities of an aging system.
The next logical question is, what do we do about it now?
So, we made a number of recommendations that we think are
critical to any investments in the existing or future system.
First, we recommended that DHS not pursue upgrades to the
system until it establishes performance requirements and tests
against those requirements.
No. 2, we recommended that they fully account for any
uncertainties and limitations in the system.
Last, that they incorporate best practices in any future
developmental testing or upgrades to the existing or new
system.
Let me now switch to NBIC. Since our 2009 report, the folks
at NBIC have implemented all of our recommendations for
strengthening collaboration and overcoming various challenges.
For example, they developed new products to communicate
disease outbreaks to their Federal biosurveillance partners,
like CDC and the Agriculture Department. However, late last
year, we reported that persistent challenges still get in the
way of it fully meeting the mission that you all set out for
it.
For example, most of the primary Federal partners told us
that NBIC's products and activities did not always add value,
did not provide new meaning or did not help them identify
biological events quicker. We also found that NBIC has
difficulty getting the data it needs because partners won't
share it or there are restrictions to sharing it.
These challenges are not easy to address, particularly by
DHS or NBIC alone. We identified options for policy or
structural changes to help NBIC better fulfill its mission.
These options ranged all the way from repealing NBIC's statute,
all the way to providing NBIC with additional authority to
better fulfill its mission.
Each option has benefits and limitations and funding
implications and they are not easy. For example, granting NBIC
access to more data did help them conduct additional analysis,
but may not identify emerging threats earlier than they or
other agencies can do now.
I want to wrap up by making a few broader points and
connections. BioWatch and NBIC are critical programs; however,
they are only pieces of a larger biosurveillance enterprise
that Dr. Brothers mentioned.
As we and others, like the Blue Ribbon Panel, have pointed
out, investments in these programs should be evaluated in terms
of cost and benefit and compared to other programs across the
Government as part of a National strategic plan.
Also critical is using the most recent threat information
to guide decision making about these investments. For example,
BioWatch is intended to detect a large, airborne bioattack.
This threat must be weighed against other threats we now face,
such as natural disease outbreaks, like Zika and Ebola.
Last, as you know, DHS is planning to merge OHA, pieces of
S&T, with other parts of DHS into a new chem/bio rad nuke
office. So, this will also impact these programs and DHS's role
moving forward.
This completes my statement. I would be happy to answer any
questions you have.
[The prepared statement of Mr. Currie follows:]
Statement of Chris P. Currie
February 11, 2016
gao highlights
Highlights of GAO-16-413T, a testimony before the Subcommittee on
Emergency Preparedness, Response, and Communications; Committee on
Homeland Security, House of Representatives.
Why GAO Did This Study
The potential threat of a naturally occurring pandemic or a
terrorist attack with a biological weapon of mass destruction
underscores the importance of a National biosurveillance capability--
that is, the ability to detect biological events of National
significance to provide early warning and information to guide public
health and emergency response. The Implementing Recommendations of the
9/11 Commission Act of 2007 addresses this capability, in part by
creating NBIC. The center was tasked with integrating information from
human health, animal, plant, food, and environmental monitoring systems
across the Federal Government, to improve the likelihood of identifying
a biological event at an earlier stage. Similarly, DHS's BioWatch
program aims to provide early indication of an aerosolized biological
weapon attack.
GAO has published a series of reports on biosurveillance efforts
spanning more than a decade. This statement describes progress and
challenges GAO has reported in DHS's implementation of NBIC and
BioWatch and considerations for the future of biosurveillance efforts
at DHS.
This testimony is based on previous GAO reports issued from
December 2009 through September 2015 related to biosurveillance. To
conduct our prior work, we reviewed relevant Presidential directives,
laws, policies, and strategic plans; and interviewed Federal, State,
and industry officials, among others. We also analyzed key program
documents, including test plans, test results, and modeling studies.
biosurveillance.--on-going challenges and future considerations for dhs
biosurveillance efforts
What GAO Found
Since 2009, GAO has reported on progress and challenges with 2 of
the Department of Homeland Security's (DHS) biosurveillance efforts--
the National Biosurveillance Integration Center (NBIC) and the BioWatch
program (designed to provide early detection of an aerosolized
biological attack). In December 2009, GAO reported that NBIC was not
fully equipped to carry out its mission because it lacked key
resources--data and personnel--from its partner agencies, which may
have been at least partially the result of collaboration challenges it
faced. For example, some partners reported that they did not trust NBIC
to use their information and resources appropriately, while others were
not convinced of the value that working with NBIC provided because
NBIC's mission was not clearly articulated. GAO recommended that NBIC
develop a strategy for addressing barriers to collaboration and develop
accountability mechanisms to monitor these efforts. DHS agreed, and in
August 2012, NBIC issued the NBIC Strategic Plan, which is intended to
provide NBIC's strategic vision, clarify the center's mission and
purpose, and articulate the value that NBIC seeks to provide to its
partners, among other things. In September 2015, GAO reported that
despite NBIC's efforts to collaborate with interagency partners to
create and issue a strategic plan that would clarify its mission and
the various efforts to fulfill its 3 roles--analyzer, coordinator, and
innovator--a variety of challenges remained when GAO surveyed NBIC's
interagency partners in 2015. Notably, many of these partners continued
to express uncertainty about the value NBIC provided. GAO identified
options for policy or structural changes that could help NBIC better
fulfill its biosurveillance integration mission, such as changes to
NBIC's roles.
Since 2012, GAO has reported that DHS has faced challenges in
clearly justifying the need for the BioWatch program and its ability to
reliably address that need (to detect attacks). In September 2012, GAO
found that DHS approved a next-generation BioWatch acquisition in
October 2009 without fully developing knowledge that would help ensure
sound investment decision making and pursuit of optimal solutions. GAO
recommended that before continuing the acquisition, DHS reevaluate the
mission need and possible alternatives based on cost-benefit and risk
information. DHS concurred and in April 2014, canceled the acquisition
because an alternatives analysis did not confirm an overwhelming
benefit to justify the cost. Having canceled the next generation
acquisition, DHS continues to rely on the currently deployed BioWatch
system for early detection of an aerosolized biological attack.
However, in 2015, GAO found that DHS lacks reliable information about
the current system's technical capabilities to detect a biological
attack, in part because in the 12 years since BioWatch's initial
deployment, DHS has not developed technical performance requirements
for the system. GAO reported in September 2015 that DHS commissioned
tests of the current system's technical performance characteristics,
but without performance requirements, DHS cannot interpret the test
results and draw conclusions about the system's ability to detect
attacks. DHS is considering upgrades to the current system, but GAO
recommended that DHS not pursue upgrades until it establishes technical
performance requirements to meet a clearly defined operational
objective and assesses the system against these performance
requirements. DHS concurred and is working to address the
recommendation.
Chairman McSally, Ranking Member Payne, and Members of the
subcommittee: I am pleased to be here today to discuss our work on the
Department of Homeland Security's (DHS) biosurveillance efforts.
Biosurveillance, as defined by the July 2012 National Strategy for
Biosurveillance, is the on-going process of gathering, integrating,
interpreting, and communicating essential information related to all-
hazards threats or disease activity affecting human, animal, or plant
health, for the purpose of: (1) Achieving early detection and warning,
(2) contributing to overall situational awareness of the health aspects
of the incident, and (3) enabling better decision making at all levels.
Threats of bioterrorism, such as anthrax attacks, and high-profile
disease outbreaks, such as Ebola in West Africa and emerging
arboviruses like chikungunya and zika in the Americas, highlight the
continued need for systems that provide early detection and warning
about biological threats.\1\ We have an on-going body of
biosurveillance work spanning more than a decade in which we have
examined specific surveillance programs and activities carried out by
DHS; the Departments of Health and Human Services; Agriculture; and
several other Federal departments and agencies.\2\
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\1\ Arthropod-borne viruses (arboviruses) are transmitted to humans
primarily through the bites of infected mosquitoes and ticks.
\2\ See, for example, GAO, Emerging Infectious Diseases: Review of
State and Federal Disease Surveillance Efforts, GAO-04-877 (Washington,
DC: Sept. 30, 2004), which discusses select Federal and non-Federal
human disease surveillance in humans; GAO, Global Health: U.S. Agencies
Support Programs to Build Overseas Capacity for Infectious Disease
Surveillance, GAO-07-1186 (Washington, DC: Sept. 28, 2007), which
discusses 4 key programs aimed at building overseas surveillance
capacity for infectious diseases in humans; and GAO, Homeland Security:
An Overall Strategy Is Needed to Strengthen Disease Surveillance in
Livestock and Poultry, GAO-13-424 (Washington, DC: May 21, 2013), which
discusses the Department of Agriculture's efforts to better detect and
control new or reemerging diseases in animals.
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We have also identified broad, cross-cutting issues in leadership,
coordination, and collaboration that arise from working across the
complex interagency, intergovernmental, and intersectoral
biosurveillance enterprise. To address these issues, in 2010 we made
recommendations that the Homeland Security Council direct the National
Security Council staff to identify a focal point to lead the
development of a National biosurveillance 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.\3\ In July 2012, the White House released the
National Strategy for Biosurveillance to describe the U.S. Government's
approach to strengthening biosurveillance, but it did not fully meet
the intent of our prior recommendations, because it did not offer a
mechanism to identify resource and investment needs, including
investment priorities among various biosurveillance efforts.\4\
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\3\ GAO, Biosurveillance: Efforts to Develop a National
Biosurveillance Capability Need a National Strategy and a Designated
Leader, GAO-10-645 (Washington, DC: June 30, 2010). See also, GAO,
Biosurveillance: Nonfederal Capabilities Should Be Considered in
Creating a National Biosurveillance Strategy, GAO-12-55 (Washington,
DC: Oct. 31, 2011), in which we recommended that the strategy also: (1)
Incorporate a means to leverage existing efforts that support non-
Federal biosurveillance capabilities, (2) consider challenges that non-
Federal jurisdictions face in building and maintaining biosurveillance
capabilities, and (3) include a framework to develop a baseline and gap
assessment of non-Federal jurisdictions' biosurveillance capabilities.
\4\ The National Security Council staff has since created an
implementation plan for the National strategy. However, it is not yet
clear the extent to which the plan has been widely shared among and
adopted by interagency decision makers as a means to help identify
opportunities to leverage resources and direct priorities.
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In 2014, a Blue Ribbon Study Panel on Biodefense was established to
assess gaps and provide recommendations to improve U.S. biodefense. The
panel's October 2015 final report identified several themes we have
also highlighted in our biosurveillance work, including the lack of a
centralized leader, no comprehensive National strategic plan, and no
all-inclusive dedicated budget for biodefense. The panel's report
highlights a sense of urgency to address the on-going and persistent
biological threats--both naturally occurring, like Ebola and zika, and
from enemies, like The Islamic State of Iraq and the Levant (also known
as ISIL and Da'esh) who have advocated for the use of biological
weapons.
While consequences of a biologic event could be catastrophic, we
have also previously reported that because the Nation cannot afford to
protect everything against all threats, choices must be made about
protection priorities given the risk and how to best allocate available
resources.\5\ As we testified before this committee in 2012, without a
National strategy that provides a framework and tool set to evaluate
trade-offs, it remains difficult for decision makers--in both the
Executive and Legislative branches--to help ensure that biosurveillance
resource allocation decisions within single departments and programs
contribute to a coherent enterprise-wide approach.\6\
---------------------------------------------------------------------------
\5\ GAO, 21st Century Challenges: Reexamining the Base of the
Federal Government, GAO-05-325SP (Washington, DC: Feb. 1, 2005).
\6\ GAO, Biosurveillance: Observations on BioWatch Generation-3 and
Other Federal Efforts, GAO-12-994T (Washington, DC, Sept. 2012).
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Nevertheless, challenges we have reported in 2 of DHS's specific
biosurveillance efforts--the National Biosurveillance Integration
Center (NBIC) and the BioWatch program--demonstrate the importance of
following Departmental policies and employing leading management
practices to help ensure that the mission of each program is clearly
and purposefully defined and that subsequent investments effectively
respond to those missions. NBIC, which was created to integrate data
across the Federal Government with the aim of enhancing detection and
situational awareness of biological events, has suffered from long-
standing issues related to its clarity of purpose. Likewise, the
BioWatch program, which is designed to detect bioterrorism attacks with
specific aerosolized pathogens, has encountered challenges that stem
from not precisely defining the need its technologies should fill and
how the technologies it pursued (and in some cases developed and
deployed) responded to that need.
Finally, DHS is currently at a crossroads for decisions regarding
not only NBIC and BioWatch, but also where these efforts fall within
DHS's broader Chemical, Biological, Radiological, and Nuclear (CBRNE)
programs. In June 2015, DHS provided Congress a report summarizing its
review of the organization, operations, and communications of its
Chemical, Biological, Radiological, and Nuclear programs and proposed
merging 6 CBRNE-related organizational components into 1 unit.\7\ This
provides an opportunity for DHS to look strategically at its
biosurveillance efforts.
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\7\ The Senate explanatory statement accompanying the Consolidated
and Further Continuing Appropriations Act, 2013, directed DHS to
conduct a review and to provide a report of the results. On December
10, 2016, the Department of Homeland Security CBRNE Defense Act of
2015, which would establish a CBRNE Office within DHS, was passed by
the House of Representatives. H.R. 3875 (114th Cong.).
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This statement describes progress and challenges we have reported
in DHS's implementation of NBIC and BioWatch and considerations for the
future of these biosurveillance efforts at DHS. Our statement is based
on our prior work issued from December 2009 through October 2015 on
various biosurveillance efforts.\8\ The work upon which this testimony
is based was conducted 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.
To conduct this prior work, we reviewed relevant Presidential
directives, laws, regulations, policies, and strategic plans; surveyed
States; and interviewed Federal, State, and industry officials, among
others. We also analyzed key program documents, including test plans,
test results, and modeling studies. More information on our scope and
methodology can be found in each of the reports cited throughout this
statement.
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\8\ GAO, Biosurveillance: Developing a Collaboration Strategy Is
Essential to Fostering Interagency Data and Resource Sharing, GAO-10-
171 (Washington, DC: Dec. 18, 2009); GAO, Biosurveillance: DHS Should
Reevaluate Mission Need and Alternatives Before Proceeding with
BioWatch Generation-3 Acquisition, GAO-12-810 (Washington, DC: Sept.
10, 2012); GAO, Biosurveillance: Challenges and Options for the
National Biosurveillance Integration Center, GAO-15-793 (Washington,
DC: Sept. 24, 2015); GAO, Biosurveillance: DHS Should Not Pursue
BioWatch Upgrades or Enhancements Until System Capabilities Are
Established, GAO-16-99 (Washington, DC: Oct. 23, 2015).
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background
DHS's Biosurveillance Roles and Responsibilities
According to DHS's 2014 Quadrennial Homeland Security Review
(QHSR), biological threats and hazards--ranging from bioterrorism to
naturally-occurring pandemics--are a top homeland security risk. The
QHSR acknowledges that numerous departments and agencies at the
Federal, State, local, Tribal, and territorial levels, as well as the
private sector, contribute to the National effort to address biological
threats and hazards. As such, according to the QHSR, DHS aims to focus
on those activities and responsibilities assigned to it through statute
or Presidential directive. Among the identified activities and
responsibilities is one that is specific to biosurveillance--
biosurveillance integration and detection--and others that can help to
support efficient and effective biosurveillance action, such as
information sharing and analysis, threat and risk awareness, and
technical forensic analysis to support attribution.
NBIC
The Implementing Recommendations of the 9/11 Commission Act of 2007
(9/11 Commission Act) established the National Biosurveillance
Integration Center (NBIC) within DHS.\9\ NBIC was specifically tasked
with integrating and analyzing information from human health, animal,
plant, food, and environmental monitoring systems across the Federal
Government and supporting the interagency biosurveillance community. As
defined in the July 2012 NBIC Strategic Plan, integration involves
combining biosurveillance information from different sources and
domains (e.g., human, animal, and plant health; food and environmental
safety and security; and homeland security) to provide partners and
stakeholders with a synthesized view of the information, and what it
could mean. Primary goals of integration include creating a common
picture or understanding of potential and on-going biological events
and providing insights that cannot be gleaned in isolation.
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\9\ 6 U.S.C. 195b.
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The 9/11 Commission Act outlines certain requirements for NBIC.
Drawing upon these requirements as well as the NBIC Strategic Plan, we
identified 3 main roles that NBIC, as a Federal-level biosurveillance
integrator, must carry out to achieve the duties and outcomes described
by NBIC's authorizing legislation.\10\ Senior NBIC officials agreed
that these 3 roles--analyzer, coordinator, and innovator--are
consistent with the center's responsibilities. These roles are not
mutually exclusive and can reinforce one other. For example, NBIC's
efforts as an Innovator might result in the development of data that
could enhance its role as an analyzer by providing the center with
another dataset to review. The biosurveillance integrators' roles we
identified:
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\10\ GAO-15-793.
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Analyzer.--Use technological tools and subject-matter
expertise to develop shared situational awareness by creating
meaningful new insights from disparate datasets and information
that could not be gleaned in isolation.
Coordinator.--Bring together multi-disciplinary partners
across interagency organizations to enhance understanding of
new or potential biological events, such as through the
collaborative development of products and services.
Innovator.--Facilitate the development of new tools,
technology, and approaches to address gaps in biosurveillance
integration.
BioWatch
According to Homeland Security Presidential Directive 10 (HSPD-10):
Biodefense for the 21st Century, a National bioawareness capability
providing early warning, detection, or recognition of a biological
weapon attack is an essential component of biodefense.\11\ To
contribute to this National capability, in 2003, DHS created the
BioWatch program to provide early warning, detection, or recognition of
a biological attack. The BioWatch program uses routine laboratory
testing designed to detect an aerosolized biological attack for 5
specific biological agents considered high-risk for use as biological
weapons. When DHS was established in 2002, a perceived urgency to
deploy useful--even if immature--technologies in the face of
potentially catastrophic consequences catalyzed the rapid deployment of
many technologies. DHS completed the initial deployment of BioWatch
quickly--within 80 days of the President's announcement of the BioWatch
program in his 2003 State of the Union Address.\12\ In 2005, DHS
expanded BioWatch to an additional 10 jurisdictions, for a total of
more than 30. The expanded deployment--referred to as Generation 2
(Gen-2)--also included the addition of indoor monitoring capabilities
in 3 high-threat jurisdictions and provided additional capacity for
events of National significance, such as major sporting events and
political conventions.
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\11\ HSPD-10: Biodefense for the 21st Century (Washington, DC,
April 2004).
\12\ In the initial deployment of BioWatch--known as Generation-1--
DHS deployed aerosol collectors to 20 major metropolitan areas, known
as BioWatch jurisdictions, to monitor primarily outdoor spaces.
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In 2015, we reported that the BioWatch program collaborates with
more than 30 BioWatch jurisdictions throughout the Nation to operate
approximately 600 Gen-2 aerosol collectors. These units rely on a
vacuum-based collection system that draws air through a filter. These
filters are manually collected and transported to State and local
public health laboratories for analysis. Using this manual process, a
result can be generated from 12 to 36 hours after an agent is initially
captured by the aerosol collection unit.
To reduce detection time, DHS began to develop an autonomous
detection capability in 2003 for the BioWatch program--known as
Generation 3 (Gen-3).\13\ Envisioned as a laboratory-in-a-box, the
autonomous detection system would automatically collect air samples,
conduct analysis to detect the presence of biothreat agents every 4 to
6 hours, and communicate the results to public health officials via an
electronic network without manual intervention. By automating the
analysis, DHS anticipated that detection time could be reduced to 6
hours or less, making the technology more appropriate for monitoring
indoor high-occupancy facilities such as transportation nodes and
enabling a more rapid response to an attack. DHS also anticipated a
reduction in operational costs by eliminating the program's daily
manual sample retrieval and laboratory analysis. However, as we
reported in 2015, the Gen-3 acquisition was canceled in April 2014,
after testing difficulties and after an analysis of alternatives was
interpreted by DHS as showing that any advantages of an autonomous
system over the current manual system were insufficient to justify the
cost of a full technology switch.
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\13\ Initially, DHS's Science & Technology Directorate, partnering
with industry, led the development of technologies to support
autonomous detection. DHS's Office of Health Affairs has had
responsibility for overseeing the acquisition of this technology since
fiscal year 2007.
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dhs has faced challenges, some persistent, in its efforts to carry out
biosurveillance programs
NBIC Has Faced Difficulty Demonstrating Value to Interagency Partners
In December 2009, 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, which may have been at least
partially the result of collaboration challenges it faced. For example,
some partners reported that they did not trust NBIC to use their
information and resources appropriately, while others were not
convinced of the value that working with NBIC provided because NBIC's
mission was not clearly articulated.
In order to help NBIC enhance and sustain collaboration, including
the provision of data, personnel, and other resources, in 2009, we
recommended that NBIC develop a strategy for addressing barriers to
collaboration and develop accountability mechanisms to monitor these
efforts. In August 2012, NBIC issued the NBIC Strategic Plan, which is
intended to provide NBIC's strategic vision, clarify the center's
mission and purpose, articulate the value that NBIC seeks to provide to
its partners, and lay the groundwork for setting interagency roles,
responsibilities, and procedures. Further, in November 2014, NBIC
completed its first biannual NBIC Federal Stakeholder Survey, which
NBIC uses to assess the usefulness of its products and activities and
to determine what improvements should be made on the basis of those
results. We believe DHS's actions addressed the recommendations in our
December 2009 report.
In September 2015, we reported that NBIC had actions and activities
underway to fulfill all 3 of the roles we identified as essential to
its ability to carry out its mission--analyzer, coordinator, and
integrator. For example, to fulfill its analyzer role NBIC compiled
information to create and circulate a variety of products to support
disease outbreak monitoring on a daily, weekly, or period basis.
Similarly, in its coordinator role, NBIC had put in place a variety of
procedures and protocols to convene partners on a routine basis or in
response to specific emerging events. Finally, in its innovator role
NBIC had efforts to conduct gap analyses, fund pilot projects that aim
to develop new biosurveillance tools and technology (such as examining
the use of social media data to identify health trends), sought new
sources of data and information, and made efforts to enhance its
internal IT system.
Although NBIC had made efforts to collaborate with interagency
partners to create and issue a strategic plan that would clarify its
mission and the various efforts to fulfill its 3 roles, we reported a
variety of challenges that remained when we surveyed NBIC's interagency
partners for our 2015 report. Notably, many of these partners continued
to express uncertainty about the value NBIC provided. Specifically, 10
of 19 partners stated that NBIC's products and activities enhance their
agencies' ability to carry out their biosurveillance roles and
responsibilities to little or no extent, 4 responded to a moderate
extent, and 5 responded that they did not have a basis to judge.\14\
Generally, partners that responded to little or no extent noted that
NBIC products and activities do not, for example, identify trends and
patterns or describe potential impacts of a biological event. For
instance, one official stated that NBIC's products and activities do
not ``connect the dots'' between dissimilar information, provide novel
synthesis of information, or recommend possible courses of action.
Moreover, most of the Federal partners with key roles in
biosurveillance (8 of 11) stated that NBIC's products help their
agencies identify biological events to little or no extent, generally
because they already obtain such information directly from other
Federal partners more quickly.
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\14\ Generally, these 5 partners stated that they did not have a
basis to judge because they are biosurveillance information consumers
or they considered their role in biosurveillance to be relatively
small.
---------------------------------------------------------------------------
We also found in 2015, as in 2009, that a variety of challenges
limited the extent to which Federal agencies shared data and personnel
with NBIC, as envisioned by the 9/11 Commission Act. First, data that
NBIC could use to identify and characterize a biological event of
National concern using statistical and analytical tools, as called for
in the 9/11 Commission Act, are limited. Also, apart from searches of
global news reports and other publically-available reports generated by
National Biosurveillance Integration System (NBIS) partners,\15\ NBIC
has been unable to secure streams of raw data from multiple domains
across the biosurveillance enterprise that would lend themselves to
near-time quantitative analysis that could reveal unusual patterns and
trends.\16\
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\15\ The NBIS is a consortium of Federal partners that was
established to rapidly identify and monitor biological events of
National concern and to collect; analyze; and share human, animal,
plant, food, and environmental biosurveillance information with NBIC.
\16\ NBIC acknowledged in its strategic plan that the data required
to carry out its mission as envisioned in the 9/11 Commission Act
either do not exist or are subject to a variety of information-sharing
challenges that make a large information technology-centered solution
less feasible than originally imagined. Additionally, NBIC and NBIS
partners noted that there were several kinds of data that could be
useful for this kind of biosurveillance integration, but these data may
not exist or may not be in a usable form, such as real-time data on
water quality and contamination from drinking water utilities and data
on wildlife disease, which makes it difficult to fully understand the
dynamics of zoonotic diseases. NBIC officials also noted that other
kinds of data are maintained in formats that make them difficult to
analyze, such as paper health records.
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Moreover, we found that Few federal partners (5 of 19) reported
that they share the data they do have with NBIC, citing legal and
regulatory restrictions, among other reasons. Some agencies are
reluctant to share their data with NBIC because they are unsure how the
information will be used. For example, one official explained that the
agency does not share some data with NBIC because sharing such
information too broadly might have substantial implications on
agricultural trade or public perception of safety. Officials from
another agency noted that there is sometimes reticence to share
information and data with components of DHS because, given the
Department's roles in law enforcement and National security, the
information might be shared outside of the health security community in
a way that lacks appropriate context and perspective. Finally, other
agencies stated that they are unable to share data for regulatory or
legal reasons, or because appropriately protecting the data would take
too long.\17\ Similarly, although NBIC would like to obtain liaisons
from each of its Federal partners, only 3 of 19 partners provided NBIC
with dedicated liaisons. Officials from one agency with key
biosurveillance responsibilities stated that it is difficult to provide
personnel to NBIC on a full- or part-time basis because of resource
constraints. Further, officials from another agency noted that the lack
of clarity about NBIC's value to its partners is a barrier to providing
the center with detailees. We also reported in September 2015 that NBIC
faces challenges prioritizing developmental efforts to identify and
address needs for new biosurveillance tools. For example, partners
noted limitations in NBIC's ability to address gaps, like limited
resources and the difficulty in prioritizing the center's innovation
efforts because its partners have diverse needs.
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\17\ For example, according to Centers for Disease Control and
Prevention (CDC) officials, their agency receives electronic data from
State, territorial, local, and Tribal sources for a variety of programs
and purposes that are covered by data-use agreements that do not allow
CDC to share the data outside the terms of those agreements and as
allowed or required by applicable Federal laws, such as the Privacy Act
of 1974 and the Freedom of Information Act, 5 U.S.C. 552a; 552. CDC
officials said of the data they can share, it would take extensive,
time-consuming work to appropriately redact the data to ensure that
individuals may not be identified and that privacy is protected, which
results in the release of the data being postponed to the point that
the data are no longer actionable.
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Multiple Structural and Policy Considerations Could Help Focus NBIC's
Efforts
NBIC officials stated that the center is working to improve its
products and its ability to contextualize the information it collects
from open sources, and has sought partner input to do so. For example,
beginning in late June 2015, partly on the basis of feedback the center
received from its November 2014 Federal Stakeholder Survey, NBIC
modified its daily Monitoring List to include an up-front summary that
identifies the status of on-going biological events as worsening,
improving, unchanged, or undetermined. Further, NBIC officials noted
that the center is also working to better integrate forecasts and
projections into its products and activities by collaborating with
others and developing a common interagency vision for specific Federal
capabilities and practical next steps leading to the application of
reliable infectious disease forecasting models in decision-making
processes.
Nevertheless, a persistent challenge NBIC faces is skepticism on
the part of some of the NBIS partners regarding the value of the
Federal biosurveillance mission as well as NBIC's role in that mission.
In our 2009 report, most of the NBIS partners we interviewed at that
time expressed uncertainty about the value of participating in the NBIS
or confusion about the purpose of NBIC's mission. In September 2015,
the NBIS partners and other major stakeholders in the biosurveillance
community acknowledged--and we agreed--that no single problem limits
NBIC's mission to integrate biosurveillance data. Rather, over the
years, several long-standing problems have combined to inhibit the
achievement of this mission as envisioned in the 9/11 Commission Act.
We identified options in our 2015 report for policy or structural
changes that could help better fulfill the biosurveillance integration
mission, which are summarized below. We identified these options and
their benefits and limitations, on the basis of the roles of a Federal-
level biosurveillance integrator we identified in the 9/11 Commission
Act, NBIC's strategic plan, and the perspectives of the NBIS partners
obtained during our structured interviews. These options are not
exhaustive, and some options could be implemented together or in
part.\18\
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\18\ In developing these options, we did not evaluate the financial
implications of implementing each option, to the extent they are
knowable, but we acknowledge they are likely to result in an increase,
decrease, or shifting of funding based on the changes described.

TABLE 1.--BENEFITS AND CHALLENGES OF OPTIONS FOR POLICY OR STRUCTURAL CHANGES FOR THE NATIONAL BIOSURVEILLANCE
INTEGRATION CENTER (NBIC)
----------------------------------------------------------------------------------------------------------------
Option Description Benefits Challenges
----------------------------------------------------------------------------------------------------------------
Reinforce NBIC's Analyzer Role....... Under this option, NBIC Developing meaningful Uncertainty in knowing
would be provided with information not whether an event would
new authorities and otherwise available. be detected more
resources designed to Capitalize on new data quickly by overlaying
access additional sources and analysis various data streams
public and private techniques. and applying
data sources and statistical and
statistical and analytical tools to
modeling tools to them.
develop meaningful There may not be a
information. significant amount of
meaningful data
available that is not
already being provided
to facilitate advanced
analytical techniques.
The concept of whether
a Federal
biosurveillance
integrator would be
able to identify
patterns or
connections that would
lead to earlier
warning of emerging
events is unproven.
Unknown impact of
earlier detection.
Increased costs.
Strengthen NBIC's Coordinator Role... Under this option, NBIC This option would Some of these
would be provided with create clear responsibilities
greater authority for leadership across the overlap with
coordinating the interagency. responsibilities that
Federal Better institutional have historically been
biosurveillance connection. the purview of the
enterprise. Routine, National Security
institutionalized Council staff.
channels to monitor It may be difficult for
for emerging trends an agency at NBIC's
and patterns. level to successfully
Enhanced accountability influence decision
for implementing the making across the
National Strategy for interagency.
Biosurveillance.
Expand NBIC's Innovator Role......... Under this option, NBIC NBIC could foster the Increased costs.
would be provided with development of tools A National integrator
new authorities and and technology that that focuses on
resources to lead benefit multiple innovation would
research and Federal partners and likely need to acquire
development other members of the more expertise in
investments of new National research and
tools and technology Biosurveillance development.
that would address Integration System Focusing attention on
gaps across the (NBIS). this role may
biosurveillance Coordinate research and represent a
community. development efforts. significant mission
shift from the status
quo, and may require
very different sets of
resources and
procedures.
Continue to Execute the 2012 NBIC In this option, NBIC NBIC has made progress NBIC will likely
Strategic Plan. would continue to in this area and may continue to face
implement the mission, continue to do so. challenges in
goals, and objectives Some agencies currently obtaining all the
detailed in the August find value in NBIC's biosurveillance data
2012 NBIC Strategic products. it needs.
Plan or subsequent Partners remain
NBIS-approved updates. skeptical of NBIC's
value.
Repeal the NBIC Statute.............. In this option, The cost of operating Although Federal
National NBIC may not be worth partners generally
biosurveillance its benefits. thought that NBIC's
integration would not products and
be pursued through activities did not
NBIC. provide meaningful new
information, they
largely thought that
the concept of having
a Federal entity to
integrate
biosurveillance
information across the
Federal Government was
important.
Defunding NBIC could
create a loss of
investment,
institutional
learning, and progress
made toward developing
a Federal
biosurveillance
integrator.
Another integrator may
experience similar
challenges.
----------------------------------------------------------------------------------------------------------------
Source: GAO analysis of DHS information. GAO-16-413T

BioWatch's Ability to Detect Attacks Uncertain Because It Lacks
Performance Requirements That Correspond to a Clearly Defined
Mission
Since 2003, DHS has focused on acquiring an autonomous detection
system to replace the current BioWatch Gen-2, but has faced challenges
in clearly justifying the BioWatch program's need and ability to
reliably address that need. In September 2012, we found that DHS
approved the Gen-3 acquisition in October 2009 without fully developing
critical knowledge that would help ensure sound investment decision
making, pursuit of optimal solutions, and reliable performance, cost,
and schedule information. Specifically, we found that DHS did not
engage the early phases of its Acquisition Life-cycle Framework, which
is designed to help ensure that the mission need driving the
acquisition warrants investment of limited resources and that an
analysis of alternatives (AoA) systematically identifies possible
alternative solutions that could satisfy the identified need. 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. However, we found that the AoA prepared for the Gen-3
acquisition did not reflect a systematic decision-making process. As
with the Mission Needs Statement, program officials told us that they
were advised that a comprehensive AoA would not be necessary because
there was already Departmental consensus that autonomous detection was
the optimal solution. Because the Gen-3 AoA did not evaluate a complete
solution set, consider complete information on cost and benefits, and
include a cost-benefit analysis, we concluded that it did not provide
information on which to base trade-off decisions.
To help ensure DHS based its acquisition decisions on reliable
performance, cost, and schedule information developed in accordance
with guidance and good practices, in our September 2012 report, we
recommended that before continuing the Gen-3 acquisition, DHS
reevaluate the mission need and possible alternatives based on cost-
benefit and risk information. DHS concurred with the recommendation and
in 2012, DHS directed the BioWatch program to complete an updated
AoA.\19\ In April 2014, DHS canceled the acquisition of Gen-3 because
the AoA did not confirm an overwhelming benefit to justify the cost of
a full technology switch to Gen-3.
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\19\ DHS contracted with the Institute for Defense Analyses to
conduct the updated AoA, which they issued in December 2013.
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Having canceled the Gen-3 acquisition, DHS continues to rely on the
Gen-2 system for early detection of an aerosolized biological attack.
However, we found DHS lacks reliable information about BioWatch Gen-2's
technical capabilities to detect a biological attack, in part, because
in the 12 years since BioWatch's initial deployment, DHS has not
developed technical performance requirements for Gen-2. We reported in
2015 that BioWatch has been criticized because it was deployed quickly
in 2003 to address a perceived urgent need, but without sufficient
testing, validation, and evaluation of its technical capabilities.\20\
In 2015, we reported that DHS officials said that the system can detect
catastrophic attacks, which they define as attacks large enough to
cause 10,000 casualties. DHS has commissioned tests of Gen-2's
technical performance characteristics, but DHS has not developed
performance requirements that would enable it to interpret the test
results and draw conclusions about the system's ability to detect
attacks.\21\ According to DHS guidance and standard practice in testing
and evaluation of defense systems, in order to assess Gen-2's
capability to detect a biological attack, DHS would have to link test
results to its conclusions about the deployed detectors' ability to
detect attacks in BioWatch operational environments. This would
ordinarily be done by developing and validating technical performance
requirements based on operational objectives, but DHS has not developed
such requirements for Gen-2.
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\20\ GAO-16-99. See also Institute of Medicine and National
Research Council, BioWatch and Public Health Surveillance (Washington,
DC: National Academies Press, 2011).
\21\ In addition to these tests, DHS commissioned a demonstration
of the system in an outdoor environment and conducts quality assurance
tests on an ongoing basis. Both of these provide additional information
about the system's capabilities; however, we do not include them in our
list of key tests because neither was designed to produce estimates of
key performance characteristics, including sensitivity, or to support
conclusions about the types and sizes of attack the system can reliably
detect.
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In the absence of technical performance requirements, DHS officials
said their assertion that the system can detect catastrophic attacks is
supported by modeling and simulation studies. However, we found none of
these studies were designed to incorporate test results from the Gen-2
system and comprehensively assess the system against the stated
operational objective. The modeling and simulation studies were
designed for purposes other than to directly and comprehensively assess
Gen-2's operational capabilities. For example, one set of modeling and
simulation studies, conducted by Sandia National Laboratories (Sandia)
in collaboration with other National laboratories, did not incorporate
information about the actual locations of Gen-2 collector units,
because they were designed to model hypothetical BioWatch deployments
in which collectors were placed in optimal locations. Sandia also
analyzed ranges of hypothetical system sensitivities rather than
incorporating the test results on the performance characteristics of
Gen-2. Therefore, these studies drew no conclusions about the actual
capabilities of the deployed Gen-2 system.\22\ DHS officials also
described modeling and simulation work that used a measure of
operational capability that does not directly support conclusions about
the BioWatch objective of detecting attacks large enough to cause
10,000 casualties.\23\
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\22\ Additionally, DHS had not prepared an analysis that combines
the modeling and simulation studies with the specific Gen-2 test
results to assess the system's capabilities to detect attacks.
\23\ In general, these studies use a measure called fraction of
population protected, or Fp. Roughly speaking, Fp represents a system's
probability of successfully detecting simulated attacks, but calculated
in a way that gives more weight to attacks that infect more people and
less weight to attacks that infect fewer people.
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Additionally, we found that because none of the modeling and
simulation work was designed to interpret Gen-2 test results and
comprehensively assess the capabilities of the Gen-2 system, none of
these studies has provided a full accounting of statistical and other
uncertainties--meaning decision makers have no means of understanding
the precision or confidence in what is known about system
capabilities.\24\ Because it is not possible to test the BioWatch
system directly by releasing live biothreat agents into the air in
operational environments, limitations of the tests described earlier
limit the applicability of the results and underscore the need for a
full accounting of statistical and other uncertainties, without which
decision makers lack a full understanding of the Gen-2 system's
capability to detect attacks of defined types and sizes.
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\24\ Best practices in risk analysis and cost-benefit analysis
require an explicit accounting of uncertainties so that decision makers
can grasp the reliability of, and precision in, estimates to be used
for decision making. See Morgan and Henrion, Uncertainty, OMB Circular
A-94, and OMB Circular A-4.
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Understanding BioWatch's Current Capabilities Could Help Inform Future
Biodetection Investments
At the time DHS canceled the Gen-3 acquisition, it also announced
that S&T will explore development and maturation of an effective and
affordable automated aerosol biodetection capability, or other
operational enhancements, that meet the operational requirements of the
BioWatch system. As such, DHS officials told us they are considering
potential improvements or upgrades to the Gen-2 system. However,
because DHS lacks reliable information about Gen-2's technical
capabilities, decision makers are not assured of having sufficient
information to ensure future investments are actually addressing a
capability gap not met by the current system. Also, because DHS lacks
targets for the current system's performance characteristics, including
limits of detection, that would enable conclusions about the system's
ability to detect attacks of defined types and sizes with specified
probabilities, it cannot ensure it has complete information to make
decisions about upgrades or enhancements.
In our September 2015 report, to help ensure that biosurveillance-
related funding is directed to programs that can demonstrate their
intended capabilities, and to help ensure sufficient information is
known about the current Gen-2 system to make informed cost-benefit
decisions about possible upgrades and enhancements to the system, we
recommended that DHS not pursue upgrades or enhancements to the current
BioWatch system until it establishes technical performance requirements
necessary for a biodetection system to meet a clearly-defined
operational objective for the BioWatch program; assesses the Gen-2
system against these performance requirements; and produces a full
accounting of statistical and other uncertainties and limitations in
what is known about the system's capability to meet its operational
objectives. DHS concurred and is taking steps to address the
recommendation.
As DHS faces decisions about investing in the future of the
BioWatch program, there are lessons to be learned from the program's
recent attempt to acquire an autonomous detection system, Gen-3. Our
recent work on BioWatch also evaluated DHS's efforts to test the Gen-3
technology from 2010 through 2011 against best practices for
developmental testing. In our 2015 report, we recommended that DHS
incorporate the best practices we identified to help enable DHS to
mitigate risk in future acquisitions, such as upgrades or enhancements
to Gen-2. DHS concurred and stated its updated acquisition guidance
largely addresses these best practices.
Chairman McSally, Ranking Member Payne, and Members of the
subcommittee, this concludes my prepared statement. I would be happy to
respond to any questions you may have.

Ms. McSally. Thank you, Mr. Currie.
I now recognize myself for 5 minutes, for initial
questions.
So, I want to start with BioWatch, and I appreciate your
testimony and all the work that has been done by all of the
witnesses. We can all agree we need to make improvements, I
think, to our current detection system, that we rolled out
BioWatch in a hurry, and so that comes with limitations.
Obviously as we look back now 12 years later, the limitations
are real.
As far as the archaic nature, Dr. Brinsfield, you mentioned
the manpower intensivity of it, maybe lack of nimbleness.
Certainly, I think we can all agree we probably want something
that has more, newer technology, that is a little bit more
responsive.
With 2 years past since Gen-3 was canceled, where are we
at? So, like, what has been going on in the last 2 years? What
is the plan for us to be able to see? Are you trying to fix
Gen-2 and upgrade Gen-2? Are you looking at requirements for a
follow-on system that is Gen-4 that is maybe a long-term
project, and then in the mean time maybe bridging the gaps with
some off-the-shelf stuff during its final development?
I mean, these are some of the things that we talked about
with industry partners yesterday. But I mean, what is the
bottom line? Where are we at and what can we expect and what
time line for, you know, the improvement of this system?
Dr. Brinsfield.
Dr. Brinsfield. So, I think, if I can, I will answer that
in 2 ways, yes and yes. We are looking both at improvements to
the current system with our partners at S&T. I am happy to say
that the BioWatch program has reached out to its stakeholder
communities, the interagency, multiple cities, sat down and
asked them on a few occasions, what is most important to you?
What do you need to see improved for the current BioWatch
system to really be more useful and to have greater, you know,
ability to affect your decision making?
To that end, a number of requirements were generated that
have been passed and worked on with S&T. I will let Dr.
Brothers address that.
Then on a second point, we have also been working with S&T
on the new IPT process and have identified timeliness of
environmental detection and how we improve that as a longer-
term goal.
Mr. Brothers. Sure. I think what we have done is we have
looked at improvements in terms of 2 different time frames. We
have got a near-term time frame, 1 to 3 years, and a longer-
term time frame, 3 to 8 years or so.
If you look, kind-of, the chain of the way BioWatch works,
from collection, et cetera, to the eventual laboratory
analysis, we have broken that down into the different areas. We
have looked at that and said, what kind of improvements can we
do?
Now, I agree with Mr. Currie. You know, we have to have the
right kind of requirements before we can do the right job to
actually figure out specifically what we want. But as you know,
technology is changing rapidly, right? This whole idea of data
analytics, predictive analytics, different ways of
understanding threats, different type of bioassays, et cetera,
has advanced tremendously.
Therefore, what we need to do, even as we are trying to
generate these kind of requirements that we are talking about,
we have to understand what the art of the possible is.
In the pursuit of that art of the possible, we are reaching
out to industry. We fully realize that we don't have all the
answers internally. The answer is with this incredibly creative
S&T ecosystem, right? This is the industry, laboratories,
academia, et cetera. We are fully cognizant of that.
As such, we are reaching out with broad area announcements,
requests for information, et cetera, to understand what that
art of the possible is. Once we understand that, that is when
we start taking that along with the kind of requirements that
we are getting working with OHA to start understanding in this
architecture, in this architecture we are talking about, this
layered architecture that Dr. Brinsfield mentioned, and what
are the right things we have to put in play.
So, some near-term things we are looking at in terms of
improving the equipment that we have, and then there is some
stuff we are looking at working with industry to actually make
a much better system.
Ms. McSally. So, time line-wise for any of this, can we--I
don't want to be holding my breath. So, are we expecting
requests to us? Is there something you need from Congress or a
report back to Congress in the next single-digit months, or are
we talking double-digit months or single-digit years on, like,
here is the plan for the follow-on for BioWatch?
Dr. Brinsfield. So, I think from the incremental
improvements I will speak to that. We are looking at a time
line that would hopefully have us coming back to start being
able to do the acquisition process and acquire some of those
improvements in the next planned fiscal year, so by fiscal year
2018.
Ms. McSally. Okay, great. Now, when we meet with just a
handful, it wasn't the whole industry obviously, yesterday and
they had shared, and I want to make sure that I get this right,
they had received some RFIs and they gave feedback. That was
about 2 years ago, right? About 2 years ago. Then they were,
like, well, what did you do with the information we gave back
to you?
So I think they explained that they really felt like there
was some off-the-shelf technology, because technology is
developing so rapidly, that could be deployed in the interim.
The perfect being the enemy of the good, you know, being our
constant challenge here where we are chasing a perfect
solution, but taking too long and then having an inadequate
solution for a long period of time.
Is there something that could be deployed more rapidly,
from your assessment, off the shelf in order to either augment
BioWatch or start to replace it as we continue to move towards
that longer-term solution?
Either Dr. Brothers or Dr. Brinsfield.
Mr. Brothers. So, let me say, right now we are trying to
determine that. I think there is a lot of technologies out
there. We have got expertise in-house that understands some of
those technologies. But I think it is a mistake for us to
choose what that is without getting a good survey of the
landscape. So that is what we are doing right now.
So, we have 4 to 6 RFIs that are either out or going out
shortly. So the industry folks should be seeing those.
Ms. McSally. Got it.
So, fiscal year 2018, Dr. Brinsfield, I mean, so you are
basically saying, for the next year-and-a-half we can expect
DHS to stay with the status quo?
Dr. Brinsfield. So, for the next year-and-a-half, we can
expect to be able to do maybe, you know, working with our
partners, these kind of incremental improvements, but for the
acquisition process to truly build through and make sure we do
it correctly, follow MD-102 and all the guidelines, that that
is about the time to build all the pieces through to meet that
guideline process.
Ms. McSally. Okay.
Dr. Brinsfield. I think one of the other challenges, if I
can just sort of go to it, has been whether or not these
systems can be deployed in an indoor environment. Clearly, that
was identified strongly by the stakeholders as something that
they want to be able to do and that sets a different set of
problems for them.
They want to be able to make decisions on whether to
evacuate, you know, different kinds of decisions than you make
on whether or not you are going to treat a large population.
To that end, some of these RFIs are actually looking at how
we take existing technologies, pair them together in a way that
they can work on top of the current BioWatch detection system
for that type of deployment.
So, I do think that what we are going to see here, even
though there are incremental improvements of off-the-shelf
technologies, will be significant improvements in the usability
of the BioWatch system.
Ms. McSally. Great. One last question, and then I will hand
it over to the Ranking Member here, on Bioshield, is that the
Blue Ribbon Study Panel related the need to implement better
military and civilian collaboration.
Dr. Brothers, you know, you came from the DOD. So, can you
speak to any sort of collaboration that you are doing with DOD?
Mr. Brothers. Absolutely. Right now we are working with
DOD's JPEO Chemical and Biological Defense, that is under JPM,
and we are working with them, we have signed an MOU with them.
We just spoke with them. Actually, I just spoke with them a
couple of weeks ago.
They have a program called Jupiter. The program Jupiter is
really about biodefense, biosurveillance. Now, they are
developing a number of different types of technologies that we
are collaborating on the development of. So, I think that we
have a very close relationship.
Outside of that MOU, we also have a relationship in a group
called the capabilities development working group, CWDG. That
is chaired by myself and under secretary AT&L, where we meet to
discuss a variety of issues. This is one of the issues we
discuss.
We also have collaboration through the mission executive
council. So, there is a number of forum, as well as through the
committee on homeland national security as well, so there are a
number of different forums where we are co-chairing committees
and subcommittees where we have the opportunity to collaborate
across the agencies.
Ms. McSally. Okay, great. Thank you.
I want to now recognize Ranking Member Thompson for
questions, for 5 minutes.
Mr. Thompson. Thank you very much, Madam Chair.
In my opening statement, I kind of dated myself on this
issue that, you know, we have been here before. To be honest, I
want to make sure that I am just not hearing another hearing
for another Congress, saying the same thing.
So, convince me that we have changed the technology.
Convince me that we have acquired better equipment and that we
are getting to where Mr. Currie said we ought to be.
Dr. Brinsfield, can you help me out with that?
Dr. Brinsfield. So, sir, if I can use an example, in your
opening statement you referred to what has been known as the
false positives. I think in the past history of BioWatch, there
were times when there were detections that were perhaps true
detections of what the system was looking for, but weren't
useful for public health or law enforcement agencies.
Since then, the program has done much to improve its
assays, change the way it does those, done quality assurance,
so that we don't actually have those false detections anymore.
As a matter of fact, instead what we have is a number of
detections of low-level environmental agents that have shown to
actually be related to human disease.
This uptick in the disease Francisella tularensis happened
in this past summer, so that we have actually had the system
truly detect an environmental uptick in disease where there
were a limited number of people who became ill and that those
detections were worked with both the CDC, FBI, and other
partners.
Now, it is not a detection of a terror attack and that, you
know, is a good thing. Surely, no detection of a biological
agent will ever determine alone if that release was naturally
occurring or intentional from a terror attack. That is what our
partnership with law enforcement and the FBI is intended to do.
But it does show that the system has progressed in its ability
to detect and has actually had true detections in this area.
Mr. Thompson. So, Mr. Currie, do you agree with that?
Mr. Currie. Sir, I think one of the--I have many of the
same questions Chairman McSally had about what is actually
happening right now. I think there are two different issues.
You have the system that is in place in over 30 cities and it
has been in place for over a decade now. We have found there
are limitations with that system and the testing has not been
fully completed and they did not set performance requirements.
Our concern, though, is that when we talked about some of
these improvements, that that information and that system is
being used as the baseline for those improvements. So, that is
one issue.
The second issue is on the next generation of technology,
which is in the R&D realm. This could be things that don't even
look like BioWatch looked. So, there is very little detail
about what exactly the next step is, because you mentioned,
``Has the technology gotten better?''--What is the next step?
We are using the same technology we have been using. It is
not clear what the next technology is going to look like at
this point.
Mr. Thompson. Dr. Brothers, can you help us out on this?
Mr. Brothers. Sure. I think that we are looking at
advanced--so looking forward, so, Mr. Currie, you are saying,
you know, what is, kind of, next? But we are looking forward,
in essence, is what Dr. Brinsfield is talking about, which is a
fully-layered approach.
The fully-layered approach involves integration of
biosurveillance, the type of thing the NBIC does, along with
advanced biodetection. There are a number of technologies that
are out there that they may be agent agnostic. Maybe you are
looking at next-generation sequencing or something like that.
Maybe you are looking at some type of advanced mass
spectrometry. There is a number of technologies that are out
there that people are talking about that could be useful in
these type of architectures.
I think we are simultaneously looking at what these
advanced architectures could be. I am not going to say that we
are going to give you an exact architecture right now, but we
know what we have to find, right? It has to be this rapid
response network. We are actually looking at advanced IT
infrastructures to enable this advance infrastructure.
The point is we need to understand what is out there and
that is what we are doing right now. We do have an existing
system that is providing important properties. We are trying to
improve that.
Mr. Thompson. I understand that. But we are on the same
horse and we need, and I am being a little--not crass, but I
think we need to get to the next level of technology because we
are still using that same equipment. I am not certain if we
can.
I understand the layered part, but we still have the same
equipment. So, how are we going to change this?
Mr. Brothers. So, from S&T's perspective, we are making
sure we understand, not just technology, but we also do a good
job of characterizing potential threats. Right? So, that is
what we do through our NBAC and through the BTRA and these
kinds of things. So, we understand the science of the agents or
the pathogens, but we also understand the technologies.
Then in terms of the requirements, that is why we are
turning to our partners in OHA to understand what we should be
building for the next-generation system.
Mr. Thompson. Okay, I am going to go at another round,
Madam Chair.
Now, I am told that what we are doing is based on incidents
where there is 10,000 or more. Are we doing anything on
incidents less than 10,000?
Dr. Brinsfield. So, it certainly raises a good question. As
the program was initially rolled out, it was intended to detect
incidents of 10,000 or more. As we look at our State and local
partners and what they are asking us for, they are asking for
inter-venues and different levels of population affected than
the system has initially been.
Certainly, the changing nature of the terrorist threat and
what we need to play for is a significant piece of what we are
going to be looking at as we roll out future requirements. To
that end, we really want to make sure we continue to partner
with them and hear from them where they are interested in. They
are interested in subway systems. They are interested in sports
venues. They are interested in a whole host of things which
will set up ways to detect much less than potentially 10,000
people.
Mr. Thompson. Madam Chair, since I am the elder in the
group, you know, we have heard this before. I am trying to get
us down the road. So my angst in this is, when can we expect
the next roll-out? You don't have to tell us what it looks
like, but we just need to have some idea that we are not still
working with 12-, 15-year-old situations when things have
changed.
Dr. Brinsfield. So, I can only speak to the near-term roll-
out and those improvements on the product, as you mentioned.
Those ones, as we said, we are working through an acquisition
process that we hope to build into the budget, that will
provide the improvements.
When you speak of the next stage, that is really our R&D
problem.
Mr. Thompson. Well, R&D?
Mr. Brothers. So, I can't give you a time frame, you know?
This is an exploratory process right now. I think we are
working with OHA on the near-term, but in terms of a next-
generation system, like I said, we have set time frames for 3
to 8 years for the longer-term improvements. I am unable to
give you greater fidelity than that.
Mr. Thompson. But you do understand the concern of Congress
in this issue.
Mr. Brothers. I absolutely under the concern. I absolutely
understand and share your concern, absolutely.
Mr. Thompson. Mr. Currie, can you provide some guidance on
this?
Mr. Currie. Well, I will try. One of my concerns about--so
as I said, again, there are 2 issues here. There is a long-term
R&D issue, which it is not really clear exactly what that looks
like and that is probably natural to R&D, but then there is the
improvements that the administration is talking about.
My concern about the improvements is the improvements are
based on the existing technology as far as I understand it. We
had some concerns about the testing in the way the existing
technology was rolled out and the uncertainties in the system.
They have done some testing. I am not saying that is bad, it
just hasn't been a comprehensive set of tests to tell you
whether it does what it is supposed to do.
So, if they are going to take the current system and they
are going to incrementally improve it, then that has
implications for that. That concerns us.
I think that gets back to our recommendations. It may seem
like we are asking folks to go back in time to set requirements
and do the testing for a system that is almost 12 years old;
however, if you are going to use the current system to improve,
then it makes sense to do that.
Mr. Thompson. Absolutely.
I yield back, Madam Chair.
Ms. McSally. The gentleman yields back.
The Chair now recognizes my subcommittee Ranking Member,
Mr. Payne, for 5 minutes.
Mr. Payne. Thank you, Madam Chair and Ranking Member.
To follow the Ranking Member's angst, the technology, what
rolled out as next gen, I guess, is 12, 15 years old. The
actual technology is 50 years old, correct?
Mr. Currie. You are referring to the laboratory component
of the technology. The testing, yes.
Mr. Payne. Yes. I, you know, I am just a Member of Congress
in my second term and, you know, no stretch of the imagination,
the experts you are, but you would think that we would have
been able to move the marker in some manner over 50-year-old
technology. I mean, my watch is going to be obsolete next
month, you know, and I bought it a year ago.
Does the Department of Defense use any of these type of
equipment or something to watch for issues around this?
Dr. Brinsfield. So, actually, the Department of Defense
uses BioWatch collectors are some of its sites. If we are
talking about the technology that is the polymerase chain
reaction, which is the current technology they are using to
validate the organism, that is one of the questions we will be
asking in the RFI to see if anybody has a better technology, as
you mentioned sequencing.
But we have also looked in the past with the National
Academy of Sciences at other possible technologies that could
be used in this area, none of which had a readiness level that
were ready to be deployed yet.
Certainly, as, you know, the biological sciences improve,
and they are vastly improving our ability to do things, such as
sequencing, may come and be fast enough and readily available
enough that it is something we could actually deploy throughout
the country in the labs. That is, you know, part of the
reasoning for the FBI. That is what we are hoping to find.
Mr. Payne. Mr. Currie, would GAO know of types of equipment
that the Department of Defense is using that could potentially
be helpful to DHS?
Mr. Currie. Well, I couldn't name very specific pieces of
technology they might be able to use in the same way that
BioWatch is being used. We do know from our work that DHS does
coordinate with the Defense Department a lot. I will say,
though, that technology development for homeland security
purposes is very different than for defense or for the
warfighter.
Mr. Payne. Okay.
Mr. Currie. There may be more restrictions. You have
privacy restrictions. These things have to operate in public
places. I think it can be challenging to do that.
However, one of the things that we--that is why it is so
important to follow the acquisition process and set
requirements early on. What I mean by requirements are, is,
what do you want that technology to do and how should it
function in whatever environment it is supposed to function?
You have to set that early on and then you have to test to
those requirements. Sometimes it is not quick. You can't just
take a piece of technology off the shelf and throw it out
there, and that is kind-of what happened at the very beginning
of the program.
It is difficult. But it is a laborious process, but it is
necessary to make sure it is going to be successful.
Mr. Payne. Okay. Let us see, I still have time.
Ms. McSally. Take a little more time.
Mr. Payne. Okay.
Dr. Brinsfield, GAO proposed several paths forward to
improve, you know, the effectiveness of NBIC. Can you describe
the process OHA is using to evaluate these proposals?
Dr. Brinsfield. So, I want to really congratulate NBIC on
getting out there and reaching its stakeholder community and
trying to make sure they are meeting their needs.
So, on a number of issues, one is they signed a memorandum
of agreement with all the different departments and agencies
that we work with on the Federal level and set up a structure
on how we will actually govern NBIC. I have a co-chair on the
oversight body for NBIC. It was HHS last year, this year it is
USDA. We hope to continue to work in that manner.
Our current partnership with USDA in chairing the oversight
body of NBIC has led a number of great ideas in terms of how we
will change the way we use detailees and structure that
process.
NBIC has also looked at changing the way that it does its
reports and reporting. As you know, many people here get them.
I think it is important to realize we are not trying to give
human health information to human health agencies, we are
trying to coordinate information and we are trying to make it
available to people who maybe don't regularly get that type of
information.
We get great feedback from our partners in Commerce, in
other types of departments, that don't day-to-day deal with
health information. They like the new setup for the reports,
they like the way they are set up so they are getting the
bottom line up front and really getting the information they
need to help them make decisions.
In fact, when the Association of State and Territorial
Health Officials went yesterday to meet with Energy and
Commerce to talk about Zika, they were asked what they could do
to help State and local public health people, and they said we
would like better access to the NBIC reports.
So, you know, those kind of feedback and comments really
help us understand that we are meeting some of the outreach
parameters that we need to do.
Now, we know without a doubt that we need to do a better
job at sharing data across human health, animal health, and
environmental health. To Mr. Currie's point, there are pieces
here we may be able to do on our own and pieces that are a
larger Government issue and pieces which may have technology
solutions that Dr. Brothers at S&T can really help us with. We
are looking forward to those types of improvements.
Mr. Payne. Mr. Currie, would you like to comment?
Mr. Currie. Sure. I agree with Dr. Brinsfield. I mean, part
of what we found in our work is that the Federal agencies, and
we actually didn't go out and talk to State and locals, too,
but the Federal agencies that aren't routinely involved in
public health issues did find the NBIC reports useful.
I want to make it clear that, you know, we aren't saying
that what NBIC produces is bad. The folks over there have
worked really hard to implement our recommendations. What we
are saying is that its core mission, in addition to
coordination, was to integrate biosurveillance information.
Part of that is providing new meaning to the information that
is out there, collecting it, analyzing it, and providing new
meaning.
What we heard from the primary biosurveillance partners,
these are folks like USDA, CDC, is that that information, they
already have it, they already understand it, and it is not new
to them, and it really doesn't provide any new meaning.
So, that is what we pointed out in our report. The reason
we did not make specific recommendations to NBIC is because we
have made many in the past, and those have been implemented to
address these challenges, but the challenges still exist.
Part of what we did was try to offer you all, as the
policymakers, options to consider in moving forward.
Mr. Payne. Okay, thank you.
Dr. Brinsfield--oh, well, my goodness, my time is--are you
sure? Okay. Thank you, Madam Chair.
[Laughter.]
Mr. Payne. Dr. Brinsfield, you are probably wishing my time
was up.
[Laughter.]
Dr. Brinsfield. I enjoy coming to visit you, Mr. Payne.
Mr. Payne. Could you give a little explanation, your
funding request for 2017, it doesn't appear to be a request for
new funding for NBIC to carry out, you know, the mission in
response to the GAO report?
Dr. Brinsfield. Sir, our funding for these programs has
remained----
Mr. Payne. Or the authorities.
Dr. Brinsfield. Our funding for these programs, our funding
request for these programs has remained level across these
different years. As you know, you have graciously given NBIC
extra funds in past years to do different sorts of
demonstration projects to look at potential improvements, and
that was greatly appreciated.
But these funds remain level from prior years' requests.
Mr. Payne. So, are you attempting to gain favor with my
colleagues on the other side of the aisle by not asking for
more funds?
Dr. Brinsfield. I think, sir, it is a complex risk space
and we are looking at a lot of potential threats and risks. As
Chairman McSally is very well aware, we are also very concerned
about our responsibilities in the chem space. We are trying to
balance our many responsibilities in this area in what is
really a changing-nature threat.
Mr. Payne. I understand.
Okay, well, Madam Chair, I will yield back at this time.
Thank you.
Ms. McSally. Thank you.
Thanks. I have some more questions. I think is Congressman
Donovan coming, do you think? Okay. Well, we will just--so I do
want to just wrap up a little bit on BioWatch and technology
and engagement with industry.
My staff reminded me that one of the RFIs you guys put out
had 10,000 responses to it. So, obviously, industry has got a
lot to share and respond to regarding these RFIs.
I know DHS, sometime in the near future, is doing an
industry day related to stuff that we are dealing with with the
visa program and all that kind of stuff.
Have you had industry days or are you interested in
industry days or even round tables where, you know, we are all
sitting together and sort-of us meeting with industry yesterday
and you today? Like, sometimes, let us all just sit down
together and try and figure out how we can move some things
forward faster? That includes us, whether there is new
authorities or anything needed.
Mr. Brothers. So, I can tell you this, that one of the
things that we have been trying to do since I have been here,
since 2014, been trying to do greater outreach to industry,
quite frankly.
One of the areas we have been trying to do greater outreach
has been into the Silicon Valley, the Bostons, the Austins,
those kind of areas to understand what new technologies there
are.
So for an example of what you are talking about, we do do
industry days, but we are taking a somewhat nontraditional
approach to this. Our approach has been to actually have an
ideation event where we pose a problem to creative people, and
then we actually do a workshop. This type of workshop is around
principles developed by the Stanford University Design School.
Coming out of that, then we generate a solicitation.
We have also worked with the under secretary of management
to try to streamline our acquisition practices so that we can
more quickly get investment dollars to companies.
Because as you know, many companies, unless they are used
to doing business with the Government, they don't have a kind
of accounting system set up and it becomes very difficult for
them to deal with some of our acquisition practices. So, we are
trying to speed that up, speed up both the pace at which we get
solicitations out, speed up the pace at which we evaluate those
proposals that we receive in, and speed up the pace where we
actually get the investment dollars out.
The point is that as fast as technology is changing, as I
mentioned earlier, we need to be able to engage at that same
tempo and to be able to quickly vet so we have fast failures
and move on and efficiently use the taxpayers' dollars.
Ms. McSally. Great, thanks.
I want to now switch over to some of my questions on the
NBIC. You know, we are always formed by our own experiences and
I have a lot of experiences in the military of being in
operation centers, the last of which was at AFRICOM.
We were hoping to be more of an interagency operations
center, right? We were a military authority, but we really
wanted other agencies to be there, we wanted other agencies to
share information with us, and it was painful because we didn't
have any authority to direct them to and it was only as good as
the information that they provided.
It seems to me it is the same exact dynamic, you know, with
what we are talking about with the NBIC. Which is, if you are
directed to be coordinating, you are basically an operations
center, you are integrating information, that is what every
kind of operations center does, trying to provide decision-
quality information to your customers.
But you don't have the authority to direct other agencies
to participate. You have to beg them to or ask them to
volunteer and participate. They are only going to do that if it
is in their best interest and under limited resources.
Then the information is only as good as what they are
sharing with you. So, it is this circular, of course it is not
useful because everybody is not participating. So you are
wanting to do that role and that mission, but you are limited
by, I guess, not the authority to, you know, be directing that.
So, are there any new authorities that are required for
NBIC to be more effective and directive of other agencies?
I don't know if you can answer that, Dr. Brinsfield.
You might need to answer that, Mr. Currie.
I mean, is the issue authorities? Because again, I feel the
pain because I know what that is like. You know, what needs to
change so that it is--and it has to be useful. We don't need to
direct people to do things that are not within their interests,
because they have missions with limited resources as well.
Mr. Currie. Absolutely. I think you have hit the nail right
on the head. Great summary.
You know, I think we did talk a little bit in the report
about these options and what it would take to actually execute
some of these options. For example, in order to get NBIC access
to certain data, there would have to probably be laws requiring
sharing or something would have to happen to require agencies
to share.
However, one of the reasons we didn't make specific
recommendations is that that wouldn't necessarily guarantee it
would fix all these problems. I mean, it wouldn't just sort-of
fix everything right off the bat.
I think one of the interesting questions that we asked the
Federal partners, though, even given what they said about NBIC,
was, do you think that this idea of having somebody be a
Federal integrator for biosurveillance is a good idea? They
said yes, somebody absolutely needs to serve in that role.
I think the question just is, you know, who should it be?
That is a difficult question to answer. I mean, it has been one
could question whether moving this to another agency would fix
the problems, maybe they would have the same exact issues
trying to get information from the other agencies, too.
So, it is a difficult problem, but it is one that, you
know, it is not going away. We have been seeing this for, you
know, over half a decade now, and I think it just needs to be
considered.
Ms. McSally. So, of the options that you listed, Mr.
Currie, in the report, which would you personally recommend?
Mr. Currie. Well, we didn't recommend anything on purpose
because, you know, at GAO we are not the policymakers, you are.
So, what we tried to do is just do our best to give the pros
and cons of each, the limitations.
The other issue is, and we didn't do an analysis on this
because it is very difficult, but this has funding
implications. I mean, if you are going to give additional
authorities, then you probably have to give money to somebody
and take it away from somebody else. That is difficult and
challenging to do that. So, we did not come out with any one
approach.
Ms. McSally. It seems that, as you mentioned, some of the
Federal agencies that are already in this space are probably
like, you know, this report of the master of the obvious is not
new information. But those that could benefit from it are the
State and local, you know, individuals that are having to deal
are the first responders, the public health officials.
So, can you share a little bit about the--did you engage
with them during the GAO----
Mr. Currie. No, we did not. We had to survey over 15
different Federal departments, so it was outside of our scope
to actually go and talk to the State and locals. But I mean, we
did hear from the folks at NBIC about situations where they
provided these reports to folks in advance of special events,
like, you know, Super Bowl and things like that.
Ms. McSally. So, Dr. Brinsfield, can you just share the
level of collaboration with State and local authorities?
Dr. Brinsfield. So, we like to make sure in 2 ways that our
reports are well-coordinated with the interagency. So, first
off, you know, if we are sharing reports on this, we are making
sure that CDC, HHS has looked specifically at the information
and they are comfortable that it is relevant and exactly where
we are. We have also worked----
Ms. McSally. So, how long does that take? I mean, that just
made my head hurt. I mean, you want timely information, but if
you are coordinating amongst multiple bureaucracies, then often
your information can be quite old.
Dr. Brinsfield. They have really done a fantastic job at
speeding that process up and creating products that can give us
the brief report so we can get immediate information out and
then more, you know, in-depth reports later. So, yes, we are
getting information out in a regular cycle.
The State and locals have numerous ways they can get these
reports. They can sign up direct, they can go through the
associations, Association of State and Territorial Health
Officials, you know, city and county health officials. They
also at times, during certain events, CDC has distributed the
NBIC reports.
Ms. McSally. Is it just to health officials, but also to,
like, law enforcement, first responders, fire?
Dr. Brinsfield. So, we work with different groups and we
have opportunities for them to sign up and get these reports as
well. Some of them find them quite useful.
We have also worked with the Governors, the homeland
security advisers and some of those other groups to make these
available. As a matter of fact, there are many people here in
this building who get these reports and also find them quite
useful.
Ms. McSally. Okay, great.
So, I am assuming you were involved in the Ebola response
then, and NBIC had a role to play there. You know, in the
military we do AARs, after-action reviews, and then we identify
some people called them lessons learned, I call them lessons
identified because they usually are not learned unless they are
implemented.
So, did you identify or do you have a process to identify
lessons identified? Or did you do an AAR after Ebola? How is
that playing out as far as what you are doing with the Zika
virus?
Dr. Brinsfield. So, there is an on-going AAR process with
Ebola, looking at some of these different issues. The
information-sharing piece was not identified as a deficiency,
it was actually considered to be something that went fairly
well and I think will continue to do that.
Most of it has to do with organizational structure and how
information is shared. We certainly are participating on an
interagency basis with Zika. As a matter of fact, NBIC first
identified and reported on an unknown Brazilian disease in
March 2015 and reported on Zika first in April 2015 and have
been coordinating closely with our HHS partners.
Ms. McSally. Okay, great.
Ranking Member, do you have another round of questions?
Mr. Payne. Let us see. This is for Dr. Brinsfield and Dr.
Brothers.
You know, as you know, the committee recently enacted
legislation that would consolidate the activities of OHA in
certain chem/bio activities at S&T into a new CBRNE office. At
this point, the chem and bio research and development
activities would remain at S&T.
Can you describe the current working relationship between
S&T and OHA with respect to pursuing the new biodetection
technologies?
Dr. Brinsfield. Yes, sir. So, currently, we co-chair the
bio IPT. This is something we are looking to continue to do in
the future. We are working with FEMA to develop those gaps, if
you will, that need to be filled in the biospace.
Mr. Brothers. Yes, I think, so, as I mentioned in my
opening statement, we develop these IPTs as a way to
consolidate capability gaps across the Department. One of those
IPTs is biothreat. Dr. Brinsfield and FEMA are the co-chairs of
the biothreat IPT.
Through that IPT, we have already got to the point where we
have identified 5 high-priority areas. These have to still be
further vetted and sent to the Secretary, but we have done it.
I have got to commend Dr. Brinsfield for just the good work on
this IPT, because we have got to these capability gaps we
haven't had before.
These will then be used as a way to drive our research
investment in those gap areas, try to close those gaps.
Mr. Payne. Okay. In light, you know, of how those things
are going, do you anticipate chem/bio research and development
staying at S&T or eventually moving over to the new office?
Mr. Brothers. So, I think there has been a lot of
discussion about this. Questions have come up of, what are the
best models for R&D? I think in a number of people's
estimation, and mine as well, if you look objectively at it, a
lot of the advances in technology these days, the innovation
that people talk about, come about because of the convergence
of ideas.
So, for example, MIT has an institute called the
Convergence Institute. What they do is they look at the
convergence of engineering and biology and physics and
mathematics. They are saying they are putting people in those
different areas of disciples in one place. What research has
shown is that when you put people of disciplines in one place,
you make a critical mass of ideas of a diverse set of ideas
across disciplines. So what you end up with is a greater result
than you could get than if you just had these individuals in
isolation.
So, here is an example. If you look at some of the
advancements that have been made in the biological sciences
recently, in genomics and proteomics and these kinds of things,
it really has to do with advancements in data analytics, which
is mathematics and computer science.
So, if you didn't have people in mathematics and computer
science co-located with people in biology, they wouldn't know
about these kind of problems to solve. What it comes down to is
creative people like to solve hard end-point problems, but they
have to understand what these problems are.
So, it is important to put them into environments of
diverse creativity. When you do that, they find out problems
they never had before.
So, now, if you keep chem/bio in an environment where you
have other types of research and development going on, where
you have other types of problems being addressed, you start
getting a cross-pollinization that is a very powerful influence
to innovation.
Mr. Payne. Okay.
Mr. Currie, along that line, you know, the committee just
passed the legislation authorizing the consolidation. I
understand DHS has begun a review of the consolidation
proposal. Can you give us an overview of your preliminary
findings?
Mr. Currie. Well, sir, we are actually doing that work for
Mr. Thompson and you. We are right in the middle of that
review, so we don't have any final results of that yet.
However, we have been watching current events. For instance
I just took a look at the budget request that came out for the
new office and it looks like I had the same questions about:
Are there going to be any changes in these programs in the new
office? It looks like there is not, they were just simply
merged together.
But quite frankly, there are not a lot of detailed plans
right now about the specifics of the reorganization. Part of
that, DHS has told us, is because they are waiting on the
legislation to be final and passed, still got to go through the
Senate.
So, they are sort of on hold according to them right now,
until they get legislation to move forward on that.
Mr. Payne. Okay, thank you.
In the interest of time, I will yield back, Madam Chair.
Ms. McSally. Thank you.
I just have one final question, Dr. Brothers, about FEMA
co-chairing the biological threat IPT. FEMA's a response
organization. I didn't think they were much involved in R&D and
technology, per se. I mean, they obviously need to respond to
crises.
So, can you just talk a little about what their role is and
kind-of how they ended up there?
Mr. Brothers. I can. I appreciate the question actually.
So, one of the things I firmly believe in is what is called
user-producer innovation. What that is is when you get the
actual stakeholders, the people who are on the ground, whether
it be FEMA or Customs and Border Protection or Coast Guard,
involved in the creative process.
Again, research has borne this to be true.
Ms. McSally. Got it.
Mr. Brothers. When you get the users involved in the
creative process, you get a better result more efficiently and
effectively.
Ms. McSally. Got it. Okay. Great, thank you.
All right. Well, I want to thank all of our witnesses for
your valuable testimony today, and Members for their questions.
Members of the subcommittee may have additional questions
for the witnesses. I will ask you to respond to these in
writing.
Pursuant to the committee Rule 7(e), the hearing record
will be held open for 10 days.
Without objection, the subcommittee stands adjourned.
[Whereupon, at 3:22 p.m., the subcommittee was adjourned.]

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