[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

                        energycommerce.house.gov
                        
                                      ______

                         U.S. GOVERNMENT PRINTING OFFICE 

85-446 PDF                     WASHINGTON : 2014 
-----------------------------------------------------------------------
  For sale by the Superintendent of Documents, U.S. Government Printing 
  Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; 
         DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, 
                          Washington, DC 20402-0001                    
                        
                        
 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:]
    [GRAPHIC] [TIFF OMITTED] T5446.001
    
    [GRAPHIC] [TIFF OMITTED] T5446.002
    
    [GRAPHIC] [TIFF OMITTED] T5446.003
    
    [GRAPHIC] [TIFF OMITTED] T5446.004
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5446.005
    
    [GRAPHIC] [TIFF OMITTED] T5446.006
    
    [GRAPHIC] [TIFF OMITTED] T5446.007
    
    [GRAPHIC] [TIFF OMITTED] T5446.008
    
    [GRAPHIC] [TIFF OMITTED] T5446.009
    
    [GRAPHIC] [TIFF OMITTED] T5446.010
    
    [GRAPHIC] [TIFF OMITTED] T5446.011
    
    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:]
    
    [GRAPHIC] [TIFF OMITTED]