[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]




 
               ANTHRAX PROTECTION: PROGRESS OR PROBLEMS?

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

                                HEARING

                               before the

                   SUBCOMMITTEE ON NATIONAL SECURITY,
                  EMERGING THREATS, AND INTERNATIONAL
                               RELATIONS

                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             SECOND SESSION

                               __________

                              MAY 9, 2006

                               __________

                           Serial No. 109-207

                               __________

       Printed for the use of the Committee on Government Reform


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html
                      http://www.house.gov/reform


                                 ______

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                     COMMITTEE ON GOVERNMENT REFORM

                     TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut       HENRY A. WAXMAN, California
DAN BURTON, Indiana                  TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota             CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana              ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio           DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania    DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee       DIANE E. WATSON, California
CANDICE S. MILLER, Michigan          STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio              CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California          LINDA T. SANCHEZ, California
JON C. PORTER, Nevada                C.A. DUTCH RUPPERSBERGER, Maryland
KENNY MARCHANT, Texas                BRIAN HIGGINS, New York
LYNN A. WESTMORELAND, Georgia        ELEANOR HOLMES NORTON, District of 
PATRICK T. McHENRY, North Carolina       Columbia
CHARLES W. DENT, Pennsylvania                    ------
VIRGINIA FOXX, North Carolina        BERNARD SANDERS, Vermont 
JEAN SCHMIDT, Ohio                       (Independent)
------ ------

                      David Marin, Staff Director
                Lawrence Halloran, Deputy Staff Director
                       Teresa Austin, Chief Clerk
          Phil Barnett, Minority Chief of Staff/Chief Counsel

Subcommittee on National Security, Emerging Threats, and International 
                               Relations

                CHRISTOPHER SHAYS, Connecticut, Chairman
KENNY MARCHANT, Texas                DENNIS J. KUCINICH, Ohio
DAN BURTON, Indiana                  TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         BERNARD SANDERS, Vermont
JOHN M. McHUGH, New York             CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio           CHRIS VAN HOLLEN, Maryland
TODD RUSSELL PLATTS, Pennsylvania    LINDA T. SANCHEZ, California
JOHN J. DUNCAN, Jr., Tennessee       C.A. DUTCH RUPPERSBERGER, Maryland
MICHAEL R. TURNER, Ohio              STEPHEN F. LYNCH, Massachusetts
JON C. PORTER, Nevada                BRIAN HIGGINS, New York
CHARLES W. DENT, Pennsylvania

                               Ex Officio

TOM DAVIS, Virginia                  HENRY A. WAXMAN, California
                  R. Nicholas Palarino, Staff Director
             Kristine Fiorentino, Professional Staff Member
                        Robert A. Briggs, Clerk
             Andrew Su, Minority Professional Staff Member


                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on May 9, 2006......................................     1
Statement of:
    Embrey, Ellen P., Deputy Assistant Secretary for Defense of 
      Defense for Health Affairs for Force Health Protection and 
      Readiness, U.S. Department of Defense; Jean Reed, Special 
      Assistant for Chemical and Biological Defense and Chemical 
      Demilitarization Programs, U.S. Department of Defense; 
      Gerald W. Parker, D.V.M., Principal Deputy to the Assistant 
      Secretary, Office of Public Health Emergency Preparedness, 
      U.S. Department of Health and Human Services; Richard E. 
      Besser, M.D., Director, Coordinating Office for Terrorism 
      Preparedness and Emergency Response, Centers for Disease 
      Control and Prevention, U.S. Department of Health and Human 
      Services; S. Elizabeth George, Ph.D., Deputy Director, 
      Biological Countermeasures Portfolio, Science and 
      Technology Directorate, U.S. Department of Homeland 
      Security, accompanied by John Vitko, Jr., Ph.D., Director, 
      Biological Countermeasures Portfolio, Science and 
      Technology Directorate, U.S. Department of Homeland 
      Security; and Dana Tulis, Deputy Director, Office of 
      Emergency Management, U.S. Environmental Protection Agency, 
      accompanied by Mark Durno, on-scene Coordinator [OSC] EPA 
      Region 5...................................................    56
        Besser, Richard E........................................    96
        Embrey, Ellen P..........................................    56
        George, S. Elizabeth.....................................   112
        Parker, Gerald W.........................................    79
        Reed, Jean...............................................    65
        Tulis, Dana..............................................   127
    Rhodes, Keith, Chief Technologist, Center for Technology and 
      Engineering, Applied Research and Methods, U.S. Government 
      Accountability Office, accompanied by Sushil Sharma, 
      Assistant Director, Center for Technology and Engineering, 
      Applied Research and Methods, U.S. Government 
      Accountability Office......................................    10
Letters, statements, etc., submitted for the record by:
    Besser, Richard E., M.D., Director, Coordinating Office for 
      Terrorism Preparedness and Emergency Response, Centers for 
      Disease Control and Prevention, U.S. Department of Health 
      and Human Services, prepared statement of..................    98
    Embrey, Ellen P., Deputy Assistant Secretary for Defense of 
      Defense for Health Affairs for Force Health Protection and 
      Readiness, U.S. Department of Defense, prepared statement 
      of.........................................................    59
    George, S. Elizabeth, Ph.D., Deputy Director, Biological 
      Countermeasures Portfolio, Science and Technology 
      Directorate, U.S. Department of Homeland Security, prepared 
      statement of...............................................   114
    Parker, Gerald W., D.V.M., Principal Deputy to the Assistant 
      Secretary, Office of Public Health Emergency Preparedness, 
      U.S. Department of Health and Human Services, prepared 
      statement of...............................................    82
    Porter, Hon. Jon C., a Representative in Congress from the 
      State of Nevada, prepared statement of.....................     7
    Reed, Jean, Special Assistant for Chemical and Biological 
      Defense and Chemical Demilitarization Programs, U.S. 
      Department of Defense, prepared statement of...............    67
    Rhodes, Keith, Chief Technologist, Center for Technology and 
      Engineering, Applied Research and Methods, U.S. Government 
      Accountability Office, prepared statement of...............    13
    Shays, Hon. Christopher, a Representative in Congress from 
      the State of Connecticut, prepared statement of............     3
    Tulis, Dana, Deputy Director, Office of Emergency Management, 
      U.S. Environmental Protection Agency, accompanied by Mark 
      Durno, on-scene Coordinator [OSC] EPA Region 5, prepared 
      statement of...............................................   130


               ANTHRAX PROTECTION: PROGRESS OR PROBLEMS?

                              ----------                              


                          TUESDAY, MAY 9, 2006

                  House of Representatives,
       Subcommittee on National Security, Emerging 
              Threats, and International Relations,
                            Committee on Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:08 p.m., in 
room 2154, Rayburn House Office Building, Hon. Christopher 
Shays (chairman of the subcommittee) presiding.
    Present: Representatives Shays, Duncan, Porter, and Van 
Hollen.
    Staff present: R. Nicholas Palarino, Ph.D., staff director; 
Kristine Fiorentino, professional staff member; Robert A. 
Briggs, analyst; Andrew Su, minority professional staff member; 
and Jean Gosa, minority assistant clerk.
    Mr. Shays. The Government Reform Committee Subcommittee on 
International Relations and National Security is called to 
order. This is a hearing on anthrax protection progress or 
problems.
    In September and October 2001, envelopes containing anthrax 
were mailed to post offices and public office buildings. 
Twenty-two individuals in four States and Washington, DC, 
contracted anthrax. Five died.
    The investigation to date has not revealed who converted 
letters and packages into vectors of disease. The only things 
we have are the lessons learned from these events. They remain 
our best defense against further attempts to contaminate the 
mail and other public places with anthrax.
    Today we ask two questions: How effective has our 
Government been in developing medical countermeasures against 
an anthrax attack? How accurate are anthrax detection 
techniques?
    The Department of Homeland Security is responsible for 
coordinating Federal operations within the United States to 
prepare for, respond to, and recover from terrorist attacks, 
major disasters, and other emergencies. Other Government 
agencies with a stake in applying the lessons learned from the 
anthrax attack include the Departments of Defense and Health 
and Human Services, the Centers for Disease Control and 
Prevention, and the Environmental Protection Agency.
    In 2004, President Bush authorized $5.6 billion over 10 
years through Project BioShield, for the Government to purchase 
and stockpile vaccines and drugs to fight anthrax, smallpox, 
and other potential agents of bioterror. This program 
represents a critical tool in the war against terrorism as a 
flexible streamlined means to identify, develop, procure, and 
stockpile medical countermeasures. However, there are 
indications inadequate planning and bureaucratic finger-
pointing are challenging the measures President Bush put in 
motion to defend the United States.
    Mr. Alex Azar, Deputy Assistant Secretary in the Department 
of Health and Human Services acknowledged in congressional 
testimony on April 6th that the lack of a strategic plan for 
BioShield has left industry guessing about the Government's 
priorities.
    A Government Accountability Office [GAO] report on anthrax 
detection addressed our inability to accurately detect anthrax. 
The report recommended the Secretary of Homeland Security work 
with all agencies to ``ensure appropriate validation studies of 
the overall process of sampling activities.''
    The Department of Homeland Security responded to the GAO 
report by stating the Environmental Protection Agency has the 
primary responsibility establishing the strategy's guidelines 
and plans for recovery from a biological attack, while the 
Department of Health and Human Services has the lead role for 
any related public health response guidelines. After 2 years, 
we are still waiting for a strategic plan and a validation of 
sampling process to determine, for instance, whether Madison 
Square Garden or even the room we are sitting in right now is 
free from anthrax.
    I believe these issues merit our earnest attention. We owe 
it to those who contracted anthrax, and particularly to those 
who died from the infection, including Ms. Ottilie Lundgren 
from Oxford in my own State of Connecticut.
    To help us understand the issues involved, we have two 
panels of distinguished witnesses, including representatives 
from the Government Accountability Office, the Departments of 
Defense, Health and Human Services, and Homeland Security, and 
the Environmental Protection Agency, and the Centers for 
Disease Control and Prevention.
    We appreciate the time our witnesses took out of their 
schedules to be with us today and we look forward to hearing 
their testimony explaining agency preparations to defend the 
Nation from another anthrax attack.
    [The prepared statement of Hon. Christopher Shays follows:]

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    Mr. Shays. At this time, the Chair would call on my 
colleague Mr. Porter to see if he has any statement he would 
like to make.
    Mr. Porter. Thank you, Mr. Chairman. I appreciate your 
holding I think a very important hearing today regarding 
anthrax protection and some of the problems in our progress. 
With the element of time, I am submitting for the record an 
opening statement and also a number of questions for DOD and 
HHS that I would appreciate their response.
    But again, I just want to say thank you very much for this 
opportunity. I think it is very important for the security of 
our Nation.
    [The prepared statement of Hon. Jon C. Porter follows:]

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    Mr. Shays. Thank you, gentlemen.
    At this time, with a quorum being present, I would ask 
unanimous consent that all members of the subcommittee be 
permitted to place an opening statement in the record. The 
record will remain open for 3 days for that purpose. Without 
objection, so ordered.
    I ask further unanimous consent that all witnesses be 
permitted to include their written statements in the record. 
And without objection, so ordered.
    I would ask unanimous consent to submit a statement 
prepared by the Emergent Bio Solutions Corp. Without objection, 
so ordered.
    At this time, the Chair would recognize our first witness. 
We appreciate him being here. His name is Mr. Keith Rhodes, the 
Chief Technologist, Center for Technology and Engineering, 
Applied Research and Methods, the Government Accountability 
Office.
    Mr. Rhodes, we welcome you here. As you know, it is our 
practice to swear you in.
    Raising your right hand--excuse me, let me ask you--you 
sure you want this guy?
    Mr. Rhodes. Yes, sir.
    Mr. Shays. OK. We go back a long ways.
    [Witness sworn.]
    Mr. Shays. Note for the record, our witness and his 
colleague have responded in the affirmative. If he takes the 
desk, then we will make sure that our recorder knows exactly 
who he is.
    Mr. Rhodes, we will put on the 5-minute clock, but if it is 
necessary for you to go over, then go over. We want to make 
sure your statement is in.
    Thank you. Welcome.

   STATEMENT OF KEITH RHODES, CHIEF TECHNOLOGIST, CENTER FOR 
TECHNOLOGY AND ENGINEERING, APPLIED RESEARCH AND METHODS, U.S. 
GOVERNMENT ACCOUNTABILITY OFFICE, ACCOMPANIED BY SUSHIL SHARMA, 
  ASSISTANT DIRECTOR, CENTER FOR TECHNOLOGY AND ENGINEERING, 
 APPLIED RESEARCH AND METHODS, U.S. GOVERNMENT ACCOUNTABILITY 
                             OFFICE

    Mr. Rhodes. Thank you. Mr. Chairman, members of the 
subcommittee, I want to state for the record that I am 
accompanied by Dr. Sushil Sharma. We are pleased to be here 
today to discuss the status of our recommendations on two 
bodies of work that we did at your request--licensed anthrax 
vaccine and anthrax detection methods. In today's testimony, I 
will specifically report on, one, the problems we identified, 
two, recommendations we made, three, the actions taken by 
Federal agencies, and four, what remains to be done.
    With regard to anthrax detection methods, last year I 
reported to you that the overall sampling process and the 
individual activities were not validated. Consequently, Federal 
agencies could not answer the basic question, is this building 
contaminated?
    Well, I am sorry to report to you that we are not much 
further along in being able to answer this question than we 
were in 2001. If this building is contaminated today and tested 
negative, you would not know for sure whether the negative 
finding is due to a small number of samples collected, or the 
samples were collected from places where anthrax was simply not 
present, or in fact anthrax is not present in this building.
    We therefore recommended that the Secretary of Homeland 
Security ensure that appropriate validation studies of the 
overall process of sampling activities, including the methods, 
are conducted.
    Although in the past there had been confusion as to which 
Federal agency would take the lead as well as the 
responsibility for ensuring that our recommendations are 
addressed, I am pleased to report to you that DHS is now 
accepting responsibility. On May 3, 2006, DHS told us that DHS 
recognizes it is the principal agency responsible for 
coordinating the Federal response and would be responsible for 
ensuring that sampling methods, including the process, are 
validated. DHS also would work toward developing a probability 
based sampling strategy.
    While actions taken by DHS are steps in the right 
direction, we recommend that DHS develop a formal strategic 
plan that includes a roadmap outlining how individual agency 
efforts would lead to, one, validation of the overall process 
of sampling activities, including the methods; and two, 
development of a probability based sampling strategy that takes 
into account the complexity of indoor environments. This would 
allow both DHS and the Congress to measure its progress against 
its stated goals.
    With regard to licensed anthrax vaccine, we identified 
several problems, all of which we have described in prior 
reports. In addition, we provided information on the 
disadvantages of the licensed vaccine and the status of Federal 
efforts to develop a next generation anthrax vaccine.
    As you know, the licensed vaccine has been given primarily 
to military personnel. DOD, however, has a unique set of 
requirements, as it has a narrow, relatively young, healthy and 
homogeneous target population. This reduces many problems, 
although not all, as in the case of reactive genicity by 
gender. DOD requirements also assume a continuous threat for 
which they require pre-exposure immunization.
    Civilian populations, in contrast, are much more diverse 
than military populations, and pre-exposure use of this vaccine 
in the civilian population would likely be difficult to justify 
based on the available biothreat assessments.
    In response to the perceived threat of bioterrorism, HHS 
decided to develop and test a second generation anthrax 
vaccine. In September 2002 and September 2003, NIAID awarded 
contracts to develop a new recombinant PA vaccine effective 
against inhalation anthrax. The contracts were for developing 
and testing candidate vaccines with a requirement for 
evaluating safety, efficacy, and a potential provider's 
capability for manufacturing the vaccine and achieving FDA 
licensing.
    The contracts, for $13.6 million in 2002 and $80.3 million 
in 2003, were awarded to VaxGen Inc., a California-based 
pharmaceutical company. In November 2004, in the first contract 
under Project BioShield, HHS awarded VaxGen a firm fixed-price 
contract for $877.5 million for the manufacture and delivery of 
75 million doses of recombinant PA anthrax vaccine.
    The normal schedule for taking a vaccine from pre-clinical 
studies to licensure varies, depending on what is known about 
both the specific nature of the infectious disease and the 
planned application of the vaccine in terms of when and on whom 
the vaccine is to be used. These factors can prolong the 
development of a vaccine as long as 15 years for civilian use, 
or as short as 8 years for military use. Because of the U.S. 
Government's stated need for a vaccine that can counter a 
domestic biothreat against civilian populations, HHS has 
undertaken an aggressive procurement of a vaccine on a very 
short schedule.
    While the Government should not pay out money to a 
contractor unless and until they have met the terms of their 
contract, the current schedule and the experimental nature of 
the vaccine itself are risk factors that could jeopardize the 
entire effort. The current schedule makes no allowance for 
delay. Everything must occur on time or there will be a 
cascading direct effect which will delay the product delivery. 
A schedule with no margin for error and a production cycle that 
has unknown elements in it are not conducive to confidence.
    The variability of schedule does not just have an effect on 
this individual vaccine development. Rather, it could have 
effects on how the biotechnology sector responds to any 
Government overtures in the future. If this contract fails, 
VaxGen does more than just fail; they cease to exist as a 
company.
    The rest of the biotechnology sector will be watching to 
see whether VaxGen and the U.S. Government can make this 
partnership work. If it fails, and VaxGen fails, then the 
biotechnology sector will be very wary about dealing with the 
U.S. Government no matter what the stated crisis levels are. 
Since the U.S. Government does not produce vaccines for general 
usage and distribution, a bad relationship between the 
Government and the biotechnology industry means that the 
Government will have to accept whatever the biotechnology 
sector sells--an unacceptable position of increased risk for a 
Government worried about bioterror threats.
    Mr. Chairman, this concludes my prepared remarks. I would 
be happy to respond to any questions that you or other members 
of the subcommittee may have.
    [The prepared statement of Mr. Rhodes follows:]

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    Mr. Shays. Thank you. We are going to start, Mr. Rhodes, 
with the professional staff asking questions.
    Mr. Rhodes. Fine.
    Ms. Fiorentino. Mr. Rhodes, why is it important DHS 
develops a formal strategic plan and roadmap for validating 
sample methods?
    Mr. Rhodes. Validation--there are two pieces. Verification 
is understanding whether you asked a question properly, and 
validation is understanding whether you asked the right 
question. If there is no roadmap, if there is no formal 
strategic plan, then there's no understanding of the 
methodology for validation, the sample sizes that are 
considered statistically acceptable, the acceptable probability 
analysis, the multiple factors associated with probability, the 
amount of money, resources, staff, and schedule associated with 
this.
    If somebody says, for example, I am in charge and I am now 
responsible, but I have no plan, then you as the buyer or you 
as the overseer of that process have no understanding when you 
get anything. When do you get the answer to what question.
    Ms. Fiorentino. And do you know what DHS's response is to 
your suggestion about creating a strategic plan?
    Mr. Rhodes. They have said as recently as standing in the 
hallway out in front of the committee room that there is a 
document, there is a research and development plan, but it has 
not been finalized and it is now--it is being staffed 
throughout DHS, I'm assuming, as we speak. And that as soon as 
it is finished, we will get a copy of that for evaluation.
    Ms. Fiorentino. How long would you expect it to take to 
validate the overall sampling process?
    Mr. Rhodes. I can't really say what a timeframe would be. 
It's a function of the plan. I don't mean to be tautological 
here and talk in a circle, but without the plan itself, there's 
no way of understanding timeframes or methodologies that can be 
evaluated. I would assume, taking from my own experience in 
validating methods, that, given the right resources and the 
amount of materials necessary to do it, it could be done 
somewhere between 2 or 3 years. So it shouldn't take--this is 
not some continuous infinite cycle that we have to go through 
so long as adequate resources are applied, milestones are 
established, and response to basic methodology is understood.
    Ms. Fiorentino. How would you evaluate the steps the 
agencies have taken to address your recommendations in your GAO 
report?
    Mr. Rhodes. That, again, is going to be tied to the 
coordination from DHS out to the other departments and 
agencies. By DHS taking the role as the principal, one of the 
questions they have to answer is how does everyone else 
respond, how does everyone else answer the questions that are 
going to be laid out based on the DHS research methodology.
    So there are two parts. There's evaluating the methodology 
itself, and then there's evaluating what everyone else does in 
relation to the methodology. Is the methodology comprehensive--
Question 1. Question 2 is do the subsequent departments and 
agencies respond to the methodology properly; that is, do they 
put the resources against that methodology that DHS has asked 
for?
    Ms. Fiorentino. Your testimony states that, quote, GAO also 
reported that the anthrax vaccine has not been adequately 
tested on humans. No studies have been done to determine the 
optimum number of doses. The long-term safety has not been 
studied. And data on short-term reactions are limited. However, 
women report higher rates of reactions than do men.
    What concerns do you have regarding the safety of the 
anthrax vaccine?
    Mr. Rhodes. The old--the current FDA licensed one?
    Ms. Fiorentino. Yes.
    Mr. Rhodes. In terms of the long-term safety, the problem 
is how is this vaccine safe relative to people. And there are 
concerns about the original vaccine being applied for 
inhalation anthrax when it was actually designed for mill 
workers. And it's been proven against cutaneous anthrax but 
there's too small a sample size to verify it relative to 
inhalation.
    If you look at the 1962 Brachman study, you're looking at 
reactions that were relatively minor. The data on prevalence 
and duration of short-term reactions does suggest that women 
are more reactive than men. However, if you look at the DOD 
studies, the DOD studies are what are called passive studies; 
that is, they take in passive information from individuals as 
opposed to doing a more structured direct collection of data. 
So trying to understand the direct relationship between is it 
cellular, acellular, is it the adjuvant, is it the other 
material that's in the vaccine, those level of study haven't 
been done relative to safety. Regarding its efficacy, the 
studies haven't been done to verify either dose, in terms of 
the amount of vaccine that's given, and the number of shots 
that should be administered. And then there are questions on 
lot-to-lot consistency because of the actual design of the 
vaccine itself.
    Ms. Fiorentino. Thank you.
    Mr. Rhodes. Thank you.
    Mr. Shays. Walk me through, if you would, the roles of DOD, 
HHS, DHS, EPA, and obviously, under the HHS, the Centers for 
Disease Control and Prevention. How do they all fit into these 
two areas of basically licensing of vaccines and the detection?
    Mr. Rhodes. In the area of detection, well, right now DHS 
is going to have the lead for coordinating all detection 
efforts in the civilian realm. So if there were a concern about 
this building, DHS would take the lead. EPA is the one that 
actually cleans the building up or oversees the cleaning up of 
the building. So DHS is going to be the one that initiates the 
emergency response plan. Then there's EPA that's actually going 
to clean the building up. CDC, as part of HHS, is going to be 
the one that says what the health implications are. DOD is sort 
of a self-contained entity over on one side taking care of its 
own locations and its own people.
    Mr. Shays. But the technology--well, just on the detection 
part----
    Mr. Rhodes. Yes.
    Mr. Shays [continuing]. Is basically universal, I mean, 
whether it is DOD or civilian. And tell me whose responsibility 
to determine and design and contract and design the vaccines?
    Mr. Rhodes. The vaccines?
    Mr. Shays. Mm-hm.
    Mr. Rhodes. The vaccines----
    Mr. Shays. I am sorry, not the vaccines.
    Mr. Rhodes. The detection methods?
    Mr. Shays. Right.
    Mr. Rhodes. Detection methods are going to be in two 
tracks, as far as we understand it at this moment. There's the 
one for civilian environments.
    Mr. Shays. And what Government agency?
    Mr. Rhodes. That's DHS. DHS will be the lead, coordinating 
with HHS, CDC, and EPA. And then there will be the Department 
of Defense.
    Mr. Shays. But we are talking about a system, a process.
    Mr. Rhodes. Yes.
    Mr. Shays. So DOD is in charge. And there is no doubt that 
they are in charge.
    Mr. Rhodes. They are in charge of their own detection 
efforts.
    Mr. Shays. And DHS is in charge of all civilian, and there 
is no----
    Mr. Rhodes. Yes.
    Mr. Shays. OK.
    Mr. Rhodes. So part of the DHS plan, strategic plan, should 
also be the coordination with the Department of Defense to 
leverage off what they know and what they have learned.
    Mr. Shays. I am not clear as to why there is not a 
strategic plan.
    Mr. Rhodes. There's not a strategic plan because, as far as 
we know, no one, DHS, hasn't until recently said they were in 
charge.
    Mr. Shays. So my questions that I am asking you are not out 
of the blue here. I mean, the bottom line is--and you have to 
explain to me, why don't they think they are in charge?
    Mr. Rhodes. Well, they are in charge now and they think 
that they are in charge now, and they told us that they are in 
charge. That's the update relative to----
    Mr. Shays. Is the law unclear?
    Mr. Rhodes. I don't know--I don't think that the law was 
unclear. I think that trying to--for departments and agencies 
to step up and say that they are in charge of a larger group, 
it just seemed that other people were unwilling--it seems like 
the Department was unwilling to take that role.
    Mr. Shays. Would you mind having your colleague join you 
here?
    Mr. Rhodes. Sushil.
    Mr. Shays. How would you respond to that question?
    Dr. Sharma. At the time of issuance of our report, as you 
know, DHS was very new, their actions----
    Mr. Shays. Define ``very new.'' I know what ``new'' means. 
What does ``very new'' mean?
    Dr. Sharma. You know, they came after the 2001 incidents. 
And when CDC, EPA had already taken initiative and FBI also 
was, you know, in charge in terms of the forensic aspect of the 
incidents.
    Also, another source of confusion comes from HSPD-10, which 
clearly delineates EPA----
    Mr. Shays. Comes from what?
    Dr. Sharma. With the Presidential Directive No. 10, which 
clearly delineates EPA as the primary responsibility for 
developing protocols for decontamination. So, you know, I guess 
from DHS's perspective, and I'm sure if you asked them----
    Mr. Shays. I am having a hard time understanding how 
protocols for decontamination would interfere with a plan 
dealing with detection. We are not talking about consequence 
right now, we are trying to detect. So just deal with 
detection.
    I mean, and wherever it lies, wherever the fault lies--and 
maybe it lies with more than one--I just want to clearly, I 
want you all to be clear. You are GAO, and we are not asking 
them. I think it is somewhat alarming that we haven't had a 
sense of who is in charge.
    First of all, is there any doubt on the part of either of 
you who should be in charge? And then explain to me why we 
don't know.
    Mr. Rhodes.
    Mr. Rhodes. I have no doubt both in law and in practicality 
that the Department of Homeland Security should be in charge. 
And as I testified last year, that was the recommendation that 
we made.
    Mr. Shays. Well ``should be'' may mean that it would be a 
good thing if law required it and if regulation required it and 
if Presidential directives required it. Are you saying that it 
doesn't require it and it is your recommendation they should be 
in charge? Or are you saying that it is clear under law they 
are in charge?
    Mr. Rhodes. It's clear under law that they are in charge 
and it was--when we did our analysis and we looked at the 
results of the detection work that was done in the fall of 
2001, it was very clear that they needed to be in charge. It 
wasn't just that in law it says it, but it was clear that from 
a scientific standpoint, from a testing standpoint, from a 
design standpoint, they needed to be in charge.
    Mr. Shays. OK. So----
    Mr. Rhodes. Because in the fall of 2001, everyone came in 
with their own charter. So the FBI came in collecting samples 
from----
    Mr. Shays. I don't know what you mean by ``the fall of 
2001.'' What do you mean by ``they came with their own 
charter''? I don't understand that.
    Mr. Rhodes. All the departments and agencies that responded 
to the anthrax events came in with their own roles and 
responsibilities.
    Mr. Shays. Right.
    Mr. Rhodes. So EPA was taking samples based on cleanup, CDC 
was taking samples based on epidemiology, FBI was taking 
samples based on evidence collection, and those things. And as 
we saw, that made it very, very difficult for anyone to have a 
good set of samples. So without having----
    Mr. Shays. I am sorry, you just introduced more 
information.
    Mr. Duncan, I welcome you here and I am going to suspend 
my--I just want to get this basic point, and then Mr. Duncan. 
Then I am going to come back to you.
    I am just wanting to be clear--I just don't understand 
something else you just said. When you say that since they all 
wanted samples, no one had good samples. Why can't they all get 
good samples?
    Mr. Rhodes. Well, I mean, good samples from being able to 
understand very clearly that a location was clean, that a 
location was now free. From our standpoint, since they weren't 
using probability based samples----
    Mr. Shays. How did we get to something being clean from the 
original issue of whether you could come into a building and 
detect--so I guess maybe this is a small point. I want to know 
if something that we don't think is exposed is exposed. You are 
talking about something that is already exposed no longer being 
exposed.
    Mr. Rhodes. Right.
    Mr. Shays. I guess they are the same?
    Mr. Rhodes. They're going to ultimately--you're going to 
have to answer the same question. The validation of the method 
and the validation of the process should be applicable to both 
environments to answer both questions.
    Mr. Shays. OK. Now, I am told that I can put a handful of 
anthrax in my hand, I would have billions of spores.
    Mr. Rhodes. Could be trillions.
    Mr. Shays. Trillions. So it is conceivable that you could, 
even scientifically, not be able to totally and completely 
determine if you were anthrax-free.
    Mr. Rhodes. Right.
    Mr. Shays. So it would be kind of hard for us--I mean, it 
would be almost--I would think it would almost be illogical for 
us to make an assumption that we could. Is that the goal, 
though? Or what is the goal?
    Mr. Rhodes. The goal is to make certain that you have 
confidence. What degree of confidence do you have that this 
building is anthrax-free or that this building is no longer 
infectious, that people who walk into this building are no 
longer going to run the risk of being infected by inhalation 
anthrax or cutaneous anthrax or gastrointestinal anthrax? 
That's really the direction on this validation process that 
we're talking about.
    Mr. Shays. All right. So before recognizing Mr. Duncan, let 
me just get back to this basic point. And I am going to say 
what I am hearing you tell me. You are saying that with regard 
to the process of establishing a detection method and to 
validate it, and to develop that strategy, that is the 
Department of Homeland Security--that you don't have any doubt 
that it is, that the law states it, and there is logic that 
they should be required to undertake that. Is that correct?
    Mr. Rhodes. That's correct.
    Mr. Shays. Do you agree as well?
    Dr. Sharma. Yes.
    Mr. Shays. Are you allowed to disagree with him if you----
    Dr. Sharma. No, no, no, I'm allowed to disagree.
    Mr. Shays. OK.
    Mr. Rhodes. I believe you know that he's allowed to 
disagree with anything.
    Mr. Shays. Well, sometimes he disagrees even when he is not 
allowed, so that is another issue.
    But, so--now, the last question is do they have any doubt 
anymore that they have that responsibility? And when did they 
finally agree that they had that responsibility? Or is it 
possible they always had the responsibility and just never did 
it--and they knew they always had the responsibility?
    Mr. Rhodes. I can't speak to your second point because I 
can't read people's minds. All I can----
    Mr. Shays. Haven't they told you? Haven't you asked them?
    Mr. Rhodes. We have asked and they have said no.
    Mr. Shays. Said no.
    Mr. Rhodes. Prior to May 3rd of--well, last week. Prior to 
last week.
    Mr. Shays. They do not accept that they have the 
responsibility to develop the strategy?
    Mr. Rhodes. They have the responsibility to develop the 
strategy, but they don't have the responsibility to order other 
people. And they didn't concur----
    Mr. Shays. What, to cooperate?
    Mr. Rhodes. Right. And they did not concur with the 
necessity for validating both the methods and the processes.
    Mr. Shays. OK. This is not good.
    Mr. Duncan.
    Mr. Duncan. Well, thank you very much, Mr. Chairman, for 
calling this hearing. This is extremely important, I think. I 
am sorry that I was not able to get here until just a few 
minutes ago, and maybe you have covered most of what I wanted 
to ask about.
    Mr. Shays. Well, if we did cover it and you ask it again, 
it will reinforce knowledge to me, so I am happy to have you 
bring it up.
    Mr. Duncan. OK. Well, thank you very much.
    The chairman noted in his statement that Congress passed 
and the President signed an authorized $5.6 billion for Project 
BioShield to be spread over 10 years. And this $877.5 million 
contract was awarded to VaxGen in 2004. It is my understanding 
that was to produce 75 million doses of anthrax vaccine, but 
there have been some problems. And what I am wondering about is 
how much of that $877.5 million has been expended and how many 
doses do we have? Or what is the current status of that 
contract?
    And then also, I see that a company called BioPort received 
a $1.22 million contract, a much, much smaller contract, to 
manufacture 5 million doses. And are they producing a 
different--you know, a different thing? What is the situation 
now with those contracts and those doses and so forth?
    Mr. Rhodes. Mr. Duncan, relative to your first question 
about the actual contract expenditures, that was not something 
we reviewed. That question is probably better directed to HHS 
on the second panel.
    Mr. Duncan. OK.
    Mr. Rhodes. Because the purpose of our review was to look 
at the Federal Government response to our recommendations 
prior, which were focused on the licensed anthrax vaccine 
versus a next generation anthrax vaccine, as opposed to the 
contract vehicle for it.
    Mr. Duncan. OK, well, I guess the questions I am wondering 
about, Mr. Chairman, will hopefully be covered by the next 
panel.
    Mr. Shays. Before we go to the next panel, what I am 
hearing you tell me is that the plan on detection and 
validation and so on is the responsibility of DHS, that they 
have never agreed that this is their responsibility, and they 
certainly don't believe that they have the right to ask 
others--certainly I am hearing you say that they do not feel 
they have the power to direct others to help them in that 
effort.
    If I am getting a distorted message from you, I need you to 
clarify it.
    Mr. Rhodes. The only thing I would alter to that is that, 
as of our discussion last week with DHS, that has changed.
    Mr. Shays. You mean now, since----
    Mr. Rhodes. Now they accept the responsibility. Now they 
are willing to coordinate other departments and agencies under 
their authority. So that has changed. The question we still 
have on the table is what is that plan, what is that roadmap, 
how does it lead to validated methods, how does it lead to a 
structured response and coordination of the varying departments 
and agencies that would have to respond to another incident 
like the fall of 2001?
    Mr. Shays. Before we get on to the next panel, let me--I 
must be too unclear about--has this just basically been a 
rather general assignment that we tasked Government to develop 
this strategy, or did we clearly state a while ago there would 
be a strategy and it would be done by a certain date? Or 
somewhere in between?
    Mr. Rhodes. You did direct them--I mean, the law states for 
a strategy, you did direct them in the last hearing for a 
strategy.
    Mr. Shays. But DHS wasn't here last time.
    Mr. Rhodes. No, DHS was not here, but the recommendation 
was made here. And it was made in the hearing. So I guess if it 
didn't get to DHS directly----
    Mr. Shays. The last panel was the session ``Anthrax 
Detection Methods.'' That was just the focus of it, just this--
and that was April 5, 2005. And DHS was not there and refused 
to provide a statement.
    Mr. Rhodes. Right.
    Mr. Shays. OK.
    Have there been any doubts on the part of the other 
departments that it was DHS's responsibility? Or is that part 
of the problem?
    Mr. Rhodes. Our experience has been that other departments 
and agencies, as you heard in the last testimony relative to 
the detection methods, they did not concur with our 
recommendations either. So I don't know that I can say that 
they wouldn't believe that DHS was responsible, but they didn't 
believe that validation of methods was necessary either and 
they didn't believe in probability sampling either. So everyone 
was agreeing to disagree with our recommendations.
    Mr. Shays. Can you explain that a little differently and 
see if I can understand it?
    Dr. Sharma. When we issued our report, HHS did not come. 
And the response was very unclear as to whether they were 
agreeing with our recommendations or disagreeing. It was very 
wishy-washy, if I may use the word.
    CDC, on the other hand, was very clear in their response 
that the sampling strategy they had used was, under the 
circumstances, was the best, and they were very concerned about 
the probability based sampling. Primarily their concerns were 
twofold; first, that it will take a long time, and second also, 
that it would result in significant cost.
    In terms of, you know, the DHS responsibility, at the time, 
everybody was given a--you know, they were doing what their 
mission required them to do. The change is now that they will 
still do what their mission requires them to do, but DHS would 
be coordinating that mission-related responsibility. In other 
words, they will be, then, saying that if we were going to test 
Rayburn building, whether or not it is contaminated, their plan 
should be able to tell you that in this room, if they were to 
collect probability based sampling using a given method, how 
many samples they need to collect and from where and who is 
going to do that.
    Mr. Shays. I mean, does the--they can determine ultimately 
the level of ascertaining whether or not there is anthrax, 
correct? In other words, they can--the strategy can say we'll 
get to this level or we'll get to this level or get to this 
level. Is that true? Or are we saying the strategy has to get 
us to almost total certainty, you just have to figure out how 
we get there? Do they get to decide what level and get to 
decide how to determine it? It would strike me that would be 
the logical thing.
    Dr. Sharma. That strategy should describe both.
    Mr. Shays. OK. So what I would think--I mean, one of the 
things that I am pretty aware of, having been involved with 
helping to create the Department of Homeland Security is we 
have given them more tasks than they can humanly do immediately 
or in the near future. So they are going to decide opportunity 
costs. But it seems to me at the very least they have to be up 
front with us and say we have been tasked this but we simply 
get to it. That, to me, would be the honest way to do it. I 
don't think they can do everything we have tasked them.
    So, you know, I cut them a little slack that way. But I 
would be bothered if nobody is taking ownership. I felt no one 
took--I felt DHS didn't take ownership of Katrina, frankly. So 
I am a little concerned that we may see that behavior in other 
areas.
    Mr. Rhodes. And, Mr. Chairman, prior to May 3, 2006, when 
we met with DHS and we were told that not only were they going 
to be in charge but they were going to be responsible for this 
effort, I was ready to sit down here and say yes, once again, 
DHS has said they won't be in charge, they won't take the 
responsibility. Now the onus is to see what their definition of 
taking responsibility means--which would be, in this plan, to 
answer the very question you just asked. There's an 
opportunity, there's a cost, there's an effort that has to be 
applied. How does detection validation rank relative to other 
things on their plate?
    Mr. Shays. Let me just jump to detection. We are taking a 
little longer here than I thought, but I think it will help for 
the next panel.
    What is DOD doing in terms of detection? Have they 
established a strategy that they are trying to follow and 
implement?
    Mr. Rhodes. We did not look at DOD as part of this effort 
on this job. I mean, they have their field methods, but we did 
not look at them specifically relative to this job.
    Mr. Shays. Isn't there a logic to have the civilian and the 
military interact with each other? I mean if they both can 
collectively do the same process, or at least--I mean it would 
seem logical to me that they would do that.
    Mr. Rhodes. They do coordinate. And they should coordinate.
    Mr. Shays. But you can't speak to the fact of whether DOD 
is just doing basically the same thing DHS is, which is 
nothing?
    Mr. Rhodes. No, I cannot speak to that here.
    Mr. Shays. Let's talk about the other aspect, and that is 
the vaccine itself. Who has ownership of developing the 
vaccine?
    Mr. Rhodes. For civilian use, it's HHS.
    Mr. Shays. And they have taken ownership?
    Mr. Rhodes. They have taken ownership and they do have 
ownership for civilian use relative to this recombinant PA 
vaccine, the next generation vaccine.
    Mr. Shays. And within DOD, are they working through 
BioPort?
    Mr. Rhodes. DOD is using the FDA licensed vaccine from 
BioPort, yes.
    Mr. Shays. OK, so they are going that route. So tell me, 
are we to be concerned--I circled your statement ``If it fails, 
the VaxGen fails and the biotechnology sector will be very 
worried about dealing with the U.S. Government no matter what 
the stated crisis levels are.''
    Well, what happens if VaxGen simply wasn't qualified and 
capable, as some say--too small, etc? I would think that would 
just validate they were too small, not that people wouldn't 
want to work with the Government. So why do you make that 
statement?
    Mr. Rhodes. I make that statement because, in firm fixed 
price on an experimental vaccine that has unknowns associated 
with it, the risk is that it will be hard to pinpoint--my 
concern is that it will be hard to pinpoint exactly why 
something is not being delivered. Is it not being delivered 
because requirements change? Is it not being delivered because 
of the uncertainty of vaccine production? Is it not being 
delivered because, as you say, the company may be too small and 
it may not be able to----
    Mr. Shays. And what is your determination?
    Mr. Rhodes. We haven't made that determination yet. We're 
highlighting that this is a risk to a firm fixed price 
contract. VaxGen, the financial burden is sitting on that 
company, and as I say----
    Mr. Shays. So is your point that a firm fixed price is not 
realistic, that it----
    Mr. Rhodes. Firm fixed price is realistic if requirements 
are firm and the understanding of the vaccine production is 
firm. If those things begin to waver, then----
    Mr. Shays. How does it waver?
    Mr. Rhodes. Well, it can waver because the Government 
levies other requirements on them or there is some problem in 
the production because the vaccine isn't as predictable as they 
might have thought, it doesn't do as well during certain 
clinical trials as it may have.
    Mr. Shays. In the case of VaxGen, it is a question of its 
potency and durability? Is that the issue?
    Mr. Rhodes. It could be, yes. I mean, those would be 
questions about--those would be questions along----
    Mr. Shays. What has delayed it right now? What are the----
    Mr. Rhodes. Pardon me?
    Mr. Shays. Do you know what has delayed the process to 
date?
    Mr. Rhodes. No. We haven't looked specifically at what has 
delayed it. We were looking just at the followup to our 
recommendations relative to next-generation vaccine.
    Mr. Shays. OK. And tell me again your recommendations?
    Mr. Rhodes. The recommendation was for HHS to--for the 
Government to look into a next-generation vaccine, develop it 
to overcome--to see its ability to overcome the questions in 
safety, efficacy, lot-to-lot consistency, and shelf life.
    Mr. Shays. OK. About half our Government is defense and 
half our Government is not defense, and I have this uneasy 
feeling that we pay more because we have two different parts of 
Government do the same thing. And I realize that we do not want 
civilian control--I realize that DOD has to do what it has to 
do, but I would just like to feel better about the whole effort 
to coordinate, and I do not have this very good feeling at the 
moment.
    We are going to go to the next panel, but before we do, is 
there something we just really did not think to ask that we 
should have? Is there something that you would like to put on 
the record? Sometimes that is the most important part of this 
hearing.
    Dr. Sharma. Just one additional comment I would like to 
make. On the recombinant vaccine, there has been very good 
coordination between DOD and HHS. The original pilot lot for 
the recombinant vaccine in these studies----
    Mr. Shays. The recombinant vaccine VaxGen is doing----
    Dr. Sharma. No, no, no. The pilot lot for the recombinant 
vaccine was developed by DOD.
    Mr. Shays. Right.
    Dr. Sharma. They transferred the technology----
    Mr. Shays. Not by BioPort, though.
    Dr. Sharma. No. They transferred the technology to VaxGen, 
and VaxGen is now taking the next step, which is to take the 
pilot lot and try to demonstrate that they can have the--you 
know, scale up production and, two, to demonstrate that the 
vaccine that they are going to produce is safe and effective. 
Indeed, as part of the first and second contract, they are 
doing those kinds of studies, and they will be submitting the 
data to FDA for determination whether this vaccine is safe and 
effective.
    Mr. Shays. Say the last sentence you just said again, 
please. I was talking. Say the last point.
    Dr. Sharma. As part of the first-year contract and second-
year contract, VaxGen is expected to demonstrate that the 
vaccine that they are producing is safe and effective as part 
of Phase I and Phase II studies. Typically, all manufacturers, 
they submit the data to FDA. They get the comments back from 
FDA. Sometimes FDS would ask them to do additional studies, and 
that is one of the examples of unexpected risk. HHS has asked 
them to do, you know, necessary studies, but what is necessary 
is not up to HHS to determine. It is up to FDA to determine.
    Mr. Shays. OK. Any point you would like to make, Mr. 
Rhodes?
    Mr. Rhodes. I would just like to make one point that we 
learned from HHS, and that is, their primary response structure 
to an incident would begin with antibiotics. The second stage, 
the second step would be the FDA-licensed vaccine. And they 
have in their estimation in the stockpile enough antibiotics 
for 40 million doses, and they have enough of the FDA-licensed 
vaccine for 25 million doses. So from a national readiness 
standpoint, HHS is developing the recombinant PA vaccine, but 
they have in their stockpile right now the antibiotics and the 
FDA-licensed, the BioPort vaccine.
    Mr. Shays. When we started, this committee was--you know, 
we had a number of hearings on anthrax before September 11th, 
but it related to the military. And it related to what we 
thought was an outrage of forced requirement of individuals to 
take a vaccine and the number of shots, at least six, in spite 
of the fact they weren't even going to be in theater. We were 
told, you know, if you did not do this, you would die if you 
contracted anthrax. And yet we know the antibiotics helped 
save--I mean, there is every indication that antibiotics were 
very purposeful in helping to prevent some deaths.
    Anyway, I guess that is a side point here. I just, before 
going, would want to ask: Are we making more of a deal about 
anthrax and is avian bird flu kind of being treated as an equal 
when on a scale of 1 to 10 anthrax would be a 2 and the avian 
bird flu would be like a 10?
    In other words, when we had this hearing today, would it 
have been more important for us to have a hearing about the 
avian bird flu?
    Mr. Rhodes. I don't know that I can answer your question 
without speculation. I can say that having looked at----
    Mr. Shays. It is a trick question.
    Mr. Rhodes. Having looked at the pathophysiology relative 
to how people are getting avian flu, you have to be very close 
to the bird in order to get it. And we have talked to people 
who have taken samples out of highly contaminated locations 
where nobody got sick. We have sort of the----
    Mr. Shays. But they had protective gear on?
    Mr. Rhodes. No. They were regular workers in Canada working 
on a regular bird location. So I don't know that----
    Mr. Shays. It can change and become more aggressive, too. I 
mean, there is no sense that is a constant, right?
    Mr. Rhodes. That's correct. That is correct.
    Mr. Shays. OK. Mr. Duncan, thank you for your patience. Do 
you have any questions?
    Mr. Duncan. No.
    Mr. Shays. So have you put everything on the record that we 
should have asked? If there is something that is not, please 
put it on the record. Is there anything else that should be put 
on the record?
    Mr. Rhodes. No. Thank you.
    Mr. Shays. Well, you know, what I think we have fallen down 
on is we should have had this hearing 5 months ago, a little 
earlier. Your study got done recently, but, you know, for DHS 
not to have been here a year from now and for us to get buy-in 
last week is regretful.
    Thank you all very much, and we will move to the next 
panel.
    Mr. Rhodes. Thank you.
    Mr. Shays. Our next panel, our last panel, panel two, is 
Ms. Ellen P. Embrey, Deputy Assistant Secretary of Defense for 
Health Affairs for Force Health Protection and Readiness, 
Department of Defense; Mr. Jean Reed, Special Assistant to the 
Secretary of Defense for Chemical and Biological Defense 
Programs, Department of Defense; Dr. Gerald Parker, Deputy 
Assistant Secretary for Public Health Preparedness, Department 
of Health and Human Services; Dr. Richard Besser, Director, 
Office of Terrorism Preparedness and Emergency Response, 
Centers for Disease Control and Prevention; Dr. Susan Elizabeth 
George, Deputy Director of Biological Countermeasures 
Portfolio, Department of Homeland Security; Ms. Dana Tulis, 
Deputy Director for the Office of Emergency Management, 
Environmental Protection Agency, accompanied by Mr. Mark Durno, 
On-Scene Coordinator.
    Sorry that our table is somewhat restrictive here.
    Let me thank all of you for spending the time here. I am 
really happy that we are having this hearing, and I am happy 
that we have the range of you, of agencies. And you all were 
here for the previous questions, so there may be something that 
you need to magnify or clarify in your statement, and feel free 
to do that.
    So let me do what we need to do, and that is, to swear you 
in. You sat down, and now you have to stand up. And, Mr. Durno, 
if you are here as well, you should stand. Anyone else that you 
may call on that might have to--great, that way we do not have 
to swear in someone twice. If you would all raise your right 
hands.
    [Witnesses sworn.]
    Mr. Shays. We will note for the record that everyone has 
responded in the affirmative, so everyone is sworn in. And we 
will go in the way you are seated. Given the number of folks, I 
think it would be good if we could stay within the 5-minute 
limit. Obviously, if you go on a few seconds more, no big deal.
    Ms. Embrey--excuse me. You mentioned members of the 
subcommittee. We have been joined by Mr. Van Hollen, and I am a 
little delinquent in not welcoming--is there any statement you 
would like to put in the record?
    Mr. Van Hollen. No. Just thank you, Mr. Chairman, for 
conducting this hearing. I think it is a very important 
subject. Sorry I missed the earlier one. I welcome the 
witnesses, and I am going to apologize in advance for having to 
leave in about half an hour, but I am looking forward to the 
testimony.
    Mr. Shays. Well, if they finish in time, we will let you 
ask the first questions.
    Ms. Embrey.

 STATEMENTS OF ELLEN P. EMBREY, DEPUTY ASSISTANT SECRETARY FOR 
    DEFENSE OF DEFENSE FOR HEALTH AFFAIRS FOR FORCE HEALTH 
  PROTECTION AND READINESS, U.S. DEPARTMENT OF DEFENSE; JEAN 
REED, SPECIAL ASSISTANT FOR CHEMICAL AND BIOLOGICAL DEFENSE AND 
CHEMICAL DEMILITARIZATION PROGRAMS, U.S. DEPARTMENT OF DEFENSE; 
  GERALD W. PARKER, D.V.M., PRINCIPAL DEPUTY TO THE ASSISTANT 
SECRETARY, OFFICE OF PUBLIC HEALTH EMERGENCY PREPAREDNESS, U.S. 
  DEPARTMENT OF HEALTH AND HUMAN SERVICES; RICHARD E. BESSER, 
M.D., DIRECTOR, COORDINATING OFFICE FOR TERRORISM PREPAREDNESS 
    AND EMERGENCY RESPONSE, CENTERS FOR DISEASE CONTROL AND 
 PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; S. 
     ELIZABETH GEORGE, PH.D., DEPUTY DIRECTOR, BIOLOGICAL 
COUNTERMEASURES PORTFOLIO, SCIENCE AND TECHNOLOGY DIRECTORATE, 
   U.S. DEPARTMENT OF HOMELAND SECURITY, ACCOMPANIED BY JOHN 
    VITKO, JR., PH.D., DIRECTOR, BIOLOGICAL COUNTERMEASURES 
PORTFOLIO, SCIENCE AND TECHNOLOGY DIRECTORATE, U.S. DEPARTMENT 
 OF HOMELAND SECURITY; AND DANA TULIS, DEPUTY DIRECTOR, OFFICE 
OF EMERGENCY MANAGEMENT, U.S. ENVIRONMENTAL PROTECTION AGENCY, 
  ACCOMPANIED BY MARK DURNO, ON-SCENE, COORDINATOR [OSC] EPA 
                            REGION 5

                  STATEMENT OF ELLEN P. EMBREY

    Ms. Embrey. Thank you. I am here today as part of a two-
member representation from the Department of Defense. I am here 
to talk specifically about Defense's programs to prevent, 
mitigate, and respond to anthrax incidents. Today, we have 
about 236,000 service men and women deployed in support of our 
Nation's defenses, including those serving in Afghanistan and 
Iraq. Protecting and preserving the health of our service 
members before, during, and after their deployments is our 
primary mission.
    With respect to weapons of mass destruction, DOD policies 
affecting immunizations, DOD Directive 6205.3, that provides 
policy guidance on vaccines and vaccination policies for 
defense against biological warfare threats, to include the 
agent that causes anthrax. Vaccination is an essential layer of 
protection, supplemented by antibiotics and other measures, for 
members of the armed forces, emergency-essential DOD civilians, 
and contractor personnel who carry out mission-essential 
services.
    The department currently uses two forms of medical 
countermeasures against anthrax: vaccines and antibiotics. 
Vaccines provide an effective means of preventing disease and 
offer an advantage of providing around-the-clock protection, 
even in the absence of biologic agent detectors. Antibiotics 
have value if given shortly after exposure. However, if 
prevention, detection, and treatment are delayed, people can 
still develop anthrax disease.
    Anthrax Vaccine Adsorbed (BioThrax) is an FDA-licensed 
vaccine. On December 19, 2005, the Food and Drug 
Administration, after a review of all available scientific 
information and consideration of extensive public comments, 
published a final order reaffirming previous conclusions that 
the Anthrax Vaccine Adsorbed prevents anthrax resulting from 
any route of exposure, including inhalation.
    The Department works closely with BioPort Corp., the 
manufacturer of the only anthrax vaccine licensed by the FDA, 
to ensure a consistent supply of vaccine to meet the 
requirements for DOD's anthrax program. Since 2002, BioPort has 
doubled its production capacity and delivered more than 8.4 
million FDA-licensed doses of Anthrax Vaccine Adsorbed to DOD. 
Inventory levels are sufficient to meet current DOD anthrax 
immunization program requirements.
    The current contract with BioPort expires this September. 
DOD is currently in negotiations with BioPort for a new 
contract beginning in fiscal year 2007 to meet our vaccination 
requirements. We anticipate needing to buy Anthrax Vaccine 
Adsorbed through at least fiscal year 2009 and possibly longer, 
depending upon when the new anthrax vaccine that HHS is working 
on may be licensed. A decision to switch to that new vaccine 
will be supported by science and a thorough business case 
analysis.
    The anthrax vaccine is safe and effective, facts that are 
fully supported by the Food and Drug Administration and other 
national experts and based on science. The National Academy of 
Sciences and its Institute of Medicine comprehensively reviewed 
the safety of anthrax vaccine in April 2002 by a report 
commissioned by Congress. The IOM stated in that report that 
adverse events after anthrax immunization are ``comparable to 
those observed with other vaccines regularly administered to 
adults.'' As with all vaccines and pharmaceuticals that have a 
benefit, there are some risks, but most adverse events after 
vaccination are minor and temporary. Anthrax immunization may 
have associated temporary pain, swelling, headache, muscle 
aches, and other side effects, similar to all immunizations. 
There are several grounds for medical exemption, including 
pregnancy. Serious events, such as those requiring 
hospitalization, are extraordinarily rare. The Department has 
established four sites in the Vaccine Healthcare Center 
Network, a network of specialty clinics, to provide the best 
possible care in rare situations where serious adverse events 
follow vaccination. DOD assesses the safety of vaccines using a 
multi-faceted program using various scientific study designs.
    Anthrax immunization remains the most effective 
countermeasure to prevent anthrax. Between March 1998 and this 
last March, in 2006, over 1.5 million personnel received over 
5.5 million doses of the anthrax vaccine. Currently, DOD 
personnel deploying to high-risk areas, specifically Korea and 
areas under the Central Command, are eligible for anthrax 
immunization and have an option to decline. In addition, 
effective antibiotics against anthrax disease and other 
biological agents are prepositioned strategically around the 
globe for rapid delivery in the event of an emergency. The 
Department is collaborating with HHS to develop plans for the 
use of post-exposure anthrax immunization combined with 
antibiotics in those personnel who were not previously 
immunized. This is consistent with the prevailing medical 
recommendation for the best clinical response to anthrax 
exposure.
    Although anthrax vaccine is licensed by the FDA, its 
approved labeling does not include post-exposure use to prevent 
anthrax disease. However, the Food, Drug and Cosmetic Act, part 
of the Project BioShield Act of 2004, allows FDA to authorize 
the use of unapproved medical products or an unapproved use of 
an approved medical product during a declared emergency 
involving an actual or heightened risk of attack on the public 
or U.S. military forces. Based on an emergency declaration by 
the Secretary of HHS, the FDA Commissioner can authorize 
emergency use of a product----
    Mr. Shays. If you would sum up.
    Ms. Embrey. I am really glad to be here, and I will answer 
your questions. [Laughter.]
    Mr. Shays. You must have one last sentence you want to say.
    Ms. Embrey. No, sir. Really, I am glad to be here and I 
will answer your questions.
    Mr. Shays. OK. Thank you.
    [The prepared statement of Ms. Embrey follows:]

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    Mr. Shays. Mr. Reed.
    I am only thinking of my colleague. I want to make sure he 
gets some questions before he goes.

                     STATEMENT OF JEAN REED

    Mr. Reed. Mr. Chairman, distinguished committee members, 
thank you for the opportunity to appear before the subcommittee 
today to discuss the Department of Defense's capabilities 
regarding detection of anthrax, an area to which the Department 
has committed considerable resources to mitigate the effects of 
anthrax on our armed forces.
    I am Jean Reed. I'm the Special Assistant for Chemical and 
Biological Defense and Chemical Demilitarization Programs. In 
this capacity, I support Dr. Dale Klein, the Assistant to the 
Secretary of Defense for Nuclear, Chemical, and Biological 
Defense Programs. As Special Assistant, I have responsibility 
for oversight of chemical and biological defense programs 
throughout the Department of Defense.
    I have been on the job for about 5 months. I came to this 
job from 15 years as a professional staffer for the House Armed 
Services Committee. In that role, my responsibilities included 
staff oversight for the Department of Defense's Chemical and 
Biological Defense Program, and I was the staff lead for Title 
16, the Defense Biomedical Countermeasures title of the 
National Defense Authorization Act for Fiscal Year 2004, which 
was closely coordinated with the Project BioShield Act of 2004.
    In my current position, I find myself on the other side of 
the table. I am now faced with the challenge of preparing U.S. 
forces to operate in environments that have been contaminated 
by chemical and biological agents. In addition to overseas 
environments and operations, U.S. forces are being prepared to 
operate in these types of environments in support of both 
homeland defense and homeland security operations.
    I am going to provide a brief status today of the DOD 
Biological Detection Systems that are relevant to the detection 
of anthrax, and they are, in summary, shown on the tripods to 
your left, my right, and I have asked committee staff to go 
ahead and distribute individual copies of the one labeled 
``Biological Detection.''
    Many of these systems are focused on protecting military 
personnel in operational environments. However, the 
technologies used in these systems may have applications to 
support protection of personnel in buildings. The Department of 
Defense orients its program primarily toward measures for 
operations of the troops in the field, but we share 
technologies and gain from technologies being developed by 
other departments in the executive branch.
    The Biological Integrated Detection System [BIDS], is a 
vehicle-mounted, fully integrated biological detection system. 
It is a core-level asset. The current model is capable of 
detecting and identifying eight biological warfare agents 
simultaneously in 30 minutes.
    Joint Portal Shield is an interim biological detection 
system used to protect high-level fixed assets. It uses an 
innovative network of sensors to increase the probability of 
detecting a biological warfare attack while decreasing false 
alarms and consumables. Each sensor is modular in design and 
can detect and identify up to 10 biological warfare agents 
simultaneously in less than 25 minutes.
    Mr. Shays. Let me encourage you to just summarize.
    Mr. Reed. Yes, sir. Joint Biological Detection System, also 
oriented now as a fully automated system that will replace both 
BIDS and the JPS. That program, a modular design variant, 
referred to as the Homeland Defense Trailer, was deployed as 
part of the network of eight JBPDS systems in the National 
Capital Region on November 28, 2001, and was fully operational 
on December 3, 2001.
    There are a number of other programs, sir, that are in my 
testimony for the record. Suffice it to say that we are working 
with currently and fielding advanced systems and then have 
additional systems under development. The issue of standoff 
biological detection is a very, very difficult problem, and 
Defense Advance Research Projects Agency is working with us in 
that effort. Additionally, DARPA is also developing the 
Handheld Isothermal Silver Standard Sensor and the Spectral 
Sensing of Biological Aerosols as fieldable systems for 
handheld portable detection of biological weapons and agents on 
the battlefield, and one of my colleagues in Health and Human 
Services emphasized that the Handheld Isothermal Silver 
Standard Sensor is a unique device that is not being followed 
in the commercial sector, but is one that is very important to 
us.
    I want to briefly underscore the importance of the anthrax 
detection programs within the Pentagon, such as the new mail 
screening facility. All mail entering the Pentagon is now 
screened with biosafety cabinets, and once screened and samples 
tested, then distributed to the recipients.
    My colleague has already addressed the biological--or the 
Anthrax Vaccination Immunization Program. I am a very early 
graduate of that program, having gotten the six shots in 1972 
when I was at Army Materiel Command, and I can attest to the 
fact that the sixth shot in that series is a loser. It hurts. 
All the reason for having and seeking advanced vaccines, but 
what we have right now, as Ms. Embrey emphasized, is the 
BioPort AVA vaccine for the use of our troops in the field.
    Sir, with that, I will be prepared to answer any questions 
you might have.
    [The prepared statement of Mr. Reed follows:]

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    Mr. Shays. Thank you very much, Mr. Reed.
    Dr. Parker.

                 STATEMENT OF GERALD W. PARKER

    Dr. Parker. Good afternoon, Mr. Chairman and subcommittee 
members. I am Gerald Parker, the Principal Deputy Assistant 
Secretary for Public Health Emergency Preparedness in the 
Department of Health and Human Services.
    The events of October 2001 made it very clear that 
bioterrorism is a serious threat to our Nation and the world. 
Within HHS, the mission to prepare for and respond to the 
medical and public health consequences of this threat is 
coordinated by the Office of Public Health Emergency 
Preparedness. I will focus my remarks this afternoon on a 
critical component of HHS' medical and public health mission, 
medical countermeasure development, and acquisition to improve 
our preparedness to meet the threat posed by anthrax.
    Development, acquisition, and deployment of safe and 
effective medical countermeasures to mitigate illness and 
prevent death in the event of an anthrax attack are top 
priorities for HHS. Among biological threat agents, anthrax is 
widely recognized as having the potential to cause catastrophic 
harm. Although much remains to be done, we have made 
substantive progress in building our Strategic National 
Stockpile from where it was pre-September 11th. Antibiotics are 
and remain a cornerstone of our anthrax response strategy, and 
their stockpiling demonstrates the dramatic improvements in our 
readiness.
    Had I been in this position testifying before you before 
September 11th, I would have told you that we had begun to 
build our antibiotic stockpile. But we would have had fewer 
than 150,000 post-exposure prophylactic courses. By contrast, 
today we have a diverse and continually growing stockpile of 
medical countermeasures to respond to an anthrax attack. This 
is built on a comprehensive strategy that includes antibiotics, 
vaccines, and antitoxins. As our front-line response, we now 
have antibiotics to provide 60-day post-exposure prophylaxis 
for over 40 million people.
    Second, we have acquired 5 million doses of a licensed 
anthrax vaccine, AVA, and we have begun to receive a second 5 
million doses for which delivery will be completed within a 
year.
    Third, we are aggressively developing a next-generation 
anthrax vaccine and have a contract to buy 75 million doses of 
this new vaccine.
    Fourth, we can treat over 800,000 symptomatic anthrax 
patients with intravenous antibiotics.
    And, fifth, we are increasing our stockpile of anthrax 
antitoxins to treat the toxemia associated with symptomatic 
anthrax disease.
    This diverse portfolio of medical countermeasures is 
necessary for our preparedness strategy. Antibiotics, the front 
line of our defense, are FDA approved, proven effective, and 
relatively inexpensive.
    Anthrax vaccines have the following benefits: One, they 
provide pre-exposure protection of individuals at increased 
risk of exposure to anthrax; two, they may provide additional 
protection in a post-exposure setting when used in combination 
with antibiotics and could potentially reduce the currently 
recommended 60-day duration of antibiotic treatment; and, 
three, they provide relatively long-term protection when 
compared with antibiotics and would expand worker protection 
for remediation efforts after anthrax contamination.
    HHS is also pursuing the acquisition of anthrax antitoxins 
to treat the toxemia that occurs as anthrax disease progresses. 
These antitoxins will be stockpiled as an adjunct to the 
antibiotic therapy for symptomatic patients.
    I would now like to return to the subject of anthrax 
vaccine and briefly describe our next-generation anthrax 
vaccine program.
    Today, this program to develop a next-generation anthrax 
vaccine represents both a development challenge and an 
opportunity to potentially enhance our preparedness for meeting 
the anthrax threat. In March 2004, the acquisition program for 
a next-generation anthrax vaccine based on recombinant 
protective antigen, a protein component of the anthrax toxin, 
was launched. This decision to move forward with an acquisition 
was based upon scientific consensus, including that of the 
Institute of Medicine, that a next-generation vaccine was 
necessary, and after two rounds of competitive milestone rPA 
anthrax vaccine development contracts at the National 
Institutes of Health and after the establishment of a 
requirement by the Interagency WMD Medical Countermeasures 
Subcommittee to acquire rPA anthrax vaccine for 25 million 
persons.
    Utilizing a rigorous, technical, and business evaluation 
process that included experts from Government, industry, and 
academia, HHS reviewed multiple proposals received as part of a 
full and open competition and awarded an $877 million contract 
in November 2004 for the acquisition of 75 million doses of the 
vaccine to VaxGen of Brisbane, CA.
    The contract requires the manufacturer to seek licensure 
for both pre-exposure and post-exposure use. The procurement 
anticipated a three-dose vaccination schedule for 25 million 
persons. In accordance with Project BioShield, no payment for 
product is made until a usable product is delivered to the 
Strategic National Stockpile.
    In late 2005, VaxGen announced that it anticipated a delay 
in the delivery of the product to the stockpile. We are 
concerned about this delay, but confident that an rPA-based 
anthrax vaccine should reach its goal of licensure. HHS has 
recently modified the contract with VaxGen and established a 
new delivery schedule acknowledging this delay. We now 
anticipate up to a 3-year delay in delivery of the initial 25 
million doses of rPA anthrax vaccine.
    It is important to note that delays in accelerated 
development programs are not unexpected and unprecedented. For 
example, while our ACAM2000 smallpox vaccine program, which 
began prior to September 11th, experienced slippages in the 
project timeline, the program was ultimately successful and the 
Federal Government received full delivery of the product.
    While awaiting delivery of the rPA vaccine, HHS has moved 
forward to meet immediate anthrax vaccine requirements through 
the acquisition of 10 million doses of AVA----
    Mr. Shays. If you could summarize.
    Dr. Parker. I will be happy to answer questions, Mr. 
Chairman.
    [The prepared statement of Dr. Parker follows:]

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    Mr. Shays. Thank you. What a great way to move forward 
here.
    Dr. Besser, thank you. And these are very helpful 
statements. They are on the record, and I think our questions 
will----

              STATEMENT OF RICHARD E. BESSER, M.D.

    Dr. Besser. Good afternoon, Chairman Shays and members of 
the subcommittee. Thank you for the opportunity to be here. I 
am Dr. Richard Besser, Director of the Centers for Disease 
Control and Prevention's Coordinating Office for Terrorism 
Preparedness and Emergency Response. With me today is Mr. Max 
Kieffer, a scientist from CDC's National Institute for 
Occupational Safety and Health, who is directly involved in our 
anthrax detection activities. I am pleased to provide this 
testimony to update you on CDC's efforts to improve the 
Government's ability to accurately detect anthrax inside a 
building.
    As part of the Department of Health and Human Services, 
CDC's responsibility is to provide national leadership in the 
public health and medical communities in a concerted effort to 
prevent, detect, diagnose, and respond to injury and illnesses, 
including those that occur as a result of a deliberate release 
of biological agents.
    CDC collaborates and coordinates closely with the 
Department of Health and Human Services, the Department of 
Homeland Security, the Department of Defense, and the 
Environmental Protection Agency, among others.
    CDC and HHS are preparing the Nation to respond to a wide 
range of threats to public health whether natural disasters or 
acts of terrorism. We are strengthening the State and local 
public health infrastructure, expanding lab capacity, 
stockpiling life-saving countermeasures for use in emergencies, 
and deploying CDC staff to respond to public health emergencies 
and other events.
    CDC has made considerable improvements in a number of areas 
that contribute to anthrax detection. I will focus my remaining 
time on three specific topics: environmental sampling 
strategies, validating sampling protocols, and laboratory 
capacity building.
    During the response to the 2001 anthrax attacks, CDC relied 
on targeted sampling strategies to determine where 
environmental samples should be collected within buildings. 
Incident-specific details such as epidemiologic data, 
interviews with U.S. Postal Service Personnel, and 
understanding of the mail-handling process were used to help 
identify locations considered most likely to be contaminated so 
that environmental samples could be collected at targeted 
locations within a facility.
    CDC continues to believe that a targeted sampling strategy 
is the most rapid, efficient, and successful approach when 
information is available on the path and/or the vehicle of 
introduction of the suspect infectious agent. However, CDC 
agrees that there is a need to further develop probabilistic 
sampling approaches to provide additional sampling strategy 
tools that may be appropriate in certain circumstances. Toward 
this end, CDC recently initiated a project with the Department 
of Energy's Pacific Northwest National Laboratory to use the 
lab's ``Visual Sample Plan'' software tool as a platform for 
this approach. This project will result in the creation of a 
sampling tool that will be available to field investigators to 
guide them through the steps needed to perform probabilistic 
sampling and to manage the documentation for the sample.
    Detecting anthrax in buildings depends on having reliable, 
trusted sampling protocols. Validation of sampling protocols is 
an important objective, and we continue to support efforts to 
validate components of the detection process. CDC researchers 
have undertaken several laboratory studies evaluating methods 
for recovering and extracting Bacillus anthracis spores. In 
addition, CDC continues to support research to evaluate 
environmental sampling methods for Bacillus anthracis in 
collaboration with other Federal agencies. CDC is funding 
research that is underway at the U.S. Army's Dugway Proving 
Ground in Utah with the goal of improving environmental 
sampling methods, determining limits of detection, and 
evaluating inter-lab variability.
    Another collaboration is between CDC and EPA with the 
Sandia National Laboratories in New Mexico on a study funded by 
DHS to evaluate current surface sample and extraction methods. 
The work has been completed, and our first publication is in 
peer review.
    Detecting anthrax in buildings, however, is contingent on 
having laboratories with diagnostic capacity. The Laboratory 
Response Network is a national network of hospitals, State and 
local public health, Federal military, veterinary, agriculture, 
food, and environmental testing laboratories that provide 
diagnostic capacity to respond to biological and chemical 
terrorism and other public health emergencies. We have expanded 
our ability to analyze more environmental samples given 
additional LRN capacity building since 2001. Currently, 87 
percent of the U.S. population resides within 100 miles of a 
Laboratory Response Network laboratory. All funded LRN 
laboratories have the capacity to test for Bacillus anthracis.
    The LRN recently developed a new technique that permits 
testing for multiple-threat agents simultaneously, which saves 
time and frees up laboratory testing capacity. This is 
particularly important when dealing with credible threats 
involving unknown infectious agents. The Laboratory Response 
Network also has made advances in electronic data exchange to 
facilitate the rapid communication of laboratory test results 
in an emergency situation.
    In conclusion, CDC has made many advancements in the past 
year. Our ability to detect anthrax has improved in a number of 
ways. As a result of research and planning activities, we now 
have better information to guide us. CDC has learned a lot 
since the anthrax attacks of 2001 about sampling and analysis 
of anthrax, and we continue to learn more so that our response 
to future incidents will be as fast and effective as possible.
    Mr. Chairman, this concludes my oral testimony. I would be 
happy to answer questions.
    [The prepared statement of Dr. Besser follows:]

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    Mr. Shays. Thank you, Dr. Besser.
    Dr. George.

                STATEMENT OF S. ELIZABETH GEORGE

    Dr. George. Good afternoon, Chairman Shays and 
distinguished members of the subcommittee. It is a pleasure to 
be with you today to discuss the role of the Department of 
Homeland Security Science and Technology Directorate in 
protecting our Nation against the biological threat, to include 
anthrax.
    Today I will provide comment in the context of the March 
2005 GAO report concerning anthrax detection. DHS concurs with 
the GAO that the use of stratified sampling strategies is an 
appropriate approach. The GAO investigation prompted valid 
recommendations, of which DHS has made significant progress. 
DHS has taken a lead role in promoting and coordinating the 
activities of various agencies that have technical expertise 
related to environmental sampling. DHS has adopted the ISO9000 
definition of ``validation.'' DHS has developed a process to 
standardize and validate methods. DHS has invested both in 
targeted and probabilistic sampling strategies, as well as 
methodologies that are appropriate for facility monitoring, and 
DHS has prioritized investments for high-risk biological agents 
through internal and interagency coordination.
    Now, please let me briefly describe some of the supporting 
activities in surveillance, restoration, interagency 
coordination, and validation that illustrate our 
accomplishments.
    In 2003, BioWatch, our national environmental monitoring 
system, was deployed, in partnership with CDC, EPA, and the 
FBI, to more than 30 major U.S. cities, and it continues its 
operation today. The BioWatch Preparedness and Response 
Guidance Document, which has a significant sampling component 
for incident characterization, was developed through a 
collaborative DHS, CDC, EPA, and FBI effort. The current 
revision will provide detail on indoor sampling strategies and 
techniques and will be tailored for specific agents.
    DHS recently completed a facility restoration research and 
demonstration program in partnership with EPA, CDC, and others. 
In the program we developed a general restoration plan for an 
international airport. The restoration plan provides a detailed 
description of sampling strategies and currently is being 
implemented in partnership with the Washington Metropolitan 
Area Transit Authority and the New York City Metropolitan 
Transportation Authority. DHS has invested in several 
additional R&D efforts to significantly improve sampling 
capability within the context of surveillance and restoration.
    The DHS S&T completed sampling efficiency studies this 
year. Last year, DHS developed an electronic data collection 
and data management tool that assists in gathering samples and 
annotates the process of merging field data with laboratory 
results. Also, DHS through TSWGs sponsored the development of 
the Visual Sample Plan module for statistically sampling 
buildings.
    DHS has been proactive in leading and coordinating 
interagency efforts associated with biological detection and 
restoration. DHS led the formulation of an MOU to integrate and 
standardize the National Biomonitoring Systems and current is 
implementing the MOU actions with interagency partners. Through 
an MOA with multiple Federal agencies, DHS is leading an effort 
to establish an integrated consortium of laboratory networks to 
develop laboratory standards and surge capability. DHS is co-
chairing with EPA the Subcommittee on Decontamination Standards 
and Technology. The subcommittee is charged to facilitate the 
development of consistent guidelines and strategies to address 
decisionmaking regarding decontamination after a chemical or 
biological incident.
    In fiscal year 2005, DHS, in collaboration with NIST, took 
the first steps to prioritize and initiate the development of 
standards related to biological sampling activities by 
standardizing and validating a method by which hazardous 
materials technicians collect, transport, and store suspicious 
powder samples. This fiscal year, DHS, in collaboration with 
our interagency partners and the private sector, will develop, 
evaluate, validate, and make available an assay set for use by 
the private sector that develops commercial, off-the-shelf 
biodetection technologies.
    The March 2005 GAO report focuses on the statistical 
confidence associated with environmental sampling strategies 
and methodologies, and DHS has made significant progress in 
addressing each of the GAO recommendations. Sampling is an 
integral part of a larger system and, thus, the requirements 
generated for sampling performance and method selection should 
be within the context of the overall system to provide for 
higher confidence decisions in a realm of uncertainty.
    Chairman Shays and distinguished members of the 
subcommittee, I again thank you for this opportunity to have 
testified before you and am happy to answer any questions that 
you may have.
    [The prepared statement of Dr. George follows:]

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    Mr. Shays. Thank you, Dr. George.
    Ms. Tulis.

                    STATEMENT OF DANA TULIS

    Ms. Tulis. Mr. Chairman and members of the subcommittee, I 
am Dana Tulis, Deputy Director of the Office of Emergency 
Management within the Office of Solid Waste and Emergency 
Response at the Environmental Protection Agency. I am 
accompanied by Mr. Mark Durno, sitting here at my left.
    I appreciate the opportunity to discuss the steps EPA is 
taking in response to the Government Accountability Office in 
their report on anthrax detection. I would also like to share 
with you other activities EPA and our Federal partners have 
underway to protect the Nation from an anthrax attack and after 
an anthrax attack.
    I will summarize my statement, but I ask that my entire 
written statement be included in the hearing record.
    EPA still believes that targeted sampling strategies are 
valid and necessary for rapidly assessing the likelihood of 
contamination to ensure that necessary actions can be taken 
quickly to protect those potentially exposed. When the source 
of contamination is known, targeted sampling of surfaces is 
determined with incident-specific details such as traffic 
patterns and airflow within the facility, epidemiological data, 
and forensic information. This was the approach used during the 
anthrax attacks in 2001, to ensure immediate steps were taken 
to protect the people potentially exposed. However, when 
contamination is known to exist but the source is unknown, the 
use of statistically based sampling may improve the probability 
of detecting contamination. Again, contamination must be 
believed or known to exist for statistical sampling.
    As to Federal agency activities, EPA has recently completed 
developing a new, dedicated National Decontamination Team to 
provide technical expertise for environmental sampling and 
decontamination associated with weapons of mass destruction. 
The team is comprised of specialist technical experts who can 
provide round-the-clock scientific expertise and operational 
support during a WMD response--that is, weapons of mass 
destruction.
    EPA is close to completing internal review of environmental 
sampling guidelines for biological incidents. This describes 
operating procedures for environmental sampling and presents a 
framework for developing a sampling approach for investigating 
biological incidents. The guidance addresses five media--air, 
bulk, wipes, liquids and solids--and seven agents, including 
anthrax.
    Another draft we have developed is on standardized 
procedures for the collection of anthrax in environmental 
matrices. This is undergoing peer review within EPA and CDC. 
This guide will tell samplers exactly how to prepare the 
samples to be sent to CDC labs for analysis.
    Development of these sampling guidelines is being 
coordinated with the multi-agency effort to improve guidance 
for BioWatch consequence management sampling. Over the past 2 
years, our emergency responders have been working with local 
BioWatch Advisory Committees to develop and exercise sampling 
strategies for us after a positive BioWatch signal.
    EPA, along with DHS, has been an active partner in Lawrence 
Livermore's National Lab development of biological sampling and 
restoration plans for an airport in San Francisco, the San 
Francisco International Airport. The work is a model for other 
airports and transportation facilities, and we plan to 
participate in developing a similar plan for an airport on the 
East Coast this year. These plans do include probabilistic 
sampling.
    GAO noted that the anthrax sampling methods have not been 
validated. Method validation is a long and complex process, and 
EPA is working closely with our colleagues in DHS, CDC, DOD, 
and other agencies to validate existing methods as well as to 
explore new ones. The biological sampling guidelines I 
mentioned earlier represent those first steps.
    EPA is currently participating with CDC, NIOSH, DHS, Sandia 
National Lab, and the U.S. Army at Dugway Proving Ground in two 
studies that evaluate the efficiency of surface sample methods 
for spore collection on porous and nonporous surfaces. Both 
studies provide a robust scientific and statistical evaluation 
of current swab, wipe, and vacuum sample collection methods.
    EPA agrees there needs to be increased capacity for 
analyzing environmental samples for anthrax and other WMDs. The 
President's fiscal year 2007 budget proposed an environmental 
laboratory response network program within EPA to start 
building environmental laboratory capacity. In the interim, our 
Homeland Security Lab Response Work Group is working with 
internal and external experts to design a functional 
environmental lab response network. EPA, CDC, and other Federal 
agencies are working closely under DHS' leadership to implement 
the Integrated Consortium of Laboratory Networks. This 
consortium, as you heard, is addressing a wide range of 
technical and planning issues for laboratory needs, scenario 
planning, and consistency in methods. Design is also complete 
for an All Hazard Receipt Facility which will screen samples 
and protect laboratory personnel. With support from DHS, units 
will be deployed this year to EPA's Region 1 lab and New York 
State Health Laboratory for testing and evaluation.
    We are also building on our expertise as EPA continues to 
look for faster, less expensive methods for recovering after an 
anthrax attack. EPA is advancing the science of test methods 
and surrogates as well as working with fumigant vendors to 
optimize procedures for decontamination.
    We are working to reduce the timeline, and we have reduced 
it already dramatically. We are refining and enhancing 
available decontamination methodologies, for example, a 
bacteriophage, which is a virus that eats bacteria but is 
harmless to humans. EPA is constantly evaluating additional 
decontamination and disposal alternatives.
    In conclusion, EPA is working closely with other Federal 
agencies to improve sampling and analytical methods, address 
national laboratory capacity, and refine and improve 
decontamination and disposal technologies. I believe we have 
taken significant steps in these areas addressing GAO concerns 
as EPA continues to look forward to our continued collaboration 
in the future.
    Thank you, Mr. Chairman. That concludes my remarks. I will 
be happy to answer any questions you or the subcommittee 
members may have.
    [The prepared statement of Ms. Tulis follows:]

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    Mr. Shays. Thank you. I am going to start off with Mr. Van 
Hollen, and then I will go to my colleague, Mr. Duncan, and 
then I will go.
    Mr. Van Hollen. Well, thank you, Mr. Chairman, and thank 
you again for holding this hearing. I thank all the witnesses 
for their testimony. I have some questions both on the 
detection issue and then on the vaccine issue. Let me start 
with the detection issue.
    Dr. Besser, you mentioned the fact that we are trying to 
expand the Laboratory Response Network and the enhancements 
there. Specifically, you mentioned the multiplex technology so 
you would able to detect multiple agents with one test, which I 
think is good news.
    I guess my question is: When do you predict we will be able 
to actually deploy that around the country so that it will 
really operate as a detection system to help protect the 
American people?
    Mr. Shays. Just for the record, each member is going to be 
provided about 10 minutes, and we will do it that way.
    Dr. Besser. Mr. Van Hollen, thank you very much for that 
question. I think that we all agree with you about the 
importance of that technology, especially when you are dealing 
with a situation where you do not have a known agent that has 
been released.
    I would like to get back to you for the record on that and 
followup with the researchers who are doing that work to be 
able to give you an appropriate update on the status of that 
project.
    Mr. Van Hollen. OK. I mean, I think it is a welcome 
development. Obviously, if its efficacy is shown, we would like 
to get it deployed as soon as possible.
    We have some testimony from the representatives from DOD 
about biological detection equipment in the field. Obviously, 
we also want to prepare not just for an attack in the military, 
but a terrorist attack on the civilian population. And the 
question is whether it makes sense to deploy some of these 
detection devices and techniques in areas where you have lots 
of people congregating. We have heard over the years the 
scenario of a Metro system attack with anthrax or some other 
kind of agent. Are we at the point where we have the technology 
that we can deploy in Metro systems? Have we?
    I have asked this of the Washington Metro representatives 
when they come up here, and we always get sort of fuzzy 
answers. I would welcome any testimony you have on that.
    Mr. Reed. Sir, if I may--and we will give you this for the 
record as well. But if you go into the Metro system, as you 
walk around, you will see a series of trailers or stanchions, 
stations, in each of the Metro stations that are, in fact, 
detection systems.
    Mr. Van Hollen. You are talking about specifically the 
Washington Metro system?
    Mr. Reed. The Washington Metro system.
    Mr. Van Hollen. And have we deployed that in other major 
cities around the country?
    Mr. Reed. I do not have that information, sir, but we will 
get it for the record.
    Mr. Van Hollen. OK. If the DHS folks, if you do not have 
the answer, if you could get us that answer, the extent to 
which we have deployed anthrax detection and whatever other 
kinds of agent detection in Metro systems in major cities 
around the country.
    Mr. Reed. Just for clarity, sir, we will give you the type. 
They may not all be anthrax.
    Mr. Van Hollen. I am sorry?
    Mr. Reed. They may be more oriented toward chemical than 
biological, but I need to give you that for the record.
    Mr. Shays. You need to give off--could the gentleman yield?
    Mr. Van Hollen. Sure.
    Mr. Shays. Or if you would just clarify, that is all.
    Mr. Van Hollen. I guess what the chairman is wondering is 
if--you are saying you do not know or you need to tell us off 
the record.
    Mr. Reed. I have to check both of those in terms of the 
detail on what is there.
    Mr. Van Hollen. All right. Well, in whatever, you know, 
means of providing the information is appropriate, I think we 
would be interested both in terms of the extent to which we 
have deployed these detection systems in Metro systems in major 
cities around the country and what exactly it is that they are 
able to detect.
    Dr. George. I probably will not comment on exactly what 
they are detecting because that would present a vulnerability, 
but, yes, we are focusing on placing detection technologies, 
both chemical and biological, in the subway systems across the 
country, typically at the discretion of the locals, where they 
want to put it, and whether it is subways or airports or 
whatever other transportation hubs, we are actively doing that.
    Mr. Van Hollen. OK, good. Let me just turn to the vaccine 
issue, specifically on anthrax, and the questions that it may 
raise about the entire BioShield program. As I understand, the 
anthrax contracts are sort of the major contract right now 
existing within the BioShield, the single largest. Is that 
right?
    Dr. Parker. Yes, sir, that is.
    Mr. Van Hollen. And we spend about close to $1 billion on 
this contract, which is now behind schedule. Is that right?
    Dr. Parker. Let me correct that. We have obligated--for the 
rPA VaxGen contract, we have obligated $877 million.
    Mr. Van Hollen. OK.
    Dr. Parker. But according to the BioShield authorities, 
payment is not made until usable product is delivered to the 
Strategic National Stockpile. Product has not yet been 
delivered to the Strategic National Stockpile.
    Mr. Van Hollen. OK. My question is this----
    Dr. Parker. And if I can complete that, we have also then 
purchased Anthrax Vaccine Adsorbed [AVA], the current licensed 
anthrax vaccine, from BioPort, also using the Project BioShield 
authority.
    Mr. Van Hollen. Right, and I commend you for doing that in 
the interim as this--because of the delay in the other 
contract.
    With respect to the other contract, look, we obviously have 
problems that have been testified to with the VaxGen contract. 
To what extent are those due to failures of the company? To 
what extent are they due to failures, you know, and changes in 
the contract at the Department of Health and Human Services? 
Which, as I am sure you know, allegations have been made to 
that effect. And to what extent are there problems in the 
structure of the BioShield Program? Because this will raise 
questions about the overall effectiveness of that as a design. 
We have heard a lot about the so-called ``Valley of Death'' and 
the fact that you do not get paid until, you know, you have 
shown a product that has demonstrated efficacy.
    If you could sort of let us know how we got behind on this 
contract and how----
    Dr. Parker. Let me give you, if I may, if I could give you 
an overview, there are some things that I am not going to be 
able to specifically discuss about this contract for the--
because I cannot. I have an obligation to not reveal company 
confidential information. But we would be glad, more than happy 
to come and talk in detail about some of those things, but 
first of all Project BioShield and some unique authorities 
there.
    As I already mentioned, payment is conditioned on 
successful delivery of usable product to the Strategic National 
Stockpile. This was set up as a very accelerated advanced 
development acquisition program. Project BioShield is meant to 
incent pharmaceutical companies, biotechnology companies, to 
help us in the development of medical countermeasures that 
otherwise would not be developed. It is meant to provide that 
market.
    I think we are recognizing the need for more prolonged 
advanced development funding, and if you will notice in our 
fiscal year 2007 budget, we have included $160 million to 
establish a new advanced development program to help support 
biodefense, late-stage advanced development projects. The 
reason is to begin to reduce--hopefully to reduce the risk 
prior to a product going into a BioShield acquisition contract.
    Now, in regards specifically to this current contract with 
VaxGen and rPA, of course, we are not happy about the delay. 
But, on the other hand, delays in accelerated advanced 
development programs like this are also not unexpected. We had 
a similar delay in our program to develop ACAM200, a smallpox 
vaccine, that was initiated prior to September 11th. It 
ultimately was a successful program and delivered the smallpox 
vaccine to the Strategic National Stockpile, and I think rather 
than getting into very specific details about the delay in this 
specific project, I would like to come and have a very detailed 
discussion with you that we can go into much more detail, if 
that is fair enough.
    Mr. Van Hollen. That is fine. The last question I have, and 
I apologize that I have to leave early. But the original intent 
was to try and get, I think it was 75 million doses by the end 
of this year in terms of anthrax. Given the shortfall and the 
delay in the contract, does it make sense to purchase even more 
of the existing and approved FDA anthrax vaccine?
    Dr. Parker. Well, as you probably already know, we did 
purchase 5 million doses of AVA, had a contract that was 
initiated in May 2005, and that complete delivery was completed 
of those 5 million doses in February 2006. We recently modified 
that contract to purchase 5 million more doses of AVA, and, in 
fact, some of the initial deliveries are already beginning, 
with the anticipation of that additional 5 million doses being 
made by the end of the year.
    Mr. Van Hollen. Right. I guess to the extent that the other 
becomes delayed even further, potentially, does it make sense 
to continue----
    Dr. Parker. We will have to continue to evaluate our 
requirements based in this bigger context.
    Mr. Van Hollen. OK. Thank you.
    Thank you, Mr. Chairman.
    Mr. Shays. I thank the gentleman.
    The Chair would recognize Mr. Duncan for 10 minutes, no 
more.
    Mr. Duncan. Well, thank you, Mr. Chairman, and, Dr. Parker, 
I guess I will just followup because I want to see if I have 
this straight. And, first of all, let me say neither I nor 
anybody that I know is connected to VaxGen or BioPort or any 
other company that does anything like this, so I am just trying 
to figure out where we are on all this money.
    You say in your testimony that no payment for product is 
made until a useful product is delivered to the SNS. And when 
it says no payment for product, does that mean that other 
payments are made for research and development? Or how much of 
this $877.5 million has been spent so far or has been given to 
VaxGen so far?
    Dr. Parker. Under the requirements of the BioShield Act, 
no--and I mean ``no''--payment for product is made until it is 
delivered to the Strategic National Stockpile. Therefore, we 
have not made any payment for rPA vaccine to this contractor to 
date.
    Mr. Duncan. OK. So the $877 million----
    Dr. Parker. By the act, you have to deliver usable product 
to the stockpile, and ``usable'' definition is in the contract, 
and actually as Dr. Sharma mentioned earlier, a lot of that 
definition is also some----
    Mr. Duncan. And there is no exception to that. You cannot--
--
    Dr. Parker. There is--there is----
    Mr. Duncan [continuing]. Pay money out for research then 
or----
    Dr. Parker. There is an exception. We have not exercised 
that exception. There is an exception. I will make sure I get 
it right, but advance payments of up to 10 percent as 
acceptable to the Secretary can be made. That exception has not 
been made, so this contractor has not received payment for any 
vaccine.
    The only--let me make sure this is correct. VaxGen did 
receive money as part of this contract for some security 
upgrades, and that is it. And then before the Project BioShield 
contract that we commenced with VaxGen, VaxGen was also funded 
from two contracts from the National Institutes of Health, 
first in 2002 and then in 2003. Those were advanced development 
contracts that preceded the Project BioShield acquisition----
    Mr. Duncan. For anthrax vaccine.
    Dr. Parker. Yes, sir, for the rPA, the next-generation 
anthrax vaccine.
    Mr. Duncan. And roughly how much was that?
    Dr. Parker. I believe they were like--I will correct the 
record, but I believe it was on the order of magnitude of $30 
million and $80 million. But please let me correct that record 
if I do not have that completely correct.
    Mr. Duncan. All right. And then----
    Dr. Parker. And that was for advanced development, not 
delivery of vaccine.
    Mr. Duncan. I understand. All right. Then you go on further 
and on the next page you say that--and you just mentioned this 
to Congressman Van Hollen, but you said that--it says, ``Last 
week, HHS modified the contract and purchased an additional 5 
million doses of AVA for the Strategic National Stockpile, 
increasing our total investment in AVA to $243 million.''
    Now, who was that contract with?
    Dr. Parker. That contract was for the currently licensed 
anthrax vaccine to BioPort.
    Mr. Duncan. That was to BioPort?
    Dr. Parker. Yes, sir.
    Mr. Duncan. And so how much total has BioPort gotten from 
you? Have they gotten all of----
    Dr. Parker. Yes, sir. That total you just read, 243, that 
was the first 5 million doses, plus the modified to purchase an 
additional 5 million doses, for a total of 10 million doses. 
That is the----
    Mr. Duncan. So all the money that you are talking about 
that you have invested in anthrax has all gone to BioPort? Is 
that correct?
    Dr. Parker. Well, we have obligated, which means it is not 
available to make another contract on the rPA contract, but it 
has not been expended. The BioPort has been obligated, and 
vaccine is being delivered.
    Mr. Duncan. On April 6th, there was a hearing on a lot of 
this before the Energy and Commerce--a subcommittee of Energy 
and Commerce Committee, and they mentioned in there some place 
that it says that there are other companies that are wanting 
these contracts. How many other--just for my own information 
now, how many other companies are there that are capable or 
involved in doing this or that are contacting you to----
    Dr. Parker. Well, the only----
    Mr. Duncan [continuing]. To try and get some of this 
business?
    Dr. Parker. For anthrax vaccine, there is only one company 
that currently has a licensed anthrax vaccine. That is BioPort. 
From the NIH contracts, we actually have--VaxGen had that 
advanced development contract that was already mentioned. There 
is another company that has an advanced development recombinant 
protective antigen advanced development contract as well with 
NIH. And then when we did the full and open competition for the 
Project BioShield acquisition contract, we did have multiple 
awards. I don't recall offhand--I was not directly involved in 
that acquisition. It was before my time. But there were 
multiple companies that did submit a proposal. Not many. Not 
many.
    Mr. Duncan. And when you say multiple awards, does that 
mean that----
    Dr. Parker. No, not multiple awards. There were multiple 
companies who submitted a proposal against that request for 
proposal. Not many. I will get the exact number, but it was not 
many. But one company was selected, and that was VaxGen.
    Mr. Duncan. OK. And when you say, though, that the only 
company that has a licensed vaccine is BioPort, what does that 
mean in relation to VaxGen? Do they have a license for a 
different----
    Dr. Parker. The recombinant protective--next-generation 
recombinant protective antigen vaccine is not licensed yet. One 
of the authorities with the Project BioShield Act is also to 
allow the purchase, acquisition of products that are on the 
track to licensure. In fact, the requirement is all scientific, 
medical, technical data should suggest that the product has a 
high probability of being licensable within 8 years. So you can 
purchase and do an acquisition contract with companies that 
have a product in advance development that with the prevailing 
scientific and technical opinion has a high probability of 
being licensed. And so the next-generation vaccine candidate is 
not currently licensed. The plan is to develop it and get it 
licensed for both post-exposure use and pre-exposure use 
against inhalational anthrax.
    Mr. Duncan. Let me ask you one other thing. The Congress 
authorized and the President signed a total bill of $5.6 
billion over the next 10 years. What do you think about that? 
You know, you were talking about $877 billion to VaxGen, $243 
million basically to BioPort. Are we doing enough? Are we doing 
more than we should? Are we way short? That $5.6 billion, I 
mean, that is a really high figure but----
    Dr. Parker. Yes, sir, it is.
    Mr. Duncan [continuing]. Is that enough or is that----
    Dr. Parker. Yes, sir, it is----
    Mr. Duncan [continuing]. Too much?
    Dr. Parker. It is a very high figure. But, on the other 
hand, medical countermeasure, advanced development procurement 
unfortunately it is expensive. It is a big number, but drug 
vaccine, diagnostic development, and particularly the advanced 
development, licensure, stockpiling is expensive. As far as----
    Mr. Shays. Would the gentleman yield?
    Dr. Parker. As far as the relative investment on anthrax, 
yes, it is a relatively large investment out of that $5.6 
billion thus far for anthrax. Nonetheless, anthrax is a top 
threat. I know my colleagues have heard me say before that the 
top three threats, in fact, are anthrax, anthrax, and anthrax. 
That is my personal opinion, but I probably have some that will 
share that opinion.
    Mr. Duncan. Thank you very much. That is all.
    Mr. Shays. I just wanted, if you would pursue the idea that 
you were developing, which is--I thought basically you were 
making the point it is very expensive, but I thought that Mr. 
Duncan's point was isn't the 5 million just a small part of 
what we have to do. Isn't that kind of where----
    Dr. Parker. I think that was--yes, Mr. Chairman, I think 
that probably was, and I did not mean to say it is too much 
money, because personally I do not believe it is, because 
medical countermeasure development is expensive. We have a lot 
of threats, whether they be threats that we need to be 
concerned about from an intentional attack, but there is also 
naturally occurring and emerging infectious diseases that we 
also need to be concerned about.
    And, unfortunately, the cost to be prepared, there is a 
cost to improving our preparedness. We have to be and we are 
committed in administering the Project BioShield acquisition, 
on the one hand, we are committed to being--developing these 
products as urgently as we can to meet the threat, but we are 
also committed to be as diligent as we can be in wisely 
expending the funds associated with the special reserve fund of 
Project BioShield.
    So it is a--you have given us a tough job.
    Mr. Duncan. All right. Thank you very much, Mr. Chairman.
    Mr. Shays. What puzzles me, Dr. Parker, about your answer 
is that I look at anthrax as being like a chemical. I view it 
as not being contagious. Briefings that we have gotten on bird 
flu and so on are that you could literally see millions of 
people killed. And so I realize one is a natural event and one 
is potentially a manmade event. But are we making the potential 
mistake that we made with FEMA of getting them focused on not 
focusing the natural enough, thinking that we would have to 
look at what an enemy might do as opposed to what Mother Nature 
might do?
    Dr. Parker. Well, actually, I guess the way I would think 
about that, Mr. Chairman, is they are both important. And I 
looked at--anthrax is a very serious threat, and if we look at 
what the letter attacks did with such a small amount, and just 
a little bit more could do a lot more damage. And we could be 
attacked at multiple locations as well.
    On the other hand, an anthrax attack, even if it is 
multiple location, is at least bounded in a relative space and 
time, unlike pandemic influenza that we are also working very 
hard now to improve our preparedness for that potential 
emerging infectious disease. And pandemic influenza, as you 
pointed out, is something that will be communicable, person to 
person, and will not be bounded in geographic space and time, 
like an intentional anthrax attack.
    Mr. Shays. So you make a good argument for not saying 
anthrax, anthrax, anthrax.
    Dr. Parker. No. When I said anthrax, anthrax, anthrax, I 
meant it stands above and beyond some of the other biological 
pathogens that could be used as a weapon intentionally against 
us. There are other ones that are serious as well, but anthrax 
poses unique characteristics that make it----
    Mr. Shays. So let me put it in a way that I think I 
understand you and tell me if I am correct. Your testimony is 
that anthrax is not potentially the greatest threat in general, 
but if you were talking about a weapon of choice and talking 
about a weapon as opposed to Mother Nature, that it would be 
the weapon of choice.
    Dr. Parker. Well, from my years experience in working in 
medical biodefense, anthrax is unique. It is not the only 
threat, though. We are----
    Mr. Shays. That is not what I am saying. I do not want you 
to--I want to just clarify. What you were saying is anthrax, 
anthrax, anthrax, and I asked you a question, and you said it 
is what concerns you the most. Now I am trying to summarize, 
and it seems to me you are going off to left field here.
    I have had so many hearings on anthrax, I do not like even 
talking about it anymore, but all I want is what you think, and 
then to be able to respond to what you think. You were saying 
to us in this hearing that not only is anthrax your primary 
concern, it is your second and third concern. And then you 
said, to amplify it, that ``Anthrax is the most likely weapon 
of choice, in my judgment.'' Are you disagreeing with that? And 
let me just add so you can fill in. What you were then saying 
is well, though, you were just talking about a weapon of 
choice. If we are talking about all kinds of threats, then you 
would not necessarily rank anthrax at the very top.
    Dr. Parker. Let me make sure--of all threats, natural 
manmade.
    Mr. Shays. Yes, exactly.
    Dr. Parker. We have some very serious natural threats as 
well, and if you looked at the potential consequences of a 
pandemic influenza, for example, that could be very severe. And 
so there are other natural threats that probably pose a larger 
challenge, particularly something like a pandemic, when it is 
not bounded in time, it is not bounded in space, and it could 
be a global threat that spread from me to you. And so we have 
both--we need to pay attention and we should pay attention, and 
we do, in our preparedness activities to both natural threats 
and intentionally used threats.
    Mr. Shays. Thank you.
    Let me ask you, Ms. Embrey, the Rand Corp. did a study. It 
is entitled, ``A Review of the Scientific Literature as It 
Pertains to Gulf War Illnesses: Volume 3-Immunizations.'' And 
they had completed the draft in 1999, and it has not been 
released publicly. I want to know why and I want to know when 
is it going to be released.
    Ms. Embrey. I did get visibility that you were going to ask 
me that question. I did put a call in to Rand this morning to 
clarify what the reasons are for their failure to release. I 
did not receive an answer from them prior----
    Mr. Shays. Is it your statement that Rand is the reason why 
they were not released, or is it DOD? Rand does not have the 
authority to release something, do they?
    Ms. Embrey. In this particular case, they do because it was 
my predecessor organization that asked them to perform an 
independent review, Rand. We commissioned them to do an 
independent review of the literature associated with Gulf war 
illness and vaccinations. And Rand is responsible for the 
product, and as it is independent, it is their product.
    Mr. Shays. They paid for it?
    Ms. Embrey. We paid them to do an independent review.
    Mr. Shays. So let me get this straight. It was paid for 
with Federal dollars?
    Ms. Embrey. Yes, sir.
    Mr. Shays. And it was a document for the Government?
    Ms. Embrey. Yes, sir.
    Mr. Shays. And we are having to ask permission from Rand 
whether they are going to release it?
    Ms. Embrey. It is their product, sir.
    Mr. Shays. We paid for it.
    Ms. Embrey. We did. But----
    Mr. Shays. We own it.
    Ms. Embrey. It is independent. We should be absolutely 
asking them for the product.
    Mr. Shays. No, that is not a good answer. No, it is not. I 
mean, you are a lovely person, but with all due respect, that 
is not a good answer. And I do not think that DOD would want to 
imply that anytime they contracted out, it is up to the group 
that they contracted out. If they were paid for a product that 
was for the public, it is not your testimony that they get to 
decide whether to release it or not, is it?
    Ms. Embrey. Because of the way in which the arrangement 
with Rand--we asked them to do a completely independent 
assessment. In other words, this is not our product, it is not 
our DOD study----
    Mr. Shays. That is irrelevant whether it is your product or 
their product. You paid for it.
    Ms. Embrey. Yes, but it is----
    Mr. Shays. We paid for it.
    Ms. Embrey. It would be Rand's--Rand would have to sign 
their company's reputation to it.
    Mr. Shays. Did they give you the document?
    Ms. Embrey. Based on what I was able to obtain this 
morning, they have provided us various versions of their 
product over the years. The most recent one was one dated in 
July of last year. We received it in the November timeframe, 
2005. We provided comments back to the Rand Corp., but I have 
to say, I need to find out more, and I will be certainly happy 
to provide you an update for the record.
    Mr. Shays. We had told you that we would be asking this 
question, correct?
    Ms. Embrey. Yes, sir. I was out of town, unfortunately, 
until this morning.
    Mr. Shays. No, my point is that this was not a sneak attack 
here.
    Ms. Embrey. No.
    Mr. Shays. This is kind of a basic thing. Well, I do not 
like your answer.
    Ms. Embrey. Acknowledged.
    Mr. Shays. And we will talk to Rand directly.
    Ms. Embrey. Thank you.
    Mr. Shays. I would like each of you to tell me what you 
think your role is as it relates to--if you have any role 
whatsoever, as it relates to the licensing of an anthrax 
vaccine and as it relates to anthrax detection methods. And we 
will start with you, Ms. Tulis.
    Ms. Tulis. Thank you. With regards to the vaccination, we 
do not have a role. With regards to detection, we are working 
on sampling methodologies, and we have two guidances I did 
mention. The next step with those guidances would be 
validation. That is our role at this point.
    Mr. Shays. OK. I wrote down, staff wrote down that EPA is 
primary responsible for coordination of the recovery process.
    Ms. Tulis. Decontamination, definitely.
    Mr. Shays. Yes. Do you agree with that?
    Ms. Tulis. Yes, I do.
    Mr. Shays. Would you add anything to it?
    Ms. Tulis. I would say that sampling and analysis is 
certainly a critical part of the decontamination process, and 
that is why we are focusing on it.
    Mr. Shays. OK.
    Ms. Tulis. In collaboration with other agencies.
    Mr. Shays. I am going to come back to you, Dr. George. 
First of all, how long have you been working with the 
Department of Homeland Security?
    Dr. George. I have been working at the Department of 
Homeland Security since it stood up on March 1, 2003.
    Mr. Shays. And you came from where before that?
    Dr. George. I came from the Department of Energy's Chemical 
and Biological National Security Program.
    Mr. Shays. So it is really a continuation of the work you 
have been doing?
    Dr. George. Yes, sir.
    Mr. Shays. So even though the Department of Homeland 
Security is new, the tasks and responsibilities are somewhat 
similar?
    Dr. George. Well, since DHS stood up, we now have this 
Homeland Security Presidential Directive No. 10, the 
President's Biodefense for the 21st century, which clearly 
delineates agencies' roles and responsibilities. And so we did 
not have that prior to a couple years ago.
    Mr. Shays. Dr. Besser, what we have written down for you is 
you support efforts to validate components of the detection 
process. I would ask you, one, your reaction to that; and, two, 
your role in licensing anthrax vaccines and anthrax detection 
methods, what roles you have in either.
    Dr. Besser. Thank you, Mr. Chairman. The CDC role in terms 
of the detection validation is really multifold. For CDC, the 
initial role of sampling is in a public health response to 
determine whether an area is contaminated and whether action 
has to be taken. And that is a very directed approach during an 
investigation.
    CDC has a role in terms of working with other agencies to 
validate assays, and there are situations, as I said in my 
testimony, where you will be faced with a situation where it is 
not a known release, where you are trying to determine whether 
people in an area are at risk, but you are trying to determine 
whether a building may have had a release in which you are 
going to need a probabilistic method.
    CDC's role there is to bring its scientific expertise in 
collaboration with other agencies to make sure that we help to 
develop products that are going to be useful in applied public 
health.
    In terms of the vaccine side, CDC is actively involved in 
collaboration with the Department of Defense on studies to look 
at dose reduction and change in route of administration for the 
currently licensed AVA vaccine, and there are a number of 
reasons for that. One is that the feeling that a change from a 
subcutaneous administration to an intramuscular administration 
is likely to result in fewer side effects; and, two, the number 
of doses that are required for administration of that licensed 
vaccine is quite high. And so if we are able to demonstrate 
protection with lower number of doses, it would be very useful 
to DOD in terms of troops. It would also be very useful in 
terms of a public health response. And so that is a 
collaborative effort.
    Mr. Shays. OK. That is not with anthrax. That is with----
    Dr. Besser. That is anthrax. That is for the AVA vaccine. 
That is the currently licensed----
    Mr. Shays. BioPort, right.
    Dr. Besser. Yes, sir.
    Mr. Shays. As it relates to HHS, obviously you are 
purchasing vaccines and so on. So that is the role. But 
basically your responsibility is developing medical 
countermeasures to anthrax. Is that one way I would describe 
your role here?
    Dr. Parker. Yes, Mr. Chairman. Within my office, we have 
the Office of Research and Development Coordination, which has 
the responsibility for implementing, overseeing, and managing 
the BioShield acquisition contracts, but also has the role of 
coordinating the within-HHS activities that span from the basic 
research, biodefense, all the way to the Strategic National 
Stockpile that is managed and implemented at CDC. Also a focal 
point for interacting with our interagency colleagues, and I 
know you are going to go to the Department of Homeland Security 
in a minute, but there is a dual role between HHS and DHS in 
the administration of the Project BioShield. And it really gets 
down to what is the threat, what are the high-priority threats, 
and then what are the medical countermeasures that need to be 
developed against those threats.
    And so our role within HHS is the development and 
acquisition of the medical countermeasures against those 
threats that are deemed to be material threats against the U.S. 
population.
    Mr. Shays. Let me go to DOD before I go to Homeland 
Security. Basically, I view--I would be leaving this hearing 
with the general view that the civilian side is handled by a 
plethora of agencies, and DOD does the duplicative process, and 
then draws on certain of the other departments as a resource. 
But basically it is going to decide how to detect say, for 
instance, anthrax and it is going to decide what it wants to do 
in terms of vaccines, and it is going to do what it wants 
separate from what the Government wants. And I am not passing 
judgment--even though I said it in a way that seemed like I 
was, I am not passing judgment. I am just thinking that is the 
way it is.
    Maybe you both could respond to that.
    Mr. Reed. I do not think I would characterize it precisely 
that way, sir. I think the Department does have ongoing 
efforts. Those efforts are coordinated with what is going on in 
the civilian sector. Much of the work that has been done--for 
instance, the AVA vaccine that is currently there was developed 
by the Department of Defense over the years. The recombinant 
vaccine came out of USAMRIID at Fort Detrick and was 
transitioned to the civilian sector.
    But specifically with regard to what my responsibilities 
are with respect to the Department or to procure and field 
existing capabilities for detection of biologicals and 
specifically among those for anthrax in support of the forces 
in the field and in their garrison locations here in the United 
States and overseas, to develop advanced capabilities for such 
fielding, to procure the existing vaccines for defense of the 
force, and to develop advanced vaccines and other therapeutics 
for treatment of the force, and in concert with the brothers 
and sisters, if you will, in the civilian side to share that 
information so that we do, in fact, have a coordinated program.
    Is it perfect? No. But we are working on that.
    Mr. Shays. Ms. Embrey.
    Ms. Embrey. With respect to my responsibility within the 
Department, our focus is on force health protection and the 
clinical protocols and policies for immunization, assuring that 
clinical practice guidelines are effective and that the 
appropriate scope of who is covered at what risks to help 
define the requirements as part of the internal process for 
what kind of protective measures we need against what kinds of 
threats, and also to prepare the military health system to 
execute an immunization response as well as to monitor the 
adverse effects.
    That is our primary objective internally. I would say that 
we do so in very close collaboration with the Centers for 
Disease Control and Prevention. In fact, what we have in the 
way of clinical protocols and response is identical and 
developed in coordination, full cooperation with CDC on the 
response side.
    Where we have differences are in our laboratory networks. 
DOD does have laboratory capacity and assays and protocols that 
are slightly different, primarily because we develop those for 
our deployable assets in theaters around the globe. We are 
making a concerted effort to ensure that those assays and 
protocols here in the United States, if they are not identical, 
they are at least equivalent, and we have studies working to 
ensure that is the case.
    Mr. Shays. And how long have you been in your position?
    Ms. Embrey. Just a little over 4 years.
    Mr. Shays. I would think that if you--when you heard Dr. 
Parker say that his big concern in terms of human intervention 
would be anthrax, anthrax, anthrax, that would be probably your 
answer as well?
    Mr. Reed. I think from a threat standpoint, there are 
number----
    Mr. Shays. Let me just ask you, why did you answer this 
question instead of Ms. Embrey? I am just curious. No, I am 
just curious. Not because I thought women should go first. I 
was just wondering if----
    Mr. Reed. I was going to give you----
    Mr. Shays. No, I just need to know why are you the one who 
would answer instead of Ms. Embrey.
    Mr. Reed. I think because I was going to approach it from 
the standpoint of--from a technical standpoint, what do we 
consider the threat that is out there.
    Mr. Shays. Based on your responsibilities in what way? I am 
still trying to sort this out a little bit.
    Mr. Reed. From the standpoint of an assessment of the 
threat that faces U.S. forces in the field today, and 
potentially in the homeland.
    Mr. Shays. Fair enough.
    Mr. Reed. There are a series of agents that lend themselves 
to asymmetric warfare, to employment on the battlefield, and 
one of the worst of those from the standpoint of, if you will, 
most capable war agents is anthrax. But there are others, like 
tularemia, like Venezuelan equine encephalitis, smallpox today, 
that present very real threats from that standpoint.
    And so the program of research and development is focused 
in those areas, and looking now at the possibility of the 
threat of bioengineered agents that could be employed on the 
battlefield.
    Ms. Embrey. From a force health protection perspective, I 
think there are multiple answers to your question. But the 
first, I think, consideration--to me, anyway--is that--and we 
learned this primarily in our preparations for pandemic 
influenza--is that this Nation needs to have a capacity to 
produce vaccines of all types and that is my burning platform, 
that our capacity as a Nation to develop and accelerate the 
production of vaccines against many threats needs to be 
enhanced significantly, and we need to have the agility to move 
from one threat to another with agility, and that requires, I 
think, some investments that I believe the pandemic is helping 
to kick-start for us, but I think it has much broader 
applicability to the larger threats. So that is a generic 
answer.
    Specifically, I view threats in the context of how many 
people would be vulnerable to an attack. From a force health 
protection perspective, there are threats that exist, but in 
employment as a weapon would affect small numbers of 
individuals. Anthrax is the kind of a threat that to me implies 
a much larger number of individuals who we would have to 
prepare a response for, and because of that, I believe we need 
to have the capacity to respond to that and should invest in 
that heavily.
    Equally, there is in a pandemic a similar kind of 
vulnerability because the human population does not have the 
immunity to deal with--that is why it is a pandemic. So I 
can't--I have a difficult time evaluating which one of those 
two is more important because they are both of great concern.
    Mr. Shays. Well, as it relates to other biological threats, 
the question is how easy can you weaponize it, and the 
testimony that we have had continually--and it has been the 
argument for the immunization plan of DOD is then that anthrax 
can be weaponized; whereas, biological agents can't be as 
easily.
    Ms. Embrey. As easily, correct. But anthrax is a biological 
agent. It is just--and it occurs naturally, but it could be 
weaponized; whereas, a pandemic influenza--Mother Nature is the 
best terrorist.
    Mr. Shays. OK. Let's go to the Department of Homeland 
Security. You heard the dialog that was in the first panel. 
Walk me through, without me having to ask the questions, walk 
me through the dialog and tell me how you would answer those 
basic points. And let me say to you that, on a scale of 1 to 
10, denying that you have a responsibility that you have is a 
worst offense than saying to me that we did not do something we 
should have and now we are doing it.
    Dr. George. Exactly, and I appreciate the opportunity to 
provide clarification on the statements that were made earlier.
    In terms of detection--detection and surveillance, attack 
warning, DHS clearly has the leadership role, and we are taking 
that role. My oral testimony as well as my written testimony 
provide examples of what we are doing. I am happy to walk 
through each one of those particular steps with you right now, 
if that is the way you want to approach it.
    Mr. Shays. Right. What I would want, though, is not to 
suggest that has been the case forever. If it has not, I do not 
need to dwell on it. But given that no one was even at our 
hearing last year, it is hard to think that this was a high 
priority. And so was it just something that DHS was finally 
able to pay more attention to? And if so, when?
    Dr. George. OK. Let me try to provide some clarification 
for you to understand the sampling process. I assume you want 
to specifically address sampling and sampling strategies and 
sampling validation? Because sampling is a continuum.
    Mr. Shays. OK. Well, let me just say that when GAO did its 
report, it was last year. They are saying you really did not 
take ownership of that issue until a few weeks ago, or at least 
acknowledge to them. You know, maybe you all have been 
communicating for a number of months. I just want to know, 
before you give me the rest of the story, I would like to know 
that part of the story.
    Dr. George. OK. Detection and sampling in terms of 
decontamination, according to Homeland Security Presidential 
Director No. 10--and with your permission, I would like to read 
this to you to make sure I get it right: ``The Administrator of 
the Environmental Protection Agency, in coordination with the 
Attorney General and the Secretaries of Defense, Agriculture, 
Labor, Health and Human Services''----
    Mr. Shays. More slowly.
    Dr. George. I am sorry. It is in HSPD-10. But, anyway, 
there is a variety of organizations----
    Mr. Shays. No, no, no. Start over again. You were trying to 
make a point to me, but if you talk too quickly----
    Dr. George. Certainly.
    Mr. Shays. The nice thing is no one else is here. I do not 
have to worry about my time.
    Dr. George. I apologize. ``The Administrator of the 
Environmental Protection Agency, in coordination with the 
Attorney General and the Secretaries of Defense, Agriculture, 
Labor, Health and Human Services, and Homeland Security, is 
developing specific standards, protocols, and capabilities to 
address the risks''--and that is a key word, ``risks''--``of 
contamination following a biological weapons attack and 
developing strategies, guidelines, and plans for 
decontamination of persons, equipment, and facilities.''
    With that said--and now I am not reading anymore--DHS is 
supporting EPA in their decontamination role.
    Mr. Shays. That is not a good answer.
    Dr. George. I apologize.
    Mr. Shays. No, you do not need to apologize because that 
may be the answer you want to give. But you had testimony of 
GAO that basically said that you all have taken ownership. That 
statement that you read me is that you do not have ownership. 
And I do not think you can have it both ways. I mean, Ms. 
Tulis, if you want to jump in----
    Dr. George. We are happy to take ownership----
    Mr. Shays. No, ``happy'' is not the word.
    Dr. George. DHS will take ownership for this problem, if 
that is appropriate.
    Mr. Shays. No, but that is different than what was said by 
GAO. They said you were taking ownership. If you disagree with 
them, then let's put it on the record. But we have on the 
record something very different.
    Dr. George. May I please defer the comment to Dr. Vitko?
    Mr. Shays. Sure.
    Dr. George. He is behind me here.
    Mr. Shays. So what you need to do, Doctor, is give a card 
to our transcriber. Please come on up here, and if you could 
just pick up the mic, it will be on.
    Mr. Vitko. Sure. I am happy to pick up the mic, and I would 
like to----
    Mr. Shays. You know what the issue is?
    Mr. Vitko. Absolutely I know what the issue is.
    Mr. Shays. Let me just say this to you. We will either 
spend 10 minutes and figure this out, or we will spend 3 hours 
figuring it out, but we are not leaving here until we figure it 
out. And so I would like not, you know, to be having a dialog 
about--I would like to deal with just the bottom-line basic 
points, and then fill in all the color.
    Mr. Vitko. I will try to, Mr. Chairman. If I miss it, 
please bring me back on target.
    Mr. Shays. Sure.
    Mr. Vitko. The bottom line is HSPD-10 clearly defines the 
roles, as you heard----
    Mr. Shays. No, that is not clearly defined. It clearly does 
not define.
    Mr. Vitko. Oh, I beg to differ, sir.
    Mr. Shays. Well, tell me. It sounds like everybody has the 
same responsibility.
    Mr. Vitko. No. It says, ``The Administrator of EPA, in 
coordination with . . . is developing . . .'' So it clearly 
establishes who the lead is and what agencies the coordinating 
is with.
    Mr. Shays. So you are saying the lead is EPA.
    Mr. Vitko. Yes. Yes, sir.
    Mr. Shays. Well, excuse me for being confused because we 
had testimony in the last panel that you all had taken on and 
acknowledged that you have the responsibility. Let me just 
start out here--and I will let you say what you need to say. Do 
you disagree with the testimony that was given in the previous 
panel?
    Mr. Vitko. I think they misunderstood the conversation we 
had. There was never an explicit discussion on May 3rd as to 
whether or not DHS had the lead responsibility. The discussion 
on May 3rd dealt with do we embrace the need for a stratified 
approach to sampling, that is, a combination of targeted and 
probabilistic sampling. The answer is yes. Do we feel that 
there is a need for validation? The answer is yes. Do we feel 
that--and are we taking steps toward that validation strategy? 
The answer is yes. And that is absolutely true, and that is 
what occurred on May 3rd.
    Mr. Shays. Well, what do you think they were saying in the 
previous panel? What do you think they were saying?
    Mr. Vitko. I think they were saying that they had 
understood, when we agreed to those other terms, that we also 
agreed that we had the lead in that. That was not discussed, 
and we did not agree because it is not according to HSPD-10. 
With that, we have, as evidenced in the testimony, played a 
significant role jointly with EPA and with the other agencies, 
just the ones that were said involved in here, in establishing 
and advancing both sampling strategies and sampling technology, 
and in doing the validation on it. And I think you have heard 
that coordination from the other panel members that testified.
    Mr. Shays. OK. You know, we will have a lot better dialog 
if we just talk the way we are talking, and then I can try to 
figure it out. In other words, Dr. George, the bottom line is 
the answer to the question I asked it here, we do not agree 
with what happened in the previous panel, and this is the 
reason why we do not agree. Is that your statement as well, Dr. 
George?
    Dr. George. Yes, I agree with what you just said and with 
what Dr. Vitko just said.
    Mr. Shays. OK. Dr. Vitko, do you have a card you can give 
our transcriber?
    Mr. Vitko. I don't have a card.
    Mr. Shays. Then you need to write out your name and full 
title.
    Mr. Vitko. I will write out my name.
    Mr. Shays. And you were sworn in.
    Mr. Vitko. Yes, sir.
    Mr. Shays. So, Ms. Tulis, it is your responsibility?
    Ms. Tulis. When you read HSPD-10, it is particular to 
decontamination, and decontamination is generally our role. We 
would not be involved in a lot of the earlier detection and 
monitoring. We were not provided resources to do that. The 
other----
    Mr. Shays. Slow down. So whose responsibility is that?
    Ms. Tulis. The various agencies that have developed some of 
those programs. Most of these efforts----
    Mr. Shays. You all talk too quickly for someone--
[laughter.]
    No, no, seriously. You know, I am just trying to 
understand.
    Ms. Tulis. OK. Our focus has been decontamination because 
sampling analysis, as I mentioned earlier, is critical to be 
able to accomplish those steps.
    Mr. Shays. Your responsibility is decontamination.
    Do you want to read me what you just read me, Dr. George?
    Dr. George. I beg your pardon? I did not----
    Mr. Shays. Would you just read me what you read me about--
--
    Ms. Tulis. It is right here.
    Dr. George. Certainly. ``The Administrator of the 
Environmental Protection Agency, in coordination with the 
Attorney General and the Secretaries of Defense, Agriculture, 
Labor, Health and Human Services, and Homeland Security, is 
developing specific standards, protocols, and capabilities to 
address the risks of contamination following a biological 
weapons attack and developing strategies, guidelines, and plans 
for decontamination of persons, equipment, and facilities.''
    Mr. Shays. OK. Now, we were talking about the need for a 
strategy to determine how to validate whether or not this room 
is clean and so on. So tell me how that relates to this issue. 
Ms. Tulis----
    Dr. George. Generally we get involved when there is known 
to be a source of contamination.
    Mr. Shays. I want to know who takes ownership for having a 
strategy at this table for developing a protocol so that we can 
validate whether or not, you know, the Madison Square Garden is 
not contaminated and that it is clear. Who takes responsibility 
here? I do not want anyone to speak until someone takes 
responsibility. Who here takes responsibility?
    [No response.]
    Mr. Shays. Thank you. I think you are proving a point.
    Ms. Tulis. If I may, generally, I think our focus, for many 
of us, is that--at least--but is we would not be monitoring 
every single building there to see whether or not potential 
contamination exists.
    Mr. Shays. No. But the issue is not that you are monitoring 
it, but that you have a protocol to determine if you actually 
can verify whether, whatever the standard is, it is a building 
that is not contaminated, hasn't been compromised.
    Do we have GAO still here? Could you all just step up a 
second? I am not interested in getting into a dog fight here, 
so that is not my motive. I just want you to help. I plead part 
of this is my own ignorance. I am not getting it, and you are 
all very bright people, but what I am not getting is, no one is 
taking ownership, and that is what I see is the problem.
    Dr. George, you read me a document, but that doesn't really 
address what I think I was hearing GAO say. Now, GAO--excuse 
me. Mr. Rhodes, if you would just tell me how you would 
contribute to this. Why don't you sit in the corner? That is 
great. We are going to sort this out, and we are going to 
figure it out.
    Mr. Rhodes. Well, obviously, Mr. Chairman, I don't 
understand either. I sat before you under oath and swore that 
on May 3rd we have a conversation where DHS took 
responsibility. Now, that was for detection as opposed to 
decontamination. That was our understanding. But if your 
question----
    Mr. Shays. Let's even forget the conversation.
    Mr. Rhodes. OK.
    Mr. Shays. Tell me, what is the position that GAO holds of 
who is responsible for developing the basic strategy--strategy 
is probably not the right word. What is the right word?
    Mr. Rhodes. Strategic plan?
    Mr. Shays. Strategic plan. Who in your judgment has the 
responsibility to develop a strategic plan?
    Mr. Rhodes. DHS, and that was the recommendation we made 
last year, and that is what we stand by right now.
    Mr. Shays. OK.
    Mr. Rhodes. Now, if DHS doesn't want to take that, so be 
it.
    Mr. Shays. Well, OK.
    Mr. Rhodes. Because they are the Department of Homeland 
Security. They have the responsibility for the National 
Response Plan, things like that. And the distinction made in 
HSPD-10 is about risk assessment and decontamination. That is 
different than determining if something is actually in this 
room. EPA cleans it up. EPA doesn't say--EPA didn't walk into 
Brentwood and say there was a problem.
    Mr. Shays. Dr. George, kind of react to that.
    Dr. George. DHS does have the responsibility for detection, 
detection and surveillance, attack warning, and the 
methodologies that are associated with detection. And we do 
take leadership on that, and I am happy to elaborate as much as 
you want.
    Mr. Shays. Then why was I confusing you then? Because that 
is kind of what I am interested in.
    Dr. George. I wonder if we are using the term differently. 
Detection means, in detection and surveillance, it is 
understanding if we have been attacked by a particular agent. 
So in our BioWatch program, we have detection. We also have 
incident characterization sampling, which we develop methods 
for in partnership with EPA, DHHS, CDC. We work very closely 
with these groups, FBI as well. And we develop sampling plans 
for incident characterization.
    Mr. Shays. Do we have a strategic plan right now?
    Dr. George. Do we have a strategic plan for R&D effort? 
Yes.
    Mr. Shays. R&D effort----
    Dr. George. For surveillance and detection, yes.
    Mr. Shays. Tell me about that plan.
    Dr. George. Our ultimate capability is our Gen 3 system. 
That is where we want to be. This system detects approximately 
20 agents----
    Mr. Shays. Could I say something? I think you are speaking 
too quickly and I think that----
    Dr. George. I am sorry.
    Mr. Shays. I think you are hurting your own cause, not mine 
right now.
    Dr. George. I am sorry.
    Mr. Shays. I am not trying to--I really have no agenda 
here.
    Dr. George. I want to be clear. I am sorry.
    Mr. Shays. I don't want you to overstate what you have. If 
you don't have it, it would be better to acknowledge you don't 
have it than to suggest that you have it. And what I thought--
and tell me if I am wrong--we want to have some kind of 
strategic plan that gets everyone to be able to agree, it seems 
to me, on whether a space has been compromised. And it was my 
judgment that the testimony, intuitively, it would strike me 
that this would be the Department of Homeland Security's 
responsibility, working with other agencies.
    I am uncomfortable with you saying you have that, and if we 
are talking about two different things and I am confusing it, 
then I don't want to keep going on. Let's clarify that.
    Mr. Rhodes, what am I trying to sort out? Where are we 
getting confused?
    Mr. Rhodes. I think the differences, who is responsible for 
the beginning of the event, who is responsible at the end of 
the event? And at the beginning of the event, it is DHS, and 
according to HSPD-10, at the end of the event--I mean, not to 
put it into simplistic terms----
    Mr. Shays. You need to for my benefit, not for them.
    Mr. Rhodes. But I was just saying I didn't want to simplify 
it too much. The point is, that at the beginning of the event 
it should be DHS. DHS should, through surveillance, 
characterization, determination, say, ``Something has occurred. 
We don't know the extent yet. We don't know exactly what has 
occurred, but something has occurred at this location where we 
are right now.''
    Mr. Shays. Is it your testimony that they have not yet done 
that, that they----
    Mr. Rhodes. It is our testimony, based on the recent work, 
that on May 3rd they said that they had taken responsibility--
--
    Mr. Shays. That is a different issue. Let's not go there. I 
don't want to get into that issue right yet.
    Mr. Rhodes. OK.
    Mr. Shays. Is it your testimony that this strategic plan 
has not yet been developed, that we do not have markers and 
whatever?
    Mr. Rhodes. I have not seen it. I have not been presented 
with it.
    Mr. Shays. Have you asked for it?
    Mr. Rhodes. What I have been told is that it is in process. 
It is in the review process, but I do not have a draft in 
hand----
    Mr. Shays. Refresh us as to what you found out a year ago?
    Mr. Rhodes. A year ago there was nothing. A year ago, we 
were disagreed with. A year ago, DHS didn't acknowledge that 
they had the responsibility, and a year ago, they didn't 
acknowledge that there needed to be a plan.
    Mr. Shays. With all due respect, Dr. George, I think that 
is true, and if it is not true, I really want you to be very 
careful in this. This is a point where I don't want you to say 
something that you would like to be true or you think might be 
true. I need you to be very, very precise.
    Dr. George. As Mr. Rhodes said, DHS has responsibility for 
the front end of the problem, which is detection and 
surveillance, attack warning, and we do the preliminary 
incident characterization to understand where the spread of 
contamination is. We then hand off to our colleagues at Health 
and Human Services, who are responsible for the public health 
response, and they then followup with the sampling 
methodologies and the epidemiology surveillance----
    Mr. Shays. By then we have already determined that it has 
been compromised.
    Dr. George. Yes, sir.
    Mr. Shays. Don't even go down there, we are not there yet. 
We had a report provided last year to which DHS was not even 
present, which implied to us that they didn't even think they 
needed to be here at the hearing. I want you to respond to what 
Mr. Rhodes said about that report.
    Dr. George. I am a little confused. Could you restate your 
question? Because he is referring to a session that I was not 
in attendance----
    Mr. Shays. No, not a session. I am talking about a report 
done a year ago. I am talking about anthrax detection. 
``Agencies need to validate staff and activities in order to 
increase confidence in negative results.''
    Dr. George. And your question specifically is?
    Mr. Shays. My point was that DHS was missing in action, and 
not there. And the implication was--and I was starting to feel 
pretty good about it, not that you weren't there, but you 
accepted--you weren't there, but now you accept responsibility. 
The implication you are trying to give this committee--it may 
be true or not--is that you were always there, and we have a 
plan, and this is dead wrong. Have you read this report?
    Dr. George. Yes, sir, I have.
    Mr. Shays. What do you disagree with this report?
    Dr. George. I don't disagree with the report, and in fact, 
in my testimony I said that we have done the recommendations 
that they have in the back of that report, and that was the 
opening of my testimony.
    Mr. Shays. When did you start doing them, before the report 
or after the report?
    Dr. George. The activities that I referred to in the 
testimony were done long before the report was written in March 
2005.
    Mr. Shays. Excuse me. You do disagree with the report 
because you basically say they said it wasn't happening, and 
you said it was happening. You are confusing the hell out of 
me, frankly.
    Dr. George. Well, I apologize, and I am a little confused 
myself. So we have been actively working in that area. For 
example, the coordination activities, the Subcommittee on 
Decontamination and Standards and Technology started----
    Mr. Shays. You know what? We are not going to get anywhere 
here. We are going to have a special hearing with DHS just on 
this, because we are getting nowhere.
    Dr. George. OK.
    Mr. Shays. We are going to have professional staff ask some 
questions.
    Ms. Fiorentino. The question is for Dr. Parker. Why does 
CDC recommend the use of anthrax vaccine in conjunction with 
antibiotics after exposure to aerosolized anthrax, when the 
vaccine is not FDA approved for post-exposure use to prevent 
anthrax disease?
    Dr. Parker. There actually is a growing scientific 
literature and studies and medical consensus that does support 
the use of an anthrax vaccine to complement and support, not 
replace, but to complement antibiotic use post exposure 
prophylaxis. The anthrax vaccine, AVA, is licensed for pre-
exposure indication. It is not licensed currently for post-
exposure use in combination with antibiotics. But there are 
publications that make that recommendation in scientific 
literature, and recommendations by the CDC for use of AVA in a 
post-exposure prophylaxis mode in combination with antibiotics. 
That would be an investigational use of AVA in that setting.
    We talked a lot about the next general anthrax vaccine and 
the intent of that development program and acquisition program 
is to license for both indications, post-exposure and pre-
exposure.
    Ms. Fiorentino. How many studies is this based off of? How 
many studies are out there that share that this works? And, Ms. 
Embrey, you may know the answer to this as well if you want to 
step in.
    Dr. Parker. I am going to ask my colleague, Dr. Besser.
    Dr. Besser. If I could just add to that. Thank you for that 
question. One of the questions with an anthrax exposure is that 
you are dealing with spores, and spores are very hardy and they 
can survive for long periods of time in the lung. So the 
theoretical goal here is that while you are taking your 
antibiotics you are protected clearly from the infection 
progressing. Once your antibiotics stop, there is an 
opportunity for spores to germinate.
    Based on some animal data showing symptomatic disease at a 
very long time after exposure, during the 2001 event, the 
feeling was that antibiotics would provide additional benefit 
in that setting. So it's a combination of theoretical--I think 
very good theoretical hypothesis, and animal data.
    Ms. Fiorentino. Ms. Embrey.
    Mr. Reed. What he said, seriously.
    Ms. Embrey. I think the idea here is that there were animal 
studies done to evaluate if you had antibiotics only, 
particularly if the spores lodged into the lungs. There was 
some concern that they may not respond to a short-term--they 
come back after the antibiotics were delivered. And so there 
was prudent judgment made that a post-exposure vaccine, in 
combination with the antibiotics would be fully protective. But 
the animal studies at that time were the only basis for that, 
and I think that's our going-in position even now.
    Ms. Fiorentino. And just to clarify, was it just one study 
that was done that showed that? Because that was my 
understanding. Is there more than one study that showed the use 
of vaccine with the antibiotics was effective against post-
exposure aerosolized anthrax?
    Dr. Parker. We will get you the specific studies that 
support that from animal model use.
    Ms. Fiorentino. My other question is, are there any steps 
being taken to obtain FDA licensing for the use of anthrax 
vaccine to prevent anthrax disease after exposure at this 
point?
    Dr. Parker. Well, I think we just discussed that the goal 
of the next generation anthrax vaccine is to develop that and 
do the requisite animal efficacy studies so we can pursue both 
a licensure for post-exposure and pre-exposure use.
    Ms. Fiorentino. One question for the panel. What steps have 
been taken to invest in validation studies of sampling process 
activities and methods for other biothreat agents besides 
anthrax?
    Ms. Embrey. I missed the question.
    Ms. Fiorentino. Clarify the question? What steps if any 
have been done now to invest in validation studies of sampling 
process activities and methods for other biothreat agents 
besides anthrax? Are there any being done at this point?
    Mr. Reed. We will take that for the record.
    Mr. Shays. What does that mean?
    Mr. Reed. It means, sir, I don't have the data available at 
this point.
    Mr. Shays. Fair enough.
    Ms. Fiorentino. Thank you.
    Mr. Shays. Did you want to respond to that question?
    Dr. George. Yes, I will be happy to respond to that.
    We have done a lot of work with the CDC to develop assays. 
We then hand those--so we work hand in hand, and we then hand 
those assays off to CDC, and they run them through a multi-lab 
validation process, and then they operationalize those assays, 
both in their LRN, as well as for our BioWatch Program.
    Mr. Shays. Yes, sir?
    Dr. Besser. Thank you, Mr. Chairman. The next set of 
studies that CDC is going to be working on on Dugway deal with 
environmental sampling for Yersinia pestis, so there is 
additional work going on for sampling.
    Mr. Shays. Here is what I want to do. I want to resolve 
this issue with DHS and the GAO tonight. I don't want to add 
one more thing to the hearing levels that I have. So I am going 
to say to Defense, we are done with you guys.
    Dr. Parker, do you have anything that you would be able to 
contribute to this dialog, or Dr. Besser, in regards to what we 
are trying to--I think DHS needs a little help here.
    Dr. Parker. Yes, sir, I will stay here.
    Mr. Shays. What I am going to ask is, Mr. Rhodes, if you 
and your colleague would take the seat of Ms. Embrey and Mr. 
Reed and those spaces. What I am going to do is--we may just 
agree to disagree, but at least I will know where the 
disagreement is. I am going to read GAO's statement to us, and 
I am going to ask you--and Dr. George, I would like you to 
invite your colleague to join you.
    Ms. Tulis, do you have anything that you might be able to--
--
    Ms. Tulis. I doubt it.
    Mr. Shays. You seem to be heavy in the document that they 
make reference to though, so I think you better stay.
    Ms. Tulis. OK.
    Mr. Shays. If we could pull up another chair here.
    Sometimes what happens in a hearing, I know when I am 
getting ready to leave for the plane, I try to cut corners with 
my staff to try to get done what I need to get done, and I end 
up not expressing myself the way I want to.
    So I am going to start over. This is a new process, a new 
hearing. Everything is just--we are going to start fresh, and 
we are going to help this committee understand. But I will tell 
you, I had a dog in a fight eventually with DOD when I felt 
that we were misusing the anthrax vaccine and requiring people 
to have it that shouldn't. And it is clear that I was happy to 
prove a point at those hearings about how wrong I thought it 
was, and I am happy the program had become discretionary, that 
people could say no.
    I have no doing in this fight, I really don't, except this. 
I don't think that we have seen the progress we need to, and I 
would like to get a handle on that. That is the only thing that 
I think. So I am going to read Mr. Rhodes' statement.
    He just said, ``We are pleased to be here today''--and I am 
going to ask for reaction. Anyone who is up at the desk, if you 
can help the two parties here sort it out, it would be helpful 
here.
    He said, ``We are pleased to be here today to discuss the 
status of our recommendations on two bodies of work that we did 
at your request: licensed anthrax vaccine and anthrax detection 
methods.'' I am just going to focus on the anthrax detection 
method. That is my words.
    In today's testimony I will specifically report on the 
problems we identified, two, recommendations we made, three, 
actions taken by Federal agencies and what remains to be done.
    Then Mr. Rhodes says: With regard to anthrax detection 
methods, last year I reported to you that the overall sampling 
process and the individual activities were not validated. 
Consequently, Federal agencies could not answer the basic 
question: is this building contaminated?
    Now, that is what he said. I would like to know from DHS if 
they disagree with that basis statement?
    Mr. Vitko. I don't think at that time, or even now, that we 
have full validation of techniques. I do believe that we have 
made significant progress.
    Mr. Shays. Let's get to it. But right now, consequently, 
Federal agencies could not answer the basic question: is this 
building contaminated? That part is true. Whether or not--you 
know, maybe Superman can't do it. That is not my issue. But do 
you agree with that statement?
    Mr. Vitko. We made our best assessment. It needs further 
validation.
    Mr. Shays. That is not my point. Do you agree with the 
statement: Consequently, Federal agencies could not answer the 
basic question: is this building contaminated? Yes, you agree 
or no, you don't, and why you don't.
    Mr. Vitko. As stated, it is too definitive. There are cases 
when we can decide whether a building is contaminated. There 
are levels below which we can't detect.
    Mr. Shays. That is a helpful answer.
    I am sorry to report to you that we are not much further 
along in being able to answer this question than we were in 
2001. Do you agree with that statement?
    Mr. Vitko. No. I believe we made significant progress in 
characterizing the sampling efficiencies of various techniques.
    Mr. Shays. If this building is contaminated today and 
tested negative, you would not know for sure whether the 
negative finding is due to a small number of samples collected 
or the samples were collected from places where anthrax was 
simply not present, or in fact, anthrax is not present in this 
building?
    Mr. Vitko. There is always a chance that we could miss it. 
We use our best strategies.
    Mr. Shays. What do you mean by always a chance?
    Mr. Vitko. What I mean, sir, is that--I want to clarify 
first what stratified sampling is, and then tell you what I 
mean by best guess.
    Mr. Shays. Sure.
    Mr. Vitko. Stratified sampling means I do both targeted 
sampling, which means if you spill a cup of coffee, I am not 
going to go randomly sample the room for where you might spill 
it, I am going to look for near where you are. So I am going to 
do a targeted sampling. And then in addition, I add some 
probabilistic sampling, which means I may cover, say, 10 
percent of the surface area, and if I deduce there is nothing 
there, I make some confident statement about it is probably not 
there.
    It is possible that I contaminated in one corner where I 
did not sample the 10 percent and get the coverage. So you can 
never say with finality that it isn't there, but you could make 
best estimates.
    Mr. Shays. Now, let me just go back to that previous 
sentence. Tell me why you feel that you have made progress 
since 2001. What has happened that makes you feel you have made 
progress?
    Mr. Vitko. OK. In 2001 we were confronted with an event of 
an anthrax contamination, a facility, and we had not 
characterized the efficiencies of different techniques, so 
whether I take the sample by swab or rubbing it this way, 
whether the swab is dry or wet, whether I use a wipe, whether I 
use a so-called HEPA vacuum, we made the quick field 
determinations of those efficiencies and the right mixes of 
those to use.
    Since then we have done well-characterized laboratory 
studies on putting a controlled number of spores down on a 
surface and seeing how much are picked up by each of those 
techniques, and quantifying those, and scientifically 
validating them and getting them peer-reviewed. And we have 
also moved that into the field. So that is on the actual 
physical sampling itself.
    The second thing that we have made a lot of progress on are 
the so-called sampling tools, how do you decide where to take 
samples and how do you log them? One of the testimonies you 
heard, that we in fact developed a hand-held personal data 
system that automatically logs where you take a sample, 
geographically registers it on the building, plots it out for 
visual inspection, and we develop techniques that help you tell 
how many samples to take for the probabilistic part, to give 
you a certain level of confidence.
    And we are also testing these things in the field, as you 
heard, with Dugway and with others, to see that actually holds 
up with agents on real-world surfaces, because the 
characterizations so far have been done on clean, smooth, 
scientific surfaces.
    Mr. Shays. Let me ask GAO just to react to that, what you 
have just heard so far. Why don't you slide over a little 
closer.
    Mr. Rhodes. The first point I would make is that we do not 
say anywhere in the report that targeted sampling should not be 
used. We say that if you do know where the sampling is, where 
the spill is, just as the description of the cup of coffee, we 
say that targeting is fine. The question is when you are going 
to declare a building clean or where you aren't certain that a 
building has been contaminated, that is the point we would 
make.
    Now, at the heart of our recommendation is the question 
about validation, and as you have heard, we concur with the 
point that was made--the methods have not been validated, and 
we still stand by that. There is no disagreement there.
    Mr. Shays. Let's keep going a second. This is just a page 
and a half: We therefore recommended that the Secretary of 
Homeland Security ensure that appropriate validation studies of 
the overall process of sampling activities, including methods, 
are conducted.
    So how does DHS react to that point?
    Mr. Vitko. DHS believes that it has a role in overall 
coordination. We believe, as in the words read to you on HSPD-
10, that the development of standards, protocols--and I forgot 
the other word in there--to assess the risk of contamination, 
EPA has the lead and we are working with them.
    Mr. Shays. Let me ask EPA. Do you believe that you have the 
responsibility? I mean has GAO given it to the wrong person? Is 
it really your responsibility and not DHS's?
    Mr. Tulis. I believe our responsibility is associated with 
sampling for decontamination.
    Mr. Shays. Which means that what?
    Mr. Tulis. Which means once an event has been verified, 
that's what we go in and decontaminate.
    Mr. Shays. So you don't take ownership the way DHS is 
suggesting?
    Mr. Tulis. No, we don't.
    Mr. Shays. OK. So she doesn't take ownership. So we have 
now a disagreement with GAO on this, and now we have--you have 
any disagreement with EPA? What is your reaction?
    Mr. Vitko. My reaction is to ask additional questions.
    Mr. Shays. OK.
    Mr. Vitko. My reaction is to ask EPA whether they believe 
that the sampling to determine the extent----
    Mr. Shays. Talk through the mic. I know you want to be 
polite.
    Mr. Vitko. I am sorry.
    Mr. Shays. You want to look at the person you are speaking 
with but you need to talk through the mic.
    Mr. Vitko. My apologies, sir.
    Mr. Shays. That is all right.
    Mr. Vitko. So my question is simply one of: EPA, do you 
believe that the sampling to assess the state of contamination 
is not an EPA task?
    Mr. Tulis. Yes, it is. Sampling for decontamination, that 
is the parameters I have said.
    Mr. Vitko. To assess the extent of contamination as well?
    Mr. Shays. Wait, hold on a second. They need to be through 
me, the questions.
    Mr. Vitko. I am sorry.
    Mr. Shays. That is all right. You do not need to apologize.
    Mr. Shays. So what I am hearing is that EPA is not saying 
though that their responsibility is to develop a strategic 
plan. They deal with the consequence. And that is what I think 
I heard when the President's directive was written.
    Let me just keep going on though: Although in the past 
there has been confusion as to which Federal agency would take 
the lead, as well as responsibility for ensuring that our 
recommendations are addressed, I am pleased to report that DHS 
is now accepting responsibility.
    You have already said you disagree with that, that was 
misunderstood.
    On May 3, 2006, DHS told us that DHS recognized that it is 
the principal agency's responsibility for coordinating the 
Federal response and would be responsible for ensuring the 
sampling methods, including the process, are validated. DHS 
also would work toward developing a probability based sampling 
strategy.
    You obviously disagree with the basic point, but what part 
of this do you agree with?
    Mr. Vitko. Excuse me for a moment, sir, that I could read 
that passage again.
    Mr. Shays. Do you have your testimony? If you just hand it 
over to him. It is on page 2 of it, and it is at the top of the 
page on--I don't know if his page is the same. It is not the 
same testimony. What GAO does is they give us a shorter version 
so they stay close to the 5 minutes.
    Mr. Vitko. Where do it start?
    Mr. Shays. Page 2. And take your time, we are not in a 
rush.
    Mr. Vitko. This is a vaccine page.
    Mr. Shays. Page 2. I would like you to look at that a 
second before you have to respond. At the top: On May 3, 2006 
DHS told us.
    Mr. Vitko. At the top, OK.
    Mr. Shays. Just look at it a second.
    Mr. Vitko. Is this the second paragraph, Mr. Chairman?
    Mr. Shays. And the first paragraph: On May 3, 2006, DHS 
told us that DHS recognizes that its principal agency 
responsibility--yes, that is it.
    Mr. Vitko. All right. As you acknowledged in the earlier 
comments, we did not tell them that we were the principal 
agency.
    Mr. Shays. I am acknowledging that you disagree with this.
    Mr. Vitko. Right.
    Mr. Shays. Let me keep going: While actions taken by DHS 
are steps in the right direction, we recommend that DHS develop 
a formal strategic plan that includes a road map outlining how 
individual agency efforts would lead to one, validation of 
the--and this is the key I think--validation of the overall 
process of sampling activities including the methods; and two, 
development of a probability-based sampling strategy that takes 
into account the complexity of indoor environments. This would 
allow DHS and the Congress to measure its progress against its 
stated goal.
    How do you react to that?
    Mr. Vitko. We are happy to do that, sir.
    Mr. Shays. Happy to do it is not--I mean I am happy you are 
happy to do it, and I mean by that, that is good, but do you 
think you don't have the role? I mean not only are you happy to 
do it, do you believe that is a responsibility that you--and if 
you don't do it, who the hell will? That is the problem I am 
having right now. I mean, when I asked who took ownership, 
nobody took ownership. And so I thought this was constructive. 
I thought it was constructive that DHS was going to take 
ownership, so I wasn't ready to throw rocks at DHS because they 
didn't take ownership before. I thought, well, I am happy DHS 
takes ownership because somebody has to.
    Mr. Vitko. I am getting a feeling that----
    Mr. Shays. Dr. George, do you want to make a point. I just 
want to give you a chance.
    Dr. George. Thank you. As I stated before, DHS is 
responsible for the characterization part as part of attack 
warning, as I said earlier. When it comes to decontamination 
effectiveness and the risks associated with the decontamination 
process, that is our interpretation of HSPD-10, which is why we 
didn't stand up and take ownership for that problem. We 
certainly support EPA as needed in that process, but it clearly 
defines EPA as having a leadership role.
    Mr. Shays. With all due respect, I think that was talking 
about consequence. That is how I read it. I read it that way. 
What is a little heartbreaking to me is that--well, before I 
tell you what is heartbreaking, Dr. Parker or Dr. Besser, do 
you have anything that you might just establish for the record 
that might be important? And let me just say it is important 
that your agencies at least give me a sense of who you think 
has the role. Otherwise, we are even worse off than I think. If 
it is not you, whose role is it? So I think you all have an 
obligation to tell us who you think the role is, and I am going 
to press you both on it, Dr. Parker and Dr. Besser?
    Dr. Besser. Thank you, Mr. Chairman. The CDC has a long 
history in environmental microbiology, over 50 years, and uses 
environmental microbiology as part of the public health 
response. So I would view CDC as having a very important role 
during an initial response.
    For example, during the recent anthrax event in 
Pennsylvania, where an individual----
    Mr. Shays. You don't need to give me a for instance. I 
understand that. So now what?
    Dr. Besser. So CDC has an important role there. We work on 
improving assays. And when it comes to the decontamination, we 
look to EPA as the lead for having the ability to say, ``Is 
this building clean? Can someone go in?''
    Mr. Shays. So that is helpful. Now what? I want you to 
address what we have been talking about. You have told me your 
role, and that is good, and you don't want to give an inch on 
your role, and that is good, I like that. I wish DHS would take 
it. But what you are avoiding is the question I am asking. 
Don't avoid it.
    Dr. Besser. I think it is an important question. I think 
CDC has an important role at the table in terms of assay 
validation.
    Mr. Shays. You already told me. Who has the role to develop 
the strategic plan, in your judgment?
    Dr. Besser. I think in terms of the GAO report from last 
year, that role was with DHS.
    Mr. Shays. Dr. Parker.
    Dr. Parker. I agree with my colleague, Dr.----
    Mr. Shays. Your mic is not on.
    Dr. Parker. I agree with my colleague, Dr. Besser.
    Mr. Shays. Let me just tell you what I think. What breaks 
my heart is that I have been working on terrorist issues since 
1998. We knew that--we had three commissions, the Bremer 
Commission, the Rudman Commission, the Gilmore Commission. They 
all agreed that there is a terrorist threat. We needed a 
strategy to deal with the threat. We needed to reorganize our 
Government to implement that strategy. And the strongest 
position was to create a Department of Homeland Security. The 
reaction I got back home from people is, what are we, Great 
Britain? And then we had September 11th and we had impetus to 
move forward.
    What I am seeing--and there was arguments, don't create a 
Department of Homeland Security, because, frankly, it would be 
too big, too bureaucratic, and it would just empower the 
various groups to do their thing.
    In a way I feel like we have created a Department of 
Homeland Security that is not acting like a Department of 
Homeland Security, and it is there. But, for instance, with 
Katrina, where I was involved in the investigation, in Katrina, 
we basically determined the White House was somewhat in a fog, 
and then DHS was missing in action, and then we determined that 
FEMA was negligent. Now, DHS basically said, we want FEMA to be 
FEMA, and they were, but they were overwhelmed and they were 
negligent.
    But DHS didn't add value, and what we wanted from DHS was 
for you all to add value, and in some cases, what I envisioned 
is there would be some potentially gray areas, but that 
intuitively we would say, ``Well, this is the role of DHS 
because nobody else has the power to do it, and we are kind of 
like the umbrella.'' And so even if it didn't specifically say 
that the whole thrust of the legislation said it was yours, 
grab it and do it, and then if some other department said, 
``No, you're treading on our territory,'' then I could see a 
little bit of dialog.
    So what you have read to me, Dr. George, to me validates 
exactly what Ms. Tulis said, that she has the consequence of 
it. But I think it is overwhelming that if you had that meeting 
last week, you should have said exactly what you said, that you 
have ownership, you take ownership, you have done some things 
to get you there. That is kind of where I am coming down. So I 
am sorry that there was a misunderstanding there because I 
think the answer you really had that was right was, ``It is our 
responsibility, we should have been moving ahead more quickly, 
but we are working on lots of things. We have made progress 
here.'' I would have just said, ``Terrific.'' Then I would have 
been happy, for you to say you would be happy to take on the 
responsibility. I don't think we need DHS to take that kind of 
position.
    Mr. Vitko. Mr. Chairman, can I speak?
    Mr. Shays. Sure.
    Mr. Vitko. First of all, if we misunderstood and if it is 
clearly accepted that we have responsibility for this, we 
accept that responsibility, first of all. Second, I think 
whether we have that responsibility or not, we believe--and our 
testimony was to that effect--that we have been playing a 
leadership role in that. I do want to make that clear and I do 
want it on the record. We, DHS, have led the interagency 
process in developing an environmental sampling document and 
protocols for contaminated areas, to assess contamination 
following a BioWatch positive. There is a volume of that is 
work jointly under DHS leadership with HHS, DOJ, EPA, and I am 
missing one--there are five agencies in that.
    Second of all, for the last 3 years we sponsored a so-
called restoration, demonstration and applications program at 
the San Francisco International Airport, that again was an 
interagency effort that was geared at looking at how do we 
rapidly characterize and clean up major contaminated 
transportation hubs? In there, we, in fact, developed sampling 
protocols. We did the sampling validation that we talked about. 
We developed the sampling tools. We worked with the EPA to have 
pre-reviewed processes to speed up that decontamination. The 
whole purpose of that was to take an end-to-end systems 
approach to the problem.
    Mr. Shays. Here is what we are going to do. We are going to 
let you have the last word. You have taken some hits today. I 
am happy to have that be your last point, and this is something 
that we will have dialog privately with all of the particular 
parties. It has been an interesting hearing for me, and 
hopefully we have made some progress.
    With that, this hearing is adjourned.
    [Whereupon, at 5:19 p.m., the subcommittee was adjourned.]
    [Additional information submitted for the hearing record 
follows:]

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