[Senate Hearing 107-583]
[From the U.S. Government Printing Office]

                                                        S. Hrg. 107-583
                          HOMELAND SECURITY


                               BEFORE THE

                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION




                             JULY 16, 2002


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

                       U. S. GOVERNMENT PRINTING OFFICE
80-875                          WASHINGTON : 2002
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512-1800  
Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001


               EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut     JUDD GREGG, New Hampshire
TOM HARKIN, Iowa                     BILL FRIST, Tennessee
BARBARA A. MIKULSKI, Maryland        MICHAEL B. ENZI, Wyoming
JAMES M. JEFFORDS (I), Vermont       TIM HUTCHINSON, Arkansas
JEFF BINGAMAN, New Mexico            JOHN W. WARNER, Virginia
PAUL D. WELLSTONE, Minnesota         CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington             PAT ROBERTS, Kansas
JACK REED, Rhode Island              SUSAN M. COLLINS, Maine
JOHN EDWARDS, North Carolina         JEFF SESSIONS, Alabama
           J. Michael Myers, Staff Director and Chief Counsel
             Townsend Lange McNitt, Minority Staff Director

                            C O N T E N T S



                         Tuesday, July 16, 2002

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

                           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 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 
    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 
    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.
    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 
    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 public 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 
    The Chairman. What are you smiling at, Governor Ridge? 
    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-past-ten, 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 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.

                         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.
    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 
    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-
    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 
    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.
    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 
    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:]
                    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 
    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.
            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 
    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 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 
    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 non-
proliferation of CBRN technologies and material.
                          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 
    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 vulnerability 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 
    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 
    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.
    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 conference 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 
    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.
    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 
    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 
    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 
Government-owned, 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?
    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 
    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 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 
    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 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 
    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 
    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 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 
    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 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 
    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 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 
    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 
    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 
    We know that we need one central agency to be able to 
coordinate response to a bioterrorism event. So as difficult 
and as painful 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 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 
    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 
    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 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--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 
    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 
    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, preparation, 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.]

                          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.
    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 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 
    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, hospital 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 
    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 
confusion, making it difficult for them to identify available federal 
preparedness resources and effectively partner with the federal 
    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 
    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 
    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 Preparedness 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 
    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 dual-purpose 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 
    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 
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 health-related 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 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, 
    Homeland Security: Intergovernmental Coordination and Partnership 
Will Be Critical to Success. GAO-02-901T. Washington, D.C.: July 3, 
    Homeland Security: Intergovernmental Coordination and Partnership 
Will Be Critical to Success. GAO-02-900T. Washington, D.C.: July 2, 
    Homeland Security: Intergovernmental Coordination and Partnership 
Will Be Critical to Success. GAO-02-899T. Washington, D.C.: July 1, 
    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 Long-Term 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.
                          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, 
    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, 
    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, 
    Combating Terrorism: Observations on the Threat of Chemical and 
Biological Terrorism. GAO/T-NSIAD-00-50. Washington, D.C.: October 20, 
    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.
    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, 
    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
    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 
    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 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 
    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 
    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, health-related 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. 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 
    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 
    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 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 
activities. 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.
    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.]