U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2250 Mail: Stop SSOP, Washington, DC 20402–0001

32–438 PDF 2007

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

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

CHRISTOPHER SHAYS, Connecticut

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

CANDICE S. MILLER, Michigan

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

JEAN SCHMIDT, Ohio

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

BRIAN HIGGINS, New York

ELEANOR HOLMES NORTON, District of

Columbia

———

BERNARD SANDERS, Vermont

(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

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

JON C. PORTER, Nevada

CHARLES W. DENT, Pennsylvania

DENNIS J. KUCINICH, Ohio

TOM LANTOS, California

BERNARD SANDERS, Vermont

CAROLYN B. MALONEY, New York

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

STEPHEN F. LYNCH, Massachusetts

BRIAN HIGGINS, New York

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

(III)

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

Page

IV

Letters, statements, etc., submitted for the record by—Continued

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, onscene Coordinator [OSC] EPA Region 5, prepared statement of .............. 130

(1)

ANTHRAX PROTECTION: PROGRESS OR

PROBLEMS?

TUESDAY, MAY 9, 2006

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON NATIONAL SECURITY, EMERGING

THREATS, AND INTERNATIONAL RELATIONS, COMMITTEE ON GOVERNMENT REFORM, Washington, DC.

The subcommittee met, pursuant to notice, at 2:08 p.m., in room

2154, Rayburn House Office Building, Hon. Christopher Shays

(chairman of the subcommittee) presiding.

Present: Representatives Shays, Duncan, Porter, and Van Hollen.

Staff present: R. Nicholas Palarino, Ph.D., staff director; Kristine

Fiorentino, professional staff member; Robert A. Briggs, analyst;

Andrew Su, minority professional staff member; and Jean Gosa,

minority assistant clerk.

Mr. SHAYS. The Government Reform Committee Subcommittee

on International Relations and National Security is called to order.

This is a hearing on anthrax protection progress or problems.

In September and October 2001, envelopes containing anthrax

were mailed to post offices and public office buildings. Twenty-two

individuals in four States and Washington, DC, contracted anthrax.

Five died.

The investigation to date has not revealed who converted letters

and packages into vectors of disease. The only things we have are

the lessons learned from these events. They remain our best defense against further attempts to contaminate the mail and other

public places with anthrax.

Today we ask two questions: How effective has our Government

been in developing medical countermeasures against an anthrax attack? How accurate are anthrax detection techniques?

The Department of Homeland Security is responsible for coordinating Federal operations within the United States to prepare for,

respond to, and recover from terrorist attacks, major disasters, and

other emergencies. Other Government agencies with a stake in applying the lessons learned from the anthrax attack include the Departments of Defense and Health and Human Services, the Centers

for Disease Control and Prevention, and the Environmental Protection Agency. In 2004, President Bush authorized $5.6 billion over 10 years

through Project BioShield, for the Government to purchase and

stockpile vaccines and drugs to fight anthrax, smallpox, and other

potential agents of bioterror. This program represents a critical tool

in the war against terrorism as a flexible streamlined means to

2

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:]

3

4

5

6

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:]

7

8

9

10

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

11

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 preexposure 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

12

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:]

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

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?

45

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.

46

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 proVerDate 11-MAY-2000 10:43 May 01, 2007 Jkt 000000 PO 00000 Frm 00050 Fmt 6633 Sfmt 6633 C:\DOCS\32438.TXT HGOVREF1 PsN: HGOVREF1
47

tocols 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

48

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 alVerDate 11-MAY-2000 10:43 May 01, 2007 Jkt 000000 PO 00000 Frm 00052 Fmt 6633 Sfmt 6633 C:\DOCS\32438.TXT HGOVREF1 PsN: HGOVREF1
49

ways 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

50

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 wishywashy, 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

51

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

52

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——

53

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

54

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.

55

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.

56

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, ONSCENE, 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

57

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 disVerDate 11-MAY-2000 10:43 May 01, 2007 Jkt 000000 PO 00000 Frm 00061 Fmt 6633 Sfmt 6633 C:\DOCS\32438.TXT HGOVREF1 PsN: HGOVREF1
58

ease. 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:]

59

60

61

62

63

64

65

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 vehiclemounted, fully integrated biological detection system. It is a corelevel 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

66

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:]

67

68

69

70

71

72

73

74

75

76

77

78

79

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 postexposure 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 postexposure 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 postexposure setting when used in combination with antibiotics and

80

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 nextgeneration 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.

81

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:]

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

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

97

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:]

98

99

100

101

102

103

104

105

106

107

108

109

110

111

112

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 highrisk 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 NaVerDate 11-MAY-2000 10:43 May 01, 2007 Jkt 000000 PO 00000 Frm 00116 Fmt 6633 Sfmt 6633 C:\DOCS\32438.TXT HGOVREF1 PsN: HGOVREF1
113

tional 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:]

114

115

116

117

118

119

120

121

122

123

124

125

126

127

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 roundthe-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.

128

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.

129

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:]

130

131

132

133

134

135

136

137

138

139

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

140

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

141

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.

142

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——

143

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——

144

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

145

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

146

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

147

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.

148

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——

149

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.

150

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.

151

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

152

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?

153

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

154

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?

155

[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

156

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.

157

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.

158

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.

159

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.

160

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.

161

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

162

how much are picked up by each of those techniques, and quantifying those, and scientifically validating them and getting them peerreviewed. 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.

163

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?

164

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

165

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

166

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-toend systems approach to the problem.

Mr. SHAYS. Here is what we are going to do. We are going to let

you have the last word. You have taken some hits today. I am

happy to have that be your last point, and this is something that

we will have dialog privately with all of the particular parties. It

has been an interesting hearing for me, and hopefully we have

made some progress.

With that, this hearing is adjourned.

[Whereupon, at 5:19 p.m., the subcommittee was adjourned.]

[Additional information submitted for the hearing record follows:]

167

168

169

170

171

Æ