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75–731 PDF 2002

S. HRG. 107–440

EFFECTIVE RESPONSES TO THE THREAT OF

BIOTERRORISM

HEARING

BEFORE THE

SUBCOMMITTEE ON PUBLIC HEALTH

OF THE

COMMITTEE ON HEALTH, EDUCATION,

LABOR, AND PENSIONS

UNITED STATES SENATE

ONE HUNDRED SEVENTH CONGRESS

FIRST SESSION

ON

EXAMINING EFFECTIVE RESPONSES TO THE THREAT OF BIOTERRORISM, FOCUSING ON DETECTION, TREATMENT, AND CONTAINMENT

MEASURES

OCTOBER 9, 2001

Printed for the use of the Committee on Health, Education, Labor, and Pensions

(
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

JAMES M. JEFFORDS (I), Vermont

JEFF BINGAMAN, New Mexico

PAUL D. WELLSTONE, Minnesota

PATTY MURRAY, Washington

JACK REED, Rhode Island

JOHN EDWARDS, North Carolina

HILLARY RODHAM CLINTON, New York

JUDD GREGG, New Hampshire

BILL FRIST, Tennessee

MICHAEL B. ENZI, Wyoming

TIM HUTCHINSON, Arkansas

JOHN W. WARNER, Virginia

CHRISTOPHER S. BOND, Missouri

PAT ROBERTS, Kansas

SUSAN M. COLLINS, Maine

JEFF SESSIONS, Alabama

MIKE DeWINE, Ohio

J. MICHAEL MYERS, Staff Director and Chief Counsel

TOWNSEND LANGE MCNITT, Minority Staff Director

SUBCOMMITTEE ON PUBLIC HEALTH

EDWARD M. KENNEDY, Chairman

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

JAMES M. JEFFORDS, Vermont

JEFF BINGAMAN, New Mexico

PAUL D. WELLSTONE, Minnesota

JACK REED, Rhode Island

JOHN EDWARDS, North Carolina

HILLARY RODHAM CLINTON, New York

BILL FRIST, Tennessee

JUDD GREGG, New Hampshire

MICHAEL B. ENZI, Wyoming

TIM HUTCHINSON, Arkansas

PAT ROBERTS, Kansas

SUSAN M. COLLINS, Maine

JEFF SESSIONS, Alabama

CHRISTOPHER S. BOND, Missouri

DAVID NEXON, Staff Director

DEAN A. ROSEN, Minority Staff Director

(II)
CONTENTS

STATEMENTS

TUESDAY, OCTOBER 9, 2001

Page

Kennedy, Hon. Edward M., Chairman, Committee on Health, Education,

Labor and Pensions .............................................................................................. 1

Frist, Hon. Bill, a U.S. Senator from the State of Tennessee .............................. 5

Cleland, Hon. Max, a U.S. Senator from the State of Georgia; Hon. Chuck

Hagel, a U.S. Senator from the State of Nebraska; Hon. Evan Bayh, a

U.S. Senator from the State of Indiana; Hon. Jon Corzine, a U.S. Senator

from the State of New Jersey ..............................................................................

Edwards, Hon. John, a U.S. Senator from the State of North Carolina ............. 12

Henderson, M.D., Donald A., Director, Johns Hopkins Center for Civilian

Biodefense Studies, Baltimore, MD; Janet Heinrich, Director, Health Care

and Public Health Issues, U.S. General Accounting Office, Washington,

DC, Mohammad N. Akhter, M.D., Executive Director, American Public

Health Association, Washington, DC; and Michael T. Osterholm, Director,

Center for Infectious Disease Research and Policy, University of Minnesota,

Minneapolis, MN .................................................................................................. 17

Prepared statements of: ...................................................................................

Dr. Henderson ........................................................................................... 20

Ms. Heinrich .............................................................................................. 24

Dr. Akhter .................................................................................................. 38

Mr. Osterholm ........................................................................................... 44

ADDITIONAL MATERIAL

Articles, publications, letters, etc.:

The Center for Infectious Disease Research and Policy, University of

Minnesota, and the Workgroup on Bioterrorism Preparedness ................ 67

(III)

(1)

EFFECTIVE RESPONSES TO THE THREAT OF

BIOTERRORISM

TUESDAY, OCTOBER 9, 2001

U.S. SENATE,

SUBCOMMITTEE ON PUBLIC HEALTH, OF THE COMMITTEE ON

HEALTH, EDUCATION, LABOR, AND PENSIONS,

Washington, DC.

The subcommittee met, pursuant to notice, at 10:02 a.m., in room

SD–430, Dirksen Senate Office Building, Hon. Edward M. Kennedy

(chairman of the subcommittee) presiding.

Present: Senators Kennedy, Mikulski, Wellstone, Reed, Edwards,

Clinton, Dodd, Murray, Frist, Hutchinson, Collins, and Sessions.

OPENING STATEMENT OF SENATOR KENNEDY

The CHAIRMAN. We will start the hearing.

We have two very important panels today. First, we welcome our

colleagues to the committee. Then, we have a very important vote

at 10:30.

Three of my colleagues are here now. Senator Frist and I will

make a statement, and I know Senator Edwards is a cosponsor of

this bill with Senator Hagel. Under normal circumstances, six

times five is 30, and that is when the bell is supposed to ring. It

may ring a few moments before, but we will try to conclude the

Senators’ statements prior to the vote. Then we will commence

with our second panel. We are enormously grateful to them for

being here and for their help and assistance to this committee.

They are old friends, and we have benefited and the country has

benefited immensely as a result of their years of study and work

on the matter of bioterrorism and drug-resistant bacteria. We are

immensely, immensely appreciative of their willingness at this time

to give us the benefit of their judgment and also to give us an idea

about where we should be going and additional steps that should

be taken.

We will proceed in that order. I will make a brief opening statement and recognize Senator Frist, and then we will turn to our colleagues.

It is a privilege to hold today’s hearing on improving the Nation’s

preparedness for bioterrorism and to continue the work that this

committee began 3 years ago on this issue of special importance.

Yesterday, Tom Ridge was sworn in as director of the new Office

of Homeland Security. One of the immediate tasks facing Governor

Ridge is to close the gaps in our ability to deal with the possibility

of bioterrorism on American soil. All of us in Congress stand ready
2

to work with Governor Ridge and Secretary Thompson on this vital

assignment.

The response to the recent confirmed anthrax case in Florida and

the suspected case in Virginia shows that there are many strengths

in our public health and law enforcement systems. But as our witnesses today will attest, there is still much to be done. Every day

we delay in expanding our capabilities exposes innocent Americans

to needless dangers. We cannot afford to wait.

Senator Frist and I began addressing this challenge 3 years ago.

Last November, our initial legislation to strengthen the Nation’s

capacity to respond to bioterrorism was enacted into law. Last

week, we proposed a fivefold increase in current Federal funding

to deal with the consequences of a possible bioterrorist attack. Today’s hearing will provide further evidence that our $1.4 billion

plan is fully justified.

Our first priority must be to prevent an attack. That means enhancing our intelligence capability and our ability to infiltrate terrorist cells. It also means using the renewed partnership between

the United States and Russia to make sure that dangerous biological agents do not fall into the hands of terrorists. We have worked

with Russia to prevent the spread of nuclear weapons, and we

must work together now to prevent the spread of biological weapons.

We must also improve America’s preparedness for a bioterrorist

attack. The keys to responding effectively to a bioterrorist attack

lie in three key components—immediate detection, immediate

treatment, and immediate containment.

To improve detection, we should enhance the ability of health

professionals to recognize the symptoms of a bioterrorist attack,

identify biological weapons accurately, and communicate essential

medical information rapidly and securely.

To improve the treatment of victims of a bioterrorist attack, we

must strengthen our hospitals and emergency medical plans.

To improve containment, we must make certain that Federal

supplies of vaccines and antibiotics are available quickly to assist

local health officials in preventing the disease from spreading. Developing new medical resources for the future is also essential. We

should use the remarkable skills of our universities and biotechnology companies to give us new and better treatments in the

battle against bioterrorism.

Senator Frist and I look forward to working with our colleagues

on this committee and in Congress to achieve these extremely important goals. Senator Edwards and Senator Hagel have already

put forward a number of significant proposals. We welcome the

contributions and leadership of our colleagues, Senator Corzine,

Senator Bayh, and Senator Cleland, a member of our Armed Services Committee who has taken a particular leadership position on

this issue, as they testify before us today.

September 11 was a turning point in American history. Our challenge now is to do everything we can to learn from that tragic day

and prepare effectively for the future.

[The prepared statement of Senator Kennedy follows:]
3

PREPARED STATEMENT OF SENATOR EDWARD M. KENNEDY

It’s a privilege to hold today’s hearing on improving the nation’s

preparedness for bioterrorism, and to continue the work that this

committee began three years ago on this issue of special importance.

Yesterday, Governor Tom Ridge was sworn in as President

Bush’s Director of the new Office of Homeland Security. As our

forces continue their actions over Afghanistan, we can expect that

our enemies will try to strike against our country again. One of the

most immediate tasks facing Governor Ridge as he takes on this

new extraordinary responsibility is to close the gaps in our ability

to deal with the possibility of bioterrorism on American soil. All of

us in Congress stand ready to work with Governor Ridge and Secretary Thompson on this vital assignment.

The response of the Centers for Disease Control, the FBI, and

local health authorities to the recent anthrax cases in Florida

shows that there are many strengths in our public health and law

enforcement system. But as our witnesses today will attest, there

is still much to be done.

Last week, Senator Frist and I proposed a five-fold increase in

current federal funding to deal with the consequences of a possible

bioterrorist attack. Today’s hearing will provide further evidence

that our $1.4 billion plan is fully justified, and that we should act

now to provide this emergency funding.

We want to reassure all Americans that much has already been

done to assure their safety from such an attack, and to minimize

the spread of biological agents if an attack does occur. The kind of

heroism we witnessed from average Americans on September 11—

with Americans caring for and protecting their fellow citizens—

would take place once again in responding to a bioterrorist threat.

But every day we delay in expanding our capabilities exposes innocent Americans to needless danger. We cannot afford to wait.

That’s why Senator Frist and I began addressing this challenge

three years ago. Last November, our initial legislation to strengthen the nation’s capacity to respond to bioterrorism was enacted into

law. Now we look forward to working with the Administration and

our colleagues in Congress to assure that the essential work of

strengthening these defenses is accomplished as soon as possible.

Our first priority must be to prevent an attack from ever occurring. That means moving quickly to enhance our intelligence capacity and our ability to infiltrate terrorist cells, wherever they may

exist. It also means using the renewed partnership between the

United States and Russia to make sure that dangerous biological

agents do not fall into the hands of terrorists.

Russia currently holds the largest supply of potential biological

weapons. We have an opportunity now to make needed progress in

securing these dangerous biological materials. We’ve worked with

Russia to prevent the spread of nuclear weapons, and we must

work together now to prevent the spread of biological weapons.

We must also enhance America’s preparedness for a bioterrorist

attack. Our citizens need not live their lives in fear of a biological

attack, but building strong defenses is the right thing to do.
4

Unlike the assaults on New York and Washington, a biological

attack would not be accompanied by explosions and police sirens.

In the days that followed, victims of the attack would visit their

family doctor or the local emergency room, complaining of fevers,

aches in the joints or perhaps a sore throat. The actions taken in

those first few days will do much to determine how severe the consequences of the attack will be.

The keys to responding effectively to a bioterrorist attack lie in

three key concepts: immediate detection, immediate treatment and

immediate containment.

To improve detection, we should improve the training of doctors

to recognize the symptoms of a bioterrorist attack, so that precious

hours will not be lost as doctors try to diagnose their patients. As

we’ve seen in recent days, patients with anthrax and other rarely

encountered diseases are often initially diagnosed incorrectly. In

addition, public health laboratories need the training, the equipment and the personnel to identify biological weapons as quickly as

possible.

In Boston, a recently installed electronic communication system

will enable physicians to report unusual symptoms rapidly to local

health officials, so that an attack could be identified quickly. Too

often, however, as a CDC report has stated: ‘‘Global travel and

commerce can move microbes around the world at jet speed, yet our

public health surveillance systems still rely on a ‘Pony Express’ system of paper-based reporting and telephone calls.’’ To improve the treatment of victims of a bioterrorist attack, we

must strengthen our hospitals and emergency medical plans. Boston, New York and a few other communities have plans to convert

National Guard armories and other public buildings into temporary

medical facilities, and other communities need to be well prepared

too. Even cities with extensive plans need more resources to ensure

that those plans will be effective when they are needed.

To improve containment, we must make certain that federal supplies of vaccines and antibiotics are available quickly to assist local

public health officials in preventing the disease from spreading.

Developing new medical resources for the future is also essential.

Scientists recently reported that they had determined the complete

DNA sequence of the microbe that causes plague. This breakthrough may allow new treatments and vaccines to be developed

against this ancient disease scourge. We should use the remarkable

skills of our universities and biotechnology companies to give us

new and better treatments in the battle against bioterrorism.

Much has already been done to improve the nation’s readiness,

but we need to be even more prepared. Senator Frist and I look forward to working with our colleagues on this committee and in Congress to achieve these extremely important goals. Senator Edwards

and Senator Hagel have already put forward a number of significant proposals. And we welcome the contributions and leadership

of our colleagues, Senator Corzine, Senator Bayh, and Senator

Cleland, as they testify before us today.

September 11th was a turning point in America’s history. Our

challenge now is to do everything we can to learn from that tragic

day, and prepare effectively for the future.

Senator Frist?
5

OPENING STATEMENT OF SENATOR FRIST

Senator FRIST. Thank you, Mr. Chairman.

As America begins to strike back against Osama bin Laden, his

terrorist cohorts, and the Taliban regime for the brutal assaults of

September 11, today we face the possibility that a new front in the

war on terrorism has opened at home—a second potentially deadly

case of anthrax discovered in Florida just yesterday.

Just as many of us never imagined that America’s commercial

airliners would be converted into weapons of mass destruction, it

is perhaps beyond the grasp of many that the weapons of choice in

the war of the 21st century may well be tularemia, smallpox, and

anthrax. But this should come as no surprise. As we will hear

today, the threats from biological and chemical agents are real.

Terrorist groups have the resources and the motivation to use germ

warfare.

Osama bin Laden has said publicly that it is his religious duty

to acquire weapons of mass destruction, including biological and

chemical weapons. We all know that rapid advances in agent delivery technology have made the weaponization of germs much, much

easier.

Finally, with the fall of the Soviet Union, the expertise of thousands and thousands of scientists knowledgeable, trained professionally in germ warfare, may be available to the highest bidder.

It can be bought.

Unfortunately, as we will also hear today, America is not yet

fully prepared to meet the threat of biological warfare. Great

strides have been made in the past 3 years, but there is much more

to be done. There are gaps to be filled.

Today some of the Nation’s leading experts on bioterrorism will

help provide us further guidance as we prepare to meet this remote

yet very real and growing threat. A biological or chemical attack

on our soil could be even more deadly and more destructive than

the recent attacks on the World Trade Center and the Pentagon.

Without a substantial new Federal investment in our public

health infrastructure, increased intelligence and preventive measures, expedited development and production of vaccines and treatments, and constant vigilance on the part of our Nation’s health

care workers, a terrorist attack using a deadly infectious agent,

whether delivered through air, through food, or by any other

means, could kill or sicken millions of Americans.

Senator Kennedy has already mentioned the Public Health

Threats and Emergencies Act of 2000 which originated in this committee and was ultimately passed. It provides a coherent and I believe relatively comprehensive framework for responding to health

threats resulting from bioterrorism.

Last week, Senator Kennedy and I asked the administration and

the Senate Committee on Appropriations to provide an additional

$1.4 billion for these activities. The vast majority of these funds

would go toward a one-time investment in strengthening the response capabilities of our hospitals, our health care professionals,

and local public health agencies that would indeed form the front

line response team in the aftermath of a bioweapons attack.
6

I look forward to working with our colleagues in the U.S. Senate

and with the administration toward this goal.

I too would like to recognize those Senators before us for their

leadership on this particular issue. I believe their presence here is

a heartening signal of the growing focus and commitment on the

part of the United States Congress to take those steps necessary

this year to make sure that our Nation is fully prepared to respond

to any threat to the American people.

The CHAIRMAN. Thank you very much.

The CHAIRMAN. Senator Cleland, we welcome you to our committee. We enjoy serving with you on the Armed Services Committee

where you have made this a particular area of your expertise.

Welcome.

STATEMENTS OF HON. MAX CLELAND, A U.S. SENATOR FROM

GEORGIA; HON. CHUCK HAGEL, A U.S. SENATOR FROM NEBRASKA; HON. EVAN BAYH, A U.S. SENATOR FROM INDIANA;

AND HON. JON CORZINE, A U.S. SENATOR FROM NEW JERSEY

Senator CLELAND. Thank you very much, Mr. Chairman. I am

honored to be here with my distinguished colleagues and with all

of you.

Mr. Chairman, we have long known that the threat of bioterrorism has existed. In the mid-1990’s, intelligence sources believed

that Iraq had a sophisticated bioweapons program, and during the

cold war, the Soviet Union produced unknown quantities of the

smallpox virus.

In the wake of the September 11 attack on America, our intelligence agencies now State that there is a 100 percent chance of

another domestic attack. What form of terror this attack will take

is unknown, but we have seen bin Laden and his followers become

more brutal and complex in their planning.

Are we fully prepared to deal with such bioterrorism events? The

answer at the moment is clearly no.

Look at the results of the Johns Hopkins-sponsored ‘‘Dark Winter’’ smallpox bioterrorism exercise, which my former colleague and

friend Sam Nunn participated in. There was another exercise,

‘‘TOPOFF,’’ regarding top officials regarding a nuclear and bioterrorism drill conducted this year to test the capabilities of the

Centers for Disease Control and Prevention, the Federal Emergency Management Agency, the FBI and DOD. Both of these tests

dramatically illustrate that our response to date is woefully inadequate to deal with a domestic bioterrorist event and that a reconsideration of both strategy and organizational structure is needed.

I would like to call the committee’s attention this morning to restructuring and improving dramatically the CDC in Atlanta, GA,

which is an international resource for fighting bioterrorism.

In 1999, I joined with Senators Kennedy, Mikulski, Murray, and

my late friend Paul Coverdell to address the critically needed repairs and upgrade of the CDC’s buildings and facilities. This has

been an ongoing effort. The CDC is universally recognized as the

lead Federal agency for protecting the health and safety of people

at home and abroad, as well as the response and readiness for bioterrorist threats against the United States.
7

However, Mr. Chairman, before last year, the CDC had been insufficiently funded to maintain the security of its perimeter and the

safety of its laboratories. The CDC, which is based in Atlanta, was

still using World War II-era buildings from a reclaimed army base.

Scientists and laboratory staff were patching holes in the ceilings

to protect their research studies. I have seen this kind of thing.

In fiscal year 2001, we started the first year of compressing a 10-

year CDC renovation plan into 5 years. That is the massive upgrade that we are talking about. This faster upgrade is more critical now than ever before.

I would like to acknowledge three of Georgia’s outstanding business leaders—Bernie Marcus, former head of Home Depot; Oz Nelson, former head of UPS; and Phil Jacobs, head of Bell South— known as friends of the CDC. They called these horrible situations

to my attention.

I would like to commend Senators Kennedy and Frist for your insights in developing and getting the Public Health Threats and

Emergencies Act passed last year. This measure is critical in helping us to develop the needed infrastructure.

I also commend key provisions in the measure which would enable CDC to maximize its bioterrorism response capabilities and to

improve the preparedness of communities and hospitals.

The level of preparedness for homeland defense that we will need

to protect Americans will require money and resources and will

take time. We can and must take the additionally needed steps and

dramatically improve what we have in place, especially the CDC.

This is one reason, Mr. Chairman, why I am seeking some $100

million extra beyond the $150 million that the President has requested for this fiscal year 2002 budget, and which will be going

after three-quarters of a billion dollars of your $1.4 billion bioterrorism budget.

I believe the President has taken an important step with the creation of a Cabinet-level position for homeland defense, but one of

the key defenders in this homeland of ours is the CDC, and I urge

my colleagues to pay special attention to that agency.

Thank you very much, Mr. Chairman.

The CHAIRMAN. I would just point out for the record, Senator,

that you were tireless in pursuing the importance of upgrading the

physical aspects of the CDC. None of us needs to be told how important that is in terms of its contribution to safety and public

health. We were able to get that authorized and funded last year

because of your intervention, and that has played an indispensable

role both in New York and Florida.

Senator CLELAND. And with the anthrax scare, Mr. Chairman,

the CDC has been able to be on top of that with 100 vials of antibiotics there to deal with that situation. But what we are talking

about here is a bioterrorist attack where you have mass casualties,

and we are patently unprepared to deal with that.

The CHAIRMAN. Thank you very much.

Senator CLELAND. I thank the chairman.

The CHAIRMAN. Senator Hagel.

Senator HAGEL. Mr. Chairman, thank you.

I wish to extend my thanks to you and Senator Frist for your

leadership. It has been very much a part of this issue over a rather
8

sustained period of time; so to each of you, we appreciate that leadership and the very fast action that you are putting into place, especially with this hearing this morning, and the actions and consequences that will result from the hearing.

My colleague and your committee colleague, Senator Edwards,

and I collaborated last week on a bill that you mentioned, Chairman Kennedy, that we have introduced. I would like to take the

time to address some of the general areas of what Senator Edwards’ and my bill will do to hopefully contribute to this very real

threat that our country and the world face, and to also thank the

professionals who will be coming behind this panel of Senators.

They are the real professionals who understand the issue and who

will be charged with some very significant responsibilities as we set

some perimeters for them and provide them with the new resources

that we must.

With that, the bill that Senator Edwards and I have introduced

is a bill that addresses some very general areas of local, State, and

Federal responders, and in particular the State and local first responders who are the ones who need, it is our belief, the resources

because they are the ones who, as we have seen in New York and

at the Pentagon, must deal with this on a real case basis and in

real time.

So the $1.6 billion bill that Senator Edwards and I have introduced focuses on some of the following key areas—developing and

stockpiling vaccines and antibiotics at the Centers for Disease Control, Department of Energy, National Institutes of Health, and Department of Agriculture; it provides additional training and equipment to State and local first responders; it enhances disease surveillance through coordinated efforts between the CDC and State

and local public health services to provide sophisticated electronic

nationwide access to medical treatment, data, guidelines, and

health alerts.

This bill also strengthens the local public health networks, including increased training, coordination, and Federal assistance. It

assists local hospital emergency rooms with response training for

personnel, biocontainment, and decontamination capabilities. It

protects food safety and the agricultural economy from biological

and chemical threats. This is a very significant part, Mr. Chairman, of our bill to focus on. It is one that I suspect, especially in

light of the conversation that you and I had last week when we testified before the Senate Appropriations Committee, needs some attention.

We provide in this bill assistance to States and local governments and health facilities through a series of block grants. We believe it is the best approach, the most accountable and responsible

approach, to let these State and local first responders deal with

these resources and frame them as they believe they need them.

And our bill adds additional funding for Federal Government

programs, much of what we are already doing, but we go further

in some of these areas, and a number of agencies are connected to

our efforts.

Mr. Chairman, Senator Frist, we are all grateful again for your

leadership and for an opportunity for me to represent my colleague,

Senator Edwards, and myself here this morning to address some of
9

the specifics of our bill and would be pleased to respond to any

questions.

Thank you.

The CHAIRMAN. Thank you very much.

Senator Bayh?

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

I would like to echo the words of my colleague, Senator Hagel,

in thanking you and Senator Frist for having this hearing today

and for your legislation. It is reassuring to the country to have two

individuals who have dedicated their lives to the cause of public

health leading us in this effort.

Senator Frist, I listened to your comments, and I whole-heartedly

concur. I believe that biological weapons have been characterized

as ‘‘the poor man’s nuclear weapon,’’ and they pose a much greater

risk to our country today than ever before. So to both you and

Chairman Kennedy, I give my thanks for focusing on this very

timely threat to our national security.

I want to acknowledge the good work of our colleague, Senator

Hagel and my friend and colleague Senator Edwards. My proposal,

Mr. Chairman, builds upon your work and Senator Frist’s work

and their work and seeks to refine and perhaps improve upon the

area of State preparedness, which is vitally important to a successful response to an attack of this kind.

To Senator Cleland, my good friend, I would say, Max, that my

proposal will be squarely within the context of the CDC, under its

umbrella and its good leadership, so I thank you for your work in

this regard as well.

Finally, Mr. Chairman, I am here today not only testifying in behalf of my own proposal but on behalf of seven of our colleagues,

six of whom also served as former Governors and are well aware

of the important role that State and local communities play in responding to any attack of this kind.

Mr. Chairman, I would like to build upon your recommendations,

your legislation, and Senator Frist’s and also Senator Hagel’s and

Senator Edwards’, particularly in the area of State preparedness,

because one of the things that we have learned, as you mentioned

in your very eloquent opening remarks, is that State and local communities are on the front lines of responding to any threat to our

country of this nature.

Yet, Mr. Chairman, it should be deeply concerning to all of us

that a recent report indicated that too many States are not as prepared as they need to be to respond to a biological or chemical attack. As a matter of fact, the GAO just a few months ago determined that many States lacked the planning, the basic public

health infrastructure, and the ability to respond to mass casualties

or a surge of casualties that would be occasioned by a biological or

chemical attack. And this, Mr. Chairman, in spite of the $124 million that has been spent over the last 2 years assisting States and

local communities to beef up their capacity. Clearly, more work

needs to be done.

This is vitally important, as both of you have mentioned, because

particularly in the area of a biological attack, it is quite possible

that for the first several days while the diseases are communicable,

cases could go undiagnosed or misdiagnosed because many of the
10

symptoms, as I am sure Senator Frist would concur, replicate those

of influenza or other diseases. So it is vitally important, Mr. Chairman, that we have trained health responders on the scene at the

State and local level to make sure that we respond as comprehensively and quickly as possible.

Specifically, Mr. Chairman, I propose the following—that we allocate $5 million per year to each individual State and an additional

$200 million to be allocated on the basis of population. I believe

that this is an improvement, Mr. Chairman, over the competitive

grant approach. Competitive grants work very well in many circumstances, but here, Mr. Chairman, I think we simply do not

want to leave any State behind in its preparedness to respond to

a biological or chemical attack.

It would be ironic, Mr. Chairman, if we left some States out.

That would have the unintended consequence perhaps of identifying them as softer targets for anyone who would wish to do our

country ill. So I would respectfully request that we allow every

State to improve its planning to prepare for this eventuality.

Our proposal is somewhat more flexible than some others that

have been suggested because it is impossible for those of us sitting

in Washington here today to identify each State’s needs and the

myriad possibilities that need to be addressed. Therefore, we require a plan to be submitted to the Secretary of Health and Human

Services detailing the State’s proposal and describing in depth its

training and other initiatives but giving greater latitude to Governors and local officials to allocate the resources as needed and as

dictated by the requirements of each individual State.

Finally, Mr. Chairman, we would fund a simulation for each

State so that each State could literally do a run-through of its plan

to see where its strengths and weaknesses are and obviously improve those areas in need of additional attention. We require that

they be part of the CDC’s national communication network that

has been underway for 2 years. We clearly need to have improved

communication.

And finally, Mr. Chairman, we would provide some additional

funding as necessary for the best practices program currently funded through the CDC so that States and local communities can learn

from one another about what works and what does not work.

Again, Mr. Chairman, I would like to thank you, Senator Frist,

and your colleagues on the committee for your courtesy today.

State Governors and local officials are clearly on the front lines,

and Mr. Chairman, I would like to work with you to ensure that

those who will respond first to a disaster of this kind are prepared

to do so in the most timely and effective manner.

I thank you for holding the hearing.

The CHAIRMAN. Thank you very much. We look forward to working with all of our panelists.

We are glad to welcome Senator Corzine. His State and its people have suffered immensely. We can understand why, having gone

through the horrific experience on September 11, Senator Corzine

wants to make sure that we as a country are prepared to deal with

other potential challenges of bioterrorism.

We welcome you.
11

Senator CORZINE. Mr. Chairman, Senator Frist, and members of

the committee, I am truly appreciative of the opportunity to talk

to you about the preparedness issue with regard to biological and

chemical weapons. It is a real issue.

Just this last Friday, I sat with 34 hospital administrators in

New Jersey and discussed this issue, and quite frankly, I came

away chilled and sobered by the lack of coordinated planning with

regard particularly to biological attacks. It is of very serious concern; I agree with many of the comments of my colleagues and do

believe very much that it needs to be a very coordinated approach

that works with the States and local governments.

I think there is a growing consensus not only in New Jersey but

across the country that we are unprepared for a serious biological

and chemical attack, and I compliment you and Senator Frist for

your efforts and leadership in this area. I think it is terrific what

you have proposed.

I would like to take it a step further, particularly with regard to

the planning and coordination, and to that end, I introduced legislation, the Biological and Chemical Attack Preparedness Act, which

happens to be S. 1508, really designed to build on your efforts, but

it deals with improving coordination and planning of hospitals,

State, local, and Federal governments in responding to these kinds

of attacks.

This bill is in concert with Senators Torricelli and Jack Reed,

and the fundamental goal is to ensure that every American has access to public health resources in the event of such an attack

through pre-prescribed comprehensive and coordinated planning.

Our Nation’s response, Mr. Chairman, to chemical and biological

attacks will depend on a system that, frankly, is patchwork at best,

and the disparities in planning and capacity of the various States

and individual hospitals is really quite serious. It is in my own

State and I suspect across the Nation.

Improving our preparedness will require, first, resources. My legislation, as the others have suggested, provides for a grant program

that would help hospitals, States, and municipalities purchase the

items, services, and training that would be needed in the event we

need to meet this kind of disaster.

But simply distributing money is not sufficient in my view. We

also need to ensure that every part of the country is covered and

that they fully take up their responsibility in this area. We need

a systematic, complete, comprehensive approach to the problem,

with more coordination among the many parties involved.

In an effort to promote such coordination, I would require each

State to promptly develop and implement a public health disaster

plan that addresses biological and chemical weapon attacks. Each

disaster plan would be created in consultation with the many

stakeholders in the State health care infrastructure, but it would

be complete.

The fact is they need to be developed for each individual State.

The needs of New Jersey are more than a little bit different than

those of Wyoming.

The legislation I propose has an accountability feature in it. It

requires certification of the Department of Health and Human

Services that we are meeting that comprehensive coverage element,
12

and it has a condition that if those plans are not in place and do

not meet the compliance requirements of Health and Human Services, then Medicaid funding would be held in abeyance.

As part of the disaster plan, each State would designate specific

hospitals to assume responsibility for meeting related medical

needs. One of the things that is very clear is that while this patchwork exists, everybody seems to be trying to meet the same problem, and there is a real need for a coordinated approach so that

we do not overspend in this effort. We want to have a coordinated

and comprehensive approach.

Mr. Chairman, I thank you for all the efforts that you and Senator Frist are making. I think we need to have an accountable system, one that takes into account the ideas of all those at the local

level; but I think we need to move very quickly. This is a danger,

and it is probably not whether, but when we will have to deal with

these issues, as we are seeing in Florida now.

I appreciate this chance to comment, and I would like to work

with my colleagues to make sure that we have that comprehensive

approach for every American.

Thank you.

The CHAIRMAN. Thank you.

Senator Edwards is a cosponsor and is also a member of the committee. As a matter of courtesy, if you want to make a brief comment, Senator, in addition to what Senator Hagel has said about

your bill, we would welcome it at this time. Then it would be our

intention to recess and vote and return with the second panel.

Senator Edwards?

OPENING STATEMENT OF SENATOR EDWARDS

Senator EDWARDS. Thank you, Mr. Chairman. I will be very brief

because I know we need to get to the second panel.

Senator Hagel covered very well the legislation that he and I

have introduced. I also want to thank the chairman and Senator

Frist for all the work you have done, the leadership you have

shown, and all the members of the panel. We need the contributions of everyone on this very important issue to our country.

The focus of Senator Hagel’s and my legislation is on the people

who will have to identify that a biological attack has occurred— your local emergency room, your local public health department,

your family physician. These are the people who have to be trained

and equipped to recognize and identify what is happening; and

once they identify it, they have got to know what to do with that

information.

In effect, what we need to do is provide education and training

for local first responders, and put a disease surveillance system in

place so they can transfer the information to the place it needs to

go.

The second thing we need to do is make to sure that we have

adequate antibiotics and vaccine available to treat whatever the biological agent is.

And the third priority is to deal with the issue of agri-terrorism,

which I know all of us have had a great concern about. Senator

Frist, Senator Kennedy, and I have discussed this. We need to protect our food supply, including our crops and farms.
13

And I might add that I think a very important component of our

bill is that, in the past, a lot of the funding that has been appropriated bioterrorism has stayed in Washington, DC. I think that

misallocation is an enormous mistake which our bill seeks to remedy. We can equip all the expert response teams in the world here

in Washington, but the people who need help are the people out

there on the front lines—the doctors, the emergency rooms, the

nurses, and the public health officials. Our bill gets the money out

of Washington to the place where I believe that it is most needed— the people on the front lines.

Mr. Chairman, I thank you for allowing me to make a statement.

Senator Hagel, I thank you for your cosponsorship, and I thank

all my colleagues for their very important contribution to this issue

of national security.

The CHAIRMAN. I want to thank all of you very much.

A number of points caught my attention. One was Senator

Bayh’s mention of the difference in the grants approach. We have

a competitive grant program because we have limited resources.

Senator Frist can speak to this as well, but we would support the

broader amounts for block grants with additional resources; we

would be glad to work with you. It may be worthwhile to start that

way in order to get this program started, but we do want to make

sure that every State gets resources—but that moves the total

amount up. I certainly feel that it would be justified, but it is basically a question of resources. We would be glad to work with you

to take that into account.

Senator BAYH. Thank you, Mr. Chairman.

The CHAIRMAN. We thank all of the members. There are a lot of

good ideas and a lot of areas covered that were not included in our

proposal, so we value all of these suggestions. There will be others

of our colleagues who have thought about this issue and have been

meeting with experts back in their own communities. I think what

is important for the American people to understand is that we have

a way to go. But we have members of the administration and of

Congress who are serious about trying to work through a process

to do everything that we possibly can. We are committed to getting

the resources out there, and we are going to go about our business

in getting this job done.

We look forward to the next panel. They are the real experts. I

think they can give the American people some very important insights about where we are in addition to what we should be doing.

We will recess now for 10 minutes.

[Recess.]

The CHAIRMAN. The committee will come to order.

We have a very distinguished panel of experts in bioterrorism.

Janet Heinrich led the team that prepared the recent GAO report

on bioterrorism. As we developed legislation last year, Senator

Frist and I were struck by how difficult it was to get a clear accounting of Federal activities in bioterrorism. We are grateful to

her for the comprehensive and insightful report on this issue.

We welcome any comments that Senator Mikulski would like to

make by way of introduction of Dr. Donald Henderson.

Senator MIKULSKI. Thank you very much, Mr. Chairman. Again,

I want to thank you and Senator Frist for organizing this hearing.
14

What I am so proud of is that both of you have taken the leadership well before this gruesome attack on the United States of

America. Your leadership in other hearings on bioterrorism as well

as your leadership in improving the public health infrastructure I

think has laid the groundwork for us to be able to be ready, prepared, and able to respond. So I wish to thank you.

Mr. Chairman, many of us have been working on this issue for

some time, and I am proud to introduce to you one of the outstanding people in the United States of America in the field of epidemiology, eradicating disease, and helping America be prepared now.

Dr. Donald Henderson comes to the table having recently been

appointed by Secretary Thompson to head his Bioterrorism Advisory Panel. You could not have picked a better witness, and Secretary Thompson could not have picked a better person. Dr. Henderson is known globally for his leadership in eliminating smallpox

around the world and also was dean of the Johns Hopkins School

of Public Health.

After leaving that post, he assembled the Center for Civilian Biodefense Studies, a small group operating out of Johns Hopkins

that, quite frankly, I have going through earmarks—those little

congressional mandates—because nobody else thought it was an

important issue. Those little earmarks enabled Dr. Henderson to

assemble the staff to do a good job.

I really encourage us to listen to him because yes, we do need

to do prevention and work through our law enforcement and national security, and yes, we need to be prepared, and we are going

to have questions of Dr. Henderson and the panel, and we need to

be able to respond. I am concerned that, after all the early surveillance and after all the detection, we will not be ready to respond

because our first responders themselves will be wounded warriors.

So we look forward to listening to our experts, and Mr. Chairman, I really think we need to move with a great sense of urgency

both here, with our authorizing, as well as with the appropriations,

because we need to be able to manage the attacks, and we also

need to manage the panic around those attacks.

So I am very honored to introduce Dr. Henderson to you.

[The prepared statement of Senator Mikulski follows:]

PREPARED STATEMENT OF SENATOR MIKULSKI

Mr. Chairman, thank you for holding this important hearing

today on bioterrorism. I want to applaud you and Senator Frist for

your leadership on this issue. I extend a special welcome to Dr. D.

A. Henderson, Director of the Center for Civilian Biodefense Studies at Johns Hopkins, a real hero and an expert in his field.

What happened on September 11th was not only an attack

against America. It was a crime against democracy, and decency.

It was a crime against humanity. American citizens, American aircraft, American buildings were brought down by these barbaric terrorist attacks. Yet the American people—and our free and open society—stand unbowed and united.

Now Americans are more determined than ever to protect the

safety and security of this great nation. Bioterrorism is one of the

gravest threats and greatest challenges we face. Preparing our federal, state, and local governments to detect and respond to a bio-
15

terrorist attack will require an enormous commitment of resources

and the coordination of nearly every federal agency. It’s a daunting

task, but the United States Congress—and the American people— are up to the challenge.

Efforts are underway. I was proud to be an early cosponsor of

Senator Frist and Senator Kennedy’s Public Health Threats and

Emergencies Act that became law last year. Strengthening our nation’s public health infrastructure is essential to our preparedness

for and response to a bioterrorist attack. I have been working with

my colleagues on the Subcommittee and on the Appropriations

Committee over the last couple of years to make sure we have the

infrastructure and resources to prepare ourselves for this threat.

Now it’s time to step up these efforts.

Many federal agencies and departments have been involved— from the Centers for Disease Control and Prevention to Ft. Detrick

in Maryland that is on the frontline of bioweapons research to develop our best defense against these weapons. As Chairman of the

Appropriations Subcommittee that funds the Federal Emergency

Management Agency (FEMA), I am working with Ranking Member

Bond and Director Allbaugh to ensure that FEMA is ready to handle its role of consequence management in the event of a bioterrorist attack.

An explosion of doctors’ visits—not the explosion of a building— may be the first sign of a bioterrorist attack. That’s why we need

a strong public health infrastructure—to detect a bioterrorist attack; to make sure federal, state, and local agencies have the resources, tools, and technology to combat bioterrorism; and to ensure that health professionals are trained to recognize the symptoms of potential biologic agents. We must encourage research into

new drugs and vaccines to prevent against the effects of a bioterrorist attack. And we must give FDA the tools and resources it

needs to protect the safety of our food supply. Investments in the

fight against bioterrorism will pay off in other public health arenas

such as antimicrobial resistance and infectious disease detection.

Public health departments are on the front lines of this new kind

of war. Let’s make sure they are combat ready and fit-for-duty.

Lines of communication and accountability among our federal

agencies, as well as at all levels, must be clear. Cowardly terrorists

don’t respect borders or boundaries. I want to make sure that our

government agencies aren’t letting jurisdictional boundaries or

smokestack mentalities prevent the type of critical planning and

training our country needs.

I look forward to the testimony of all our witnesses today. We

have much to learn and much to do. This is a national problem

that requires a national solution and national leadership from the

federal government. It requires the best and the brightest at all

levels of government and industry. We must not wait for another

disaster to occur. We must be ready with a plan of defense and a

plan of offense. I look forward to working with my colleagues to

make sure that we are combat ready for a bioterrorist attack.

Thank you.

The CHAIRMAN. Thank you so much.

Dr. Henderson, Senator Frist and I both want to thank you so

much for your help in drafting our own legislation. You were good
16

enough to give up part of your vacation to come back. You have a

longstanding commitment in this area, and we look forward to your

testimony.

I see my colleague Senator Wellstone here, who would like to introduce a very special witness, and we are glad to hear from him.

Senator WELLSTONE. Thank you, Mr. Chairman. I will be very

brief.

Mr. Chairman, it is interesting that Michael Osterholm, of whom

we are very proud in Minnesota, dedicated his book, ‘‘Living Terrors: What America Needs to Know to Survive the Coming Bioterrorist Catastrophe’’—which is unfortunately prophetic—to ‘‘Donald Henderson who, more than 20 years ago, led mankind’s greatest public health and medical accomplishment, the eradication of

smallpox, and who has courageously entered the fight again to prevent its horrible return.’’

I also want to honor you, Dr. Henderson. If Dr. Osterholm does,

then I certainly as a Senator from Minnesota will do so as well.

Michael Osterholm was the former Minnesota State Epidemiologist, and he has been internationally recognized. I think Senator

Frist and Senator Kennedy have both met with Michael, and I

thank both of you for your very fine work. He has been an internationally recognized leader in the area of infectious disease for the

past two decades. He is a recipient of numerous honors and

awards, and he served as personal advisor on bioterrorism to the

late King Hussein of Jordan. He has led numerous successful investigations into infectious disease outbreaks of global importance.

He has lectured around the world, and he is now director of the

Center for Infectious Disease Research and Policy and professor at

the School of Public Health at the University of Minnesota.

He is a very strong, steady, intelligent, experienced voice, and we

thank him for being with us.

The CHAIRMAN. Thank you very much.

We are also fortunate to have Dr. Mohammad Akhter, who has

been a leader in public health, director of the American Public

Health Association. He has been a dedicated and skilled advocate

for better health for all, and through his clinical practice around

the world, he has encountered some of the infectious diseases that

might be used in a biological attack. So our committee looks forward to hearing from him.

And finally, Janet Heinrich led the team that prepared the recent GAO report on bioterrorism. I mentioned earlier, Dr. Heinrich,

how helpful it was to get your report and how much we appreciate

your assistance in finding out where the gaps are and the areas we

should be addressing. We are looking forward to continuing to work

with you to try to address those observations. So, in the great tradition of the GAO, it is very constructive and helpful work, and we

are looking forward to your testimony.

Dr. Henderson, please.
17

STATEMENTS OF DR. DONALD A. HENDERSON, DIRECTOR,

JOHNS HOPKINS CENTER FOR CIVILIAN BIODEFENSE STUDIES, BALTIMORE, MD; JANET HEINRICH, DIRECTOR, HEALTH

CARE AND PUBLIC HEALTH ISSUES, U.S. GENERAL ACCOUNTING OFFICE, WASHINGTON, DC; DR. MOHAMMAD N.

AKHTER, EXECUTIVE DIRECTOR, AMERICAN PUBLIC

HEALTH ASSOCIATION, WASHINGTON, DC; AND MICHAEL T.

OSTERHOLM, DIRECTOR, CENTER FOR INFECTIOUS DISEASE RESEARCH AND POLICY, UNIVERSITY OF MINNESOTA,

MINNEAPOLIS, MN

Dr. HENDERSON. Thank you, Mr. Chairman and distinguished

members of the committee, for this hearing and for your leadership

in this field, and my appreciation to Senator Mikulski for her very

generous introduction.

Tragically, we find ourselves contemplating the possibility of a

bioterrorist attack on U.S. civilians. As we consider these grave

matters, it is important that we recognize that that attack is by no

means a foregone conclusion; but the risk of this is not zero.

Some of the distinguished experts in this field have pointed out

that it is difficult to identify a pathogenic organism, to grow it

properly, to put it in the proper form, and then to disperse it. I

think we need to remind some of our distinguished experts in the

field that those who flew the airplanes into the trade towers did

not know how to make airplanes. They have money, they have access, and they can coopt that which they do not have.

There is much that can be done if we take some prudent action

beforehand. It has been emphasized by several that the first responders are health care workers and public health officials. There

are many who still do not appreciate this and who still seem to

think that we would be dealing with fire, police, and emergency

rescue people. They will be needed for explosive and chemical

events, but a bioterrorist attack on the United States would be

completely different from the events of September 11. It would in

all likelihood be a covert attack. There would be no discrete event,

no explosion, no immediately obvious disaster to which the firefighters and the police and the ambulances would rush. We would

know we had been attacked only when people began appearing in

emergency rooms and doctors’ offices.

Our ability to effectively deal with such an event depends directly on the capacity of our medical care institutions and our public health system to quickly recognize that an attack has occurred,

to promptly identify those who might be at risk, and to deliver effective medical care, possibly on a massive scale.

A number of steps have been taken to prepare the Nation to respond, and clearly, I would say from my position that we are better

positioned to do this now than we were several months ago, indeed,

several weeks ago. But there is an awfully great deal that needs

to be done yet.

On October 4, Secretary of Health and Human Services Tommy

Thompson named me to chair an advisory council which is to work

with him in furthering efforts to prepare the Nation to respond. I

am honored to accept this post. The council is intended to draw on

expertise and persons from across the country with varied experience at local, State, and Federal levels. The membership of the
18

council and its precise functions will be established within the next

few days.

There is particular concern on the part of your committee and

certainly at this time in the executive office as to needs in the immediate and near term—really, within the next 30 to 90 days—to

better prepare the Nation to respond to possible acts of bioterrorism, and that is what I will tend to focus on.

In doing so, however, it is important that we bear in mind that

there are no simple actions that we can take or one-time infusions

of funding that will rebuild a deteriorated public health system

quickly and provide the needed surge capacity in our hospitals to

be able to cope on an emergency basis with large numbers of casualties. We do need a longer-term strategy.

The Department of Health and Human Services over the past

several years, and especially in recent months, has taken a number

of important steps to improve our readiness to respond to bioterrorism. There are many capable people working on a number of different projects. The efforts, however, still lack coherence. The diverse and disconnected efforts have to be brought together into a

single unified program, and that is, I know, high on the Secretary’s

agenda. We need a single, centralized medical and public health

strategy for preparing the Nation to respond.

State and local public health departments across the country are

the real backbone for detection and response to biological weapons

attack, and that has been noted earlier this morning. They need resources, and they need them urgently if they are to effectively

carry out even the rudimentary actions which are absolutely essential for dealing with a major infectious disease outbreak.

It is difficult for me to exaggerate the deficiencies of our present

public health capabilities. Assuming that Federal funds could expeditiously be made available, there will be need for an expedited

process to get those funds to State and local levels. Reference has

been made to block grants as perhaps being an approach to do

that.

Such funds cannot be overly constrained, because certainly, priorities and needs do differ from Newark to Phoenix to Montgomery

County, AL.

There are specific public health functions in need of immediate

improvement. If we are to detect and rapidly identify a new health

problem, health officials must be available 24 hours a day, 7 days

a week, to take calls from clinicians reporting cases which may be

suggestive of a bioweapons-related disease. In many areas of the

country today, this is not done, and indeed it is not possible because of lack of personnel to take those calls.

Support in terms of training and equipment is being provided to

a national network of 80 laboratories capable of diagnosing the

principal threat agents. One of these laboratories in Florida is the

one responsible for the early diagnosis of the anthrax case. That

process needs to be substantially speeded up—that is, their capacity to differentiate a number of different organisms which ordinarily laboratories would not see—so that the full range of potential agents could be rapidly and accurately identified.

The Department of Health and Human Service began some years

ago to require a national stockpile of drugs and equipment that
19

could be called upon in case of need for a mass casualty situation.

Because of recent events, the nature and quantity of materials

available will need to be reviewed, and I have been asked to meet

with an expert advisory group later this month to do exactly that.

Secretary Thompson has initiated a number of steps to ensure

that the supplies of smallpox vaccine are immediately ready for distribution if needed and has taken steps to expand the amount of

smallpox vaccine available at an early time.

But perhaps the most uncertain part of the equation that has not

really been addressed is how to get those drugs and vaccines to the

population involved in a very short period of time. Distribution is

not easy. Health departments have had very little experience in the

large-scale, rapid distribution of either drugs or vaccines. Here

again is where resources are needed for the State and local health

departments to undertaken contingency planning for distribution

and to prepare themselves.

However much we try to provide from the Federal level, we will

be highly dependent on the knowledgeable people at the local level

who know the area, as they say, know the territory, and know the

buttons to push to get something done.

For our public health officials, emergency room health personnel,

and infectious disease physicians, educational materials are urgently in need. At this time, many of these diseases are totally unknown to those who would be likely to see cases. To date, few good

materials have yet to be provided.

Obviously, it does little good to have a public health system that

can detect disease outbreaks and manage epidemics if we cannot

take care of the sick people. Over the past decade, our hospitals

and the medical care system have labored under intense financial

pressures. One reaction to these pressures has been the elimination

of excess capacity from the health care system. Today, few hospitals could respond effectively to a sudden, significant surge in patient demand. Indeed, based on our contacts with hospitals and

hospital associations, we believe that 500 patients would overwhelm the health care systems of most cities.

The first step is to recognize that the problem exists and to encourage hospitals to join forces in the search for solutions. We

would advocate an effort to establish regional consortia of hospitals, groups of institutions collocated in cities or counties around

the Nation, to begin planning. Here, they need to plan with the

State and local health departments.

But even simple steps will require money, and financial relief or

incentives to enable hospitals to carry out these initial steps should

be considered.

Finally, just a word on research and development. A well-conceived and integrated plan for research and development is clearly

needed. We have a number of challenges. In the near term, we

could use an improved anthrax vaccine, and a great deal has been

done. With an intensive effort, that vaccine should be able to be

available within a matter of a couple of years. There are new therapies to treat anthrax. We need drugs to deal with the complications

of smallpox vaccine.

Beyond this, one could envisage an array of solutions that might

prevent the use of biological weapons or at least mitigate the likeli-
20

hood of their use and so make bioterrorism and its consequences

less likely or less severe. The science section of The New York

Times today provides an interesting array to display some of the

initiatives that might be taken.

But years and not months will be required for the development.

Regrettably, I am afraid that biological weapons and biological terrorism will be with us for the foreseeable future.

Thank you, Mr. Chairman.

The CHAIRMAN. Thank you, Dr. Henderson.

[The prepared statement of Dr. Henderson follows:]

PREPARED STATEMENT OF DONALD A. HENDERSON, M.D., MPH, DIRECTOR, JOHNS

HOPKINS CENTER FOR CIVILIAN BIODEFENSE STUDIES

Mr. Chairman, distinguished members of the Committee, tragically, we find ourselves contemplating the possibility of a bioterrorist attack on US civilians. As we

consider these grave matters, it is important that we recognize that such an attack

is by no means a foregone conclusion although the risk is not zero. However, there

is much that can be done—if we take prudent actions beforehand—to mitigate the

consequences of an epidemic deliberately initiated by terrorists.

A bioterrorist attack on the US would be completely different from the events of

11 September. It would in all likelihood be a covert attack. There would be no discrete ‘‘event’’; no explosion, no immediately obvious disaster to which firefighters

and police and ambulances would rush. We would know we had been attacked only

when people began appearing in emergency rooms and doctors’ offices with inexplicable illnesses or with seemingly common illnesses of unusual severity.

The ‘‘first responders’’ to bioterrorism would be health care workers and public

health officials. Our ability to effectively deal with such an event depends directly

on the capacity of our medical care institutions and our public health system to

quickly recognize that an attack has occurred; to promptly identify those who might

be a risk; to deliver effective medical care—possibly on a massive scale; and, should

the bioweapon prove to be transmitted from person to person, to rapidly track and

contain the spread of disease. A number of steps have been taken to fully prepare

the nation to respond and, clearly, we are better positioned than we were several

months ago, indeed several weeks ago, but much remains to be done.

On October 4, Secretary of Health and Human Services Tommy Thompson named

me Chair of an Advisory body which is to work with the Secretary in furthering efforts to prepare the nation to respond to acts of bioterrorism or other attacks which

could place large numbers of US civilian victims needing medical attention. I am

honored to accept this post, but as I am sure you will understand, it is premature

to discuss either the functions or composition of the Advisory Council other than to

say that it will operate in accordance with the Federal Advisory Committee Act

(FACA). It will draw on expertise and persons from across the country and with varied experience at local, state and federal level. The membership of the Council and

its precise functions will be established within the next few weeks.

There is concern on the part of your Committee as to needs in the immediate and

near-term—that is, the next 30–60 days—to better prepare the nation to respond

to possible acts of bioterrorism and that I am happy to address. In doing so, however, it is important that we bear in mind that there are no simple actions or onetime infusions of funding that will rebuild a deteriorated public health system and

provide the needed surge capacity in our hospitals to be able to cope, on an emergency basis, with large numbers of casualties. A longer-term strategy is critical. We

must also, at the same time, embark on a search for better ways to prevent and

treat infectious disease, especially those diseases likely to be used as biological

weapons. We must find ways to use our significant assets in biomedical research

to make bioweapons effectively obsolete as weapons of mass destruction.

HHS, over the past several years but especially in recent months, has taken a

number of important steps to improve our readiness to respond to bioterrorism.

There have been many laudable new initiatives, and existing programs that have

relevance to bioterrorism response that have been promoted. Many capable people

are working hard on a number of projects. The efforts, however, lack needed coherence. The task now is to combine these diverse and disconnected efforts into a unified program of action. We need a single, centralized medical and public health

strategy for preparing the nation to detect and respond to bioterrorist attacks. It

is an effort that appropriately should be managed by HHS, integrated across the
21

Department, coordinated with state and local authorities, and able to interface efficiently with other federal agencies.

The difficulty of understanding and managing the complex interactions among the

different agencies, levels of government and private sector organizations that have

roles to play in bioterrorism response is profound. New partnerships must be forged.

Policy makers must be educated to understand the operational realities faced by

hospitals and public health agencies. They must recognize that protecting national

security will demand investments in sectors not typically considered integral to defense strategy.

State and local public health departments across the country are the backbone for

detection and response to a biological weapons attack. They need resources and they

need them urgently if they are to effectively carry out even the rudimentary actions

that are absolutely essential for dealing with a major infectious disease outbreak.

It is difficult to exaggerate the deficiencies of our present public health capacities.

Indeed, it is inaccurate to even call the varied public health structures at state, city

and county level a public health ‘‘system’’, since many of these units are not connected or coordinated in any meaningful way. In the near term, it is important that

we identify and support the essential steps needed to make this motley arrangement

functional.

Assuming that federal funds can expeditiously be made available, there will be

a need for an expedited process to get these funds to state and local level. The leisurely and tortuous administrative channels will need to be foreshortened so that

funds become available in weeks, not months. Moreover, such funds should not be

overly constrained by restrictive definitions of how they are to be spent. The variety

of needs in the 50 state and 3000 local public health departments around the country are such that, for a program of this urgency and complexity, it would not be

sensible for the federal government to dictate what the most urgent spending priorities should be in Newark or Phoenix or Montgomery County, Maryland.

Public Health Functions in Need of Immediate Improvement

Systems Linking the Medical Community to Public Health

If we are to detect and rapidly identify a new health problem, public health officials must be available 24 hours a day seven days a week to take calls from clinicians reporting cases which may be suggestive of such as a bioweapons-related disease. This is not possible in most areas of the country. Creating this vital link between the medical system—which is likely to be where the first evidence of a bioterrorist attack arises—and public health will in some cases require hiring more

health department staff. In some locales, it may require purchasing beepers or an

answering service. It need not—indeed, should not be—a high-tech operation, but

it is vital to the early discovery of an intentional epidemic. And early discovery is

vital to saving lives.

Improved Communications and ‘‘Connectivity’’ among Public Health Agencies

There is a need to augment communications at local, state and federal level to

assure the possibility for rapid communications 24 hours per day, 7 days per week

between agencies.

Improved Laboratory Diagnostic Capacity

Support in terms of training and equipment is being provided to a national network of more than 60 laboratories capable of diagnosing the principal threat agents.

This process needs to be substantially speeded up so that the full range of potential

agents can be rapidly and accurately identified.

Ensuring the Adequacy, Availability of the National Pharmaceutical Stockpile (NPS)

HHS began some years ago to acquire a national stockpile of drugs and equipment

that could be called upon in time of need for mass casualty situations. Today, the

NPS consists of caches of such supplies, located in strategic locations around the

country. CDC has reported that these supplies can be delivered within 12 hours to

any point in the nation. Because of recent events, the nature and quantities of materials available will be reviewed by an expert advisory group later this month.

In addition, Secretary Thompson has initiated a number of steps to ensure that

the supplies of smallpox vaccine held by the federal Centers for Disease Control and

Prevention (CDC) are immediately ready for distribution if needed. The Secretary

has recently directed that the amount of smallpox vaccine produced under the HHS

contract with Acambis be significantly increased, and has taken steps to move up

the date of delivery.

Perhaps the most uncertain part of the equation in getting drugs and vaccine to

the population relates to the question of distribution. Health departments have had
22

little experience in the large scale, rapid distribution of either drugs or vaccines.

Should such be needed, there predictably would be staggering logistical problems.

Here again is where resources are needed for state and local health departments

to undertake contingency planning for distribution.

Improved Training of Public Health Officials, Emergency Room Health Personnel

and Infectious Disease Physicians

These three groups of professionals along with the laboratory personnel represent

the foundation for early detection, diagnosis, definition of the epidemic and application of preventive and therapeutic measures. Educational materials are urgently in

need. Resources are required for training programs, drills, tabletop exercises, etc.

In the longer term there is a need for rigorous curricula and training programs to

prepare public health professionals to manage deliberate epidemics, and to incorporate public health practice-related curricula into academic training programs.

Medical Care Functions In Need of Improvement

Obviously, it does little good to have a public health system that can detect disease outbreaks and manage epidemics if we cannot effectively take care of sick people. Over the past decade, hospitals and the medical care system generally, have

labored under intense financial pressures. One reaction to these pressures has been

the elimination of excess capacity from the health care system.

Today, few hospitals could respond effectively to a sudden, significant surge in patient demand. Research done by the Hopkins Biodefense Center indicates that no

hospital, or geographically contiguous group of hospitals, could effectively manage

even 500 patients demanding sophisticated medical care such as would be required

in an outbreak of anthrax, for example. In the event of a contagious disease outbreak—such as smallpox—far fewer patients could be handled. There isn’t enough

staff, enough supplies, enough drugs on hand to cope with such an emergency. This

problem of lack of surge capacity has no simple solutions.

The first step is to recognize that the problem exists and to encourage hospitals

to join forces in the search for solutions. We advocate an immediate effort to establish regional consortia of hospitals—groups of institutions co-located in cities or

counties around the nation—to begin planning how best to use available resources

most efficiently. Hospitals should immediately review their existing disaster plans,

paying particular attention to management of mass casualties and to how they

would handle large numbers of patients with potentially contagious disease. Even

these simple steps will require money. Congress should immediately investigate how

they might provide financial relief or incentives to enable hospitals to carry out

these initial steps. Secondly, medical professionals must be made aware of the possibility of bioterrorist attacks and learn to recognize the symptoms of the six or so

pathogens thought most likely to be used as bioweapons. It is imperative that clinicians not only be able to recognize the symptoms of anthrax, smallpox, etc., but that

they be aware of the responsibility to report suspicions of such diseases to the public

health authorities—and that they know exactly who to call and how to reach them.

Research and Development

A well-conceived and integrated plan for research and development is needed to

deal with a number of challenges—in the near term: an improved anthrax vaccine,

new therapies to treat anthrax, and drugs to deal with the complications of smallpox vaccine. But beyond this, one could envisage an array of solutions that might

prevent the use of biological weapons or at least mitigate the likelihood of their use

and so make bioterrorism and its consequences less likely or less severe—new vaccines and treatments for currently untreatable viral and toxin diseases; rapid diagnostic tests; sensor systems; and immune enhancement mechanisms. Years, not

months, will be required for their development but, regrettably, biological weapons

and biological terrorism will be with us for the foreseeable future.

The CHAIRMAN. Dr. Heinrich?

Ms. HEINRICH. Mr. Chairman and members of the subcommittee,

I appreciate the opportunity to be here today to discuss our ongoing

work on public health preparedness for a domestic bioterrorist attack.

We recently released a report which you referred to on Federal

research and preparedness activities related to public health and

medical consequences of a bioterrorist attack on the civilian population. I would like to begin by giving a brief overview of the find-
23

ings in our report and then address weaknesses in the public

health infrastructure that we believe warrant special attention.

We identified more than 20 Federal departments and agencies as

having a role in preparing for or responding to the public health

or medical consequences of a bioterrorist attack. These agencies are

participating in a variety of activities, from improving the detection

of a biological agent and developing new vaccines to managing a

national stockpile of pharmaceuticals.

Coordination of these activities across departments and agencies

is fragmented. The chart that we have prepared gives examples of

efforts to coordinate these activities at the Federal level as they existed before the creation of the Office of Homeland Security. I will

not walk you through the whole chart, but as you can see, a multitude of agencies have overlapping responsibilities for various aspects of bioterrorism preparedness. Bringing order to this picture

will be challenging, and as Dr. Henderson said, we are in great

need of coherence.

Federal spending on domestic preparedness for bioterrorist attacks involving all types of weapons of mass destruction has risen

310 percent since fiscal year 1998 to approximately $1.7 billion in

fiscal year 2001.

Funding information and research in preparedness of a bioterrorist attack as reported to us by the Federal agencies involved shows

increases year by year from generally low or zero levels in 1998.

For example, within HHS, CDC’s Bioterrorism Preparedness and

Response Program first received funding in fiscal year 1999. Its

funding has increased from approximately $121 million at that

time to approximately $194 million in fiscal year 2001.

While many of the Federal activities are designed to provide support for local responders, inadequacies in the public health infrastructure at the State and local levels may reduce the effectiveness

of the overall response effort. Our work has pointed to weaknesses

in three key areas—training of health care providers, communication among responsible parties, and capacity of hospitals and laboratories.

As we have heard, physicians and nurses in emergency rooms

and private offices will most likely be the first health care workers

to see patients following a bioterrorist attack. They need training

to ensure their ability to make astute observations of unusual

symptoms and patterns and report them appropriately. Most physicians and nurses have never seen diseases such as smallpox or

plague, and some biological agents initially produce symptoms that

can be easily confused with influenza or other common illnesses,

leading to a delay in diagnosis.

In addition, physicians and other providers are currently underreporting identified cases of diseases to the infectious disease surveillance system.

Because the pathogen used in a biological attack could take days

or weeks to identify, good channels of communication among the

parties involved in the response are essential to ensure as timely

a response as possible. Once the disease outbreak has been recognized, local health departments will need to collaborate closely with

personnel across a variety of agencies to bring in the needed expertise and resources.
24

1 Bioterrorism is the threat or intentional release of biological agents (viruses, bacteria, or

their toxins) for the purposes of influencing the conduct of government or intimidating or coercing a civilian population. 2See Bioterrorism: Federal Research and Preparedness Activities (GAO-01-915, Sept. 28, 2001).

This report was mandated by the Public Health Improvement Act of 2000 (P.L. 106505, sec.

102). Also, see the list of related GAO products at the end of this statement. 3We conducted interviews with and obtained information from the Departments of Agriculture, Commerce, Defense, Energy, Health and Human Services, Justice, Transportation, the

Treasury, and Veterans Affairs-, the Environmental Protection Agency-, and the Federal Emergency Management Agency.

Past experiences with infectious disease outbreaks have revealed

a lack of sufficient secure channels in sharing such information.

Adequate laboratory and hospital capacity is also in question.

Even though the West Nile virus outbreak was relatively small, it

strained laboratory resources for several months. Further, Federal

and local officials told us that there is little or no excess capacity

in the health care system in most communities for accepting and

treating mass casualty patients.

In conclusion, although numerous bioterrorist-related research

and preparedness activities are underway in Federal agencies, we

remain concerned about weaknesses in public health and medical

preparedness at the State and local levels.

Mr. Chairman, this concludes my prepared remarks. I would be

happy to answer questions.

The CHAIRMAN. Thank you very much.

[The prepared statement of Ms. Heinrich follows:]

PREPARED STATEMENT OF JANET HEINRICH, DIRECTOR, HEALTH CARE—PUBLIC

HEALTH ISSUES

Mr. Chairman and Members of the Subcommittee: I appreciate the opportunity

to be here today to discuss our work on the activities of federal agencies to prepare

the nation to respond to the public health and medical consequences of a bioterrorist

attack.1 Preparing to respond to the public health and medical consequences of a

bioterrorist attack poses some challenges that are different from those in other types

of terrorist attacks, such as bombings. On September 28, 2001, we released a report 2 that describes (1) the research and preparedness activities being undertaken

by federal departments and agencies to manage the consequences of a bioterrorist

attack,3 (2) the coordination of these activities, and (3) the findings of reports on

the preparedness of state and local jurisdictions to respond to a bioterrorist attack.

My testimony will summarize the detailed findings included in our report, highlighting weaknesses in the public health infrastructure that we have identified in our

ongoing work and which we believe warrant special attention.

In summary, we identified more than 20 federal departments and agencies as

having a role in preparing for or responding to the public health and medical consequences of a bioterrorist attack. These agencies are participating in a variety of

activities, from improving the detection of biological agents to developing a national

stockpile of pharmaceuticals to treat victims of disasters. Federal departments and

agencies have engaged in a number of efforts to coordinate these activities on a formal and informal basis, such as interagency work groups. Despite these efforts, we

found evidence that coordination between departments and agencies is fragmented.

We did, however, find recent actions to improve coordination across federal departments and agencies. In addition, we found emerging concerns about the preparedness of state and local jurisdictions, including insufficient state and local planning

for response to terrorist events, a lack of hospital participation in training on terrorism and emergency response planning, the timely availability of medical teams and

resources in an emergency, and inadequacies in the public health infrastructure.

The last includes weaknesses in the training of health care providers, communication among responsible parties, and capacity of laboratories and hospitals, including

the ability to treat mass casualties.

Background

A domestic bioterrorist attack is considered to be a low-probability event, in part

because of the various difficulties involved in successfully delivering biological
25

4See Combating Terrorism: Need for Comprehensive Threat and Risk Assessments of Chemical

and Biological Attacks (GAO/NSIAD-99-163, Sept. 14, 1999), pp. 10-15, for a discussion of the

ease or difficulty for a terrorist to create mass casualties by making or using chemical or biological agents without the assistance of a state-sponsored program. 5For example, in January 2000, threatening letters were sent to a variety of recipients, including the Planned Parenthood office in Naples, Florida, warning of the release of anthrax.

Federal authorities found no signs of anthrax or any other traces of harmful substances and

determined these incidences to be hoaxes. 6The Federal Response Plan, originally drafted in 1992 and updated in 1999, is authorized

under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act; P.L.

93-288, as amended). The plan outlines the planning assumptions, policies, concept of operations, organizational structures, and specific assignment of responsibilities to lead departments

and agencies in providing federal assistance once the President has declared an emergency requiring federal assistance. 7Some agencies define WMDs to include large conventional explosives as well.

8Disease surveillance systems provide for the ongoing collection, analysis, and dissemination

of data to prevent and control disease. 9 Epidemiological investigation is the study of patterns of health or disease and the factors

that influence these patterns. 10For example, an agency providing appropriations is not necessarily indicating the level of

its commitments (that is, obligations) or expenditures for that year—only the amount of budget

authority made available to it by the Congress, some of which may be unspent. Similarly, an

agency that provided expenditure information for fiscal year 2000 may have obligated the funds

in fiscal year 1999 based on an appropriation for fiscal year 1998. To simplify presentation, we

generally refer to all the budget data we received from agencies as ‘‘reported funding.’’

agents to achieve large-scale casualties.4 However, a number of cases involving biological agents, including at least one completed bioterrorist act and numerous

threats and hoaxes, 5 have occurred domestically. In 1984, a group intentionally contaminated salad bars in restaurants in Oregon with salmonella bacteria. Although

no one died, 751 people were diagnosed with foodborne illness. Some experts predict

that more domestic bioterrorist attacks are likely to occur.

The burden of responding to such an attack would fall initially on personnel in

state and local emergency response agencies. These ‘‘first responders’’ include firefighters, emergency medical service personnel, law enforcement officers, public

health officials, health care workers (including doctors, nurses, and other medical

professionals), and public works personnel. If the emergency were to require federal

disaster assistance, federal departments and agencies would respond according to

responsibilities outlined in the Federal Response Plan. 6 Several groups, including

the Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving Weapons of Mass Destruction (known as the Gilmore Panel), have assessed the

capabilities at the federal, state, and local levels to respond to a domestic terrorist

incident involving a weapon of mass destruction (WMD), that is, a chemical, biological, radiological, or nuclear agent or weapon.7

While many aspects of an effective response to bioterrorism are the same as those

for any disaster, there are some unique features. For example, if a biological agent

is released covertly, it may not be recognized for a week or more because symptoms

may not appear for several days after the initial exposure and may be misdiagnosed

at first. In addition, some biological agents, such as smallpox, are communicable and

can spread to others who were not initially exposed. These differences require a type

of response that is unique to bioterrorism, including infectious disease surveillance, 8

epidemiologic investigation, 9 laboratory identification of biological agents, and distribution of antibiotics to large segments of the population to prevent the spread of

an infectious disease. However, some aspects of an effective response to bioterrorism

are also important in responding to any type of large-scale disaster, such as providing emergency medical services, continuing health care services delivery, and managing mass fatalities.

Federal Departments and Agencies Reported a Variety of Research and

Preparedness Activities

Federal spending on domestic preparedness for terrorist attacks involving WMD’s

has risen 310 percent since fiscal year 1998, to approximately $1.7 billion in fiscal

year 2001, and may increase significantly after the events of September 11, 2001.

However, only a portion of these funds were used to conduct a variety of activities

related to research on and preparedness for the public health and medical consequences of a bioterrorist attack. We cannot measure the total investment in such

activities because departments and agencies provided funding information in various forms—as appropriations, obligations, or expenditures. Because the funding information provided is not equivalent,10 we summarized funding by department or
26

11 Although there are generally no specific appropriations for activities on bioterrorism, some

departments and agencies did provide estimates of the funds they were devoting to activities

on bioterrorism. Other departments and agencies provided estimates for overall terrorism activities, but were unable to provide funding amounts for activities on bioterrorism specifically. Still

others stated that their activities were relevant for bioterrorism, but they were unable to specify

the funding amounts. Funding levels for activities on terrorism, including bioterrorism, were reported for activities prior to the 2001 Emergency Supplemental Appropriations Act for Recovery

From and Response to Terrorist Attacks on the United States (P.L. 107–38). 12Presidential Decision Directive 62, issued May 22, 1998, created a category of special events

called National Security Special Events, which are events of such significance that they warrant

greater federal planning and protection than other special events.

agency, but not across the federal government (see apps. I and II).11 Reported funding generally shows increases from fiscal year 1998 to fiscal year 2001. Several

agencies received little or no funding in fiscal year 1998. For example, within the

Department of Health and Human Services (HHS), the Centers for Disease Control

and Prevention’s (CDC) Bioterrorism Preparedness and Response Program was established and first received funding in fiscal year 1999 (see app. I and app. II). Its

funding has increased from approximately $121 million at that time to approximately $194 million in fiscal year 2001.

Research Activities Focus on Detection, Treatment, Vaccination, and

Equipment

Research is currently being done to enable the rapid identification of biological

agents in a variety of settings; develop new or improved vaccines, antibiotics, and

antivirals to improve treatment and vaccination for infectious diseases caused by biological agents; and develop and test emergency response equipment such as respiratory and other personal protective equipment. Appendix I provides information

on the total reported funding for all the departments and agencies carrying out research, along with examples of this research.

The Department of Agriculture (USDA), Department of Defense (DOD), Department of Energy, HHS, Department of Justice (DOJ), Department of the Treasury,

and the Environmental Protection Agency (EPA) have all sponsored or conducted

projects to improve the detection and characterization of biological agents in a variety of different settings, from water to clinical samples (such as blood). For example,

EPA is sponsoring research to improve its ability to detect biological agents in the

water supply. Some of these projects, such as those conducted or sponsored by DOD

and DOJ, are not primarily for the public health and medical consequences of a bioterrorist attack against the civilian population, but could eventually benefit research

for those purposes.

Departments and agencies are also conducting or sponsoring studies to improve

treatment and vaccination for diseases caused by biological agents. For example,

HHS’ projects include basic research sponsored by the National Institutes of Health

to develop drugs and diagnostics and applied research sponsored by the Agency for

Healthcare Research and Quality to improve health care delivery systems by studying the use of information systems and decision support systems to enhance preparedness for the delivery of medical care in an emergency.

In addition, several agencies, including the Department of Commerce’s National

Institute of Standards and Technology and DOJ’s National Institute of Justice are

conducting research that focuses on developing performance standards and methods

for testing the performance of emergency response equipment, such as respirators

and personal protective equipment.

Preparedness Efforts Include Multiple Actions

Federal departments’ and agencies’ preparedness efforts have included efforts to

increase federal, state, and local response capabilities, develop response teams of

medical professionals, increase availability of medical treatments, participate in and

sponsor terrorism response exercises, plan to aid victims, and provide support during special events such as presidential inaugurations, major political party conventions, and the Superbowl.12 Appendix H contains information on total reported funding for all the departments and agencies with bioterrorism preparedness activities,

along with examples of these activities.

Several federal departments and agencies, such as the Federal Emergency Management Agency (FEMA) and CDC, have programs to increase the ability of state

and local authorities to successfully respond to an emergency, including a bioterrorist attack. These departments and agencies contribute to state and local jurisdictions by helping them pay for equipment and develop emergency response plans,

providing technical assistance, increasing communications capabilities, and conducting training courses.
27

13 1n addition to simulating a bioterrorism attack in Denver, the exercise also simulated a

chemical weapons incident in Portsmouth, New Hampshire. A concurrent exercise, referred to

as National Capital Region 2000, simulated a radiological event in the greater Washington, D.C.

area.

Federal departments and agencies have also been increasing their own capacity

to identify and deal with a bioterrorist incident. For example, CDC, USDA, and the

Food and Drug Administration (FDA) are improving surveillance methods for detecting disease outbreaks in humans and animals. They have also established laboratory response networks to maintain state-of-the-art capabilities for biological agent

identification and the characterization of human clinical samples.

Some federal departments and agencies have developed teams to directly respond

to terrorist events and other emergencies. For example, HHS’ Office of Emergency

Preparedness (OEP) created Disaster Medical Assistance Teams to provide medical

treatment and assistance in the event of an emergency. Four of these teams, known

as National Medical Response Team, are specially trained and equipped to provide

medical care to victims of WMD events, such as bioterrorist attacks.

Several agencies are involved in increasing the availability of medical supplies

that could be used in an emergency, including a bioterrorist attack. CDC’s National

Pharmaceutical Stockpile contains pharmaceuticals, antidotes, and medical supplies

that can be delivered anywhere in the United States within 12 hours of the decision

to deploy. The stockpile was deployed for the first time on September 11, 2001, in

response to the terrorist attacks on New York City.

Federally initiated bioterrorism response exercises have been conducted across the

country. For example, in May 2000, many departments and agencies took part in

the Top Officials 2000 exercise (TOPOFF 2000) in Denver, Colorado, which featured

the simulated release of a biological agent. 13 Participants included local fire departments, police, hospitals, the Colorado Department of Public Health and the Environment, the Colorado Office of Emergency Management, the Colorado National Guard,

the American Red Cross, the Salvation Army, HHS, DOD, FEMA, the Federal Bureau of Investigation (FBI), and EPA.

Several agencies also provide assistance to victims of terrorism. FEMA can provide supplemental funds to state and local mental health agencies for crisis counseling to eligible survivors of presidentially declared emergencies. In the aftermath of

the recent terrorist attacks, HHS released $1 million in funding to New York State

to support mental health services and strategic planning for comprehensive and

long-term support to address the mental health needs of the community. DOJ’s Office of Justice Programs (OJP) also manages a program that provides funds for victims of terrorist attacks that can be used to provide a variety of services, including

mental health treatment and financial assistance to attend related criminal proceedings.

Federal departments and agencies also provide support at special events to improve response in case of an emergency. For example, CDC has deployed a system

to provide increased surveillance and epidemiological capacity before, during, and

after special events. Besides improving emergency response at the events, participation by departments and agencies gives them valuable experience working together

to develop and practice plans to combat terrorism.

Fragmentation Remains Despite Efforts to Coordinate Federal Programs

Federal departments and agencies are using a variety of interagency plans, work

groups, and agreements to coordinate their activities to combat terrorism. However,

we found evidence that coordination remains fragmented. For example, several different agencies are responsible for various coordination functions, which limits accountability and hinders unity of effort; several key agencies have not been included

in bioterrorism-related policy and response planning; and the programs that agencies have developed to provide assistance to state and local governments are similar

and potentially duplicative. The President recently took steps to improve oversight

and coordination, including the creation of the Office of Homeland Security.

Departments and Agencies Use a Variety of Methods to Coordinate Activities

Over 40 federal departments and agencies have some role in combating terrorism,

and coordinating their activities is a significant challenge. We identified over 20 departments and agencies as having a role in preparing for or responding to the public

health and medical consequences of a bioterrorist attack. Appendix III, which is

based on the framework given in the Terrorism Incident Annex of the Federal Response Plan, shows a sample of the coordination efforts by federal departments and

agencies with responsibilities for the public health and medical consequences of a
28

14See also Combating Terrorism: Comments on Counterterrorism Leadership and National

Strategy (GAO–01–556T, Mar. 27,2001), p. 1. 15See Combating Terrorism: Selected Challenges and Related Recommendations (GAO–01–

822, Sept. 20, 2001), pp. 79, 84. 16 Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving Weapons

of Mass Destruction (Gilmore Panel), Toward a National Strategy for Combating Terrorism, Second Annual Report (Arlington, Va.: RAND, Dec. 15, 2000), p. 7. 17See also Combating Terrorism: Issues in Managing Counterterrorist Programs (GAO/T–

NSIAD–00–145, Apr. 6, 2000), p. 8. 18See GAO–01–822, Sept. 20, 2001, pp. 104–106.

bioterrorist attack, as they existed prior to the recent creation of the Office of Homeland Security. This figure illustrates the complex relationships among the many federal departments and agencies involved.

Departments and agencies use several approaches to coordinate their activities on

terrorism, including interagency response plans, work groups, and formal agreements. Interagency plans for responding to a terrorist incident help outline agency

responsibilities and identify resources that could be used during a response. For example, the Federal Response Plan provides a broad framework for coordinating the

delivery of federal disaster assistance to state and local governments when an emergency overwhelms their ability to respond effectively. The Federal Response Plan

also designates primary and supporting federal agencies for a variety of emergency

support operations. For example, HHS is the primary agency for coordinating federal assistance in response to public health and medical care needs in an emergency. HHS could receive support from other agencies and organizations, such as

DOD, USDA, and FEMA, to assist state and local jurisdictions.

Interagency work groups are being used to minimize duplication of funding and

effort in federal activities to combat terrorism. For example, the Technical Support

Working Group is chartered to coordinate interagency research and development requirements across the federal government in order to prevent duplication of effort

between agencies. The Technical Support Working Group, among other projects,

helped to identify research needs and fund a project to detect biological agents in

food that can be used by both DOD and USDA.

Formal agreements between departments and agencies are being used to share resources and knowledge. For example, CDC contracts with the Department of Veterans Affairs (VA) to purchase drugs and medical supplies for the National Pharmaceutical Stockpile because of VA’s purchasing power and ability to negotiate large

discounts.

Coordination Remains Fragmented Within the Federal Government

Overall coordination of federal programs to combat terrorism is fragmented.14 For

example, several agencies have coordination functions, including DOJ, the FBI,

FEMA, and the Office of Management and Budget. Officials from a number of the

agencies that combat terrorism told us that the coordination roles of these various

agencies are not always clear and sometimes overlap, leading to a fragmented approach. We have found that the overall coordination of federal research and development efforts to combat terrorism is still limited by several factors, including the

compartmentalization or security classification of some research efforts.15 The Gilmore Panel also concluded that the current coordination structure does not provide

for the requisite authority or accountability to impose the discipline necessary

among the federal agencies involved.16

The multiplicity of federal assistance programs requires focus and attention to

minimize redundancy of effort.17 Table 1 shows some of the federal programs providing assistance to state and local governments for emergency planning that would

be relevant to responding to a bioterrorist attack. While the programs vary somewhat in their target audiences, the potential redundancy of these federal efforts

highlights the need for scrutiny. In our report on combating terrorism, issued on

September 20, 2001, we recommended that the President, working closely with the

Congress, consolidate some of the activities of DOJ’s OJP under FEMA. 18
29

19See Combating Terrorism: Threat and Risk Assessments Can Help Prioritize and Target Program Investments (GAO/NSIAD–98–74, Apr. 9, 1998) and GAO/NSIAD–99–163, Sept. 14, 1999.

Table 1: Selected Federal Activities Providing Assistance to State and Local Governments for

Emergency Planning Relevant to a Bioterrorist Attack

Department or agency Activities Target audience

HHS–CDC Provides grants, technical support, and performance

standards to support bioterrorism preparedness

and response planning.

State and local health agencies.

HHS–OEP Enters into contracts to enhance medical response

capability. The program includes a focus on response to bioterrorism, including early recognition,

mass postexposure treatment, mass casualty care,

and mass fatality management.

Local jurisdictions (for fire, police, and emergency

medical services; hospitals; public health agencies; and other services).

DOJ–OJP Assists states in developing strategic plans. Includes

funding for training, equipment acquisition, technical assistance, and exercise planning and execution to enhance state and local capabilities to

respond to terrorist incidents.

States (for fire, law enforcement, emergency medical,

and hazardous materials response services; hospitals; public health departments; and other services).

FEMA Provides grant assistance to support state and local

consequence management planning, training, and

exercises for all types of terrorism, including bioterrorism.

State emergency management agencies.

Source: Information obtained from departments and agencies.

We have also recommended that the federal government conduct multidisciplinary

and analytically sound threat and risk assessments to define and prioritize requirements and properly focus programs and investments in combating terrorism.19 Such

assessments would be useful in addressing the fragmentation that is evident in the

different threat lists of biological agents developed by federal departments and agencies.

Understanding which biological agents are considered most likely to be used in

an act of domestic terrorism is necessary to focus the investment in new technologies, equipment, training, and planning. Several different agencies have or are

in the process of developing biological agent threat lists, which differ based on the

agencies’ focus. For example, CDC collaborated with law enforcement, intelligence,

and defense agencies to develop a critical agent list that focuses on the biological

agents that would have the greatest impact on public health. The FBI, the National

Institute of Justice, and the Technical Support Working Group are completing a report that lists biological agents that may be more likely to be used by a terrorist

group working in the United States that is not sponsored by a foreign government.

In addition, an official at USDA’s Animal and Plant Health Inspection Service told

us that it uses two lists of agents of concern for a potential bioterrorist attack.

These lists of agents, only some of which are capable of making both animals and

humans sick, were developed through an international process. According to agency

officials, separate threat lists are appropriate because of the different focuses of

these agencies. In our view, the existence of competing lists makes the assignment

of priorities difficult for state and local officials.

Fragmentation is also apparent in the composition of groups of federal agencies

involved in bioterrorism-related planning and policy. Officials at the Department of

Transportation (DOT) told us that even though the nation’s transportation centers

account for a significant percentage of the nation’s potential terrorist targets, the

department was not part of the founding group of agencies that worked on bioterrorism issues and has not been included in bioterrorism response plans. DOT officials

also told us that the department is supposed to deliver supplies for FEMA under

the Federal Response Plan, but it was not brought into the planning early enough

to understand the extent of its responsibilities in the transportation process. The department learned what its responsibilities would be during the TOPOFF 2000 exercise, which simulated a release of a biological agent.
30

20 According to the Office of the Vice President, as of June 2001, details on the Vice President’s efforts had not yet been determined. 21See GAO–01–822, Sept. 20, 2001, pp. 41–42. 22 A.E. Smithson and L.-A. Levy, Ataxia: The Chemical and Biological Terrorism Threat and

the U.S. Response (Washington, D.C.: The Henry L. Stimson Center, Oct. 2000), p. 271. 23 Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving Weapons

of Mass Destruction, p. 32. 24D.C. Wetter, W.E. Daniell, and C.D. Treser, ‘‘Hospital Preparedness for Victims of Chemical

or Biological Terrorism,’’ American Journal of Public Health, Vol. 91, No. 5 (May 2001), pp. 710–

16.25Smithson and Levy, p. 227.

Recent Actions Seek to Improve Coordination Across Federal Departments

and Agencies

In May 2001, the President asked the Vice President to oversee the development

of a coordinated national effort dealing with WMDs.20 At the same time, the President asked the Director of FEMA to establish an Office of National Preparedness

to implement the results of the Vice President’s effort that relate to programs within

federal agencies that address consequence management resulting from the use of

WMDs. The purpose of this effort is to better focus policies and ensure that programs and activities are fully coordinated in support of building the needed preparedness and response capabilities. In addition, on September 20, 2001, the President announced the creation of the Office of Homeland Security to lead, oversee, and

coordinate a comprehensive national strategy to protect the country from terrorism

and respond to any attacks that may occur. These actions represent potentially significant steps toward improved coordination of federal activities. Our recent report

highlighted a number of important characteristics and responsibilities necessary for

a single focal point, such as the proposed Office of Homeland Security, to improve

coordination and accountability. 21

Despite Federal Efforts, Concerns Exist Regarding Preparedness at State

and Local Levels

Nonprofit research organizations, congressionally chartered advisory panels, government documents, and articles in peer-reviewed literature have identified concerns about the preparedness of states and local areas to respond to a bioterrorist

attack. These concerns include insufficient state and local planning for response to

terrorist events, a lack of hospital participation in training on terrorism and emergency response planning, questions regarding the timely availability of medical

teams and resources in an emergency, and inadequacies in the public health infrastructure. In our view, there are weaknesses in three key areas of the public health

infrastructure: training of health care providers, communication among responsible

parties, and capacity of laboratories and hospitals, including the ability to treat

mass casualties.

Questions exist regarding how effectively federal programs have prepared state

and local governments to respond to terrorism. All 50 states and approximately 255

local jurisdictions have received or are scheduled to receive at least some federal assistance, including training and equipment grants, to help them prepare for a terrorist WMD incident. In 1997, FEMA identified planning and equipment for response to nuclear, biological, and chemical incidents as areas in need of significant

improvement at the state level. However, an October 2000 research report concluded

that even those cities receiving federal aid are still not adequately prepared to respond to a bioterrorist attack. 22

Inadequate training and planning for bioterrorism response by hospitals is a

major problem. The Gilmore Panel concluded that the level of expertise in recognizing and dealing with a terrorist attack involving a biological or chemical agent is

problematic in many hospitals. 23 A recent research report concluded that hospitals

need to improve their preparedness for mass casualty incidents. 24 Local officials

told us that it has been difficult to get hospitals and medical personnel to participate in local training, planning, and exercises to improve their preparedness.

Local officials are also concerned about whether the federal government could

quickly deliver enough medical teams and resources to help after a biological attack. 25 Agency officials say that federal response teams, such as Disaster Medical

Assistance Teams, could be on site within 12 to 24 hours. However, local officials

who have deployed with such teams say that the federal assistance probably would

not arrive for 24 to 72 hours. Local officials also told us that they were concerned

about the time and resources required to prepare and distribute drugs from the National Pharmaceutical Stockpile during an emergency. Partially in response to these

concerns, CDC has developed training for state and local officials in using the stock-
31

26Smithson and Levy, p. 248. 27See West Nile Virus Outbreak: Lessons for Public Health Preparedness (GAO/HEHS–00–180,

Sept. 11, 2000), pp. 21–22. 28 J.R. Richards, M.L. Navarro, and R.W. Derlet, ‘‘Survey of Directors of Emergency Departments in California on Overcrowding,’’ Western Journal of Medicine, Vol. 172 (June 2000), pp.

385–88. R. Derlet, J. Richards, and R. Kravitz, ‘‘Frequent Overcrowding in U.S. Emergency Departments,’’ Academic Emergency Medicine, Vol. 8, No. 2 (2001), pp. 151–55. Smithson and Levy,

p. 262.

pile and will deploy a small staff with the supplies to assist the local jurisdiction

with distribution.

Components of the nation’s public health system are also not well prepared to detect or respond to a bioterrorist attack. In particular, weaknesses exist in the key

areas of training, communication, and hospital and laboratory capacity. It has been

reported that physicians and nurses in emergency rooms and private offices, who

will most likely be the first health care workers to see patients following a bioterrorist attack, lack the needed training to ensure their ability to make observations of

unusual symptoms and patterns. 26 Most physicians and nurses have never seen

cases of certain diseases, such as smallpox or plague, and some biological agents initially produce symptoms that can be easily confused with influenza or other, less

virulent illnesses, leading to a delay in diagnosis or identification. Medical laboratory personnel require training because they also lack experience in identifying biological agents such as anthrax.

Because it could take days to weeks to identify the pathogen used in a biological

attack, good channels of communication among the parties involved in the response

are essential to ensure that the response proceeds as rapidly as possible. Physicians

will need to report their observations to the infectious disease surveillance system.

Once the disease outbreak has been recognized, local health departments will need

to collaborate closely with personnel across a variety of agencies to bring in the

needed expertise and resources. They will need to obtain the information necessary

to conduct epidemiological investigations to establish the likely site and time of exposure, the size and location of the exposed population, and the prospects for secondary transmission. However, past experiences with infectious disease response

have revealed a lack of sufficient and secure channels for sharing information. Our

report last year on the initial West Nile virus outbreak in New York City found that

as the public health investigation grew, lines of communication were often unclear,

and efforts to keep everyone informed were awkward, such as conference calls that

lasted for hours and involved dozens of people. 27

Adequate laboratory and hospital capacity is also a concern. Reductions in public

health laboratory staffing and training have affected the ability of state and local

authorities to identify biological agents. Even the initial West Nile virus outbreak

in 1999, which was relatively small and occurred in an area with one of the nation’s

largest local public health agencies, taxed the federal, state, and local laboratory resources. Both the New York State and the CDC laboratories were inundated with

requests for tests, and the CDC laboratory handled the bulk of the testing because

of the limited capacity at the New York laboratories. Officials indicated that the

CDC laboratory would have been unable to respond to another outbreak, had one

occurred at the same time. In fiscal year 2000, CDC awarded approximately $11

million to 48 states and four major urban health departments to improve and upgrade their surveillance and epidemiological capabilities. With regard to hospitals,

several federal and local officials reported that there is little excess capacity in the

health care system in most communities for accepting and treating mass casualty

patients. Research reports have concluded that the patient load of a regular influenza season in the late 1990s overtaxed primary care facilities and that emergency

rooms in major metropolitan areas are routinely filled and unable to accept patients

in need of urgent care. 28

Concluding Observations

We found that federal departments and agencies are participating in a variety of

research and preparedness activities that are important steps in improving our

readiness. Although federal departments and agencies have engaged in a number

of efforts to coordinate these activities on a formal and informal basis, we found that

coordination between departments and agencies is fragmented. In addition, we remain concerned about weaknesses in public health preparedness at the state and

local levels, a lack of hospital participation in training on terrorism and emergency

response planning, the timely availability of medical teams and resources in an

emergency, and, in particular, inadequacies in the public health infrastructure. The

latter include weaknesses in the training of health care providers, communication
32

among responsible parties, and capacity of laboratories and hospitals, including the

ability to treat mass casualties.

Mr. Chairman, this completes my prepared statement. I would be happy to respond to any questions you or other Members of the Subcommittee may have at this

time.

Contact and Acknowledgments

For further information about this testimony, please contact me at (202) 512–

7118. Barbara Chapman, Robert Copeland, Marcia Crosse, Greg Ferrante, Deborah

Miller, and Roseanne Price also made key contributions to this statement.

Appendix 1: Funding for Research

Total Reported Funding for Research on Bioterrorism and Terrorism by Federal Departments and

Agencies, Fiscal Year 2000 and Fiscal Year 2001

Dollars in millions

Department or agency Fiscal year

2000 funding

Fiscal year

2001 funding Sample activities

U.S. Department of Agriculture (USDA)—

Agricultural Research Service

0 $0.5 Improving detection of biological agents.

Department of Energy $35.5 $39.6 Developing technologies for detecting and responding to a bioterrorist attack.

Developing models of the spread of and exposure

to a biological agent after release.

Department of Health and Human Services (HHS)—Agency for Healthcare

Research and Quality

$5.0 0 Examining clinical training and ability of frontline

medical staff to detect and respond to a bioterrorist threat.

Studying use of information systems and decision

support systems to enhance preparedness for

medical care in the event of a bioterrorist

event.

HHS—Centers for Disease Control and

Prevention (CDC)

$48.2 $46.6 Developing equipment performance standards.

Conducting research on smallpox and anthrax viruses and therapeutics.

HHS—Food and Drug Administration

(FDA)

$8.8 $9.1 Licensing of vaccines for anthrax and smallpox.

Determining procedures for allowing use of notyet-approved drugs and specifying data needed

for approval and labeling.

HHS—National Institutes of Health $43.0 $49.7 Developing new therapies for smallpox virus.

Developing smallpox and bacterial antigen detection system.

HHS—Office of Emergency Preparedness

(OEP)

0 $4.6 Overseeing a study on response systems.

Department of Justice (DOJ)—

Office of Justice Programs (OJP)

$0.7 $4.6 Developing a biological agent detector.

DOJ—Federal Bureau of Investigation 0 $1.1 Conducting work on detection and characterization of biological materials.

Department of the Treasury—Secret

Service

0 $0.5 Developing a biological agent detector.

Environmental Protection Agency (EPA) 0 $0.5 Improving detection of biological agents.

Note: Total reported funding refers to budget data we received from agencies. Agencies reported appropriations, actual or estimated obligations, or actual or estimated expenditures. An agency providing appropriations is not necessarily indicating the level of its obligations or expenditures for that year—only the amount of budget authority made available to it by the Congress. Similarly, an agency that provided expenditure information for fiscal year 2000 may have obligated the funds in fiscal year 1999 based on an appropriation for fiscal year 1998.

Source: Information obtained from departments and agencies.
33

Appendix II: Funding for Preparedness Activities

Total Reported Funding for Preparedness Activities on Bioterrorism and Terrorism by Federal

Departments and Agencies, Fiscal Year 2000 and Fiscal Year 2001

Dollars in millions

Department or agency Fiscal year

2000 funding

Fiscal year

2001 funding Sample activities

USDA—Animal and Plant

Health Inspection Service

0 $0.2 Developing educational materials and training programs specifically dealing with bioterrorism.

Department of Defense

(DOD)—Joint Task Force for

Civil Support

$3.4 $8.7 Planning, and when directed, commanding and controlling

DOD’s WMD and high-yield explosive consequence management capabilities in support of FEMA.

DOD—National Guard $70.0 $93.3 Managing response teams that would enter a contaminated

area to gather samples for on-site evaluation.

DOD—U.S. Army $29.5 $11.7 Maintaining a repository of information about chemical and

biological weapons and agents, detectors, and protection

and decontamination equipment.

HHS—CDC $124.9 $147.3 Awarding planning grants to state and local health departments to prepare bioterrorism response plans.

Improving surveillance methods for detecting disease outbreaks.

Increasing communication capabilities in order to improve

the gathering and exchanging of information related to

bioterrorist incidents.

HHS—FDA $0.1 $2.1 Improving capabilities to identify and characterize foodborne

pathogens.

Identifying biological agents using animal studies and

microbiological surveillance.

HHS—OEP $35.3 $46.1 Providing contracts to increase local emergency response capabilities.

Developing and managing response teams that can provide

support at the site of a disaster.

DOJ—OJP $7.6 $5.3 Helping prepare state and local emergency responders

through training, exercises, technical assistance, and

equipment programs.

Developing a data collection tool to assist states in conducting their threat, risk, and needs assessments, and in developing their preparedness strategy for terrorism, including bioterrorism.

EPA $0.1 $2.0 Providing technical assistance in identifying biological

agents and decontaminating affected areas.

Conducting assessments of water supply vulnerability to terrorism, including contamination with biological agents.

Federal Emergency Management Agency$25.1 $30.3 Providing grant assistance and guidance to states for planning and training.

Maintaining databases of safety precautions for biological,

chemical, and nuclear agents.

Note: Total reported funding refers to budget data we received from agencies. Agencies reported appropriations, actual or estimated obligations, or actual or estimated expenditures. An agency providing appropriations is not necessarily indicating the level of its obligations or expenditures for that year—only the amount of budget authority made available to it by the Congress. Similarly, an agency that provided expenditure information for fiscal year 2000 may have obligated the funds in fiscal year 1999 based on an appropriation for fiscal year 1998.

Source: Information obtained from departments and agencies.
34

Appendix III: Examples of Coordination Activities on Bioterrorism Among

Federal Departments and Agencies

We identified the following federal departments and agencies as having responsibilities related to the public health and medical consequences of a bioterrorist attack:

• USDA—U.S. Department of Agriculture

• APHIS—Animal and Plant Health Inspection Service

• ARS—Agricultural Research Service

• FSIS—Food Safety Inspection Service

• OCPM—Office of Crisis Planning and Management

• DOC—Department of Commerce

• NIST—National Institute of Standards and Technology

• DOD—Department of Defense

• DARPA—Defense Advanced Research Projects Agency

• JTFCS—Joint Task Force for Civil Support

• National Guard

• U.S. Army

• DOE—Department of Energy

• HHS—Department of Health and Human Services

• AHRQ—Agency for Healthcare Research and Quality

• CDC—Centers for Disease Control and Prevention

• FDA—Food and Drug Administration

• NIH—National Institutes of Health

• OEP—Office of Emergency Preparedness

• DOJ—Department of Justice

• FBI—Federal Bureau of Investigation

• OJP—Office of Justice Programs

• DOT—Department of Transportation

• USCG—U.S. Coast Guard

• Treasury—Department of the Treasury

• USSS—U.S. Secret Service

• VA—Department of Veterans Affairs

• EPA—Environmental Protection Agency

• FEMA—Federal Emergency Management Agency

Figure 1, which is based on the framework given in the Terrorism Incident Annex

of the Federal Response Plan, shows a sample of the coordination activities by these

federal departments and agencies, as they existed prior to the recent creation of the

Office of Homeland Security. This figure illustrates the complex relationships among

the many federal departments and agencies involved. (Note: This GAO chart is

maintained in the Committee file.)

The following coordination activities are represented on the figure:

• OMB Oversight of Terrorism Funding. The Office of Management and Budget

established a reporting system on the budgeting and expenditure of funds to combat

terrorism, with goals to reduce overlap and improve coordination as part of the annual budget cycle.

• Federal Response Plan—Health and Medical Services Annex. This annex to the

Federal Response Plan states that HHS is the primary agency for coordinating federal assistance to supplement state and local resources in response to public health

and medical care needs in an emergency, including a bioterrorist attack.

• Informal Working Group—Equipment Request Review. This group meets as

necessary to review equipment requests of state and local jurisdictions to ensure

that duplicative funding is not being given for the same activities.

• Agreement on Tracking Diseases in Animals That Can Be Transmitted to Humans. This group is negotiating an agreement to share information and expertise

on tracking diseases that can be transmitted from animals to people and could be

used in a bioterrorist attack.

• National Medical Response Team Caches. These caches form a stockpile of

drugs for OEP’s National Medical Response Teams.

• Domestic Preparedness Program. This program was formed in response to the

National Defense Authorization Act of Fiscal Year 1997 (P.L. 104–201) and required

DOD to enhance the capability of federal, state, and local emergency responders regarding terrorist incidents involving WMDs and high-yield explosives. As of October

1, 2000, DOD and DOJ share responsibilities under this program.

• Office of National Preparedness—Consequence Management of WMD Attack. In

May 2001, the President asked the Director of FEMA to establish this office to coordinate activities of the listed agencies that address consequence management resulting from the use of WMDs.
35

• Food Safety Surveillance Systems. These systems are FoodNet and PulseNet,

two surveillance systems for identifying and characterizing contaminated food.

• National Disaster Medical System. This system, a partnership between federal

agencies, state and local governments, and the private sector, is intended to ensure

that resources are available to provide medical services following a disaster that

overwhelms the local health care resources.

• Collaborative Funding of Smallpox Research. These agencies conduct research

on vaccines for smallpox.

• National Pharmaceutical Stockpile Program. This program maintains repositories of life-saving pharmaceuticals, antidotes, and medical supplies that can be delivered to the site of a biological (or other) attack.

• National Response Teams. The teams constitute a national planning, policy,

and coordinating body to provide guidance before and assistance during an incident.

• Interagency Group for Equipment Standards. This group develops and maintains a standardized equipment list of essential items for responding to a terrorist

WMD attack. (The complete name for this group is the Interagency Board for Equipment Standardization and Interoperability.)

• Force Packages Response Team. This is a grouping of military units that are

designated to respond to an incident.

• Cooperative Work on Rapid Detection of Biological Agents in Animals, Plants,

and Food. This cooperative group is developing a system to improve on-site rapid

detection of biological agents in animals, plants, and food.

Related GAO Products

Bioterroilsm: Coordination and Preparedness (GAO–02–129T, Oct. 5, 2001).

Bioterrorism: Federal Research and Preparedness Activities (GAO–01–915, Sept. 28,

2001).

Combating Terrorism: Selected Challenges and Related Recommendations (GAO–01–

822, Sept. 20, 2001).

Combating Terrorism: Comments on H.R. 525 to Create a President’s Council on Domestic Terrorism Preparedness (GAO–01–555T, May 9, 2001).

Combating Terrorism: Accountability Over Medical Supplies Needs Further Improvement (GAO–01–666T, May 1, 2001).

Combating Terrorism: Observations on Options to Improve the Federal Response

(GAO–01–660T, Apr. 24, 2001).

Combating Terrorism: Accountability Over Medical Supplies Needs Further Improvement (GAO–01–463, Mar. 30, 2001).

Combating Terrorism: Comments on Counterterrorism Leadership and National

Strategy (GAO–01–556T, Mar. 27, 2001).

Combating Terrorism: FEMA Continues to Make Progress in Coordinating Preparedness and Response (GAO–01–15, Mar. 20, 2001).

Combating Terrorism: Federal Response Teams Provide Varied Capabilities; Opportunities Remain to Improve Coordination (GAO–01–14, Nov. 30, 2000).

West Nile Virus Outbreak: Lessons for Public Health Preparedness (GAO/HEHS–00–

180, Sept. 11, 2000).

Combating Terrorism: Linking Threats to Strategies and Resources (GAO/T–NSIAD–

00–218, July 26, 2000).

Chemical and Biological Defense. Observations on Nonmedical Chemical and Biological R&D Programs (GAO/T–NSIAD–00–130, Mar. 22, 2000).

Combating Terrorism: Need to Eliminate Duplicate Federal Weapons of Mass Destruction Training (GAO/NSIAD–00–64, Mar. 21, 2000).

Combating Terrorism: Chemical and Biological Medical Supplies Are Poorly Managed (GAO/T–HEHS/AIMD–00–59, Mar. 8, 2000).

Combating Terrorism: Chemical and Biological Medical Supplies Are Poorly Managed (GAO/HEHS/AIMD–00–36, Oct. 29,1999).

Food Safety: Agencies Should Further Test Plans for Responding to Deliberate Contamination (GAO/RCED–00–3, Oct. 27, 1999).

The CHAIRMAN. Dr. Akhter?

Dr. AKHTER. Thank you, Mr. Chairman, members of the committee. I really appreciate this opportunity to be here today to discuss

with you our views.

I represent the public health community. We are 55,000 public

health workers working at the State, local, and Federal levels to

protect the health of the American people, and we are all very
36

much ready to serve in any capacity to help deal with this new

threat to America’s security and the peace of our people.

We are a scientific community. Our people are experts in the

field. We wrote the book on ‘‘Dealing with Communicable Diseases.’’ We have been publishing this book since 1917. This is the

book which is used worldwide to deal with infectious diseases. The

United States Army buys 24,000 copies of this book to be distributed to its members to be able to protect against communicable diseases.

So we have a significant amount of knowledge about how to proceed, and we also have knowledge as to what is the reality on the

ground. So I want to present to you, Mr. Chairman and members

of the committee, the reality on the ground on different arenas.

First, prevention of bioterrorism is the key. There has not been

any relationship between the public health community and the intelligence community. These two communities have never worked

together in the past. There is very limited contact between these

two communities. Good intelligence, not only looking at the foreign

agents coming in but at our own labs, where these things could be

manufactured, is very, very important. In fact, I would suggest that

we make our State public health directors part of the intelligence

community. Let us get them the clearance and get them hooked up,

because the sooner there is free communication, the better work we

as a public health community can do.

The second part is the local health department capacity. There

are 3,000 local health departments. Ten percent of them do not

even have email or Internet connection. Most health departments

are 9 to 5 operations. So if there is an outbreak on Friday afternoon, there will be nobody there to take care of them on Friday

evening, Saturday, Sunday, or Monday. The window of opportunity

to deal with these infectious agents is 24 to 48 hours during which

we need to either provide the vaccine or provide treatment to save

the life of the individual and also to prevent the spread of disease.

If nobody is there, how are we going to deal with this?

What I suggest we do is to look at the regional approach, get

these health departments together, and have someplace where, 24

hours a day, 7 days week, people are available whom the local

health providers could talk to and could provide service.

As we look at our local situation, we see the weakest link. I was

State health director in Missouri and also health commissioner in

our Nation’s Capital, and I had the great pleasure of being the

emergency medical services director for the States of Illinois and

Michigan. The weakest link between the health department and

health care providers just at the moment—there is no direct connection and no direct link in most places so that the emergency

providers, EMTs, paramedics, could send in direct information immediately to the hospitals, clinics, and private providers. The information comes too late. We need to have that relationship and that

link strengthened. Simply giving money and resources to the States

to do things without asking them to do these specific things would

not solve our situation.

Finally, Mr. Chairman, there is a lack of epidemiological capacity

at the State level—the people who are trained, the medical detectives, to go after such things day in and day out—almost half of
37

our States do not have such people on board as we speak today.

I think we need to build that capacity; we need to have these folks

in there to carry out this responsibility.

Now I come to our premier agency, the Centers for Disease Control and Prevention. This is the lead agency in the world. The quality of this agency is unmatched by any other institution in the

world. But its capacity is very narrow. Its ability to fight on multiple fronts is very, very limited. We need to expand that capacity.

In the natural history of disease, one case leads to another case;

another case leads to another case. In a terrorist attack, large

numbers of cases take place at the same time. And remember—the

incubation period of a disease could be from one to 7 days; so by

the time the first case appears, in our mobile society, people will

have traveled many, many places. So that being available on multiple fronts is very important.

I suggest the capacity of CDC be increased and also that its capacity be placed at strategic locations, most likely at the regional

offices, so that in case of transportation failure, people can get to

it, or in case of a terrorist attack in Atlanta. So we need to decentralize some of this capacity so that we can provide the trained personnel, provide the drugs, provide the vaccines to the people in a

timely manner where they need it.

Of course, there are many, many other issues dealing with the

distribution of drugs. You all saw yesterday people in Florida

standing outside, waiting for several hours to get their share of the

medication. That is just a small group of people. Think about if you

had to provide medication in New York City to all the population,

or if you had to provide immunization to all the people in San

Francisco. Do we have built up that kind of capacity, that kind of

ability to be able to do this work?

The reason I am telling you all of this is not to scare you, but

to tell you that we are vigilant, we are looking at it, and we will

do whatever we need to do, but that this requires a long-term, sustained commitment by the Federal Government, the State governments, and the local authorities to be able to deal with the situation.

Finally, Mr. Chairman and members of the committee, I was

born in India and grew up in Pakistan. As a child, I saw many of

these diseases. There was an outbreak of smallpox when I was a

child, and one-third of my classmates were infected. These are no

‘‘walk in the garden’’ kinds of diseases where you give medicine,

and they get better. There are consequences besides death from

these diseases which are lifelong.

We cannot afford not to be fully prepared to deal with these diseases. The unthinkable has already happened, and I as a public

health official cannot sit here and say yes, we are ready, we are

prepared. I say to you that we are underprepared, and we had better get ourselves ready to do the best we can.

Thirty years ago, this Nation made a choice that we would not

immunize people against smallpox. We discontinued that immunization because the threat was low—thanks to Dr. Henderson and

his colleagues, smallpox was eradicated. Now the threat has risen

to a higher level once again.
38

It is time to revisit that policy. We should appoint a high-level

panel of experts from both the medical side of the community as

well as the intelligence community so that we can look at the

threat level, and at the risks and benefits, and truly reexamine

once again whether we should look at immunizing our people

against common bioterrorist agents like anthrax and smallpox.

A lot more research needs to be done. We might find wonderful

modalities. But I must submit to you that after seeing the firefighters and the EMTs and the paramedics working on the front

line in New York City, the firemen running into the fire as others

ran away, the same kind of situation will take place when there

is a terrorist attack. These people have to go in, they have got to

get folks out, and these people must be protected.

The United States Army right now provides immunization

against smallpox and anthrax to its people. We should seriously reconsider making available these vaccines to our firefighters and our

front-line workers. It would be a tragedy if these people had to

stand in line, waiting to get their antibiotics and their vaccines

when they could be working and helping other people.

Mr. Chairman, I appreciate greatly this opportunity and would

be glad to answer any questions you and members of the committee

might have.

Thank you.

The CHAIRMAN. Thank you very much, Dr. Akhter.

[The prepared statement of Dr. Akhter follows:]

PREPARED STATEMENT OF MOHAMMAD N. AKHTER, M.D., MPH, EXECUTIVE

DIRECTOR OF THE AMERICAN PUBLIC HEALTH ASSOCIATION

Mr. Chairman and members of the Committee, my name is Mohammad Akhter,

and I am the Executive Director of the American Public Health Association. APHA

is the oldest and largest public health association in the world, representing approximately 50,000 public health professionals in the United States and abroad. I

am honored to appear before you to discuss the role of our public health infrastructure in preparing for, preventing, detecting, and responding to a bioterrorist event.

On behalf of our colleagues and members, I salute you, Mr. Chairman, and the

members of the Committee for your timely recognition of the importance of public

health in addressing the threats currently facing our great nation. My role today

will be to assess how the public health infrastructure can and must be enhanced

to respond to a bioterrorism emergency with greater speed, efficiency, and effectiveness.

Preventing a Bioterrorist Event is Preferable to Responding to One

On September 1 1th, the Centers for Disease Control and Prevention issued precautionary instructions to health departments to be on special alert for possible

clusters of unusual disease symptoms, and hospitals were notified by state and local

health officials to report any such incidents promptly. This was an appropriate action in the face of an obvious disaster. But, a bioterrorist attack itself won’t be obvious. Links must be established between the intelligence community and public

health officials on a routine basis to discern the actual attack, eliminate the response lag-time of the agent’s incubation period, and thereby prevent casualties.

Public health must be included in the intelligence process, and given appropriate

clearance to review suspicious occurrences and threats much earlier in the process.

There must also be a new segment of the intelligence community that is devoted

to detecting bioterrorist threats. Good intelligence is key to preventing attacks.

Communication and Coordination

We have heard over the last several weeks that we must enhance our ability to

gather information in an emergency, and to communicate it efficiently to all relevant parties. This means establishing linkages among emergency managers, local

health departments, clinics, and hospitals so that critical data in an emergency situation can travel seamlessly to identify, contain, and respond to an emergency in the
39

most efficient way possible. This is mandatory, not optional, and yet the reality is

that approximately ten percent of the health departments in the United States do

not even have e-mail.

We must remember, however, that merely providing funding to bolster technical

support is not enough. We also have to change the way we do business to meet the

level of the threats now facing us. If a bioterrorist attack occurred on a Friday afternoon, there would be no report of it until Monday morning under the current staffing profile of most health departments. The events of September 11th demand that

we now provide access to the public health network twenty-four hours a day.

Training and Expansion of the Public Health Workforce and Infrastructure

Members of the Committee, you have heard before about the gaps in our most

basic public health capacities. Indeed, this Committee, under the leadership of Senators Frist and Kennedy, led the charge last year with the Public Health Threats

and Emergencies Act, and the public health community is both grateful, and ready

to advance the objectives of that legislation. Recognizing that you are already familiar with gaps in staffing, training, laboratory and information capacity and coordination, I will focus on only a few specific points.

CDC must expand its capacity to respond to more than one event. As the world’s

premiere agency for public health response, CDC must re-consider its own surge capacity, when state and local health departments rely on the agency so heavily. As

such, CDC should integrate into the Health and Human Services regional system,

establishing a new layer of workforce and supporting capacity regionally. This will

allow continued federal technical support in all regions if the national transportation system is affected, while also recognizing that metropolitan areas and bioterrorist attack zones themselves may cut across state boundaries.

It is essential that every state have essential epidemiology personnel in place.

CDC’s Epidemic Intelligence Service Officers, the ‘‘Disease Detectives,’’ can provide

a set of very skilled hands to address a host of unanticipated events. Only 25 states

have EIS officers at this time. Also, only 32 states employ a designated public

health veterinarian. This is another lapse we can’t afford. Seventeen of the 20 designated bioterrorism agents are either zoonotic, meaning they are transmitted from

animals to man, such as plague; or they are fairly common diseases of animals, such

as anthrax; or, they are foodborne illnesses such as Salmonella, about which public

health veterinarians receive extensive training. These and other core communicable

disease experts must be based in every state.

Training of the Medical Workforce and Enhancing Institutional Capacity

Even if we succeed in enhancing our communication and intelligence capabilities,

this will not suffice unless the workforce of first-responders is adequately trained

to detect and respond to bioterrorist threats. Last week in Florida, the first reported

case of inhalational anthrax in the U.S. since 1976 was quickly identified, and appropriate therapy initiated. We are encouraged by this, but know that this might

not be the norm. We cannot underestimate the importance of our front line health

professionals; enhancing their technical expertise and knowledge of a broader array

of health threats is of paramount importance at this time.

The capacity of our hospitals to accommodate a large number of patients is also

under scrutiny. Emergency rooms can barely address current needs. In the event

of a terrorist attack, there would be a surge in need for trained personnel who can

diagnose and treat rare diseases, and also for isolation areas and rapid mobilization

of special drugs and vaccines. The economic efficiencies of the ‘‘just in time’’ drug

inventory system clearly operate to the disadvantage of a population confronted

with an epidemic. Despite the negative impact on the bottom line, we must maintain a sufficient inventory of essential vaccines and drugs, and develop more surge

capacities on a daily basis if we are to approach an adequate level of preparedness

for a bioterrorist event.

The Safety of our Food Supply

So far, our only known domestic bioterrorist event occurred in 1976, when members of a religious cult contaminated a salad bar with Salmonella, sickening more

than 700 people. Our food supply remains vulnerable. The number of inspectors employed to safeguard our food supply is vastly insufficient, especially the workforce

of the Food and Drug Administration. So much of our food is imported from countries that utilize few precautions in the production of their products, yet we lack

the authority and the personnel to scrutinize these products properly. Jurisdiction

over food safety is currently spread among a host of agencies. APHA has long advocated for a single agency to address food safety, and current events have validated

the wisdom of this position. We are grateful that many members of this Committee
40

have, over the years, engaged the problems of understaffing, imported food safety,

and the regulatory structure.

Conclusion

We have focused on recognition of unique illnesses that may signal an attack, and

were an attack to occur, we hope we will all be ready. But I must caution that the

agents themselves pose such a challenge; hardwired into them is their incubation

period, unique for each one but always too long for our liking; smallpox, 7 to 19

days; anthrax, up to 60 days; Ebola virus, 2 to 21 days. What does it mean, in a

mobile, global society, if we recognize the first case of smallpox 7 days after exposure? And, there is the matter that for most of these agents, the symptoms are innocent and nondescript. No amount of money or planning or good intention can lower

the hurdles the germs themselves impose. Our very best response can’t approximate

prevention.

I was born and raised on the Indian subcontinent. I have lived through the outbreaks of smallpox, malaria, typhoid, Hepatitis A, and many other diseases. When

the risk is high, we must re-evaluate our position about making vaccines available

to the public. Mr. Chairman, I suggest that a national committee of experts from

the medical, scientific and intelligence communities be formed to review the level

of threat, as well as the risks and benefits of making smallpox and anthrax vaccines

available to the population at large. Assessing the risk at this stage will help us

protect our people from the most common agents that could be used against us by

a terrorist.

On behalf of the members of the American Public Health Association, I thank you

for this opportunity to discuss this matter of critical national security, and I am

happy to answer any questions you may have.

The CHAIRMAN. Dr. Osterholm?

Mr. OSTERHOLM. Thank you, Mr. Chairman, members of the subcommittee, and thank you, Senator Wellstone, for your kind introduction.

I am Michael Osterholm, and I am director of the Center for Infectious Disease Research and Policy at the University of Minnesota where I am also a professor in the School of Public Health.

For 24 years, I served with the Minnesota Department of Health,

including 14 years as the State Epidemiologist. It was in that capacity that I testified before this committee in the past. I am here

today to address the critical need for our country to prepare its

homeland security against a potential bioterrorist attack. At the

same time we can and must capitalize on that preparation to respond to the everyday growing threat of emerging infections that

are not related to potential bioterrorism.

My comments will reflect my combined experience in the trenches as one of those infectious disease epidemiologists, as a leader in

several national infectious disease and microbiology professional organizations, my time as a personal advisor to His Majesty King

Hussein of Jordan on this topic, and as an author of the recently

published book, ‘‘Living Terrors: What America Needs to Know to

Survive the Coming Bioterrorist Catastrophe.’’

Today we are here because of the tragedy of September 11 and

the wake-up call to America that catastrophic terrorism is now a

reality within the borders of our own homeland. The consequences

of an infectious disease outbreak due to a bioterrorist attack dramatically illustrate the critical importance of shoring up our public

health system. Without a comprehensive and timely response, we

will realize both an increase in deaths and the potential for previously unseen panic and fear.

Preparing us for such an event will also prepare us for the daily

barrage of exotic agents from abroad, antibiotic-resistant microbes,
41

and the ever-growing problems of our food safety. This represents

the very essence of dual-purpose resources.

We have heard much over the past 3 weeks about the potential

risk of a bioterrorism event occurring in this country. I will not address the issues any further other than to say that as a Nation, we

cannot afford to be underprepared to respond to such an event as

we are today.

Recently, our center at the University of Minnesota convened a

working group on bioterrorism preparedness that reflects the expertise and experience of a number of important front-line organizations whose members will be responsible for responding to a bioterrorist attack. They include the American Society for Microbiology, the Alfred P. Sloan Foundation, the Association of Public

Health Laboratories, the Association of State and Territorial

Health Officials, the Council of State and Territorial Epidemiologists, Emory University School of Public Health, the Infectious Disease Society of America, the Johns Hopkins Center for Civilian Biodefense Studies, the National Association of County and City

Health Officials, the National Association of Public Health Veterinarians, and NTI.

This group has provided a framework for your use for the public

health action and bioterrorist preparedness we need. Out of this

meeting grew a set of recommendations for critical funding for our

public health activities. These members did not seek endorsement

from their respective organizations for the recommendations contained in our report, and therefore it may not reflect the exact position of these respective organizations. However, we believe that at

this time, this represents our best estimate of the necessary resources it will take to revitalize the public health system so it will

pass the test of a catastrophic bioterrorist attack. The committee

has a summary of that framework.

The designated amounts, as you will note, are needed for hospitals and Federal, State, and local public health agencies to effectively recognize and respond to bioterrorism. At the State and local

levels, it is essential for these activities to be housed within existing communicable disease programs—that is where the foundation

for controlling communicable diseases exists. By enhancing these

systems, we can maximize the efficiency of putting new resources

to their best use in the quickest amount of time.

I would also like to point out that the funds outlined are needed

as an initial investment in building the surveillance systems, training programs, communication systems, and laboratory networks

that are required to recognize a bioterrorist event.

I can promise you that these numbers are not some inflated,

‘‘come to the table, give us all the money’’ under an ideal time situation. We made an honest attempt to give you our best estimate

of what it will really take to honestly and effectively deal with this

system.

Ongoing funding is critical to keep these systems operational at

the level needed for effective homeland security over time. Let me

provide you with a quick overview of the funding requirements

with some discussion of what we are requesting. I would also note

that many of our comments here reflect quite closely what we

heard in the first panel this morning and some of the other ideas
42

that have been proposed in terms of funding for bioterrorism preparedness. First, we are requesting $35 million for State and local agencies

to develop and test bioterrorism response plans. This amounts to

about $500,000 per jurisdiction, assuming about 70 jurisdictions. A

wide-scale bioterrorism attack would create mass panic and overwhelm almost every State and local system within a matter of just

a few days. We know this from simulation exercises such as

TOPOFF and Dark Winter. Therefore, State and local plans for recognizing and responding to a bioterrorism attack are urgently

needed.

We believe that these plans should be completed in the next 90

to 120 days. In its last funding cycle, the Centers for Disease Control and Prevention funded 11 States to develop bioterrorism plans.

Other State applications for funding were approved through the

grant program but were not funded. Those applications should be

funded immediately so that planning, which we heard about this

morning and which we agree will be the critical step to any effective response, can be undertaken now.

We also emphasize that it is important to include cities and

counties in a meaningful way in any planning activity that takes

place.

Second, under the category of improving State and local preparedness, staffing, training, epidemiology and surveillance, we

have requested $400 million. These funds amount to about $1.3

million per million population, or basically $1.30 per head.

Activities under this category are broad and include the following. We have to develop the sensitive surveillance systems that can

rapidly detect illnesses caused by bioterrorism. Part of developing

these systems involves educating physicians and other health care

providers about illnesses that may be caused by bioterrorism.

Second, we must ensure that sufficient staff are available to collect epidemiologic data from suspected cases and to make the necessary connections as to the where, when, who, and why.

Third, we must ensure adequate statistical and epidemiologic

support is available to manage and analyze data from surveillance

systems and from suspect cases if bioterrorism events occur, particularly when they are over large regions of the country.

Fourth, we must ensure that adequate personnel are available to

direct public health aspects of response to a bioterrorism attack,

such as setting up triage systems and delivery systems for prophylactic medications and vaccine. Parenthetically, let me say that I

headed up one of the largest emergency vaccine response programs

in recent years in this country when we had to vaccinate 30,000

Minnesota residents in one community for a meningitis outbreak.

We did that in a period of 4 days with one of the very best State

health departments in the country, and it stretched us to the very

edge of our ability. If today someone told me that we had to vaccinate 2.5 million Twin Cities residents, I would look at you and

throw up my hands and ask ‘‘How?’’

Fifth, we must assure that adequate personnel are available for

containment and addressing issues of infection control in our hospitals, where secondary spread of agents like smallpox will cause

additional panic and fear.
43

And sixth, we must provide rapid and updated information to

other public health officials, the medical community, and the public

itself as the situation unfolds.

Third, we are requesting $200 million to upgrade the rapid

health alert networks and national communication systems. We

heard about that earlier this morning. Sharing accurate information with those who need to know is essential during a time of crisis.

We also believe that it is essential to have a national electronic

reporting system so that data can be collected efficiently and rapidly analyzed—not on the back of an envelope. This kind of system

is needed to monitor a national epidemic that could follow the release of a bioterrorism agent even in only one location.

Agents such as smallpox or plague could set off widespread

chains of illness that would require effective, accurate, and rapid

communication about patterns of spread and needed control measures.

Fourth, we are asking for $200 million to upgrade our laboratory

capacity. Two systems need to be enhanced and broadly implemented. One is the Laboratory Response Network. This system

puts into place a multilevel network that can receive and analyze

laboratory specimens from a range of sources. The system is designed to ensure definitive identification of suspected bioterrorism

agents as quickly as possible.

The second system is the National Laboratory System. This is a

communication system designed to rapidly share information between public health, hospital, and commercial laboratories. Such

communication will be critical if we are to contribute to the early

detection and effective monitoring of bioterrorist events.

Additional laboratory resources for chemical terrorism preparedness are also needed and should be integrated into the laboratory

improvements.

Finally, resources for improved diagnostic testing and identification of potential bioterrorism agents by animal and wildlife laboratories are also needed, as is improved communication between

human, animal, and wildlife laboratories.

All of us in this room are very aware of the issue of West Nile

virus and the relationship to the wildlife populations. That was

clearly not a bioterrorist event, but should it be anthrax, should it

be plague, any number of infectious agents associated with bioterrorism may very well show up in the animal population as the

first sentinel of what is going on.

Foodborne agents could be involved in a bioterrorist attack.

Therefore, we are requesting $100 million be allocated to improve

food safety in this country. Funds are needed to improve surveillance for foodborne disease at the State and local level, to improve

outbreak response capabilities, to enhance rapid communication of

information about foodborne disease outbreaks, and to provide Federal oversight for food safety activities.

Additional funds are needed to upgrade other Federal programs

for bioterrorism. These include enhancements at the CDC to conduct deterrence, preparedness, detection, confirmation, response,

and mitigation activities; development of Federal expert response

team—individuals such as Dr. Henderson and others who may not
44

currently be part of the established Government structure. These

teams would include experts who have extensive experience in

management of outbreaks or have clinical experience with diseases

caused by potential bioterrorism agents. The teams would be maintained on alert status and federalized as needed for deployment.

Third is improvements in the national pharmaceutical stockpile.

Ideally, we should have at least enough medication stockpiled to

provide treatment or prophylaxis to up to 40 million persons. Imagine the stockpile running out, the panic and fear that will ensue

in this country if we have to tell people, ‘‘I am sorry, you were not

in line soon enough.’’ Therefore, we should continue to build the

stockpile and rotate medications as needed.

Fourth, as heard earlier, we have to accelerate development of

smallpox vaccines and research and development and production of

other vaccines for civilian populations.

Finally, we have to improve our international surveillance by the

CDC and the Department of Defense, as we may actually have our

first early warning occur across the shore when, even by accident,

an agent intended for bioterrorist use gets out of somebody’s laboratory. That will be a very important step.

Finally, we need to assess what works and what does not work

through implementation of applied research initiatives. We do not

want to spend money just to spend money. We should conduct research studies predominantly at the State and local level which tell

us what is really effectively making a difference. We are requesting

$50 million to fund several research initiatives in this manner.

In conclusion, we as a nation must depend on our Government

to provide us with the necessary resources to effectively and convincingly respond to a bioterrorist attack. Front and center to that

response will be an effective and comprehensive public health, clinical laboratory and medical services system.

Today we are here to address in part those systems. If we fail,

I fear history will judge all of us in this room as well as other leaders negligent for having wasted the opportunity to prepare ourselves for the new world. We must never allow ourselves the possibility of experiencing a bioterrorist event which makes the pain

and suffering of September 11 less significant.

Thank you.

[The prepared statement of Mr. Osterholm follows:]

PREPARED STATEMENT OF MICHAEL T. OSTERHOLM, PHD, MPH, DIRECTOR, CENTER

FOR INFECTIOUS DISEASE RESEARCH AND POLICY, PROFESSOR, SCHOOL OF PUBLIC

HEALTH

Mr. Chairman and members of the subcommittee, my name is Michael T.

Osterholm, PhD, MPH. I am the Director for the Center for Infectious Disease Research and Policy at the University of Minnesota. I am also a Professor, School of

Public Health at the University.

For 24 years, I served at the Minnesota Department of Health, including 14 years

as the State Epidemiologist. It was in that capacity that I testified before this Committee in the past. I am here today to address the critical need for our country to

prepare its homeland security against a potential bioterrorist attack. At the same

time we can and must capitalize on that preparation to respond to the everyday

growing threat of emerging infections that are not related to potential bioterrorism.

My comments will reflect my combined experience in the trenches as an infectious

disease epidemiologist in one of the premier outbreak investigation groups in the

country, as a leader in several national infectious disease and microbiology professional organizations, my time as a personal advisor to His Majesty King Hussein
45

of Jordan on bioterrorism and as an author of the recently published book, ‘‘Living

Terrors: What American Needs to Know to Survive the Coming Bioterrorist Catastrophe.

First, let me remind all of us here that the substance of what we are talking

about today, the need to adequately fund the ‘‘Public Health Improvement Act’’ au- thored by you, Mr. Chairman and Senator Frist, is no different now than it was last

year. The importance of this issue was compelling before the passage of that important legislation; as microbial threats to our public health have continued to increase

for the past decade. Last year I urged the Congress to pass and fund this legislation

in an invited editorial in the New England Journal of Medicine.

Today, we are here because of the tragedy of September 11th and the wake-up

call to America that catastrophic terrorism is now a reality within the borders of

our own homeland. The consequences of an infectious disease outbreak due to a bioterrorist attack dramatically illustrate the critical importance of shoring up our public health system; without a comprehensive and timely response we will realize both

an increase in deaths and the potential for previously unseen panic and fear. Preparing us for such an event, will also prepare us for the daily barrage of exotic

agents from abroad, antibiotic resistant microbes and the ever-growing problem

with food safety. This represents the very essence of dual purpose resources.

We have heard much over the past three weeks about the potential risk of a bioterrorism event occurring in this country. I will not address that issue any further

other than to say that as a nation we cannot afford to be under-prepared to respond

to such an event as we are today.

Recently, our Center at the University of Minnesota convened a Workgroup on

Bioterrorism Preparedness that reflects the expertise and experience of a number

of important front line organizations whose members will be responsible for responding to a bioterrorist attack. They include the American Society for Microbiology, the Alfred P. Sloan Foundation, the Association of Public Health Laboratories,

The Association of State and Territorial Health Officials, the Council of State and

Territorial Epidemiologists, Emory University School of Public Health, the Infectious Disease Society of America, the Johns Hopkins Center for Civilian Biodefense

Studies, the National Association of County and City Health Officials, the National

Association of Public Health Veterinarians and NTI. This group has provided a

framework for public health action and bioterrorist preparedness. Out of this meeting grew a set of recommendations for critical funding for these public health activities. The members did not seek endorsement from their respective organizations for

the recommendations contained in our report and therefore it may not reflect the

position of the respective organizations. However, we believe at this time that it represents our best estimate of the necessary resources it will take to revitalize the

public health system so it will pass the test of a catastrophic bioterrorist attack. Enclosed is a summary of that framework.

The designated amounts, as you will see noted, are needed for hospitals and federal, state, and local public health agencies to effectively recognize and respond to

bioterrorism. At the state and local levels it is essential for these activities to be

housed within existing communicable disease programs—that is where the foundations for controlling communicable diseases exist. By enhancing existing systems, we

can maximize the efficiency of putting new resources to their best use. I would also

like to point out that the funds outlined are needed as an initial investment in

building the surveillance systems, training programs, communication systems, and

laboratory networks that are required for recognizing a bioterrorism event. Ongoing

funding is critical to keep these systems operational at the level needed for effective

homeland security over time. Let me provide you with a quick overview of the funding requirements with some discussion of what we are requesting.

First, we are requesting $35 million for state and local agencies to develop and

test bioterrorism response plans. This amounts to about $500,000 per jurisdiction,

assuming about 70 jurisdictions. A wide scale bioterrorism attack would create mass

panic and overwhelm most existing state and local systems within a few days. We

know this from simulation exercises such as TOPOFF and Dark Winter. Therefore,

state and local plans for recognizing and responding to a bioterrorism attack are urgently needed. We believe that these plans should be completed in the next 90 to

120 days. In its last funding cycle, the Centers for Disease Control and Prevention

(CDC) funded 11 states to develop bioterrorism plans. Other state applications for

funding were approved through this grant program, but were not funded. Those applications should be funded immediately so that planning, which will be critical to

any effective response, can be undertaken.

Second, under the category of Improving State and Local Preparedness: Staffing,

Training, Epidemiology and Surveillance, we have requested $400 million. These

funds amount to about $1.33 million per million population. Activities under this
46

category are broad and include the following. 1) Develop sensitive surveillance systems that can rapidly detect illnesses caused by bioterrorism. Part of developing

these systems involves educating the physicians and other healthcare providers

about illnesses that may be caused by bioterrorism. 2) Assure that sufficient staff

are available to collect epidemiologic data from suspected cases and to make the

necessary connections as to ‘‘where, when, who and how.’’ 3) Assure that adequate

statistical and epidemiologic support is available to manage and analyze data from

surveillance systems and from suspect cases if a bioterrorism event occurs. 4) Assure that adequate personnel are available to direct the public health aspects of a

response to a bioterrorism attack (such as setting up triage systems and delivery

systems for prophylactic medications and vaccines). 5) Assure that adequate personnel are available for containment and addressing issues of infection control. 6) Provide rapid and updated information to other public health officials, the medical community, and the public as the situation unfolds.

Third, we are requesting $200 million to upgrade rapid health alert networks and

national communication systems. Sharing accurate information with those that need

to know is essential during times of crisis. We also believe that it is essential to

have a national electronic reporting system so that data can be collected efficiently

and rapidly analyzed. This kind of system will be needed to monitor a national epidemic that could occur following release of a bioterorrism agent even in only one

location. Agents such as smallpox or plague could set off widespread chains of illness that would require effective, accurate, and rapid communication about patterns

of spread and needed control measures.

Fourth, we are asking for $200 million to upgrade laboratory capacity. Two systems need to be enhanced and broadly implemented. One is the Laboratory Response Network. This system puts into place a multi-level network that can receive

and analyze laboratory specimens from a range of sources. The system is designed

to assure definitive identification of suspected bioterrorism agents as quickly as possible. The second system is the National Laboratory System. This is a communication system designed to rapidly share laboratory information between public health,

hospital, and commercial laboratories. Such communication will contribute to early

detection and effective monitoring of bioterrorism events. Additional laboratory resources for chemical terrorism preparedness also are needed and should be integrated into the laboratory improvements. Finally, resources for improved diagnostic

testing and identification of potential bioterrorism agents by animal and wildlife

laboratories also are needed, as is improved communication between human, animal, and wildlife laboratories.

Foodborne agents could be involved in a bioterrorism attack; therefore, we are requesting that $100 million be allocated to improve food safety in this country. Funds

are needed to improve surveillance for foodborne diseases at the state and local

level, to improve outbreak response capabilities, to enhance rapid communication of

information about foodborne disease outbreaks, and to provide federal oversight for

food safety activities.

Additional funds also are needed to upgrade other federal programs for

bioterorrism. These include the following. 1) Enhancements at the CDC to conduct

deterrence, preparedness, detection, confirmation, response, and mitigation activities ($153 million). 2) Development of federal expert response teams ($45 million).

These teams would include experts who have extensive experience in management

of outbreaks or have clinical experience with diseases caused by potential bioterrorism agents. The teams should be maintained on alert status and federalized as

needed for deployment. 3) Improvements in the national pharmaceutical stockpile

($250 million). Ideally, we should have enough medication stockpiled to provide

treatment or prophylaxis to up to 40 million persons. Therefore, we should continue

to build the stockpile and to rotate medications as needed. 4) Accelerated development of smallpox vaccine ($60 million) and research on the development and production of other vaccines for the civilian population ($100 million). 5) Improvements in

international surveillance by the CDC or the Department of Defense ($20 million).

Finally, we need to assess what works and what doesn’t work through implementation of applied research initiatives. These should be conducted predominantly at

the state or local level. We are requesting $50 million to fund several research initiatives throughout the country.

In conclusion, we as a nation, must depend on our government to provide us with

the necessary resources to effectively and convincingly respond to a bioterrorist attack. Front and center to that response will be an effective and comprehensive public health, clinical laboratory and medical services systems. Today we are here to

address, in part those systems. If we fail, I fear history will judge us negligent for

having wasted the opportunity to prepare ourselves for the new world. We must
47

never allow ourselves the possibility of experiencing a bioterrorist event which

makes the pain and suffering of September 11th less significant.

The CHAIRMAN. Thank you very much.

This is an excellent panel, and I regret we do not have a great

deal of time. We have nine members and 3 or 4 minutes per member to inquire, and obviously, the panel can take some time to answer the questions. I would ask staff to keep track of the time.

Senator Clinton has requested that she be able to inquire first

since she has another engagement, so we will recognize her for that

purpose.

Senator CLINTON. Mr. Chairman, I have to preside at noon, so

I very much appreciate your kindness in letting me first of all

thank the panel for this extraordinary testimony and the work and

experience that brings each of you here. We look forward to working with you.

I want to address very briefly just two issues—one that has been

alluded to in several of the presentations, including by our colleagues, namely, food safety and security, which I think has to

have a higher priority. I believe we have to increase the number

of FDA inspectors as well as assure that the USDA has what it requires in order to cover the needs that we have to protect our food

supply.

But I also have a second issue that we have not addressed yet.

I have grave concerns about our ability to protect and treat our

most vulnerable citizens, namely, our children. I am very concerned

that we are not paying adequate attention to the unique needs of

children in our efforts to plan and prepare for any of these future

possibilities.

We know that children have special vulnerabilities related to bioterrorism. First, they are particularly susceptible to biological and

chemical attacks. Some dense nerve gas agents like sarin concentrate lower to the ground, closer to the breathing zone of children. Also, because children have more rapid respiratory rates and

larger surface-to-mass ratios, they are anatomically more vulnerable to exposures that might not be quite so serious with adults.

Yet the tools for our response to bioterrorism are even less effective for children than they are for adults. As many of us know, particularly Senators Kennedy, Dodd, DeWine, and others who have

worked on the pediatric testing issue, many pharmaceutical manufacturers have not tested or properly dosed antidotes, antibiotics,

or other agents for use in children. And the CDC push-packs and

other emergency response supply systems do not take into account

the special needs of children. For example, adult-size gas masks

can potentially suffocate children. A lot of people I know are rushing out to buy gas masks without any real understanding of how

to use them for themselves, and especially without understanding

of their potential dangers to children.

So we have to add another item to this rather daunting agenda

we face, and that is a particular emphasis on the needs of our children. I would hope to get the support of my colleagues on a bill

that I plan to introduce in the next day or two to establish a national task force on children and terrorism to bring attention specifically to children’s needs. In all the literature I have read as I

have tried to educate myself, I rarely see any mention of children.
48

Yet most mothers I speak to and fathers as well—but it is mostly

mothers who have been coming to me in New York—their principal

concern is their children. That is what they ask me to give them

some reassurance on—how will we protect our children. And there

is a whole agenda of protecting our children that I think we have

to pay particular and special attention to.

This task force would make very prompt recommendations, I

would hope within the time that Dr. Henderson and others have

suggested we need to have such recommendations from those who

would be studying it, and perhaps it could even be a part of the

ongoing work that is already undertaken, so that we could have

specific protocols. If there are amendments to legislation that are

needed to expedite treatments for children and preventive steps for

children, we could begin the necessary research, training, and dissemination of information.

We have got to begin testing for the proper treatment and doses

of vaccines and antidotes. We have to ensure that we support

model programs to train physicians and health care personnel in

what we know about pediatric consequences, symptoms, and treatments of care. And I believe—and this will be part of the bill that

I introduce—that we should set up a national clearinghouse to

begin disseminating information to communities, health care providers, and schools on how best to prepare for a biological or chemical attack and to take whatever steps are necessary to ensure that

children get the care they need.

This is an area that I hope we can address specifically and very

quickly, because most of the people with whom I come into contact,

particularly in New York, are increasingly worried and have very

specific questions about children that all of us need to answer.

So I would appreciate getting just a very brief response from

whichever panelists would like to respond.

The CHAIRMAN. Dr. Henderson, do you want to start?

Dr. HENDERSON. I think the Senator has a very good point, and

it is particularly true with the antidote for chemical agents and

certainly some antibiotics.

I think this should be looked at—whether we need a special task

force, I do not know—but we have had recently a number of discussions about this, and I think the point is well-taken.

Senator CLINTON. Thank you.

The CHAIRMAN. Thank you very much.

If I could, Dr. Henderson, many experts are concerned that potential biological weapons in the former Soviet Union are poorly secured. Do you share that concern, and if so, what is the best way

to make sure that dangerous biological agents are accounted for

and secured?

Dr. HENDERSON. I do share that concern very much, Senator. The

bioweapons research and development program of the former Soviet Union is very extensive, and many of the laboratories which

were very active in this field are now at least partially open, doing

other things—we are not quite sure whether they are all doing the

right things. There are four laboratories which are under the ministry of defense which are completely closed even today.

I think the problem is that there are many scientists who have

left the laboratories where they were making biological weapons
49

and are no longer there. Some of them are in this country, but

some of them we are quite sure are other places.

In the light of a new president in Russia, with different relationships—and most of these places are in Russia, not in the other

states of the Commonwealth—I think a new approach to President

Putin and perhaps opening up this subject—it may be an appropriate time to do this and to see what could be done in terms of

providing—again, as has been done but on a very limited scale— alternative support for these people who do other types of research

and perhaps actually persuade them to open up at least these four

laboratories which are closed.

The CHAIRMAN. I could not agree with you more.

A final question for the panel, and I hope you can be brief. Based

on your knowledge of the event, do you think the Florida anthrax

incident resulted from an act of terrorism? We have seen reports

that individuals have bought gas masks and large doses of antibiotics. Do you think there is any value to this?

Dr. Osterholm, would you start?

Mr. OSTERHOLM. First, I think most of us would agree that the

circumstances in Florida are beyond that of circumstantial, that

there in fact is something that happened there. I think we all have

to be very careful in making conclusions in the public about this,

as these are obviously very fragile times.

Whether this has anything to do with the events of September

11 or whether it is a totally separate event, I do not know, and I

do not know if anyone knows right now. I think the important message from that, Senator, is that someone had anthrax out there;

someone was able to put it into a situation where it did what it

did. I think there has been much skepticism over the past several

weeks, and I have heard it voiced by any number of individuals,

and Dr. Henderson referred to it, that this is too technologically

difficult.

I think the point of the Florida experience is that somebody out

there did grow anthrax; they put it into a form which could in fact

potentially be used, and whether that was a very limited hit or a

potentially large hit, it is another wake-up call to us that something is out there that we have to be prepared for, and we can no

longer hide behind the explanation that it is just too tough.

The CHAIRMAN. I will turn to the rest of the panel, and you

might comment about how you would characterize our reaction.

Dr. AKHTER. I think the incident in Florida truly is not an isolated event. Somebody did something that was criminal, and until

we have the complete FBI investigation, we just do not know the

extent of it.

If you find anthrax spores among two people, it does not really

build my confidence to say there may not be a third person, a

fourth person, or some other spot. So I will wait until I get the full

investigation before I can say for sure.

The CHAIRMAN. Dr. Heinrich?

Ms. HEINRICH. My initial reaction was amazement at how well

the Federal organizations, CDC especially, and the State and local

official actually worked together. I think it is quite remarkable. I

also think it is quite remarkable that the State lab was able to so

quickly identify the agent.
50

The CHAIRMAN. That is an important point.

Dr. Henderson, the final word.

Dr. HENDERSON. I think the system worked in this case, and I

was very impressed with the speed with which the diagnosis was

made and the response initiated. But this is not a typical area, and

I think there are a lot of places in this country where we would

not distinguish ourselves at all, and I think there is a lot of work

needed to strengthen the State and local health systems.

I am a little reluctant at this time to say that I am persuaded

that this is a release by a terrorist. I used to be in charge of dispatching teams on epidemics from CDC and then in WHO, and we

would get all sorts of strange reports, and the preliminary reports

would come in, and you would be inclined to draw conclusions only

to find that there were strange things that happened. And there

are some strange things here that do not quite make sense to me.

We isolated anthrax from the man’s nose, but he does not seem

to have an anthrax illness. This is very strange. The organism that

is involved is really a common, garden-variety anthrax that has

been isolated, something like this, from animal outbreaks in different parts of the country. It is fully susceptible to antibiotics; it

is not an engineered organism as far as can be told.

I think we will get a lot more information when some of the surface samples come in and the further studies are done on that. So

I think I would be inclined at this point not to draw the solid conclusion that this is a terrorist event until we have a little more information.

The CHAIRMAN. A very solid recommendation.

Senator Frist?

Senator FRIST. Thank you, Mr. Chairman.

I will be brief. With regard to the last discussion, I think it is

important that we address what is going on in Florida today because in many ways, it gives us a microcosm of how the system

should work. And just looking at the last several days, the system

is working well. We have the very best labs, the very best epidemiologists, the very best public and private sector people responding. So I am confident that we will get to the root of this.

We do have to be careful in terms of speculation, yet in light of

September 11, in light of what we have heard from both the first

and second panels, that the threat is real, number one, and number two, it is increasing, in part because of technology so that we

can aerosolize much better today than we could 5 years ago or 10

years ago, in part because, as I mentioned in my opening comments, Osama bin Laden, who has very much become the focus of

what we in the United States are trying to address today, has specifically said that it is a goal of his to develop and to acquire biological weapons. When you put all of that together, I think it is

worth us addressing in a very careful way as we go forward.

We know that anthrax is deadly. We saw that this weekend—a

death. There is 80 to 100 mortality from inhalational anthrax.

There are three different kinds; that is one kind. And that is important for us to know.

No. 2, we know and the American people should know that in

terms of treatment, we have very good treatment for it. It has to

be given in the asymptomatic stage, the very early stage.
51

On vaccines, I will add, because everybody is calling, asking if

they should get vaccinated, that that is an 18-month process, so it

is an adjunct to treatment, not the treatment itself.

So we know it is deadly, number one. No. 2—and we need to recognize this up front without being alarmist too much—anthrax has

been weaponized in the past. We have heard references to Russia.

We all know that in Russia in 1979, one ounce of weaponized anthrax leaked from a manufacturing plant; there were 79 cases

downwind and 68 deaths even when treated at that point in time.

So number one, it is deadly. Yes, it is rare—there have been only

18 cases—but it has been weaponized in the past.

The third thing I have to comment on because it has been mentioned—with one case, you think it could be happenstance, circumstance, spontaneous; with two cases, from a medical and epidemiologic standpoint, it does lower the threshold, and that is why

you heard the comments over the weekend; and obviously, three

cases lower it much more.

So I guess my question—and Dr. Henderson, you are the best,

because you have talked about what has happened in India with

similar kinds of outbreaks—right now, the system is working very,

very well. Careful investigation will get to the root of it, I am absolutely convinced. So whether it is a terrorist or somebody who just

had bad intention, we will know the end of that, I believe. But

what if it had been 100 cases, and we know that the incubation period is from several days, but because of spores, it could be several

months, where people could travel around the country. Would we

be as proud of our system as I think we should be in Florida if

there were 100 cases? How quickly could that potentially overwhelm our system?

Dr. HENDERSON. I think we would find with 100 cases, Senator,

that it would be another order of magnitude difficulty, because one

of the things that we would want to do with people who might have

been exposed to a plume or an aerosol of that anthrax would be to

provide them antibiotics for 60 days. Providing antibiotic for 60

days to any large population is a huge effort.

Anthrax is not spread from person to person, so that is not so

much a concern, but we would then also be concerned that there

would be other rumors, rumors of other cases, and there would be

need to do laboratory studies in a number of different parts of the

country just because of rumors and concerns.

With the system we have, we do have a framework, but it certainly needs a lot of strengthening to really respond as well as we

would like, and I think that is a point to be made.

Senator FRIST. Thank you.

Dr. Osterholm, we have had a chance to talk, and in terms of the

numbers you presented, we will take them and study them once

again. But again, just so my colleagues will know, your numbers

are very much in line with the numbers that Senator Kennedy and

I have put together in terms of State and local preparedness, hospital preparedness, improving disaster response, improved research

and development, international surveillance, the FDA, which we

have talked about and the first panel mentioned, and smallpox vaccine. All of our numbers are very much the same. Areas the where

you add—upgrading CDC further than we recommend; improving
52

the national pharmaceutical stockpile beyond what we have proposed—we will be looking at very carefully. So I appreciate in fact

the entire panel and the information that you have given us today.

Thank you, Mr. Chairman.

The CHAIRMAN. Senator Mikulski?

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

First of all, to the panelists and those of you who represent the

field of public health, I think you should know that we are really

proud of you. You are really the germ warriors, and you have been

at this for a long time—and germs are germs, whether they are

these deadly diseases that could affect large populations or whether

it is issues around the day-to-day things that our public health system deals with—so we are really very proud of you. We also know

that public health personnel, the training available for them, and

the infrastructure have been long neglected.

So I think this is an opportunity while we are dealing with this

crisis. But while we are talking about managing the sick and our

response—and I will come back to that—I would like to talk about

the issue of panic, which is equally insidious and I believe equally

dangerous. When rumors occur, when there is an isolated incident,

when people could confuse flu symptoms with anthrax symptoms,

I am concerned that panic will ensue.

What we are hearing is that America is already scared. America

is really scared. I have a gas mask manufacturing facility in my

home State, and requests are up 3,000 percent. People are driving

in from all parts of the country wanting to buy gas masks and willing to pay any price.

We also hear about this underground effort where people are

going to their doctors and their pharmacists to stock up on antibiotics and the hoarding of antibiotics.

The panic is already here—it is not visible. Then, we have these

really unusual circumstances in Florida, and congratulations to all

who have properly responded, but now we are into rumor. The

press comes up with all kinds of questions, certainly to us but to

others, pouncing on every rumor like they are looking for something, exacerbating the tensions. At the same time, we hear on the

24-hour cable stations people who are so-called experts, which I am

sure causes you to blanch, listening to the most ghoulish of predictions, sounding like they write more for the ‘‘X-Files’’ than carefully written plans for disaster management.

So my question to the panel is how can we now get a grip on the

fear that America is facing without placating; and number two,

what practical advice can we give parents in particular who, as

Senator Clinton has said and I know all of us are hearing from constituents, what can moms and dads do, even within our own families.

I know this is a big question. I grew up during World War II.

My father helped out as an air raid warden, and he was also a grocer. We had a little space downstairs. I always felt that the war

was someplace ‘‘over there,’’ but that if something happened in our

community, my father could protect me. I do not know if fathers

feel they can protect their children now. So I think this is a big

issue that needs to be addressed. I do not know if you would even

recommend that experts go on television, organized by Secretary
53

Thompson and President Bush, to talk about this and get everybody where they need to be.

Do you have any thoughts on this, Dr. Osterholm?

Mr. OSTERHOLM. Yes, Mr. Chairman, Senator Mikulski. First of

all, obviously, this is not a new topic to you. You have covered this

in the past. But part of the issue that we have today, frankly—and

I am one of those who abide by the fact that being scared is not

a bad thing if it is scared for the right reasons and the right reflexes and the right responses occur because of it. Physiologically,

when you are scared, adrenaline flows, and a lot of good things

happen. The issue is when inappropriate things happen or nothing

productive.

Frankly, I will be real honest with you in this committee—you

are part of the problem. Part of the problem that we have is that

we have been coming to you for the last 5 years, telling you about

this issue, and other than Senator Kennedy and Senator Frist and

some of the efforts which were passed but not appropriated, we

have had to continue to build out there a kind of groundswell to

come to you to say we need help.

Well, that does require citizens to get more interested and more

involved in this issue. So what we are really trying to do today is

come to you and say the best thing we can do for panic and fear

is to provide the resources so that we can honestly and certainly

assure the population a) that we will detect it, b) we will respond

effectively, and c) we will make sure that you are told honestly that

this is what we have available, and this is what you will have access to.

I think that that is going to be a very important piece of

downplaying or minimizing that. None of us wants to be on the air

informing citizens of this issue when the only thing they can do is

write their Congressmen. We can take that off the agenda—— Senator MIKULSKI. Well, I do not think so, Dr. Osterholm. One,

I take the criticism; I think it is an accurate one. But number two,

I am telling you that with all that is going on the air right this

minute, writing your Congressman is not what they want to hear.

But your point is well-taken, and I am not minimizing it. I think

we have to have a sense of urgency about how to address this

issue, really within the next 72 hours.

Yes, Dr. Akhter?

Dr. AKHTER. Senator, I think there needs to be a very quick dissemination of information among the health officials throughout

the country. In 1994, there was a water crisis in Washington, DC.,

and I happened to be the health commissioner. Each jurisdiction

has its own view, and there is always disagreement about how to

deal with something. Somebody wanted water to be boiled for 1

minute; others want it boiled for 10 minutes.

Once we started to share information quickly, each health officer

had the same information, and they got on the television in their

own jurisdictions and said, ‘‘This is what we need to do. You are

safe. We are taking action.’’ That is what needs to happen now.

Somebody from the CDC needs to have the central information that

should be available to all health professionals in a timely manner.

The media goes to other people when we are unable to provide

them the information when we do not have it.
54

Senator MIKULSKI. Dr. Henderson, did you want to comment?

Dr. HENDERSON. Yes. I think there is really a concern out there,

as you point out. What is very difficult is to try to convey to a

broad public that we have a risk here, we think it is a small risk—

that is, that in any given area, there is going to be a release—that

it is a small risk, but if it happened, it would be catastrophic, and

we need to be prepared for it, and not to feel that there is going

to be anthrax in your back yard tomorrow.

So it is trying to hit some sort of balance, and this does not come

across very well.

It seems to me that what we need more than anything else is to

explain to the public by, say, the CDC or what-have-you, in an authoritative way where are we really. I think we need to be honest.

I think we need to keep it in perspective. I think we need to work

to convey that message.

I was pleased, actually, on a number of the reports with regard

to anthrax in Florida how the first case came up on page 5 or 6.

I think a lot of media covered this with some balance. But there

are people calling us asking what can parents do, and the last

thing you would recommend is that they get a gas mask, which is

really useless and in fact can be dangerous. There were a number

of Israeli adults and children who actually suffocated with gas

masks. So this is certainly not going to help in the biologic event,

and you are not going to be carrying it around with you all the

time for a gas event.

As far as stocking up on antibiotics, we recommend that they not

do so, because there is a shelf life, will you have the right antibiotic, this is costly, etc.

People ask, ‘‘Well, what do we do?’’ and we ask them, ‘‘Well, what

are you doing to protect your family against an airplane coming out

of the sky?’’ You really cannot do anything. You are depending on

your Government to be ready to respond and take precautionary

measures.

I think this is the best thing we can do is to convey that your

Government is actively involved in a number of activities all the

way from the intelligence side to stockpiling to responding quickly

to providing you protections should an outbreak occur. And I think

the fact that the Congress is acting as they are acting this time to

identify those initiatives and that we can then go to the public and

say we are doing these things, and we are prepared to respond, and

this is the danger that we have—I think this is the only way that

I can see that we can really act on this.

Senator MIKULSKI. I really appreciate everyone’s testimony. I

have just one follow-up question.

Dr. Heinrich, as you have looked at all these responses in an excellent report—and many thanks—is public information, an organized effort for public information, included in the plan either for

Federal or State in a way that there would be a mandate to have

a one-stop shop for appropriate information to the public? Did you

note that in your report?

Ms. HEINRICH. No, there was no such one-stop shop focus on public information, although we certainly found when we did the investigation of the West Nile outbreak that the need for public informa-
55

tion is tremendous and in fact in that instance really overwhelmed

the local and State authorities.

Senator MIKULSKI. Thank you.

My time has expired, but to you, Mr. Chairman and colleagues,

I would say that I think this is something we need to incorporate

very quickly into whatever is going to be our plan, picking up on

the excellent recommendations.

And Dr. Henderson, in your role with Secretary Thompson, I

think we have got to get that pretty quickly included, because I

think it could be one of our most important tools. I would much

rather hear from germ warriors like you than from those who have

come out of the X-Files.

Thank you, Mr. Chairman.

The CHAIRMAN. Senator Hutchinson?

Senator HUTCHINSON. Thank you, Mr. Chairman. Thanks for

holding the hearing today, and I want to thank our panel.

I would like to touch on something that we really have not

dwelled on much today, and that is the issue of vaccine production.

Dr. Heinrich, I thank you also for the GAO report. In your conclusions, you mention that ‘‘there are too many Federal agencies responsible for various bioterrorism coordination functions, with limited accountability and hindered unity of effort.’’ I think that that

is so true, and I hope the appointment of Governor Ridge is going

to help alleviate that problem.

Dr. Osterholm, you said that September 11 was a wake-up call,

and it was. But the first wake-up call occurred back in the early

1990’s when we went into the Gulf War and sent our troops over

there—and I serve on the Armed Services as well as the HELP

Committees, and I am on the Emerging Threats Subcommittee,

and we have become keenly aware of what is a tragic saga over the

last decade, one that we must not allow to be repeated.

At that time, there was a DOD report that said that we needed

to establish a Government-owned, contractor-operated facility to

produce vaccine to protect our forces when we sent them into dangerous areas. The Department of Defense for whatever reason rejected that recommendation and instead went to the commercial

sector and contracted with a commercial firm, Bioport, up in Michigan to produce that vaccine. We know that over the last decade,

they have failed to receive FDA approval. So that while we went

through this entire PR campaign where the Secretary of Defense

received an anthrax vaccination and various other public officials

did, DOD officials, to show that it was safe, and we convinced our

troops that it is safe for the most part, and then did not have the

vaccine to give them. So that today we are sending thousands of

our troops into harm’s way unprotected.

So Dr. Akhter, when you said that they are protected, that we

vaccinate our troops, we really do not today, because we do not

have a facility that is producing that vaccine.

So I think there are a lot of lessons that we need to learn.

I authorized another report last year in DOD authorization. We

got another report, and DOD has once again recommended that we

have a Government-owned facility producing this vaccine. And Dr.

Satcher, our Surgeon General, wrote a letter to Secretary of De-
56

fense Donald Rumsfeld saying in effect—and I will summarize it,

and I would like it to be included in the record, Mr. Chairman—— The CHAIRMAN. It will be so included.

Senator HUTCHINSON [continuing]. Essentially, the Surgeon said

that if we do it—and we should—we ought to do it not just for our

troops, but we should make it available for our civilian population

for domestic preparedness. I think that that is so essential.

Now, a decade later, here we are. Our troops are unprotected and

our civilian population is unprotected from a vaccine standpoint. I

think there are some conclusions here. We cannot have a sole

source for vaccine, so the idea of saying let us contract with the private firm and let them do it is misguided. A sole source is an easy

target for terrorists; we are too reliant upon a single producer. If

they fail, we are in the situation that we are in today.

We cannot rely on the commercial sector alone. They do many

things in a great way, but these are not necessarily financially feasible vaccines—and I am not talking just about anthrax but other

deadly pathogens. We have to have the Government involved in

this.

Senator WELLSTONE. Excuse me. Could I hear that again? I did

not hear what you just said.

Senator HUTCHINSON. I am for the Government doing this, Paul.

Senator WELLSTONE. I got it.

Senator HUTCHINSON. There are certain things only Government

can do, and in this case, the private sector has failed us terribly.

And I am glad to repeat that, and I am glad you caught that.

We cannot limit it to just one pathogen like anthrax, because

there are others that we are going to be threatened with. That is

why I think this facility, this production capability, is so critical.

So with that background and with all of my biases now laid out,

let me just ask the panel how important is such a production capability, production facility; should the Government own it, at least

have the guarantee of the Government’s backing; and if we made

a national commitment—because I have heard 5, 6 years for such

a production facility to be up and running—but if we made a national commitment to it, and we coordinated with FDA, the Department of Defense, the CDC, and these various agencies, how quickly

could we get this kind of protection available?

Let us begin with Dr. Osterholm and then anybody else who

would like to comment.

Mr. OSTERHOLM. First of all, thank you very much for those comments. I think there are many people who are in complete agreement with you on the public health side. We need these resources

however we can get them and effectively keep them on line is what

we are trying to do.

Right now, I believe honestly—and this goes back Senator Mikulski’s very good question about panic and fear—the very most important thing that will allay panic and fear is being prepared. And

I think you have hit on a very important issue, that having the access and the capability to produce these vaccines is one way in

which the public will feel assured.

Unlike my colleague here, I am not sure that we are ready to

talk about routine population-based immunization yet for a lot of

reasons, but I know darn well that if I were in the middle of a fire-
57

fight and an outbreak right now, and we had the vaccines we needed, and we had the pharmaceutical products we needed, that would

be a major, major asset in trying to fight that epidemic both from

the standpoint of the actual epidemic but also the panic and fear.

So I very much support your point of view. I do not know if any

of us have the exact answer on how to do it, but we all know the

current system is not working and has to be addressed, so I thank

you for that.

Senator HUTCHINSON. Thank you.

Dr. Akhter?

Dr. AKHTER. It is a wonderful question, and I must say that I

tend to agree with you. We need to have a Government facility to

do the research and development, because nobody else will see it

worth their while to do it, because you cannot sell these things

commercially, and there is not a market out there. So this is something that really comes very close to home. It is the Government’s

responsibility to really do that.

Now, we could have private contractor in addition to the Government itself so that the contractor really concentrates on these areas

and makes the resources. Having two sources is important not only

from the point of view that one could be destroyed or attacked, but

also from the point of view of comparison so that we can compare

the two vaccines and make sure which one is better and continue

to study that and make sure we have adequate supplies when the

need arises.

I tend to agree with my colleague here that we need to have an

adequate supply of vaccine so that I can stand up and look into the

eyes of the American people and say, ‘‘Folks, we are ready, as

ready as can be humanly possible. We have the vaccine, and in

case something happens, we can provide it to you.’’ Senator HUTCHINSON. Dr. Heinrich?

Ms. HEINRICH. Yes, I just wanted to mention that we will be

doing work for Senator Frist and Senator Kennedy on vaccine

shortages and what are the issues underlying what is happening

currently in the commercial sector. As these issues play out, it is

interesting, because we are currently short of tetanus, which is a

common vaccine, and there is only one sole source manufacturer at

this point in time. We studied what was going on with the flu vaccine and the reasons for the shortage last year and the slower production this year, and there are many, many factors involved.

I guess, being from GAO, I would be hardpressed to say that one

approach, the Government taking over vaccine production, is the

only answer, but I do think we need to better understand what is

happening in production in newer plants, what incentives can we

put in place so that we do have a healthy market.

We also know that there are certain vaccines where there is not

going to be a large market in the United States. I know that CDC

and DOD and FDA currently have a contract in place to develop

plans for such a facility that is Government-operated.

Dr. HENDERSON. I think there is a problem with vaccines as has

been pointed out, and it extends across the board. It is not just

these vaccines, but it is the childhood vaccines, where many of

them have just one manufacturer, and we have been running into

shortages.
58

Traditionally, in many countries, vaccines have been produced by

government manufacturers. This has been the experience a long

time ago. Many places made vaccines—Massachusetts, Michigan,

and Texas had their own vaccine production facilities.

So I think it needs to be explored, there is no question, to see

how to accomplish this to ensure that we do have vaccines. The private sector does not seem to be doing all that well at the moment.

There is a second piece to this, and that is the research and development, where I think we need a plan to develop vaccines.

There is, for example, a second-generation anthrax vaccine which

was developed within the military at USAMRD that looks very,

very promising, and it really needs to be accelerated. The research

on this should be accelerated. I think many of us who have looked

at the question of what vaccines should we provide would say that

if we had today an anthrax vaccine of the second generation, which

perhaps could immunize with two doses, would we recommend it— I think we would for first responders and many others. It would be

a very good thing to do.

We would not recommend a smallpox vaccination simply because

of the complications given the risk. But if somebody walks through

O’Hare Airport tomorrow and we find that he is carrying smallpox

virus, that risk-benefit ratio could change overnight.

So that yes, with the smallpox, they are now looking for a second

manufacturer so there would be two manufacturers and a longterm supply of that vaccine.

Senator HUTCHINSON. Thank you, Doctor. I thank all of the panel

for their excellent responses.

Mr. Chairman, I would just say that the Department of Defense

is saying they are going to be making a decision, but if they determine to go Government-owned, contractor-operated, the civilian

population ought to get the benefit of that, too. We do not need to

be duplicating those kinds of efforts when it is going to require

such a huge investment.

So thank you very much for your timely comments.

The CHAIRMAN. Senator, we should have a hearing on that subject. It is another feature of this whole issue. Senator Frist and I

have asked the GAO to do some definitive work.

There are enormous ethical issues—and time is moving along,

and other colleagues want to question—but we have issues between

killed and live vaccines. If you remember years ago, if a child received the killed vaccine, they had protection, but none of the other

children in the classroom had any protection. If they used the live

vaccine, the other children got protection and that child got protection, but you had one in a million cases resulting in the child getting the disease. So you had a defined number of 12 to 15 children

getting the disease, and you can imagine the mothers out there, appearing before this committee, saying, ‘‘I was thoughtful enough to

bring my child down there to get the vaccine, and now my child is

going to be paralyzed for the rest of his life.’’ And other mothers

who did not bring their children, their children were immune, and

how can you have that as a matter of public policy.

So there are enormous ethical issues, and we still do not know

the right answer. These are ethical and moral issues and questions—as Dr. Henderson pointed out, we produced vaccines in my
59

own State of Massachusetts, and Michigan and other States did as

well. So this is something that we ought to give good thought to,

and we should get some recommendations from Pharma.

A fellow who is very interested in this is named Leschley, who

is with SmithKline. He has talked about the failure of doing research into drug-resistant bacteria. Not many of the pharmaceutical companies are doing it. It is complex, it is expensive, but

it needs to be done in terms of the public health. As a public health

issue down the line, that is somewhat of a different issue, but some

of these things overlap.

I thank the Senator for bringing this up. It is very important,

and maybe we will ask our staffs to get together and give us a

sense about how we can get good information in the committee.

Senator Wellstone?

Senator WELLSTONE. Thank you, Mr. Chairman.

I appreciate this hearing. I do not think Dr. Osterholm will be

that sympathetic to what I am about to say, but in a lot of ways,

I am having to pinch myself to realize that we are having this

hearing. You cannot help but be very serious when focusing on

these issues.

We have been talking about panic, but I do not know if that is

the right word as I think about how people in our country are

thinking about this now. The other night, our youngest grandchild

had a 6-year-old birthday, and all the kids were there and grandchildren, and I said to Sheila as we left—I have never talked like

this before in my life—but I said, ‘‘We are 57, and we have had a

good life, but what is ahead for them?’’

I do not know that that is panic, but people are very focused and

worried and frightened. I have been thinking about this, and I have

a particular question to ask you, and it is a small one. I do not

want to repeat what others have said. I have learned something

today, a lot, but there is one thing in particular. There has got to

be—and I think, Dr. Henderson, you started to touch on this— there is a dilemma for you and for us as well, because to the extent

that you want people to be aware of it and know this is ahead of

us, you have to figure out how to do it without just terrifying people or making them just numb in their sense of hopelessness and

powerlessness, and you have to know how to draw that line.

I have thought about this, too, Michael, back home. This would

be an easy thing to do to get a lot of coverage. I could meet with

you alone—I am serious—with people in the State, and everybody

would come. But what I think would be better is if you can, at the

same time you are outlining the problems, you can outline the action plan. So the whole thing is rapidity of response. The airline

industry came in and the carriers said on Friday, ‘‘If we do not get

indemnified by Monday, we are not going to be able to fly’’—and

by God, we passed a $15 billion package just like that.

So I think the key is the rapidity of response, and I think we

need to do this in the public health field just as we did for the airlines. So what I look forward to very soon is to meet with our people in Minnesota, our local people—all of you have put emphasis

on State and local—and to be able to say, ‘‘Tell me what you need,’’

but at the same time be able to say, ‘‘This is exactly what we are

going to do,’’ so people hear about both—they hear about the prob-
60

lems, but also, about the action plan and what is being done by

Government now. To me, that is the key, rapidity of response.

My quick question—and maybe it is because this is an area that

I work in—in this whole public health infrastructure of care, it is

my own belief that mental health services ought to be a part of

this. It is part of the area that I work in, and it has not been discussed today, and I wanted to get your response. Whatever we are

dealing with, trying to head off people becoming too frightened, if

something has happened, trying to deal with a lot of different people—to what extent should this be part of the infrastructure that

is there in our local and State communities?

Mr. OSTERHOLM. Senator Wellstone, let me say that I think it is

as two levels that you have identified. One is for the individuals

themselves out there, and clearly this is an important area. I do

not think there is anyone in America who did not lose sleep, who

was not restless or concerned, after September 11. We are not used

to that kind of phenomenon, and that is an important mental

health consideration.

I am in a very selfish way concerned about it, because frankly,

how one of these episodes could unfold is going to be dependent not

just on the bug and who is exposed, but on the psychology behind

it. And for us to contain, control, and basically direct an outbreak

investigation and the outbreak itself is going to be in part dependent on the population psychology, which I think we have very little

experience with in modern times. What will happen; how will people actually respond to Government directives? How will they believe in their Government? Will they in fact do the things that we

are recommending? Will they feel confident that we can respond in

a way that allows them to stay rational and move forward?

I think that all of us who have been involved in this issue have

talked about the fact of the relative absence of information on that

kind of study of the mental health of the population when that

happens, and that will be a key part of what we do to respond.

Senator WELLSTONE. Dr. Henderson?

Dr. HENDERSON. You raise a very good point indeed, and I think

one of the most important concerns we have as we go through the

exercise of an epidemic is how we communicate with the public.

This has not received as much attention as I think it deserves on

how we work through and anticipate how we communicate a message to the public.

There is a second piece, and that is the mental health piece. We

have a group of cultural anthropologists who are working with us,

trying to identify what the reactions of people will be or might be

in an epidemic situation, and they have been off on several different kinds of exercises. It is easier, of course, to identify something like an explosion or a crash, but it is hard to find an epidemic

that is big enough to get a sense of just what it is going to be like

in a serious circumstance.

As we look at it historically, we have not had a serious infectious

disease epidemic in the United States since 1918, and we are just

not at all sure how people are going to respond or how the medical

profession is going to respond. Are they going to flee? Are they

going to work? Are people going to flee the city? What are they

going to do?
61

So I think this deserves a lot of attention, and we have a unit

on that at the moment, and I think we are finding some interesting

things, but that is, of course, for another time to describe all of

that.

Dr. AKHTER. I think there are two other components that are absolutely essential. One is dealing with people who are suffering

grief reaction because they have lost somebody or because they

themselves are hurt. The second is posttraumatic stress syndrome.

The closest we have come is the New York incident, for example.

A lot of people needed grief counseling, the people who are dealing

with it, the firemen, the police, everybody else—but also, 800 families, 4 weeks after the incident, have signed up because their children are having difficulty sleeping, difficulty concentrating, having

nightmares, not being able to go to school, and these are the children who need long-term care.

So a really good mental health response, also ready, is an important component.

Senator WELLSTONE. I thank all of you. Mr. Chairman, this is an

area where you all have done so much of the work, but it is one

area where I want to dig in. This whole mental health area is really near and dear to my heart, and I think it fits in.

I would like to thank each of you. Dr. Osterholm, thank you for

coming to Minnesota, and thank the University of Minnesota for

giving you to us.

The CHAIRMAN. Thank you very much, Senator Wellstone.

Senator Collins?

Senator COLLINS. Thank you, Mr. Chairman.

I want to start by praising your efforts and leadership, along

with Senator Frist, in really being out front on this issue.

As I listen to the testimony today outlining the weaknesses and

the unevenness of our public health infrastructure, and I hear Dr.

Akhter talk about the criticality of the first 24 to 48 hours in identifying an outbreak, and Dr. Henderson talking about that we only

have 80 labs that would be able to identify anthrax, I cannot help

but think that if the anthrax case or cases in Florida had happened

in another part of the country, we still might not realize what we

are dealing with. And while this may well turn out not to be a terrorist attack, the implications of someone deliberately exposing a

larger population are really frightening in terms of our ability to

quickly identify, contain, and treat, and that is the overwhelming

impression that I am getting from the panel today.

I want to talk about another issue that we really have not dealt

with, and that is the vulnerability of our food supply to a bioterrorism attack. I held extensive hearings a couple of years ago in my

Permanent Subcommittee on Investigations to look at the FDA system for inspecting imported fruits and vegetables. What we found

was not reassuring.

I got interested in this after reading about cases where tainted

raspberries from Central America had come into the United States

and resulted in dozens of people getting sick. I learned that our

system was really no system at all, that only about one percent of

food shipments that are imported are subject to inspections, that

there were all sorts of opportunities for unscrupulous shippers to

avoid inspection.
62

So this is of great concern to me, because although my subcommittee made a number of recommendations, only some of them

were implemented, and part of it was for more resources.

So I would like to have each of you comment on the vulnerability

of our food supply and, starting with Dr. Henderson, I would also

be interested to know whether the new bioterrorism advisory committee is going to take a hard look at FDA’s procedures for screening imported foods, because what I found was very disturbing in

terms of our vulnerability.

Dr. Henderson?

Dr. HENDERSON. I think the real expert on the food supply, actually, is Dr. Osterholm. Clearly there is a risk with the food supply.

There is more food coming in from overseas and all sorts of different places. It is very difficult to inspect, and this is one very difficult problem, there is absolutely no doubt about it.

We are not well-prepared to deal with this, and I think there is

a lot of research that could be done that we have just not taken

advantage of, or should take advantage of, and trying to do something about it.

It is a problem, and I think we have focused more on aerosol dissemination of agents as being a way by which the worst of the

agents we can imagine are best distributed, and looking at the moment on catastrophic events recognizing that the food supply may

be even more likely to occur, but some of the more catastrophic

agents, you cannot distribute in food, there is a balance here.

Clearly that needs to be looked at. We have focused on food, but

we have also looked at water and come to the conclusion by and

large that our water systems are really not that much of a problem,

that food is a bigger problem, and I think this needs to be looked

at.

What our council will do, I really don’t know, but that should be

on our agenda, no question.

Senator COLLINS. I want to share our report and hearings with

you.

Dr. Osterholm, I am going to turn to you now and then go back

to the other two witnesses, because I remember reading a lot of

your work when we were doing the investigation, so if you would

comment, please.

Mr. OSTERHOLM. Senator, thank you. I was one of those who was

very impressed with and appreciative of what you did and your attention to that issue. You drew early attention to some of the

changing problems that we are seeing with the food supply.

To follow up on what Dr. Henderson said, fortunately, the food

supply does not pose the risk of the catastrophic agents, but the

problem is—I have worked up the largest outbreak of salmonella

in the country of 300,000 cases in contaminated ice cream—today

the problem is that our system is so vulnerable because we now

feed literally thousands to millions of people off of single-source

supplies that are easily contaminated. I think that one of the ares

that we need to look at is that vulnerability, not just from Mother

Nature-made, but also manmade attempts. I think industry is very

concerned about that, and we have to do that.

I think we would all like to be part of the dialogue about how

that is done. Frankly, some of us are concerned that more inspec-
63

tors will not really make any difference, but there may be things

that could make a difference, and we would very much like to be

a part of that.

One of the areas I would draw your attention to as part of the

ongoing continuity of the food supply—and I think Senator Edwards mentioned it very briefly—is agri-terrorism issues and the

concerns we have around that.

I think that frankly today—and we are all careful about how we

talk about this, but it has been rather publicly talked about—if we

have just one incident of foot-and-mouth disease entered into this

country intentionally, and we can understand the implications of

that and how well we are prepared to respond.

The other area, frankly, that we are very worried about is the

hoax situation where, if I just tell you that your food is contaminated, what does that do to the trust, the integrity, and in many

cases the actual ability to sell certain products.

So we need to work much more closely with industry, and industry itself recognizes this. We have been approached at our center

by many, many different industry representatives over the last 3

weeks saying, ‘‘Help us. We really believe it now. We know that we

have to do something.’’ And I think Government has to be a key

piece in that.

So I do not have a prescription for you today other than to say

that your concerns are well-founded and right on target. We need

to do something about that, because loss of confidence in our food

supply has, I think, tremendous economic implications besides the

illness cost issues.

Senator COLLINS. Thank you.

Dr. Akhter?

Dr. AKHTER. I think that with the terrorist threats now, business

as usual is not acceptable. It is no longer possible for us to continue

to have 12 different agencies of the Federal Government deal with

food. I think this needs to be coordinated. We at the American Public Health Association had a position on this of creating a single

food agency. This is something which everyone uses every, single

day, and we need to make sure that things are coordinated, that

all agencies are working together; maybe they could be brought

under the new department that is being created.

I also believe that we need to have more inspectors to make sure

that food is inspected, not only when it enters our borders, but at

the source, and work with the producers to make sure we avoid

contamination of food coming into this country.

Senator COLLINS. Thank you.

Dr. Heinrich?

Ms. HEINRICH. Just a brief comment, and that is that the U.S.

Department of Agriculture really has minimum funding and programming related to bioterrorism, and they certainly reminded us

that the pathogens that affect humans also affect animals. And

also just to reinforce your point that there are very low levels of

inspection of imports, and we know that we import a lot of food

items.

Senator COLLINS. Thank you.

Thank you, Mr. Chairman.

The CHAIRMAN. Thank you.
64

Senator Edwards?

Senator EDWARDS. Thank you, Mr. Chairman.

I thank the panel very much. Let me just follow up briefly on the

issue that Senator Collins was just asking about. As probably all

four of you know, Senator Hagel and I have included in our legislation some specific provisions addressing the problem of food safety

and agri-terrorism.

Dr. Heinrich, you just commented that there is a low level of inspection of imports. That is one of the issues that we have tried

to address with our legislation, but could you talk more about what

you think needs to be done?

Ms. HEINRICH. At this point, it would be very hard for me to address what needs to be done. There are others at GAO who are

doing work specifically targeted in this area. I do not think any of

us at this point has recommendations on what would be done.

Senator EDWARDS. But you do recognize that something needs to

be done.

Ms. HEINRICH. Yes.

Senator EDWARDS. Do any of the other witnesses have comments

on that subject?

Mr. OSTERHOLM. Senator Edwards, first of all, having been very

involved with foodborne diseases over the years, I do not want to

take on a ‘‘sacred cow’’ to say the least, but I think we ought to

look at what role inspectors really play. I can honestly tell you that

I do not know what someone who looks at a product coming in from

a foreign country does to add value to that product when it is a

microbial level of contamination.

So while we are very concerned about it, and we agree with you

that it definitely needs to be addressed, it is an area where I think

the apparent solution may be more cosmetic than real.

One area that we have looked at is how do you actually provide

the integrity of the product control from the time that it is actually

grown in the fields to the point where it is actually given to the

consumer; how do you trace issues back. One area where we have

run into many problems is that when we have outbreaks or possible outbreaks, you can never trace back to the source of the product because there is such a poor product tracing chain there which

then does not allow you to make the definitive answer as to whether it is or is not really a problem, and if it is, what product is involved.

How many times have we had to have a nationwide recall of melons or berries because nobody knew where they all went because

they got mixed and mingled; if we could have just identified that

field source, we could have done something about it.

So we would be very happy to work with your staff. I talked with

Senator Hagel about that this morning. I think that your interest

in this is right on target, as I mentioned just now to the Senator,

and we would be very happy to work with you on that piece—and

it is needed desperately.

Senator EDWARDS. Yes, it is clearly desperately needed. Thank

you very much.

If I could switch gears for a moment, the GAO report indicated

that there was a real fragmentation at the Federal level in our efforts to deal with this issue of bioterrorism. I wonder if any of the
65

witnesses—this is not directed at any particular witness—could

comment on that and what needs to be done, or what is being done,

to deal with that issue of fragmentation, to have our Federal agencies operating more efficiently and more cohesively.

Dr. HENDERSON. Senator, that is a $64,000 question and not easy

at all.

Senator EDWARDS. Yes—I saw everybody backing away from the

microphones.

Dr. HENDERSON. I think what is true here as we get into this is

that this is one of the most complicated undertakings, trying to be

ready to detect and to detect and investigate and so forth, involving

so many different agencies, State, Federal, and local, that to try to

put together a group of people all working together from FBI to

physicians in hospitals to those in the public health sector to various people coming from Washington and the different agencies

with a concern—it may even involve EPA or the Defense Department. This has been a problem that we have all thought a lot about

and are trying to figure out just how you can do it, and the new

agency that is being created is I think one more effort to do this.

The only thing I can say is that it is not easy. The department

that I am working with mainly now is the Department of Health

and Human Services, and I think a lot can be done to bring that

together and at least have one agency that has fewer pieces to it.

But there are many agencies and many different components to

this, and how to do it is probably one of the most difficult responses

that one could have in, let us say, a Government action.

Senator EDWARDS. But you agree that it is critically important

that they be able to operate cohesively?

Dr. HENDERSON. Absolutely. I think that is critical, yes.

Senator EDWARDS. Other witnesses’ comments?

Dr. AKHTER. I think, Senator, that whenever there is a national

emergency, all of us roll up our sleeves and come out and work together to get the job done. I think the real challenge is when there

is no emergency, how can we all work together. And there are

many ways, but it must start from the top. We must have a domestic security council type of situation where all parties sit around

the table on a regular basis and really talk this stuff out, because

if top people are not working together, do not expect the lower level

folks to really——

Senator EDWARDS. It is impossible, yes.

Dr. AKHTER. So it takes the same kind of coordination, and it

takes many, many years before we really get down to a smooth

working relationship among the agencies.

Senator EDWARDS. Dr. Heinrich?

Ms. HEINRICH. Certainly in the past, some of our colleagues who

work in defense have put forward some basic principles on what

you need to have if you are going to have the kind of coordinated

effort that we see that we need here in bioterrorism.

What we have found in our overview of the Federal agencies is

that there are oftentimes overlapping areas of jurisdiction and responsibility, and when that happens, it is not clear who is in control, and that leads to no one organization or group having accountability.
66

So that certainly one thing that can be done is clarification of

those areas of jurisdiction.

What is interesting to me is that when you look at some functions such as research for vaccines, for example, there are different

agencies that have responsibility—NIH, Department of Defense,

CDC, FDA—but in that instance, they seem to be very clear about

what the function of each organization is, and there seems to be

a lot of collaboration, both formal and informal, but in other areas

such as response teams or the kinds of materials or grants that

local agencies can apply for, there is a lot of overlap and not the

same kind of coherence.

Senator EDWARDS. Clearer lines would obviously help. Thank

you.

I thank the witnesses very much for their work, and Mr. Chairman, thank you so much for your leadership on this issue.

The CHAIRMAN. Thank you.

I want to thank the panelists as well as my colleagues. I think

you could tell both by the number of our colleagues present and the

probing aspects of their questions and the issues that they have

raised that this is something that we are all very, very much interested in. We want to try to be responsive and take the recommendations that so many of you have helped us with as a result

of a lifetime of experience in this area. We are very fortunate to

have you here.

I think all Americans are mindful—as we are meeting today in

the late morning—of our service men and women and all the support that they are receiving overseas. We must recognize that we

have another battle here. It is of enormous importance and incredible consequence as we are committing as a nation to make sure

that we have the best-trained, best-led, with the best equipment

overseas, that we ought to do no less for the children and the families who are left behind. And you have given us a very important

blueprint to try to follow. We understand that there will be a number of different policy issues and questions as we go down the road,

but we ought to get about the business of doing that at this time.

I thank all of you for being here. The committee stands in recess.

[Additional material follows:]
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ADDITIONAL MATERIAL

THE CENTER FOR INFECTIOUS DISEASE RESEARCH AND POLICY, UNIVERSITY OF

MINNESOTA, AND THE WORKGROUP ON BIOTERORRISM PREPAREDNESS

The Center for Infectious Disease Research and Policy, University of Minnesota,

brought together a Workgroup on Bioterrorism Preparedness on October 3, 2001. The

Workgroup included members from the following organizations: the American Society

for Microbiology, the Alfred P. Sloan Foundation, the Association of Public Health

Laboratories, the Association of State and Territorial Health Officials, the Center for

Infectious Disease Research and Policy at the University of Minnesota, the Council

of State and Territorial Epidemiologists, Emory University School of Public Health,

the Infectious Diseases Society of America, the Johns Hopkins Center for Civilian

Biodefense Studies, the National Association of County and City Health Officials, the

National Association of State Public Health Veterinarians, and NTI. The members

did not seek endorsement from their respective organizations for the recommendations contained in this report and the recommendations may not reflect the position

of the respective organizations. The meeting of the Workgroup was supported by NTI.

RECOMMENDED FEDERAL FUNDING FOR A PUBLIC HEALTH RESPONSE TO BIOTERRORISM

The following amounts are needed for hospitals and federal, state, and local public

health agencies to effectively respond to bioterrorism. The funds identified below

represent an initial investment in upgrading the public health system for biodefense. Additional funds will be needed to effectively maintain such systems over

time. The numbers provided below represent a first effort to achieve broad consensus in the public health community regarding funding for bioterrorism; the numbers

will likely be refined with further discussion.

1. Improve State and Local Preparedness

a. Bioterrorism Preparedness Planning ................................................ $35 million

b. Staffing, Training, Epidemiology, and Surveillance ......................... $400 million

c. Information and Communication Systems ....................................... $200 million

d. Laboratory Enhancement .................................................................. $200 million

TOTAL ............................................................................................ ........................ $835 million

2. Upgrade CDC Capacity for Bioterrorism ................................................... ........................ $153 million

2. Develop Federal Expert Response Teams .................................................. ........................ $45 million

2. Improve Hospital Response Capabilities ................................................... ........................ $295 million

2. Improve Disaster Response Medical Systems ........................................... ........................ $62 million

2. Improve International Surveillance ............................................................ ........................ $20 million

2. Improve Food Safety .................................................................................. ........................ $100 million

2. Develop and Implement Applied Research Initiatives .............................. ........................ $50 million

2. Improve the National Pharmaceutical Stockpile (NPS) ............................. ........................ $250 million

2. Accelerate Development of Smallpox Vaccine ........................................... ........................ $60 million

2. Develop Other Vaccines for Civilian Use .................................................. ........................ $100 million

TOTAL ............................................................................................ ........................ $1.97 billion

JUSTIFICATION FOR FUNDING RECOMMENDATIONS

1a. Improve State and Local Preparedness: Bioterrorism Preparedness

Planning—(Amount: $35 million)

• Every state and certain key local metropolitan areas should have a bioterrorism

preparedness plan in place and the plan should be validated through simulation exercises. Planning at the state level or local level should involve the public health

agency (or agencies) and all other agencies that would be involved in responding to

a bioterrorism event. An estimated $500,000 is needed for each jurisdiction to immediately develop and test a comprehensive plan (assuming up to 70 jurisdictions).

• In 1999, many states applied for CDC funding for bioterrorism preparedness

planning, but only 11 were funded. For those states whose applications were approved but not funded, the existing CDC cooperative agreement provides a mechanism to fully fund those activities and to rapidly move funds out to those states for

implementation.
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1b. Improve State and Local Preparedness: Personnel, Training, Epidemiology, and Surveillance—(Amount: $400 million)

• State and selected local health departments must improve their ability to recognize and respond to bioterrorism events by integrating bioterrorism preparedness

activities into existing communicable disease prevention and control programs.

• The CDC’s Emerging Infections Programs, which are now operational in nine

states, have been highly successful in enhancing the kind of long-term capacity

needed at the state level and should be redesigned to include bioterrorism activities

and expanded to other states and selected large metropolitan areas.

• Additional funds are needed to train public health practitioners (epidemiologists, physicians, nurses, educators, and other program staff) to respond to bioterrorism events and to rapidly and effectively coordinate their actions across local,

state, and federal agencies. Resources also are needed to recruit and train more

public health practitioners (including medical and veterinary epidemiologists)

through schools of public health and other colleges.

• An effective response will require close coordination between federal, state, and

local agencies. Expertise must be available at each level to meet the demands of a

bioterrorism crisis. Although federal leadership will be critical, too much reliance on

federal resources may limit the overall effectiveness of a response. An estimated

1.33 million dollars is needed per 1 million population per year to implement and

maintain bioterrorism preparedness activities.

1c. Improve State and Local Preparedness: Information and Communication Systems—(Amount: $200 million)

• Several essential information systems have been developed (or are in development) to effectively disseminate outbreak and disease information within or across

jurisdictions. Funds are needed to expand or fully implement these systems to assure an effective response to bioterrorism.

• A system for emergency alerts (i.e., the Health Alert Network or HAN) must

be in place in each jurisdiction so that public health agencies can rapidly communicate critical health information with each other in the event of a bioterrorism attack. Additional funding is needed to assure that all jurisdictions have fully operational alert systems in place.

• The National Electronic Disease Surveillance System (NEDSS) is a system designed by CDC to integrate a myriad of separate databases for public health surveillance so that reporting can be simplified and outbreaks (including bioterrorism attacks) can be rapidly detected and characterized across the different systems. Additional funds are needed to fully implement NEDSS.

• Epi-X is a rapid secure communication system for public health agencies that

is sponsored by CDC for sharing information about outbreaks and critical health

events as they unfold. This system would allow rapid communication of critical public health information in the event of a bioterrorism attack. Ongoing funds are needed to maintain the operation of Epi-X.

• Rapid communication systems (such as two-way radios or other systems) also

are needed to allow state and local agencies to effectively communicate during times

of crisis when conventional modes of communication may not be accessible.

1d. Improve State and Local Preparedness: Laboratory Enhancement—

(Amount: $200 million)

• The Laboratory Response Network (LRN) is critical to a successful response to

bioterrorism. The LRN is a multi-level laboratory network composed of county, city,

state, and federal public health laboratories and is designed to receive and analyze

laboratory specimens from a range of sources. The system is designed to assure definitive identification of suspected bioterrorism agents as quickly as possible. Additional funding is needed to assure that LRN laboratories are prepared to accurately

identify potential for full implementation.

• The National Laboratory System (NLS) is a communication system designed to

rapidly share laboratory information between public health, hospital, and commercial laboratories. Such communication will contribute to early detection and effective

monitoring of bioterrorism events. Additional funding is needed for full implementation.

• Chemical terrorism preparedness also is needed and should be integrated into

the laboratory improvements.

• Resources for improved diagnostic testing and identification of potential bioterrorism agents by animal and wildlife laboratories also are needed, as is improved

communication between human, animal, and wildlife laboratories.
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2. Upgrade CDC Capacity for Bioterrorism—(Amount: $153 million)

• CDC is the lead public health agency for federal bioterrorism preparedness and

must be able to provide effective leadership to the public health and medical communities. Additional funding is needed for CDC to conduct deterrence, preparedness, detection, confirmation, response, and mitigation activities.

3. Develop Expert Response Teams—(Amount: $45 million)

• Public health management of a bioterrorism attack will be extremely challenging. Teams of national experts who can deal effectively with the demands of such

a crisis should be recruited and trained. These experts should have extensive experience in management of outbreaks or have clinical experience with diseases caused

by potential bioterrorism agents. The teams should be maintained on alert status

and federalized as needed for deployment.

4. Improve Hospital Response Capabilities—(Amount: $295 million)

• Hospitals must be able to effectively triage and treat victims of a bioterrorism

attack. This requires improvements in infection control (i.e., adequate isolation capabilities), expanded ability to provide intensive care, and adequate protections for

healthcare workers (antibiotic prophylaxis, personal protective equipment, and vaccines [if available]).

5. Improve Disaster Response Medical Systems—(Amount: $62 million)

• Adequate disaster response systems are needed to coordinate disaster management during a bioterrorism event.

5. Improve International Surveillance—(Amount: $20 million)

• International surveillance is needed to monitor the occurrence of illnesses

caused by potential bioterrorism events in other areas of the world.

5. Improve Food Safety—(Amount: $100 million)

• Foodborne agents could be involved in a bioterrorism attack. Funds are needed:

1) to improve surveillance for foodborne diseases at the state and local level, 2) to

improve outbreak response capabilities, 3) to enhance rapid communication of information about foodborne disease outbreaks, and 4) to provide federal oversight for

food safety activities.

5. Develop and Implement Applied Research Initiatives—(Amount: $50 million)

• Applied research is needed (particularly at the state and local level) to assess

effectiveness of various public health strategies, such as evaluation of surveillance

methods, evaluation of laboratory preparedness, and evaluation of rapid communication networks.

9. Improve the National Pharmaceutical Stockpile (NPS)—(Amount: $250

million)

• Additional stockpiles of anti-infective agents are needed to effectively provide

treatment and prophylaxis to large populations in the event of a wide scale bioterrorism attack. Ideally, enough medication to treat or provide prophylaxis to 40

million persons should be stockpiled. These supplies will need to be rotated on an

ongoing basis.

10. Accelerate the Development of Smallpox Vaccine—(Amount: $60 million)

• Release of smallpox virus has serious global public health ramifications. Containment measures, including the ability to conduct mass vaccination campaigns,

will be critical to a successful response effort. Enhanced production of smallpox vaccine is urgently needed to contain the spread of smallpox if this agent is released

through a bioterrorism attack. Also, lack of vaccine availability will cause widespread panic in the face of an epidemic, which will be extremely difficult to control.

Ideally, enough vaccine should be available to vaccinate the entire US population.
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11. Develop Other Vaccines for Civilian Use—(Amount: $100 million)

• Development and production of vaccines for civilians (other than smallpox as indicated above) is important to the long-term protection of the U.S. population

against bioterrorism attacks.

[Whereupon, at 1 o’clock p.m., the committee was adjourned.]

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