U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

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

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

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

80–875 PDF 2002

S. HRG. 107–583

HOMELAND SECURITY

HEARING

BEFORE THE

COMMITTEE ON HEALTH, EDUCATION,

LABOR, AND PENSIONS

UNITED STATES SENATE

ONE HUNDRED SEVENTH CONGRESS

SECOND SESSION

ON

EXAMINING THE PRESIDENT’S PROPOSAL TO ESTABLISH A DEPARTMENT OF HOMELAND SECURITY, FOCUSING ON ITS IMPACT ON PUBLIC HEALTH PREPAREDNESS PROGRAMS, AND ON THE COLLECTIVE

BARGAINING RIGHTS OF CERTAIN UNION WORKERS

JULY 16, 2002

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

(
(II)

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
(III)

CONTENTS

STATEMENTS

TUESDAY, JULY 16, 2002

Page

Kennedy, Hon. Edward M., a U.S. Senator from the State of Massachusetts ... 1

Gregg, Hon. Judd, a U.S. Senator from the State of New Hampshire ................ 3

Ridge, Hon. Tom, Director, Office of Homeland Security, Washington, D.C. ..... 5

Prepared statement .......................................................................................... 8

ADDITIONAL MATERIAL

Articles, publications, letters, etc.: .........................................................................

Heinrich, Pat, Director, Health Care, Washington, D.C. .............................. 26

American Society for Microbiology .................................................................. 34

(1)

HOMELAND SECURITY

TUESDAY, JULY 16, 2002

U.S. SENATE,

COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS,

Washington, D.C.

The committee met, pursuant to notice, at 10:05 a.m., in room

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

(chairman of the committee) presiding.

Present: Senators Kennedy, Murray, Reed, Gregg, Frist, Hutchinson, and Sessions.

OPENING STATEMENT OF SENATOR KENNEDY

The CHAIRMAN. It is a privilege to convene this morning hearing

on the Administration’s proposal to create a Department of Homeland Security. We welcome Governor Tom Ridge to our committee,

and we are grateful for his leadership and all that he has done to

protect our Nation’s security.

We live in a Nation forever changed by the tragic events of September 11. The searing images of the terrorist attacks on that fateful day were grim proof to every American that we are vulnerable

to grave new threats, and that we must take whatever steps are

necessary to protect America from these dangers.

As the anthrax attacks that followed soon after made clear, the

remarkable new techniques of modern biological science can be

used to harm rather than to heal, to kill and not to cure.

The magnitude of this aspect of the new threat was highlighted

again by recent chilling reports that a polio virus has been created

from inert and widely available chemicals.

Our defenses against the threat of bioterrorism have been neglected and underfunded for too long. Congress took action to correct many aspects of this deficiency by enacting the bioterrorism

bill signed by President Bush last month. This legislation prepares

the Nation to deal with biological attacks by strengthening hospitals, public health agencies, and medical research laboratories

across the country.

A deadly biological attack is likely to be detected first by a local

physician, who will turn to the agency that responds to disease outbreaks every day of the year—the CDC. To deal with an attack,

doctors will rely on the vaccines and antibiotics developed by the

Nation’s medical research agency—the NIH.

Thanks to the new resources provided recently by Congress for

bioterrorism preparedness, these and other agencies in the Department of Health and Human Services are now making significant
2

progress in improving the Nation’s readiness for bioterrorist attacks.

Research at NIH has demonstrated that the Nation’s stocks of

smallpox vaccine can be diluted yet still retain their potency to defend against that deadly virus. Grants by CDC to every State and

territory have already begun to strengthen the Nation’s ability to

detect, contain, and treat a biological attack.

Many of us feel that we should build on the strengths of these

existing programs rather than create potential confusion by transferring them to the new Department of Homeland Security or by

giving that new Department the responsibility for their direction.

Our concerns about the President’s proposals are not based on an

aversion to change but rather on a careful analysis of the impact

of these moves on our common goal—enhancing the Nation’s security. Many major health organizations and expert panels have also

carefully scrutinized the President’s proposal. Their overwhelming

conclusion is that transferring public health preparedness programs from CDC or stripping NIH of its ability to make key decisions about the Nation’s bioterrorism research program would do a

disservice to the goal of enhancing our security.

For example, the Brookings Institution just completed a thorough

analysis of the President’s plan and determined that ‘‘researching

natural disease and researching biological weapons have a great

deal of overlap. Trying to place the latter under DHS auspices

while keeping the former under current HHS control risks creating

artificial divides.’’ The report concluded that ‘‘the administration has not made a

strong case for why a substantial amount of biological research

should be taken away from the Department of Health and Human

Services.’’ Reservations about transferring public health preparedness activities away from CDC are equally strong. The President recently

received a letter signed by a coalition of major health groups, including the American Nurses’ Association, the American Public

Health Association, and the Association of Academic Health Centers. In their letter, these organizations conclude that ‘‘separating

bioterrorism preparedness from the rest of the Nation’s public

health infrastructure is likely to reverse the most important steps

the Nation has taken in decades to achieve broad-based public

health preparedness.’’

I believe that it is our responsibility on this committee to pay

close attention to these concerns and to ensure that the legislation

establishing the new Department does not undermine the important ongoing programs at HHS to enhance our national preparedness for bioterrorism.

The terrorist attacks last fall also made clear that union workers

are true heroes in protecting homeland security. Union members

risked and lost their lives and saved countless others by their actions on September 11. We will never forget the example set by

firefighters, construction workers, and Government workers on that

day. The brave flight attendant recognized by the President in the

State of the Union Address was a member of a union. The postal

workers and the hospital worker killed as a result of the bioterrorist attacks were all union members.
3

The dedication and resolve of these men and women represent

the best of America. Nearly 50,000 of the Federal workers affected

by the proposed homeland security reorganization are union members. We must protect their right to remain union members and enable other employees in the new Department to exercise their fundamental right to form a union. Unions are essential in order to

protect the ability of workers to speak out in the face of security

lapses and to enhance our national security in many other ways.

Unfortunately, the administration’s proposal does not adequately

protect the collective bargaining rights of these vital Federal workers. The administration should not be able to use an executive

order to deprive Federal workers of their collective bargaining

rights in the new Department. Earlier this year, however, the administration stripped clerical and other workers in the Department

of Justice of their long-held union membership after years of dedicated service.

Many of us feel that Federal workers in the new homeland security agency should be able to retain those rights unless their primary responsibility consists of intelligence, counterintelligence, or

other investigative duties directly related to the investigation of

terrorism. It is essential that any reorganization respect and protect the rights of these dedicated Federal employees whose work is

so vital to its success.

I recognize Senator Gregg.

OPENING STATEMENT OF SENATOR GREGG

Senator GREGG. Mr. Chairman, I am going to have to leave to go

to the floor, but I do want to welcome Governor Ridge here who is

working so hard to try to pull together the matrix of this extremely

complex issue and make sense of it as we move down the road toward getting better prepared to defend our Nation in this time of

extreme peril when there are people who want to do us harm, very

evil people.

I think that our sole criterion for evaluating the proposals from

the administration on creating the homeland security agency

should be does it improve our capacity to fight terrorism. That

should be the only test. The other issues which are important, obviously, such as were outlined by the chairman in his opening statement are significant public policy questions at a time when we are

not at war. But the issue of war supersedes those issues in my

opinion.

The administration has come forward with an aggressive proposal, and I think it deserves to be given a presumption that it

makes sense and is moving in the right direction, and unless I am

dissuaded by some clear argument that it does not make sense, I

intend to support it.

The NIH has a huge role here, obviously, in developing technology to fight bioterrorism. How it integrates—because it is obviously still going to do the research—with the homeland security

agency is an issue which I think the chairman has appropriately

highlighted.

Increasing public health capability is something that we were

doing before 9/11 and something that we have expanded radically

since 9/11. I do think that the efforts which we are making in pub-
4

lic health to try to address terrorism issues, the issues which

evolve around as biological attack especially, but any type of attack

that involves a significant amount of injury which immediately

calls in the public health agencies, those do work in tandem with

benefiting the entire society because in upgrading public health to

address those issues, you upgrade public health to address other

issues, that might occur within the community, other accidents, for

that matter.

So I do not see them as mutually exclusive, and I do not see that

they are going to be pulling each other apart. I see them working

together to move forward and significantly improve our public

health capability as a result of that.

On the labor issues, I think this Department has a right and a

need to have special labor treatment. We simply cannot afford incompetence in this Department. The people who are running the

different elements within this agency are going to have to have the

capacity to replace people who are not doing the job.

We saw specifically in an agency which I have direct appropriating authority over, the Immigration and Naturalization Agency, incompetence, and as a result, things happened that should not have

happened. Would 9/11 have been avoided? Probably not. But certainly we could make large strides toward muting it and having it

not occur again if we have an agency that is efficient.

So I do think that the people who run these various agencies

which are charged with protecting our population from terrorist attack have to have the authority to run them efficiently and effectively and have to have the authority to replace people who simply

are not cutting it. And that is just a fact of life if we are going to

survive and win this war. So I suspect we will have issues there.

In general, I want to thank the Governor for his superb effort

and his incredible focus on this, reflecting the President’s obvious

commitment to this. The President appears to have a one-item

agenda some days, and I think it is the item that we should have,

which is fighting terrorism and making sure that our Nation survives this war and that our culture is not undermined by these extraordinarily evil people.

So I thank the Governor for coming and I apologize for having

to leave in order to protect certain rights which I know the chairman would want me to do on the floor involving another bill.

The CHAIRMAN. What are you smiling at, Governor Ridge?

[Laughter.]

Thank you, Senator Gregg.

The CHAIRMAN. As you have already caught in the wind, Governor Ridge, we are considering legislation on the floor at half-pastten, so we will ask you to proceed, and I know that our colleagues

will be here for as long as they can, but we wanted to have a

chance to get your views on these matters. We want to thank you

very much for being here.

Governor Ridge is a decorated veteran, a former Member of the

House, a leading Governor, who now carries great responsibilities

for coordinating our national effort in homeland security. We welcome him today.

I have said that Governor Ridge has reached out to us on this

committee to gain our ideas as well as in the Judiciary Committee
5

on issues of immigration, and he has been accessible and available

to us here. We are very appreciative of those efforts, and we look

forward to hearing from you, Governor.

STATEMENT OF TOM RIDGE, DIRECTOR, OFFICE OF

HOMELAND SECURITY, WASHINGTON, DC

Mr. RIDGE. Thank you very much, Mr. Chairman.

On a personal note, I want to publicly acknowledge and express

my appreciation for your availability and openness to begin discussion on many of these issues long before this legislation was ever

established. From time to time, we have entertained in a very respectful way a different view on how we accomplish certain goals,

but we are united I think as Republicans and Democrats to get the

job done, and terrorists can do what they might, but they are not

going to infringe on our ability to conduct business as we have been

conducting it for 200 years, and we will keep conducting it that

way.

I am grateful to have this opportunity to appear before you and

Senator Gregg and understand his hectic schedule as well as that

of other members of the committee, including the chairman.

So to all of the distinguished members of this committee, please

know that President Bush has asked me to convey his appreciation

for the comprehensive, timely, and bipartisan manner in which the

Senate has considered his proposal to make America safer by creating a Department of Homeland Security.

The President has signed an executive order creating a transition

planning office for the new Department housed within the Office of

Management and Budget. I testify today in my capacity as director

of this office, and I look forward to working with you this today and

in the future.

When President Bush established the Office of Homeland Security last October, the first mission he assigned was, and I quote,

‘‘to develop and coordinate the implementation of a comprehensive

national strategy to secure the United States from terrorist threats

or attacks.’’

This morning, the President released the Nation’s first ever National Strategy for Homeland Security, and at some point in time,

I do commend it to my colleagues in public service on the Hill. It

does lay out a road map of how we not only reorient the Federal

Government, and it certainly provides the foundation and the justification for the new Department, but how through this reorganization, we develop the strategic partnerships we need to build a

national capacity to deal with the terrorist threat.

It is a focused and forward-looking strategy to secure the Nation

from terrorism. It builds on the significant improvements that the

Federal Government, Congress, States, and localities have made to

our security since September 11, and it provides a framework to

guide our actions in the future. A vital component, obviously, of

this strategy is the new Department of Homeland Security.

The fundamental mission of the Department of Homeland Security is threefold, Mr. Chairman and members of the committee—

to prevent terrorist attacks within the United States, to measure

and reduce our vulnerability to terrorism, and to minimize the loss

of life and damage and speedy recovery from any future attack.
6

The Department of Homeland Security is needed not just to

strengthen the Federal Government’s response to terrorism, but to

strengthen our partnerships with States and localities and the private sector. When the home town is secure, the homeland will be

secure, and these partnerships are critical to securing the homeland.

As you know, States and localities have the primary role in responding to a crisis, including outbreaks of disease. Terrorists are

actively trying to get their hands on biological agents and weapons

to use against our citizens and against our communities. When a

doctor or local public health official determines that a disease may

have been caused by a terrorist, they need to know they can count

on one department to inform the public and coordinate and manage

the Nation’s response.

Just as important, the new Department will help ensure our preparedness well before an attack occurs. It will help train health

care professionals to recognize rare diseases and treat toxic exposures. It will help hospitalizes expand their surge capabilities and

build isolation facilities. It will assist in upgrading public health

laboratories. It will develop regional disease surveillance systems

so we can quickly determine if an outbreak is caused by man or

by mother nature. And it will encourage States and localities to

take sensible measures such as mutual aid compacts and emergency credentialing for out-of-area first responders, particularly

from within the medical community.

The Department will coordinate with its Federal partners as

well. Working with the Secretary of Health and Human Services,

it will develop, maintain, and deploy the national pharmaceutical

stockpile. Working with Health and Human Services and the Department of Agriculture, it will administer the Select Agents Program. Working with the Department of Agriculture, it will help

protect our food supply from agro-terrorism.

Working with the Department of Energy, it will oversee research

that may one day unlock the micro-bio components of our deadliest

pathogens and help make the 21st century, in Senator Kennedy’s

words, ‘‘the century of the life sciences.’’

Indeed, the success of our response to bioterrorism incident depends in large part on the quality of our vaccines, therapeutics,

and diagnostic tests.

The President’s proposal envisions a national network of laboratories modeled on the national laboratories that helped us win the

cold war. The new Department will harness the greatest minds of

our Nation to counter the greatest threat of our generation.

I would add that the President’s budget proposes $2.4 billion to

update our medical toolkit. Nearly three-fourths of that is dedicated to a public-private academic partnership led by the National

Institutes of Health. It is all part of a proposed 300 percent increase in the Federal budget for biodefense.

Currently, the bulk of our bioterrorism research and development

is located in the Department of Health and Human Services. It is

isolated from other Federal research and development on weapons

of mass destruction. The President’s plan will consolidate funding

and oversight for these programs to ensure a synergy of effort.
7

The current homeland security apparatus grew up in an ad hoc

fashion, without any real strategic direction, over the course of

many decades. The President’s reorganization plan, on the other

hand, is well-planned and well thought out. It proposes that 22

agencies with significant homeland security responsibilities be

moved into the new Department. The President faced many difficult, tough, real world choices. I believe he made the right ones.

In developing the plan, we heard from first responders—businessmen and businesswomen, doctors and health care workers, scientists, academics, other experts, and of course, we took the counsel of Members of Congress. Their best efforts and their best ideas

are reflected in both the new Department and the National Strategy as well.

This is not about moving managerial boxes around on an organizational chart. It is about ensuring that we have the resources and

the people in place to address the ever-changing threat of terrorism. Terrorists are strategic actors. They choose their targets deliberately based on observed weaknesses in our defense and preparations. They use speed and surprise to terrorize.

Protecting ourselves requires that we be just as flexible and just

as nimble, with the ability to quickly spot the gaps in our defense

and just as quickly fill them.

The new Secretary of Homeland Security must be able to set

goals and priorities. Under the President’s plan, he or she will have

freedom to manage—in the President’s words, get the right people

in the right place at the right time with the right pay.

Under the President’s proposal, the new Secretary will also have

latitude to shift resources to counter the threat. I know this is

problematic, having been a Member of Congress and understanding

very much the congressional mandate to oversee every dollar expended, but I would say very respectfully to my former colleagues

that you have a budget process, an authorization process, and an

appropriations process, and giving the new Secretary the latitude

to transfer and reprogram dollars will not be without oversight. It

will continue with the most vigorous oversight Congress can provide and will for that reason hopefully be included as part of the

congressional response to the President’s initiative.

Change is never easy, but we do face a different kind of enemy.

Their strategy and their tactics are different. They do not distinguish between combatants and noncombatants. They do not distinguish between soldiers and citizens. They do not respect borders,

and they do not fight on traditional battlefields. Instead, these are

shadow soldiers who seek to turn our cities into battlefields and

use our openness and our freedom and our diversity against us. It

is a new threat from a very new and deadly enemy, and the President believes it is time for us to think anew as well.

I thank the members of the Committee on Health, Education,

Labor, and Pensions and the Senate as a whole for their serious

and expeditious action on behalf of the President’s proposal.

Thank you.

[The prepared statement of Mr. Ridge follows:]
8

PREPARED STATEMENT OF TOM RIDGE

I. INTRODUCTION

Mr. Chairman, Mr. Gregg, distinguished members of the Committee on Health,

Education, Labor, and Pensions. President Bush asked me to convey his appreciation for the comprehensive, expeditious, and most importantly, bipartisan manner

in which the Senate is considering his proposal to make America safer by creating

a Cabinet-level Department of Homeland Security to unite essential agencies that

must work more closely together.

In the weeks since the President submitted a detailed legislative proposal to Congress, both the Senate and the House of Representatives have conducted hearings

to consider different aspects of the draft Homeland Security Act of 2002. In the Administration’s view, many of the amendments to the Administration’s legislative

proposal under consideration in both chambers would strengthen the ability of the

new Department to provide a unified homeland security structure that will improve

protection against today’s threats and be flexible enough to help meet the unknown

threats of the future. Some of the amendments under consideration, however, would

impair the Department’s ability to secure our homeland. In this statement, I will

review aspects of the President’s proposal related to preventing bioterrorism.

Through all of this legislative activity, it is important to stay focused on our goal.

The United States is a nation at risk of terrorist attacks and it will remain so for

the foreseeable future. We need to strengthen our efforts to protect America, and

the current governmental structure limits our ability to do so. Change is needed

now. It is our job—Executive Branch and Legislative Branch working together—to

implement this change.

II. THE NEED FOR HOMELAND SECURITY: THREAT AND VULNERABILITY

We are today a Nation at risk to terrorist attacks and will remain so for the foreseeable future. The terrorist threat to America takes many forms, has many places

to hide, and is often invisible. Yet the need for improved homeland security is not

tied solely to today’s terrorist threat. It is tied to our enduring vulnerability.

All assessments of the terrorist threat must start with a clear understanding that

terrorists are strategic actors. They choose their targets deliberately based on the

weaknesses they observe in our defenses and our preparations. They can balance

the difficulty in successfully executing a particular attack against the magnitude of

loss it might cause. They can monitor our media and listen to our policymakers as

our Nation discusses how to protect itself—and adjust their plans accordingly.

Where we insulate ourselves from one form of attack, they can shift and focus on

an other exposed vulnerability.

The United States faces a profound danger of terrorism. We were dealt a grave

blow on September 11 and we face today the real possibility of additional attacks

of similar or even greater magnitude. Our enemies are working to obtain chemical,

biological, radiological, and nuclear weapons for the stated purpose of killing vast

numbers of Americans. Terrorists continue to employ conventional means of attack,

such as bombs and guns. At the same time, they are gaining expertise in less traditional means, such as cyber attacks. And, as we saw on September 11, our terrorist

enemies will use new tactics and exploit surprise to carry out their attacks and

magnify their deadly effects.

Our population and way of life are the source of our Nation’s great strength, but

also a source of inherent vulnerability. Our population is large, diverse, and highly

mobile, allowing terrorists to hide within our midst. Americans assemble at schools,

sporting arenas, malls, concert halls, office buildings, high-rise residences, and

places of worship, presenting targets with the potential for many casualties. Much

of America lives in densely populated urban areas, making our major cities conspicuous potential targets. Our factories, power plants, and parts of our transportation system could be attacked to cause systemic disruption. Americans subsist on

the produce of farms in rural areas nationwide, making our heartland a potential

target for agroterrorism.

The U.S. government has no higher purpose than to ensure the security of our

people and preserve our democratic way of life. Terrorism directly threatens the

foundations of our Nation—our people, our way of life, and our economic prosperity.

In the war on terrorism, as in all wars, the more we know about our enemy, the

easier it is to defeat him. Similarly, the more we know about our vulnerabilities,

the better we can protect them.
9

III. THE NATIONAL STRATEGY FOR HOMELAND SECURITY

When President Bush established the Office of Homeland Security in October

2001, the first mission he assigned the Office was ‘‘to develop and coordinate the

implementation of a comprehensive national strategy to secure the United States

from terrorist threats or attacks.’’ The President recognized that the United States

has never had a shared national vision of what must be done to secure the homeland against the full range of terrorist threats we face today and might face in the

future.

The National Strategy for Homeland Security released this morning by President

Bush is the product of over eight months of intense consultation across the breadth

of the United States. In preparing this document, we consulted with thousands of

people across the country—from the public and private sector and from numerous

disciplines. Their ideas are reflected in the Strategy. Above all, we sought to create

a national strategy that can mobilize and organize our Nation to secure the U.S.

homeland from the threat of terrorism.

The National Strategy for Homeland Security will help to prepare our Nation for

the work ahead in several ways. It is a single, comprehensive statement of virtually

everything that needs to be done to secure the homeland to which all Americans

can refer. It provides direction to the federal government departments and agencies

that have a role in homeland security. It suggests steps that state and local governments, private companies and organizations, and individual Americans can take to

improve our security and offers incentives for them to do so. It recommends certain

actions to the Congress. In this way, the Strategy provides a framework for the contributions that we all can make to secure our homeland.

The Strategy aligns and focuses homeland security functions into six critical mission areas: Intelligence and warning; Border and transportation security; Domestic

counterterrorism; Protecting critical infrastructure; Defending against catastrophic

terrorism; and Emergency preparedness and response.

The first three of these mission areas focus primarily on preventing terrorist attacks; the next two on reducing our vulnerability; and the final one on minimizing

the damage and recovering from attacks. Starting with the President’s FY04 Budget, every homeland security dollar in future budgets will correspond with one, and

only one, critical mission area. In this way, the Strategy provides a framework to

align the resources of the federal budget directly to the task of securing the homeland.

In addition, the Strategy also describes four foundations of our homeland security

effort—unique American strengths that cut across all of the mission areas, across

all levels of government, and across all sectors of our society. There are: (1) law;

(2) science and technology; (3) information sharing and systems; and (4) international cooperation.

The Strategy is a national, not just federal, strategy. It recognizes that homeland

security is a shared responsibility and that the federal government does not have

the solution to all problems. The Strategy pays close attention to the roles of the

state and local government, the private-sector, and citizens. The President’s intent

in publishing the National Strategy for Homeland Security is to help Americans

achieve a shared cooperation in the area of homeland security for years to come.

IV. OVERVIEW OF THE PROPOSED DEPARTMENT OF HOMELAND SECURITY

When President Bush directed his Administration to develop the National Strategy for Homeland Security, it was immediately clear that doing so would require

careful study of how the federal government is organized for the mission of homeland security. Like many who have examined this question, we quickly concluded

that the federal government can be much better organized than it presently is.

Homeland security is, in many respects, a new mission, so it should come as no surprise that our strategic review concluded that the structure of the federal government must be adapted to meet the challenges before us.

The President proposed the establishment of the Department of Homeland Security on June 6, roughly five weeks prior to the publication of the Strategy. The proposal to create the Department preceded the Strategy because we finished our work

on the organizational issue first and because of our wish to deliver the proposal to

create the new Department to the Congress in time for action during the current

legislative session. As the President said in his June 6 address to the Nation, ‘‘we

face an urgent need, and we must move quickly, this year, before the end of the

congressional session.’’

Creating the Department of Homeland Security proposed by President Bush

would result in the most significant transformation of the U.S. government in over

a half-century. It would transform and largely realign the government’s confusing
10

patchwork of homeland security activities into a single department whose primary

mission is to protect our homeland.

Currently, no federal government department has homeland security as its primary mission. In fact, responsibilities for homeland security are dispersed among

more than 100 different government organizations. Creating a unified homeland security structure will align the efforts of many of these organizations and ensure that

this crucial mission—protecting our homeland—is the top priority and responsibility

of one department and one Cabinet secretary. The fundamental mission of the Department would be to: Prevent terrorist attacks within the United States; Reduce

America’s vulnerability to terrorism; and Minimize the damage and recover from attacks that do occur.

The Department of Homeland Security would mobilize and focus the resources of

the federal government, state and local governments, the private sector, and the

American people to accomplish its mission. It would have a clear, efficient organizational structure with four primary divisions.

Establishing a new department to meet current and future homeland security

challenges is both a vital enterprise and an extraordinarily difficult and complex

one. The success of a new department in protecting our country will depend upon

two principal factors: (1) ensuring that the new Department has the right building

blocks moved into it, and (2) ensuring that the leadership of the new Department

is given the right set of tools to work with and manage those blocks to ensure that

the benefits of consolidation, in terms of both security and efficiency, can be

achieved. There are a variety of issues in both categories, and we have strong views

about many of them. I look forward to answering any specific questions members

of the Committee may have about the President’s proposal. I’ll use the balance of

this statement to focus on aspects of the proposal that relate to protecting the American people from the threat of bioterrorism.

RESPONDING TO THE THREAT OF BIOTERRORISM

There are few threats that could endanger our national survival. The threat posed

by the Soviet Union’s vast nuclear arsenal was one such threat. The threat of bioterrorism is another. If properly employed, certain biological agents could cause tens

or hundreds of thousands of casualties and wreak huge economic damage. Given the

vast quantities of biological weapons that already exist around the world, the risk

of terrorists and their supporters obtaining and using these weapons is sufficient

to warrant a massive effort to prevent such attacks.

Under the President’s proposal, the Department of Homeland Security would

unify much of the federal government’s efforts to develop and implement scientific

and technological countermeasures against human, animal, and plant diseases that

could be used as terrorist weapons. The Department would sponsor and establish

national priorities for research, development, and testing to invent new vaccines,

antidotes, diagnostics, therapies, and other technologies against bioterrorism; to recognize, identify, and confirm the occurrence of an attack; and to minimize the morbidity and mortality caused by such an attack. In addition, the federal government

will set standards and guidelines for state and local biological preparedness and response efforts.

The President recognizes that all these efforts against bioterrorism must be part

of a broader research and development program. Therefore, the President’s proposal

would charge the new Department with leading the federal government’s whole

range of homeland security science and technology efforts. Currently, the bulk of our

scientific efforts against biological terrorism are conducted by the Department of

Health and Human Services and are separate from research against other weapons

of mass destruction. The President’s proposal would consolidate the funding and

oversight for these programs with other scientific initiatives in order to ensure that

priority threats receive an appropriate percentage of our national research and development investment. This effort would avoid stove-piped approaches to research

and development by pursuing priority programs in multipurpose research institutions such as the National Institute of Health. Working within the context of the

national priorities established by the Department of Homeland Security, the NIH

and others would continue to make decisions on the disbursement of research funding dollars consistent with sound science and expertise.

The President’s proposed legislation would transfer the select agent registration

enforcement programs and activities of HHS, the National Pharmaceutical Stockpile, the new National Bio-Weapons Defense Analysis Center of the Department of

Defense, the Plum Island Animal Disease Center of the Department of Agriculture,

and various programs and activities of the Department of Energy related to the nonproliferation of CBRN technologies and material.
11

SELECT AGENT PROGRAM

The recently enacted Public Health Security and Bioterrorism Preparedness and

Response Act of 2002 authorized the Department of Human Services (HHS) and the

Department of Agriculture (USDA) to promulgate and enforce regulations concerning the possession and use of Select Agents—certain hazardous biological organisms

and toxins widely used in over 300 research laboratories across America. Examples

include the bacterium that causes anthrax, the bacterium that causes Plague, and

the virus that causes Ebola, a lethal hemorrhagic fever. Select Agents are prime

candidates for use by would-be bioterrorists and thus, when used in research, must

be kept constantly under safe and secure conditions.

The Administration believes that the new Department, with its strong multi-purpose security infrastructure, will be best suited to prevent nefarious or other irresponsible uses of Select Agents. The Administration proposes that the Secretary of

Homeland Security would administer the select agents program in consultation with

the Secretaries of HHS and USDA with these agencies continuing to make key medical and scientific decisions, such as which biological agents should be included in

the select agents list.

THE NATIONAL PHARMACEUTICAL STOCKPILE

CDC currently manages 12 ‘‘push packages’’ of pharmaceutical and medical supplies and equipment strategically located around the United States; additional lots

of pharmaceuticals and caches of medical materiel are maintained by manufacturers

under special contractual arrangements with CDC. One of the push packages was

dispatched to New York City on September 11 and elements of the stockpile were

used to respond to the anthrax attacks.

The President’s proposal integrates the stockpile with other national emergency

preparedness and response assets at the new Department. The Secretary of Homeland Security will assume responsibility for continued development, maintenance,

and deployment of the stockpile—making it an integral part of the larger suite of

federal response assets managed by FEMA and other future DHS components—

while the Secretary of Health and Human Services will continue to determine its

contents. The arrangement will ensure effective blending of the public health expertise of HHS with the logistical and emergency management expertise of DHS.

RESEARCH IN LIFE AND ENVIRONMENTAL SCIENCES

The Department of Homeland Security would also oversee portions of the Department of Energy program in the life and environmental sciences. This activity will

provide a core around which to grow DHS programs in, for example, identifying and

understanding the microbial components that define a pathogen’s life cycle, transmission, virulence, and invasiveness; sequencing the genomes of select organisms

and strains as well as developing central bioinformatic resources or tools for rapid

use of genomic information; and dealing with the threat of engineered pathogens.

V. CONCLUSION

Over the past nine months, the Administration has conducted a thorough review

of existing government institutions and systems for providing homeland security,

such as law enforcement, public safety, public health, and emergency management.

We concluded that the current arrangement was not the best way to organize for

homeland security because responsibility is scattered across the government, information is not fully shared, authority is shared by multiple agencies, and numerous

redundancies cause inefficiency.

The fragmentation of border security responsibilities is a case in point. In his testimony before a House Committee last week, Treasury Secretary Paul O’Neill cited

a recent example of overlapping responsibilities. The Customs Service—part of the

Department of Treasury—stopped a suspicious boat and searched it for illegal drugs

and other contraband. However, the Customs agents found illegal aliens. Customs

transferred the aliens to the Coast Guard—currently part of the Department of

Transportation. The Coast Guard, upon reaching land, then turned over the aliens

to the Immigration and Naturalization Service—currently part of the Department

of Justice. In such a fragmented system, a terrorist can easily slip through the bureaucratic maze undetected. Under the President’s reorganization proposal, a single

department would be responsible for border security.

The Homeland Security Act of 2002 includes twenty-two of the more than one

hundred Executive Branch organizations or entities that have significant homeland

security responsibilities. The President’s proposal includes those agencies whose primary focus is in the areas of preventing terrorist attacks, reducing our Nation’s vul-
12

nerability to terrorism, and building our recovery capabilities. It includes those

agencies whose ability to contribute to homeland security would be improved by

being in a Department whose core competency and single mission was homeland security.

In the weeks since President Bush submitted a concise draft bill to the Congress,

the Administration has worked closely with Senate committees as they have considered our proposal. Our intent is to ensure that the final bill establishes clear and

workable lines of authority and accountability, leverages the strengths of the agencies that will compose the Department of Homeland Security, and provides the new

Secretary the authorities and management flexibility he or she will need to effect

enormous change so that the new Department can adapt to the changing threat of

terrorism. The Administration’s proposal does not seek to usurp the prerogatives of

the Congress or any Committee. We are simply trying to ensure that, on a practical

basis, the Department of Homeland Security can get organized and operational— and do the best possible job of protecting Americans.

Again, I thank the members of the Committee on Health, Education, Labor, and

Pensions and the Senate for the serious and expeditious action you are taking on

this proposal to strengthen the Nation’s collective effort to secure America.

Senator REED. [presiding]. Thank you very much, Governor

Ridge, for your statement and also for your great leadership and

service in this demanding role as Director of Homeland Security.

I had the privilege of serving with you in the House, and I am not

surprised that you have responded so significantly well to this challenge.

Let me begin with a question that was introduced by both Senator Kennedy and Senator Gregg, and that is the status of employees and workers who might be in this Homeland Security Department.

Everyone recognizes the need for flexibility, particularly in an

international emergency, but as I understand Federal labor laws,

they do give a great degree of flexibility in emergencies. There is

a danger, though, that this might be used simply to create a work

force that is not fairly represented in a collective way, which has

been consistent with our policy for years.

I note that the President last January through executive order

used a very rarely used authority to forbid secretaries for Federal

attorneys to organize. Previously, this power was used only for

army intelligence, naval intelligence, those people who were dealing with very sensitive materials.

So can you give us the assurance that legitimate rights of workers in your proposed Department will be protected through their

right to organize and bargain?

Mr. RIDGE. Senator, I would like to reiterate not just my assurance but, more important, the President’s assurance. These men

and women, if Congress goes along with the President’s plan,

transfer into this new agency with their collective bargaining rights

that would be preserved as well as the benefits associated with

that. They would transfer in with the same whistleblower protection, civil rights protections, veterans’ preference protections.

However, the President is hopeful that, working with Congress,

we can carve out some new prerogatives for the management team

so that we can create the kind of flexibility to attract and retain

not only the men and women who may be thinking about retirement—and there are many Senators who are worried about work

force retirement; it is going to reach a very critical stage in the

next 2 or 3 years—but also to give this new management team the

capacity outside the existing civil service limitations to go out and

attract the very best people at certain levels of the administration.
13

So we want to preserve those protections, and we are certainly

hopeful that while we preserve the Title V protections, we can give

the new management team some options, some discretion, to go out

and attract and retain the best people possible.

But I reiterate the President’s commitment. These men and

women are encouraged to be upright and to operate in an environment that encourages their recognition of not only their mission,

but if there is a problem that they see, I think the President would

view any analysis that said we have a problem structurally as a

constructive piece of information, and we would want that to be

shared, and the President wants a workplace that is free of discrimination and any kind of potential retaliation.

This work force needs to be empowered. They need to be empowered with a sense of mission. They need to be comfortable with

their job security. But the management team also needs to be empowered—empowered to give these employees more technology, empowered to go out from time to time and attract the best people

throughout this country, be it from the public sector or the private

sector.

Senator REED. Thank you, Governor. I am sure this is not the

last time that you will be asked about this.

Mr. RIDGE. It is a legitimate concern, President, and the President appreciates it as well. And it is not about the Title V protections. What we are hoping to do—because the President has said

they will apply—whistleblowers, civil rights, veterans’ preference— but there needs to be a way that the new management team can

go out and attract some of the best people.

I know the concern on the Hill, legitimately, is will it be used to

undermine collective bargaining rights. Well, it will not. But the

question is should this new management team have the flexibility

to be able to deal with an employee who does not do the job. The

agency is going to be held accountable, and I think we are just

looking for ways to create some discretion for the new Secretary.

Senator REED. Let me follow up with another question, Governor.

In fact, your experience as Governor is vitally important to your

new role, because a lot of what is going to be done is not at the

Federal Government, but it is a partnership between Federal,

State, and local governments.

As we speak here today in Washington, the Governors are assembled in Idaho, bemoaning the fact that their budgets are in tatters, that they are looking at exhausting all of their extra capital

and resources. And yet collectively, we have to marshal significant

resources to this fight.

This Homeland Security Department that you are proposing

would be involved in using State health departments to monitor

disease, and helping local hospitals to construct capacity and increase their response capabilities.

I guess the basic question is even if we assume we can put the

pieces together here in Washington, where are the States going to

get the money to match the effort that is needed. If they cannot

come up with resources, will the Federal Government have to step

in and provide those resources?

Mr. RIDGE. Senator, that is a very appropriate question because

I talked to 30-plus Governors yesterday when we set up a con-
14

ference call to talk about the President’s National Strategy, and not

surprisingly, that very issue came up. Having been a Governor during 5 or 6 years when the economy was booming, I appreciate the

challenges that my colleagues have had for the past year.

Senator REED. You got out in time.

Mr. RIDGE. Of course, if they had been like Pennsylvania and set

aside or created a huge rainy day fund, it might not have been

quite a predicament, but it is a huge predicament for my former

colleagues; it is massive no matter how much money they set aside.

I think it is pretty clear, number one, that later today or tomorrow, we are going to set out a companion piece that shows what

the States and locals have begun to do on their own—and obviously, they are already expending money, and a lot of it, and we

applaud that.

Second, there will be some investments that the Federal Government makes that they will make unilaterally—there will be no

match.

Third, in anticipation of the legitimate concerns that the Governors presently have with the economic status of their States and

ability of those States, there are a couple of places here where we

do have matching funds required, but in many instances, one could

say it is a very soft match, that by and large, the primary source

of revenue to get us through the first year, the 2003 budget year,

will be the Federal Government. But it is not to be denied—States

and local governments have stepped up, and when you get a chance

to take a look at the initiatives undertaken by the States and local

communities, the country can be proud that there are a lot of people working very hard on securing their home towns and the

States. The Governors and the mayors on both sides of the aisle

have done an outstanding job in doing just that.

Senator REED. Thank you very much, Governor.

Senator Frist, Senator Hutchinson?

Senator FRIST. I will defer to my colleague.

Senator REED. The early bird rule.

Senator Hutchinson?

Senator HUTCHINSON. Thank you, Mr. Chairman.

Governor Ridge, thank you for your appearance today and for

your leadership and willingness to serve in a time of crisis for our

Nation and to serve with great distinction. We are grateful for your

service.

In your testimony, you indicate that one of the fundamental missions of the Department as the President has envisioned it, is to

reduce America’s vulnerability to terrorism. You very rightly testified that if properly employed, certainly biological agents could

cause tens of hundreds of thousands of casualties and wreak huge

economic damage.

You say that ‘‘Given the vast quality of biological weapons that

already exist around the world, the risk of terrorists and their supporters obtaining and using these weapons is sufficient to warrant

a massive effort to prevent such attacks.’’

I could not agree more, and I think this is probably the great

nightmare for most public policy officials. Senior administration officials have told me that what keeps them awake at night is their

concern about the possibility of a biological terrorist attack.
15

And we face a very real and very serious crisis in the supply of

vaccines against biological weapons. According to the Defense

Science Board, we currently have effective countermeasures

against only 13 of the 50 pathogens most likely to be used as bioweapons. We only have four major vaccine manufacturers in the

Nation, and even in basic childhood vaccines we have a serious

shortage in our country.

As the Department of Defense and the Department of Health and

Human Services work to finalize a proposal to create a new Vaccine Council to coordinate the requirement for vaccines against biological weapons, is it your understanding that that council will be

located in the Office of Homeland Security or the new Department

of Homeland Security? What is your vision for how we can address

this crisis in the area of biological vaccines?

Mr. RIDGE. Senator, that interagency effort would play, I think,

an invaluable role in providing some guidance and leadership in

tandem with the new Secretary of the Department of Homeland Security. It is pretty clear, as you have very appropriately identified,

that Health and Human Services, the Department of Homeland Security, the Department of Defense, and even other agencies have

an interest in identifying not only the potential pathogens and the

potential biological threats but also, in anticipation of their use,

coming up with diagnostic tools, vaccines, and the like to deal with

those threats.

So I suspect, one, that it would just add value to the deliberations that the new Secretary and his team would make as they try

to give a strategic focus to the bioterrorism research and development dollars that the President would like to task this agency to

do. I know it is a matter of concern here, particularly with Congress, who have worked so hard and so successfully on your own

bioterrorism measure. Having identified the problem and committed resources to it and having Health and Human Services as the

lead agency in dealing with this issue, there is a transfer of some

of that responsibility—not a transfer of personnel, not a transfer of

assets—but there is a transfer of some of that responsibility in

identifying where some of those dollars are going to be spent, and

I know that that is a point of consideration and concern that Members have that that money would end up being directed by the Department of Homeland Security. But it would be directed in consultation with Health and Human Services and the Department of

Defense as we take in the strategic need of the country based on

threat information.

Senator HUTCHINSON. And, Governor, if I might just follow that

up, there have been numerous studies that have recommended that

in the area of vaccine production, we not rely upon a sole provider

or the private sector and that our Nation establish a Governmentowned, contractor-operated, GO–CO, production facility for our vaccine needs.

DOD has recommended this approach at least twice from their

own internal studies, and the Institute of Medicine has likewise

recommended, as well as the previous Surgeon General.

Right now, we are totally dependent upon Bioport for anthrax

vaccine production. What is your personal attitude toward where

we should rely and where we should look for vaccine production?
16

Mr. RIDGE. Well, I think again you have highlighted a need that

has been identified by other departments within the Federal Government. You mentioned the Department of Defense suggested that

building up this capacity is something that we ought to consider

doing. I suspect that the Secretary of Health and Human Services,

as he takes a look at the vaccine production capacity in this country, depending on if we had a surge need—I understand that they

have talked positively about this kind of arrangement. And I would

suspect that the new Secretary would want to entertain a collaborative effort with DOD and HHS in that direction. I do not think

I could prejudge where the new Secretary would take that discussion, but since the need has been identified in part by some of his

or her colleagues on the Cabinet, it might be a very appropriate

subject for interagency collaboration and interagency financing

since the benefit will go across both defense and civilian use.

So I think it is certainly worth the new Secretary examining in

collaboration with a couple of Cabinet partners.

Senator HUTCHINSON. Thank you, Governor.

Senator REED. Thank you, Senator.

Senator Murray?

Senator MURRAY. Thank you, Mr. Chairman.

Governor, thank you for being here today. I appreciate the good

job that you have been doing. You have been asked to take on a

very challenging position at a very important time in our Nation’s

history, and I appreciate all of your efforts. You have been accessible and have worked with us on a number of issues, and I really

appreciate it.

One of the issues that I have talked with you a lot about is our

Northern border. There is no doubt that we need to have an effective, strong plan between ourselves and the Canadian Government

and the Mexican Government about people who come in, but it also

really impacts our economy as well, as we slow it down. In Washington State, we have the second highest unemployment in the Nation, and part of that is because the flow of goods between Canada

and Washington State has been tremendously impacted since September 11.

So we need to have a good plan. We need to work well with those

governments. We need to make sure that we do not impact the free

flow of goods, but we also want to make sure that we have good

contacts with those governments to ensure they are doing everything they can so we can move those goods effectively without worrying about who is coming across our border.

I wonder if you could share with us today your assessment of the

Northern border situation, where we are working with the Government of Canada to ensure that we have the security that we require as we work through this.

Mr. RIDGE. Senator, I appreciate you raising the issue, because

you and I have had this conversation many times, that while we

look to securing our borders, we also understand that we must do

so in a way that does not jeopardize communities, families, and

jobs and the economic vitality particularly of the border States

where there is so much economic interaction.

We are moving ahead I think very positively and quite aggressively on a 30-point proposal that we began with our Canadian
17

counterparts in December of last year. It involves creating a

‘‘smart’’ border between the two countries. And if you will take a

look at the National Strategy for Homeland Security, you will be

able to see some of the priorities for the 2004 budget, and one of

those priorities as identified in the strategy is the ‘‘smart’’ border

with Canada and Mexico, which means that while we are going to

work with the private sector to set up protocols, to secure goods

and the transfer of goods across the borders, and while we are

going to work with the Canadian Government, we may have to

make some strategic infrastructure investments as well, and certainly to make some technological investments.

I know that the Canadian Government and my counterpart, John

Manley, who is the Vice Prime Minister, actually has a fund that

they can use for some infrastructure improvements at the border.

So once we get this border accord completed—we are hoping to get

it done within the next, I would say, 2 or 3 months—and people

are working very hard on it; it is very complicated; it talks about

infrastructure, it talks about people, it talks about cargo, and it involves the private sector—we would then want to take a look at the

other issues, and one of those would be infrastructure needs.

So again, I think a lot of progress has been made, and it is specifically directed by the President, who said we need 21st century

smart borders; we have to secure them, but let us be mindful of the

fact that people’s livelihoods depend on it.

So I appreciate your support of that initiative, and I think there

is more to be said as we get closer and closer to the final agreement. But it also takes in sharing passenger information lists. We

are working on protocols for railroad transportation. We may have

something coming into this country from Nova Scotia or Vancouver,

and we want to establish a means by which, if they are cleared in

Canada, they can move unimpeded into this country; they feel the

same way.

So a lot of good progress has been made, and hopefully, we can

bring it to conclusion before the end of the year.

Senator MURRAY. Another challenge to that is if there is some

kind of bioterrorist or agro-terrorist act right along the border, do

you believe that we have good, quick exchange of information,

channels available, between Canada and the United States?

Mr. RIDGE. Your question is timely and appropriate inasmuch as

one of the things that the Deputy Prime Minister and I have identified is that we really focused in on people, cargo and infrastructure. That is the first series of things that we want to do. But we

also see the possibility, because we are such good neighbors and we

have such a unique relationship among countries, that we take the

next step, the next accord, between the two countries into issues

like this—perhaps collaborative research, sharing the kind of information that would help both countries deal with a bioterrorism

event.

So I think there is still more work to be done, but I must tell

you that I have been very encouraged by the extraordinary commitment of our Department of State, INS, Customs—everybody is

working very hard to accomplish this—but the total commitment of

the Canadian Government to get it done and then, once this phase
18

is completed, move on to the next phase to discuss some of the

issue that you have addressed in your question to me.

Senator MURRAY. Very good. I look forward to working with you

on that.

I do have one more question that I specifically wanted to raise

with you this morning. In the administration proposal, you are proposing to transfer much of the chemical, biological, and nuclear response and the research activities to the Department of Homeland

Security. I have to say that that does cause me some concern, because we are transferring some very important efforts into an organization that is really struggling to find its niche. What is really

of special concern to me is specific populations—children, elderly,

pregnant women. I do not believe they receive as much attention

when we develop our medical research and our emergency evacuation plans and responses to that.

A specific and very good example of that is the hoods that we

have been hearing a lot of publicity about here, that we have

placed in the Capitol for people who are here. They are designed

to protect Members, staff, and the public who are here in case of

some kind of exposure.

Those hoods do not fit kids. As one of our first questions when

we saw that—you have a parent with a child, and everybody has

a hood on, and that parent is panicked because their child does not

have a hood that fits, and that is the case here today.

How do you and other organizations that are putting together

these plans take into account the research, whether it is on immunization or whether it is the hoods or all the other things that we

are looking at? How do we make sure that people are not just all

categorized as one set of people, but that we do take into account

children and women and pregnant women in many of these areas?

Mr. RIDGE. I think that the primary focal point for this kind of

research and the sensitive to unique populations within that research is very much part of the protocol of the CDC and the NIH.

I think that is where it has been, and that is where it should continue to reside.

I want to focus on the research and development concerns that

you have expressed. As part of the overall NIH budget, which I

think is about $27 billion—I am not sure—is really limited to about

$1.5 billion, and that sum—and there is very, very appropriate language in the President’s measure that says that we share this responsibility with the Secretary of Health and Human Services, that

the research infrastructure remains there. This is really a very significant collaboration between the new Department in this one area

of terrorism-related research.

I say that because the President would like to give this Secretary

and this Department the benefit of not only the relationship with

Health and Human Services but also with the intelligence community so that on an annual basis, a piece of the research that we do

in this country—and $1.5 billion out of $27 billion is a significant

piece, but only about 6 or 7 percent—can be directed, depending on

the circumstances, to a potential biological threat. It would be in

that context that the new Secretary would work to bring a strategic

focus to this limited number of research dollars, and hopefully in

tandem with HHS, with NIH and the CDC, who obviously do not
19

aggregate America’s population. They understand that, depending

on your immune system, depending on your age, depending on a

variety of things, it will affect how you respond to any of the antidotes or vaccines. But this basic research is to deal with potential

threats and use of that information in collaboration with NIH and

the Centers for Disease Control and Health and Human Services

I think will certainly recognize the unique nature of some of these

populations.

Senator MURRAY. As we move quickly to consolidate, I think it

is very important that we do not lose sight of those very important

roles of some of those agencies and their focus, especially on these

populations. Sometimes that can get lost when you crunch a bunch

of people together. So I just want to point that out, and I will be

reminding us over and over again as we move through this.

Thank you.

Mr. RIDGE. Thank you, Senator.

Senator REED. Before I recognize Senator Frist, I have to go to

the floor and be the presiding officer at 11, so I would ask the Senator to, at the conclusion of his questioning, adjourn the hearing

or recognize other colleagues who may have arrived.

Senator Frist.

Senator FRIST. [presiding]. Thank you, Mr. Chairman.

Governor Ridge, welcome. I apologize for not being here earlier.

I did read your written comments.

Mr. RIDGE. You have probably heard most of it before, Senator.

Senator FRIST. No, no. I want to restate what everybody has

said. Your tremendous leadership and insight during difficult times

has been something that we should both thank you and congratulate you.

Let me make some general comments, and then I want to come

back and ask some clarifying questions. Some of which you may

have already answered, but I have a few questions just to predict

where we would be in 3 years under this new structure.

But before doing that, I want to comment on two things—coordination and communication. In August of last year, the GAO released its report stating that the coordination of Federal terrorism

research and preparedness and response programs was fragmented

creating inefficiencies. These inefficiencies were reflected in what

we saw in the response to anthrax last October. We did the best

we could, but the inevitable outcome of having fragmentation are

barriers in both coordination and communication.

There are 21 different agencies that have the task of responding

to bioterrorism, and there are several other agencies in charge of

coordination. Inevitably, you will see the confusion and lack of accountability inherent in a fragmented system.

I mention because I think the Homeland Security proposal directly focuses on problems we saw in October and November as

well as what is structurally inherent in the current system.

We started dealing through this committee in a bipartisan way

with the issue of bioterrorism about 4 years ago due to a disconnect

between our intelligence community, our public health community,

and our research community. Coming from the medical profession,

if the intelligence community had identified risks, why wasn’t there

sufficient research? How the research is outlined and prioritized in
20

this country is based on the input, the lobbying, the identified objectives, but there was no communication with the intelligence community. So I am delighted to see that that is being addressed in

the proposal.

The components that you mention that I fully support as part of

the Department of Homeland Security are the stockpile, the National Disaster Medical System, and some of the public health components.

However, I do have certain concerns. We must ensure that we

have a strong public health infrastructure.

In this country, we have not sufficiently in vested in that infrastructure over the last 30 years. It has not been supported as much

as I would like, or as I think is necessary.

Our public health infrastructure has not been a priority. And I

want to make absolutely sure that in terms of preparedness, we

have a system in place that will inherently be supporting public

health.

I mention that because as we developed our bioterrorism bill in

this committee in 2000 and 2002, I found myself spending more

time with my colleagues to make sure that, of the initial $3 billion,

about $1 billion continued to support public health. I fear we are

going to lose the support for public health. Second, dual use is absolutely critical. When we spend $3 billion on bioterrorism, or $6 billion this coming year, one of the beautiful

things is that it involves dual use. There are about 1,000 people

hospitalized every day for foodborne infections, and about 5,000

people die every year. Additionally, 20,000 people die of the flu

every year. If it is not a bioterrorist attack of Ebola virus or the

plague or anthrax or smallpox or hemorrhagic viral fever, the same

system that responds in terms of surveillance is the system that

picks up the foodborne or the flu. I want to make absolutely sure

that structurally, we are addressing issues of dual use.

Finally—and I think you answered the question with Senator

Murray—when we talk about vaccines and the great expertise that

is currently in place, the big fear is that as we strip away certain,

more targeted research, there is a stripping away instead of being

able to capitalize on the shared benefits of peer-to-peer professional

researchers working together. Research related to a vaccine for

HIV/AIDS, which may be outside of direct concern to developing an

anthrax or smallpox a vaccine, may provide insight into developing

the other vaccines. A vaccine is a vaccine.

Let me just throw those concerns out there and let you respond,

and then I would like to ask a couple of other questions.

Mr. RIDGE. Well, Senator, I think you have highlighted one of the

most critical initiatives contained within the President’s proposal

and obviously one of the highest priorities of this country.

We know that these terrorists will use, if they can get their

hands on them by theft, by their own research, or by acquisition,

bioterrorism weapons against us. We know that. Someone used anthrax as a weapon, and we know what we did right in response to

that, and we know where there are gaps and weaknesses in our

public health infrastructure in response to that.

We know that we need one central agency to be able to coordinate response to a bioterrorism event. So as difficult and as painful
21

to the families who were affected by the anthrax crisis—the loss

was tragic, and irreplaceable—the country learned a great deal

about itself. Unfortunately, there probably were not enough advocates for public health support prior to October 2001, such as yourself and a few others. Now there is enormous support. As you

know, the President in his 2003 budget has a significant request

in which, with your leadership and continued support, I am confident that the Congress will make available to the public health

community.

So as we identify the task before us—and I think you have very

appropriately sequenced the responsibilities—prevention, preparation and response—I think those call for a rather unique relationship between the new Secretary of the Department of Homeland

Security and the Secretary of Health and Human Services. It is the

only relationship between the new Secretary and an existing member of the Cabinet that I think is reiterated in very clear terms in

the President’s legislation. And if I might, where it says ‘‘the conduct of certain public health-related activities,’’ it says ‘‘except as

the President may otherwise direct, the Secretary’’—that is the

Secretary of the Department of Homeland Security—‘‘shall carry

out the civilian, human, fundamental health-related, biological, biomedical, infectious disease, defense, research and development, including vaccine research and development, responsibilities

through’’—not independently—‘‘the Department of Health and

Human Services, including the Public Health Service, under agreements with the Secretary of Health and Human Services and may

transfer moneys to those entities.’’ There are many other references to that kind of relationship that

the new Secretary will have. So I think pretty clearly in recognition

of what we need to accomplish, the President has said that this

cannot be done without, frankly, the collaboration and the interagency agreement between the two Secretaries.

Second, if I might, I do want to focus on the research and development component, because I understand the concern that—I want

to underscore that the $1.5 billion gives the Secretary the flexibility to engage the NIH and other pieces of the national research infrastructure that we have for very specifically related scientific research based upon a threat assessment. To your point, you saw before—there was never a connection between the intelligence community, the medical community, the scientific community.

So I think it is reasonable and very responsible, again in collaboration with the Secretary of Health and Human Services, to say

that out of this funding that NIH receives, about $27 billion, a

piece of that be directed—it may be that perhaps all of it ends up

with NIH—but not necessarily where the science of ongoing research is taking them, which are very legitimate needs and causes,

but depending upon the threat, direct that research to a specific

outcome.

And as you pointed out, more often than not, in this kind of research, there is dual use—not only will we be able to combat potential bioterrorist attack, but there will applications across medicine

generally.

Senator FRIST. On the relationship between the Cabinet members and the language stating the ‘‘Secretary acting through the
22

Secretary of Health and Human Services’’ a different construct, you

began to explain it by emphasizing the close coordination. Is there

another example in Federal statute where a Cabinet member has

statutory authority over activities of personnel who report to a different Cabinet member?

Mr. RIDGE. Well, I do not believe so, although I am not—I do not

want to give you a conclusion based on research, because I have

done none. I do not know if it exists elsewhere. I do know that in

response to the new threat and in recognition of the enormous capacity and the technical infrastructure, the scientific infrastructure, and the personnel, the President believes that the decisions

made as to where to send these dollars should be made in conjunction with the Secretary of Health and Human Services, and there

is great likelihood—more possibility than not—that we will end up

going back down to CDC or NIH.

Senator FRIST. In the prevention and even the preparedness component, the coordination, communication, and is the prioritization

is critical. In the response component, when you have the Secretary

of Homeland Security acting through the Secretary of Health and

Human Services, if there is a disagreement between the two Secretaries in terms of responding to a emergency, how are disputes

resolved between these two Secretaries?

Mr. RIDGE. Senator, I believe that included in the President’s

proposal to the Congress is the retention of the nonstatutory office

within the white House with regard to the existence of the position

that I present hold as an Assistant to the President for Homeland

Security, and that is a coordination role, and from time to time, a

monitoring role and a decisionmaking role that is a specific process.

Again, you do not want to get bogged down in process if you have

to make quick decisions, but I think there is a decisionmaking capacity within the White House if there is a dispute that cannot be

resolved between the principals to move this along as quickly as

possible, and more often than not, it may end up with that assistant to the President being involved in getting it done.

I guess I cannot think of too many occasions when they would

be at ends, because again, it is not matter of transferring personnel

or any of the assets from Health and Human Services over to the

Department of Homeland Security. It is really coordinating the direction of the research.

In regard to an incident that would occur, you mentioned—and

I recall you and I having a lengthy conversation when we were

dealing with the anthrax challenges confronting the Congress of

the United States—we know there were good, thoughtful, well-intentioned voices, but there were a lot of them. We know that there

was not a great deal of coordination at the outset generally around

this country.

I think the President’s vision is that if you work with HHS to

direct some of this research, if an incident like that occurred, the

Department of Homeland Security would be the coordinator, but

the medical and scientific response would still be through Health

and Human Services. The investigative work would continue to be

through the FBI and traditional law enforcement. So you would finally have one agency, one person accountable for coordinating the

public response, public information, and overseeing the medical
23

work, the investigative work, the law enforcement work that might

necessarily be associated with that.

It is not designed to replace the scientific or medical expertise

that HHS and NIH bring to public health generally or to a bioterrorism incident. It is designed to coordinate that aspect of a Federal response. It is a national incident management system. The

Department would be in charge of coordinating the activities, but

we would be leaning on Dr. Fauci, and we would be leaning on Secretary Thompson and others to provide the medical and scientific

response.

Senator FRIST. Because this is an important issue, both from a

legislative standpoint as well as an administration standpoint, we

need to be prepared, in terms of response by having one voice in

that response. I do not want to see a debate regarding a response

playing out in a Cabinet room, with language like ‘‘Secretary of

Homeland Security acting through the Secretary of Health and

Human Services.’’ We need to recognize who is in charge at the end

of the day.

And that just reminds me— Mr. RIDGE. If I might, Senator, I think you set up the possibility

of a conflict like that. We know that NIH and HHS historically

have focused on naturally-occurring disease. They have, they will,

they should—they are good. They are very good at what they do.

But I have to say that if it came down to a point where you were

going to carve out five or six percentage points of a research budget

to direct, redirect—or it may even be new money depending on how

Congress acted—in anticipation of a very specific, credible bioterrorism threat based on information we get from the intelligence

community, hopefully, there will not be too much dispute.

Obviously, you have ongoing research into naturally-occurring

diseases, and we should continue to do that, but if there is a need

to shift just a modest sum of these resources in anticipation of a

terrorist-injected pathogen into America, I would hope that there

would not be too much disagreement that for the time being, that

is where the priority should be.

Senator FRIST. That reminds me—because I will probably submit

some other questions—that we are going to hold the record open

for 14 days for members who might have additional questions but

who were unable to be with us today.

Let me close with one other series of questions that focus on personnel. We hear a lot from our colleagues and constituents about

this.

There has been some confusion with regard to transfer of personnel to the Department of Homeland Security from the Department

of Health and Human Services.

Could you clarify or expand upon—which of the personnel who

are currently in HHS would actually be transferred to the new Department?

Mr. RIDGE. It would be very few. I think those who maintain the

national pharmaceutical stockpile—it is a very limited number. I

think there is a sense that we are going to have a massive transfer

of HHS personnel, and that is not the case.

And I will—thank you—it is good to be assisted by very capable

and responsive people as I am and always have been, fortunately—
24

out of the 62,000 full-time-equivalent employees, we take a look at

a proposed transfer out of the 62,000 of about 600.

Senator FRIST. Okay. Just for the record, could you give us some

sort of feel for who that 600 would be? That information would be

helpful.

Mr. RIDGE. Yes. The Civilian Biodefense Research Programs and

the Biological Preparedness and Response Programs; and there are

300 in the general category, for which I would have to give you

more explicit—a better explanation.

Senator FRIST. Governor, thank you.

The issue of prevention, preparedness, and response; the fragmentation that has been so inherent in our existing structure; the

lack of coordination and communication that has been institutionally inherited by the current administration must be addressed. Although I have not gone through the proposal in detail, the heart

of the proposal is coordination and communication and better use

of resources. You, the President, and the administration should be

congratulated for leadership.

In my mind, this risk is real. This risk is increasing and not decreasing over time—and people do not realize that; they do not realize that we are at greater risk now than we were 6 months ago,

a year ago, or 2 years ago. The only thing that is going to reduce

that risk is an effort to reduce our vulnerabilities as a Nation. The

purpose of bioterrorism is to personalize terror, and you do personalize that terror by going where people are not fully prepared. We

must move from an underprepared to a more and more prepared

state.

I want to thank you, and I would like to give you the opportunity

to say anything in closing. If not, we will keep the record open for

14 days for other questions as we go forward.

Mr. RIDGE. Thank you, Senator, for the courtesies extended to

me not only at this hearing but in the private conversations that

we have had in the past as we continue to work on the bioterrorist

threat. You and your colleagues have been more than open and accessible, and I look forward to a continued relationship with you,

and I really appreciate your leadership on the bioterorism threat

to this country.

Just to underscore what you have stated, I think we do need to

understand in this country that the globalization of science and information means that every, single day, we are at potentially greater risk. Heretofore, in the fifties and sixties, when by and large, the

body of scientific knowledge and technology and equipment that

was available to create these weapons of terror was unique, and it

was held by a few sovereigns and a few countries, and by a few

scientists. But over the past 40 or 50 years, as education has been

global, as the markets become global, as access to this information

and science has become global, the notion that we are immune to

attack simply because we have the best scientists and the best research facilities is no longer accurate. We are no longer immune.

The others may not have the best, but they have enough to create

havoc and terror through a bioterrorism event.

So I appreciate your underscoring the fact that we will have to

accept an enduring vulnerability, a permanent condition, and the

best way for us to reduce the threat is to focus on prevention, prep-
25

aration, and response, and I look forward to working with you in

that regard.

Senator FRIST. Governor, thank you. Thanks for your leadership,

and thanks for being with us today.

With that, we stand adjourned.

[Additional material follows.]
26

ADDITIONAL MATERIAL

PREPARED STATEMENT OF JANET HEINRICH

Mr. Chairman and Members of the Committee: I appreciate the opportunity to

submit this statement for the record on the proposed creation of the Department

of Homeland Security. Since the terrorist attacks of September 11, 2001, and the

subsequent anthrax incidents, there has been concern about the ability of the federal government to prepare for and coordinate an effective public health response

to such events, given the broad distribution of responsibility for that task at the federal level. Our earlier work found, for example, that more than 20 federal departments and agencies carry some responsibility for bioterrorism preparedness and response and that these efforts are fragmented. Emergency response is further complicated by the need to coordinate actions with agencies at the state and local level,

where much of the response activity would occur.

The President’s proposed Homeland Security Act of 2002 would bring many of

these federal entities with homeland security responsibilities—including public

health preparedness and response—into one department, in an effort to mobilize

and focus assets and resources at all levels of government. The aspects of the proposal concerned with public health preparedness and response would involve two

primary changes to the current system, which are found in Title V of the proposed

legislation. First, the proposal would transfer certain emergency preparedness and

response programs from multiple agencies to the new department. Second, it would

transfer the control over, but not the operation of, other public health preparedness

assistance programs, such as providing emergency preparedness planning assistance

to state and local governments, from the Department of Health and Human Services

(HHS) to the new department. Title III of the proposed legislation would also transfer responsibility for certain chemical, biological, radiological, and nuclear research

and development programs and activities to the new department.

In order to assist the Committee in its consideration of this extensive reorganization of our government, this statement focuses on Titles III and V of the President’s proposal and the implications of (1) the proposed transfer of specific public health

preparedness and response programs currently housed in HHS into the new department, (2) the proposed transfer of control over certain other public health preparedness assistance programs from HHS to the new department, and (3) the proposed

transfer of responsibility for research and development on chemical, biological, radiological, and nuclear threats to the new department. The statement is based largely

on our previous and ongoing work on homeland security, as well as a review of the

proposed legislation.

In summary, we believe that the proposed reorganization has the potential to repair the fragmentation we have noted in the coordination of public health preparedness and response programs at the federal, state, and local levels. As we have recommended, the proposal would institutionalize the responsibility for homeland security in federal statute. We expect that, in addition to improving overall coordination,

the transfer of programs from multiple agencies to the new department could reduce

overlap among programs and facilitate response in times of disaster. However, we

have concerns about the proposed transfer of control of public health assistance programs that have both basic public health and homeland security functions from

HHS to the new department. These dual-purpose programs have important

synergies that we believe should be maintained. We are concerned that transferring

control over these programs, including priority setting, to the new department has

the potential to disrupt some programs that are critical to basic public health responsibilities. We do not believe that the President’s proposal is sufficiently clear

on how both the homeland security and the public health objectives would be accomplished. The proposed Department of Homeland Security would also be tasked with

developing national policy for and coordination of the federal government’s civilian

research and development efforts to counter chemical, biological, radiological, and

nuclear threats. However, we are concerned that the proposed transfer of control

and priority setting for research from the organizations where the research would

be conducted could also be disruptive to dual-purpose programs.

BACKGROUND

In response to global challenges the government faces in the coming years, we

have a unique opportunity to create an extremely effective and performance-based

organization that can strengthen the nation’s ability to protect its borders and citizens against terrorism. There is likely to be considerable benefit over time from restructuring some of the homeland security functions, including reducing risk and

improving the economy, efficiency, and effectiveness of these consolidated agencies
27

and programs. Realistically, however, in the short term, the magnitude of the challenges that the new department faces will clearly require substantial time and effort, and will take additional resources to make it fully effective.

The Comptroller General has testified that the Congress should consider several

very specific criteria in its evaluation of whether individual agencies or programs

should be included or excluded from the proposed department. Those criteria include

the following:

Mission Relevancy: Is homeland security a major part of the agency or program

mission? Is it the primary mission of the agency or program?

Similar Goals and Objectives: Does the agency or program being considered for

the new department share primary goals and objectives with the other agencies or

programs being consolidated?

Leverage Effectiveness: Does the agency or program being considered for the new

department promote synergy and help to leverage the effectiveness of other agencies

and programs or the new department as a whole? In other words, is the whole

greater than the sum of the parts?

Gains Through Consolidation: Does the agency or program being considered for

the new department improve the efficiency and effectiveness of homeland security

missions through eliminating duplications and overlaps, closing gaps, and aligning

or merging common roles and responsibilities?

Integrated Information Sharing/Coordination: Does the agency or program being

considered for the new department contribute to or leverage the ability of the new

department to enhance the sharing of critical information or otherwise improve the

coordination of missions and activities related to homeland security?

Compatible Cultures: Can the organizational culture of the agency or program

being considered for the new department effectively meld with the other entities

that will be consolidated? Field structures and approaches to achieving missions

vary considerably between agencies.

Impact on Excluded Agencies: What is the impact on departments losing components to the new department? What is the impact on agencies with homeland security missions left out of the new department?

Federal, state, and local government agencies have differing roles with regard to

public health emergency preparedness and response. The federal government conducts a variety of activities, including developing interagency response plans, increasing state and local response capabilities, developing and deploying federal response teams, increasing the availability of medical treatments, participating in and

sponsoring exercises, planning for victim aid, and providing support in times of disaster and during special events such as the Olympic games. One of its main functions is to provide support for the primary responders at the state and local level,

including emergency medical service personnel, public health officials, doctors, and

nurses. This support is critical because the burden of response falls initially on state

and local emergency response agencies.

The President’s proposal would transfer the Laboratory Registration/ Select Agent

Transfer Program—which controls biological agents with the potential for use in bioterrorism—from HHS to the new department. Currently administered by the Centers for Disease Control and Prevention (CDC), the program’s mission is the security

of those biologic agents that have the potential for use by terrorists. The proposal

provides for the new department to consult with appropriate agencies, which would

include HHS, in maintaining the select agent list.

In addition, the President’s proposal transfers control over many of the programs

that provide preparedness and response support for the state and local governments

to a new Department of Homeland Security. Among other changes, the proposed legislation transfers HHS’s Office of the Assistant Secretary for Public Health Emergency Preparedness to the new department. Included in this transfer is the Office

of Emergency Preparedness (OEP), which currently leads the National Disaster

Medical System (NDMS) in conjunction with several other agencies and the Metropolitan Medical Response System (MMRS).8 The Strategic National Stockpile, currently administered by CDC, would also be transferred, although the Secretary of

HHS would still manage the stockpile and continue to determine its contents.

Under the President’s proposal, the new department would also be responsible for

all current HHS public health emergency preparedness activities carried out to assist state and local governments or private organizations to plan, prepare for, prevent, identify, and respond to biological, chemical, radiological, and nuclear events

and public health emergencies. Although not specifically named in the proposal, this

would include CDC’s Bioterrorism Preparedness and Response program and the

Health Resources and Services Administration’s (HRSA) Bioterrorism Hospital Preparedness Program. These programs provide grants to states and cities to develop

plans and build capacity for communication, disease surveillance, epidemiology, hos-
28

pital planning, laboratory analysis, and other basic public health functions. Except

as otherwise directed by the President, the Secretary of Homeland Security would

carry out these activities through HHS under agreements to be negotiated with the

Secretary of HHS. Further, the Secretary of Homeland Security would be authorized

to set the priorities for these preparedness and response activities.

The new Department of Homeland Security would also be responsible for conducting a national scientific research and development program, including developing

national policy and coordinating the federal government’s civilian efforts to counter

chemical, biological, radiological, and nuclear weapons or other emerging terrorist

threats. Its responsibilities would also include establishing priorities and directing

and supporting national research and development and procurement of technology

and systems for detecting, preventing, protecting against, and responding to terrorist acts using chemical, biological, radiological, or nuclear weapons. Portions of the

Departments of Agriculture, Defense, and Energy that conduct research would be

transferred to the new Department of Homeland Security. The Department of

Homeland Security would carry out its civilian health-related biological, biomedical,

and infectious disease defense research and development through agreements with

HHS, unless otherwise directed by the President. As part of this responsibility, the

new department would establish priorities and direction for programs of basic and

applied research on the detection, treatment, and prevention of infectious diseases

such as those conducted by the National Institutes of Health (NIH).

TRANSFER OF CERTAIN PUBLIC HEALTH PROGRAMS HAS POTENTIAL TO IMPROVE

COORDINATION

The transfer of federal assets and resources in the President’s proposed legislation

has the potential to improve coordination of public health preparedness and response activities at the federal, state, and local levels. Our past work has detailed

a lack of coordination in the programs that house these activities, which are currently dispersed across numerous federal agencies. In addition, we have discussed

the need for an institutionalized responsibility for homeland security in federal statute.

The proposal would transfer the Laboratory Registration/Select Agent Transfer

Program from HHS to the new department. The select agent program, recently revised and expanded by the Public Health Security and Bioterrorism Preparedness

and Response Act of 2002, generally requires the registration of persons and laboratory facilities possessing specific biologic agents and toxins-called select agents-that

have the potential to pose a serious threat to public health and safety. Select agents

include approximately 40 viruses, bacteria, rickettsia, fungi, and toxins. Examples

include Ebola, anthrax, botulinum, and ricin. The 2002 act expanded the program

to cover facilities that possess the agents as well as the facilities that transfer the

agents.

The mission of the select agent program appears to be closely aligned with homeland security. As stated earlier, one key consideration in evaluating whether individual agencies or programs should be included or excluded from the proposed department is the extent to which homeland security is a major part of the agency

or program mission. By these criteria, the transfer of the select agent program

would enhance efficiency and accountability.

The President’s proposal also provides the potential to consolidate programs,

thereby reducing the number of points of contact with which state and local officials

have to contend. However, coordination would still be required with multiple agencies across departments. Many of the agencies involved in these programs have differing perspectives and priorities, and the proposal does not sufficiently clarify the

lines of authority of different parties in the event of an emergency, such as between

the Federal Bureau of Investigation (FBI) and public health officials investigating

a suspected bioterrorist incident.

We have reported that many state and local officials have expressed concerns

about the coordination of federal public health preparedness and response efforts.

Officials from state public health agencies and state emergency management agencies have told us that federal programs for improving state and local preparedness

are not carefully coordinated or well organized. For example, federal programs managed by the Federal Emergency Management Agency (FEMA), Department of Justice (DOJ), OEP, and CDC all currently provide funds to assist state and local governments. Each program conditions the receipt of funds on the completion of a plan,

but officials have told us that the preparation of multiple, generally overlapping

plans can be an inefficient process. In addition, state and local officials told us that

having so many federal entities involved in preparedness and response has led to
29

confusion, making it difficult for them to identify available federal preparedness resources and effectively partner with the federal government.

The proposed transfer of numerous federal response teams and assets to the new

department would enhance efficiency and accountability for these activities. This

would involve a number of separate federal programs for emergency preparedness

and response, whose missions are closely aligned with homeland security, including

FEMA; certain units of DOJ; and HHS’s Office of the Assistant Secretary for Public

Health Emergency Preparedness, including OEP and its NDMS and MMRS programs, along with the Strategic National Stockpile. In our previous work, we found

that in spite of numerous efforts to improve coordination of the separate federal programs, problems remained, and we recommended consolidating the FEMA and DOJ

programs to improve the coordination. The proposal places these programs under

the control of the Under Secretary for Emergency Preparedness and Response, who

could potentially reduce overlap and improve coordination. This change would make

one individual accountable for these programs and would provide a central source

for federal assistance.

The proposed transfer of MMRS, a collection of local response systems funded by

HHS in metropolitan areas, has the potential to enhance its communication and coordination. Officials from one state told us that their state has MMRSs in multiple

cities but there is no mechanism in place to allow communication and coordination

among them. Although the proposed department has the potential to facilitate the

coordination of this program, this example highlights the need for greater regional

coordination, an issue on which the proposal is silent.

Because the new department would not include all agencies with public health responsibilities related to homeland security, coordination across departments would

still be required for some programs. For example, NDMS functions as a partnership

among HHS, the Department of Defense (DOD), the Department of Veterans Affairs

(VA), FEMA, state and local governments, and the private sector. However, as the

DOD and VA programs are not included in the proposal, only some of these federal

organizations would be brought under the umbrella of the Department of Homeland

Security. Similarly, the Strategic National Stockpile currently involves multiple

agencies. It is administered by CDC, which contracts with VA to purchase and store

pharmaceutical and medical supplies that could be used in the event of a terrorist

incident. Recently expanded and reorganized, the program will now include management of the nation’s inventory of smallpox vaccine. Under the President’s proposal,

CDC’s responsibilities for the stockpile would be transferred to the new department,

but VA and HHS involvement would be retained, as well as continuing review by

experts of the contents of the stockpile to ensure that emerging threats, advanced

technologies, and new countermeasures are adequately considered.

Although the proposed department has the potential to improve emergency response functions, its success depends on several factors. In addition to facilitating

coordination and maintaining key relationships with other departments, these factors include merging the perspectives of the various programs that would be integrated under the proposal and clarifying the lines of authority of different parties

in the event of an emergency. As an example, in the recent anthrax events, local

officials complained about differing priorities between the FBI and the public health

officials in handling suspicious specimens. According to the public health officials,

FBI officials insisted on first informing FBI managers of any test results, which delayed getting test results to treating physicians. The public health officials viewed

contacting physicians as the first priority in order to ensure that effective treatment

could begin as quickly as possible.

NEW DEPARTMENT’S CONTROL OF ESSENTIAL PUBLIC HEALTH CAPACITIES RAISES

CONCERN

The President’s proposal to shift the responsibility for all programs assisting state

and local agencies in public health emergency preparedness and response from HHS

to the new department raises concern because of the dual-purpose nature of these

activities. These programs include essential public health functions that, while important for homeland security, are critical to basic public health core capacities.

Therefore, we are concerned about the transfer of control over the programs, including priority setting, that the proposal would give to the new department. We recognize the need for coordination of these activities with other homeland security functions, but the President’s proposal is not clear on how the public health and homeland security objectives would be balanced.

Under the President’s proposal, responsibility for programs with dual homeland

security and public health purposes would be transferred to the new department.

These include such current HHS assistance programs as CDC’s Bioterrorism Pre-
30

paredness and Response program and HRSA’s Bioterrorism Hospital Preparedness

Program. Functions funded through these programs are central to investigations of

naturally occurring infectious disease outbreaks and to regular public health communications, as well as to identifying and responding to a bioterrorist event. For

example, CDC has used funds from these programs to help state and local health

agencies build an electronic infrastructure for public health communications to improve the collection and transmission of information related to both bioterrorist incidents and other public health events. Just as with the West Nile virus outbreak in

New York City, which initially was feared to be the result of bioterrorism, when an

unusual case of disease occurs public health officials must investigate to determine

whether it is naturally occurring or intentionally caused. Although the origin of the

disease may not be clear at the outset, the same public health resources are needed

to investigate, regardless of the source.

States are planning to use funds from these assistance programs to build the

dual-purpose public health infrastructure and core capacities that the recently enacted Public Health Security and Bioterrorism Preparedness and Response Act of

2002 stated are needed. States plan to expand laboratory capacity, enhance their

ability to conduct infectious disease surveillance and epidemiological investigations,

improve communication among public health agencies, and develop plans for communicating with the public. States also plan to use these funds to hire and train

additional staff in many of these areas, including epidemiology.

Our concern regarding these dual-purpose programs relates to the structure provided for in the President’s proposal. The Secretary of Homeland Security would be

given control over programs to be carried out by HHS. The proposal also authorizes

the President to direct that these programs no longer be carried out through agreements with HHS, without addressing the circumstances under which such authority

would be exercised. We are concerned that this approach may disrupt the synergy

that exists in these dual-purpose programs. We are also concerned that the separation of control over the programs from their operations could lead to difficulty in

balancing priorities. Although the HHS programs are important for homeland security, they are just as important to the day-to-day needs of public health agencies

and hospitals, such as reporting on disease outbreaks and providing alerts to the

medical community. The current proposal does not clearly provide a structure that

ensures that the goals of both homeland security and public health will be met.

TRANSFER OF CONTROL AND PRIORITY SETTING OVER DUAL-PURPOSE RESEARCH AND

DEVELOPMENT RAISES CONCERN

The proposed Department of Homeland Security would be tasked with developing

national policy for and coordinating the federal government’s civilian research and

development efforts to counter chemical, biological, radiological, and nuclear threats.

In addition to coordination, we believe the role of the new department should include forging collaborative relationships with programs at all levels of government

and developing a strategic plan for research and development. However, we have

many of the same concerns regarding the transfer of responsibility for the research

and development programs that we have regarding the transfer of the public health

preparedness programs. We are concerned about the implications of the proposed

transfer of control and priority setting for dual-purpose research. For example, some

research programs have broad missions that are not easily separated into homeland

security research and research for other purposes. We are concerned that such dualpurpose research activities may lose the synergy of their current placement in programs. In addition, we see a potential for duplication of capacity that already exists

in the federal laboratories.

We have previously reported that while federal research and development programs are coordinated in a variety of ways, coordination is limited, raising the potential for duplication of efforts among federal agencies. Coordination is limited by

the extent of compartmentalization of efforts because of the sensitivity of the research and development programs, security classification of research, and the absence of a single coordinating entity to ensure against duplication. For example,

DOD’s Defense Advanced Research Projects Agency was unaware of U.S. Coast

Guard plans to develop methods to detect biological agents on infected cruise ships

and, therefore, was unable to share information on its research to develop biological

detection devices for buildings that could have applicability in this area.

The new department will need to develop mechanisms to coordinate and integrate

information on research and development being performed across the government

related to chemical, biological, radiological, and nuclear terrorism, as well as user

needs. We reported in 1999 and again in 2001 that the current formal and informal

research and development coordination mechanisms may not ensure that potential
31

overlaps, gaps, and opportunities for collaboration are addressed. It should be noted,

however, that the President’s proposal tasks the new department with coordinating

the federal government’s ‘‘civilian efforts’’ only. We believe the new department will

also need to coordinate with DOD and the intelligence agencies that conduct research and development efforts designed to detect and respond to weapons of mass

destruction. In addition, the first responders and local governments possess practical knowledge about their technological needs and relevant design limitations that

should be taken into account in federal efforts to provide new equipment, such as

protective gear and sensor systems, and help set standards for performance and

interoperability. Therefore, the new department will have to develop collaborative

relationships with these organizations to facilitate technological improvements and

encourage cooperative behavior.

The President’s proposal could help improve coordination of federal research and

development by giving one person the responsibility for creating a single national

research and development strategy that could address coordination, reduce potential

duplication, and ensure that important issues are addressed. In 2001, we recommended the creation of a unified strategy to reduce duplication and leverage resources, and suggested that the plan be coordinated with federal agencies performing research as well as state and local authorities. The development of such a plan

would help to ensure that research gaps are filled, unproductive duplication is minimized, and that individual agency plans are consistent with the overall goals.

The President’s proposal would also transfer the responsibility for civilian healthrelated biological defense research and development programs to the new department, but the programs would continue to be carried out through HHS. These programs, now primarily sponsored by NIH, include a variety of efforts to understand

basic biological mechanisms of infection and to develop and test rapid diagnostic

tools, vaccines, and antibacterial and antiviral drugs. These efforts have dual-purpose applicability. The scientific research on biologic agents that could be used by

terrorists cannot be readily separated from research on emerging infectious diseases. For example, NIH-funded research on a drug to treat cytomegalovirus complications in patients with HIV is now being investigated as a prototype for developing antiviral drugs against smallpox. Conversely, research being carried out on

antiviral drugs in the NIH biodefense research program is expected to be useful in

the development of treatments for hepatitis C.

The proposal to transfer responsibility to the new department for research and development programs that would continue to be carried out by HHS raises many of

the same concerns we have with the structure the proposal creates for public health

preparedness programs. Although there is a clear need for the new department to

have responsibility for setting policy, developing a strategy, providing leadership,

and overall coordinating of research and development efforts in these areas, we are

concerned that control and priority-setting responsibility will not be vested in those

best positioned to understand the potential of basic research efforts or the relevance

of research being carried out in other, non-biodefense programs.

In addition, the proposal would allow the new department to direct, fund, and

conduct research related to chemical, biological, radiological, nuclear, and other

emerging terrorist threats on its own. This raises the potential for duplication of efforts, lack of efficiency, and an increased need for coordination with other departments that would continue to carry out relevant research. We are concerned that

the proposal could result in a duplication of capacity that already exists in the current federal laboratories.

CONCLUDING OBSERVATIONS

Many aspects of the proposed consolidation of response activities are in line with

our previous recommendations to consolidate programs, coordinate functions, and

provide a statutory basis for leadership of homeland security. The transfer of the

HHS medical response programs has the potential to reduce overlap among programs and facilitate response in times of disaster. However, we are concerned that

the proposal does not provide the clear delineation of roles and responsibilities that

is needed. We are also concerned about the broad control the proposal grants to the

new department for research and development and public health preparedness programs. Although there is a need to coordinate these activities with the other homeland security preparedness and response programs that would be brought into the

new department, there is also a need to maintain the priorities for basic public

health capacities that are currently funded through these dual-purpose programs.

We do not believe that the President’s proposal adequately addresses how to accomplish both objectives. We are also concerned that the proposal would transfer the
32

control and priority setting over dual-purpose research and has the potential to create an unnecessary duplication of federal research capacity.

CONTACT AND ACKNOWLEDGMENTS

For further information about this statement, please contact me at (202) 512–

7118. Robert Copeland, Marcia Crosse, Greg Ferrante, and Deborah Miller also

made key contributions to this statement.

RELATED GAO PRODUCTS—HOMELAND SECURITY

Homeland Security: Title III of the Homeland Security Act of 2002. GAO–02–

927T. Washington, D.C.: July 9, 2002.

Homeland Security: New Department Could Improve Biomedical R&D Coordination but May Disrupt Dual-Purpose Efforts. GAO–02–924T. Washington, D.C.: July

9, 2002.

Critical Infrastructure Protection: Significant Homeland Security Challenges Need

to Be Addressed. GAO–02–918T. Washington, D.C.: July 9, 2002.

Homeland Security: Intergovernmental Coordination and Partnership Will Be

Critical to Success. GAO–02–901T. Washington, D.C.: July 3, 2002.

Homeland Security: Intergovernmental Coordination and Partnership Will Be

Critical to Success. GAO–02–900T. Washington, D.C.: July 2, 2002.

Homeland Security: Intergovernmental Coordination and Partnership Will Be

Critical to Success. GAO–02–899T. Washington, D.C.: July 1, 2002.

Homeland Security: New Department Could Improve Coordination but May Complicate Priority Setting. GAO–02–893T. Washington, D.C.: June 28, 2002.

Homeland Security: Proposal for Cabinet Agency Has Merit, but Implementation

Will Be Pivotal to Success. GAO–02–886T. Washington, D.C.: June 25, 2002.

Homeland Security: New Department Could Improve Coordination but May Complicate Public Health Priority Setting. GAO–02–883T. Washington, D.C.: June 25,

2002.

Homeland Security: Key Elements to Unify Efforts Are Underway but Uncertainty Remains. GAO–02–610. Washington, D.C.: June 7, 2002.

Homeland Security: Responsibility and Accountability for Achieving National

Goals. GAO–02–627T. Washington, D.C.: April 11, 2002.

Homeland Security: Progress Made; More Direction and Partnership Sought.

GAO–02–490T. Washington, D.C.: March 12, 2002.

Homeland Security: Challenges and Strategies in Addressing Short- and LongTerm National Needs. GAO–02–160T. Washington, D.C.: November 7, 2001.

Homeland Security: A Risk Management Approach Can Guide Preparedness Efforts. GAO–02–208T. Washington, D.C.: October 31, 2001.

Homeland Security: Need to Consider VA’s Role in Strengthening Federal Preparedness. GAO–02–145T. Washington, D.C.: October 15, 2001.

Homeland Security: Key Elements of a Risk Management Approach. GAO–02–

150T. Washington, D.C.: October 12, 2001.

Homeland Security: A Framework for Addressing the Nation’s Efforts. GAO–01–

1158T. Washington, D.C.: September 21, 2001.

PUBLIC HEALTH

Bioterrorism: The Centers for Disease Control and Prevention’s Role in Public

Health Protection. GAO–02–235T. Washington, D.C.: November 15, 2001.

Bioterrorism: Review of Public Health Preparedness Programs. GAO–02–149T.

Washington, D.C.: October 10, 2001.

Bioterrorism: Public Health and Medical Preparedness. GAO–02–141T. Washington, D.C.: October 9, 2001.

Bioterrorism: Coordination and Preparedness. GAO–02–129T. Washington, D.C.:

October 5, 2001.

Bioterrorism: Federal Research and Preparedness Activities. GAO–01–915. Washington, D.C.: September 28, 2001.

Chemical and Biological Defense: Improved Risk Assessment and Inventory Management Are Needed. GAO–01–667. Washington, D.C.: September 28, 2001.

West Nile Virus Outbreak: Lessons for Public Health Preparedness. GAO/HEHS–

00–180. Washington, D.C.: September 11, 2000.

Chemical and Biological Defense: Program Planning and Evaluation Should Follow Results Act Framework. GAO/NSIAD–99–159. Washington, D.C.: August 16,

1999.

Combating Terrorism: Observations on Biological Terrorism and Public Health

Initiatives. GAO/T–NSIAD–99–112. Washington, D.C.: March 16, 1999.
33

COMBATING TERRORISM

National Preparedness: Technologies to Secure Federal Buildings. GAO–02–687T.

Washington, D.C.: April 25, 2002.

National Preparedness: Integration of Federal, State, Local, and Private Sector

Efforts Is Critical to an Effective National Strategy for Homeland Security. GAO– 02–621T. Washington, D.C.: April 11, 2002.

Combating Terrorism: Intergovernmental Cooperation in the Development of a

National Strategy to Enhance State and Local Preparedness. GAO–02–550T. Washington, D.C.: April 2, 2002.

Combating Terrorism: Enhancing Partnerships Through a National Preparedness

Strategy. GAO–02–549T. Washington, D.C.: March 28, 2002.

Combating Terrorism: Critical Components of a National Strategy to Enhance

State and Local Preparedness. GAO–02–548T. Washington, D.C.: March 25, 2002.

Combating Terrorism: Intergovernmental Partnership in a National Strategy to

Enhance State and Local Preparedness. GAO–02–547T. Washington, D.C.: March

22, 2002.

Combating Terrorism: Key Aspects of a National Strategy to Enhance State and

Local Preparedness. GAO–02–473T. Washington, D.C.: March 1, 2002.

Chemical and Biological Defense: DOD Should Clarify Expectations for Medical

Readiness. GAO–02–219T. Washington, D.C.: November 7, 2001.

Anthrax Vaccine: Changes to the Manufacturing Process. GAO–02–181T. Washington, D.C.: October 23, 2001.

Chemical and Biological Defense: DOD Needs to Clarify Expectations for Medical

Readiness. GAO–02–38. Washington, D.C.: October 19, 2001.

Combating Terrorism: Considerations for Investing Resources in Chemical and Biological Preparedness. GAO–02–162T. Washington, D.C.: October 17, 2001.

Combating Terrorism: Selected Challenges and Related Recommendations. GAO–

01–822. Washington, D.C.: September 20, 2001.

Combating Terrorism: Actions Needed to Improve DOD Antiterrorism Program

Implementation and Management. GAO–01–909. Washington, D.C.: September 19,

2001.

Combating Terrorism: Comments on H.R. 525 to Create a President’s Council on

Domestic Terrorism Preparedness. GAO–01–555T. Washington, D.C.: May 9, 2001.

Combating Terrorism: Accountability Over Medical Supplies Needs Further Improvement. GAO–01–666T. Washington, D.C.: May 1, 2001.

Combating Terrorism: Observations on Options to Improve the Federal Response.

GAO–01–660T. Washington, DC: April 24, 2001.

Combating Terrorism: Accountability Over Medical Supplies Needs Further Improvement. GAO–01–463. Washington, D.C.: March 30, 2001.

Combating Terrorism: Comments on Counterterrorism Leadership and National

Strategy. GAO–01–556T. Washington, D.C.: March 27, 2001.

Combating Terrorism: FEMA Continues to Make Progress in Coordinating Preparedness and Response. GAO–01–15. Washington, D.C.: March 20, 2001.

Combating Terrorism: Federal Response Teams Provide Varied Capabilities; Opportunities Remain to Improve Coordination. GAO–01–14. Washington, D.C.: November 30, 2000.

Combating Terrorism: Need to Eliminate Duplicate Federal Weapons of Mass Destruction Training. GAO/NSIAD–00–64. Washington, D.C.: March 21, 2000.

Combating Terrorism: Chemical and Biological Medical Supplies Are Poorly Managed. GAO/T–HEHS/AIMD–00–59. Washington, D.C.: March 8, 2000.

Combating Terrorism: Chemical and Biological Medical Supplies Are Poorly Managed. GAO/HEHS/AIMD–00–36. Washington, D.C.: October 29, 1999.

Combating Terrorism: Observations on the Threat of Chemical and Biological Terrorism. GAO/T–NSIAD–00–50. Washington, D.C.: October 20, 1999.

Combating Terrorism: Need for Comprehensive Threat and Risk Assessments of

Chemical and Biological Attacks. GAO/NSIAD–99–163. Washington, D.C.: September 14, 1999.

Chemical and Biological Defense: Coordination of Nonmedical Chemical and Biological R&D Programs. GAO/NSIAD–99–160. Washington, D.C.: August 16, 1999.

Combating Terrorism: Use of National Guard Response Teams Is Unclear. GAO/

T–NSIAD–99–184. Washington, D.C.: June 23, 1999.

Combating Terrorism: Observations on Growth in Federal Programs. GAO/T–

NSIAD–99–181. Washington, D.C.: June 9, 1999.

Combating Terrorism: Analysis of Potential Emergency Response Equipment and

Sustainment Costs. GAO/NSIAD–99–151. Washington, D.C.: June 9, 1999.

Combating Terrorism: Use of National Guard Response Teams Is Unclear. GAO/

NSIAD–99–110. Washington, D.C.: May 21, 1999.
34

Combating Terrorism: Observations on Federal Spending to Combat Terrorism.

GAO/T–NSIAD/GGD–99–107. Washington, D.C.: March 11, 1999.

Combating Terrorism: Opportunities to Improve Domestic Preparedness Program

Focus and Efficiency. GAO/NSIAD–99–3. Washington, D.C.: November 12, 1998.

Combating Terrorism: Observations on the Nunn-Lugar-Domenici Domestic Preparedness Program. GAO/T–NSIAD–99–16. Washington, D.C.: October 2, 1998.

Combating Terrorism: Observations on Crosscutting Issues. GAO/T–NSIAD–98–

164. Washington, D.C.: April 23, 1998.

Combating Terrorism: Threat and Risk Assessments Can Help Prioritize and Target Program Investments. GAO/NSIAD–98–74. Washington, D.C.: April 9, 1998.

Combating Terrorism: Spending on Governmentwide Programs Requires Better

Management and Coordination. GAO/NSIAD–98–39. Washington, D.C.: December 1,

1997.

DISASTER ASSISTANCE

Disaster Assistance: Improvement Needed in Disaster Declaration Criteria and

Eligibility Assurance Procedures. GAO–01–837. Washington, D.C.: August 31, 2001.

Chemical Weapons: FEMA and Army Must Be Proactive in Preparing States for

Emergencies. GAO–01–850. Washington, D.C.: August 13, 2001.

Federal Emergency Management Agency: Status of Achieving Key Outcomes and

Addressing Major Management Challenges. GAO–01–832. Washington, D.C.: July 9,

2001.

BUDGET AND MANAGEMENT

Budget Issues: Long-Term Fiscal Challenges. GAO–02–467T.

Washington, D.C.: February 27, 2002.

Results-Oriented Budget Practices in Federal Agencies. GAO–01–1084SP. Washington, D.C.: August 2001.

Managing for Results: Federal Managers’ Views on Key Management Issues Vary

Widely Across Agencies. GAO–01–592. Washington, D.C.: May 25, 2001.

Determining Performance and Accountability Challenges and High Risks. GAO–

01–159SP. Washington, D.C.: November 2000.

Managing for Results: Using the Results Act to Address Mission Fragmentation

and Program Overlap. GAO–AIMD–97–146. Washington, D.C.: August 29, 1997.

Government Restructuring: Identifying Potential Duplication in Federal Missions

and Approaches. GAO/T–AIMD–95–161. Washington, D.C.: June 7, 1995.

Government Reorganization: Issues and Principles. GAO/T–GGD/AIMD–95–166.

Washington, D.C.: May 17, 1995.

GRANT DESIGN

Grant Programs: Design Features Shape Flexibility, Accountability, and Performance Information. GAO/GGD–98–137. Washington, D.C.: June 22, 1998.

Federal Grants: Design Improvements Could Help Federal Resources Go Further.

GAO/AIMD–97–7. Washington, D.C.: December 18, 1996.

Block Grants: Issues in Designing Accountability Provisions. GAO/AIMD–95–226.

Washington, D.C.: September 1, 1995.

STATEMENT OF THE AMERICAN SOCIETY FOR MICROBIOLOGY

INTRODUCTION

The American Society for Microbiology (ASM) wishes to submit the following

statement for the record to the Senate Health, Education, Labor and Pensions Committee for the hearing on Homeland Security and bioterrorism issues. The ASM is

the largest life science society with over 40,000 members and its principal goal is

the study and advancement of scientific knowledge of microbiology for the benefit

of human welfare.

The ASM has worked with the Administration, the Congress and federal agencies

on measures to protect against biological weapons and bioterrorism. Most recently,

ASM provided expert advice on provisions to expand the Biological Weapons Statute

in the USA Patriot Act and on Title II of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which expands controls on certain dangerous biological agents and toxins. ASM members are involved in research and

public health initiatives aimed at eradicating the scourge of infectious diseases,

which daily end the lives of thousands of Americans and tens of thousands around

the world. Infectious diseases remain the major cause of death in the world for those
35

under the age of 45 and particularly for children. They are the third leading cause

of death in the United States.

The ASM considers it critical that the proposed DHS build upon existing science

and technology programs that hold promise in the defense against bioterrorism and

in the effort against deadly infectious diseases. We would like to focus our comments

on issues that Congress should consider on how best to achieve this goal.

THE ROLE OF THE DEPARTMENT OF HOMELAND SECURITY

1. Role of science and technology in Homeland Security is Critical

The terrorist events of September 11 and the anthrax biocrimes reveal the need

and complexity of homeland defense. The ASM, therefore, supports oversight, coordination and leadership for biodefense activities in a Department of Homeland Security (DHS). Given that science and technology will play a vital role in the biodefense

of the nation, the ASM believes it is essential to establish a strong science and technology function in the DHS. This science component will provide the necessary linkage between the Secretary of Homeland Security and the numerous mission agencies charged with science and technology development.

2. The Department of Homeland Security has an important role to play in defending the nation against biological threats.

The DHS will have an important role in developing the nation’s defenses against,

and responses to, biological threats. The role of DHS should be to integrate threat

analysis and vulnerability assessments and to identify priorities for preventive and

protective steps to be taken by other federal agencies to protect the American public.

The DHS can coordinate, review, and evaluate scientific and technical programs related to human, animal, and plant life. The DHS will be a proper governmental vehicle to coordinate and to integrate the expanded roles of mission agencies in bioterrorism related research. The important role of the United States Army Medical

Research Institute for Infectious Diseases (USAMRIID) should be recognized and

strengthened and it should interface with the proposed DHS.

It will be important to define the boundaries between DHS and the mission agency with major responsibility for protecting the nation’s health, HHS. An appropriate

coordination office or position should be established within DHS. One approach, for

example, would be for DHS to establish a position or appoint a person with the appropriate scientific background who would report to both the DHS Secretary and the

HHS Secretary. That person would also work with the National Institutes of Health

(NIH) and National Institute of Allergies and Infectious Diseases to ensure integration of threat and vulnerability analysis about bioterrorism. The goal, of course,

would be mutually agreed upon research priorities that address threatening biological agents.

Other mechanisms and/or functions may be needed for HHS and DHS to serve

the vital role of coordinating the pursuit of an integrated research and development

agenda for counter-terrorism, including highly directed, high risk, fast-paced, classified projects, and to manage between research results and applications to develop

and evaluate specific technologies and for procurement. For example, NIH/NIAID

has already accelerated basic and clinical research related to bioterrorism to focus

on ‘‘Category A’’ agents considered by CDC to pose the highest threat. Last fall, the

NIAID conducted a study to show that existing stocks of smallpox vaccine could be

diluted at least 5-fold to provide immediate protection in case of a smallpox attack.

NIAID also accelerated screening of antiviral compounds for activity against smallpox and related viruses and accelerated development of a ‘‘new generation’’ bioengineered anthrax vaccine and a promising Ebola virus vaccine. It has launched seven

new fiscal year 2002 initiatives to expedite biodefense research.

3. ASM recommends that HHS continue to be responsible for the prioritization,

direction, and conduct of federal research efforts related to civilian, human, healthrelated biological, biomedical, and infectious diseases.

Pathogenic microbes pose a threat to national security whether they occur naturally or are released in a bioterrorism attack. Biodefense research is part of the continuum of biomedical research aimed at protecting the nation and the world against

infectious diseases. The capability to develop countermeasures and interventions is

directly related to information generated by biomedical research on pathogenic microbes and the host response to these microbes. Therefore, it is critical that federal

research efforts related to civilian human health-related biological, biomedical, and

infectious diseases should be prioritized and conducted by, and at the direction of,

the Department of Health and Human Services (HHS).

It is important to distinguish between oversight functions such as policy and planning guidance and coordination, which would be served by the DHS and the responsibility and authority for the direction, control and conduct of scientific research.
36

ASM recommends that HHS, a public health and biomedical research agency of unparalleled success, should continue to be responsible for the conduct and direction

of scientific research.

The Administration’s Bill recognizes the necessity that HHS conduct the research

and development programs related to infectious diseases. Section 303(a)(1) of the

Bill provides that the Secretary of DHS shall carry out responsibilities related to

civilian human health-related biological, biomedical, and infectious diseases through

HHS and the Public Health Service ‘‘under agreements with the Secretary of Health

and Human Services, and may transfer funds to him in connection with such agreements.’’ Section 301(2) of the Administration’s Bill, however, gives DHS primary authority and responsibility for the conduct of national scientific research including

‘‘directing, funding, and conducting research and development’’ related to biological

threats. Additionally, at Section 303(a)(2), the Bill provides that DHS, in consultation with HHS, ‘‘shall have authority to establish the research and development program, including the setting of priorities.’’ The ASM believes that the proposed restructuring of program authorities in the Administration’s bill will create unpredictability for research programs, will divert monies from research and will not be the

best approach to achieving the goal of civilian biodefense, which requires the involvement of the best scientific minds and the support of excellent science based on

merit review.

The HHS, the federal agency with the major mission for protecting the public

health, is best qualified to establish biomedical research and development programs,

identify scientific opportunities and the research approaches for ensuring that biodefense needs are met in the best way possible. The National Institute of Allergy

and Infectious Diseases (NIAID) is best able to bring together all aspects of biomedical research and the full capability of science to ensure breakthroughs and advances of high quality for biodefense. The ability to build on the body of scientific

knowledge underpins the capability of the United States to combat bioterrorism. For

example, the national response mounted by NIH/NIAID to AIDS demonstrates the

capability of science to respond to a threat. The response was based on years of accumulated scientific knowledge and biomedical research that had been well supported by Congress. The response to bioterrorism will require the same long-term

dedication of financial resources and scientific talent.

The NIAID, working with the DHS, has the knowledge about scientific capabilities to respond to threats and vulnerabilities related to the biological sciences. It can

identify the science and infrastructure relevant to the most pressing issues and take

advantage of the most highly leveraged opportunities for research that can contribute to counter-terrorism solutions. Because it is difficult to distinguish an introduced infectious disease from a naturally occurring one, the strategies to protect

against either event in terms of new scientific and technical approaches, including

surveillance, prevention and response, are the same. There will be dual benefits for

public health in that investment in research to develop new therapeutics, vaccines,

antivirals, genomics, diagnostics, sensitive detection devices and innovative surveillance approaches for biological agents will carry over to public health breakthroughs

for all infectious diseases.

The nation has already seen the ability of HHS to respond to bioterrorism. In the

months since September 11, 2001, the NIAID has rapidly accelerated work to protect the nation against the threat of bioterrorism. This acceleration has occurred

across the spectrum of scientific activities from basic research in microbial biology

to the development of vaccines and therapeutics to research related to diagnostic

systems. It is critical that this work continue to develop rapidly and efficiently without delay, disruption or loss of momentum.

A scientific health agency, HHS, rather than the nonscientific, nonpublic health

DHS should have the principal authority for developing and prioritizing scientific

and health related programs. Essentially, therefore, the ASM suggests reversing the

responsibilities identified in Section 303(a)(2) of the Administration’s Bill. HHS, in

consultation and coordination with DHS, should retain responsibility for accelerated

research and development programs, including prioritizing such projects

THE PUBLIC HEALTH SYSTEM FOR BIODEFENSE

The ASM is also concerned that the nation not create a separate public health

system for biodefense. Therefore, the ASM would leave primary responsibility for

planning for public health emergencies arising from biological causes with the HHS

and Center for Disease Control. At the earliest possible moment after the outbreak

of a contagion, it is critical to determine the nature of the organism and to distinguish between a bioterrorism attack and a natural event. Then, public authorities
37

must respond rapidly and appropriately to the health threat that either one would

present. The ASM believes CDC should be charged with these tasks.

Section 505(a)(2) of the Administration’s Bill requires DHS to carry out these

functions under agreement with HHS. Again, the ASM believes the important and

appropriate role for DHS is to coordinate planning and development of programs

and to lend technical assistance to the responsible agency. It is entirely appropriate

for HHS to coordinate and consult with DHS. As with the direction and control of

research, however, the primary duty and authority should remain with the scientific

agency with the existing knowledge, experience, and expertise to fulfill the critical

mission. A scientific person within the DHS with the appropriate public health

background and reporting to both the DHS Secretary and HHS Secretary could

work closely with the CDC Director to achieve mutually agreed upon public health

priorities for bioterrorism preparedness and response.

ADMINISTRATION AND ENFORCEMENT OF THE PROGRAM FOR REGISTRATION FOR

POSSESSION AND USE OF SELECT AGENTS

Agriculture, the food supply, and the environment are potential targets of bioterrorism along with humans. It is important, therefore, to integrate and coordinate

programs related to human, animal, and plant agents. Section 302(a) of the Administration Bill transfers to DHS the select agent registration and enforcement programs of HHS. However, it does not transfer the select agent registration and enforcement programs of the Department of Agriculture to the DHS. Subtitle C of the

Public Health Security and Bioterrorism Preparedness Act of 2002 mandated coordination of activities of HHS and the Secretary of Agriculture regarding ‘‘overlap

agents’’—that is, agents that appear on the separate lists prepared by HHS and Agriculture. Without doubt, such coordination must occur. Bioterrorism research and

surveillance extends and applies to infectious disease and select agent research. The

ASM believes that integration of the select agent registration program inevitably

will assist in the creation of an efficient registration process thereby expediting registration.

The proper administration of the select agent program is key to the development

of the nation’s biodefense capability and response and must balance the concerns

for public safety with the need to not unduly encumber legitimate scientific research

and laboratory diagnostic testing. The ASM continues to believe that HHS has the

scientific and institutional knowledge and expertise related to dangerous biological

agents, biosafety, and biosecurity in microbiological and biomedical laboratories and

that it is best qualified to achieve the goal of protecting the public health and safety

without interfering with research, and clinical and diagnostic laboratory medicine.

Transferring this program to DHS raises many questions with regard to the administration of this program which must be carefully considered by Congress, which recently enacted new legislation and additional requirements for select agents. The

ASM, therefore, requests that a review be done by an interagency group with the

involvement of scientific societies to assess the advisability of removing the select

agent program from HHS authority.

EACH TRANSFER OF A SCIENIFIC FUNCTION SHOULD BE SPECIFICALLY REVIEWED

Some additional specific measures in the Administration Bill require further consideration and comment by the ASM. The ASM continues to study the Administration Bill to evaluate the best approach to achieving expedited research that advances the defense against bioterrorism but does not dilute the continuing, critical

battle against naturally occurring infectious diseases. The ASM suggests expeditious

review of the appropriateness of each transfer of a facility or responsibility related

to biological organisms from an existing agency. Similarly, the proposed transfers

within the USDA should be carefully reviewed, in particular the justification should

be considered for transferring Plum Island which addresses animal diseases but not

incorporating the equivalent functional unit that addresses plant diseases.

For example, as noted above, the defense against bioterrorism must be fully integrated into the nation’s public health system that is led by the Centers for Disease

Control and Prevention. Currently, CDC would use the national pharmaceutical

stockpile in response to infectious disease outbreaks—both natural and intentional.

Sections 501(3)(B) and 502(6) would transfer the Strategic National Stockpile to

DHS. Such transfer should be reviewed carefully during further consideration of the

Bill. HHS should be responsible for developing the materials in the stockpile. Therefore, it seems appropriate for HHS to continue management of the stockpile. The

ASM, however, understands the coordination and oversight function envisioned for

DHS, and the final resolution of the management of the stockpile ultimately must

depend upon the resolution of the scope and role of DHS responsibilities and activi-
38

ties. At this time, we also recommend that there be an external review of the CDC

to ensure optimal preparedness for public health emergences and bioterrorism and

to ensure appropriate integration with existing programs.

CONCLUSION

We appreciate the opportunity to submit this statement. The ASM is committed

to working with Congress and the Administration to achieve the most efficient and

effective system in the world for research, control, and response to the threat posed

by biological agents.

[Whereupon, at 11:12 a.m., the committee was adjourned.]

Æ