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S. Hrg. 110–558 

SIX YEARS AFTER ANTHRAX: 

ARE WE BETTER PREPARED TO RESPOND 

TO BIOTERRORISM? 

HEARING 

BEFORE THE

COMMITTEE ON 

HOMELAND SECURITY AND 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE 

ONE HUNDRED TENTH CONGRESS 

FIRST SESSION 

OCTOBER 23, 2007 

Available via http://www.gpoaccess.gov/congress/index.html 

Printed for the use of the 

Committee on Homeland Security and Governmental Affairs 

( 

(II) 

COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS 

JOSEPH I. LIEBERMAN, Connecticut, Chairman 

CARL LEVIN, Michigan 

DANIEL K. AKAKA, Hawaii 

THOMAS R. CARPER, Delaware 

MARK L. PRYOR, Arkansas 

MARY L. LANDRIEU, Louisiana 

BARACK OBAMA, Illinois 

CLAIRE MCCASKILL, Missouri 

JON TESTER, Montana 

SUSAN M. COLLINS, Maine 

TED STEVENS, Alaska 

GEORGE V. VOINOVICH, Ohio 

NORM COLEMAN, Minnesota 

TOM COBURN, Oklahoma 

PETE V. DOMENICI, New Mexico 

JOHN WARNER, Virginia 

JOHN E. SUNUNU, New Hampshire 

MICHAEL L. ALEXANDER, Staff Director 

AARON M. FIROVED, Professional Staff Member 

BRANDON L. MILHORN, Minority Staff Director and Chief Counsel 

ASHA A. MATHEW, Minority Senior Counsel 

TRINA DRIESSNACK TYRER, Chief Clerk 

(III) 

C O N T E N T S 

Opening statements: Page 

Senator Lieberman ........................................................................................... 1 

Senator Collins ................................................................................................. 3 

Senator Akaka .................................................................................................. 21 

WITNESSES 

TUESDAY, OCTOBER 23, 2007 

Hon. Jay M. Cohen, Under Secretary for Science and Technology, U.S. Department of Homeland Security .......................................................................... 5 

Gerald W. Parker, D.V.M., Ph.D., M.S., Principal Deputy Assistant Secretary, 

Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services .......................................................... 9 

Keith A. Rhodes, Chief Technologist, Director, Center for Technology and 

Engineering, Applied Research and Methods, Government Accountability 

Office ..................................................................................................................... 12 

Tara O’Toole, M.D., MPH, Director and Chief Executive Officer, Center for 

Biosecurity, University of Pittsburgh Medical Center ...................................... 14 

ALPHABETICAL LIST OF WITNESSES

Cohen, Hon. Jay M.: 

Testimony .......................................................................................................... 5 

Prepared statement .......................................................................................... 29 

O’Toole, Tara, M.D., MPH: 

Testimony .......................................................................................................... 14 

Prepared statement .......................................................................................... 71 

Parker, Gerald W., D.V.M., Ph.D., M.S.: 

Testimony .......................................................................................................... 9 

Prepared statement .......................................................................................... 42 

Rhodes, Keith A.: 

Testimony .......................................................................................................... 12 

Prepared statement .......................................................................................... 54 

APPENDIX 

Slides submitted for the Record from Mr. Cohen ................................................. 38 

Questions and responses for the record from: 

Mr. Cohen .......................................................................................................... 80 

Mr. Parker ......................................................................................................... 87 

Mr. Rhodes ........................................................................................................ 103 

Dr. O’Toole ........................................................................................................ 105 

GAO Report to Congressional Requesters, ‘‘Project Bioshield—Actions Needed 

to Avoid Repeating Past Problems with Procuring New Anthrax Vaccine 

and Managing the Stockpile of Licensed Vaccine,’’ GAO–08–88, October 

2007 ....................................................................................................................... 116

(1) 

SIX YEARS AFTER ANTHRAX: ARE WE BETTER 

PREPARED TO RESPOND TO BIOTERRORISM? 

TUESDAY, OCTOBER 23, 2007 

U.S. SENATE,

COMMITTEE ON HOMELAND SECURITY

AND GOVERNMENTAL AFFAIRS, 

Washington, DC. 

The Committee met, pursuant to notice, at 10:01 a.m., in Room 

SD–342, Dirksen Senate Office Building, Hon. Joseph I. Lieberman, Chairman of the Committee, presiding. 

Present: Senators Lieberman, Akaka, and Collins. 

OPENING STATEMENT OF CHAIRMAN LIEBERMAN 

Chairman LIEBERMAN. Good morning and welcome to our hearing today where we will assess whether the Federal Government 

has developed the tools that we need in the post-September 11, 

2001, world to respond to bioterrorist attacks on the United States 

and also to the effects of pandemic events. 

Six years ago—just one week after the September 11 attacks 

traumatized America—we were shaken again by a string of anthrax attacks that, over the course of 2 months, killed five people, 

sickened 22, and drove more than 10,000 others to take powerful 

antibiotics as a precautionary measure. Postal Service workers 

were hit the hardest as the attack came in letters through the 

mail, but I will say, it also hit close to home. In Wallingford, Connecticut, a wonderful woman, Ottilie Lundgren, was one of those 

who died because she opened a letter containing the deadly substance. 

I know that we all certainly here in the Capitol remember those 

days because a mailroom employee of then-Majority Leader Tom 

Daschle opened a letter containing the deadly white powder. The 

Hart Building was evacuated, closed for months while environmental HAZMAT teams scoured the building. 

Regrettably, whoever was responsible for the anthrax attacks, 

has remained unknown and, therefore, unfortunately, unpunished. 

But we do know that a catastrophe can strike Americans in their 

homes or places of work or places of assembly as a result of bioterrorism or naturally occurring diseases such as pandemic flu. And, 

therefore, we must be ready. 

So 6 years after those anthrax attacks, are we better prepared 

to respond to bioterrorism than we were then? My answer, unfortunately, is yes, but not much, and certainly not enough. And I base 

that on the testimony and the GAO report that we will hear today. 

2 

1GAO Report to Congressional Requesters, ‘‘Project Bioshield—Actions Needed to Avoid Repeating Past Problems with Procuring New Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine,’’ GAO–08–88, October 2007, appears in the Appendix on page 116. 

We have a lot to do in the area of medical readiness. Last week, 

the Administration finally produced its National Strategy for Public Health and Medical Preparedness. It covers the range of emergency responses that would be required after various types of biological attacks. As I read it, I became increasingly concerned that 

right now we are far from capable of achieving many of those requirements as stated in the National Strategy. For instance, we are 

still not able to monitor biological incidents and their effects on 

people in real time. We cannot reliably field sufficient medical 

surge capacity to respond to either a bioterrorism attack or a naturally occurring pandemic. We cannot dispense drugs to entire populations or track the spread of disease through a community. These 

are essential requirements of national health security post-September 11, 2001, and they are today, unfortunately, unmet. So we 

will ask why we have not met those requirements and how together we can do so as soon as possible. 

Today’s hearing will also consider how well the government is 

protecting its citizens from biological threats through medical countermeasures and technologies, and here I specifically mean a 21st 

Century anthrax vaccine, a system of biological sensors in cities 

throughout the Nation, and better standards for anthrax field tests 

to speed response and reduce false alarms. 

In these areas, the status of our government’s activities I think 

has been mixed. On the up side—and there is an up side here— 

the Strategic National Stockpile has been enlarged with additional 

doses of an anthrax vaccine, new antidotes to counter the toxins it 

produces, antibiotics for over 40 million people, and countermeasures to other diseases such as smallpox and botulism toxins 

that can be spread by a terrorist attack. 

As a result, the ability to treat victims of biological attacks with 

medical countermeasures has genuinely improved since 2001. Our 

research is also getting better as a result of centers that have been 

established specifically to study bioterrorism agents, their compositions, capabilities, and provenance. 

On the down side, however, the Department of Health and 

Human Services’ efforts to develop a second-generation anthrax 

vaccine have, in a word, failed. This is a very disappointing breakdown that has put us back at square one after 4 years of work, a 

lot of it apparently misguided, to improve on the 30-year-old technology that we now have in the stockpile. 

Today, this Committee is releasing a report by the Government 

Accountability Office,1 the first of a series in related topics that reviews HSS’ missteps, describes the Department’s failure to minimize waste of the stockpiled vaccine, and provides recommendations for how to avoid similar mistakes in the future. 

I must say that I am particularly concerned about this problem 

because the Department of Health and Human Services is preparing to seek bids on a new contract for an anthrax vaccine without, according to GAO, having conducted a thorough postmortem of 

its errors with regard to the awarding of the first contract. 

3 

The brief history of this vaccine began after Congress passed the 

BioShield legislation in 2004 to establish a method for the Federal 

Government to buy medical countermeasures to biological agents. 

The first contract was awarded later that year to a small company 

called VaxGen. They were to develop a next-generation vaccine to 

replace the current one, which, though safe, is often painful, requires six injections to be effective, and has had problems maintaining required purity. 

Multiple problems arose, as we know, in the VaxGen contract, 

and they have been well documented in previous congressional 

hearings so we need not go over them here. The contract was eventually canceled, and, needless to say, the second-generation vaccine 

was never produced. 

Today in its report, GAO points out that HHS has not yet fully 

examined its BioShield failure, much less adopted measures to 

avoid a repeat of it. So I will ask our HHS witness this morning 

how the Department expects to avoid similar failure the next time 

around. 

Beyond countermeasures, we are also going to look at detection 

technologies under development and those already being implemented. And there is some encouraging news here, too, including 

the Department of Homeland Security’s BioWatch system, a network of sensors placed in over 30 cities to test the air for anthrax 

and other biological agents. How successful has that program been 

and should it be expanded further? I am going to ask the Department of Homeland Security also for an explanation of why it has 

not yet adopted standards it and other stakeholders created for anthrax field tests so that new technologies will be as effective as possible. 

To say the obvious, we are very fortunate that during the last 

6 years we have not experienced another attack from biological 

agents or any other form of weapon of mass destruction. And so far 

we have, fortunately, also managed to avoid the major pandemics 

that seem to sweep the globe naturally every few decades. But that 

obviously does not mean that we will be so lucky in the future. 

The Departments of Homeland Security and Health and Human 

Services, working in coordination with State and local governments 

and the private sector, have very awesome responsibilities here to 

protect the public from deadly biological attacks, awesome in the 

sense of the scope of the responsibility and what has to be done to 

meet it. This Committee wants to work with both Departments to 

get it right because the consequences of failing to do so would obviously be catastrophic. 

I look forward to the testimony of our witnesses today. I thank 

you for being here, and now I am pleased to call on Senator Collins. 

OPENING STATEMENT OF SENATOR COLLINS 

Senator COLLINS. Thank you, Mr. Chairman. 

Six years ago, anthrax-laced letters resulted in the deaths of five 

people, widespread concern about the safety of postal workers and 

the U.S. mail, the treatment of thousands of people with powerful 

antibiotics, and the evacuation of the Hart Senate Office Building. 

Today’s hearing concerns two matters of great importance for 

this Committee and for all Americans: Our preparedness for bioterVerDate Aug 31 2005 15:03 Oct 23, 2008 Jkt 038988 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 P:\DOCS\38988.TXT SAFFAIRS PsN: PAT
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rorism and efficiency in government operations. Unfortunately, the 

report that Senator Lieberman and I requested from the GAO 

makes clear that the Federal attempt to procure an improved anthrax vaccine has yielded not a new vaccine but instead a textbook 

example of prodigious waste. As the GAO also discovered, taxpayers stand to lose $128 million 

in 2008 as the stocks of the current vaccine expire. The Department of Health and Human Services currently has no system to 

transfer them for use by the Department of Defense, the only largescale user of anthrax vaccine, before the stocks expire. 

In 1996, former Army Chief of Staff Gordon Sullivan wrote a 

wise book on a systematic approach to management in settings of 

uncertainty and change. Its title alone offers a kernel of wisdom: 

‘‘Hope Is Not a Method.’’ The story of the now canceled $877 million procurement contract 

between HHS and VaxGen demonstrates the danger of relying on 

hope for progress. The Department hoped that a small company 

could not only develop an effective vaccine, but also could obtain 

approval for it and manufacture 75 million doses all on an unrealistically fast track. 

VaxGen officials hoped that they could meet the terms and deadlines of a contract that lacked specific requirements and was critically vulnerable to future decisions by the Food and Drug Administration. 

VaxGen also hoped that its small staff, lack of expertise in vaccine formulation, and limited access to additional capital would not 

impede the required rapid progress to contract fulfillment. 

Not one of these hopes survived the collision with reality. 

The reality is that HHS’ contracting practices for Project BioShield have displayed many of the same problems that this Committee has observed in procurements in other departments and 

agencies related, for example, to Hurricane Katrina and to reconstruction work in Iraq and Afghanistan—flaws that we hope to correct through contracting reform legislation. 

HHS was responding to a crisis in the wake of the September 11, 

2001, terrorist attacks and the anthrax mailings. No one knew how 

soon or in what number follow-on attacks might appear. But the 

risks, uncertainties, and vulnerabilities revealed by the anthrax attacks made a methodical approach to vaccine procurement more, 

not less, important. 

A methodical rather than a hopeful approach to Project BioShield 

contracts might have included a more realistic evaluation of the 

suitability of using a small vendor with limited experience, a vendor that had been de-listed from the NASDAQ securities market 3 

months before the November 2004 contract signing. 

A methodical approach would have included a fact-driven assessment of vaccine development prospects and production capabilities—an assessment that GAO’s interviews with industry experts 

suggest would have been bleak indeed. 

And perhaps most important, a methodical approach would have 

identified and specified contract requirements up front. 

I have no doubt that many lessons could be drawn from this very 

troubling story. But as the GAO notes, HHS has yet to conduct a 

formal lessons-learned study. 

5 

1The prepared statement of Mr. Cohen appears in the Appendix on page 29. 

We will spend additional time today discussing two other disturbing issues outside the immediate ambit of the VaxGen contracts—the lack of a process to move the stocks of current anthrax 

vaccine to the military before they expire, and the reported willingness of HHS to deploy the vaccine even if it has expired. 

I look forward to hearing the testimony of our witnesses today 

on the procurement and the other challenges we must address to 

ensure that our Strategic National Stockpile fulfills its purpose of 

maintaining readily available stocks of vital medical supplies for 

victims of major disasters. I am particularly interested in hearing 

Admiral Cohen’s thoughts on how the findings from the GAO report can be applied to the important work he is leading at DHS. 

The only good news in the GAO report was the obvious observation that we have suffered no new anthrax attacks since 2001. If 

we had, our hearing could have unfolded in the wake of another 

tragedy. We must apply the lessons learned from the failures documented by the GAO to improve our preparations for a possible terrorist attack using biological weapons before it is too late. 

Chairman LIEBERMAN. Thanks, Senator Collins, for that excellent opening statement. 

We appreciate the four witnesses before us who can help us answer the questions we have. We will begin with Jay Cohen, Under 

Secretary of the Department of Homeland Security for the Science 

and Technology Directorate, Retired Admiral of the U.S. Navy. 

Good to see you. This is actually your first appearance before the 

Committee since assuming this role. We welcome you. I think you 

know that the Science and Technology Directorate is one of the totally new entities created at the Department of Homeland Security 

effectively by this Committee. So just to make you feel younger, we 

take a paternalistic interest in what you are doing. Admiral Cohen? 

TESTIMONY OF HON. JAY M. COHEN,1 UNDER SECRETARY FOR 

SCIENCE AND TECHNOLOGY, U.S. DEPARTMENT OF HOMELAND SECURITY 

Mr. COHEN. Well, good morning, Chairman Lieberman, Senator 

Collins, and distinguished Members of the Committee. I am honored to appear before you on this solemn occasion of the sixth anniversary of the anthrax attacks against our Nation to report on the 

progress made by the Department of Homeland Security’s Science 

and Technology (S&T) Directorate. Those events of 6 years ago 

served as a wake-up call that an adversary could produce or obtain 

biological agents to use against this country. 

Thank you for entering my formal written statement into the 

record. I will quickly summarize it here. But before I do, I wanted 

to thank the Congress, this Committee, and your very professional 

staff for the strong bipartisan leadership and support you have 

given me and the dedicated, hard-working men and women of the 

Department of Homeland Security Science and Technology Directorate as they work to make the Nation safer. Thomas Jefferson 

said, ‘‘The price of freedom is eternal vigilance.’’ And vigilant we 

must be. 

6 

1The slides submitted by Mr. Cohen appear in the Appendix on page 38. 

I am humbled to appear alongside such distinguished panel 

members. The Congress and the American people want to know, 6 

years after anthrax, are we better prepared to respond to bioterrorism? And I will tell you the answer is yes, and I would like to 

give you a few examples.1

Prior to the anthrax attack, the Nation lacked a comprehensive 

understanding of the risks posed by acts of bioterrorism. We did 

not have a dedicated research and development capability for addressing those risks, civilian attack warning systems to know if we 

had been attacked, dedicated forensic analysis capabilities and adequate capacity to rapidly characterize samples from the attack to 

help others in trying to identify who might have perpetrated the 

attacks, plans and tools for cleaning up after such an attack, and 

focus on the additional significant threats posed by bioterrorism. 

In the intervening 6 years, DHS S&T, in collaboration with its 

interagency partners, represented here and in the audience, conducted formal risk assessments of 28 biological agents. This analysis is guiding the prioritization of the Nation’s biodefense efforts 

and has resulted in nine additional material threat determinations, 

a list of key agents to be detected by warning systems, and identification of key vulnerability and research gaps. 

We established a National Biodefense Analysis and Countermeasures Center to provide a dedicated capability for conducting 

both unclassified and classified biodefense research; developed and 

operated the Nation’s first bioattack warning system, which has already been referred to here, known as the BioWatch system. This 

system, first fielded in 2003—and I am very pleased that Dr. John 

Vitko, who is my Director of the Chemical and Biological Division, 

is largely responsible for that development and deployment. It was 

fielded in 2003 and is operating in more than 30 cities, as has already been stated, and has conducted some 4 million tests to date 

without a single false positive. 

We have conducted development of the next-generation fully autonomous detection systems to significantly increase the BioWatch 

capabilities, and I know your interest in that, and those systems 

are now entering field tests; developed standards and processes for 

biodetection tools to be used by first responders; in partnership 

with HHS, DOD, Department of Justice, the Postal Service developed a coordinated national biomonitoring architecture; established 

a National Bioforensic Analysis Center, and we are conducting 

operational bioforensic analysis today in partnership with the FBI. 

This provides the Nation with its first dedicated contaminationfree biocontainment laboratory space for forensic analysis and the 

necessary analytic tools and chain of custody control for conducting 

that analysis. We have worked with the EPA, HHS, and State and 

local authorities to develop protocols and tools for cleaning up complex transportation hubs following a biological attack, and we are 

working closely with the U.S. Department of Agriculture to better 

characterize the existing veterinary countermeasures for agro-defense and to develop next-generation countermeasures. 

In the future, I am pleased to tell you that we will extend the 

formal risk assessments to include all of chemical, biological, radioVerDate Aug 31 2005 15:03 Oct 23, 2008 Jkt 038988 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 P:\DOCS\38988.TXT SAFFAIRS PsN: PAT
7 

logical, and nuclear threats. We will complete construction and occupy the new National Biodefense and Analysis Countermeasures 

Center (NBACC) facility at Fort Detrick, Maryland, and that 

should occur at this time next year. And working with our colleagues on the National Interagency Biodefense Campus at Fort 

Detrick, we will provide the Nation with the understanding it 

needs to identify and prioritize threats and the tools it needs to defend them. 

We will develop the understanding and tools to defend against 

enhanced and advanced biological threats. We will complete testing 

of the next-generation BioWatch systems and work with the DHS 

Office of Health Affairs—and thank you for establishing that customer for me, critically important—to transition BioWatch III into 

operation. We will develop an expanded range of detection systems 

and tools for use in facility protection, protection of the food supply, 

and first responders. We will partner with the EPA, HHS, and 

State and local governments to develop the framework, plans, and 

tools for restoring entire city neighborhoods in the event of a biological attack. We will partner with the U.S. Department of Agriculture to develop next-generation veterinary countermeasures. 

And, finally, we will design, construct, and operate the National 

Bio- and Agro-defense Facility (NBAF), to provide the Nation with 

state-of-the-art biocontainment laboratory space to accelerate the 

development of veterinary countermeasures against foreign animal 

and zoonotic diseases. And you know we look to have that downselect at this time next year. 

And so before I conclude, I am pleased to be joined here today, 

as I said, by Dr. John Vitko, and also Jamie Johnson, who is my 

Director of the Office of National Labs in the S&T Directorate, who 

will help this shade tree engineer with your more technical questions. 

Additionally, my DOD partners have brought examples of devices 

that we have developed together for our first responders. You see 

a new chem/bio suit that our firemen can use. 

So, in summary, DHS S&T has taken the wake-up call of the 

2001 anthrax events very seriously. Much has been accomplished. 

However, because of the evolving nature of the threat, much also 

remains to be done. We look forward to continuing to support the 

Nation in responding to this challenge. I welcome your oversight, 

and I welcome your questions. Thank you so much. 

Chairman LIEBERMAN. Thanks, Admiral. Do you want to take a 

minute to describe the chem/bio outfit? 

Mr. COHEN. Yes, sir. In today’s world, where we ask our heroes, 

our first responders—the enabling legislation that you so eloquently put in place, I am reminded that it is 183 pages of which 

17 pages are DHS S&T. I just completed 6 years as Chief of Naval 

Research, and the legislation in Title X for the Office of Naval Research, 1946, is half a page. It says there will be an Office of Naval 

Research, it will be led by an admiral, you will do good S&T, and 

you will report to the Secretary of the Navy. 

Here, 60 years later, we have 17 pages, and it shows you the impact of word processing on the legislative process. But it is very 

well thought out. 

8 

Chairman LIEBERMAN. You and your predecessors made a lot out 

of that half-page. [Laughter.] 

Mr. COHEN. And we continue to, I can assure you. But everyone 

is well represented. It is very well thought out, and, of course, the 

support I got from your Committee and from all of the Congress 

the first 3 weeks I was on board a year ago, in August, in getting 

the new organization in place and the new investment portfolio 

was because I xeroxed those 17 pages, I highlighted them, and we 

organized to fulfill your vision, which I think was very thoughtful. 

But today, and I think you are very wise in this, I am not to recreate National Institutes of Health, National Science Foundation, 

DOD or DOE labs. But you have given me the authorities to leverage them and take my precious dollars and add on top. 

So we deal with the Technology Support Working Group (TSWG), 

which is a very strong, very proactive, and very innovative Department of Defense group, and working together with them, what you 

see here is an ensemble for our firemen where, when they go into 

a hazardous situation—and, as you have indicated, Chairman, they 

may not know initially that there are biological or chemical hazards. It provides the additional protection because we know they do 

not only have to worry about smoke and worry about the heat and 

the fire, but we know that when they come out we can monitor 

them, and they will not have been exposed internally to chemical 

and biological threats. And we do that through filters, the self-contained breathing apparatus, even the gloves—and there are two 

different variations because I am a big believer, as is TSWG, in 

competition of ideas. The gloves have magnetic seals, so when you 

put the glove on, even at the glove area you do not get the leakage. 

And so these are, in fact, in operation today. 

We have an iris scanner. Now, this is really expensive. It is about $15,000 a copy. But it will give us detection against your face 

of biological and chemical threats. If we were to deploy these in the 

hundreds, it would be $10,000 to $15,000 a copy, but you can imagine—and this is a wonderful thing about America, our innovation, 

the Bayh-Dole Act that you provided. In thousands, we would drive 

the price down, and this would be an export for American technology. 

Chairman LIEBERMAN. What would you do with that? Just take 

a minute. 

Mr. COHEN. You would just put it—I am the first responder. 

Chairman LIEBERMAN. Yes, you want to make sure that the first 

responder has not been compromised. 

Mr. COHEN. Or a victim. 

Chairman LIEBERMAN. Or a victim, right. 

Mr. COHEN. It does not matter. It is the human subject. We put 

it there, we press the button, and it will give us a readout for the 

various biological and chemical contamination and give us a high 

confidence level. 

Chairman LIEBERMAN. That is great. 

Mr. COHEN. This is in the final stage of testing. 

And, finally—and you are very kind to give me this extra time, 

Chairman—this little device, I thought it was a chocolate wafer. I 

was really pleased that my staff had provided that for me. I am 

a chocoholic. But it is actually this disposable mask. You can carry 

9 

1The prepared statement of Mr. Parker appears in the Appendix on page 42. 

this in your back pocket. And, again, this provides the near-term— 

not against smoke, but against biological and chemical hazards so 

that you can evacuate the area of contamination. 

This is just a small example. We filled up the Cannon Caucus 

Room last spring, DHS and TSWG, showing the kind of progress 

that we have made in all these areas. Thank you so much. 

Chairman LIEBERMAN. Thanks, Admiral. I am glad you did that. 

Look, part of why Senator Collins and I wanted to put the S&T Directorate in DHS was because we in our service on the Armed 

Services Committee had seen the power of putting Federal money 

into research when there is, in that case, national security, and 

now here, homeland security. And, of course, there is tremendous 

spillover into commercial applications as well. So it has been very 

encouraging to see the combination of American innovation or 

American entrepreneurship come together to try to meet the needs 

that we have now. You are going to give that first responder the 

rest of the morning off? 

Mr. COHEN. Yes, sir. We will give him gangway liberty. [Laughter.] 

Chairman LIEBERMAN. OK. 

Dr. Parker, welcome. Thank you for being here. Principal Deputy 

Assistant Secretary, Office of the Assistant Secretary for Preparedness and Response at the U.S. Department Health and Human 

Services. We welcome your testimony. Obviously, GAO had some 

tough things to say about HHS, so this is your opportunity to respond. 

TESTIMONY OF GERALD W. PARKER, D.V.M., PH.D., M.S.,1 PRINCIPAL DEPUTY ASSISTANT SECRETARY, OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, 

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Mr. PARKER. Thank you and good morning. Chairman Lieberman, Ranking Member Collins, and distinguished Members of the 

Committee, I am honored to be here today to discuss the development and acquisition of medical countermeasures to address the 

threat of bioterrorism. 

I would like to make it clear that medical countermeasures development and acquisition is only one component of our overall preparedness efforts that range from research, development, and acquisition of medical countermeasures to response delivery platforms that support State and local authorities in dealing with the 

medical aspects of major disasters. 

Today I will focus on three themes related to how HHS has made 

significant progress in our medical preparedness activities. 

First, we have made significant progress; we have made significant acquisitions for the stockpile against the most serious threats 

facing the Nation. 

Second, as a result of the lessons learned from previous acquisition successes and setbacks, and with the help of Congress, we 

have changed the way we do business at HHS. 

10 

Third, we have taken an all-hazards approach to public health 

preparedness. The gains we make against each threat will help us 

across the spectrum of public health emergencies and disasters. 

HHS has already achieved a significant level of preparedness 

against a number of threats using all authorities available to us. 

For example, we have a stockpile of antibiotics that provides a substantial level of preparedness for bacterial threat agents, including 

anthrax, plague, and tularemia. This includes enough antibiotics 

for the first-line defense against anthrax to provide a 60-day postexposure prophylaxis for over 40 million people. We also have 

enough smallpox vaccine for every American. That includes a new 

vaccine, ACAM–2000, developed by Acambis, that was just licensed 

by the FDA this year. Project BioShield, enacted in 2004, authorized the $5.6 billion Special Reserve Fund for the procurement of 

security medical countermeasures. 

During the first 3 years of implementation, Project BioShield 

awarded procurement contracts for the current and next-generation 

anthrax vaccines, anthrax antitoxins, a next-generation smallpox 

vaccine, botulism antitoxins, and two medical countermeasures for 

radiological threats. Additionally, we have made great progress in 

improving our Nation’s ability to respond to an influenza pandemic. 

Since December 2005, HHS has awarded over $3 billion to support the first stage of our pandemic preparedness activities, including expanding and diversifying domestic influenza vaccine production and surge capacity, increasing H5N1 vaccine and antiviral 

stockpiles, and supporting advanced development of cell culture 

and antigen-sparing influenza vaccines, antivirals, and diagnostics. 

While we have achieved successes, we have also learned lessons. 

The discovery and development of new medical countermeasures is 

complex and an inherently risky endeavor. The termination of the 

contract to procure an rPA anthrax vaccine exemplifies the multifactorial challenges encountered in implementation of Project BioShield. We have observed several lessons in implementing Project 

BioShield: 

First, contract terms dictated by the BioShield statute were challenging, particularly for less experienced companies. 

Second, it is critical that developers establish effective relationships with the FDA to gain a clear understanding of the regulatory 

requirements with respect to their product for the stockpile. 

And, third, or finally, absence of a robust advanced development 

program placed too much risk on BioShield projects. 

In response to these lessons, in July 2006, HHS established the 

Public Health Emergency Medical Countermeasures Enterprise to 

coordinate the range of work being done to develop and procure 

countermeasures against terrorist and naturally occurring threats 

and to define priority requirements and make more efficient decisions. 

We have established the Biomedical Advanced Research and Development Authority (BARDA), as called for in the Pandemic and 

All-Hazards Preparedness Act. And we are working to improve and 

accelerate medical countermeasures advanced research and development using these new authorities. We also are building on the 

successes of the pandemic influenza program to support an adVerDate Aug 31 2005 15:03 Oct 23, 2008 Jkt 038988 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 P:\DOCS\38988.TXT SAFFAIRS PsN: PAT
11 

vanced development portfolio of new products and technologies 

across the threat spectrum. We have requested $189 million for advanced development for 

fiscal year 2008 to increase the maturity of potential Project BioShield products, bridging the Valley of Death gap between NIH 

and other research and development programs in Project BioShield 

procurements. 

I cannot overstate the importance of advanced development, and 

the fiscal year 2008 request for advanced development funding is 

critical to BARDA implementation and effective utilization of the 

Special Reserve Fund for Project BioShield. We are using new 

BARDA authorities, such as advanced and milestone payments, in 

the new BioShield contract for the next-generation smallpox vaccine and have recently awarded a number of advanced development 

contracts. These include advanced development contracts for anthrax antitoxins, rPA anthrax vaccine, a smallpox antiviral, novel 

antibiotic formulations, and radiological/nuclear medical countermeasures. 

We are facilitating stakeholder discussions with the FDA to establish a better understanding of the regulatory requirements for 

countermeasures. We will continue to insist on and verify demonstrated understanding of those requirements by manufacturers. 

Last spring, we released the enterprise strategy and implementation plans which identified the top priority medical countermeasures development and acquisition thrust and requirements. 

These plans were informed by significant stakeholder input. The 

strategy and implementation plan reaffirms and further identifies 

our commitments to the development and acquisition of anthrax 

vaccines, anthrax antitoxins, and therapeutics for radiological and 

nuclear threats. It also identifies the need for the continued development and acquisition of broad spectrum antibiotics, antivirals, 

and diagnostics against the high-priority threats identified by the 

Department of Homeland Security. 

The National Biodefense Science Board was established last May 

to provide expert advice and guidance to the HHS on all matters 

related to preparedness and response to public health emergencies 

resulting from current or future threats, whether naturally occurring, accidental, or deliberate. These and other efforts signal our 

commitment to greater transparency, predictability, and partnership with our stakeholders. We will build on past successes, lessons 

learned, and new authorities to continue to improve implementation of all BARDA programs, including Project BioShield. 

This concludes my testimony, and I would be happy to answer 

any questions. Thank you. 

Chairman LIEBERMAN. Thanks, Dr. Parker. We look forward to 

the questions. 

Our next witness is Keith Rhodes, who is the Chief Technologist 

of the Government Accountability Office and Director of the Center 

for Technology and Engineering. In this capacity, Mr. Rhodes provides assistance throughout the Legislative Branch, throughout 

Congress, on issues requiring significant technical expertise. 

Mr. Rhodes, we welcome your testimony. As I mentioned in my 

opening statement, one of the things that I found most troubling 

in your testimony was the conclusion that the folks at HHS had 

12 

1The prepared statement of Mr. Rhodes appears in the Appendix on page 54. 

2The report by GAO appears in the Appendix on page 116. 

not done a thorough postmortem of the failed VaxGen contract, 

which was particularly troubling since they are in the process of 

going to a second try at it. Dr. Parker has just used the phrase 

‘‘lessons learned’’ and mentioned some things, and I welcome your 

response as to whether that is adequate to meet the concerns that 

you expressed in your report. 

TESTIMONY OF KEITH A. RHODES,1 CHIEF TECHNOLOGIST, 

CENTER FOR TECHNOLOGY AND ENGINEERING, APPLIED 

RESEARCH AND METHODS, GOVERNMENT ACCOUNTABILITY 

OFFICE 

Mr. RHODES. Thank you, Mr. Chairman. I will try and address 

that as quickly as I can. 

Chairman Lieberman and Senator Collins and Members of the 

Committee, thank you for asking us here to discuss our findings on 

Project BioShield’s first major procurement contract for the new 

rPA anthrax vaccine and the potential for waste in the Strategic 

National Stockpile. My statement is based on our report,2 which we 

are releasing today, and will focus on the following two issues that 

you asked us to address: One, factors that contributed to the failure of ASPR’s first Project BioShield procurement effort with 

VaxGen for an rPA anthrax vaccine; and, two, potential for waste 

in the licensed anthrax vaccine BioThrax in the Strategic National 

Stockpile. 

In November 2004, ASPR awarded VaxGen a procurement contract for $877.5 million. Two years later, in December 2006, ASPR 

terminated VaxGen’s contract for failure to meet a critical contractual milestone. We identified three major factors that contributed 

to the failure of this effort: 

First, ASPR awarded the first BioShield procurement contract to 

VaxGen when its product was at a very early stage of development, 

when many critical manufacturing issues such as stability and 

scale-up production had not been addressed. Similarly, the requirement to deliver 25 million doses of rPA anthrax vaccine within 2 

years was not based on objective data. This requirement, according 

to industry experts, would have been unrealistic even for a large 

pharmaceutical firm, given that the product was at such an early 

stage of development. 

Second, VaxGen took unrealistic risks in accepting the contract 

terms. According to VaxGen officials, they understood that their 

chances of success were limited. Nonetheless, they accepted the 

contract terms in spite of the aggressive delivery timeline, their 

lack of in-house technical expertise and stability in vaccine formulation, and their limited options for securing additional funding 

should the need arise for additional testing to meet regulatory requirements. 

Third, important FDA requirements regarding the type of data 

and testing required for the rPA anthrax vaccine to be eligible for 

use in an emergency were not known to FDA, NIAID, ASPR, and 

VaxGen at the outset of the procurement contract. The requirements for use of the new anthrax vaccine were defined later when 

13 

FDA introduced new general guidance on emergency use authorization and specifically in January 2006, after VaxGen asked FDA for 

clarification. In addition, ASPR’s anticipated use of the rPA anthrax vaccine was not articulated to all parties clearly enough and 

evolved over time. 

Finally, according to VaxGen, the purchase of BioThrax for the 

stockpile as a stopgap measure for post-exposure situations increased the requirements for using the VaxGen rPA vaccine. 

All of these factors created confusion over the acceptance criteria 

for VaxGen’s product and significantly diminished VaxGen’s ability 

to meet contract timelines. 

According to industry experts, the lack of clear requirements is 

a cause of concern to companies asked to partner with the government since they invest significant resources in just trying to meet 

government needs. These companies are now questioning whether 

the government can clearly define its requirements for future procurement contracts. 

With regard to potential for waste in the stockpile, we identified 

two issues: 

First, ASPR lacks an effective strategy to minimize waste. Vac- cine valued at more than $12 million has already expired and is 

no longer usable. Without an effective management strategy in the 

future, over $100 million per year could be lost over the life of the 

licensed anthrax vaccine currently in the stockpile. ASPR could 

minimize such potential waste by developing a single inventory 

system for BioThrax in conjunction with the Department of Defense, with rotation based on a first-in, first-out principle. 

Second, ASPR plans to use expired vaccine in violation of FDA’s 

current rules. According to CDC, ASPR told CDC not to dispose of 

the three lots of BioThrax vaccine in 2006 and 2007. ASPR officials 

told us that the agency’s decision was based on the possible need 

to use the lots of vaccines in an emergency. However, FDA rules 

prohibit the use of expired vaccine. Thus, ASPR’s planned use of 

expired vaccine would violate FDA’s current rules and could undermine public confidence because ASPR would be unable to guarantee the potency of the vaccine. 

Mr. Chairman, in our May 2006 testimony, we concluded that 

ASPR’s procurement strategy for rPA anthrax vaccine had been 

very aggressive. We stated that, ‘‘It is important to understand the 

unique issues at stake in this early phase of implementation for 

the biodefense strategy. The rest of the biotechnology sector will be 

watching to see whether the industry and the U.S. Government can 

make this partnership work.’’ 

And so, Mr. Chairman, Senator Collins, as you have said, 6 years 

after the anthrax attacks of 2001, the government does not have 

a new, improved anthrax vaccine for protecting the public. The failure of this procurement effort has raised large questions regarding 

our country’s ability to build a partnership between pharmaceutical 

and biotechnology firms and the government to develop both new 

vaccines and a robust and sustainable biodefense industrial base. 

This goes beyond just this individual vaccine procurement and 

could have an impact on how the biotechnology industry responds 

to government overtures in the future for tools to counter the many 

biothreat agents still to be addressed. 

14 

1The prepared statement of Dr. O’Toole appears in the Appendix on page 71. 

Finally, given that the amount of money appropriated to procure 

medical countermeasures for the stockpile is limited, it is imperative that ASPR develop effective strategies to minimize waste. This 

point is the basis for maintaining public confidence. Since vaccines 

are perishable commodities that should not be used after their expiration dates, it is prudent for ASPR to destroy the expired lots 

to ensure the public that they will not be given an expired vaccine 

in case of an emergency. In addition, ASPR should find users for 

the stockpiled products before they expire to minimize waste. 

Regarding your question on lessons learned, we have seen no formal lessons learned. We have seen no documentation. If Dr. Parker’s statements are credible, that is fine, but we have not seen a 

formal document explaining what I just explained to you and what 

we have stated in our report and in the testimony. 

Mr. Chairman, Senator Collins, this concludes my summary. I 

will be happy to answer any question you or other Members of the 

Committee may have. 

Chairman LIEBERMAN. Thanks, Mr. Rhodes. 

Dr. Parker, during the question-and-answer period, we will give 

you a chance to respond. 

Our final witness on the panel, returning by popular demand, 

Dr. Tara O’Toole is the CEO and Director of the Center for Biosecurity at the University of Pittsburgh Medical Center and a professor of medicine at the University of Pittsburgh. The center conducts policy analyses and works to prevent the development and 

use of biological weapons, among other challenges it takes on. 

It is very good to see you, and I look forward to your testimony 

now. 

TESTIMONY OF TARA O’TOOLE, M.D., M.P.H.,1 DIRECTOR AND 

CHIEF EXECUTIVE OFFICER, CENTER FOR BIOSECURITY, 

UNIVERSITY OF PITTSBURGH MEDICAL CENTER 

Dr. O’TOOLE. Thank you, Mr. Chairman, Senator Collins, and 

Members of the Committee. Thanks for the opportunity to be here 

today and thank you for this Committee’s continuing dedication to 

homeland security and biodefense issues. 

I would like to start by thanking the Federal employees who 

have worked so hard on these vital programs, including Admiral 

Cohen and his team and Dr. Parker and his colleagues. I have been 

amongst the sternest critics of both of these programs, and at this 

point, after studying biodefense issues since 1998, I think my colleagues and I have concluded that the scale of the challenges we 

face in constructing an adequate biodefense exceeds all our expectations as of 2001. The challenges are technical, they are organizational, and they are political. 

I will also say that I think that our narrow gauge and focus of 

some of these programs and the absence of what I would call a biodefense strategy has led us to miss some opportunities that we 

might take advantage of in our efforts to create a biodefense. 

What we are going to have to build is systems, not just technologies and vaccines, but systems for getting and deploying and 

using technologies and countermeasures, and those take a long 

15 

time to build and, frankly, a lot more money than we have invested 

in biodefense so far. But I would like to start by reviewing why we 

are having this hearing and why we are worried about this problem. 

The Defense Science Board said in 2000, 6 months before the anthrax attacks, that there are no technical barriers to terrorist 

groups or individuals building and disseminating a devastating biological attack. That is even more true today. In 2005, the National 

Intelligence Council Report said that of all the terrorist attacks and 

challenges facing U.S. security, they were most worried about a biological attack, which they thought was more likely than a nuclear 

attack. Those are the only two types of assaults that could really 

destabilize the United States of America. 

Chairman LIEBERMAN. We are more worried—excuse me for interrupting—because of the relative ease with which a devastating 

amount of bioterrorist agents can be brought into the country. 

Dr. O’TOOLE. I think it was the ease of carrying out a biological 

attack, because these organisms live naturally in the world and are 

available in hundreds of gene banks across the world, and also because these are replicating organisms. So if you can mount one attack, you can make enough anthrax, for example, if you are patient, to do two or ten attacks. So everyone is going to feel vulnerable after the first attack. The whole country is going to want anthrax vaccine. That is why sitting here today with enough anthrax 

vaccine to cover only about 3 million people is so worrisome and, 

I suspect, part of the reason behind HHS’ reluctance to get rid of 

expired vaccine. It might not be perfect, it might not be what you 

would use on a good day, but it might be a lot better than nothing 

in the breach. 

So we need to take, I believe, a much more strategic look both 

at these two programs that we are discussing today—and they are 

both vital programs—as well as at our overall biosecurity strategy. 

I think there is a lot of complacency and misinformation abroad 

in the leadership of the country about the biothreat and biodefense. 

I think people think the threat is much more remote and much less 

potentially destabilizing than is the case, and I think they believe 

we are more prepared than is the case because we have done a lot. 

We have worked hard and spent about $40 billion since 2001 on 

civilian biodefense. 

But the problem is that drugs and vaccines are a lot harder and 

trickier to make and a lot more expensive than sensors or engineering products. I do not think that when we embarked on the BioShield program in 2004, the complexity of this endeavor was fully 

realized either by the Congress or by HHS. The fact is that the $5.6 billion in BioShield is a fraction of what 

we are going to need, and part of the delay on HHS’ part is trying 

to figure out how do we get countermeasures for all the possible 

CBRN threats within that sum of money. We are not asking, 

‘‘What do we need to defend the country against bioattacks?’’ We 

are, in effect, asking, ‘‘What countermeasures can we get for this 

amount of money?’’ We are basically shopping at Costco. This is 

part of the reason why big pharmaceutical companies do not want 

to get into the game. It is also why we are dependent upon small, 

daring biotech companies who have never made anything before, 

16 

and making a new drug or a vaccine is a lot more art than science. 

That is just where we are. We are in the midst of a revolution in 

bioscience. There are lots of very tempting possibilities coming 

down the pike in terms of new drugs and new vaccines. But at the 

current pace, it is going to take us about 10 years to get there. 

So the whole problem of trying to get what we need for a fairly 

paltry sum of money when you compare it to other national security expenditures is one of the big problems with countermeasures. 

There have also been real process problems, as HHS staffed up 

and figured out how to do what it was trying to do. Some of these 

process problems are very well documented in the GAO report. I 

think some of these problems have been improved upon. The 

BARDA legislation that the Congress passed last year attempts to 

fix a lot of these process problems, but Congress has not appropriated any money for BARDA yet. And that is sending, I think totally unintentionally but very loudly, a message to the biotech and 

pharmaceutical companies who are in this game that Congress 

does not really take biodefense seriously. I know that is not the 

truth as far as this Committee is concerned, but that is how it is 

being read. I would be happy to talk more about that, but I think 

one of the vital tasks before this Congress is to appropriate some 

money for BARDA. 

Finally, I think the BioWatch program has made tremendous 

progress over the years. I think it is good technology. It is not clear 

to me that it is the right technology given our choices. It may be 

that we could make more strategic purchases, particularly in obtaining situational awareness, the information we need once an 

event is underway, through other investments. My recommendation is that DHS or an interagency process steps back and takes 

a strategic look at what we are doing across the board in biosurveillance and sets out clear goals for what we want to be able 

to do in 5 years and 10 years. Thank you. 

Chairman LIEBERMAN. Thanks, Dr. O’Toole. As usual, very good 

testimony. 

Let me go back briefly to the discussion between Mr. Rhodes and 

Dr. Parker. Dr. Parker, obviously there is a lot of concern here on 

Capitol Hill and generally about the VaxGen experience because 

we ultimately have spent hundreds of millions of taxpayer dollars 

with nothing to show. Mr. Rhodes in his report is upset that HHS 

did not do a very thorough postmortem at all, or lessons learned. 

Today you cited some lessons learned in your testimony. Mr. 

Rhodes said he is not satisfied with that. He would like to see, particularly as you go on and try to do this, something more formal 

about what you put in place to avoid repeating the mistakes. So 

tell us what you are doing and what you are going to do to make 

sure that the next millions of dollars get something for that. 

Mr. PARKER. Thank you, Senator, and actually, if I may, I may 

also pick up on a couple themes that Dr. O’Toole picked up, because I think that is important. 

Chairman LIEBERMAN. Yes. 

Mr. PARKER. There are some themes that she mentioned as well, 

in addition to Keith’s comments. 

Chairman LIEBERMAN. So just respond to Mr. Rhodes first, and 

then you can—— 

17 

Mr. PARKER. Yes, I will, but a little bit about my history. I joined 

the Department just a little over 2 years ago—actually just before 

Hurricane Katrina, and so I was completely engrossed for about 3 

months in Hurricanes Katrina, Rita, and Wilma. And when I began 

to then take a look at Project BioShield and the progress and the 

potential setbacks that were already kind of looming there, it became obvious that there needed to be some corrections and fixes. 

I think Dr. O’Toole properly described it as a young program, setting up a new organization. So we actually looked at some of these 

things, and we kind of categorized these issues as internal, interagency, and external with our stakeholders. And, yes, internal 

within the Department, within our office, did we have a large 

enough staff to effectively manage this, particularly when the experience was that we did not have large pharmaceutical companies, 

that we were dependent upon the up-and-coming, energetic biotechnology industry. We needed a larger staff because this was 

going to require greater government oversight and hand-holding, so 

to speak, to be successful in this endeavor. 

So, we had to go and get the budget resources and the direct 

management of budget line items so we could build the staff of 

qualified professionals, and we are doing that. 

Chairman LIEBERMAN. So you feel that is one lesson learned that 

you are beginning to make better. 

Mr. PARKER. Yes, sir. We are building a highly qualified acquisition and scientific staff so we can provide much better oversight of 

all of our BARDA programs, not only Project BioShield but pandemic influenza and the advanced development program authorities that we just got in the Pandemic and All-Hazards Preparedness Act. 

Interagency: If you are not really familiar with the BioShield— 

most people do not understand the details of the BioShield statute 

and the legislation, and the fact that contracts—there are really 

fixed-cost procurement contracts, and you can build some of the 

R&D into that development cycle. But there is so much uncertainty 

in R&D that the earlier you let a contract for a procurement under 

Project BioShield, the higher the risk. And so that was a recognized need that we needed to bring products further into the pipeline, developmental, and mature them before we would bring them 

into Project BioShield. But also associated with that interagency is 

it is a very complex, also, approval process to make any acquisition 

decision. We need two Cabinet Secretaries and the President—now 

it has been delegated down to the OMB Director—to make a decision on individual procurements. 

Chairman LIEBERMAN. So the decisionmaking process has been 

better streamlined now. 

Mr. PARKER. The decision has been better streamlined, and then 

the other part was transparency in working with industry. 

Chairman LIEBERMAN. Let me interrupt you there because I have 

only got about a minute and 45 seconds. Let me suggest first that 

you and the Department present your responses of lessons learned 

in writing to GAO so they can respond to it, also for the benefit 

of the Committee. But I wanted to give you a little bit of time on 

another topic because I noticed you were shaking your head when 

18 

there was reference to the vaccines that may be distributed that 

have expired. So why were you shaking your head? 

Mr. PARKER. First, we totally agree with the GAO report that 

those expired products need to be destroyed, and we would do so. 

HHS never had an intention to use expired vaccine in an emergency use, so those products will be discarded. But it is also important to note—I think it has come up—but medical products, medical countermeasures, particularly biologics, they have a discrete 

shelf life. 

Chairman LIEBERMAN. Sure. 

Mr. PARKER. And so we are always going to be in a position that 

as they expire, they need to be discarded. 

Now, in regard to can we do a better job working with the Department of Defense to look at inventory management, sure, and 

we had begun, before the GAO began looking at this, talking to 

DOD about this. We have some particular challenges involved that 

include contracting, legal, and liability and so forth, but we are redoubling our efforts with the Department of Defense to see how we 

can better overcome some of those challenges so that we can minimize—we will never completely eliminate it, but perhaps minimize 

some that has to get discarded. 

Chairman LIEBERMAN. OK. My time is just about up. I do want 

to say very briefly that Dr. O’Toole made a good point, and part 

of the problem that led HHS to enter into this enormous contract 

with really an untested start-up company, VaxGen, was because 

you could not get the big pharmaceutical companies interested in 

it. And part of the problem here is still us, Congress, in the sense— 

it is not that it is an easy problem, but we have to find a way literally to entice the big pharmaceutical companies to get into this 

because there is not an obvious typical market incentive to do it. 

And we have tried various ways to try to create that incentive for 

the public good. They all run into some interest group that does not 

like the incentive. But, meantime, the Nation remains vulnerable 

to a bioterrorist attack, and the strongest part of our country to 

present an answer—a vaccine, a treatment—is essentially not on 

the playing field, and we have got to find a way to get them out 

there. 

My time is up. Senator Collins. 

Senator COLLINS. Thank you, Mr. Chairman. 

Dr. O’Toole, you made a very interesting comment when you said 

that we need to be building systems that can deliver the countermeasures or the technologies, and then you went on to make a very 

interesting comment about the BioWatch project. This is the project 

that deploys sensors in some 30 cities. I have always thought that 

it was an excellent idea, an early-warning system. But I think you 

are causing us to take a second look at how we are deploying our 

resources. 

If there is a biological agent that is detected by Project 

BioWatch, how prepared do you think State and local first responders and emergency managers are to respond? In other words, we 

may have a great technology in place to detect a biological agent’s 

release. But if we do not have the system in place to respond to 

that detection, are we any further ahead? 

19 

Dr. O’TOOLE. Yes, well, that is the question, Senator, and I cannot directly answer your query as to how the public health officials 

who are charged with triggering response would react. But I can 

tell you that at a meeting called by the White House last spring, 

which included about 60 public health officials and emergency response experts, there was quite a widespread articulation of skepticism about BioWatch. And I have heard in other hearings of users 

being very critical of the resources BioWatch takes, of the lack of 

coordination in some places—not all—between those who operate 

the BioWatch system and those who are charged with public 

health. I am sure those kinds of problems are fixable, but they do 

need attention because this complaint litany has been going on for 

years now. 

My concern is that we cannot afford to put sensors in every nook 

and cranny of every city or every town in the country, so the first 

question is: Will the BioWatch sensors detect a release? The second 

question is basically the hinge point upon which BioWatch, at least 

its efficacy, depends. The whole idea of BioWatch is that early 

warning gets you an earlier and hence a better response. But it is 

not clear that public health is going to be willing to pull the trigger 

to respond—to move the stockpile, to tell everybody we have had 

an anthrax attack, etc.—until they have clinical evidence of an attack, meaning someone who is sick with symptoms or a lot of people who are sick with symptoms similar to a bioterror agent, or 

clinical diagnostic tests—cultures, PCRs, saying, yes, this person is 

infected with anthrax. That has been the case so far. 

Now, in practice, if they do get a BioWatch alert, public health 

starts actively querying emergency rooms and so forth for people 

who are sick and fit the description of this disease. Would we be 

better off—if it is a zero sum game—investing some money in rapid 

point-of-service diagnostic tests so that a doctor could tell you immediately or within an hour that you have anthrax or you do not? 

Would we be better off making electronic links between hospital 

emergency rooms and public health, which more or less do not exist 

in most places today? Are we spending too much of our attention 

on detecting a bioattack based on the unproven and untested assumption that early detection improves response? Or would we be 

better off investing in systems that are going to give us more situational awareness during an attack? Situational awareness is going 

to be critical to managing an attack effectively and to mitigating 

the consequences. We are spending almost nothing on situational 

awareness right now comparatively in terms of energy, talent, and 

money, and I think that would be a very important part of the 

strategy. 

Senator COLLINS. Thank you. Admiral Cohen, I am going to ask 

you to comment on Dr. O’Toole’s comments. I know that you are 

working on second-generation technology that is going to shorten 

the time involved in issuing an alert, and I have always thought 

the idea of sensors in key places in key cities was an excellent idea. 

But I think Dr. O’Toole also raises a very good point about what 

happens next. 

What is your response? Are we prepared in terms of public 

health authorities, emergency managers, medical personnel, first 

20 

responders, to react quickly when you issue a report based on the 

BioWatch sensors? 

Mr. COHEN. Well, Senator, first of all, I think your question is 

right on the mark, and I think Dr. O’Toole’s comments are very articulate, very thoughtful, and get right to the heart of the issue. 

Now, in my prepared statement, I told you that the existing 

BioWatch sensors have processed over 4 million samples, and we 

have had no false positives. But we have had close to two dozen 

positives in that same period of time. All of those positives that 

were determined to be valid, they were environmentally based. In 

the 14 months that I have been on board in this position, I have 

had an opportunity to see how different cities, different health organizations at the State, city, and local level, respond to the report 

of those valid positives. And I must tell you it varies significantly. 

In some of our larger metropolitan areas, they go, as we say, to 

battle stations. They take it very seriously. They bring in secondary 

sensors. They do surveys. They check the pharmacies to ensure 

that the Tylenol shelves are not emptied. They check with the 

emergency rooms. They do all of the things that you and Dr. 

O’Toole indicated would be necessary as part of a system, a systems approach. In other areas, well, it is a time-late sample, and 

if something is going to develop, we will know about it anyway. 

The Founding Fathers were very wise. Those powers not specifically given to the Federal Government are retained by the States 

and locals. So we wanted an inefficient and confrontational form of 

government, and the good news is that is what we have, and the 

bad news is that is what we have. 

In defense, it was quite easy. We can tell medical doctors and we 

can tell the patients what to do, what vaccines you are going to 

take, when to report to sick bay. It is not that simple or straightforward in health care, certainly the distributed health care or public service health care that we have throughout. 

So as we go forward, I do think Dr. O’Toole has one thing especially right. The more ubiquitous the sampling, the less expensive 

the sampling, the more responsive, meaning short time and accuracy, the sampling, whether it is at point of care or it is distributed 

throughout a city or it is on mobile trucks, or one of the things we 

are working on in my high-risk portfolio is what we call ‘‘Cell-All.’’ 

There are 2.8 billion cell phones today. Now, a cell phone is no 

longer just a phone. It is a mini-computer that has computing 

power that exceeds what a super-computer had 10 years ago. It has 

voice, it has video, it can take pictures, it has GPS in it. So if we 

could have even a single sensor, whether it is radiological or biological, every one of us would have a sensor and would then report 

through 911 the location, the fact there was a radiological or a biological event occurring. We are not talking about a CO, carbon 

monoxide, monitor that has numbers. It is a 1 or a 0. Did it hit 

the trip point that was established by HHS, CDC, etc.? And then 

if we have multiple of these in a metro station or in a hospital, etc., 

we know an event is occurring. 

Now, this is on the high end. This is the 9/11 Commission, not 

suffering from a lack of imagination, but I can tell you we are actively pursuing this. And coupled with BioWatch III, which will be 

more near term, wireless, more digital than BioWatch II, and beVerDate Aug 31 2005 15:03 Oct 23, 2008 Jkt 038988 PO 00000 Frm 00024 Fmt 6633 Sfmt 6633 P:\DOCS\38988.TXT SAFFAIRS PsN: PAT
21 

cause it will be cheaper, we will be able to put it, we hope, in four 

times as many cities. But we have got to go in the direction that 

Dr. O’Toole has said in the area of the response, in the linking of 

emergency rooms, etc., critically important, but I really do think 

that this is an HHS, CDC, and congressional area. We can give the 

tools. We cannot mandate their use. 

Senator COLLINS. Thank you. 

Chairman LIEBERMAN. Thanks, Senator Collins. Senator Akaka, 

good morning. Thanks for being here. 

OPENING STATEMENT OF SENATOR AKAKA 

Senator AKAKA. Thank you very much, Mr. Chairman. I want to 

congratulate you and the Ranking Member for having this hearing. 

It is fascinating for me to sit here and listen to all of this and to 

hear from our experts what they have been facing in dealing with 

the crisis. 

I was interested, Secretary Cohen, in some of the new equipment 

that you have been holding up here, and I specifically wanted to 

ask you about the iris scanner that you have. I wonder how accurate it is. Can it detect specific chemical or biological agents? 

Mr. COHEN. Well, Senator, aloha. 

Senator AKAKA. Aloha. 

Mr. COHEN. The short answer is yes, it does select specific 

agents, both chemical and biological. That is why we have an LED 

screen so that when you hold it up to the face and you press the 

button, it identifies to you which specific agent you might be looking at. 

We are refining its accuracy, its false alarms, etc. This is cutting 

edge technology. It is in the final test phases. I am glad to come 

by and give you a demonstration, or your staff, or take for the 

record the specific sensitivities that it has. I was in your lovely 

State 2 weeks ago with Major General Bob Lee, your Adjutant General. Of course, Maine suffers from nor’easters, and Connecticut 

has the occasional influx where they lose all their beautiful elm 

trees about every 17 years—I remember that. But in Hawaii, you 

have not only the terrorist threats in the middle of the Pacific 

Basin, but you have a variety of natural threats, be it earthquakes 

or tsunamis, flooding, etc. And I am reminded of the loss of power 

on Oahu just months ago from the earthquake. And I am so 

pleased that we are able to work closely with your Adjutant General and all the Adjutants General in providing these kinds—initially in small numbers on an experimental basis so they can work 

with the first responders to make the people of Hawaii and the Nation safer. 

Senator AKAKA. As these are developed, it is important that 

there is training down the line to the first responders so that it can 

be applied and used wherever it is necessary. 

Secretary Cohen and Secretary Parker, going back to the earlier 

discussion on anthrax, why is anthrax vaccine the only near-term 

anthrax BioShield procurement priority? What other near-term or 

non-antibiotic therapies is HHS focusing on? 

Mr. PARKER. Well, anthrax vaccine is not the only near-time priority, and anthrax vaccine is not the only component of our strategy to have therapeutics for anthrax. The first line of defense is 

22 

antibiotics; vaccine is important for post-exposure use in conjunction with antibiotics; but, also, anthrax antitoxins to treat symptomatic anthrax. And so it is important that we pursue that continuum and that complete tool chest for the medical countermeasures against anthrax. 

But we also have other priorities, and they tier from the DHS 

threat assessment and the material threat determinations, but 

they include antitoxins and botulinum neurotoxins. They include 

the need to pursue medical countermeasures for the radiological 

and the nuclear threat. They also include the need to have medical 

countermeasures against smallpox. And as I mentioned in my 

opening remarks, we have a vaccine now for every American, and 

we are also under a Project BioShield contract pursuing a modified 

and a second-generation smallpox vaccine that could be particularly useful in certain populations, at-risk populations. But we also 

need an antiviral for smallpox, and we just continued and extended 

an advance development contract to continue the development of a 

smallpox antiviral. But with the list of threats that we do face, we 

need to be turning our attention—and we are—to looking at more 

broad spectrum, both antibiotics and broad spectrum antivirals. 

One other category for which we actually have no medical countermeasures yet are the viral hemorrhagic fevers, but there has 

been a great deal of research and development in the discovery 

phase, and there is actually some reason for optimism that there 

may be some countermeasures for some of the viral hemorrhagic fevers that are maturing out of the tech base that could go into early 

development. 

So there are a number of projects that we have underway, and, 

again, I must emphasize the need for advanced development to 

bring those out of the tech base and mature those in a way that 

will ultimately make them more suitable for a Project BioShield 

type procurement. 

Senator AKAKA. Thank you very much, Mr. Chairman. 

Chairman LIEBERMAN. Thanks, Senator Akaka. 

I think we can do another round before a round of votes is called 

on the floor. I want to go back to the conversation about situational 

awareness. This Committee in our extensive investigation of Hurricane Katrina found that one of the great problems was that the responders did not have situational awareness. They could not talk 

to each other. They could not talk to their superiors. Here we are 

talking about something else, so I wanted just to ask you, Dr. 

O’Toole, give us a real brief definition of what you mean by situational awareness in a bioterrorist context or a pandemic context. 

Dr. O’TOOLE. Well, imagine yourself mayor of a city that has 

been attacked with anthrax. You may have knowledge of half a 

dozen or a dozen people who are in the hospital sick, and what you 

know is there is more to come. What you are going to want to know 

is, for example, how many people are sick, how many people are 

at risk, where are the sick people. Are the hospitals caring for 

them about to collapse because they are being overwhelmed, both 

by people who are infected and people who fear they might be? Do 

they have the resources they need, whether they be drugs, equipment, ventilators, whatever? If not, where are those resources and 

how could I get them to where they are? And this situation of conVerDate Aug 31 2005 15:03 Oct 23, 2008 Jkt 038988 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 P:\DOCS\38988.TXT SAFFAIRS PsN: PAT
23 

fusion and of active management is not going to be over in a day 

or a week. It is going to go on for weeks and months. 

In 1918, in Baltimore, the Public Health Department completely 

lost its credibility overnight during the pandemic flu epidemic by 

saying we are seeing fewer and fewer reports from doctors of new 

patients with flu. At that time, as now, doctors submitted little 

green cards saying ‘‘I have seen a case of flu’’ via the mail to the 

Health Department. And what was happening at the time was that 

the doctors were so busy taking care of the surge in patients that 

the little green cards were not getting filled out. 

Chairman LIEBERMAN. Let me stop you there. That is an excellent introduction. I want to now turn to Admiral Cohen and Dr. 

Parker and ask them to respond because obviously it is almost 90 

years after the Baltimore situation, so this is the question that we 

want to ask, which is that if a biological agent has been distributed 

in a population by terrorists or if a pandemic is beginning, what 

systems are in place for the authorities, locally and then nationally, 

to know quickly enough that this is happening? I mean, obviously, 

we have enormous electronic capacity, telecommunications capacity 

that did not exist in 1918. Still, I fear—as I mentioned when I read 

the National Strategy for Public Health and Medical Preparedness—that a lot of the requirements in the strategy I do not think 

we have yet. 

Tell me where we are and what we are doing to try to close 

whatever gaps exist. 

Mr. COHEN. Well, Chairman, I will start at a macro level, and 

in terms of the detail of the health care, I will leave that, of course, 

to Dr. Parker. 

Chairman LIEBERMAN. Let me ask you, if you can from your position at DHS, to respond to that type of situation, not 1918 but to 

the mayor of a present-day city. Anthrax has been released in a 

city, a town, and it is beginning to turn up. Are we going to know 

about it quickly enough? 

Mr. COHEN. Well, the short answer is if we are monitoring for 

it in BioWatch, we have a high probability of knowing about it. Of 

course, there are many other ways to detect the anthrax. There is 

a great sense of awareness and alertness today in the general population, whether you go on a plane or you open a letter, you do it 

carefully. You know there are many reports that we get of white 

powder. Some turn out to be false. We have had some naturally occurring anthrax, as you know, from untanned animal hides over 

the last several years. 

Chairman LIEBERMAN. Right. 

Mr. COHEN. It is a naturally occurring disease. But I have a 

higher confidence that in the near term, before we depleted the 

stocks of Tylenol, in major population areas we would know that 

there was a medical emergency occurring and that we would quickly know that it was anthrax. 

Chairman LIEBERMAN. Would we know because of the monitors 

that you have set up or because there is a system where doctors 

will feed into some electronic process to let us know something is 

spreading rapidly? 

24 

Mr. COHEN. Well, for us it is the monitors, for us it is the number of sick people. You both are very familiar with our operations 

center, which has come an awfully long way. 

Chairman LIEBERMAN. Right. 

Mr. COHEN. You are aware that we do these exercises like 

TOPOFF. In fact, 2 weeks ago, we just did one in Phoenix. While 

it was a nuclear/radiological exercise, the dispersion models, etc., 

are very similar. We learned a lot about shelter in place, especially 

school children, the effect that the parents would worry about 

wanting to go out and get them. The doctor will talk much more 

about how you transmit these various diseases. Radiological is not 

biological. But there is a general awareness that, I think, works to 

our benefit. You then have to go into all of the other interoperability coordination issues and authorities that are necessary. And 

right now, last night we had with Secretary Chertoff a late-night 

phone call, all of the leadership, on how we are going to respond 

and help with the terrible tragedy that is occurring in California 

right now, with 250,000 people who have been displaced— 

Qualcomm Center, the convention center, working with the Red 

Cross, getting planes, cots, etc., there. 

So while biological may be very threatening and unique and have 

medical aspects to it, these kinds of events tend to replicate in how 

they develop and how we respond. 

Chairman LIEBERMAN. OK. Dr. Parker, I am over my time, but 

just take a moment and tell us whether there is an electronic system in place. 

Mr. PARKER. Yes, if I can add to that, the CDC is developing an 

electronic system—they have several surveillance systems that are 

very effective and active and serve local and State public health 

communities. And one of the surveillance systems that they have 

been developing is called BioSense. And, in fact, we refocused it recently to make sure that it is focusing on some of the high-consequence bioterrorism pathogens. But it is designed to build that 

electronic bridge between the public health community and the 

medical community and to help speed the flow of information electronically. 

Now, frankly, though, our vision really for the future to much 

better improve our situational awareness from a medical perspective is the electronic health record and to be able to use that in an 

improved way. But we are not there yet. 

Chairman LIEBERMAN. We are not where we need to be there yet, 

are we? I would really challenge you to—I know a lot comes down 

to money, but to come back to us with a proposal for what we could 

do to facilitate that. 

Mr. PARKER. I would be glad to. 

Chairman LIEBERMAN. Because that will become the first line of 

defense. 

Mr. PARKER. It is. And another thing with the Pandemic and AllHazards Preparedness Act (PAHPA), recently, we have begun to 

also make sure that the Poison Control Centers are part of this because they are an important component in our real-time disease detection and monitoring. 

But I also have to emphasize this is part of our all-hazards approach, and we have made a lot of accomplishments, I believe, in 

25 

our pandemic influenza preparedness activities and working with 

State and local communities on these very issues, and that will 

have implication for a bioterrorism event as well. 

Chairman LIEBERMAN. OK. Senator Collins. 

Senator COLLINS. Dr. Parker, I want to go back to the issue of 

the stockpiled anthrax vaccine. It seems so logical to me for you to 

have a joint effort with DOD whereby, as your vaccine is getting 

closer to the expiration date, you rotate it out to DOD to use, and 

then you buy new and repeat the process over and over again. And 

if that kind of system does not occur, we know from GAO’s estimates that it is going to cost the taxpayers $128 million in 2008, 

and then each year another $100 million. 

Now, you said you are working with the Defense Department on 

such a plan, but you alluded to certain obstacles. What are those 

obstacles? Are they legislative obstacles? Are they funding? What 

is the problem? It just seems like a common-sense solution to a 

problem that otherwise is going to cost the taxpayers hundreds of 

millions of dollars. 

Mr. PARKER. Well, first, it does seem like a common-sense solution, and we are working to try to find that common-sense solution. 

But there are realities in the contracting issues because we use two 

different contracts, and we are working on that, too. That is another issue because we have worked very closely with the Department of Defense, particularly on all of our medical countermeasures, but even more specifically on Anthrax Vaccine Absorbed. 

But there are liability issues associated with each individual contract, and all that is associated with some legal issues. Both the 

Department and I, though, feel pretty optimistic that we can work 

through those issues. I have not identified that there is any need 

for legislative help on this, but we will be looking for that if it 

comes up. But so far, we will do everything we can to work through 

that and overcome it. 

But let me just talk also about the expense. I am not quite sure I agree with the $100 million figure in 2008, but that is something 

we can talk offline and work on that. Fortunately, we have not had 

to use these medical countermeasures—hopefully we will never 

have to use these medical countermeasures. They are part of our 

preparedness activities. But as medical countermeasures expire, 

though, we will have to discard medical countermeasures. 

I am not sure if I would want to couch the fact that we have to 

discard expired medical countermeasures in our stockpile because 

they passed their expiration and we cannot use them as wastage. 

That is part of our cost of being prepared. We know we are going 

to have to lose some of that. We will work and redouble our efforts 

with the Department of Defense to try to do everything we can to 

minimize what has to be discarded and make sure it can be appropriately utilized. But just knowing the requirements, what the Department of Defense does, and how our stockpile is going to grow, 

we can never eliminate it. We are always going to be in a position 

that some will have to be expired. 

Senator COLLINS. Mr. Rhodes, do you see a potential for saving 

literally hundreds of millions of dollars over the next decade if we 

are able to come up with an integrated system whereby the BioShield vaccines are rotated to DOD to use? 

26 

Mr. RHODES. Yes, ma’am. I know Dr. Parker and I will probably 

always disagree on the exact number, and that is fine. But I think 

this also gets to the larger discussion that leads back to Dr. 

O’Toole’s point about strategic vision. It is one thing to store vaccine in a vial. It is another to store it in bulk. It is one thing to 

rotate vials out of the Strategic National Stockpile and into DOD 

usage, the coordination between there. But it is also a function of 

how are we going to use it. 

Dr. O’Toole is absolutely right. A series of vaccines that have 

gone a certain period of time beyond their expiration date may indeed be better than nothing. But that is the discussion that needs 

to take place at the strategic level based on scientific data so that 

we can maintain the public’s confidence in our Nation’s ability to 

respond. 

Dr. Parker is absolutely right. Biologics expire. They get old. 

They die. They lose their efficacy. The point is to make certain that 

we have the strategy in place tied to the systems that Dr. O’Toole 

is describing where we can deliver the countermeasure and that we 

do have a pipeline for the countermeasure and we understand how 

the countermeasure is going to be used for emergency use. Is it directly in its most effective time of life? Can we rotate it to DOD? 

That is ultimately the message we are trying to deliver, is that 

broader view, whether it is looking at what is the next generation 

of anthrax vaccine going to be and how are we going to procure it, 

or how are we going to store what we already have. 

Senator COLLINS. Mr. Rhodes, my time is almost expired. Let me 

just ask you one final question. We still need an improved anthrax 

vaccine, one that is easier to administer, less painful, etc. How prepared do you think HHS is at this point to award a new contract 

for the development of a new vaccine that does not have the same 

very unfortunate and expensive ending that the previous one had? 

Mr. RHODES. I appreciate the Committee asking Dr. Parker to 

put together the lessons learned. Based on documentation that we 

have, I cannot give you the assurance here now that the next contract will be successful because I do not know that the lessons have 

been learned and incorporated directly into the process for acquiring the next version, letting the next contract. 

While we were having discussions this summer, we were told 

that there was internal analysis about the lessons learned. We 

have not seen it. And at the same time, the contract was being let. 

So I have to go with what I have, and what I have does not counter 

the position—the track record that I have already seen. 

Senator COLLINS. Thank you. Mr. Chairman, it looks like Dr. 

Parker wants to respond. 

Chairman LIEBERMAN. Go ahead, Mr. Parker. 

Mr. PARKER. I have just three major points as far as the lessons 

learned on individual contracts. 

One, we have moved away from a performance-based contract, 

which was basically deliver the product, to one that has very detailed milestones and deliverables along the way to delivering the 

product. And so that way we ensure that there is complete understanding by all parties at the beginning of what are the specific 

milestones that must be met. 

27 

Two, we verify and ensure that there is early, often communication with the Food and Drug Administration; and as the science 

matures and the information matures, that the product continues 

to develop, it is critical that the manufacturer engage early and 

often with the FDA. 

And then, finally, our ability now to have advanced development 

through the BARDA is just absolutely critical that we can take 

products further down the developmental pipeline and experience 

some of the setbacks that you are going to have and that you will 

have in R&D with the appropriate type of funding and advanced 

development and have those products so they are more mature before they do go into a Project BioShield procurement. 

Senator COLLINS. Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thank you very much, Senator Collins. 

Dr. Parker, have you agreeded to respond in writing and present 

a kind of lessons learned plan to GAO? 

Mr. PARKER. Yes, Senator. 

Chairman LIEBERMAN. I appreciate that very much. The roll call 

has gone off, so Senator Collins and I have to go over to the Senate. 

We will have to close the hearing. 

I do just want to draw attention to something Dr. O’Toole said 

in her testimony, and perhaps we will form a question to the panel 

on it. But it is that a concept of operations to counter another anthrax attack is lacking. And by coincidence, Senator Collins and I 

last week sent a letter to Secretary Chertoff in which we said that 

we know he is working on the National Response Framework, 

which is the groundwork for planning efforts, but there is no substitute for actual operational plans. In some of the materials we 

read here, I got the feeling that the vaccine might be able to be delivered to a general area, but then it was not clear how it would 

get to the people who really need it. And this is a critical factor 

to stress. 

As you know, everyone talks about what keeps you up at night 

post-September 11, 2001. This keeps me and a lot of other people 

up at night for the reasons we have discussed. The ease of bringing 

biological agents into the country or actually preparing them here, 

and then the propensity they have to multiply and spread has devastating consequences. 

So the Committee is going to stay on this. We are going to look 

over your shoulder at DHS and HHS. We do not consider ourselves 

to be antagonists, but we are representing the public that we all 

serve. We are also going to say to you, tell us what you are not getting that is standing in the way of you achieving what we need to 

achieve as soon as possible. And I am pleased to say that Mr. 

Rhodes and the Committee and GAO are going to be working together. We have agreed that the excellent report issued today is 

the first of a series that will be issued with regard to the bioterrorist threat to our country. 

Admiral Cohen, do you want a last word? 

Mr. COHEN. Yes, sir. I know you are facing a vote. I just want 

to make one clarification. On the retinal scanner, what we are looking at are the physiological effects on the human, which we then 

track back to various chemical and biological agents. And I wanted 

to correct that record. And you asked is there anything you could 

28 

do to help. I think your staff is aware that wisely you sunsetted 

many of the provisions of the initial Homeland Security Act, but 

one that is coming up on January 25, 2008, is the other transaction 

agreements. This is a critically important tool that we use, especially in the BioWatch and biodefense areas, and I would just with 

great respect ask that if there is any thing that its renewal could 

be attached to before it expires, we would greatly appreciate that 

and will not abuse it. 

Thank you so much for your leadership. 

Chairman LIEBERMAN. Time flies. That is quick. Thank you. 

The record of the hearing will remain open for 15 days for any 

additional comments that the witnesses would like to submit or for 

us to ask you additional questions. This has been a very productive, direct hearing with, I think, the appropriate sense of urgency 

to it, and I thank you for all that you have all contributed. 

Senator Collins, would you like to add anything? 

Senator COLLINS. Thank you to our witnesses and to you, Mr. 

Chairman, for holding this very important hearing. 

Chairman LIEBERMAN. Thank you. The hearing is adjourned. 

[Whereupon, at 11:40 a.m., the Committee was adjourned.] 

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