[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?
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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
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