[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
CONTINUING CONCERNS OVER BIOWATCH AND
THE SURVEILLANCE OF BIOTERRORISM
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
----------
JUNE 18, 2013
----------
Serial No. 113-56
Printed for the use of the Committee on Energy and Commerce
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CONTINUING CONCERNS OVER BIOWATCH AND THE SURVEILLANCE OF BIOTERRORISM
COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas
JOE BARTON, Texas
Chairman Emeritus
ED WHITFIELD, Kentucky
JOHN SHIMKUS, Illinois
JOSEPH R. PITTS, Pennsylvania
GREG WALDEN, Oregon
LEE TERRY, Nebraska
MIKE ROGERS, Michigan
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee
Vice Chairman
PHIL GINGREY, Georgia
STEVE SCALISE, Louisiana
ROBERT E. LATTA, Ohio
CATHY McMORRIS RODGERS, Washington
GREGG HARPER, Mississippi
LEONARD LANCE, New Jersey
BILL CASSIDY, Louisiana
BRETT GUTHRIE, Kentucky
PETE OLSON, Texas
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California
Ranking Member
JOHN D. DINGELL, Michigan
Chairman Emeritus
EDWARD J. MARKEY, Massachusetts
FRANK PALLONE, Jr., New Jersey
BOBBY L. RUSH, Illinois
ANNA G. ESHOO, California
ELIOT L. ENGEL, New York
GENE GREEN, Texas
DIANA DeGETTE, Colorado
LOIS CAPPS, California
MICHAEL F. DOYLE, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois
JIM MATHESON, Utah
G.K. BUTTERFIELD, North Carolina
JOHN BARROW, Georgia
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
JERRY McNERNEY, California
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
BEN RAY LUJAN, New Mexico
PAUL TONKO, New York
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
MARSHA BLACKBURN, Tennessee BRUCE L. BRALEY, Iowa
PHIL GINGREY, Georgia BEN RAY LUJAN, New Mexico
STEVE SCALISE, Louisiana EDWARD J. MARKEY, Massachusetts
GREGG HARPER, Mississippi JANICE D. SCHAKOWSKY, Illinois
PETE OLSON, Texas G.K. BUTTERFIELD, North Carolina
CORY GARDNER, Colorado KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia PETER WELCH, Vermont
BILL JOHNSON, Ohio PAUL TONKO, New York
BILLY LONG, Missouri GENE GREEN, Texas
RENEE L. ELLMERS, North Carolina JOHN D. DINGELL, Michigan
JOE BARTON, Texas HENRY A. WAXMAN, California (ex
FRED UPTON, Michigan (ex officio) officio)
C O N T E N T S
----------
Page
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania................................... 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the state
of Colorado, opening statement................................. 5
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 6
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 7
Witnesses
Michael Walter, Ph.D., Biowatch Program Manager, U.S. Department
of Homeland Security, Office of Health Affairs................. 9
Prepared statement........................................... 12
Answers to submitted questions............................... 307
Toby L. Merlin, MD., Director, Division of Preparedness and
Emerging Infections, National Center for Emerging and Zoonotic
Infectious Diseases, Centers for Disease Control and Prevention 16
Prepared statement........................................... 18
Answers to submitted questions............................... 324
Submitted Material
Document binder.................................................. 48
Majority supplemental memorandum dated June 18, 2013............. 280
CONTINUING CONCERNS OVER BIOWATCH AND THE SURVEILLANCE OF BIOTERRORISM
----------
TUESDAY, JUNE 18, 2013
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10 a.m., in room
2322 of the Rayburn House Office Building, Hon. Tim Murphy
(chairman of the subcommittee) presiding.
Present: Representatives Murphy, Burgess, Blackburn,
Scalise, Harper, Olson, Gardner, Johnson, Long, Ellmers,
Bilirakis, DeGette, Butterfield, Tonko, Green, and Waxman (ex
officio).
Staff present: Carl Anderson, Counsel, Oversight; Sean
Bonyun, Communications Director; Karen Christian, Chief
Counsel, Oversight; Andy Duberstein, Deputy Press Secretary;
Brad Grantz, Policy Coordinator, Oversight and Investigations;
Brittany Havens, Legislative Clerk; Sean Hayes, Counsel,
Oversight and Investigations; Alan Slobodin, Deputy Chief
Counsel, Oversight; Phil Barnett, Democratic Staff Director;
Stacia Cardille, Democratic Deputy Chief Counsel; Kiren Gopal,
Democratic Counsel; Hannah Green, Democratic Staff Assistant;
Elizabeth Letter, Democratic Assistant Press Secretary; Stephen
Salsbury, Democratic Special Assistant; and Roger Sherman,
Democratic Chief Counsel.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Good morning. I convene this hearing of the
Subcommittee on Oversight and Investigations on Continuing
Concerns Over BioWatch and the Surveillance of Bioterrorism. We
will be examining the effectiveness and efficiency of BioWatch,
a Department of Homeland Security program that relies heavily
on the Centers for Disease Control and Prevention, and the
State and local public health laboratories that are members of
the CDC Laboratory Response Network.
BioWatch is an early warning system designed to detect a
large-scale, covert attack that releases anthrax or other
agents of bioterrorism into the air. The program was launched
in January 2003 as this country was preparing for war against
Iraq when many believed that state-actor programs had
stockpiles of anthrax, smallpox, and botulinum.
BioWatch deploys collectors in 34 of the largest U.S.
metropolitan areas in outdoor locations, with indoor
deployments in three sites, and special event capacity. These
collectors hold filters that gather air samples. Every 24
hours, a government worker goes to these collectors, manually
retrieves the filters, and takes them to a State or local
laboratory for analysis and testing. If the lab testing shows a
positive result, called a BioWatch Actionable Result, or BAR
for short, government officials review other evidence and
information to decide if it is an actual attack, or just the
detection of a bacteria in the environment that has a similar
DNA to the pathogen of concern. Since the program started,
there have been 149 BARs, none of them being an actual attack.
BioWatch costs about $85 million a year to operate, and over $1
billion spent since 2003.
For 9 years BioWatch has sought to develop and deploy a
more advanced type of technology that would include air
sampling and analysis of the samples in the same device, a so-
called lab-in-a-box. This technology, known as Generation 3, is
estimated by GAO to cost $5.8 billion over 10 years. According
to a senior CDC official, the cost is ``an abomination.''
Unfortunately, after much hype, versions of the lab-in-a-
box technology have failed. One version, BioWatch Generation
2.5, was actually deployed for 2 years and then halted because
it was ineffective. The latest version of technologies for
Generation 3 failed testing. About $300 million has already
been spent on these failed detection technologies. Last year,
the Senate and House Appropriations Committees removed the $40
million requested by the Administration for Generation 3, and
no procurement of this technology can proceed until after the
Secretary of Homeland Security certifies that the science is
proven.
Almost a year ago, this committee opened this investigation
after a National Academy of Sciences report in 2011 and an
article in the Los Angeles Times in July 2012 noted that the
BioWatch system was generating false positives or indicating
the ``the potential occurrence of a terrorist attack when none
has occurred.'' A DHS official responded, stating that the
reports of false positives were incorrect and unsubstantiated,
and that there ``has never been a false positive result.''
However, the committee's investigation found other serious
problems with the BioWatch program besides the BAR false
positives. Most troubling is whether we are better prepared to
respond to bioterrorism than we were 5 years ago.
Unfortunately, the answer would seem to be no.
The public health workforce has been reduced by 21 percent
over the last 5 years, with emergency preparedness being
hardest hit. Several of the bioterrorism threats we thought we
faced in 2003 no longer apply or have been lessened. According
to the DHS experts interviewed by committee staff, recent
threat assessments show that a large-scale catastrophic attack
is less likely. However, the threat is still dangerous because
of certain technological advances and the greater likelihood of
smaller-scale attacks that would probably not be detected by
BioWatch.
Yet, if the science of Generation 3 is proven, DHS would be
expected to pursue the multibillion-dollar Generation 3. We
cannot afford another DHS boondoggle. This costly approach is
unbalanced and misdirected. It makes no sense to expand outdoor
monitoring for a less likely large-scale attack, while not
addressing the declining number of public health responders who
are needed in any kind of attack. If public health authorities
lack the capability to respond, BioWatch will not produce a
benefit.
The committee's investigation did not find a strategy
reflecting changes in the threat and the reduced resources in
the public health workforce. Last July, the President put out a
National Strategy for Biosurveillance. He directed that a
strategic implementation plan be completed within 120 days, but
there is no strategic implementation plan that has been
publicly released, and the committee staff have been unable to
confirm if this plan even exists.
Once the role of BioWatch is appropriately analyzed in the
context of an overarching biodefense strategy, tough questions
need to be examined. After 10 years of operation, we still
don't know if the current BioWatch technology can detect an
aerosolized bioterrorism agent in a real-world environment. DHS
expects to have this data this fall. We don't know if past
management problems have been corrected. Bipartisan committee
staff asked DHS to produce documents from an internal DHS
investigation of a DHS official's conduct related to BioWatch,
but DHS has not done so.
There has been bipartisan and non-partisan concern over
BioWatch, including the ranking member of the House Homeland
Security Committee, Bennie Thompson, the GAO, the National
Academies of Science, Congressman David Price, Democrats and
Republicans on the Senate and House Appropriations Committees,
House Homeland Security Committee Republicans, Congressman Gus
Bilirakis, now a member of the House Energy and Commerce
Committee, and Congressman Dan Lungren. Let us work together to
get the right solution.
We want to thank the witnesses for being here today. I
would now like to give the ranking member, my good friend from
Colorado, Ms. DeGette, an opportunity to give her opening
statement for 5 minutes.
[The prepared statement of Mr. Murphy follows:]
Prepared statement of Hon. Tim Murphy
I convene this hearing of the Subcommittee on Oversight and
Investigations on ``Continuing Concerns Over BioWatch and the
Surveillance of Bioterrorism.'' We will be examining the
effectiveness and efficiency of BioWatch, a Department of
Homeland Security (DHS) program that relies heavily on the
Centers for Disease Control and Prevention (CDC), and the state
and local public health laboratories that are members of the
CDC Laboratory Response Network.
BioWatch is an early warning system designed to detect a
large-scale, covert attack that releases anthrax or other
agents of bioterrorism into the air. BioWatch is an early
warning system designed to detect a large-scale, covert attack
that releases anthrax or other agents of bioterrorism into the
air. The program was launched in January 2003 as this country
was preparing for war, and it was intended to protect against
threats of state-sponsored programs that may have had anthrax,
smallpox, and botulinum.
BioWatch deploys collectors in 34 of the largest U.S.
metropolitan areas in outdoor locations, with indoor
deployments in three sites, and special event capacity. These
collectors hold filters that gather air samples. Every 24
hours, a government worker goes to these collectors, manually
retrieves the filters, and takes them to a state or local
laboratory for analysis and testing. If the lab testing shows a
positive result, called a BioWatch Actionable Result, or BAR
for short, government officials review other evidence and
information to decide if it is an actual attack, or just the
detection of a bacteria in the environment that has similar DNA
to the pathogen of concern. Since the program started, there
have been 149 BARs, none of them being an actual attack.
BioWatch costs about $85 million a year to operate, with over
$1 billion spent since 2003.
For nine years BioWatch has sought to develop and deploy a
more advanced type of technology that would include air
sampling and analysis of the samples in the same device, a so-
called ``lab-in-a-box.'' This technology known as Generation 3,
is estimated by GAO to cost $5.8 billion over 10 years.
According to a senior CDC official, the cost is ``an
abomination.''
Unfortunately, after much hype, versions of ``lab-in-a-
box'' technology have failed. One version, BioWatch Generation
2.5, was actually deployed for two years and then halted
because it was ineffective. The latest version of technologies
for Generation 3, failed testing. About $300 million has
already been spent on these failed detection technologies. Last
year, the Senate and House Appropriations Committees removed
the $40 million requested by the administration for Generation
3, and no procurement of this technology can proceed until
after the Secretary of Homeland Security certifies that the
science is proven.
Almost a year ago, this committee opened this investigation
after a National Academy of Sciences (NAS) report in 2011 and
an article in the Los Angeles Times in July 2012 noted that the
BioWatch system was generating ``false positives'' or
indicating the ``the potential occurrence of a terrorist attack
when none has occurred.'' A DHS official responded, stating
that the reports of ``false positives'' were incorrect and
unsubstantiated, and that ``there has never been a false
positive result.''
However, the committee's investigation found other serious
problems with the BioWatch program, besides the BAR false-
positives.
Most troubling is whether we are better prepared to respond
to bioterrorism than we were five years ago. Unfortunately, the
answer would seem to be no.
The public health workforce has been reduced by 21% over
the last five years, with emergency preparedness being hardest
hit. Several of the bioterrorism threats we thought we faced in
2003 no longer apply or have been lessened. According to the
DHS expert interviewed by committee staff, recent threat
assessments show that a large-scale catastrophic attack is less
likely. However, the threat is still dangerous because of
certain technological advances and the greater likelihood of
smaller-scale attacks that would probably not be detected by
BioWatch.
Yet, if the science of Generation 3 is proven, DHS would be
expected to pursue the multi-billion dollar Generation 3. We
cannot afford another DHS boondoggle. This costly approach is
unbalanced and misdirected. It makes no sense to expand outdoor
monitoring for a less likely large-scale attack, while not
addressing the declining number of public health responders who
are needed in any kind of attack. If public health authorities
lack the capability to respond, BioWatch will not produce a
benefit.
The committee's investigation did not find a strategy
reflecting changes in the threat and the reduced resources in
the public health workforce. Last July, the president put out a
National Strategy for Biosurveillance. He directed that a
strategic implementation plan be completed within 120 days. But
there is no strategic implementation plan that has been
publicly released, and the committee staff have been unable to
confirm if this plan even exists.
Once the role of BioWatch is appropriately analyzed in the
context of an overarching biodefense strategy, tough questions
need to be examined. After ten years of operation, we don't
still know if the current BioWatch technology can detect an
aerosolized bioterrorism agent in a real-world environment. DHS
expects to have this data this fall. We don't know if past
management problems have been corrected. Bipartisan committee
staff asked DHS to produce documents from an internal DHS
investigation of a DHS official's conduct related to BioWatch,
but DHS has not done so.
There has been bipartisan and non-partisan concern over
BioWatch, including: the Ranking Member of the House Homeland
Security Committee, Bennie Thompson; the GAO; the National
Academies of Science; Congressman David Price; Democrats and
Republicans on the Senate and House Appropriations Committees;
House Homeland Security Committee Republicans, Congressman Gus
Bilirakis, now a Member of the House Energy and Commerce
Committee, and Congressman Dan Lungren. Let's work together to
get the right solution.
# # #
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you, very much, Mr. Chairman.
Mr. Chairman, I am so glad we are here talking about this
BioWatch surveillance program. Bioterrorism remains a threat to
our nation, and BioWatch's detection capabilities are critical,
and I agree with you, that is why we need to make sure that the
program is operating efficiently.
After the anthrax mailings of 2001, the federal government
needed to act fast. In September 2001, the New York Times
reported that the government's bioterrorism planning was so
disjointed that the agencies involved could not even agree on
which biological agents posed the biggest threat. Boy, we have
come a long way since then, in large part because of the
BioWatch program.
BioWatch has been monitoring the air for potential
bioterror agents like anthrax for the last decade. It is a
valuable tool because it provides us with advanced warning of a
biological attack. If a release of anthrax was detected before
it began to adversely affect people, for example, public health
officials could take action to mitigate its impact and prevent
it from being spread. Local hospitals could be told to be on
the lookout for certain symptoms and ensure victims weren't
being misdiagnosed. Any time that we can buy through early
detection could mean many lives saved.
With this kind of biosurveillance system in place, the
likelihood of a biological attack inflicting mass casualties
and overwhelming our public health system would be greatly
reduced. That is why biosurveillance is an essential activity
and a national priority, and that is BioWatch is a beneficial
program that helps meet our national security needs. But, Mr.
Chairman, there is a big ``if'', and I agree with you: those
facts only hold true if we can be confident that the BioWatch
program works the way it says it should.
Experts have in recent years raised a number of technical
and management concerns with the BioWatch program. Mr.
Chairman, you talked about some of those in your opening
statement. This committee's job is to hear about those concerns
so we can make sure that the program is on the right path
forward. Is the federal, state, and local collaboration running
smoothly? Are constructive recommendations being implemented?
Is the program now being effectively managed? Is the current
generation of BioWatch technology meeting appropriate
standards, and is the next generation of BioWatch technology
fiscally and technically feasible.
I appreciate both of our witnesses today, and I hope they
can help us answer these questions. We have heard from
officials that Generation 3 that you discussed, which is the
proposed new BioWatch technology, could provide more timely
threat detection. Before we expend considerable resources on
that, though, I think we can be in agreement, we have got to be
confident that this technology works. If it can be tested and
proven, Generation 3 holds the potential to provide continuous
and autonomous detection and expanded population coverage.
Unfortunately, the acquisition process for BioWatch Generation
3 has been married with difficulties, and serious questions
remain about whether Generation 3 is a viable advance.
Last September, GAO reported that decisions were made to go
forward with this automation detection technology without the
proper due diligence and without justifying the mission need.
DHS didn't develop a complete and reliable performance schedule
and cost information before approving the acquisition, and if
there is one thing we have learned since September 11th, let us
just stop throwing money around willy-nilly. Let us make sure
that we target it to programs that work.
Generation 3 acquisition is currently on hold as DHS tries
to resolve these issues, and that seems like the prudent course
of action to me. The delays and mismanagement that led us to
this point, however, are unacceptable, and DHS must do better.
I am looking forward to hearing from Dr. Walter about what has
been done to rectify these deficiencies so that we can move
forward.
The BioWatch program is only a small part of our efforts to
detect and to deter bioterrorism. That is why part of our
discussion about BioWatch must also ask about broader
biosurveillance activities and where this picture fits into the
large picture. We obviously can't protect against every
potential threat but we should be figuring out what the
likeliest threats are, and if our current infrastructure meets
the challenges of today as well as the future, given the
limited resources.
I look forward again to hearing from the witnesses about
BioWatch, and I know we will be able to have a constructive
discussion about where we go from here, and I yield back, Mr.
Chairman.
Mr. Murphy. The gentlelady yields back, and now I turn
towards the vice chairman of the committee, Dr. Burgess, for 5
minutes.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. I thank the chairman for the recognition.
We have already heard this morning the result of the 9/11
attacks, the anthrax letters in 2001 of escalated bioterrorism
from a concept to a reality. In response, the BioWatch program
was launched as an early-detection warning system for
bioterrorist attacks. Unfortunately, in the rush to launch
BioWatch, the government failed to ensure the proper role for
the program in the greater United States biosurveillance
strategy.
Public health is best administered at the local and
community level. While BioWatch has the potential to provide
valuable data to federal, State and local officials, the
promise continues to remain one in theory.
The Centers for Disease Control requires reliable, high-
quality evidence in order to decide to respond to a
bioterrorism event. The Department of Homeland Security, who is
in charge of the BioWatch system, has failed to utilize
BioWatch to gather the information necessary to guide the
decisions of public health authorities.
We have another problem. Since 2003, BioWatch has produced
56 false alarms. This unfortunately has the effect of
destroying public confidence that public health officials may
have had in the system. Federal, state, and local agencies
already operate and maintain a wide variety of outdoor air
monitoring systems across the United States. The 26th district
of Texas, which produces a lot of natural gas through a process
known as fracking, maintains a number of air quality sensors,
both from the Texas Commission for Environmental Quality as
well as the private sector as well. If private companies have
the ability to capture real-time air quality data through
remote sensing, why do we still lack the ability to detect that
that came from a bioterrorism attack?
Terrorist threats have changed since 2001. The enemies are
developing new strategies that will circumvent our
surveillance. Our surveillance and response strategy must
improve at an even faster pace. We should identify and address
the evidence gaps in our public health surveillance system,
ensuring that all United States surveillance systems cooperate
to achieve our biosurveillance strategy and prevent those
threats before they become a reality.
And then lastly, I feel obligated just to mention that back
in the early 1950s, the United States Navy undertook a series
of exercises that were famously declassified in the mid-1970s
that provided evidence that yes, indeed there can be a problem.
The dispersal of what was thought to be a harmless bacteria
along the coastline in the United States ended up causing
illness in a limited number of individuals but nevertheless
illness all the same. So it certainly underscores the
importance of undertaking this work but it is also important
that we get it right.
Mr. Chairman, I thank you for the consideration and I will
yield back to you.
Mr. Murphy. The gentleman yields back. I now recognize the
ranking member of the committee, Mr. Waxman, for his opening
statement for 5 minutes.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you, Mr. Chairman, and my comments are
going to be similar to my colleagues because we all understand
what we are facing today.
The history of this is that in 2003 in his State of the
Union address, President Bush announced the deployment of ``the
Nation's first early warning network of sensors to detect
biological attack.'' Just months after this announcement, the
BioWatch program was up and running. We have since learned that
BioWatch, like other post-September 11 programs, was
implemented too hastily and without appropriate long-term
planning.
But that doesn't mean that the program cannot be repaired.
In fact, progress is already being made. In recent years,
Government Accountability Office and other analysts have
identified legitimate concerns with the management of the
BioWatch program that should be addressed, particularly with
respect to the acquisition of new early-detection Generation 3
technology. This new technology is promising because it could
lead to faster detection in the event of a bioterror attack.
According to GAO, however, the Department of Homeland
Security approved the Gen-3 acquisition ``without fully
developing critical knowledge that would help ensure sound
investment, decision making, pursuit of optimal solutions, and
reliable performance, cost, and schedule information.'' To
protect taxpayers, DHS officials have now put the acquisition
on hold until all the necessary steps are taken to ensure we
are making a wise investment decision that is grounded in the
facts, and that of course is a prudent approach.
The L.A. Times, however, has brought other issues to light.
In its reporting, the Los Angeles Times exposed a series of
false positives identified by BioWatch sensors. As the Times
documented, BioWatch sensors have repeatedly indicated the
detection of possible bioterror agents that were later found to
be harmless, naturally occurring organisms. Fortunately, all of
these false positives were identified before the public was
needlessly alarmed. When the sensors went off, scientists were
alerted to determine if these were legitimate bioterror agents
or detections of benign agents. The Department is now working
to lower the incidence of false positives, and this seems to be
improving. There have been none so far this year.
We have also heard about scientific disagreements within
the program. Much of the debate about the program's path
forward and particularly the acquisition of new Generation 3
technology revolves around complex scientific questions. These
types of scientific questions are not surprising in a highly
technical program like this. We can't answer the questions
ourselves, but we can listen to the experts in biology,
epidemiology and detection technology to become better
informed, and I hope today's hearing will help in this area.
While we hear criticism of the BioWatch program, especially
today, we also need to bear in mind its important public safety
objectives. BioWatch's early-detection capabilities and its
role in facilitating communication between key state and local
decision makers can help protect our communities. We should use
this hearing as an opportunity to strengthen the program. That
is why I am glad that Dr. Walter is here today to discuss the
history of the BioWatch program and how the Administration is
learning from past mistakes to make the program even more
effective in the future. It shouldn't be all that hard, but if
we are going to keep this program, let us make sure it is
effective.
Mr. Chairman, I thank you for calling this hearing, and I
thank our witnesses for being with us today to help us answer
these questions about this important Homeland Security program.
I want to apologize to the witnesses in advance. We have
another hearing going on simultaneously, and I am going to have
to be going back and forth, but I will have a chance to review
the record and my staff is here to learn all the information
that will be brought out at this hearing. I yield back the
balance of my time, and thank you for calling on me.
Mr. Murphy. The gentleman yields back, and thank you for
your opening statement.
I would like to note and state that all those who just had
opening statements agree that this is an area we are unified on
in purpose, so now to our witnesses.
First let me introduce the witnesses so everybody knows who
you are. First, Dr. Michael Walter, welcome here. He is the
Detection Branch Chief and BioWatch Program Manager with the
Office of Health Affairs at the Department of Homeland
Security. He works with labs, public health, law enforcement,
and emergency management personnel to assist federal, state,
and local governments in developing and testing response
measures to biological attacks. In addition to directing
operations of the current BioWatch system, Dr. Walter also
oversees the testing, acquisition, and deployment of the newer
technology referred to as Generation 3. Welcome. Our second
witness is Dr. Toby Merlin. He has been with the Centers for
Disease Control and Prevention since 2003. He is the Director
of the Center for Disease Control and Prevention's Division of
Preparedness and Emerging Infections and has been the CDC's
main interface with the BioWatch program since 2011. Prior to
his current role, Dr. Merlin served as the Deputy Director of
the Influenza Coordination Unit during the 2009 H1N1 pandemic.
I will now swear in the witnesses, and you are that the
committee is holding an investigative hearing, and when doing
so has the practice of taking testimony under oath. Do you have
any objections to testifying under oath?
Mr. Walter. No.
Dr. Merlin. No.
Mr. Murphy. So now the Chair then advises you that under
the rules of the House and the rules of the committee, you are
entitled to be advised by counsel. Do you desire to be advised
by counsel during your testimony today? Both witnesses
indicated no. In that case, if you would please rise and raise
your right hand and I will swear you in?
[Witnesses sworn.]
Mr. Murphy. Both of the witnesses are now under oath and
subject to the penalties set forth in Title XVIII, Section 1001
of the United States Code. You may now each give a 5-minute
summary of your written statement. Dr. Walter, you may begin.
TESTIMONY OF MICHAEL WALTER, PH.D., BIOWATCH PROGRAM MANAGER,
U.S. DEPARTMENT OF HOMELAND SECURITY, OFFICE OF HEALTH AFFAIRS;
AND TOBY L. MERLIN, MD., DIRECTOR, DIVISION OF PREPAREDNESS AND
EMERGING INFECTIONS, NATIONAL CENTER FOR EMERGING AND ZOONOTIC
INFECTIOUS DISEASES, CENTERS FOR DISEASE CONTROL AND PREVENTION
TESTIMONY OF MICHAEL WALTER
Mr. Walter. Chairman Murphy, Ranking Member DeGette, and
distinguished members of the subcommittee, thank you for
inviting me to speak with you today. I appreciate the
opportunity to testify on the Office of Health Affairs'
BioWatch program, and I am honored to testify alongside my
distinguished colleague from the Centers for Disease Control
and Prevention, Dr. Toby Merlin. My name is Dr. Michael Walter.
I am the Program Manager for the DHS Office of Health Affairs'
BioWatch program.
Bioterrorism remains a continuing threat to the security of
our Nation. A biological attack would impact every sector of
our society and place enormous burdens on our Nation's public
health with rippling effects on critical infrastructure.
Biological attacks are particularly challenging because they
can be so difficult to detect. Early detection is critical to
the successful treatment of affected populations and provides
public health decision makers more time and thereby more
options in responding to, mitigating and recovering from a
bioterrorism event. If a bioagent is detected and confirmed to
be a threat to the public health, prophylactic treatment could
be started prior to the widespread onset of symptoms resulting
in a more cohesive response and more lives saved.
The BioWatch program is the country's only nationwide
program whose goal is to continuously monitor for aerosolized
environmental agents. The program consists of planning,
preparedness, exercising, training and early-detection
capabilities. Deployed 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.
The current detection capabilities used by the BioWatch program
consist of aerosol collectors whose filters are manually
collected and retrieved for subsequent analysis in BioWatch
laboratories that are located in state or county public health
laboratories that are members of the CDC laboratory response
network.
When a detection of a positive signal occurs, a BAR, or a
BioWatch Actionable Result, is declared. A BAR is declared by
the Director of the Public Health Laboratory or their designee,
not by the federal government. To be clear, a BAR does not mean
a terrorist attack has occurred, a viable agent has been
released or that people have been exposed, additional
information is needed to determine if an attack has occurred
and if there is a threat to the public health. A BAR simply
means that DNA of a select organism is present. Each BioWatch
jurisdiction across the country has a BioWatch Advisory
Committee, or BAC, made up of state, local, and federal
partners who operate the program and are responsible for
planning and leading response efforts.
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 for an all-hazards
response. The BioWatch program relies heavily on our federal
partners for expertise in public health, law enforcement,
intelligence and technical support to ensure optimum operations
throughout the program.
To that end, the BioWatch is supported by federal partners
including the CDC, the Federal Bureau of Investigations, the
Department of Defense and the Environmental Protection Agency,
and I would like to take this opportunity to thank Dr. Merlin
and the CDC for their continued engagement in support of the
program.
Consistent with the National Strategy for Biosurveillance,
we have been looking at new technologies that could shorten the
time to detect including autonomous detection technology. The
BioWatch program understands the importance of providing public
health officials the timeliest information possible to help
them make high-consequence decisions. Automated detection would
reduce the time to detect significantly, handing back precious
time to our public health officials faced with responding to a
potential bioterrorism event. In addition, it would reduce cost
of operations while providing continuous collection and
analysis capability. The Department is currently conducting an
analysis of alternatives consistent with Government
Accountability Office recommendations prior to moving forward
with a potential acquisition of advanced automated detection
technologies.
I appreciate the committee's interest in the BioWatch
program and your continued partnership as we work to improve
our Nation's biopreparedness. The Office of Health Affairs
believes strongly in a comprehensive surveillance approach that
includes environmental and clinical surveillance as well as
point-of-care diagnostics.
Thank you for the opportunity to appear today, and I look
forward to your questions.
[The prepared statement of Mr. Walter follows:]
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Mr. Murphy. Thank you.
Dr. Merlin, you are recognized for 5 minutes.
TESTIMONY OF TOBY MERLIN
Dr. Merlin. Thank you, Mr. Chairman.
Chairman Murphy, Ranking Member DeGette and members of the
subcommittee, I want to thank you for the opportunity to speak
to you today about the Department of Homeland Security's
BioWatch program. I am Dr. Toby Merlin, Director of CDC's
Division of Preparedness and Emerging Infections in the
National Center for Emerging and Zoonotic Infectious Diseases.
I am honored to testify alongside my distinguished colleague
from DHS, Dr. Michael Walter, with whom I regularly work.
CDC works 24/7 to save lives and protect Americans from
health threats. Throughout its history, CDC and its local,
national, and international partners have worked to detect,
respond to and prevent health security threats. My remarks
today will describe how CDC collaborates with DHS on the
BioWatch program, explain the related role that CDC's
Laboratory Response Network plays in this program, and discuss
CDC's broader role in outbreak detection and response. All of
these efforts are designed to protect Americans from infectious
public health threats including threats of bioterrorism.
In 2003, DHS initially launched the BioWatch program, which
is a nationwide biosurveillance system designed to detect the
intentional aerosolized release of selected biologic agents. At
that time, CDC helped establish and staff BioWatch laboratories
and develop and validate laboratory methods for detection of
targeted biologic agents. Since the establishment of the
BioWatch program, CDC has provided technical assistance to DHS
by ensuring that scientific experts are available for
consultations with the BioWatch laboratories and conducting
additional laboratory testing at CDC when requested. CDC
provides BioWatch laboratories with specialized reagents used
in the testing and a system for secure electronic messaging of
results.
CDC also provides scientific expertise and guidance,
especially as it pertains to laboratory methodology and
analyses to DHS and states and localities that participate in
the BioWatch program. In the event that a biological threat
agent is detected through the BioWatch program and it is
determined that a response is needed, CDC would coordinate any
needed federal public health response.
CDC's Laboratory Response Network, or LRN, has 150 member
facilities and provides support to DHS's BioWatch program. The
LRN is a network of local, state, and federal public health and
other laboratories that provide the laboratory infrastructure
and capacity to respond to biological and chemical threats and
other public health emergencies. Participation in the network
is voluntary, and all member laboratories work under a single
operational plan and adhere to strict policies of safety,
biocontainment and security. Laboratories also perform testing
using LRN procedures and reagents provided by CDC, which allows
for rapid testing, reproducible results and standard reporting.
BioWatch laboratories are usually collocated with LRN sites in
the states and they use LRN procedures and reagents in the
second phase of testing of material collected from air samples.
CDC and the LRN provide support to the BioWatch program by
participating in this BioWatch testing and the review steps
which are designed to detect a possible release of a biological
agent into the air.
Laboratory detection and epidemiological response to
disease are the foundation of CDC's activities. In addition to
managing the LRN and providing support to DHS's BioWatch
program, CDC plays a broader, critical role in the detection of
and response to local, state, national and international
outbreaks of infectious diseases whether naturally occurring or
manmade. CDC is home to the country's leading experts and gold-
standard laboratories in infectious disease prevention and
control. CDC's laboratories serve as an early warning system to
rapidly identify, confirm and characterize new infectious
disease threats. CDC often serves as a resource for our state
and local partners during outbreaks and plays a critical role
in identifying disease patterns and linkages across state and
local lines.
In closing, CDC and LRN laboratories are critical and
unique laboratory-based assets to ensure that our Nation is
prepared to detect and respond to biological and chemical
terrorism. CDC and LRN laboratories are essential to assuring
rapid detection of these threat agents and other infectious
diseases that pose a threat to the public. The BioWatch program
is an important component of this national effort at early
detection of biological threats. CDC will continue to work
closely with DHS to support the BioWatch program whenever
requested specifically in the areas of laboratory testing and
public health response.
Thank you, Mr. Chairman, and I would be pleased to answer
any questions.
[The prepared statement of Dr. Merlin follows:]
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Mr. Murphy. I thank both the witnesses here. We want to
find out if this BioWatch system actually works, and I guess
this speaks to the old adage, we want to know what time it is
and we are told how a clock is made, so help us. I respect both
of your experience and your intelligence, so help us walk
through this.Dr. Walter, this question is for you. In
yesterday's Los Angeles Times, former Homeland Security
Secretary Tom Ridge, who oversaw the start of BioWatch, stated,
``Everyone knew it''--that is, the BioWatch program--``was a
primitive, labor-intensive, fairly unsophisticated attempt.''
That same technology for BioWatch is still out in the field. Do
you agree with former Homeland Security Secretary Ridge that
BioWatch is a primitive, labor-intensive and fairly
unsophisticated tool?
Mr. Walter. Thank you for that question, sir. With respect
to Mr. Ridge, no, I do not agree with his assessment, and I
think it lacks the insight of where the program has come from
since the beginning of the program's origin. BioWatch uses the
same collector technology that was deployed in 2003, that is
true, and BioWatch is a labor-intensive process; that is also
true. In the areas of laboratory analysis, our preparedness,
our response and our training, Mr. Ridge is unaware of those
advances to the BioWatch program and I think they have taken
the BioWatch program to the next level and made it more
effective.
Mr. Murphy. Let me ask you, the BioWatch is designed to
detect a catastrophic, covert bioterrorism attack. Is that
correct?
Mr. Walter. Yes, sir.
Mr. Murphy. And for BioWatch to meet its mission, the DHS
is supported especially by the state and public health
laboratories, correct?
Mr. Walter. That is correct, sir.
Mr. Murphy. And do you agree that state and local health
departments need to have the capability to respond with public
health or medical measures to minimize illness and death?
Mr. Walter. It is essential, sir.
Mr. Murphy. OK. Well, the threat that BioWatch is detecting
is a large-scale covert bioterrorism attack, so when BioWatch
was launched in 2003, the threat assessment was concerned with
large-scale threats posed by state actor programs or terrorists
getting possession of biological weapons from state actor
programs. Do you agree that there was a large-scale threat in
2003?
Mr. Walter. There was a perceived threat, yes, sir.
Mr. Murphy. And isn't it correct that the DHS official who
conducts the bioterrorism risk assessment has found that under
the current threat assessment, a large-scale bioterrorism
attack is less likely and small-scale bioterrorism attacks are
more likely?
Mr. Walter. That is possible, but ``less likely'' doesn't
mean impossible, and ``less likely'' means there is still a
threat.
Mr. Murphy. Let me go on to this. Dr. Merlin, if you could
turn to tab 48 of that binder, and I will note while you are
looking at that, in a May 23, 2012, email, you wrote, and I
will quote it here, ``The Material Threat Assessment, or MTA,
which DHS is required to perform by statute, these drive the
downstream decisions about medical countermeasure acquisition,
diagnostic test development, BioWatch testing and preparedness
plans. But the MTAs seem to be developed without input from
people who really understand the agents, the diseases or
practical implications of these decisions.'' Do you still have
these concerns about CDC having input in DHS threat assessment,
sir?
Dr. Merlin. Mr. Chairman, the answer is no. My concerns
have been diminished. The Department of Homeland Security has
been working with the Department of Health and Human Services
to have a more inclusive process for developing the Material
Threat Assessments, and this process is designed to address
some of the concerns I addressed so that experts from Health
and Human Services are more actively engaged in developing the
Material Threat Assessments and Material Threat Determination.
Mr. Murphy. Let me try to understand. So you are saying
that you don't agree with that statement anymore or you do
agree with that statement?
Dr. Merlin. I believe steps have been taken to address my
concerns. I believe what I said was true, and the existing
Material Threat Assessments were performed by the Department of
Homeland Security without the desired level of consultation
with individuals from Department of Health and Human Services
who have more knowledge of the agents. I believe this has been
corrected by DHS.
Mr. Murphy. Well, let me add a couple levels here and/or
concerns. Dr. Merlin, isn't it true that more than 46,000 state
and local health department jobs have been lost since 2008,
representing nearly 21 percent of the total state and local
health department workforce?
Dr. Merlin. Yes, that is my understanding.
Mr. Murphy. And Dr. Merlin, if you go to tab 34, this
document is a presentation to the CDC Director on the quarterly
performance review of NCEZID May 25, 2011. Is this your
presentation?
Dr. Merlin. Yes, it is.
Mr. Murphy. And according to this internal CDC document,
CDC has concerns about Gen-3 because of potential workload
impact on LRN, or the Laboratory Response Network, from an
increased number of devices that are continuously sampling and
reporting. Do you agree that there would be concerns about Gen-
3 from the potential workload impact on the LRN?
Dr. Merlin. Yes.
Mr. Murphy. Well, I see I am out of time. I may have to
come back to some of these, but I will turn to my ranking
member, Ms. DeGette, for 5 minutes.
Ms. DeGette. Thank you very much, Mr. Chairman. Well, let
us keep talking about this Gen-3 for a while.
As I noted in my opening statement, what we were told was
this Gen-3 was supposed to provide automated biological threat
detections so it would be sort of like a lab in the box, and
there have been a number of issues around that. So I am
wondering, Dr. Walter, first, can you describe briefly for us
exactly what is BioWatch Generation 3?
Mr. Walter. Yes, ma'am. I would be happy to do that. If you
look at the parts that make up the BioWatch program--filter
collection, laboratory analysis and reporting out the results--
and you were to take all of those pieces and put them into a
machine, that is what Generation-3, the acquisition program,
Generation-3, is to do.
Ms. DeGette. And how does that differ from the existing
technology?
Mr. Walter. The existing technology is very labor-
intensive. Somebody has to go and collect the filter, somebody
has to bring it to the laboratory, somebody has to analyze the
filter, and somebody has to make a phone call with the result.
What Generation-3 would do essentially would automate all of
that.
Ms. DeGette. Right. So it would take the sample and it
would do the test, and then if there was some abnormality, then
they would notify the folks and then they would come in, right?
Mr. Walter. That is correct, if it identified a detection,
essentially it creates a BAR. The other thing that Generation-3
does, would also do, is it continuously collects and analyzes,
whereas now we have got one sample----
Ms. DeGette. You don't have to go in and collect it?
Mr. Walter. Right.
Ms. DeGette. Right. So how much do you think it will cost
to implement Generation-3?
Mr. Walter. I currently don't know because the acquisition
program has been on hold, and that would depend on what
technologies are eventually selected for deployment.
Ms. DeGette. Well, before it was on hold, did you get any
kind of bids for it, any estimates?
Mr. Walter. We had a lifecycle cost estimate that was done
as part of the acquisition process.
Ms. DeGette. And what did that show?
Mr. Walter. That showed a 20-year lifecycle of $5.8
billion, and the lifecycle cost estimate number goes from
initial testing all the way through disposal.
Ms. DeGette. Of the 20 years?
Mr. Walter. Yes, ma'am.
Ms. DeGette. Now, the benefits of a system like this are
obvious from your description but do you think that it would be
worth the cost, given the fact that we haven't really found
any--I mean, I agree, we need to have systems in place but
given the fact over 10 years we haven't really had any large-
scale bioterrorism, do you think it is worth the cost?
Mr. Walter. I think it is. I think the advantages that we
would gain from such a system would make the cost worthwhile. I
think the increased flexibility that we would get from such a
system would make the cost worthwhile. I think the ability to
take the system indoors would make the cost worthwhile. And I
believe that it would actually reduce the workload on state and
local public health laboratories because currently we get a
sample every day. With that system, we would only get a sample
if something is seen.
Ms. DeGette. So it might be really cost-effective over the
long run even though there would be a big initial investment?
Mr. Walter. Yes, ma'am.
Ms. DeGette. Now, you mentioned that the program has been
stopped for now. Why, and how did we get to that point?
Mr. Walter. There was a Government Accountability Office
review of the acquisition methods used as part of the
acquisition program, and what they found was essential the Gen-
3 acquisition program straddled the implementation of MD-102,
which is, I believe, the acquisition directive that garners how
the Department does its acquisitions. When BioWatch Gen-3, the
acquisition program, was started, they weren't being deployed
or they were just being implemented, so we kind of started in
the middle, if you will, and when the GAO came in and did its
assessment, they said well, you followed the acquisition
processes that were in place at the time but really it is a big
program, you probably want to be careful and go back and kind
of dot the i's and cross the t's.
Ms. DeGette. Are you going back and dotting the i's and
crossing the t's? What steps are you taking now to evaluate and
develop Gen-3 in a way that will not just satisfy the GAO but
will also satisfy the budget hawks on this committee?
Mr. Walter. We have instituted an analysis of alternatives.
That is being conducted independently of the Department. We
have rewritten the mission needs statement and we have
formulated what we call an acquisition con ops, which is part
of the formal acquisition process, which essentially says if
you had this technology, how would you use it.
Ms. DeGette. And what kind of a timeline are you on?
Mr. Walter. We are expecting the final briefing for the
analysis of alternatives in the August-September time frame
with a final report in September-October.
Ms. DeGette. Super. Mr. Chairman, I would suggest we bring
these folks back to talk to us about that timeline and see what
they have looked at, see if they have looked at the
alternatives, and see if they are planning to go forward with
Gen-3. I yield back.
Mr. Murphy. Thank you. I now recognize Dr. Burgess of Texas
for 5 minutes.
Mr. Burgess. Thank you, Mr. Chairman.
Dr. Merlin, let me just start out by thanking you and your
organization. The CDC has unfailingly been helpful on not just
this issue but any time there has been an issue that has
affected the public health and welfare of the United States,
and your director, Dr. Frieden, has of course come to this
committee and discussed with us the nature of novel flu, called
me personally when West Nile virus was a problem in north
Texas, and then the fungal meningitis outbreak occurred, CDC
was in fact the only federal agency that would talk to me and
answer the telephone, so I thank you for that. It is good to
know that you are there and on the job.
Dr. Walter, let me just ask you, you referenced something
called the BioWatch Actionable Result and the role of the DHS.
Could you kind of define for us what constitutes a BioWatch
Actionable Result?
Mr. Walter. That is an excellent question, sir. A BioWatch
Actionable Result is an analytical result, a laboratory result,
and what we do is, we conduct--we don't look for the actual
bacteria, we actually look for the DNA of the bacteria and we
look for very specific pieces of DNA that we do a two-step
process. The first essentially is kind of a screen. We look for
signs of the agent, and if it shows up, then we run
additional--look for additional pieces of DNA using the
Laboratory Response Network agents or reagents that we get from
the CDC. And then----
Mr. Burgess. So you do some confirmational activity?
Mr. Walter. Oh, absolutely, sir.
Mr. Burgess. Now, just from that, you can't confirm or deny
that a terrorist attack has taken place, correct?
Mr. Walter. No, sir, and that is never the purpose of the
BAR. The BAR is simply the detection of the DNA from the agent.
Mr. Burgess. And will it show whether or not people have
actually been exposed or it just detects the presence of the
sentinel DNA in the environment?
Mr. Walter. It just detects the DNA, and we have modeling
that we can look at to go back and look at where would this
plume have gone. But the assessment as far as whether there is
a threat to the public health, whether this is a terrorism
attack or whether this is something that naturally exists in
the environment is made following the BAR, and that is during
the national conference call which brings a host of agencies
together including the CDC that essentially discusses what the
context of this detection is.
Mr. Burgess. So I guess that leads to my next question.
What process is then put in place? Poor Dr. Merlin is sitting
there at the CDC. You give him this information that oh, my
gosh, we have got a real problem here, so Dr. Merlin is then
looped in through a conference call? Is that what----
Mr. Walter. That is correct. Dr. Merlin or his designee is
part of the conference call, and that discussion is, what do we
have, where was it found, have we ever seen it before, is there
a lot of it, is there a little of it. It includes the FBI and
local and state and federal law enforcement and emergency
responders.
Mr. Burgess. Now, you referenced in your testimony the
preventive measures that might be instituted. At what juncture
at those triggered? You referenced the prophylaxis that might
need to be administered. Where does that come in?
Mr. Walter. That would take place after this national
conference call if the decision is made that we think this is a
bioterrorism attack and/or there is a threat to the public
health because they don't necessarily have to be linked.
Mr. Burgess. Then Dr. Merlin, when at the CDC level, I
mean, you referenced the Laboratory Research Networks. Is this
what you do to confirm or to gain additional knowledge about
the information that you are given from DHS? Because at some
point you have got to tell the doctors yes or no. I mean, DHS
can't tell the doctors to prescribe something. You all have to
play a role. Is that correct?
Dr. Merlin. Yes. We work with DHS and the local
jurisdiction that has made the detection as well as other
federal agencies to try to gather as much additional
information as possible to determine whether the BAR represents
an anomaly or a threat, and the sorts of things we will do is,
we will ask the local jurisdiction to do additional testing on
the sample that they have. We may ask them to go out and
perform environmental sampling in the area where the detector
was located. We will query intelligence agencies to find out
whether there is any indication that there might be a threat
with this agent. We will ask subject-matter experts in the
field if there are other things they think might be causing
this positive, and we will try to quickly gather the
information we need to sort of make an informed decision.
Mr. Burgess. Very good. In my opening statement, I
referenced the data that was generated back in the early 1950s.
No one want to see that type of testing go on again but I think
it does--the lesson from that is, there is a vulnerability here
from a biologic agent, and certainly the work--we want you to
get it right, and I was called a budget hawk a minute ago. Yes,
I am guilty as charged but at the same time, the primary role,
my role defined in the Constitution is the defense of my
Nation. I want you all to get it right. It is critically
important that you do, and I agree with Ranking Member DeGette
that we will need to hear from you again in the fall. So thank
you.
Mr. Murphy. Thank you. The gentleman's time is expired. We
will now go to the gentleman from New York, Mr. Tonko, for 5
minutes. You are recognized.
Mr. Tonko. Thank you, Mr. Chair.
The whole issue of relationship between DHS and CDC and
local public health partners is critical because the BioWatch
program depends on local officials in order to execute many of
these programs. In the very early days of BioWatch, as has been
discussed, the relationship between federal agencies and local
public health partners did not work as well as it should. Dr.
Merlin, what would you cite as examples of improved
communications amongst DHS, CDC and local officials over recent
years?
Dr. Merlin. There are several things. I think DHS has made
a concerted effort to include public health officials and
public health responders in their national BioWatch meetings.
They hold regular webinars that I believe are monthly for all
stakeholders including public health, and whenever they have
working groups, they reach out to public health participants,
and I am impressed they reach out to public health participants
including those whom they know are not their fans. So they try
to have those voices at the table. There is an IOM meeting
scheduled, Institute of Medicine meeting scheduled next week to
go over some BioWatch questions, and I notice there is a panel
with a diverse range of public health officials on it. So I do
think they actively reach out to include public health.
Mr. Tonko. And Dr. Walter, in terms of the overview of
DHS's communication efforts with local public health officials,
can you give us a sense of how that collaboration has been
improved on a day-to-day basis?
Mr. Walter. I believe that it has improved in our routine
communications because it does take place on a day-to-day
basis. We spend a lot of time talking to our state and local
partners, and it has been my business since coming into the
program in 2009 to arrange the relationship that we have with
our state and local public health community as partners in this
program. I don't command the BioWatch program and they are not
a subordinate command. We work in partnership with them. We
have done our utmost to include them in all of the testing and
evaluation that we have conducted so far in the acquisition
program, the Gen-3 acquisition. We hold focus groups because we
have noticed that when we get a large group of them on the
phone, they don't say a lot, but when we bring them into a
small room with a select group, they are very opinionated and
there is a wealth of expertise that we can tap into there. We
have brought their laboratories into the program. Prior to my
coming into the program, there was--if technology improvements
were put in, they were done at a national lab and handed to the
state and local labs. Now we work with the laboratories
themselves to bring those in. So we have done our utmost to
make sure that they are part of the program and that
communication is there.
Mr. Tonko. Thank you very much.
Last July, I believe it was, the President released a
National Strategy for Biosurveillance, which outlined guiding
principles for strengthening our capabilities, and it called
for focusing on core functions, increasing integration and
improving information sharing. To each of you, my question
would be, how does BioWatch fit into the Nation's larger
biosurveillance strategy?
Mr. Walter. BioWatch complements the national strategy.
There is nothing about environmental surveillance that
precludes doing any other surveillance. BioWatch, I believe,
complements medical surveillance, it complements syndromic
surveillance, it complements point-of-care diagnostics, and it
also provides the early detection that we would need because
the downside of medical surveillance is, people have to get
sick for us to be able to detect them using those methods.
BioWatch provides us the opportunity to detect them before they
show symptoms so that we get medicines to them before they are
sick and start to overwhelm the public health infrastructure,
integration as far as the exercising, but the big part of what
we do too is the planning and preparedness side, and we know we
are not going to be able to--or it is going to be very
difficult to respond to a bioterrorism event on the fly. All of
that has to be worked out in advance, and a big part of what
the program does is work with our state and local jurisdictions
to get them prepared, provide them exercises so we know their
plans make sense.
Mr. Tonko. Dr. Merlin, would you add to any of that?
Dr. Merlin. Yes. I basically agree with Dr. Walter. When
you look at the biosurveillance strategy, it addresses the
spectrum of biological threats to the American population, and
the threats can range from small threats that threaten a small
number of people to very large threats. The BioWatch system
addresses really the very far end of the threat spectrum. It
addresses the catastrophic aerosol released, the sort of thing
that would be really sort of an act of war, a nation-state type
of action. And that is part of the threat spectrum that needs
to be addressed. There are of course other things in there, and
much smaller attacks like the anthrax letters of 2001, which
were a much smaller attack, are a high risk and also need to be
addressed in our strategy.
Mr. Tonko. Thank you very much. Mr. Chair, I yield back.
Mr. Murphy. Thank you. We will now go to the gentleman from
Louisiana, Mr. Scalise. You are recognized for 5 minutes.
Mr. Scalise. Thank you, Mr. Chairman. I appreciate you
having this hearing. Thank you to our panelists.
I want to really get into the BioWatch program, Mr. Walter.
It is my understanding from the reports I have read that
somewhere in the neighborhood of a billion taxpayer dollars has
been spent on developing BioWatch since it started in, I think,
2003. Is that correct?
Mr. Walter. I think a little less than a billion dollars
has been invested in running the BioWatch program, not
developing it.
Mr. Scalise. How much total between both developing and
running?
Mr. Walter. Oh, I don't think a lot was put into developing
it because the technologies that we use are developed
technologies. So----
Mr. Scalise. Developed by whom, and how much money? Who
gets the money? Where does that money come from?
Mr. Walter. Most of the technologies we use were developed
by the Department of Defense, the Centers for Disease Control
and Prevention, the technical aspects. We are an operational
program. We don't conduct research and development. I take what
is available to accomplish the mission and use that. So most of
the funding that----
Mr. Scalise. When I read that the Department of Homeland
Security spent about $300 million developing this technology,
you just said you don't develop technology.
Mr. Walter. The BioWatch program doesn't develop it. A lot
of that developmental work was done by the Science and
Technology Group, which does do research and development and
does develop.
Mr. Scalise. So for a billion dollars, whether some of it
was spent by the Department of Defense, I am sure you all
coordinate because ultimately you are implementing it, the
bottom line is, it hasn't worked yet. At least it hasn't worked
the way it was supposed to. Is that accurate?
Mr. Walter. I would respectfully disagree with that, sir. I
think everything that we have shows that the process does work.
We have instituted an extremely robust quality assurance
program that tracks the ability of our laboratories to detect
any agent that may be on a filter.
Mr. Scalise. Do you get a lot of false positive tests?
Mr. Walter. No, sir. What we get--what we have--what we
detect are naturally occurring agents. All of the agents that
we look for are naturally occurring somewhere in the
environment. Most of them are out there endemic, and it stands
to reason that we will occasionally detect one or two of them.
Mr. Scalise. So I am looking at this report again. It says
Department of Homeland Security spent about $300 million
developing this technology as well as on Gen-2.5, which was
deployed for 2 years and then pulled. Was it pulled because it
was working so well or was it pulled because it wasn't working?
Mr. Walter. That was before my time, sir.
Mr. Scalise. Are you familiar with what the status is and
why it was pulled?
Mr. Walter. Everything I got was secondhand. My
understanding, and this is just my understanding, was that it
was pulled because it was expensive, it was pulled because of
preparation for the acquisition program, the Gen-3 program.
Mr. Scalise. Do you know how much we have spent on it?
Mr. Walter. I do not, sir. I am sorry.
Mr. Scalise. If you could get the committee that
information?
Mr. Walter. Sure thing, sir.
Mr. Scalise. I wanted to ask you about the internal
investigation. It is our understanding that there has been an
internal investigation into BioWatch. First of all, are you
familiar? Did you all do an internal--maybe before you were
there, but I mean, are you aware of an internal investigation?
Mr. Walter. I am not aware of an internal investigation
into BioWatch itself.
Mr. Scalise. Or an employee at BioWatch that may have been
removed for mismanagement?
Mr. Walter. It may have been but that is before my time,
sir, and I can't comment on that.
Mr. Scalise. OK, but I mean, you are there now, you are
heading this up. We are trying to get more details. Again, a
lot of taxpayer money is involved in this. If there was
mismanagement by an employee, by many employees, if someone was
removed and maybe somebody that was removed is now back working
on the program, we are hearing about all this secondhand but
supposedly there is an internal investigation that was done and
some documentation about this that we don't have. I think it is
real important that this committee get that information. Can
you, number one, go and find out if there was an investigation
done by your agency, and if so, can we get a copy of that
information?
Mr. Walter. I am aware of an investigation that was
undertaken. I don't know really the details of why it was
undertaken.
Mr. Scalise. Can you at least assure us that you will get
us a copy of that investigation?
Mr. Walter. I give you my word, I will try, sir.
Mr. Scalise. Why would you not be able to get it to us?
Mr. Walter. I don't know.
Mr. Scalise. If you tried, it would happen, so I am just
asking if you can make it happen.
Mr. Walter. I will make it happen, sir.
Mr. Scalise. I appreciate that very much because, I mean,
when we are hearing about all this and we are hearing that
maybe there was an employee involved in mismanagement and that
the employee was maybe removed but now the employee is back
over there, I mean, that raises a lot of questions that we have
about the program.
Mr. Walter. I can tell you that no one currently on the
BioWatch program was removed and then brought back into the
program.
Mr. Scalise. So as long as you are going to get us that
information, that will at least help answer a lot of these
questions. We shouldn't have to wonder and speculate about it
if you have got an investigation somewhere in your agency, you
can get that to us and then that will remove the cloud of
speculation and we will know exactly what is going on to be
able to proceed from there. So I appreciate that, and I thank
the chairman for his discretion and yield back the balance of
my time.
Mr. Murphy. The gentleman yields back. We will now go to
the gentleman from North Carolina, Mr. Butterfield.
Mr. Butterfield. Thank you very much, Mr. Chairman, and let
me thank both of the witnesses for their testimony today.
Mr. Chairman, I always begin whenever I can asking
witnesses questions about the impact of sequestration is having
on their agency because so many of our constituents really
don't fully understand the full impact that sequestration is
having on the functions of government, and so let me just start
with sequestration and start with you, Dr. Walter. It is my
understanding that many DHS programs are exempt from the impact
of sequester but certain programs related to the implementation
of the BioWatch program may be impacted. What impact has
sequester had on DHS programs related to the BioWatch program?
Mr. Walter. The BioWatch program was not exempt from
sequestration. It has decreased our contact with our state and
local jurisdictions in that our travel budgets have been
reduced. It has decreased our ability to bring state and local
public health and emergency responders in for focus groups and
discussions with them. And it has decreased our ability to
carry out certain improvements to the program that we had
planned.
Mr. Butterfield. Can you quantify this by percentage? Is it
8 percent, 6 percent?
Mr. Walter. We are looking at around--I think we are
looking at around 5 to 10 percent, in that range.
Mr. Butterfield. And you do realize that unless
sequestration is reversed or repealed, this is a 10-year
proposition? It is not a 1-year deal.
Mr. Walter. I understand.
Mr. Butterfield. And does it have long-range implications
for the program?
Mr. Walter. Yes, sir, it does. As we move over time,
obviously we have contracts that have inflation clauses built
in that we will have to cover, and we will basically have to
pare the program down to doing just the basics of what we need
to do and not improve the program as we would like to.
Mr. Butterfield. And I understand the GAO has made some
recommendations to you that you would like to implement that
this may impact. Has the GAO made any recommendations?
Mr. Walter. Not that I am aware of, not relative to
sequestration that I am aware of, sir.
Mr. Butterfield. I mean to the actual programmatic part of
your work.
Mr. Walter. They have done that, and we have implemented
them. This primarily was geared towards the acquisition
program, the so-called Gen-3 program, and we have implemented
those recommendations.
Mr. Butterfield. And Dr. Merlin, can you speak to it from
the CDC aspect?
Dr. Merlin. Yes, Congressman. I can tell you about the
immediate impacts it has on the work in my division. We have
decreased the number of proficiency testing challenges that we
provide to the members of our Laboratory Response Network
because those are--each one has a cost associated with it. We
have also had to decrease the amount of reagents that we keep
for surge, a potential surge in demand in reagents that we
would need in a large-scale event, and in terms of the funding
that we provide to state and local health departments through
my division and other parts of CDC that contribute to the
ability of those health departments to respond to outbreaks in
bioterrorism, the amount of money has gone down. It has gone
down through our budget constraints because most of the money
that CDC receives goes out to state and locals. The response of
the cut to us passed on to state and locals.
Mr. Butterfield. Are we talking between 5 and 10 percent as
DHS has experienced?
Dr. Merlin. For us, the number is around 5 percent.
Mr. Butterfield. All right. Back to you, Dr. Walter. Is it
possible that newer and more efficient biosurveillance
technologies could reduce costs enough to enable the expansion
of the BioWatch program to new municipalities?
Mr. Walter. Yes, sir, it is.
Mr. Butterfield. And Dr. Merlin, the number of false
positive BAR results in 2013 has decreased to zero, and that is
probably good. Can you explain the CDC's role in eliminating
false positives and elaborate on the success of the serial
testing strategy?
Dr. Merlin. We worked closely with Department of Homeland
Security to try to effectively reduce the number of false
positives that were being caused by an organism related to one
of the target organisms, Francisella tularensis, and together
we have implemented three changes in the testing protocol that
have caused a reduction in false positives. One is that we
reduced the number of cycles of reaction that is used for
detection. Another thing we have done is, we have--DHS has
actually implemented use of another reagent for screening. They
have used the Critical Reagents program reagent rather than a
CDC reagent for screening. And the third thing and
importantly----
Mr. Butterfield. I think the chairman is tapping on the
table there. Can you just give us the last sentence?
Dr. Merlin. They have put in a test that distinguishes this
near neighbor from the target, which enables us to say no, that
is a near neighbor, and we know it is not a target, and to not
react to it.
Mr. Butterfield. Thank you. Yield back.
Mr. Murphy. The gentleman yields back. Now we will
recognize the gentleman from Texas, Mr. Olson, for 5 minutes.
Mr. Olson. I thank the chair, and welcome to the witnesses.
Dr. Walter, Dr. Merlin, welcome. I am concerned like we all are
about an attack by a biological weapon. I am a Member of
Congress from Houston, Texas, about to be the third largest
city in America. There is no better target for biological
attack than Houston, Texas. We are the largest foreign tonnage
port in America lined by the largest petrochemical complex in
the world. We have the largest medical center, the Texas
Medical Center, just south of downtown. There is no better
target for biological attack by terrorists either with
conventional bombs, sort of dirty nuclear weapon, chemical
weapons or a biological weapon, and the scariest of these may
be a biological attack. Say let us go to the Texas Medical
Center and launch that weapon in the air conditioning system
and disappear, long gone before anybody realizes that you have
been attacked. The biological weapon flows through the air
conditioning system all over the Texas Medical Center. Within
hours, days, weeks, people are becoming infected, and that is a
big problem. Most importantly, it is not just people being
infected but the people that are infected are the professionals
that are needed to recover from this attack.
And so one other point for my colleagues: If you want to
lose some sleep, come down to Galveston, Texas, to the
Galveston National Laboratory on the campus of the University
of Texas medical branch. It is one of two bio 4 labs in
America, a very, very secure place with all sorts of very
dangerous chemical and biological weapons, mostly biological. I
have been down there on a tour. I put on this pressure suit,
negative pressure, went through a couple of locked doors and
watched these men and women working on agents that if they got
out in this room right now, many of us would not walk out of
here alive within minutes. So this is a very, very scary
proposition, and we need--it is so important that we spend our
limited resources on products that work. I am concerned about
Gen-2, more importantly, Gen-3.
And my first question is for you, Dr. Walter. Is there a
concern that the BioWatch program doesn't fully understand how
the current generation Gen-2 works, that these concerns are
real? How we can be confident that Gen-3 will work?
Mr. Walter. No, we are very confident in the way the
Generation-2 system works, sir. We track our performance under
our laboratory analysis. We know what we can detect at what
concentrations and with what statistical confidence. We have
recently actually just completed another test of our collection
and analysis operations out at Dugway, Utah, where we looked at
what is the minimum number of bacteria we could collect in the
atmosphere using chambers, of course, and then how would we--
how does that number translate through our analysis. So we have
a very good understanding of what our technology is capable of
doing.
Mr. Olson. And you mentioned Dugway, sir. The analysis on
alternative testing done by this fall includes a cost-benefit
comparison between Gen-2 and Gen-3 but DHS won't have the data
from Dugway until sometime in the fall of this year so you are
bringing up online before you actually have the data.
Mr. Walter. No, the data that will be produced from Dugway
will be the technical performance of the technology. That will
be done in the July-August time frame. We expect the analysis
of alternatives that is going to include the Gen-2 system to be
done about the same time, and any information that the
performer for the AOA is requesting, we are making sure that
they get it as quickly as we can get it to them.
Mr. Olson. Dr. Merlin, how about your concerns about Gen-3?
Dr. Merlin. Congressman, my concerns about Gen-3 have
primarily to do with lack of information about the performance
of the assays, and Dr. Walter and I have had and his staff have
had exchanges about a number of concerns that my colleagues at
CDC had about particular technical aspects of what was in the
phase I of Gen-3, and we are just concerned that the technology
be right and that we know what the limits of detection are
likely to be and that we know what the limits of detection are
going to be in a performing area. So my concerns are basically
about the availability of data on the performance and an
appropriate review of the data on the performance.
Mr. Olson. I share those concerns. I am out of time. I
yield back.
Mr. Murphy. I thank the gentleman from Texas. Now to the
other gentleman from Texas, Mr. Green, for 5 minutes.
Mr. Green. Thank you, Mr. Chairman, and again, I thank our
witnesses for being here. I also have a district just north of
Galveston, and I have been to the bio lab. I was impressed in
watching it being built, and in 2008 when Hurricane Ike
literally went over that area, that was the one building at the
University of Texas Medical Branch that was not damaged, and
there was no issue because we have learned in Texas, you don't
put your generating equipment on the bottom floor when you have
four or five foot of water. So you put it on top.
But again, I am pleased that we are taking the time to
examine BioWatch because of how importance it is. Last
Congress, I worked with colleagues on this committee on the
legislation, the Pandemic and All Hazards Preparedness Act. We
worked together to make sure the relevant agencies had the
tools to identify threats including those originating from
terrorists and address those threats effectively, and I know at
the bio lab, as my colleague and my neighbor talked about, the
National Lab there in Galveston, does tests and working on
developing vaccines for SARS, West Nile encephalitis, avian
flu, influenza as well as microbes that are being deployed by
terrorists. That topic is important to me.
The relationship between DHS, CDC, and local public health
partners is critical because BioWatch programs depend on our
local officials. They execute many of the program's most
important functions. But in the early days of BioWatch, the
relationship between federal agencies and local public health
partners did not work as well as it should have.
Dr. Merlin, have communications between DHS, CDC, and local
officials improved in the last few years?
Dr. Merlin. Congressman, I have been with this program at
CDC for 2 years, and I personally think there has been
substantial improvement in the communications. I believe that
we now regularly have very candid discussions about concerns
from local public health and that we have very candid
discussions about concerns that my colleagues at CDC have about
technical aspects of the BioWatch assays. I admire the fact
that Dr. Walter includes, as I mentioned earlier, includes
people in these discussions that he knows are critical to the
program, and I think that is a good thing.
Mr. Green. Do local public health labs have proper federal
guidance on what to do in the event of what appears to be
initial positive test result known as a BioWatch Actionable
Result?
Dr. Merlin. Congressman, I think the answer to that is both
a yes and a no. The BioWatch program recently released a new
version of its outdoor guidance, which is guidance to the
BioWatch jurisdictions on how to respond to an outdoor release.
There is--and Dr. Walter is aware of this, there is no indoor
guidance, which means that there is no formal guidance on how
jurisdictions should respond to an indoor release, and I know
the program is working on that.
There are also a number of important issues related to
environmental sampling and how to conduct the appropriate
environmental sampling that had been worked on collaborative by
DHS and EPA and CDC for a number of years but there is no
formal guidance out there that I think the locals really need.
Mr. Green. I only have another minute. Obviously the
partnership between the CDC and locals is very important. In
fact, just as we came up, welcome to the Gulf Coast in summer,
we have some our mosquitoes that have been tested and found to
have West Nile encephalitis, not in the Galveston area but
further north, and so this is important. And I know from your
testimony you have had to cut back some of your public health
meetings with local officials because of the budget constraints
but I know you also do conference calls. Have you all increased
that since you can't do the physical presence?
Mr. Walter. That is correct, sir. We have increased our
conference calls. We have started a webinar series. And we are
doing our best to keep our communications open. We also have a
number of liaisons, we call them jurisdictional coordinators,
who are in all of our BioWatch jurisdictions who also serve to
keep us informed and keep the program and our state and locals
informed as to what is happening.
Mr. Green. And again, from a military perspective, the
troops on the ground are those public health agencies, so
obviously the more we can relate from what we do here and CDC
and what you all do. Thank you.
Mr. Murphy. The gentleman's time is expired. Now we will go
to the gentleman from Ohio, Mr. Johnson, for 5 minutes.
Mr. Johnson. Thank you, Mr. Chairman.
Dr. Walter, I will try to look around you here and still
get to my microphone. According to the information provided by
DHS, there have been 149 BioWatch Actionable Results, or BARs,
since the BioWatch program started in 2003. is that correct?
Mr. Walter. That is correct, sir.
Mr. Johnson. And these BARs represent naturally occurring
biological pathogens detected from environmental sources. Is
that correct?
Mr. Walter. Yes, sir.
Mr. Johnson. In a July 12, 2012, DHS blog posting, DHS
Assistant Secretary for Health Affairs, Alexander Garza, wrote
this. He said, ``Out of these more than 7 million tests,
BioWatch has reported 37 instances in which naturally occurring
biological pathogens were detected from environmental
sources.'' Given the figure of 149 BARs reported to the
committee, the 37 instances was an incorrect number. Is that
correct?
Mr. Walter. That is correct, sir.
Mr. Johnson. OK. Were you involved in writing the blog
posting for Dr. Garza?
Mr. Walter. I reviewed it, and I missed that.
Mr. Johnson. OK. Were you the one that provided him with
those statistics?
Mr. Walter. No, I don't know where those statistics came
from but I should have caught it, and I didn't.
Mr. Johnson. As the BioWatch program manager, didn't you
know you had over 149 BARs by July 2012?
Mr. Walter. Yes, sir.
Mr. Johnson. You got any thoughts if you reviewed it, how
did we miss it? I mean, this is an important system.
Mr. Walter. I missed that number in his blog. I am very
aware of the performance of the system, and I am very aware of
any issues that come up with the system that impact its
performance.
Mr. Johnson. Did you provide the correct statistics--or let
me go back. When did you find the error? When did you realize
that there was an error?
Mr. Walter. It was shortly after the blog was posted.
Mr. Johnson. Did you provide the correct statistics to Dr.
Garza?
Mr. Walter. Yes, sir, I did.
Mr. Johnson. Do you know if they corrected the record?
Mr. Walter. I believe they did.
Mr. Johnson. Dr. Merlin, would you please go to tab 36 in
your material? In this June 24, 2011, e-mail, you discussed,
and I quote, ``the squishy definition of a BAR.'' You go on to
write, ``What is the action here? Who has made the final
determination of the action to take? What is that
determination? There seem to be different definitions of a BAR
according to the jurisdiction, e.g., New York City versus
Houston.'' How do definitions differ between New York City and
Houston?
Dr. Merlin. Congressman, the primary source of the problem,
I believe, is use of the word ``actionable'' because without
defining specifically what actions are taken on the basis of
this, it leaves it to the mind of the jurisdiction on to what
the appropriate action is, and I personally believe that we
should do a better job of defining of what an appropriate
action is and based on concerns like this, the Department of
Homeland Security in this most recent outdoor guidance has
become much more specific about what they mean by an action. In
the absence of a definition of an action, some jurisdictions
may feel that this means that the area where the BAR is
detected should be cordoned off and evacuated. Other
jurisdictions may simply feel that it means that they send in a
team to do sampling, and I think because we know technically
what testing is being done, I think we need to tell people what
we think is appropriate.
Mr. Johnson. Are there still different definitions of BARs
today based on your concerns about ``actionable''?
Dr. Merlin. I will defer to Dr. Walter. He may know better
than I do. I think we have gotten closer with the most recent
outdoor guidance in terms of situational assessment but I am
sure that all of the BioWatch jurisdiction committees are on
the same page.
Mr. Johnson. Mr. Chairman, I yield back.
Mr. Murphy. The gentleman yields back, and now to the
ranking member of the full committee, Mr. Waxman, for 5
minutes.
Mr. Waxman. Thank you, Mr. Chairman.
Last October, the Los Angeles Times reported on the failed
deployment of BioWatch Generation 2.5, which was supposed to
provide interim automated detection capability before the
deployment of Generation 3. The technology suffered from delays
and issues related to scientific validation and I would like to
hear from our witnesses today about how this happened and what
steps have been taken to ensure that it won't happen again. The
Los Angeles Times reported that the BioWatch program put new
testing assays called multiplex assays into use without
adequately validating them. According to the article, the tests
were used for 2 years from 2007 to 2009 before it became clear
that they were so insensitive to the presence of bioterror
agents that they were unsuitable for BioWatch.
Dr. Walter, I know these programs occurred before you
became the head of the BioWatch program. Still, I would like to
get your views on the allegations of the L.A. Times story. Was
the BioWatch program relying on inadequate tests for two full
years?
Mr. Walter. I honestly can't answer that question. I would
like to think they are not, but what I can tell you is that
before we deploy assays now, we have a very robust testing and
evaluation process in place. We track the performance of those
assays on a daily basis. We conduct proficiency tests of our
laboratories periodically throughout the year and we conduct
independent audits of our laboratories periodically throughout
the year.
Mr. Waxman. And what actions were taken when the program
officials discovered these problems?
Mr. Walter. I believe the system was withdrawn but, like I
said, this is before my time and I really can't speak to it.
Mr. Waxman. Well, this is an important development, and it
is like being told that the salesperson that defrauded you was
no longer here and therefore you don't know anything about it,
but you are the head of the program and you ought to know what
happened not that long ago, 2007 to 2009. Well, there was a
problem. What corrective measures were taken to ensure that
something like this won't happen again?
Mr. Walter. For the Gen-3 program, which is the acquisition
program, which is the technology that would be deployed in
place of the Gen-2.5, we have instituted a multiple-phase
process that has an enormous amount of testing and evaluation
attached to it. That testing and evaluation is decided upon in
a committee that includes our interagency partners including
the CDC. Those results are made available to all of the members
of that group, and nothing goes forward unless it meets the
requirements that we have set forward for the deployment of
this technology.
Mr. Waxman. Can Americans have confidence now that the
tests used in the BioWatch programs are capable of detecting a
bioterror attack so public health officials can act quickly?
Mr. Walter. I believe they can, sir. We have done our best
to make that happen.
Mr. Waxman. You have done your best to make sure that
doesn't happen but you don't know what happened in the past.
Mr. Walter. I mean, I am hesitant to speculate on what
happened to the program before I was here. I understand that
the technology was deployed. My understanding was that it was
essentially initially thought to be kind of a pilot to look at
developing con ops. It was then actually deployed, from what I
understand, and then there were issues that developed relative
to some of the assays that were used. I am sorry I don't have
the details of that.
Mr. Waxman. Well, the BioWatch program has been plagued by
technical and management problems, and I hope you and your team
have put these problems behind us so that the program can move
forward.
Mr. Walter. We are doing our best.
Mr. Waxman. Thank you. Mr. Chairman, I yield back my time.
Mr. Murphy. The gentleman yields back. Now to Mr. Harper
for 5 minutes.
Mr. Harper. Thank you, Mr. Chairman, and thank you,
gentlemen, for being here, and Dr. Merlin, I know we have had a
lot of concerns obviously and work done on the state and local
level as they try to look through this, and I would ask if you
would go to tab 35 in your notebook there. In a May 26, 2011,
email, CDC scientist Michael Farrell wrote this in part in that
email that you are looking at: ``Bottom line for me is that
despite whatever changes they have done or assay or systems
validation that they performed, the Gen-3 system with these
assays is going to be dead on arrival at the public health
service labs, especially and importantly at NYC. This will be
simply because of a lack of confidence due to previous
experience with environmental cross-reactivity and the
problematic APDS, or Gen 2.5 deployment. Confidence in the
system is going to be paramount with the current actionable
nature of the signal that is intended. I just don't see how
this is going to be possible.''
Now, Dr. Merlin, do you agree with that statement or
disagree?
Dr. Merlin. It is difficult to give a yes or no answer. My
colleague, Dr. Farrell, was talking about what he knew about
the development of Gen-3, the basis of the testing and the
signatures that were being used, and the similarities of that
system to the multiplex system that was just referenced that
had been withdrawn, and because that previous system had
failed, Dr. Farrell was very concerned that this was going down
the same line. What Dr. Farrell didn't know at the time and we
found out subsequently was that this system was the first phase
of a multi-phase development for Gen-3 and was not intended to
be the final product, and that is what we found out in a
meeting with Dr. Walter and his staff. I am benefited by having
people who report to me who are quite candid about their
concerns, and I take them forward to the BioWatch program.
Mr. Harper. Dr. Merlin, let me ask you this. Has prior
mismanagement by DHS and extended scientific disputes with DHS
negatively impacted the confidence the CDC and the public
health laboratories in working with BioWatch Gen-3?
Dr. Merlin. I think the scientific community wants to see
data. They want to see data, and it needs to be conveyed in a
fashion that isn't ``trust me, I have the data, it supports
that this works.'' They really want to see the data.
Mr. Harper. Can you go to tab 46 and let us look at that
for a moment? And this is a May 2012 email where you stated
about the historical tensions in the BioWatch program, and you
said, in part, ``I think the bottom line is that NYC public
health feels that public health is struggling to be heard in a
program that is dominated by DHS and law enforcement but which
has huge implications for public health departments.'' Is this
still the case?
Dr. Merlin. This references the particular situation in New
York City and the New York City jurisdictional BioWatch
Advisory Committee, and I know that both Dr. Walter and I have
struggled with this. New York City specifically asked me to
become personally engaged and to go there as a CDC
representative because they thought there wasn't a sufficient
scientific voice at the table of these discussions. It is the
nature of the constitution of these individual BioWatch
Advisory Committees and I think they vary from jurisdiction to
jurisdiction.
Mr. Harper. So is this still the case?
Dr. Merlin. I think it is still the case.
Mr. Harper. Thank you. I will yield back the balance of my
time.
Mr. Murphy. The gentleman yields back. Now to the
gentlelady from North Carolina, Ms. Ellmers, for 5 minutes.
Mrs. Ellmers. Thank you, Mr. Chairman, and thank you to our
two gentlemen who are with us today.
I am listening to the testimony, and I am listening to the
questioning, and you know, sometimes I end up with more
questions after I hear the discussion. I am concerned about
some of the issues with false positives or no false positives,
what has been detected in the past, what has not, and you know,
basically is this an effective system, and are we, you know,
developing a system for future use but not necessarily taking
into account things that have happened in the past and making
it the most effective plan as possible.
Going back to some of the discussion that has already taken
place in association with Assistant Secretary of Health
Affairs, Dr. Alexander Garza, Dr. Merlin, do you agree with the
way that Dr. Garza articulated the performance record of
BioWatch by stating that BioWatch has never had a false
positive result?
Dr. Merlin. No, Congresswoman, I do not agree with that
characterization.
Mrs. Ellmers. OK. Great.
Dr. Walter, according to the GAO, in order to build user
confidence in the system, BioWatch has established a stringent
threshold of one in 10 million for the false positive rate.
That is the rate at which the system is allowed to indicate a
pathogen is present when one is not. Is that still the
threshold and is that correct?
Dr. Merlin. I believe it is, yes, ma'am.
Mrs. Ellmers. OK. Moving on, in that thinking, a pathogen,
we mean the threat agent to be detected, not the near neighbor
background organism?
Dr. Merlin. That is correct, ma'am.
Mrs. Ellmers. OK. That is two yeses. Wonderful. So keeping
that in mind with the development of Generation-3, DHS has
changed the definition of false positive from the one used in
Generation-2 in which the definition of false positive means
the system indicated the DNA of the bacteria including those of
the near neighbor. Is that correct? Is that the change--has
that change occurred in relation to the Generation-3 or is that
yet to be determined?
Dr. Merlin. No, I think that has yet to be determined but
when we look at a detection, we believe we are detecting the
actual organism, not the near neighbor. With Francisella
tularensis, the DNA assays we had deployed weren't specific
enough to go down into what are known in--and I am sorry I am
going to throw microbiology at you but the subtypes of these
organisms that actually cause the disease, and so what we were
detecting was actually there. It was Francisella tularensis. It
is not a near neighbor. It is potentially not the pathogenic
form, that subtype of Francisella tularensis.
Mrs. Ellmers. I guess that brings me to the question of
specificity. So the Generation-3 operational requirement
document defines specificity as the ability to detect strains
of the target species without detecting near neighbor or
background organisms. So under that definition, the BioWatch
systems detection of near neighbors would be false positives?
Dr. Merlin. That is correct.
Mrs. Ellmers. That is correct? OK. And then one last
question, I have about a minute left.
Dr. Merlin, during the interview with the committee staff,
you compared BioWatch to the Magna Line. What did you mean by
that?
Dr. Merlin. I compared it to the Maginot Line, which was a
French defensive line built prior to World War II to protect
against a German invasion where the French general staff
believed that the Germans were most likely to invade.
Ms. Ellmers. Right.
Dr. Merlin. And it was a wonderful defensive mechanism. The
problem was, it wasn't where the Germans chose to invade; they
invaded through Belgium and the Netherlands into northern
France. And I made the comparison because we need to be careful
that we build our defenses across the entire spectrum of where
attacks might come, not where we think, you know, this is going
to be, and that is what--in reference to the earlier strategy,
biosurveillance strategy, we need to a strategy that cuts
across a spectrum of threats.
Mrs. Ellmers. Right, not just where we might assume
something would happen.
Dr. Merlin. Or we most fear.
Mrs. Ellmers. OK. Thank you very much. Thank you both very
much. I yield back the remainder of my time.
Mr. Murphy. On your time, I want to ask a follow-up
question to what she said. Do we have actual numbers on the
specificity and sensitivity of the Gen-2 and the Gen-2.5 and
Gen-3 in term of these, you know, similar to other medical
tests that we have some sense of, is it 20 percent, 50 percent,
80 percent? Where are we with those?
Mr. Walter. We conducted--as part of the first phase of the
Gen-3 acquisition, we conducted a number of assay evaluations
using the CDC assays and the critical reagent assays that we
employ operationally to test the assays that were being
proposed for the first phase of the Gen-3 systems that we were
testing, and that data essentially looked at the specificity
and the sensitivity of the assays that we employ under
laboratory conditions, and that information was compiled and
actually transferred to the CDC for their use as well.
Mr. Murphy. Well, do we have those numbers?
Dr. Merlin. Yes. We have turned over to the committee staff
information related to the testing we performed on the LRN
assays that are used in the Generation-2 system, and you can
certainly--if you don't have it----
Mr. Murphy. We will put it out then. Thank you.
I now recognize the gentleman from Florida, Mr. Bilirakis
from the full committee, for 5 minutes.
Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it
very much. Thank you for allowing me to sit on this panel. I
have been actively interested and involved in oversight over
BioWatch, the program, for a couple years now.
We all wish to ensure a comprehensive biosurveillance
capability. However, we must be smart about how we accomplish
that goal. I think we all agree, this capability must be
reached in the most effective and efficient manner, must be
based on sound science and must ensure an appropriate return on
taxpayers' investment. We must not lose sight of the greater
goal of overall preparedness by harnessing all of our resources
toward a single static technology.
I have a question for Dr. Walter. When it used this report
on BioWatch last year, the GAO confirmed that there has been no
comprehensive cost-benefit analysis done to ensure that the
$5.8 billion that have been spent over BioWatch's lifecycle
will buy down risk sufficient to justify such a large
expenditure. Doctor, can you please update the subcommittee on
any efforts to measure the cost-effectiveness of the BioWatch
program?
Mr. Walter. We are currently conducting an analysis of
alternatives relative to the Gen-3 acquisition, and part of
that analysis of all alternatives will include a cost-benefit
analysis.
Mr. Bilirakis. OK. When are we going to have any----
Mr. Walter. We should be getting the final briefing on that
in August. We expect that with a final report in the September-
October time frame.
Mr. Bilirakis. And you will report back to us?
Mr. Walter. I will do that, sir.
Mr. Bilirakis. OK. How much more certainty is gained from
Generation-3 machines? Do we know the decrease in human
morbidity and mortality? I know most of the members have
touched on this, but if you can expand.
Mr. Walter. Currently, there is no Gen-3 program,
acquisition program. It has all been placed on hold. So that
would depend on the acquisition, the technology that would be
eventually deployed. As originally advertised, we would be
increasing the number of systems that were deployed and
actually increasing the number of cities to which the systems
were also deployed in and then also taking the system indoors.
Based on all of that, you would expect that our resolution of
where the attack took place would be better because we have
more sensors out. We would be getting more frequent analysis
during the day. We would be getting up to eight analyses as
opposed to one, so our timeliness would be improved and we can
take the system indoors so we would know a lot more a lot
faster and able to reduce morbidity and mortality if we can
respond appropriately.
Mr. Bilirakis. Dr. Merlin, do you want to comment on that?
Dr. Merlin. I agree with Dr. Walter's assessment that the
transition from Generation 2 to Generation 3 would increase the
testing frequency and increase the number of testing sites, and
would decrease the amount of time available, and those are
essential features. What we need to know is how sensitive the
system would be, what its lower limits of detection would be,
and how specific it would, how many false positives it would
give in an operating environment in order to know how it truly
performs. There are a number of determinants of performance.
One is how many you have, how often you do it, and the other is
how well it works, and what we don't know is how well it would
work.
Mr. Bilirakis. OK. Thank you. Next question. BioWatch
comprises about 80 percent of the Office of Health Affairs'
budget but constitutes just a single niche of the very broad
mandate that is biosurveillance. Aside from BioWatch, are there
other things we need to be doing to fill other capability gaps,
Dr. Walter?
Mr. Walter. I think we need to make sure that BioWatch is
not mutually exclusive of other surveillance systems. BioWatch
needs to complement medical surveillance. BioWatch needs to
complement syndromic surveillance. BioWatch needs to complement
point-of-care diagnostics. Also, out of the detection realm but
into the preparedness and training realm, we need to make sure
that our jurisdictions, our state and locals, know what they
are going to do in the event of a biological attack, which is a
major part of what the BioWatch program spends its time doing.
It is not our responsibility nor do we want to develop their
response cutoffs but we do provide them with guidance
documents, points to consider, and we do provide them with a
robust exercise program to see if those plans they put in place
make sense. All of that together is a big part of how we are
going to--what we need to do improve biodefense in the country.
Mr. Bilirakis. Very good. I understand that Gen-3 BioWatch
system uses local laboratories to manually analyze filter
samples for the presence of suspicious bacteria. I can imagine
that there are likely several hundreds of scientists and
laboratory technicians involved in this activity across the
United States. If Gen-3 technology works as planned, then the
need for manual analysis would be most likely eliminated. Would
this result in reduction of BioWatch laboratory workforce and
thereby saving taxpayer dollars, or does it not save money
because the system is so expensive? Either one of you.
Mr. Walter. I think that is probably mine. You are correct
in that as we envision it, the only laboratory analysis that
would need to be done is in the event of an automated system
detecting something, and either going forward and collecting
additional samples or getting an archived sample from the unit
or units that have shown a positive in doing that analysis. So
we would actually need less support on our field operations and
also less support in our laboratory operations. We would still
need to support state and local public health because we would
basically be trading the manual part in for interpretation of
results. What is the machine telling us? Who do I need to make
sense of that. So there wouldn't be a wholesale--we couldn't
subtract off the funding that we need to support the field and
laboratories but I believe that would be reduced.
Mr. Bilirakis. What do you think, Dr. Merlin? Do you think
we will save some money?
Dr. Merlin. I think the jury is out on that. I think almost
invariably new technology programs are offered with the promise
that they are going to save money by saving labor and
decreasing costs, and often that doesn't turn out to be the
case. One question will be the actual acquisition costs, and
from the numbers I have heard, the actual acquisition costs and
operating costs are greater than the current Gen-2 costs. I
don't see how there could be a net savings of money. There is
going to be an increase anyhow. And then there is a question in
the rollout period once it is rolled out what the implications
are of the downstream effects on public health departments and
the need to support it. I think it is just very hard in a
program like this to speculate what the operating costs are
truly going to be.
Mr. Bilirakis. I appreciate that. Thank you very much. I
yield back, Mr. Chairman.
Mr. Murphy. Thank you. Just a quick question. The President
in July 2012 released the National Strategy for
Biosurveillance. He said he would have a strategic
implementation plan in 120 days. Do either of you gentlemen
know if we have one yet?
Dr. Merlin. On the way here yesterday from Atlanta, I got
an email saying that the implementation plan had been posted. I
didn't have a chance to look but it should be--if it is there,
it should be on the Executive Office of the President Web site.
Mr. Murphy. Would you please help make sure we see that
too? And also about the costs. On July 16, 2008, the GAO
testified at the House Homeland Security Subcommittee hearing
that the Generation-2.5 lab-in-a-box units would cost $120,000
per unit and $65,000 to $72,000 annually per unit to operate
and maintain. According to a slide from DHS scientists in
December of 2011, the cost estimates for Gen-3 showed $117,000
per unit, which is comparable to Gen-2.5, but a much higher
$174,000 per unit for operation and maintenance for Gen-3 lab-
in-a-box services. So Dr. Walter, why is the operation and
maintenance for Gen-3 devices more than $100,000 higher per
unit than the Gen-2.5? Do you know?
Mr. Walter. I do not know that. Like I said, Gen-2.5
predates me. I know Gen-2.5 was a fairly expensive system to
maintain but we are also looking as part of the acquisition to
reduce the costs of maintaining those systems. Most of the
costs in maintaining or fielding an automated detection system
is going to be in operations and maintenance, and anything we
can do to reduce those costs is going to work in our favor.
Mr. Murphy. Well, thank you. I think we heard today on both
sides of the aisle the concern about these costs, the
effectiveness, the sensitivity and specificity, and we will
want to continue to work with you to make sure that we have
that information.
I ask for unanimous consent that the written opening
statements of members be introduced into the record, and
without objection, the documents will be entered into the
record.
I also ask unanimous consent that the contents of the
document binder be introduced into the record and authorize
staff to make any appropriate redactions. So without
objection----
Mr. Tonko. Without objection.
Mr. Murphy. The documents will be entered into the record
with any redactions staff determines are appropriate.
I also ask for unanimous consent to put the majority
staff's supplemental memorandum into the record, so without
objection, this memorandum will be put into the record.
So in conclusion, I would like to thank the witnesses and
the members for their hard work and thoughtful participation in
today's hearing. I remind members they have 10 business days to
submit questions for the record, and I ask that the witnesses
all agree to respond promptly to the questions.
So with that, the subcommittee is adjourned.
[Whereupon, at 11:49 a.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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