[Senate Hearing 108-126]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 108-126

                      FEDERAL BIODEFENSE READINESS

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                                   ON

 EXAMINING FEDERAL BIODEFENSE READINESS, FOCUSING ON THE PUBLIC HEALTH 
    WORKFORCE, THE STATUS OF CENTERS FOR DISEASE CONTROL TERRORISM 
     PREPAREDNESS AND EMERGENCY RESPONSE ACTIVITIES, THE EMERGENCY 
    COMMUNICATION SYSTEM, SMALLPOX PREPAREDNESS, THE FOOD AND DRUG 
ADMINISTRATION'S ROLE IN COUNTERTERRORISM ACTIVITIES, VULNERABILITY AND 
   THREAT ASSESSMENTS, LABORATORY ENHANCEMENTS, RESEARCH, OPERATION 
       LIBERTY SHIELD, AND DEVELOPING THE RESEARCH INFRASTRUCTURE

                               __________

                             JULY 24, 2003

                               __________

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



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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  JUDD GREGG, New Hampshire, Chairman

BILL FRIST, Tennessee                EDWARD M. KENNEDY, Massachusetts
MICHAEL B. ENZI, Wyoming             CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
CHRISTOPHER S. BOND, Missouri        BARBARA A. MIKULSKI, Maryland
MIKE DeWINE, Ohio                    JAMES M. JEFFORDS (I), Vermont
PAT ROBERTS, Kansas                  JEFF BINGAMAN, New Mexico
JEFF SESSIONS, Alabama               PATTY MURRAY, Washington
JOHN ENSIGN, Nevada                  JACK REED, Rhode Island
LINDSEY O. GRAHAM, South Carolina    JOHN EDWARDS, North Carolina
JOHN W. WARNER, Virginia             HILLARY RODHAM CLINTON, New York

                  Sharon R. Soderstrom, Staff Director

      J. Michael Myers, Minority Staff Director and Chief Counsel

                                  (ii)

  




                            C O N T E N T S

                               __________

                               STATEMENTS

                        THURSDAY, JULY 24, 2003

                                                                   Page
Gregg, Hon. Judd, a U.S. Senator from the State of New Hampshire.     1
Kennedy, Hon. Edward M., a U.S. Senator from the State of 
  Massachusetts..................................................     2
Gerberding, Julie Louise, M.D., Director, Centers For Disease 
  Control and Prevention, Department of Health and Human 
  Services; Mark B. McClellan, M.D., Commissioner of Food and 
  Drugs, Department of Health and Human Services; and Elias A. 
  Zerhouni, M.D., Director, National Institutes of Health, 
  accompanied by Anthony Fauci, M.D., Director, National 
  Institute For Allergy and Infectious Diseases, National 
  Institutes of Health, Department of Health and Human Services..     5
Statements, articles, publications, letters, etc.:
    Julie Louise Gerberding, M.D.................................    33
    Progress Report to Secretary Tommy G. Thompson...............    37
    Mark B. McClellan, M.D.......................................    48
    Elias A. Zerhouni, M.D.......................................    55

                                 (iii)

  

 
                      FEDERAL BIODEFENSE READINESS

                              ----------                              


                        THURSDAY, JULY 24, 2003

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:00 a.m., in 
room SD-430, Dirksen Senate Office Building, Senator Gregg, 
chairman of the committee, presiding.
    Present: Senators Gregg, Kennedy, Murray, and Clinton.

                   Opening Statement of Senator Gregg

    The Chairman. Let me begin by thanking members of the panel 
for participating in this hearing, which the purpose of which 
is to update us on the status of our Nation's defenses and 
capability to deal with a potential biological or chemical 
attack.
    As I look at this panel, the expertise, genius, and 
brilliance, and leadership gives me considerable confidence, 
and I am sure it gives the American people confidence to think 
that our key agencies in the area of defending our health care 
status as a nation are led by such talented individuals. We 
really are fortunate to have all of you involved in public 
service. It is a tremendous sacrifice financially on your 
parts, but it is a tremendous benefit to the Nation. I thank 
you for your service. It is something that is very much 
appreciated.
    There are basically three issues that I would like to hear 
about. The first is, what is the status of the threat? We have 
talked in the past about the threat of smallpox. We have talked 
about the threat of course of anthrax, the attack on the 
Capitol. We have talked about the chemical threats that are out 
there also, and the threats to various health systems. In 
addition, are there new threats? What is the status of the 
threats that we know exist? Has it changed from our last 
discussion, and if it has, in what way?
    Second, what is the status of our reaction to those threats 
and our preparation to try to deal with them? Obviously, we are 
now well into the issue of the smallpox vaccination initiative. 
I believe the example that was set in dealing with the SARS 
threat represents a very significant effort and exercise that 
we can take a lot of pride in as a Nation, and especially your 
agencies, especially CDC can take a lot of pride in the way you 
handled it. I would be interested in how that relates to 
dealing with the overall threat of the potential of a 
biological or chemical attack.
    Third, what should we be doing that we are not doing? What 
should you be doing that is not being done? What do you need in 
the way of resources? What do you need in the way of people 
specifically? What should the Congress be doing that we are not 
doing? How critical is it that we get the BioShield bill 
through the Congress? How critical is it that we address the 
issue of vaccine liability and other questions, funding 
questions for that matter, that you consider to be important?
    Those are the three areas I would like to have addressed if 
you can. I understand that Dr. McClellan may have to head off 
here, and so I appreciate that. If that is the case, we 
understand.
    At this point I would yield to Senator Kennedy.

                  Opening Statement of Senator Kennedy

    Senator Kennedy. Thank you, Mr. Chairman. Thank you for 
holding today's hearing on the Nation's preparedness for 
biological attack. Our goal is to do all we can to see that 
America is well prepared for bioterrorism.
    It is a privilege to welcome the distinguished leaders of 
the Nation's public health agencies. Elias Zerhouni has brought 
his scientific talent to the helm at the NIH and has an 
ambitious vision for NIH in this new century of the life 
sciences. Mark McClellan has brought his skills as a physician 
and as an economist to the FDA.
    The last time Dr. Gerberding was here, we were discussing 
the SARS outbreak. It is a tribute to the skill of the CDC and 
WHO and public health agencies in many nations that the threat 
of SARS has subsided at least for now.
    It is always a pleasure to see Dr. Fauci, who is an old 
friend and a friend of this committee.
    SARS has shown how well the Nation can react to a health 
threat. But as we all know, the best time to prepare for a 
threat is before it becomes a crisis. Many of us are concerned 
that the Nation is doing too little to see that we are properly 
prepared for bioterrorism. Across the country many local and 
State health agencies and laboratories are underfunded, 
understaffed and poorly equipped to respond to modern diseases. 
Strong hospitals are the foundation of our response to 
bioterrorism. They too are starved for funds because of the 
unwise budget cuts.
    In one area where this administration has tried to take 
action, smallpox vaccination, the result has been a shambles. 
Instead of a coordinated plan to educate health care 
professionals about the risks of disease, evaluate the possible 
health hazards of vaccination, provide the compensation to 
those who were injured, the administration rushed forward with 
a poorly planned program of vaccination. The result is that the 
vaccination program is off course and behind schedule.
    A major cause of the problem was the failure to include a 
compensation plan for persons injured by the vaccine. Three 
months ago, a broad bipartisan majority in Congress approved 
important legislation to establish the compensation program. 
Three months later there is still no working plan. So far, over 
60 serious injuries have been reported from the vaccine. As of 
today, how many victims have received compensation? None. How 
much has been paid out of the compensation fund? Nothing.
    The result of this of this failure is simple. The 
administration delayed in issuing the table of injuries needed 
to start paying the claims.
    The administration has also failed to provide the adequate 
funding for States and local communities to implement the 
smallpox plan. Two years after the anthrax attacks we are still 
playing catch-up and reacting, rather than carefully planning 
and coordinating our local, State and national efforts. 
Understaffed public health offices are being pulled in too many 
different directions to achieve the preparedness we need.
    We need a genuine preparedness plan for bioterrorism 
response and for coordination between the Federal, State and 
local agencies. Agencies need to know which issue and 
responsibility they have jurisdiction over. Who is deciding 
what the biggest biological threats are? How are the many 
different agencies coordinating their activities? Are we 
spending our financial and human resources on the most pressing 
needs? Does the administration have a comprehensive biodefense 
strategy? If so, what is it?
    These are basic questions that need to be answered, and I 
hope our panelists today can shed some light on these issues. I 
look forward to their testimony and their responses to these 
important questions.
    I thank the Chair for having this today. As we all know, 
the Government commissioned reports on the intelligence gaps 
leading up to 9/11, but the gaps also remain in our defense 
against bioterrorism as a result. We need a plan.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Kennedy.
    [The prepared statement of Senator Kennedy follows:]

                 Prepared Statement of Senator Kennedy

    I commend the Chairman for holding today's hearing on the 
nation's preparedness for a biological attack. Our goal is to 
do all we can to see that America is well-prepared to deal with 
bioterrorism.
    Today, a government commission reports on the intelligence 
gaps leading up to the terrorism of 9/11. But frightening gaps 
also remain in our defenses against bioterrorism. And as a 
result, millions of Americans are still at risk. As every 
mayor, police officer, hospital worker, and firefighter can 
tell you we need a plan.
    NIH, CDC, FDA and all our other public health agencies 
spend just over three and a half billion dollars every year to 
help make our cities, our hospitals and our health agencies 
ready for the threat of bioterrorism. That may sound like a lot 
of money but consider this. All these agencies combined spend 
less in a year to keep us safe from bioterrorism than it costs 
every month to keep our troops in Iraq.
    It's a privilege to welcome the distinguished leaders of 
the nation's public health agencies. Elias Zerhouni has brought 
his scientific talent to the helm of the NIH, and he has an 
ambitious vision for NIH in this new century of the life 
sciences. Mark McClellan has brought his skills as a physician 
and as an economist to the FDA.
    The last time Dr. Gerberding was here, we were discussing 
the SARS outbreak. It's a tribute to the skill of the CDC, WHO, 
and public health agencies in many other nations that the 
threat of SARS has subsided, at least for now. In fact, dealing 
with the SARS emergency showed how effectively the NIH could 
mobilize the talents of its researchers to confront a new 
health threat, and how well FDA can work with researchers to 
assure swift consideration of any new treatments or vaccines.
    SARS showed how well the nation could react to a health 
threat. But as we all know, the best time to prepare for a 
threat is before it becomes a crisis, and many of us are 
concerned that the nation is doing too little to see that we 
are properly prepared for bioterrorism.
    September 11th and the anthrax attacks of 2001 were a wake 
up call. Our sense of invincibility was shattered. Although we 
have the strongest military in the world to defend against 
conventional attacks, we were ill-prepared for acts of 
terrorism. Across the country, many local and State health 
agencies and laboratories are underfunded, understaffed, and 
poorly equipped to respond to modern diseases. Strong hospitals 
are the foundation of our response to bioterrorism but they too 
are starved of funds because of unwise budget cuts.
    In one area where this Administration has tried to take 
action--smallpox vaccination--the result has been a shambles. 
Instead of a coordinated plan to educate health care 
professionals about the risks of disease, evaluate the possible 
health hazards of vaccination and provide compensation to those 
who were injured, the Administration rushed forward with a 
poorly planned program of vaccination. The result is that the 
vaccination program is off course and behind schedule. The 
target number of 450,000 vaccinated health care workers in 
hospitals and public health departments is far from met. In 
fact, seven months and $1 billion into the program, not even 
one-tenth of those 450,000 health workers have been vaccinated.
    A major cause of the problem was the failure to include a 
compensation plan for persons injured by the vaccine. Three 
months ago, a broad bipartisan majority in Congress approved 
important legislation to establish the compensation program. 
Three months later, there is still no working plan. So far, 
over 60 serious injuries have been reported from the vaccine. 
As of today, how many victims have received compensation? None. 
How much has been paid out of the compensation fund? Nothing.
    The reason for this failure is simple. The Administration 
delayed in issuing the table of injuries needed to start paying 
claims.
    The Administration also failed to provide adequate funding 
for States and local communities to implement the smallpox 
plan. Coast to coast, hospitals and health agencies have been 
struggling with the inadequacies of the Administration's plan. 
Without needed funding, States were forced to use dollars from 
other public health programs to pay for the smallpox 
vaccination. Robbing Peter to pay Paul put other aspects of 
bioterrorism preparedness on hold. It also resulted in less 
attention being given to other public health problems. At the 
time the smallpox vaccination program began, Boston, Miami and 
San Francisco were facing outbreaks of syphilis. Seattle was 
facing the highest number of tuberculosis cases in 30 years. 
These problems were exacerbated because States and cities had 
to rob other parts of their public health budgets to pay for 
smallpox vaccination.
    Two years after the anthrax attacks, we are still playing 
catch-up and reacting, rather than carefully preparing and 
coordinating our local, State and national efforts. 
Understaffed public health offices are being pulled in too many 
different directions to achieve the preparedness we need.
    Nearly a quarter of all State Government employees will be 
eligible for retirement within the next 5 years. In the past 
month alone, one State lost a third of its laboratory staff to 
retirement. Another, because of the budget problems facing all 
the States, has been allowed to fill only 1 in 4 public health 
vacancies. These cutbacks are happening while we are supposed 
to be expanding our capacity to respond to terrorist threats.
    We need a genuine preparedness plan for bioterrorism 
response and for coordination between Federal, State, and local 
agencies. Agencies need to know which issue and responsibility 
they have jurisdiction over. We should not have to guess who is 
responsible for ensuring that hospitals are prepared to handle 
mass casualties following a terrorist attack. We should not 
have to guess what the Federal plan for bioterrorism is. We 
don't have a plan for the next big flu season.
    Who is deciding what the biggest biological threats are? 
How are the many different agencies coordinating their 
activities? Are we spending our financial and human resources 
on the most pressing needs? Does the Administration have a 
comprehensive biodefense strategy? If so, what is it?
    These are basic questions that need to be answered, and I 
hope our panelists today can shed some light on these issues. I 
look forward to their testimony and to their responses to these 
important questions.
    The Chairman. What is your time frame, Dr. McClellan?
    Dr. McClellan. I can be here until at least 11:30.
    The Chairman. That being the case, then I think we will 
just go right down the panel for your presentations, because I 
am sure that everybody is certainly not going to take anywhere 
near that amount of time.
    We will start with Dr. Gerberding. And again, 
congratulations on your effort on the SARS. It was 
extraordinarily impressive. You were involved in the issue from 
the beginning, and I think the leadership that CDC showed in 
this was not only good for our Nation, but for the world. So 
thank you.

STATEMENTS OF JULIE LOUISE GERBERDING, M.D., M.P.H., DIRECTOR, 
   CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF 
  HEALTH AND HUMAN SERVICES; MARK B. McCLELLAN, M.D., PH.D., 
COMMISSIONER OF FOOD AND DRUGS, DEPARTMENT OF HEALTH AND HUMAN 
   SERVICES; AND ELIAS A. ZERHOUNI, M.D., DIRECTOR, NATIONAL 
    INSTITUTES OF HEALTH, ACCOMPANIED BY DR. ANTHONY FAUCI, 
    DIRECTOR, NATIONAL INSTITUTE FOR ALLERGY AND INFECTIOUS 
 DISEASES, NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH 
                       AND HUMAN SERVICES

    Dr. Gerberding. Thank you, and thank you for having me here 
on this panel today. This committee has really provided 
leadership in preparing our Nation against terrorism threats 
long before 9/11, and without that support and wisdom, I do not 
think we would have made the progress that we have made so far, 
so I really appreciate the opportunity to be here and respond 
to some of your interests.
    I would like to address three main issue in my few minutes. 
The first is the current status of preparedness. The second is 
a quick snapshot about the smallpox program. I am sure there 
will be more questions later. Then third, just a couple of 
comments on workforce, because that is something that is a 
concern to the entire public health system.
    It is important, I think, to start out by recognizing that 
preparedness is not all or none, yes or no, off or on. It is a 
process, and it is going to be an ongoing process for a long 
period of time, because it is very complex, it is very 
difficult to achieve the full-scale preparedness that we need 
for all the kinds of threats that we are facing, and we are 
starting with the public health system that has been long 
neglected. So we have a great deal of work in front of us.
    Having said that, I think in the last year there has been 
substantive progress in many areas, and let me just point out a 
few of the highlights that we have prepared for this particular 
presentation. First of all, as you know, one of the major 
aspects of preparedness is detection, and we now have, through 
the State and local health investments, a situation where more 
than 90 percent of jurisdictions can initiate a field 
investigation in response to a threatening report, 24 hours a 
day, 7 days a week, within 6 hours. That is a giant step 
forward in our ability to initiate a response.
    In addition, we have an information network that continues 
to evolve, and is now highly standards based and able to 
integrate information up and down the food chain. There is more 
work to be done on that, but we have made substantial progress.
    With respect to the laboratories, I think we have some 
amazing achievements. We have 117 laboratories now linked 
through our Laboratory Response Network. More than 90 percent 
of these laboratories can confirm a rapid diagnosis of anthrax, 
plague and tularemia, when 70 percent of them can rule out 
other conditions that would be confused with smallpox and we 
have already 50 BSL-3 laboratories funded in this network, 
which are the laboratories capable of working with infectious 
pathogens. That is three times more than we had when we started 
in 1999. We also have supported more than 880 trainings for 
those personnel in the laboratory networks. Actually, 8,800 
people have been trained.
    In terms of alerting, we have expanded our capacity to 
conduct health alerts 24/7 so that right now we can get 70 
percent of the population covered in every State. In more than 
half the States we have the entire population covered through a 
health alerting process. Again, progress, not done yet, but a 
substantial change from where we were a year ago.
    In terms of training and workforce development in the 
preparedness regard, we have extensive training. More than $96 
million has gone out to the States to support workforce 
development and training. In addition to that, we have had some 
very specific benchmarks such as that 1.8 million health care 
providers have been specifically trained in smallpox 
recognition and response, and more than 14,000 individuals have 
been trained to administer smallpox vaccine within the context 
of vaccine clinics. I think importantly, we also have developed 
an innovative emergency communication system which allows CDC 
to take content from the world's experts in whatever the threat 
might be, and repackage that information to meet the needs of a 
whole host of target audiences, clinicians, public health 
officials, the media, and so on and so forth, and use multiple 
channels, including the Internet, plus briefings, all sorts of 
channels to get that information out. That system is replicated 
now in an increasing number of State health departments, again, 
through the billion dollars of money that has gone out to the 
State and locals. We also have created a risk communication CD-
Rom training, with several hours of training, to help local 
officials be able to do a better job communicating about risk 
in the setting of a crisis and postcrisis situation.
    At CDC we have opened our Director's Operations Center, 
which is a command center that was built on a 24/7 basis, and 
was completed 1 year early, and we were able to get that open 
just in time for SARS, where I think we have now demonstrated 
the utility and the capacity of that particular facility as 
well as the personnel and support that goes into it to function 
effectively in the case of a public health emergency.
    Finally, just to emphasize that although the Department of 
Homeland Security has the overall responsibility for the 
Strategic National Stockpile, CDC does have a collaboration 
with the stockpile in DHS, and we are managing the stockpile, 
we are exercising the stockpile. Just yesterday we ran a 
mission to one of the stockpile secure sites to check on the 
status of the stockpile and our ability to mobilize it if we 
needed to.
    Let me turn now to some comments about smallpox. If I could 
have the graphic, and I hope you are able to see this, but I 
think you have some reprints of this in front of you. As I 
said, preparedness is a process, not an event. What I have on 
this diagram which is just an illustration, not a quantitative 
assessment, the various elements that are required for adequate 
smallpox preparedness, where we were a year ago and where we 
are today. What we would like to see of course is that all of 
those bars be full, brilliant green, and they are not. So we do 
have, as Senator Kennedy mentioned, we have work to be done. 
But we do have some I think important steps forward. First of 
all, in terms of vaccine supply, the new vaccine is being 
delivered on time and on budget. We have more than 155 million 
doses and we are initiating Phase III clinical trials, so that 
we should be able to get that vaccine licensed by next year.
    In addition, as I mentioned, we have trained more than 1.8 
million clinicians to be able to detect and respond to 
smallpox, and those efforts are ongoing through multiple 
channels. We have improved our capacity to detect and report 
smallpox cases. We have had many false positive missions where 
we have run people in our smallpox group or the stockpile to 
areas where someone has reported a fever and a rash. We have 
now used digital imaging to get that information back to us, 
but the reporting system is incomplete. It is not fully 
electronic and we need to do more in that regard.
    Laboratory diagnosis we have improved. In addition to the 
70 percent of labs that can rule out vaccinia or other orthopox 
viruses, we have now 24 laboratories who can rule in smallpox 
definitely, and that has gone from zero to 24 over the last 
year, so significant progress there.
    Hospital care we have improved. SARS helped us develop 
better quarantine and isolation protocols in hospitals, and I 
think made the threat real, but we have got a ways to go before 
we could begin to believe we could manage to take care of a 
large scale smallpox attack. We need regional planning for this 
as well.
    Vaccine safety screening is a success. We have demonstrated 
both in the military program and the civilian program that we 
have fewer incidents of vaccine side effects than predicted 
based on historical experience, in large part because of the 
efforts of the screening process and the ability to weed out 
people who would be at the highest risk for the most severe 
complications.
    Response team vaccination. If I could show the next 
graphic, I could illustrate where we are in this regard. This 
represents jurisdictions that have prepared health care teams 
to respond to the smallpox attack. You can see that there is 
incomplete coverage. Some States and jurisdictions are doing 
quite well. Others are lagging behind or have very little 
hospital preparedness at all.
    On the next graphic I have a picture of the smallpox 
response teams, and this is a capacity to--the next graphic, 
please. I will have an image of where we are able to do 
clinics, so that those response teams can participate in a mass 
vaccination program. Here we are doing much better. Most 
jurisdictions have the capacity to set up at least some sort of 
vaccine clinic to initiate response to a large-scale attack to 
the population, but we are not done yet. Progress was made, but 
there is still a ways to go.
    If I can go back to the prior slide just very quickly and 
finish up there. With respect to adverse event monitoring of 
the vaccine, I think we have the best monitored system for a 
vaccine that we have had for any vaccine for the smallpox 
program. We have multiple sources of data coming in. We were 
able to detect an unexpected problem with myocarditis and 
pericarditis. The system has also learned this to other 
potential side effects such as myocardial infarction, which our 
data indicate are not likely to be attributable to the vaccine 
per se, but until we know more, we have added exclusion 
criteria to our screening process to eliminate those hazards.
    Finally, vaccine clinic planning. I showed you we have a 
widespread clinic capacity, but it is incomplete, and the 
planning for the mass vaccination is incomplete. We are still 
working on this in the next grant cycle, but there is a way to 
go.
    Finally, just very specifically to address the issue of 
workforce, because this is a bottleneck in our preparedness 
process, there are a lot of reasons. The preparedness is 
complicated. The pool of eligible people for the workforce is 
very limited. We are competing over the same group of talented 
people. It takes time to hire trained people, and our pipeline 
in our schools is not a torrent, it is more like a trickle. But 
we have made some steps. We have hired more than 3,800 people 
in the States to support the Bioterrorism Preparedness program. 
At CDC our dedicated FTEs have gone from 174 and will be 529 in 
the next fiscal year. We have set up our public health training 
network and our national laboratory training network, which are 
satellite networks to help improve people's skill sets, and we 
are moving toward a competency-based certification program, so 
it is not just are you in the job, but are you competent and 
certified that you know what you are doing and you have the 
expertise to really contribute.
    We also have 19 academic medical centers funded to 
specifically train people on the various skill sets needed for 
bioterrorism. We have put $196 million out to States to support 
these activities, and we overall have a great emphasis at CDC 
on the retention, recruitment and career development, including 
use of retention bonuses and other incentives to try to retain 
our top scientists.
    One final thing that we are able to do now that we could 
not do before is to put CDC FTEs in the field without counting 
against our Federal FTE ceiling. Right now we have 64 field 
epidemiologists. We have someone in every State, but by 2008 we 
expect to have more than 500 CDC staff deployed to the State to 
provide Federal support for the programs that the States are 
responsible for. A long way to go before we have filled in all 
the gaps, but again, I would like to emphasize the progress as 
well as the work that remains to be done.
    Thank you.
    [The prepared statement of Dr. Gerberding may be found in 
additional material.]
    The Chairman. Thank you, doctor.
    Dr. McClellan?
    Dr. McClellan. Thank you, Mr. Chairman, Mr. Ranking Member, 
Senator. Very pleased to be here today, this morning, with my 
good friends from CDC and from NIH. We have been working 
together on the Nation's counterterrorism activities.
    I also want to thank you all for your work that culminated 
last night in the passage by unanimous consent of legislation 
giving FDA the authority to compel pediatric studies when 
necessary. That is going to have a role in our preparedness for 
counterterrorism activities as well, because we need to know 
about the effects of medications in children in that area too, 
so thank you for your leadership there.
    We are facing some real threats, and we all share the goal 
of being as effectively prepared for terrorist attack as 
possible. I would like to echo Dr. Gerberding's comments about 
how this is a process, one that we are very committed to. FDA's 
critical roles in protecting the Nation include making the food 
supply more secure than ever, helping to develop medical 
countermeasures and make them available quickly, and assuring a 
high-quality professional workforce that is able to carry out 
these responsibilities.
    The safety and security of 80 percent of our food supply is 
our responsibility at FDA, and we take our leadership on food 
security very seriously. Yesterday Secretary Thompson and I 
issued a report that outlines our progress in implementing a 
clear and comprehensive approach to protecting the safety and 
security of our food supply. This report is entitled ``Ensuring 
the Safety and Security of the Nation's Foods,'' and it 
outlines our progress in 10 areas. I would like to request that 
a copy of the report be included in the record of this hearing.
    [The report may be found in additional material.]
    Dr. McClellan. Overall, the changes that we are 
implementing now in food security amount to the most 
fundamental enhancements of our food safety activities in many, 
many years.
    One of our 10 priorities is implementation of the 
Bioterrorism Act of 2002. I would again like to comment you, 
Mr. Chairman, Mr. Ranking Member, and members of this committee 
for your leadership in enacting this landmark legislation. As 
you know, it provided us with new authorities to protect the 
Nation's food supply against the threat of intentional 
contamination and other food-related emergencies. FDA has 
already published four major proposed regulations to implement 
the key provisions of this act: registration of domestic and 
foreign food facilities; prior notice of imported food 
shipments; the establishment and maintenance of records on 
where foods come from and where they go in the distribution 
system; and administrative detention of worrisome foods. After 
we take a full and careful count of all of the comments that we 
have received on these proposed regulations, we intend to 
publish final regulations to fully implement this law before 
the end of the year. These new regulations will enable FDA to 
act quickly in responding to a threatened or actual attack on 
food supply, and it will improve our ability to prevent and to 
contain naturally-occurring food-borne illnesses as well.
    Another key area is food imports. Thanks to supplemental 
counterterrorism funds in 2002 FDA was able to hire over 650 
additional employees to work on food safety and security issues 
mainly at the borders. We have increased surveillance of 
imported foods, increased our domestic inspections and enhanced 
our laboratory analysis capabilities. These are just a few of 
our many recent activities to enhance food safety and security.
    I would also like to discuss briefly our work on medical 
countermeasures in Project BioShield. As you know, FDA's been 
engaged with other Government agencies, including the ones 
represented here, and the private sector, in an accelerated 
effort to develop and make available better medical 
countermeasures. For example, in recent months we have taken 
major steps to make available safe and effective treatments for 
certain nerve gases and radiological agents, and we have 
enhanced our stockpiles of vaccines and treatment for smallpox 
and other possible agents of biowarfare, with safe and 
effective treatments that have been reviewed by FDA. Working 
with other Federal agencies and private companies, we are 
taking more steps to determine as quickly as possible what 
other available products may be of benefit to Americans. We are 
engaged in interagency research to look at new drugs to treat 
plague, the safety of long-term antibiotic use, the use of 
medical countermeasures in special populations, including 
children, and the development of animal models to test drugs 
for biological threats such as viral hemorrhagic fevers where 
tests in humans just are not feasible.
    While the countermeasures resulting from these activities 
are providing a deeper and more extensive stockpile for 
treatments in this Nation than ever before, in many cases they 
are based on old technology. Research and development into next 
generation countermeasures has been much slower than for 
naturally-occurring diseases in recent decades, largely because 
there is no clear financial reward for success. Project 
BioShield would correct this obstacle, and that is why its 
rapid enactment is critically important. This is a priority in 
the administration, and I want to thank this committee for your 
leadership on BioShield as well.
    Finally, I would like to address FDA's efforts to recruit 
and retain an effective counterterrorism workforce. A key 
component of FDA's strategic plan is assuring a high-quality 
workforce. That is what our agency is. We do not give out many 
grants. We do not provide medical services. We ensure the 
safety and security of medicines and foods in this Nation.
    Our workforce includes a solid cadre of highly-qualified 
and dedicated professionals. FDA currently has over 10,600 
employees. Of these, there are almost 1,500 professionals with 
Ph.D.'s and well over 400 with medical degrees. We have created 
many new human resource policies to attract and to keep these 
high-caliber employees, such as the establishment of 
occupational retention allowances for hard-to-fill and hard-to-
retain positions such as medical officers. We pay these 
positions an additional 10 percent of their salary. The 
creation of a pay banding schedule for scientific, supervisory 
and managerial positions. This allows us to set salaries up to 
$200,000 per year for our skilled scientific workforce.
    In addition we have implemented flexible work schedules and 
telecommuting and other family-friendly programs to attract and 
retain the best employees.
    Like other agencies that are represented here today, we 
play a critical role in the Nation's defense against terrorism. 
Although we are better prepared than ever before, much more 
work remains to be done, and I look forward to continuing to 
work with this committee to help keep our Nation as secure as 
possible.
    Thank you.
    [The prepared statement of Dr. McClellan may be found in 
additional material.]
    The Chairman. Thank you very much, doctor.
    Dr. Zerhouni?
    Dr. Zerhouni. Thank you, Mr. Chairman, and members of the 
committee. I am really pleased to be here to discuss how the 
National Institutes of Health are responding to the threat of 
bioterrorism. I am really pleased to join the head of my sister 
agencies, Dr. Gerberding, and Dr. McClellan to describe how we 
are working together to strengthen and expand programs designed 
to protect the American people against the broad range of 
potential terrorist threats.
    I am also accompanied today by the Director of the National 
Institutes for Allergy and Infectious Diseases, Dr. Anthony 
Fauci, who has led much of our efforts with great distinction.
    The Nation's investment in biomedical research has put us 
in a good position to respond to the threats of bioterrorism. 
For fiscal year 2003 the NIH received a budget appropriation of 
more than $1.5 billion for biodefense research. The funds are 
being used primarily to build the necessary infrastructure and 
resources to step up the research programs on dangerous 
microbes and their toxins and in all relevant categories of 
biodefense research during this year, this coming year. We will 
also continue to address and expand our portfolio across all of 
NIH's institutes to address chemical, nuclear, radiological, as 
well as research into the mental health impact of terrorism on 
individuals and our society.
    I will briefly describe our implementation plans in each of 
these four components and also talk about the issue of 
workforce development in these activities.
    No. 1, we have focused almost exclusively our attention on 
developing the adequate countermeasures to the terrorist agents 
that we knew had the highest likelihood of being used in our 
country. Last year the NIH devised and developed the Strategic 
Plan for Biodefense Research, which contains short-, medium- 
and long-range plans for basic research and the development of 
vaccines, drugs, diagnostics and other countermeasures for 
Category A, B and C agents. As we implemented the strategic 
plans, NIH developed a total of 46 biodefense initiatives in 
fiscal year 2002 and 2003.
    I have to say that the response from the scientific 
community was swift and strong. As we were keeping track of our 
applications and success rates in areas of research relevant to 
biodefense, we are observing that our lead biodefense agency, 
NIAID, has seen a 30 percent increase in number of applications 
and the vast majority of those applications are in the area of 
biodefense, expanding the portfolio of research in biodefense.
    Implementation of Part I of our plan led to several 
advances in particularly the discovery that the existing U.S. 
supply of smallpox vaccine was still potent and could be 
diluted five-fold and retain effective protection. This 
discovery made it possible to greatly expand the number of 
doses of smallpox vaccine in the United States. Today we have 
stockpiled sufficient quantities of smallpox vaccine to 
vaccinate all Americans. NIH is now developing and testing the 
next generation of smallpox vaccines and interviral compounds 
that will be safer and more effective than those available 
today.
    Progress on anthrax is following a similar pattern of 
success. Last year NIH-funded scientists identified the 
specific site on the human cell that binds the anthrax toxin, 
and developed a compound that may block its lethal effects. 
This is significant information because it will likely speed up 
the development of new drugs to treat anthrax. In addition, as 
of July 2003, there are four clinical trials of a next-
generation DNA-based vaccine for anthrax called recombinant 
Protective Antigen, which are under way. This vaccine will 
allow protection of the population with a lower number of doses 
over a shorter period of time than currently existing 
technology.
    We are also developing and testing candidate vaccines for 
Ebola and are currently in the planning stages for initiation 
of a Phase I clinical trial to evaluate a candidate DNA vaccine 
for Ebola. Over a dozen more research initiatives are planned 
for fiscal 2004, all of which will help accelerate the 
development of medical countermeasures against biological 
agents.
    Similar planning is under way, across all of NIH, through 
an established standing committee for biodefense research 
coordination, which we established last December. The committee 
is tasked to address not only the threat of biological agents 
such as microbes and toxins, but the threats of chemical, 
radiological weapons that could affect the civilian population, 
as well as the psychological consequences of bioterrorism, to 
provide a research-based, evidence-based approach to decision 
making that the public health authorities of the country may 
have to make in cases of attacks.
    One important component that I think you have been 
extremely supportive and receptive to is the development of the 
BioShield legislation pending in Congress, which specifically 
authorizes NIH to investigate these other areas of biodefense 
in addition to the more obvious threats of microbes and new 
toxins.
    Our activities have also focused on developing the research 
infrastructure of the country by promoting the development of 
the national network of Regional Centers of Excellence for 
Biodefense and Emerging Infectious Disease Research at both 
nongovernmental and governmental institutions. These facilities 
will serve as the national resources for biodefense research 
and product development as well as for the study of other 
infectious diseases such as SARS and the West Nile virus which 
require biocontainment laboratories of the same degree of 
sophistication.
    We are also developing other research resources as quickly 
as we can. All of these investments will enhance our ability to 
rapidly attract both established scientists and new scientists 
to the field of biodefense research so they can support a 
national effort.
    One particular characteristic in our challenge to attract 
scientists to the biodefense effort is that the core knowledge 
that, one, a scientist needs to have in terms of infectious 
disease and immunology, is similar to what the same scientist 
needs to have to attack biodefense organisms. So we are 
positioned in a way where one of our immediate strategies was 
to find incentives and appropriate pathways to convert the 
attention, effort and focus of our existing talent pool toward 
biodefense research. On the basis of that we are continuing to 
build the next step, meaning infrastructure, training, and the 
ability to be able to attract new scientists to the field. This 
is our strategy.
    We are working in collaboration with our sister agencies 
both within HHS as well as with the Department of Defense. We 
have developed an extensive relationship with FDA in terms of 
developing products. I will not repeat the comments that Dr. 
McClellan made about the importance of BioShield and the need 
for us to expand the current statutory limits on our authority 
to develop new approaches for public and private partnerships 
that will entice industry to enter the field once research has 
been developed down to the point where advanced development of 
these products is needed. It will greatly strengthen our 
ability to respond to the many challenges of biodefense 
research and development by providing streamlined authority, 
increased flexibility in awarding grants and cooperative 
agreements, expediting peer review procedures, bolster 
authority for acquisition, construction and renovation of 
facilities, and more importantly, greater flexibility in hiring 
technical experts.
    I would like to finish my comments on the issue of the 
development and sustaining of human capital. We must hire, 
train and retain the most highly-qualified and dedicated men 
and women to form the core of the NIH research enterprise. Our 
current manpower levels have been sufficient to foster the 
initial progress that I described in biodefense research.
    NIH is committed to the education and training of 
biomedical research scientists focused on biodefense needs to 
meet future challenges. We have initiated a number of programs, 
as our sister agencies have, but as an agency we need to also 
remain competitive in attracting the best talent to Federal 
service. Much remains to be done in that regard and we are 
definitely focused on trying to have a strategic plan that pro-
actively looks at the abilities that we have to maintain both 
outside of the Federal Government but also inside the Federal 
Government the best and brightest workforce we can have to 
maintain the research effort over the long-term.
    Thank you very much.
    [The prepared statement of Dr. Zerhouni may be found in 
additional material.]
    The Chairman. Thank you. Again, I want to thank you all for 
your service. There may be questions that come up, Dr. Fauci, 
that you may want to comment on as we proceed. Just jump in, 
please.
    We are, as I said earlier, incredibly fortunate to have 
people of your talent leading these agencies, and we very much 
appreciate your commitment to public service.
    Let me start with the obvious, which is, Dr. Gerberding, 
you talked about the smallpox issue. Clearly we have not gotten 
the vaccine out as aggressively as we wanted. Why, and what do 
we need to do to be more successful, and has there been a 
change in the thinking in light of the reticence of people to 
be vaccinated as to how many we need to have vaccinated, and 
what areas they should be vaccinated in?
    Dr. Gerberding. Thank you. Let me first say that it is 
important to----
    The Chairman. And also what the threat is; do you still 
maintain the threat as being a significant threat?
    Dr. Gerberding. I was just going to start with that because 
I think it is very important to be clear that from the CDC 
perspective and from Secretary Thompson's perspective, we are 
still operating with the assumption that the smallpox threat is 
real. It is not imminent, but it has not gone away and it has 
not been attenuated even in the aftermath of the war, and I 
think there is a temptation on the part of a lot of people to 
believe that somehow the threat has dissipated, and in fact, we 
are still operating under the expectation that we need to be 
prepared as a nation for the possibility of smallpox attack.
    So with that in mind, I think we are, as I said, pleased 
with the overall progress because all of those elements have to 
be in place if we are going to successfully manage a smallpox 
attack. But we believe that pre-event immunization of the 
response team workforce is an essential component of 
preparedness, and we have not successfully accomplished that 
yet. The particular weakness is in the health care delivery 
side. The public health side has geared up in most 
jurisdictions, but we are still lagging behind in ensuring that 
health care workers would be able to take care of cases of 
smallpox should an event occur.
    One reason for that is the concept that the threat is not 
present and there is no need to take these preparedness steps. 
Many of the barriers that we experienced when we started out 
have been lifted, although Senator Kennedy is absolutely right, 
we were slow in getting the smallpox table together, and we 
cannot reassure people that their complications will be covered 
until that table is complete. The reason the table has taken a 
long time is because first of all we wanted it science based, 
and we wanted it to have adequate inclusion of all the things 
that can be attributable to smallpox. Right in the area of 
preparing it this new issue of myocarditis and pericarditis 
emerged, as well as the cardiac complications. So we had to 
very quickly get the data together from the DOD and the HHS 
side to try to get the information into a tabular form. And I 
am told by the Department that the table is very close to 
completion, and I do hope that we are able to get it out in the 
very near future.
    The Chairman. Is that a legal issue?
    Dr. Gerberding. It is a legal and a scientific issue. I 
think it is also an equity issue of wanting to be sure that the 
table does adequately include all of the things for both the 
recipients of the vaccine as well as their contacts. So that 
remains a barrier. And last, I think, in truth, the workforce 
issue is relevant in the sense that in the middle of our 
smallpox program we did have to take the very same people and 
work on the SARS outbreak, and then a monkeypox outbreak, and 
now a West Nile outbreak. We have a number of very high 
priorities throughout CDC and the public health system that 
compete for the same personnel and the same enterprise, and so 
we have been in crisis mode for 2 years now, and it is very 
difficult to sustain a focus on smallpox when we have new and 
imminent issues in front of us, but having said that, we do 
intend to continue to work on this as a high priority, and $100 
million new dollars will be going out through the next cycle of 
the preparedness funding to have more resources to support 
their smallpox preparedness efforts.
    The Chairman. Dr. McClellan, you talked about the food 
risk. Basically, we were starting from what I viewed as zero on 
this issue. How far down the road are we? You said you have 
hired these inspectors, but the food supply is such a huge 
chain, and not only internationally provided but domestically 
grown. You have got the threat of hoof and mouth disease, any 
number of opportunities there. Where do we really stand on this 
whole issue of protecting food supply or at least having a 
sense that we could get an outbreak that was food supply 
oriented under control quickly?
    Dr. McClellan. Well, you and Secretary Thompson have both 
identified this, even before 9/11, as an area where we need to 
be doing more, and as I said, we are better prepared than ever.
    We released in this report yesterday some of the numbers to 
indicate how we have responded to the additional staff that has 
been made available, and what other steps that we have taken. 
For example, examinations of imported foods have more than 
quintupled this year compared to previous fiscal years, from 
around 12,000 to over 60,000, and the fiscal year is not even 
over. We have implemented guidances for every sector of this 
very diverse feed industry that you were describing, something 
like 60,000 domestic food producers, distributors and others 
that we regulate, and a couple hundred thousand farms they 
support. We are trying to get appropriate messages out to them 
about steps that they can take to increase security, and we are 
working hard implementing these regulations. I envision us 
getting to a system where we will have good, accurate 
information about the imports coming into the country, the 
foods being produced, distributed around the country, that will 
match up with intelligence information on real threats to the 
food supply so that we can respond quickly and target our 
resources effectively. We have got more resources going into 
this than ever before, something like $190 million in support 
added over the last 2 years, and we are trying our best to make 
sure that we get the most mileage out of those resources to 
protect the food supply.
    The Chairman. Maybe both you and Dr. Gerberding could 
comment on the coordination issue with the intelligence 
agencies that might have information that would be useful, to 
the extent you can without going to the point that it would be 
inappropriate? How is it working?
    Dr. McClellan. It is working. We have had to change the way 
that we do business, with setting up a cadre of staff within 
FDA and throughout HHS who are cleared at the top levels of 
security, even above the top secret level, to get certain kinds 
of intelligence about specific types of threats. We get 
briefings on a regular basis. We have an emergency response 
office that is set up in coordination with the Secretary's 
Office of Public Health and Emergency Preparedness to handle 
intelligence information in an integrated way throughout the 
Department, and we are working more closely than ever with the 
Department of Homeland Security through the White House's 
Homeland Security Council, on making sure that information gets 
to us in an organized fashion.
    One of the big challenges that we have had is that because 
a lot of the food security responses are steps that the private 
sector needs to take--this is a largely private industry, a 
very diverse one as well--we need to find ways to share 
important information with the private sector in a way that 
does not jeopardize sources, in a way that does not unduly 
alarm the public, but that does get steps implemented that we 
think are important, given the threats and vulnerabilities out 
there, for making our food supply more secure. And we are on 
the road right now to setting up a more extensive intelligence 
sharing program than ever. The Department of Homeland Security 
is coordinating with us, with the Department of Agriculture, 
and with representatives from throughout this very diverse food 
industry. So there is more coordination and more rapid and 
real-time sharing intelligence information than ever before. I 
think we have some more steps that we need to take, especially 
in coordinating with the private sector in how to respond to 
this information. We are trying to do that now.
    The Chairman. Dr. Gerberding, how is your relationship on 
intelligence?
    Dr. Gerberding. We are very pleased with our relationship 
with intelligence. First of all, Secretary Thompson gets 
briefed basically daily with a high-level intelligence briefing 
and that information gets cascaded down to all of us. But in 
addition, at CDC we have two FBI agents on our staff, and we 
have our own elevated capacity at CDC, so we get the same intel 
stream that the rest of the high-level intelligence personnel 
receive in the country. We are integrated. In addition, we have 
a CDC liaison to the FBI who works on the WMD program, and we 
have now established across the country a series of joint 
training programs, where we take field investigators in the FBI 
together with field investigators in the public health 
community, run them through a curriculum for a couple of days, 
where they learn how to investigate collaboratively and how to 
share skills such as chain of evidence or epidemiology.
    So we are integrating in the field. We are integrating in 
the CDC and we are integrated across the Department. Then of 
course through the Office of Homeland Security and the White 
House we have some very high level opportunities to focus in on 
specific problems and look at the intelligence information as 
needed on that basis as well.
    The Chairman. Dr. Zerhouni, on this issue of basic research 
and how quickly we can put in place a research response to a 
threat, do you have the people you need to do that? Do you have 
the resources outside NIH that are coordinated? In other words, 
the research centers around the country that are not 
independent? Is there a coordinated effort there, so that if we 
see a threat we can move quickly on it, and how that is that 
structured?
    Dr. Zerhouni. Well, we have a network of laboratories both 
in the country and outside of the country as well, as you may 
know. In the SARS outbreak we collaborated very closely with 
CDC, with some of our grantees in Hong Kong. We have also very 
specific relationships with many of the biodefense institutes 
and inside of our academic institutions.
    When an outbreak comes we do have a prioritization 
mechanism that goes through the trans NIH and Biodefense 
Research Coordinating Committee that Dr. Fauci chairs and 
reports directly to me. So that when we have the need to 
allocate resources quickly, we have a three-tiered possibility 
of response. One is our own program which can immediately move 
resources, and we have done that repeatedly over the past 2 
years. The second is our collaboration with the Department of 
Defense at Fort Detrick in the USAMRIID, where we can 
immediately set programs for screening, countermeasures, drugs. 
For example, in the case of SARS or now smallpox, we have done 
a lot of--or anthrax--we have done a screening immediately. So 
those are short-term responses.
    In terms of the development of the infrastructure, as I 
mentioned, this is the year where we are doing this on the 
scale that is required. We have competed regional centers for 
biodefense research this year. We have had over, I think, about 
20 to 25 applications for four to six centers, which will be 
granted this year. That is going to be the real resource that 
we on the regional basis will rely on to establish priority 
areas of research focus for each one of these centers, 
depending on their excellence level coordinated with the trans 
NIH activities, not only to microbes and toxins, but we are 
looking increasingly at the issue of chemicals, radiological, 
biodefense for civilian population.
    The Chairman. I wanted to mention that, but obviously I 
want to let other people have an opportunity. But as we look at 
the biologics issues, which is critical, and that is where the 
most aggressive threat is, we still--I do not think we can 
ignore the sarin gases and the VXs, which though their area of 
damage would be less in the sense of numbers and region, it is 
clearly a significant event, and I hope we are aggressively 
pursuing that.
    Senator Kennedy?
    Senator Kennedy. Thank you very much.
    And again, thank all of you. You have all shown 
extraordinary leadership in the areas of public health, and the 
country is very well served.
    I was listening to the comments of all of you, and I think 
anybody that goes over and visits with Secretary Thompson does 
not go in there without going into his master center that he 
takes enormous pride in. You never know whether he has pressed 
a button and has everybody in there ready to go when you go 
over there, but it is incredibly impressive, and I think he 
does deserve a good deal of credit for all of the work in 
coordinating with you in attempting to try and develop a plan.
    We have responsibilities that we have not come through 
with. One is in the BioShield, and others are in some very 
creative, innovative ideas and suggestions that made a great 
deal of sense. Senator Gregg and I have--he is a key member on 
our Appropriations Committee. We talked to members of the 
Appropriations Committee, Budget Committee and the 
administration to try and get that. I think we are very, very 
close to it, but that is something that we have to do if we are 
looking over the longer range and expect the private sector to 
be factored in this. We fail to meet our responsibilities 
unless we can find ways of including them. So we are certainly 
working on that.
    And we appreciate the work that is being done in the area 
of the smallpox. It looks now like only 60 people have been 
hurt, and we pointed out very early in the process that as a 
result of the careful screening and the follow-through that 
would not be a large number of people seeking compensation. 
Therefore, with only 60 people getting hurt we ought to be able 
to be generous enough to make sure that these people are 
treated and treated well, which will be a source of inspiration 
to others to be included.
    As I understand, there is also some question about one of 
the advisory committees considering about the safety issues in 
some of these as well, and therefore, there is sort of a 
general kind of a pause in terms of the program. Maybe you 
could just comment quickly on it?
    Dr. Gerberding. Yes. There is just actually a 
misunderstanding about the advice from the Advisory Committee. 
We asked the IOM to help us evaluate the safety of the program. 
We also have an Immunization Practices Advisory Committee and 
the National Vaccine Advisory Committee, so there are three 
weighing in on this. All three have said that we should 
continue to vaccinate the smallpox response teams, that that is 
an essential element of preparedness. We are not done yet with 
that part. But the committee has suggested that when we finish 
that part of the preparation, that we take a look at the 
experience before expanding out to include all of the police 
and firemen who may wish to be included for broadening the 
overall preparedness effort.
    So we right now have a fair amount of confidence in our 
ability to get real-time information and evaluating so there is 
not a planned pause, but we are at a point where we do not have 
to worry about it too much because we still have a way to go 
before we get to that point.
    Senator Kennedy. The new report points out that there are 
new unanticipated safety concerns. That is what they included 
in the report what you are just addressing.
    I have just a number of points in a short period of time. 
One is with regard to the safety of the food supply. What 
percent actually is being inspected now? It is still pretty 
small.
    Dr. McClellan. It is under 2 percent.
    Senator Kennedy. Under 2 percent. As Senator Gregg pointed 
out, we have the continuing growth curve in terms of imported 
food.
    Dr. McClellan. That is right, and more diversely and 
massively produced food and rapid growth imports as a result of 
all of the improvements----
    Senator Kennedy. So even with the additional kinds of 
resources that we have provided, we are still only at 2 
percent, and this is--we can get to money does not solve 
everything, as my friend to my right reminds me of. But also, 
if it is only at 2 percent we need to try and make sure--I am 
not going to ask you what percent will guarantee the safety and 
security, but I think we could certainly do with additional 
kinds of resources, I imagine, in order to find additional 
kinds of capabilities in this area. I will just say to the 
record, that Dr. McClellan smiled, but did not nod or say yes 
[Laughter.]
    Let me turn to another point. One of the important aspects 
of the legislation that we passed both in the year 2000, and it 
was the development of a workforce group to try and coordinate 
all of what you are doing, plus what the Secretary is doing, 
what all of the agencies are doing, and that is all spelled out 
in the act that was passed in December of 2000, before the 
September attacks. And then on the June 12th legislation that 
was also developed, which the President signed, was the 
National Preparedness of Bioterrorism, other public agencies. 
Very specifically, the importance of the development of the 
working group, and it illustrates all the different things that 
you have talked about and many others. I am not going to take 
the time to do it, but I would refer you to the Section 108, 
the working group. This is supposedly developed by, I imagine, 
Homeland Security, and it talks about the coordination of all 
the agencies that would be affected. It is an expansion of what 
we passed here in the Senate 2 years earlier, and takes 
advantage of what we have learned since then. But I would hope 
there is, as I understand--I do not know if we have any--you 
have given brilliant and very reassuring comments about the 
plannings that are being done by your agencies, but I do not 
know who we would call, who you would call here to speak, and 
is coordinating the whole comprehensive program in terms of 
bioterrorism. I do not know whether you know who it is. Is it 
the Secretary? The Assistant Secretary? Is it Homeland 
Security? Again, I do not want to spend a lot of time on it. 
But what I thought was particularly interesting, is that they 
had the hearings over in the House, and you could see in 
reading through those hearings, it just was not a located 
place. I do not know whether it ought to be Secretary Ridge or 
others who ought to be doing it, but at least from my personal 
impression--and it is not in your particular responsibility. 
You are key elements and I think no one can listen to what you 
have been doing without being enormously impressed, but I do 
not know whether we are also missing out on some very important 
other kind of coordinating aspects which I think we probably 
ought to bring up.
    This is the testimony of Paul Redmond, who is Assistant 
Secretary of Homeland Security, and was a representative 
selected by the Homeland Security Department to testify on 
bioterrorism in the House Homeland Security Committee. First of 
all, I guess he admitted that he had not read, even seen his 
own testimony, and then he admitted that there was no real 
plan.
    This is Redmond. ``I am sorry, Mr. Chairman, I am rather 
new to the process. I misspoke. It is my statement, 
certainly.''
    This is Congressman Shays. ``I hope you don't say that. 
Tell me what you wrote in it.''
    Redmond. ``I didn't see it until I got down here.''
    Shays. ``Well, there is nothing in the statement that deals 
with your area, is it?''
    Redmond. ``No.''
    Shays. ``So it is not your statement.''
    ``No.''
    I just wonder in this area--and I will talk with the 
Chairman and get back--but I just think there should be the 
location and the coordination of these kinds of activities if 
we are going to really expect to get this job done.
    Let me ask you, Dr. Zerhouti. I am very concerned that 
you--not just you--the NIH, are doing the work that you have 
outlined here, and that this is also short-changing our battle 
against cancer, against stroke, against Parkinson's. If we look 
over the number of new grants that you are going to have next 
year in these areas that have been the key concerns of the 
Congress, the American people, the families in this country, we 
are seeing a diminution in the total numbers. And I am 
interested, wondering if we are shortchanging the war on cancer 
or stroke or Parkinson's disease to fight the war on 
bioterrorism? And if that is so, what does that say about our 
responsibilities in making sure you have the adequate resources 
to be able to do both?
    Dr. Zerhouni. First of all, let me say I did read my 
testimony. [Laughter.]
    Senator Kennedy. You do not need to.
    Dr. Zerhouni. But this is a real concern because we have a 
sort amount of capacity of research, and you need to make sure 
that the portfolio is balanced. In terms of 2004 there is no 
doubt that the major increase that we are going to see in terms 
of number of grants is related to biodefense as we are building 
up the capacity. We try to protect, actually, the rest of the 
portfolio. We are not seeing a decrease in the rest of the 
portfolio. It is almost flat in terms of what the number of new 
grants is going to be afforded by NIH in all the other areas.
    However, I think this is a valid question in terms of how 
do you balance the total portfolio of activities when you have 
a national priority like biodefense? As I said, and Dr. Fauci 
may comment, what our first strategy was, was to identify those 
who had the skill set to be able to do biodefense research with 
a minimal, minimal additional investment because they already 
had the fundamental knowledge. They could vary--for example, 
the genomics of microbial agents for bioterrorism research is 
not that different than doing it for normal agents, for natural 
agents.
    However, what we are doing, Senator, is we have formed a 
steering committee of a select group of directors, which was 
really formed to address those issues. We have a process called 
the Roadmap Planning Process, which is a trans NIH funding 
process in which we are trying to identify priorities of the 
agency that go beyond biodefense, so that we will avoid 
imbalance in the portfolio. So we are completely sensitive to 
your remarks, Senator.
    Senator Kennedy. It comes back to sort of who is in charge. 
They can find out that there are not the resources there in the 
NIH because we are diverting them in this, or we are only doing 
2 percent in terms of food supply and we really ought to be 
doing something more, or the help and assistance, that is CDC, 
and that is a concern.
    I know others want to inquire. One of the areas that I am 
very concerned about is what is happening in the hospitals. I 
know Dr. Gerberding gave an enormously interesting and 
impressive statement about what we are doing in the early 
detection, the expansion of the public health areas. I would 
agree that we have let that deteriorate dramatically. These 
first responders, how are we going to deal with that? It is 
incredibly important.
    We find in just talking to people back in my State, 
Massachusetts, the Boston Medical Center, they have spent 
35,000 on personal protective equipment, 15,000 on supplies, 
extra pharmaceutical, 30,000 training. Boston Medical Center 
spends 275 this year, 317,000 next year. Lahey Clinics, 109,000 
this year, expect to spend a good deal more next year. Quincy 
Medical Center, 280,000. In Attleboro at Sturdy Memorial 
Hospital, 34,000. And it just goes on and on.
    We have seen that Congress has appropriated 500 million, 
but also at the same time, our hospitals also, many of these 
major urban areas, graduate medical education has lost 750 
million. We have seen the Medicaid slash that will attribute 
300 million. The net result is the hospitals are losing 
$1,900,000,000 this year. Every hospital I have spoken to 
reports that they are trying, trying, trying in terms of the 
terrorism preparedness as a key cost, but they just are under 
so much financial pressure. I have mentioned this to Secretary 
Ridge and Secretary Thompson, anybody else that would listen to 
this part. But I think unless we are going to be able to 
provide some additional kind of help and assistance in terms of 
hospitals, whether they are the teaching or the community 
hospitals, and these things that will really be outside even 
first responders who are the containers on this kind of thing, 
we are going to really fail in an important way, even with the 
kinds of detection and the public health laboratories and all 
of the others out there, and even with the sophisticated 
ability to move vaccines around the country overnight, if we 
are not going to be able to have the centers that are going to 
be well equipped and well trained people with the equipment, I 
think that is going to be a major gap in the whole system.
    Dr. Gerberding, your reaction?
    Dr. Gerberding. Well, first of all, I agree with you that 
our health care system is under enormous stress from a lot of 
different directions. I spent 2 weeks at San Francisco General 
Hospital, working on medical alerts in June, and I can only 
agree with you. I also do not think we can solve those problems 
through biodefense preparation, per se. We are, Secretary 
Thompson and HERSA are increasing the level of support to 
hospitals for bioterrorism preparedness this year, so we will 
expect to see some increasing returns on that investment. But 
there are other things that we are doing and need to do more 
of.
    One is we need to have a regional approach. It is not 
realistic for every hospital in every jurisdiction to be able 
to be the bioterrorism hospital. We learned that with SARS. 
That just does not work. So we need to consolidate and invest 
strategically in preparedness resources.
    Another thing is CDC and HHS can do more to help hospitals 
not have to reinvent the wheel every time they want to train or 
prepare, so we are putting together tool kits and other 
resources and using our distance learning systems, as well as 
our many colleagues within the professional organizations and 
the schools to create modules that say, this is what good 
hospital preparedness looks like. These are the benchmarks. 
These are the performance standards, and this is what you need 
to do, just to help give them more technical and infrastructure 
support to get there. That is going to have to be a very high 
priority this year.
    Senator Kennedy. Just finally, doctor, you talked about 
maintaining NIH as having the best in biodefense probably being 
a subject for another hearing, but I hope you will feel free to 
let us know about what we ought to be doing.
    The Chairman. That is true of all these agencies.
    Senator Kennedy. All the agencies. I hope, as the Chairman 
has just said, that this is an open invitation to communicate 
with us about this, particularly----
    The Chairman. What you all need.
    Senator Kennedy. If you are an appropriator you can say 
that.
    But in a serious way, with all the agencies, maintaining 
these personnel, keeping the people that are really making the 
difference and that are the real backbone is enormously 
important and we should hear from you about those. There are a 
lot of things that we can do.
    Thank you very much.
    The Chairman. Thank you. And just quickly on that point, 
that is very important. We have done a lot of special things 
for a lot of agencies that have had unique personnel issues. I 
know in my appropriating committee we have done special things 
for the FCC and for the FBI. So we are interested in ideas you 
have for how to keep your talent.
    Senator Murray, I would say that Dr. McClellan is going to 
be leaving in a little while, so if you could keep your 
questions to 10 minutes.
    Senator Murray. I can do better than that. Mr. Chairman, I 
really appreciate your having this hearing, and really want to 
show my appreciation for each one of the panelists here. It is 
very clear that this country is well represented and has 
tremendous talent in all of these agencies that are so critical 
to our public health system and to all of us as we live our 
daily lives, and I really want to thank you for your tremendous 
work.
    I have had the opportunity to ask many questions of you 
through my committee assignments, a lot of questions focused on 
this issue. But I think sometimes when we are not at orange 
alert, we tend to forget all the work you are doing, and the 
work you are doing right now is so critical in case we ever get 
to an orange alert again. I know the threat of terror is real. 
We sometimes lose sight of that, but what I feel good about in 
this country is we do have great intellects, we have great 
creativity, we have great technology, and if we invest in those 
things we will be prepared, and I know each one of your 
agencies is working on doing that in your own way.
    Dr. Zerhouni, let me start with you. I know in your 
testimony you indicated that NIH is working on a next-
generation smallpox vaccine, and again, our creativity and 
engineering is going to get us to where we need to be. But I 
have asked you this before. I just want to keep you focused on 
it. It is a real concern of mine that as we do this new 
research for any new vaccine or any kind of prevention or any 
kind of medicine out there, that we remember our children, 
pregnant women, and other vulnerable populations. I want to ask 
you what we are doing to make sure that these kinds of vaccines 
are being tested for those vulnerable populations?
    Dr. Zerhouni. First of all, I think this is an appropriate 
concern and an important consideration of strategic planning. 
In fact, the development of the MVA version of smallpox 
vaccine, the Ankara strain, which is a strain that has a much, 
much lower level of morbidity and mortality, from which a much 
kinder, gentler vaccine was developed and designed in fact to 
address the issues of populations that are vulnerable, 
particularly children and immuno-compromised patients. But as 
we see, it is also becoming very critical for us to develop in 
this area vaccines that have much, much lower risk profile to 
the recipient of the vaccine, because we have a risk-benefit 
ratio of threat versus risk of the vaccination computation that 
is occurring in our mind as public health officials that we 
need to improve by reducing as much as we can through research 
the risk not just to special populations which we care about 
and we worry about. We are really pleased to see that through 
the Better Pharmaceuticals for Children's Act as well as the 
BioShield contacts, that there is as much emphasis on those 
populations as there is in the general population.
    Dr. Fauci might want to comment.
    Senator Murray. I would love to hear his comment. We can 
hear about Cipro, but it has never been approved for children, 
and we are sitting here watching children unable to be 
protected, I think that is a real disservice to our country.
    Dr. Fauci. You make a very good point. If you can remember 
a previous hearing we had when we discussed the ultimate 
approval or lack thereof of this smallpox vaccine that we 
currently use, was that in the clinical trial apparatus, we are 
actually doing a clinical trial on children so that we could 
give the FDA enough data for them to make an informed 
decisions. The institutional review boards themselves had a 
great deal of hesitancy of even doing the clinical trial on 
children, which really created a kind of vicious Catch-22 for 
us because we could not do what we felt was right for the 
Nation or the children because we could not get past the IRB.
    The subsequent vaccines that are in trial now, the major 
prototype of which is the one that Dr. Zerhouni just mentioned, 
the modified vaccinia Ankara, as a matter of fact, we do not 
anticipate that as a problem because of the well-known lack of 
toxic side effects in any population that we have used them in 
so far, antedating the smallpox problem, because we have used 
this in cancer patients, we have used this in HIV-infected 
patients. So your point is right on, and that is something that 
we will be addressing in the future endeavors.
    Dr. Gerberding. Senator Murray, if I could just add one 
thing. Secretary Thompson charged CDC with managing the 
National Advisory Committee on Children and Terrorism, and we 
have received the first round of recommendations from that 
advisory committee, so we would be happy to make this available 
to you because there are a number of things in there that are 
action steps for all of us.
    Senator Murray. It is important not just because we need to 
be able to protect our children and our pregnant women, 
vulnerable populations, but if you have the population fearing 
being inoculated because of it has not been tested on even a 
small number of people, people will not go and get their 
vaccinations. So I really appreciate that.
    Dr. McClellan. We would be happy to provide you all with 
the data that we put together on the use of many of these 
agents. In a control group, for example, in Cipro, as you 
mentioned, we put together a database of about 3,400 pediatric 
patients developed a profile of side effects and other 
complications that we are using as a basis for pediatric 
labeling.
    Senator Murray. The information needs to be known right 
away because if a parent does not give their child something 
because they fear there may be side effects, their delay could 
be critical for that child's health.
    Dr. Gerberding, I think you are the person I need to ask 
this question to, but anybody who wants to can answer. I have 
raised this issue so many times. I have raised it with SARS and 
with all the other issues we have gone through before. But what 
concerns me a lot is that these diseases know no boundaries, 
and a biological attack knows no boundary. Vancouver, B.C. is 
only 8 miles across the border from Washington State. I am sure 
New York shares this concern as well. And we saw it, like I 
said, with the SARS vaccine. The administration has told us 
before that they are working on bilateral agreements both for 
planning and in case something occurs. How are those bilateral 
agreements going with Mexico and Canada?
    Dr. Gerberding. Thank you. Two aspects to the answer. First 
of all, we have completed a bilateral negotiation with the 
border of Mexico, and so we have a memorandum of understanding 
and some support for activities across that border.
    With Canada, so far the effort has been on a State-by-State 
basis. The money in the terrorism funding can be used by States 
to deal with jurisdiction over the border and to enter into 
bilateral agreements on a jurisdiction-by-jurisdiction basis.
    In addition, Secretary Thompson, I think working through 
HERSA, is creating opportunities for more comprehensive 
planning with the border countries of Canada, which obviously 
would be one of your major concerns.
    Senator Murray. Do you think we need to be doing more on 
this?
    Dr. Gerberding. I think right now that our interaction with 
Health Canada and with the Minister of Health is such that we 
are collaborating on a very high level. Canada, for example, is 
interested in creating a Canadian CDC, and so we are working on 
how we could collaborate, not just on infectious diseases, but 
on a number of disease----
    Senator Murray. Did we learn anything from the SARS?
    Dr. Gerberding. We absolutely learned a great deal from 
Canada and the SARS, and we were very appreciative of their 
generosity in sharing those--particularly with hospital 
preparedness. In fact, we sent CDC teams up there twice now to 
learn about what is happening with the ongoing transmission. 
But more importantly, to bring back the protocols and all of 
the procedures that were successful in containment, and we have 
a--there is actually a committee at CDC taking those now and 
creating these protocols for isolation and quarantine, so that 
hospitals not only know how to isolate a patient, but know how 
to deal with a whole system of care if it had to change.
    Senator Murray. Are our State agencies, particularly on the 
northern border, ready and know who to call? For example, if it 
was a bioterrorist attack in Bellingham, Washington or in the 
northern part of New York? Do those cities or counties or State 
agencies, do they know who to call in Canada, or do they call 
the national Government here and we call some Canadian agency? 
Is there a plan in place for that?
    Dr. Gerberding. I should know the answer, and I do not, but 
I will find out.
    Senator Murray. OK. I would really appreciate knowing that.
    One more quick question, Mr. Chairman. My concern always 
goes back to the fact that we do such great here in your 
agencies, but the first people to ever see a bioterrorist 
attack or SARS outbreak are the emergency room doctors as 
people start coming in. All the good information you develop, 
how does it get to those ER doctors so that they recognize it 
quickly and can notify whoever they need to notify and begin to 
start any plan that needs to be put into place?
    Dr. Gerberding. The answer to that now is we use multiple 
channels. First of all we have the ``just in case'' training 
and education, and the College of Emergency Physicians is one 
of our key partners to take CDC content and then redeploy it 
through their website and their national meetings and their 
information channels. So we have the ``just in case'' 
background ready.
    And then in the time of an event, when we need ``just in 
time'' information because now there is a case or a potential 
case in front of them, we have additional amplification 
channels will include the Internet, the e-mail system, the 
health alert system, the secure information exchange. And we 
take our MMWR reports and bulletize them, and then we have many 
partner organizations including the college that blasts that 
out to their membership. So we use multiple channels for both 
of those types of scenarios, and I think increasingly, we are 
filling in the gaps there and we are able to speed up the whole 
process. So that has been an area of great progress.
    Senator Murray. It is an area I continue to be concerned 
about. Our emergency room doctors are overwhelmed right now. 
They are facing a health care crisis everywhere I go in my own 
State, and I am certain elsewhere. With a lot of doctors 
leaving, hospitals just struggling, and yet these are the 
people we are going to rely on to notice quickly and 
effectively and efficiently any kind of outbreaks. So making 
sure they have the resources and the training and the support, 
I think is really critical.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator. I would just note for the 
edification of everyone, we are going to terminate the hearing 
at 11:30. That will be plenty of time in case one of our fellow 
members just wanders in. I will have given fair warning on 
that.
    Senator Clinton.
    Senator Clinton. Thank you, Mr. Chairman. Thank you for 
holding this hearing. I cannot imagine any more important 
subject, and I want to join with my colleagues in thanking and 
congratulating our four witnesses for their service to our 
country. I am deeply impressed and very grateful.
    Let me start with asking that my full opening statement, if 
I could, be submitted to the record, Mr. Chairman.
    The Chairman. Yes, of course.
    [The prepared statement of Senator Clinton follows:]

                 Prepared Statement of Senator Clinton

    I want to thank Chairman Gregg for calling this important 
hearing. I recognize the significant effort the Administration 
has invested into preparing for a potential biological, 
chemical or radiological attack. If we are serious about 
remaining prepared for a bioterrorist attack, it is critical 
that we continue to reassess our capability, and raise those 
concerns where they remain and not simply rest on the laurels 
of our accomplishments.
    Unfortunately, a recent Council for Foreign Relations 
Report, entitled ``Emergency Responders: Drastically 
Underfunded, Dangerously Unprepared'' sounded a chilling alarm. 
Its report found that most states' public health labs still 
lack basic equipment and expertise to respond adequately to a 
chemical or biological attack. Seventy-five percent of state 
laboratories reported being overwhelmed by too many testing 
requests. We clearly need to devote more funding if we are 
serious about defending our nation against bioterrorism.
    The smallpox vaccination effort championed by CDC exposed 
this critical weakness in our public health workforce. In order 
to meet the demands of Phase I of the Smallpox vaccinations, 
Onondaga County in New York has shifted staff members resulting 
in the reduction of services by more than one-third. There will 
be 835 fewer pediatric dental visits and a reduction of 221 
visits for women who need breast and cervical cancer screening. 
Our public health departments are stretched thin already, and 
with the state and local budget crunch, these departments lack 
the resources to even keep some of the staff they currently 
have.
    In many of the states and localities most likely to be the 
victim of a bioterrorist attack, the existing public health 
infrastructure that would help us detect and respond to a 
bioterrorist threat is crumbling. In New York City, the key 
facility that handles and screens specimens for bioterrorist 
agents has a deteriorating roof and cooling system and has 
significant water damage in its interior. Yet New York City was 
45th in per capita bioterrorism funding from CDC in Fiscal Year 
2003, and New York State was 49th.
    Currently, bioterrorism funding is not distributed based on 
threat level, despite the fact that Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 authorizes 
those funds to be distributed based on the threats that 
particular states and localities face. Historically, cities 
have proven to be at higher risk of bioterrorist attacks--for 
example, sarin in Tokyo and anthrax in Washington. We should 
also encourage those cities, such as New York, that have 
developed model programs in screening for and responding to 
bioterrorism that other localities can apply in efficiently 
implementing their own preparedness programs.
    Another recent report from the Partnership for Public 
Service raises an equally alarming concern. The report tells us 
that fifty percent of federal experts trained to respond to a 
biological or chemical attack will retire over the next five 
years alone. Our public health professionals in the FDA, CDC, 
USDA, and other agencies have critical expertise that has given 
us peace of mind that we will be protected from a bioterrorist 
threat. Yet that peace of mind will soon crumble. At the state 
and local level, the problem is even worse; the Council for 
State and Territorial Epidemiologists tells us that we will 
need to train an additional 1600 epidemiologists over the next 
ten years just to prevent a worsening shortage of these 
professionals at the state and local level.
    While the Epidemic Intelligence Service in CDC trains 
doctors and other health professionals to become the public 
health experts of tomorrow, the Partnership for Public Service 
report tells us that we need to prime our pipeline of public 
health experts if we want to avoid a crisis in biodefense. That 
is why I will be introducing an amendment to the Labor-HHS 
Appropriations bill that will ensure that we can have the 
expertise we need to protect our citizens from a bioterrorist 
attack.
    My proposal would double funding for the Epidemic 
Intelligence Services, the ``pipeline'' program that trains and 
recruits federal public health personnel like those at CDC, and 
establish a new ``pipeline'' training program to recruit, train 
and retain desperately needed state and local laboratory 
personnel, epidemiologists and public health nurses. This 
amendment would also add funding to Title VII programs that 
currently train public health personnel, and would also 
increase funding for the CDC's Centers for Public Health 
Preparedness so that these centers can collaborate with state 
and local public health agencies in developing training 
programs for public health personnel. It would also ensure an 
annual audit of federal, state and local bioterrorism personnel 
with recommendations to Congress so that we can continue to 
monitor our workforce needs and intervene if necessary.
    I hope Director Gerberding and Secretary Thompson will work 
with me on this amendment, and the authorizing legislation I 
plan to introduce subsequently. I eagerly anticipate a fruitful 
discussion with our expert panel, one that will move us closer 
to our shared goal of protecting our nation from terrorism.
    Senator Clinton. Dr. McClellan, let me first thank you. 
Last night was a red letter day for American children and 
clinicians, physicians, nurses and others. We finally passed, 
by unanimous consent, the Pediatric Research Equity Act of 
2003, which will add another tool in the tool kit that Senator 
Murray was discussing about how to best prepare our children, 
and how we get adequate information about the safety and 
efficacy of drugs that are prescribed for children, and I want 
to thank the Chairman and the Ranking Member, and certainly my 
colleagues, Senators DeWine and Dodd, for their perseverance. I 
particularly want to thank you personally and your staff for 
your technical input and your personal involvement.
    I am hoping that we can count on your help in the House. 
Obviously, now that we have passed it in the Senate, if we 
could get it through the House, then we could get it to the 
President to be signed. So I would ask that you do everything 
possible to help the House, as you did with us, in moving this 
important legislation forward. And may I also assume that you 
are supporting undisputed authority for the FDA to enforce 
pediatric studies, and supporting the Senate in the position 
that we have taken?
    Dr. McClellan. That is right. We are strong supporters of 
the bill that you and your colleagues here worked to pass. We 
deeply appreciate your efforts to get that done. We need the 
pediatric rule back in place for all the reasons that you 
mentioned. And Secretary Thompson and I issued a statement 
today, urging rapid action to get the bill to the President's 
desk, and I hope that will happen quickly. We will work just as 
closely with the House as we have worked with you to get this 
done.
    Senator Clinton. Thank you so much.
    And I would be remiss if I did not thank Dr. Fauci for 
starting down this road with me and others so many years ago, 
and I am very grateful that we are nearly at the destination 
point.
    I have a few more questions that I would like, Dr. 
McClellan, to submit for the record to receive responses on.
    [The response to questions of Senator Clinton was not 
received by press time.]
    Dr. McClellan. Certainly.
    Senator Clinton. Let me also turn to an issue that Dr. 
Gerberding talked at great length about in her written 
testimony, and I think it is one of the critical issues. The 
Chairman referred to it in his remarks, and he of course is in 
a very strong position to offer the leadership needed in his 
joint position here and on the Appropriations Committee.
    Because the recent Partnership for Public Service Report, 
entitled, ``Homeland Insecurity: Building the Expertise to 
Defend America from Bioterrorism,'' as you point out, has some 
startling figures about the impending loss of medical and 
biological experts who are on the road to retirement in the 
next 5 to 10 years, do you think, Doctor, that the Epidemic 
Intelligence Service and other Federal training programs will 
be able to provide enough personnel to fill this potential 
workforce shortage and, if not, or if in doubt, what are some 
of the activities we should be pursuing right now to get in a 
position to avoid this collision course I see us heading 
toward?
    Dr. Gerberding. I will try to give a short answer. I think 
it is a long answer that would be most informative.
    I do not think that the current system is adequate to 
sustain the public health workforce, particularly the workforce 
that we are going to need in 5 years because the skill set is 
changing. We need informaticians, we need molecular biologists, 
we need public health experts in genomics. And so there is a 
whole new generation of skills that we need for terrorism or 
for other issues.
    There are some short-term steps that we can take, and just 
like I think you have heard from all of my partners here in 
HHS, we are developing a strategic framework for workforce 
development throughout the entire public health system, which 
includes going way back to junior highs and high schools, where 
we are engaging kids in the concept that public health is a 
great profession. We had Olympiad winners this year in 
epidemiology in the science contest in the field of 
epidemiology.
    So we are starting way back at the beginning and trying to 
interest people in this career pathway, working with colleges 
and universities to support summer internships and training for 
students to make this field exciting, working with minority 
health organizations to get those students involved and to deal 
with some of our disparity in diversity issues, working with 
the schools of medicine, schools of public health and other 
professional organizations, academic organizations, to develop 
bona fide curricula and training.
    And a very immediate step that we will be taking at CDC is 
to implement training grants in public health so that 
postdoctoral students who are interested in careers in public 
health have an opportunity for research experience in the same 
way that they would if they were interested in infectious 
disease or other fields of endeavor. So we will be creating 
some training grants in this field.
    These are all going to take a long time to come to 
fruition, but if we do not start strategically, with the long 
view in mind, in 5 years, we will be in a crisis State.
    At the other end of the pipeline, of course, we want the 
kinds of flexibilities that Senator Gregg was making reference 
to so that we can give retention bonuses and that we can 
compete salaries and the critical job classifications that 
right now Government is not very competitive in. So I think if 
we work together on this, the problems are going to be similar 
across our agencies, and we will probably be able to come up 
with a framework that makes some sense. And I am sure we will 
have Secretary Thompson's support in that, but it is nice to 
know that you are interested.
    Senator Clinton. Well, and I think the concern extends down 
to State and local public health departments, as well as the 
Federal workforce. The Council for State and Territorial 
Epidemiology tells us they will need to train an additional 
1,600 epidemiologists over the next 10 years just to prevent a 
worsening shortage of professionals working at State and local 
levels.
    And I am so concerned because, historically, as I read the 
data, professionals were trained by the Epidemic Intelligence 
Service that you are referring to, and the other programs, in 
conjunction with academic institutions and the like, usually 
choose to work in the Federal and academic public health 
positions, and we desperately need them there. So it is not an 
either/or kind of question.
    The Centers for Public Health Preparedness, located at the 
Schools of Public Health, have historically trained the 
academic and Federal public health experts. So we also have to 
be thinking about a pipeline for the State and local public 
health professionals.
    And I think that is a double challenge we face, Mr. 
Chairman, because not only in the area of biodefense, but even 
in the increasing awareness of environmental impact on health, 
we are not having enough personnel at the State and local level 
to follow up on legitimate questions that are raised, that 
maybe can begin to acquire enough information, we can make 
sense of cancer clusters or, you know, increasing spikes in 
other diseases.
    So I think that we've got to think on both levels, both 
what, as the doctor clearly states in her oral and written 
testimony, we can do at the Federal level, but then I think we 
are going to have to provide some boosts at the State and local 
level. And I would appreciate thoughts that any of our experts 
have on this because you work with the State and local level.
    Then, in another arena, I wish to briefly mention our 
continuing efforts globally and what we need to do to maximize 
our reach globally. And I want to commend all of you for the 
contributions that the American medical establishment made in 
the SARS epidemic, but any thoughts you have got that we should 
take and consider, with respect to the WHO. I mean, we have 
got, for example, this bizarre problem that Taiwan is not in 
the WHO, and so you have got political obstacles to figuring 
out what is going on with an epidemic in Taiwan.
    These things are just hard to understand given the global 
village that we all inhabit. So any thoughts you have may not 
be directly in our jurisdiction, but if you need additional 
personnel, laboratories overseas, other kinds of protocols that 
we have anything to do with, we need to hear that from you 
because this is an increasing concern of mine.
    There are some of my colleagues who do not believe in 
things like global climate change, but it does seem to me that 
some of these diseases are creeping northward. Disease that we 
never had at these latitudes, we are now finding. And 
certainly, even apart from that, all kinds of critters get on 
airplanes, and ships, and end up on our shores. So I think we 
have got to think more globally, as well as globally. So there 
are many, many levels to this.
    Finally, Dr. Gerberding, the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 authorizes 
the distribution of public health emergency preparedness funds 
based on threat. However, in fiscal year 2003, New York City 
was forty-fifth in public health emergency preparedness funding 
at $2.59 per capita.
    I think history has proven that our cities are the 
principal targets for any kind of attack. That is where sarin 
was used, in Tokyo, anthrax here, in Washington. Can you tell 
us how you are planning to ensure that the funds are, in the 
future, distributed, as we intended them to be, on the basis of 
threat.
    Dr. Gerberding. Thank you.
    Yesterday, I had a chance to talk with the commissioner of 
Health in New York City, and he brought the same issue to my 
attention. I do not think anyone would argue that New York City 
is a target, and we recognize that.
    The dilemma is that we did not think of Boca Raton as being 
a target before the first case of inhalational anthrax was 
identified there. So it is a real challenge to make a 
hierarchical arrangement of our cities and really, ultimately, 
we have to concentrate on having no weak links in the system.
    And so I promised the Commission that I would talk about 
this with Secretary Thompson and bring to his attention that 
there are inabilities to provide resources for all of the 
priorities in some of our major metropolitan areas. As you 
know, we do have special funding for four cities because we 
recognize that they are higher in population and also higher in 
threat. So we will look at the resource allocation and identify 
how we can get the balance right if it is out of balance right 
now.
    Senator Clinton. I would appreciate being kept informed 
about that. And I thank you for your attention to this.
    Finally, I think that perhaps the Chairman and I could 
discuss further, and get the expertise from all of you, about 
whether there is anything we could do right now. I have 
prepared an amendment to Labor-HHS about this public health 
workforce issue because I hear it all over. It is not just a 
New York City problem, it is throughout New York State, but 
then many people around the country are, you know, they are 
panicked now because they do not think they have enough 
resources, and they look over the horizon, and they just see a 
terrible shortage developing. So perhaps we could discuss some 
about that.
    Then, finally, Dr. Gerberding, I have one very local 
question, and I will be happy to provide additional information 
concerning this, but I want to thank you for your assistance 
and the aid of your staff in setting up the Health Tracking 
System for everyone who labored at Ground Zero--our 
firefighters, our police officers, our construction workers. 
This was such an important effort, and obviously it means the 
world to the individuals who are directly affected. But I think 
it is also significant to the data we are collecting about what 
the exposures might possibly be and the impacts that they will 
have when people are thrust in these unbelievable, dangerous 
situations.
    We may need your help in another pressing matter at this 
time in Endicott, New York. In 1979, there was a release of 
approximately 4,100 gallons of industrial solvents at the 
former IBM facility in the Village of Endicott. The spill 
contaminated local groundwater and associated vapors have 
recently been found in people's homes, although this is now 20 
years-plus after the spill itself.
    The groundwater contamination is being addressed through a 
number of pump and treatment systems, and we are sampling local 
buildings, and we are trying to fix ventilation systems. It is 
a very complex environmental and public health challenge, but 
it is the kind of thing we are seeing more and more often 
across our country. And I think CDC could provide meaningful 
assistance in helping the local authorities and even the State 
try to come to grips with these indoor air situations, the 
problems that are associated with the contamination, and I look 
forward working with you.
    The county executive, Mr. Jeffrey Kraham, has expressed a 
particular concern about trying to set up some kind of an 
assessment system, perhaps through the National Institute for 
Occupational Safety and Health so that we can, again, kind of 
track and learn from these kinds of massive contaminant events 
and apparently have long-term effects. It is not something that 
goes away in a year or two. So I will provide you additional 
information on that.
    Dr. Gerberding. Thank you. We do have the expertise to 
address those kinds of issues, so we will definitely follow up.
    Senator Clinton. Thank you.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator.
    I think you have sensed a real interest in this committee 
at least in doing something about your personnel issues. I 
understand there are bureaucratic issues that may limit your 
capacity to be aggressive in this area, but this committee 
would like to be aggressive in the area, so hopefully we will 
get some counsel from you as to what we should be doing.
    Again, we thank you very much for the extraordinary work 
you do on behalf of the American citizenry in all sorts of 
areas, obviously, not only protecting us from the threat of 
terrorism, but protecting the health of the Nation, and we are 
very, very lucky to have talent of your level and capabilities 
involved in public service. So thank you again, and I 
appreciate your taking the time to be here.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

               Statement of Julie Louise Gerberding, M.D.

    Good afternoon, Mr. Chairman and members of the Committee. I am Dr. 
Julie Gerberding, Director of the Centers for Disease Control and 
Prevention (CDC) and Administrator of the Agency for Toxic Substances 
and Disease Registry (ATSDR). Thank you for the opportunity to testify 
today about terrorism preparedness and emergency response at CDC. The 
United States is experiencing threats to its national security that 
require preparedness for potential biological, chemical, radiological, 
and mass trauma attacks and other public health emergencies. Helping 
lead this effort is the Centers for Disease Control and Prevention.
    HHS has set a strategic course to ready our nation for any 
potential public health threat including terrorism and CDC has played 
an important part in this strategy. CDC's public health emergency 
preparedness vision, ``People Protected--Public Health Prepared,'' and 
the mission statement, ``Prevent death, disability, disease and injury 
associated with urgent health threats by improving preparedness of the 
public health system and the public through excellence in science and 
services.'' are wide reaching concepts that convey our sense of purpose 
and commitment. CDC's preparedness strategies include: timely, 
effective and integrated detection and investigation; sustained 
prevention and consequence management programs; coordinated public 
health emergency preparedness and response; qualified, equipped and 
integrated laboratories; competent and sustainable workforce; protected 
workers and workplaces; innovative, relevant and applied research and 
evaluation; and timely, accurate and coordinated communications. These 
strategic imperatives target our agency's core competencies to prepare 
the public health system for all types of emergencies. CDC is committed 
to protecting people by preparing for and responding to acts of 
terrorism and other public health emergencies.
    In today's testimony, I will speak to three specific issues: the 
public health workforce; the current status of CDC terrorism 
preparedness and emergency response activities: and smallpox 
preparedness.

                        PUBLIC HEALTH WORKFORCE

    The recently released report of the Partnership for Public Service 
entitled ``Homeland Insecurity: Building the Expertise to Defend 
America from Bioterrorism'' pointed to the critical need of addressing 
the Biodefense Workforce. CDC recognizes that a significant challenge 
exists in developing and retaining a qualified and competent workforce 
to address the needs both at CDC and within Local and State Health 
Departments. In fact, nearly half of CDC's physicians and biologists 
will be eligible, although only 10% will actually take early 
retirement, for retirement in the next five years and it has been 
estimated that one-quarter of all government employees will be eligible 
within that same time period. In order to prepare for these retirements 
and to increase the overall number of qualified and competent workers 
in public health preparedness and research, we are looking to new 
strategies for recruitment and retention of scientists, physicians, 
emergency planners responders, and managers. Successful programs like 
the Epidemic Intelligence Service, the Preventive Medicine Residency 
and the Public Health Prevention Service can assist in addressing this 
issue and we are looking into new strategies to reach out to fill 
laboratory diagnostic and critical research positions.
    Prior to September 11, 2001, CDC had a total of 174 FTEs designated 
to support bioterrorism activities. Internally at CDC in FY03, 444 
staff are now employed in various skills sets to support terrorism 
preparedness and response. In FY04, this will increase to 529. CDC has 
increased to 64 the number of field staff (epidemiologists and public 
health advisors) assigned to State and Local Health Departments. CDC is 
planning to move additional staff into the field and has been given 
authority to assign CDC staff to State and Local Health Departments as 
FTE exempt. Through the state and local grant program, at least 3,850 
people have been funded (in part or whole) within the past 18 months to 
support (scientific, programmatic, administrative) public health 
preparedness activities.
    A competent and sustainable workforce is one of the strategic 
imperatives within CDC's National Strategy for Terrorism Preparedness 
and Emergency Response. CDC's support to address this imperative will 
focus on:
    Increasing the number and type of professionals that comprise a 
preparedness and response workforce.
    Delivery of certification and competency based training.
    Recruitment and retention of the highest quality workforce.
    Evaluation of the impact of training on workforce competency.
    Support for Schools of Public Health, Medicine and other Academic 
partners to increase the number of individuals entering the field and 
trained throughout their career. Currently, CDC funds Academic Centers 
for Public Health Preparedness at Schools of Public Health to address 
workforce training and ``workforce pipeline'' issues.
    Through the CDC State and Local Preparedness Program, CDC made 
funds available to each grantee, and charged them with training and 
educating their public health workforce regarding preparedness and 
response activities. CDC is also the home of the Public Health Training 
Network (PHTN) and National Laboratory Training Network (NLTN) using 
distance learning mechanisms as the framework for delivery of training 
to the widest possible audience across the public health system. CDC 
also provides funds through the National Association of City and County 
Health Officials (NACCHO) to support ``Public Health Ready,'' a pilot 
program to develop and test competencies of the local public health 
workforce, in 11 local health agencies.
status of cdc terrorism preparedness and emergency response activities; 

                   UPGRADING STATE AND LOCAL CAPACITY

    In FY 2003, CDC is providing $1.03 billion to continue upgrading 
state and local capacity to prepare for bioterrorism and other public 
health emergencies. This funding includes a $100 million supplemental 
funding for smallpox preparedness activities. To support the state and 
local programs, CDC has developed the following goals, including: 1) to 
rapidly detect public health emergencies involving biological, 
chemical, radiological and nuclear agents: 2) to rapidly investigate 
and respond to public health emergencies involving biological, 
chemical, radiological and nuclear agents; and 3) to rapidly control, 
contain, and recover from public health emergencies involving 
biological, chemical, radiological and nuclear agents. Each goal is 
paired with longterm performance measures that will provide a framework 
to increase the nation's preparedness. Examples of long-term 
performance measures are: 100% of LRN laboratories will pass 
proficiency testing for bacillus anthracis, yersina pestis, Francisella 
tularensis, Clostridium botulinum toxin, Variola major, vaccina, and 
varicella; 100% of states will have level 1 chemical laboratory 
capacity, and have agreements with and access to (specimens arriving 
within 8 hours): a level-three chemical laboratory equipped to detect 
exposure to nerve agents, mycotoxins and select industrial toxins; and 
100% of state and local public health agencies will be in compliance 
with CDC recommendations for using standards-based electronic disease 
surveillance systems appropriate routine public health information 
collection, analysis, and reporting to appropriate public health 
authorities.
    CDC conducted numerous activities with resources provided in FY 
2002. Within 90 days of the FY 2002 appropriation. CDC provided all of 
the appropriated $918 million to states and selected cities. Because of 
this quick action, states were able to fund urgent needs. Up to 20% of 
the FY2003 funds were made available on an expedited basis to the 
states and other eligible entities, should they opt to seek it, for 
smallpox activities and other ongoing initiatives that could benefit 
from enhanced funding. In FY2002, CDC provided training for more than 
1.5 million health professionals in terrorism preparedness and 
response; and, trained approximately 8,800 clinical laboratorians in 
terrorism preparedness and response. CDC, also provided reference 
materials to approximately 4,600 clinical laboratories following 
September 11, 2001. CDC is helping public health laboratories in all 50 
states identify bioterrorist threat agents and efficiently communicate 
laboratory findings. In addition, CDC is providing 117 public health 
laboratories with the capacity to detect and respond to critical agents 
and is increasing national response capacity to include food, 
veterinary, environmental and chemical laboratories in the Laboratory 
Response Network. This work continues during the FY2003 awards process.
    With support from CDC, some states conducted mock exercises to 
prepare for terrorism events involving numerous state, county and local 
agencies; undertook initiatives to develop near realtime syndromic 
surveillance systems; trained large numbers of staff from public health 
agencies, health care facilities, emergency management organizations, 
police and fire departments and other key institutions; created and 
tested communication systems linking local public health staff and 
first responders with senior staff from state public health 
departments, emergency management agencies and other critical state 
agencies; and enhanced critical capacity at their public health 
laboratories.

                         UPGRADING CDC CAPACITY

Emergency Preparedness and Response
    CDC has strengthened its internal Emergency Preparedness and 
Response by establishing the new CDC Director's Operations Center and 
in support of further infrastructure to provide enhanced technical and 
programmatic assistance to states. Some examples include: improved 
rapid identification and characterization of potential biologic agents; 
expanded the Epidemic Intelligence Service to assure that well-trained, 
first-line responders are available to respond to public health 
emergencies; and developed a secure information infrastructure to 
provide enhanced Geographic Information System (GIS) capability at the 
federal, state and local levels.

Emergency Communication System
    CDC moved quickly to assure that its Emergency Communication System 
can comprehensively, efficiently, and rapidly respond to communication 
needs associated with terrorism. This system, currently used to respond 
to SARS and adverse events related to smallpox vaccinations, can 
develop critical information; arrange for immediate direct 
communication with key collaborators and stakeholders around the world; 
provide real-time updates to the media; make sure essential information 
is available to the public through the CDC Web site; maintain a public 
health response hotline; develop training for clinicians; and develop 
public service announcements. A centralcomponent of this system is the 
state-of-the-art Marcus Emergency Operations Center. This facility is a 
unique example of a public/private partnership, and was completed in 
only six months.
    In addition, CDC has made great strides to help enhance 
communications with state and local health departments through a 
variety of platforms including the Health Alert Network (HAN), Epi-X, 
the National Electronic Disease Surveillance System (NEDSS) and the 
Public Health Information Network (PAIN). All of these systems are 
meant to increase the ability of CDC to communicate quickly and 
directly with health officers providing them with emergency messages 
24/7 within 30 minutes (HAN) and via a secure, interactive web portal 
that allows for exchange of important epidemiological information (Epi-
X). Both of these systems fall under the rubric of PHIN. NEDSS is 
currently being implemented at the state level to provide a common 
standard to all states and localities for disease reporting to help 
maximize the ability of CDC and states/locals to stay up to date on 
emerging infectious diseases.

Strategic National Stockpile
    CDC continues to be responsible for managing the Strategic National 
Stockpile (SNS, now supported by the Department of Homeland Security 
resources, but operationally managed through the CDC). The mission of 
SNS is to ensure the availability of life-saying pharmaceuticals, 
antidotes and other medical supplies and equipment necessary to counter 
the effects of nerve agents, biological pathogens and chemical agents. 
The SNS Program stands ready for immediate deployment to any U.S. 
location in the event of a terrorist attack using a biological, toxin 
or chemical agent directed against a civilian population. It is 
comprised of pharmaceuticals, vaccines, medical supplies, and medical 
equipment that exist to augment state and local resources for 
responding to terrorist attacks and other emergencies. These packages 
are stored in strategic locations around the U.S. to ensure rapid 
delivery anywhere in the country. Recently, the SNS has prepared 
specific guidance, and provided technical, planning assistance to 
states as well as providing funding to them to help them effectively 
manage the deployment of the SNS at the state level. CDC will now be 
working closely with DHS on stockpile issues.

Smallpox Preparedness
    In order to better prepare the country for a possible smallpox 
attack, the President, in December of 2002, announced the establishment 
of the National Smallpox Vaccination Program, outlining the 
government's intent to offer voluntary precautionary smallpox 
vaccination with licensed vaccine to selected health care and public 
health workers, traditional first responders, and, in time, to 
individuals in the general population interested in receiving the 
vaccine under appropriate protocols. CDC moved swiftly to do its part 
to assure the availability of smallpox vaccine for every person in the 
United States.
    To improve national smallpox preparedness, CDC has increased its 
focus on elements needed to assure acceptable levels of preparedness. 
Based on knowledge of the disease and public health response strategies 
needed to control and contain an outbreak of smallpox, the following 
preparedness elements are being addressed:
    1. Preparing key responders before an event occurs,
    2. Rapid detection, identification, investigation and response to 
suspect or confirmed casts of smallpox, and
    3. Protection of the public including provision of mass vaccination 
clinics.
    As of July 18, 2003 nearly 38,000 civilian public health and 
healthcare professionals have received the vaccine. Participation in 
the vaccination program has varied widely across the country, with 10, 
states (TX, FL, TN, OH, CA, MN, NE, NC, MO, LA) having vaccinated over 
1,000 volunteers.
    The fact that the participation rate is lower than some projected 
has been generally attributed to: 1) the low perceived threat of a 
smallpox attack, and 2) continuing concerns about the risk of adverse 
reactions to vaccination. CDC has conducted at least 74 training and 
education sessions, reaching 1,847,112 health care professionals. 
Thirty-nine different training products are, available for public 
health and healthcare professionals. At least 14,036 individuals who 
have been comprehensively trained have the capacity to administer 
smallpox vaccine, if necessary.
    Last spring, Congress enacted legislation that addressed 
vaccination-related compensation and liability concerns. This 
legislation, the Smallpox Emergency Personnel Protection Act of 2003, 
established a no-fault program (``the Program'') to provide benefits 
and/or compensation to certain individuals, including health-care 
workers and emergency responders, who are injured as the result of the 
administration of smallpox countermeasures, including the smallpox 
(vaccinia) vaccine. The Program will also provide benefits and/or 
compensation to certain individuals who are injured as a result of 
accidental vaccinia inoculation through contact.
    To date, the incidence of adverse reactions in both civilian and 
military populations has been lower than anticipated. The military 
smallpox vaccination program provided an unprecedented opportunity to 
better characterize the safety profile of smallpox vaccine when 450,000 
military personnel were vaccinated. The low adverse reaction rate 
appears to be directly attributable to the efficacy of pre-vaccination 
screening that has ensured those at risk for complications do not 
receive the vaccine. The occurrence of possible vaccine related heart 
problems, however, did surface as a possible adverse event that 
required further restricting the possible use of the smallpox vaccine 
in those at risk for heart disease. As a result, CDC issued further 
guidance to modify the screening criteria to keep the volunteers safe. 
CDC, working with our medical/scientific partners, continues to 
investigate Whether these particular adverse events are causally 
related to the vaccine.
    Precautionary vaccination is only one element of overall smallpox 
preparedness and we continue to make progress in other crucial areas 
that contribute to preparedness.
    All states and four designated cities have developed detailed pre-
event and post-event smallpox response plans.
    Public health teams are now organized nationwide to respond to a 
suspected smallpox outbreak within 6 hours.
    A national information system has been implemented that can support 
smallpox and other emergency vaccination administration needs. It 
advances our preparedness to know who needs to be vaccinated, to 
monitor vaccine ``take'' results, and track adverse vaccination events. 
The system produces information that decision makers and response teams 
need to support the protection of the population from communicable 
diseases in an emergency setting.
    Clinical and public health laboratories have improved their ability 
to detect and diagnose rash illness within 24 hours of presentation. 
Twenty-three laboratories nationwide have the training and reagents to 
screen for smallpox and differentiate it from other pox related 
diseases (e.g. chickenpox and monkey pox).
    Current vaccine supplies and projected production continue to meet 
the goal of having sufficient smallpox vaccine for every American in 
the event of an emergency.
    Over 290,000 doses of vaccine are currently deployed, with vaccine 
available in every state and four major cities (New York, Chicago, Los 
Angeles, and Washington, D.C.).
    CDC, along with State and Local Health Departments, will continue 
to enhance smallpox preparedness in the coming year. We are creating 
performance standards to guide and assess state and local smallpox 
preparedness. Performance-based evaluation will target activities in 
the areas of: public health and health care response teams formed and 
trained, members vaccinated and trained as vaccinators, increases in 
the number of Laboratory Response Network (LRN) labs that can perform 
confirmatory testing for vaccina and Variola major, progress on 
developing real-time electronic disease reporting, demonstrated 
proficiency in receiving large quantities of smallpox vaccine, and, 
identification and training of volunteers needed to run mass 
vaccination clinics capable of vaccinating the entire population in 10 
days.
    Performance standards are being developed to incorporate tiered 
levels of achievement based on performance standards associated with 
the activities I just described. Actual performance will be monitored 
through a dual evaluation process: self-evaluation by grantee, and 
formal and informal CDC program evaluation.
    In closing, CDC has refocused it priorities to be sure the nation 
is prepared for all types of public health emergencies including 
biological, chemical, radiological, and conventional terrorist threats. 
CDC will continue to implement the successful strategies begun in 
previous years, while remaining flexible in its capability to respond 
to known and emerging threats. As we continue these efforts, I want to 
thank the Committee again for its support and for enabling us to do 
this essential work.

Progress Report to Secretary Tommy G. Thompson--Prepared by: U.S. Food 
                        and Drug Administration

             MESSAGE FROM THE COMMISSION OF FOOD AND DRUGS

    On July 23, 2003, the Food and Drug Administration (FDA) submitted 
to the Department of Health and Human Services Secretary Tommy G. 
Thompson this progress report entitled, ``Ensuring the Safety and 
Security of the Nation's Food Supply,'' which summarizes the leadership 
demonstrated at FDA in combating the terrorist threat to foods.
    FDA is responsible for ensuring the safety and security of 80% of 
the U.S. food supply. FDA's legislative mandate is to protect the 
public health by ensuring the safety of the production, processing, 
packaging, storage, and holding of domestic and imported food except 
those products (meat, poultry, and processed egg products) that are 
under the jurisdiction of the U.S. Department of Agriculture.
    Although food safety and security are different aspects of food 
protection, they are inherently connected. FDA, at the direction of the 
Department of Health and Human Services (DHHS), has established a 10-
Point Program for ensuring the safety and security of the food supply. 
Based on activities in FDA's 10-Point Program, the Agency is employing 
overall strategies to (1) develop increased awareness among federal, 
state, local, and tribal governments and the private sector by 
collecting, analyzing, and disseminating information and knowledge 
(Awareness); (2) develop capacity for identification of a specific 
threat or attack on the food supply (Prevention); (3) develop effective 
protection strategies to ``shield'' the food supply from terrorist 
threats (Protection); (4) develop capacity for a rapid, coordinated 
response to a foodborne terrorist attack (Response); and (5) develop 
capacity for a rapid, coordinated recovery from a foodborne terrorist 
attack (Recovery).
    Within the food safety and security strategies, FDA's program 
features 10 areas of focus, based on the following principles:
    Food security and safety are integrated goals. By building upon the 
Nation's core food safety/public health systems and expertise, while 
strengthening expertise and capabilities needed to address the 
terrorist threat, FDA is enhancing food security and is improving food 
safety in the process.
    The food safety and security system is comprehensive, addressing 
the full range of assessment, prevention, and response needs, 
throughout the food production and distribution chain. The system must 
be efficient and in the context of both safety and security, address 
the most significant threats first whenever possible.
    The food safety and security system is also built on a solid 
foundation of a national partnership with other entities involved in 
food safety and security that fully integrates the assets of state, 
local and tribal governments, other federal agencies, and the private 
sector.
    Americans must have confidence that the Government is taking all 
reasonable steps to protect the food supply, and is providing Americans 
with timely and relevant information about threats and will provide 
timely and relevant information about an attack if one occurs.
    The events of September 11, 2001, heightened the nation's awareness 
and placed a renewed focus on ensuring the protection of the nation's 
critical infrastructures. A terrorist attack on the food supply could 
pose both severe public health and economic impacts, while damaging the 
public's confidence in the food we eat. Several food incidents since 
the fall of 2001 highlight the significance of FDA's food security 
activities. In the fall of 2002, a competitor of a restauranteur in 
China added a chemical compound to his competitor's food and killed 
dozens of people and sent hundreds more to hospitals. Also in the fall 
of 2002, three individuals were arrested in Jerusalem for allegedly 
planning to carry out a mass poisoning of patrons at a local cafe. One 
of the arrested individuals worked as a chef at the cafe. In January 
2003, several individuals were arrested in Britain for plotting to add 
ricin to the food supply on a British military base Each of these 
incidents shows the potential for the nation's food supply to be used 
in an attack.
    Even before September 11, DHHS was taking steps to improve food 
security. As part of the initial response to these heightened concerns 
after September 11, Congress provided FDA with new statutory 
authorities and some additional resources for food inspection. As a 
result of new threats to the food supply and new opportunities, FDA has 
made fundamental changes in how we implement our mission of protecting 
our food supply, so that all Americans can have confidence that their 
foods are not only safe but also secure. The attached 10Point Program 
reflects a risk-based strategy to achieve the greatest food security 
and safety improvements with the least additional costs or food 
restrictions for consumers. In these efforts, FDA will continue to work 
with the White House Homeland Security Council, the USDA, and the 
Department of Homeland Security (DHS) to further enhance our ability to 
detect, deter, and respond to an attack on our food supply.
                                     Mark B. McClellan, M.D., Ph.D.
      Ensuring the Safety and Security of the Nation's Food Supply
    ``Securing our food supply against terrorist threats is one of our 
most important public health priorities, especially at a time of 
heightened alert,'' said Tommy G. Thompson, Secretary of Health and 
Human Services.

                       FDA FOOD SECURITY STRATEGY

    In the months before and after Sept. 11, 2001, Secretary Thompson 
led the effort to encourage Congress to increase FDA funding to protect 
the nation's families from an attack on the food supply. In fiscal 
years 2002 and 2003, Congress enacted more than $195 million for food 
safety programs, allowing FDA to hire 655 new food personnel and 
conduct more than double the previous number of food import 
examinations. In President Bush's fiscal year 2004 budget, the 
Department of Health and Human Services (DHHS) is requesting $116.3 
million, an increase of $20.5 million over FY 2003, to further protect 
the nation's food supply.
    The Agency is employing overall strategies to (1) develop increased 
awareness among federal, state, local, and tribal governments and the 
private sector by collecting, analyzing, and disseminating information 
and knowledge (Awareness); (2) develop capacity for identification of a 
specific threat or attack on the food supply (Prevention); (3) develop 
effective protection strategies to ``shield'' the food supply from 
terrorist threats (Preparedness); (4) develop capacity for a rapid, 
coordinated response to a foodborne terrorist attack (Response); and 
(5) develop capacity for a rapid, coordinated recovery from a foodborne 
terrorist attack (Recovery).
    Within the food safety and security strategies, FDA's program 
provides 10 areas of focus. The table below illustrates FDA's 10-Point 
Program and how each program area fits within the overall food safety 
and security strategies.
    FDA has worked and continues to work closely with the states and 
other food safety, law enforcement, and intelligence agencies to 
collaborate on research, emergency response, and information exchange, 
all of which significantly strengthen the Nation's food safety and 
security system.



                        PROGRESS AND NEXT STEPS

1. Stronger FDA--New Staff
    In the wake of September 11, 2001, HHS, working with bipartisan 
Congressional support and action, obtained funding for the FDA. FDA 
moved expeditiously and quickly to establish this additional 
investigative and scientific team by rapidly hiring and training 655 
additional field personnel. Of the 655, 97% are allocated to food 
safety field activities: 300 support the conduct of consumer safety 
investigations at U.S. ports of entry, 100 support laboratory analyses 
on imported products, 33 are for criminal investigations of import 
activities, and the remaining personnel support domestic efforts.
    The Public Health Security and Bioterrorism Preparedness and 
Response Act (Bioterrorism Act) was enacted in June 2002 and by the end 
of the year, FDA had started to place additional, trained investigators 
and analysts at targeted locations. Training of these new personnel has 
been paramount. Utilizing the platform provided by the Office of 
Regulatory Affairs' University (ORA U), FDA has retooled its existing 
``new hire'' curriculum for investigators and its ``new hire'' 
curriculum for analysts so that new investigators and new analysts are 
prepared to do basic work within three months of employment. This basic 
investigatory work includes recall audits, sample collections complaint 
follow-up investigations, and import exams. The basic analytical work 
includes basic lab operations and sample preparation. The curricula 
continue through the first 12 months of employment, culminating in an 
on-the-job audit of performance where the new employee demonstrates job 
competency to an auditor using standardized criteria.
    U.S. borders are flooded with FDA-regulated imports from all over 
the world, and the continuous threat of terrorism requires FDA to 
remain vigilant in its effort to retain a competent, trained workforce 
if we are to maintain a high level of readiness. With FDA's limited 
resources to meet the challenge of assuring the food safety and 
security for more than 6 million entries per year, FDA must 
strategically develop hiring, targeting resources and succession 
planning to be prepared in the event of a terrorist attack.
    FDA not only mobilized new staff but redirected, trained current 
investigators and scientists to integrate and strengthen its food 
safety and security mission and ensured that the agency has the 
necessary scientific and logistical expertise to respond to an event 
that could threaten the safety and security of the food supply. FDA has 
hired or re-trained scientific experts in biological, chemical and 
radiological agent research, detection methodology, preventive 
technologies and acquired substantial knowledge of these agents to help 
support domestic and import activities. FDA's Office of Regulatory 
Affairs (ORA) has developed a succession plan to ensure that the agency 
will continue to have highly trained and competent scientists, 
investigators, analysts, and managers to accomplish the agency's 
overall mission of consumer protection. FDA realizes that recruitment 
and retention of our highly skilled and sometimes very specialized 
workforce requires thoughtful planning so that we will be ready to 
effectively and efficiently meet the future challenges FDA faces.

2. Imports--Strategic Approach
    FDA continues to adjust its import program via the development of 
an Import Strategic Plan (ISP) to reflect the changing nature of risks 
and trade associated with imported goods. This approach encompasses and 
addresses the full ``life-cycle'' of imported products. As part of the 
ISP, FDA is assessing information derived from foreign and domestic 
inspectional operations, adverse events, consumer complaints, recall 
activities, and information technology. The goal of the ISP is to 
better protect the public health and safety by decreasing the risk that 
unsafe, ineffective, or violative products will enter U.S. commerce 
through our borders, ports, and other import hubs. Moreover, when 
implemented, the ISP will provide FDA with the critical flexibility it 
needs to shift resources as import trends alter the risks and change 
priorities for public health and safety protection.
    Historically, the volume of U.S. imports of FDA-regulated products 
was relatively small and consisted of raw ingredients and bulk 
materials intended for further processing or incorporation into 
finished products. Therefore, FDA could rely more heavily on physical 
examination and domestic inspections to ensure that imported raw 
ingredients and bulk materials were properly handled, received, 
quarantined, released and processed according to good manufacturing 
practices and sanitation principles.
    Even with the recent increases of personnel for counter terrorism 
efforts, border inspections cannot manage the changes in the nature of 
risks and trade. FDA is taking steps to implement a risk-based approach 
towards covering the importation of FDA-regulated goods. These 
proactive steps will assist FDA in identifying patterns of 
transportation while goods are in international streams of commerce; 
increase our ability to conduct effective, efficient foreign 
inspections; and will aid FDA in making admissibility decisions before 
goods enter domestic commerce. Moreover, the riskbased approaches we 
are contemplating include exploring the feasibility of forming 
regulatory partnerships to provide better information to FDA--and, 
ultimately, better protection to U.S. consumers.
    FDA is supporting this enhanced import strategic plan by providing 
a greater import presence at our nation's borders. FDA is enhancing our 
capacity and capability to perform normal import operations such as 
sample collection and analysis, field examinations, and inspections 
across all our programs. In 2001, FDA provided coverage at about 40 
ports of entry. By 2002, FDA had more than doubled its presence to 90 
ports of entry.
    In addition, since 2001, FDA more than quintupled the number of 
food import examinations. In 2001, FDA conducted 12,000 food exams. FDA 
has conducted over 62,000 food exams already this fiscal year and has 
surpassed its 2003 year-end goal of 48,000 food exams. This increased 
coverage was due to redirecting resources dedicated to assure increased 
import coverage during Operation Liberty Shield when the Nation was at 
a heightened security alert.
    FDA is working to increase import filer evaluations to ensure 
integrity of importers and import entry data and to increase 
collections of samples for laboratory analysis.
    FDA is working on additional enhancements to the Operational and 
Administrative System for Import Support (OASIS) to include real-time 
screening with multi-agency import databases to help target inspection 
resources.

3. Bioterrorism Act Regulations
    FDA is on schedule to publish four major new regulations in 
accordance with provisions of the Bioterrorism Act. The agency intends 
to publish two final rules in October of this year and two additional 
final rules by the end of this year. These rules implement new 
authority that FDA received in the Bioterrorism Act and, are one of the 
most significant enhancements of FDA's statutory authority to keep food 
imports secure.
    On February 3, 2003, FDA and the Department of Treasury jointly 
published in the Federal Register a proposed regulation implementing 
the provisions in the Bioterrorism Act that would require owners, 
operators, or agents of a foreign or domestic facility where food is 
manufactured/processed, packed, or held to submit a registration to the 
FDA that includes basic information about the facility, emergency 
contact information, and the categories of food the facility handles.
    On February 3, 2003, FDA and the Department of Treasury also 
jointly published in the Federal Register a proposed regulation 
implementing the provisions in the Bioterrorism Act that would require 
FDA to receive prior notice before imported food arrives at the U.S. 
port of arrival.
    On May 9, 2003, FDA published in the Federal Register a proposed 
regulation implementing the provisions in the Bioterrorism Act that 
would require manufacturers, processors, packers, transporters, 
distributors, receivers, holders, and importers of food to keep records 
identifying the immediate previous source from which they receive food, 
as well as the immediate subsequent recipient, to whom they sent food.
    On May 9, 2003, FDA also published in the Federal Register a 
proposed regulation implementing the provisions in the Bioterrorism Act 
related to FDA's new authority to detain any article of food for which 
there is credible evidence or information that the article poses a 
threat of serious adverse health consequences or death to human or 
animals. The administrative detention authority granted to FDA under 
the Bioterrorism Act is self-executing and currently in effect.
    FDA published each of the regulations with a 60-day comment period. 
We received many comments on each rule that suggested ways the rules 
could be improved to minimize the impact on commerce, while 
accomplishing the statutory objective. FDA is considering these 
comments and will make appropriate changes to the rules before issuing 
them in final form. These rules primarily are designed to give FDA 
additional information about food intended for consumption in the 
United States and the facilities that handle that food. As such, these 
statutory provisions do not raise the ``science issues'' as many of our 
rulemakings do (nor did the Agency receive comment in that area), or as 
other provisions in the Bioterrorism Act do.
    FDA held two major satellite downlinks to explain the proposed 
regulations to affected parties around the world. The first was held on 
January 29, 2003 and discussed food facility registration and prior 
notice proposed requirements. The second was held on May 7, 2003 and 
discussed the proposed administrative detention procedures and the 
proposed requirements governing the establishment and maintenance of 
records. The broadcasts were made available in English, Spanish and 
French and were viewed at over 20 FDA sites, in Canada, Mexico, and 
South America. Viewers included importers, brokers, manufacturers and 
processors of foods and feeds, transporters, state officials, foreign 
embassy officials, foreign governments, and representatives of trade 
associations. In addition, the agency has conducted outreach regarding 
these regulations in other forums.
    FDA has trained a cadre of speakers and has participated in over 80 
meetings in many venues such as the Alliance for Food Safety and 
Security in Washington, DC, the World Trade Organization in Geneva, 
Switzerland, and at a meeting hosted by the government of Japan in 
Tokyo, Japan, giving presentations and talks on the proposed rules. FDA 
senior officials involved in developing the rules also attended 
meetings with government officials and industry representatives in 
Canada, Mexico, and the European Union.
    FDA is intent on reviewing the many comments concerning the 
proposed regulations and is taking steps to implement these regulations 
with recognizing current business practices and emphasizing efficiency 
to implement and meet the intent of the Act.
    FDA also developed and conducted demonstrations of the rapid, easy-
to-use on-line registration system that companies can use to register 
starting in mid-October 2003.
    FDA is working with the Bureau of Customs and Border Protection 
(CBP), to streamline the implementation of the prior notice 
requirements of the Bioterrorism Act. This will allow food importers to 
provide required information on food imports to both agencies using a 
single IT process.
    FDA is working to finalize these regulations. We are currently 
considering all the timely comments that were submitted, and where 
appropriate, making appropriate changes to the regulations for food 
facility registration, prior notice, establishment and maintenance of 
records, and administrative detention before issuing them in final 
form. FDA is planning to host satellite downlinks and regional meetings 
to assist stakeholders in understanding and complying with the final 
rules. FDA is also developing ``user-friendly'' materials to serve as 
aids and to assist stakeholders.

4. Industry Guidance and Preventive Measures
    On January 9, 2002, FDA published in the Federal Register and made 
available on its Website two draft guidance documents related to food 
security. The first, ``Food Producers, Processors, and Transporters: 
Food Security Preventive Measures Guidance,'' is designed to aid 
operators of food establishments. The second, ``Importers and Filers: 
Food Security Preventive Measures Guidance,'' is designed to help food 
importers. Each document recommends the types of preventive measures 
that companies can consider to minimize the risk that food under their 
control will be subject to tampering or criminal or terrorist actions. 
Following public comment, FDA issued final versions of the guidance 
documents on March 21, 2003, in conjunction with FDA's efforts during 
Operation Liberty Shield. We discuss Operation Liberty Shield in more 
detail later in the document.
    On March 21, 2003, FDA published in the Federal Register and made 
available on its Website two additional draft guidance documents 
related to food and cosmetic security. The first, ``Retail Food Stores 
and Food Service Establishments: Food Security Preventive Measures 
Guidance,'' is designed to aid operators of food retail food stores and 
food service establishments. The second, ``Cosmetic Processors and 
Transporters Cosmetic Security Preventive Measures Guidance,'' is 
designed to help operators of cosmetic establishments. Each document 
recommends the types of preventive measures that companies can consider 
to minimize the risk that food or cosmetics under their control will be 
subject to tampering or criminal or terrorist actions.
    FDA developed and made available on July 11, 2003, an additional 
guidance document related to food security preventive measures for 
milk, ``Guidance for Industry: Dairy Farms, Bulk Milk Transporters, 
Bulk Milk Transfer Stations and Fluid Milk Processors; Food Security 
Preventive Measures Guidance.''
    FDA, in collaboration with the Technical Support Working Group 
(TSWG) of the Department of Defense, is working with the John A. Volpe 
National Transportation Systems Center in Cambridge, Massachusetts on a 
project related to the security of domestic and overseas transport of 
food.
    TSWG and FDA are also working with St. Joseph's University, 
Philadelphia, Pennsylvania, to develop an accredited modular food 
security and protection training curriculum for both academics and 
professionals that is capable of being delivered in a traditional 
classroom setting as well as via CD-ROM and though web-based delivery 
formats. Industry representatives at the first user's group meeting in 
June 2003 confirmed the value of the training.
    TWSG and FDA are working with Sensor Research and Development, a 
small company in Orono, Maine, to develop a prototype of a food 
pathogen detector (MIPSTRIP).
    Consumers play a critical role in preventing illness due to food 
tampering. FDA encourages consumers when shopping to carefully examine 
all food product packaging, check any anti-tampering devices on the 
packaging, not to purchase products if the packaging is open, torn, or 
damaged, not to buy products that are damaged or that look unusual and 
to check the ``sell-by'' dates. Consumers are also encouraged to 
carefully inspect products at home when opening the container and to 
never eat food from products that are damaged or that look unusual.

5. Vulnerability and Threat Assessments
    Using the methodology called Operational Risk Management (ORM), FDA 
developed a vulnerability assessment for foods. The assessment 
evaluates the public health consequences of a range of product-agent 
scenarios associated with potential tampering, criminal, malicious, or 
terrorist activity. This relative risk ranking is designed to 
facilitate decision-making about the assignment of limited federal, 
state, and local public health resources to minimize such risks. It is 
also designed to assist the food industry in identifying areas where 
enhancements in preventive measures could increase the security of the 
food supply. This internal assessment identified a number of food/agent 
combinations that FDA is focusing on to implement shields for 
protecting those commodities. These shields will be implemented in 
partnership with our regulatory counterparts and industry.
    FDA initiated and awarded a task order to the Institute of Food 
Technologists (IFT) to conduct an in-depth review of ORM and provide a 
critique on its application to Food Security. As part of this review, 
IFT was asked to apply ORM to food and to evaluate the relative public 
health consequences of a range of product-agent scenarios. This review 
validated FDA's vulnerability assessment process and provided 
additional information on the public health consequences of a range of 
product, agent, and process scenarios. This assessment affirmed the 
food/agent combinations identified in the FDA ORM assessment and 
identified additional commodities to consider for shield 
implementation.
    As an additional step, on June 4, 2003, FDA awarded an additional 
task order to IFT, requesting that IFT conduct an in-depth review of 
preventive measures that food processors may take to reduce the risk of 
an intentional act of terrorism or contamination. The review will 
assess ways to prevent or reduce the risk of contamination of processed 
food and will provide information on various research needs related to 
elimination or reduction of the risks. IFT will provide information on 
various processing technologies that might be used for eliminating or 
reducing the risk of an intentional act of terrorism or contamination 
for several commodity, agent, and processing combinations.
    FDA also contracted with Battelle Memorial Institute to conduct a 
``Food and Cosmetics, Chemical, Biological, and Radiological Threat 
Assessment''. The assessment affirmed the findings of the FDA/CFSAN 
Operational Risk Management Assessment, provided an additional 
decision-making tool for performing risk assessments, incorporating a 
Hazard Analysis Critical Control Points (HACCP) type approach, and made 
a number of recommendations about research needs, the need for enhanced 
laboratory capability and capacity, and the need for enhanced 
partnerships between federal, state, and local governments to ensure 
food security.
    FDA provides regular updates to Congress about threat assessments 
and vulnerabilities related to the safety and security of the U.S. food 
supply. FDA will be providing to Congress the threat assessments 
conducted by FDA, IFT and the Battelle Memorial Institute.
    FDA is conducting additional assessments of the vulnerability of 
FDA-regulated foods to intentional contamination with biological, 
chemical and radiological agents. These assessments use processes 
adapted from techniques developed by the U.S. Department of Defense for 
use in assessing the vulnerabilities of military targets to asymmetric 
threats. Results of the assessments will be used to develop 
countermeasures, identify research needs, and provide guidance to the 
private sector

6. Operation Liberty Shield: FDA Food Security Enhancements in Times of 
        Heightened Alert
    In March 2003, the United States government launched Operation 
Liberty Shield to increase security and readiness in the United States 
at a time of elevated risk for a terrorist attack. Operation Liberty 
Shield, a comprehensive national plan of action to protect many of 
America's critical infrastructures, was a unified operation coordinated 
by the Department of Homeland Security that integrated selected 
national protective measures with the involvement and support of 
federal, state, local, and private responders and authorities from 
around the country. Operation Liberty Shield was designed to provide 
increased protection for America's citizens and infrastructure while 
maintaining the free flow of goods and people across our border with 
minimal disruption to our economy and way of life. FDA has established 
protocols, trained staff and deployed supplies and equipment for future 
and similar elevated threat level actions. A key component of Operation 
Liberty Shield was increasing and targeting surveillance of both 
domestic and imported food. The Agency initiated the following 
activities;
    FDA issued new industry guidance documents on security measures and 
encouraged industry to voluntarily assess their security measures in 
response to an increased threat level. These guidance documents were 
discussed earlier in the document.
    FDA held a series of conference calls to brief state regulatory 
agencies, industry trade associations, consumer groups, and their 
federal counterparts, on Operation Liberty Shield and to request their 
assistance in distributing the food security guidance documents to 
domestic facilities and the portion of the import community that 
handles food products.
    FDA increased its surveillance of the domestic food industry, 
during Operation Liberty Shield, by conducting 844 inspections of 
domestic firms based on risk/threat assessments with a focus on 
enhancing awareness of food security at these facilities by providing 
copies of appropriate food security guidance documents. These 
investigations targeted examinations of specific commodities based on 
risk/threat assessments and sampled specific commodities based on risk/
threat.
    FDA increased its monitoring of imported foods, during Operation 
Liberty Shield, by conducting increased examinations of specific 
imported commodities based on FDA's risk/threat assessments; enhancing 
the import communities' awareness of food security at ports by 
providing copies of FDA's food security guidance documents and sampling 
imported foods based on risk/threat assessments. FDA collected and 
analyzed 387 import samples for chemical and microbiological 
contaminants.
    FDA conducted domestic and import reconciliation exams to confirm 
that regulated commodities were what they purported to be, exposed 
unexplained differences between associated documentation and the 
product, and uncovered signs of tampering or counterfeiting.
    FDA increased joint activities with federal, state, and local 
partners to help ensure a safe and secure food supply, including 
working with the Centers for Disease Control and Prevention to ensure 
that outbreaks or unusual patterns of illness or injury are quickly 
investigated.
    Likewise, USDA undertook similar food security measures and 
activities for its regulated industries including meat, poultry and 
processed egg products. Thus, in combination, FDA and USDA 
comprehensively covered the U.S. food supply.

7. Emergency Preparedness and Response
    FDA has established an Office of Crisis Management (OCM) to 
coordinate the preparedness and emergency response activities of the 
five FDA Centers, ORA and their Offices working with their federal, 
state and local counterparts that may be engaged in a variety of 
different emergencies involving FDA regulated products and/or the need 
to provide medical countermeasures. Within OCM, the FDA Emergency 
Operations Center serves as the chief communications node and point of 
contact within FDA.
    Over the past two years, FDA has participated in and conducted 
multiple emergency response exercises. Frequently, these exercises are 
coordinated with other federal and state agencies. In both exercises 
and everyday issues, FDA's OCM works closely with the Department of 
Health and Human Services/Office of Public Health Emergency 
Preparedness (OPHEP) and the Secretary's Command Center (SCC). This 
relationship facilitates communication between all HHS Operating 
Divisions, the Department, and other federal agencies and Departments, 
including the Department of Homeland Security. In particular, FDA has 
focused on strengthening its working relationship with USDA by joint 
testing of several response plans in an exercise environment. In May 
2003, FDA participated in the TOPOFF 2 terrorism exercise, a national, 
full scale, fully functional exercise intended to simulate two separate 
terrorist acts that had implications for food products (e.g., the 
possibility of food contamination by radiation), as well as the ensuing 
response by federal, state, and local governments.
    FDA has also signed an Inter Agency Agreement (IAG) with the U.S. 
Army to design and develop two mobile laboratories to be deployed at 
borders, ports, or other locations, to provide timely and efficient 
analyses of samples being offered for import into the U.S. and/or in 
the event of terrorist activity. The mobile laboratories are expected 
to be ready for deployment in 2004.
    Within current resources, FDA is assessing its ability to respond 
to high-risk product agent scenarios and for what sustained period. 
This includes a review of our current scientific capabilities that may 
be available for extramural sources (academia, DoD, etc.) and efforts 
to enhance the nation's food laboratory capacity at federal, state and 
local facilities to conduct rapid, accurate tests to determine quickly 
the precise extent of food contamination in the event of an actual or 
suspected terrorist attack.

8. Laboratory Enhancements--Methods Development
    FDA has redirected laboratory staff to develop laboratory methods 
for priority biological and chemical agents in food. Methods have been 
developed for the highest priority select agents.
    FDA has reviewed and modified current regulatory analytical methods 
for their applicability to terrorism related samples. Methods have been 
modified to provide more rapid analysis while maintaining practical 
sensitivity.
    FDA is enhancing its capacity to develop methods that can be used 
for rapid analysis of suspect foods for select agents or toxins, 
including the development of rapid methods that can be deployed and 
used in a field setting.
    FDA is working to adapt an FDA toxin screening method for 
application as a surveillance tool.
    FDA has established an IAG with Edgewood Arsenal and a task order 
contract with Midwest Research Institute for the validation of methods 
for the detection of microbiological agents in foods.
    FDA has partnered with the Department of Defense to develop and 
validate methods to detect agents most likely to be used in a terrorist 
attack on the food supply, and engaged in interagency agreements that 
would allow the Department of Defense to provide laboratory support in 
the event of an attack.
    Under contract to FDA, the New Mexico State University (NMSU) 
Physical Science Laboratory (PSL) is evaluating rapid test methods for 
microbiological analyses of produce samples. NMSU's evaluation includes 
the assessment of rapid test methods for a particular analyte(s) or 
food commodity--which is required prior to the agency adoption of any 
kit for use in the regulatory arena.

Network Development
    FDA has worked with CDC, USDA, EPA, DOE and the States to initiate 
development of a nationwide Food Emergency Response Network (FERN). 
FERN is a network of state and federal laboratories that is committed 
to analyzing food samples in the event of a biological, chemical, or 
radiological terrorist event in this country. As of June 2003, there 
were 63 laboratories participating in the FERN network, representing 27 
states and 5 federal agencies. Following the events of September 11, 
2001, FDA took aggressive action to develop this network building on 
then-existing laboratory capabilities. FDA is working to add additional 
food laboratories to the FERN. Furthermore, FDA will work with CDC and 
the states to improve laboratory capacity to enhance response 
capability for food security concerns, With CDC grant funds, states are 
initiating additional activities to increase lab capacity for food-
related emergencies.
    FDA has made available methods for the isolation and detection of 
high-priority microorganisms and chemical agents not usually found in 
food that can be utilized by Laboratory Response Network (LRN) and FERN 
laboratories on a password protected website.
    FDA has used emergency funding to purchase rapid method test kits 
for chemical and microbiological agents and has distributed the 
materials to laboratories within FERN.
    Ninety five laboratories representing 48 states are participating 
in the Electronic Laboratory Exchange Network (eLEXNET), the nation's 
first seamless, integrated, webbased data exchange system for food 
testing information. eLEXNET allows health officials at multiple 
government agencies engaged in food safety activities to compare, 
share, and coordinate laboratory analysis findings on food products. At 
its inception in 2000, eLEXNET included a mere 8 labs from 7 states and 
was capable of tracking a sole analyte. Whereas FERN laboratories are 
involved in the actual analysis of food samples, eLEXNET provides a 
forum for the exchange of laboratory data. FDA is continuing efforts to 
expand eLEXNET to provide better nationwide data on food product 
analyses by regulatory agencies.

Staff Development and Training
    FDA has trained its staff as well as staff from USDA, state food 
laboratories and the CDC Laboratory Response Network public health 
laboratories in the analysis of foods for several microorganisms.

9. Research
    HHS Secretary Tommy Thompson and FDA Commissioner Dr. Mark 
McClellan announced the commitment of $5M in supplemental funding from 
the Office of Management and Budget (OMB) to support FDA's food 
security research initiative. The FDA plans to focus this new food 
security research thrust on three broad areas: (1) development of 
prevention and mitigation technologies/strategies, (2) the elucidation 
of agent characteristics needed to develop these prevention 
technologies, and (3) the development of means for continuously 
assessing foods (raw or finished product) for contamination with 
chemical, microbiological, and radiological agents. This integrated 
program will draw upon all three components of FDA's research 
infrastructure: its intramural research capabilities, its collaborative 
Centers of Excellence (e.g., National Center for Food Safety and 
Technology, Joint Institute for Food Safety and Applied Nutrition, 
National Center for Natural Products Research), and extramural research 
programs that provides competitive research contracts and grants. 
Specific projects will involve: determining the stability of select 
chemical threat agents in foods and the impact of processing 
operations; the development of enrichment techniques for the isolation 
of select microbial agents from high priority foods; the development of 
prevention/mitigation strategies for intentional contamination of 
animal feed used for food-producing animals; the development of risk 
assessment tools for assessing critical control points within a food 
security/safety system; the development of methods for decontaminating 
food processing facilities, retail establishments, and transportation 
equipment that have been exposed to microbiological, chemical, or 
radiological agents as a result of a terrorism incident involving 
foods; the acceleration of the development of rapid, field deployable 
analytical methods for detecting select agents in foods; and the 
development of a PC-based Analytical Modeling Tool to facilitate rapid 
response to food security and safety emergencies.
Intramural Program
    Although modern technology has considerable potential to improve 
our ability to keep the nation's food supply secure, research on food 
security is a relatively new concept. To take advantage of the 
opportunities for making foods safer and more secure through research 
and development of new technologies, FDA, HHS, and the Administration 
are taking unprecedented steps to develop this new area of research. In 
particular, FDA has already redirected existing research staff to 
ensure that appropriate resources are focused on key priority food 
safety and security issues. FDA has over 25 intramural research 
projects ongoing related to food security.

Steps Toward Establishment of Extramural Food Security Research Program
    On June 25, 2003, FDA published in the Federal Register a Request 
for Applications (RFA) entitled ``Food Safety, Nutrition, Bioterrorism, 
Agricultural Research, Medical, Analytical Methods and Risk 
Assessment.'' The RFA requested applications to support collaborative 
research efforts and to complement and accelerate ongoing research in 
four project areas: (1) development and rapid analytical screening 
methods for the detection of pathogens that are not usually associated 
with food and foodborne illness at a contamination level of 100 to 
10,000 microbial pathogens/gram of food without pregrowth or selective 
enrichment; (2) development of PCR-based methods for rapid confirmatory 
identification of pathogens that are not usually associated food and 
foodborne illness; (3) development of rapid screening methods capable 
of detecting a broad range of non-traditional chemical and toxin 
adulterants; and (4) development of improved equipment, software, 
procedures, and/or methods for determining radionuclide contamination 
in foods.

New Research Collaborations
    FDA is collaborating with the National Institutes of Health (NIH) 
on a joint project to fund critical research on the thermal stability 
of key select agent(s) in high risk food(s).
    FDA has initiated cooperative research programs with the National 
Center for Food Safety and Technology (NCFST) on the impact of food 
processing on the stability of microbiological and chemical agents in 
foods under conditions that would occur in commercial operations.
    FDA participates in the Technical Support Working Group (TSWG), the 
U.S. national forum that identifies, prioritizes and coordinates 
interagency and international research and development requirements for 
combating terrorism.
    The Joint Institute for Food Safety and Applied Nutrition (JIFSAN), 
a public-private partnership established between FDA and the University 
of Maryland in 1996, in collaboration with the US-Israel Binational 
Agricultural Research and Development (BARD) Fund held a food security 
conference, ``Science and Technology Based Countermeasures to Foodborne 
Terrorism,'' on June 29--July 2, 2003. The conference provided a forum 
to discuss the current state of knowledge about foodborne terrorism, 
including threat assessment methods, methods of detection, tracking, 
tracing, authenticating and anti-tampering technologies and hazard 
mitigation.

Establishing Broader Research Agenda
    FDA is developing a broader research agenda to address critical 
research needs to aggressively meet food security challenges. The 
research would focus on three broad areas: (1) development of 
prevention and mitigation technologies/strategies, (2) the elucidation 
of agent characteristics needed to develop prevention technologies, and 
(3) the development of means for continuously assessing foods (raw or 
finished product) for contamination with chemical, microbiological, and 
radiological agents. These research needs are being prioritized into 
short, medium, and longer-term phases: (1) technological assessment and 
critical data deficiencies that can be addressed in the short-term (12 
months), (2) critical knowledge deficiencies or technology applications 
that can be addressed with targeted research and development projects 
lasting 12-24 months, and (3) research and development that will 
require elucidation of new technologies or substantial extension of 
existing scientific knowledge (24--60 months). Such research is being 
planned as an integrated program that will draw upon all three 
components of FDA research infrastructure: its intramural capabilities, 
its collaborative Centers of Excellence (e.g., National Center for Food 
Safety and Technology, Joint Institute for Food Safety and Applied 
Nutrition, and National Center for Natural Products Research), and 
extramural research program that provides competitive research 
contracts. FDA will also actively collaborate with other federal 
government research organizations, including NIH, USDA, and DoD.

10. Interagency and International Communication and Collaboration
    Food security, like other aspects of protecting our Nation's 
critical infrastructures, requires effective and enhanced coordination 
across many government agencies at the federal, state, and local level. 
FDA's activities in public health security are coordinated through the 
Department of Health and Human Services (DHHS) Secretary's Command 
Center. This relationship facilitates communication between all HHS 
Operating Divisions, the Department, and other federal agencies and 
Departments, including Homeland Security. Some of these security steps 
facilitated by this coordination are outlined below.
    FDA holds regularly scheduled interagency conference calls with 
representatives from USDA [Animal and Plant Health Inspection Service 
(APHIS) and FSIS], CDC, Environmental Protection Agency (EPA), DoD, 
Department of Commerce, Tax and Trade Bureau, and the Bureau of Customs 
and Border Protection (CBP). FDA also regularly consults with its 
interagency partners.
    On February 4, 2003, FDA, in conjunction with the National 
Association of State Departments of Agriculture (NASDA), the 
Association of State and Territorial Health Officials, USDA, and CDC, 
sponsored a one day executive level meeting with the Secretaries of 
State Departments of Agriculture and the State Departments of Health 
titled ``Homeland Security--Protecting Agriculture, the Food Supply and 
Public Health--The Role of the States.''
    FDA is also actively promoting the commissioning by FDA of State 
secretaries of agriculture and health so they can receive and review 
food safety and security documents from FDA. This helps promote 
information sharing between States and FDA.
    FDA is also represented on the White House Homeland Security 
Council's Interagency Food Working Group (IFWG). The IFWG includes 
representation from DHHS/FDA, USDA/FSIS, Department of Defense, 
Environmental Protection Agency, Department of Transportation, Central 
Intelligence Agency, Federal Bureau of Investigation, Department of 
Treasury, Federal Emergency Management Agency, and a variety of White 
House representatives. FDA is developing plans for improved laboratory 
preparedness, and product security, and is drafting a National 
Interagency Food Response Plan in coordination with states, industry, 
and food trade associations. FDA is represented on three IFWG 
subgroups: Laboratory Subgroup, Shields Subgroup, and Incident Command 
Subgroup.
    As part of the Department-wide collaboration and effort to improve 
nationwide capacity, the Centers for Disease Control and Prevention 
(CDC) has initiated a cooperative agreement program and has made funds 
available to upgrade state and local jurisdictions' public health 
preparedness for and in response to bioterrorism, other outbreaks of 
infectious disease, and other public health threats and emergencies. 
CDC is making available $870 million this fiscal year. Awards will be 
made to address needs in seven focus areas: (1) Preparedness Planning 
and Readiness Assessment, (2) Surveillance and Epidemiology Capacity, 
(3) Laboratory Capacity--Biologic Agents, (4) Laboratory Capacity--
Chemical Agents, (5) Health Alert Network/Communications and 
Information Technology, (6) Communicating Health Risks and Health 
Information Dissemination, and (7) Education and Training. Improving 
laboratory capacity, including for food analysis, is an integral part 
of this effort.
    FDA is working very closely with the Department of Homeland 
Security and the White House Homeland Security Council on a variety of 
issues. We are consulting with DHS and HSC on research initiatives, 
shield implementation, and seeking security clearances for appropriate 
individuals within the food industry in order to share classified 
information.
    FDA has conducted numerous emergency response exercises with our 
federal counterparts to strengthen the federal response to a food 
incident. The Department of Health and Human Services has participated 
in several Deputy Secretary level exercises with USDA, DoD, EPA, CIA, 
and FBI to test our emergency response capabilities. TOPOFF 2 was an 
excellent example of interagency cooperation by USDA/FSIS sending 
representatives to the DHHS/Command Center and the FDA Emergency 
Operations Center.
    Despite the comprehensive work that FDA has accomplished to date, 
there are additional steps that are being contemplated. These future 
projects are discussed below.
    FDA is working with the Department of Homeland Security and USDA, 
to establish a Food Sector and a Food Information Sharing and Analysis 
Center (ISAC) to facilitate the overall protection of the food sector's 
critical infrastructure and to share information about vulnerabilities, 
threats, and incidents.
    FDA is working closely with Canada and Mexico in an effort to 
assess and strengthen our public health and food security systems and 
infrastructure at our mutual borders. FDA and USDA are working with our 
Canadian and Mexican counterparts through bilateral workgroups to 
enhance existing partnerships, e.g. Global Health Security Action 
Group, forge new and improved food and agriculture security measures 
and systems covering prevention and preparedness; response to and 
recovery from potential threats.
    FDA is collaborating with the Department of Homeland Security and 
USDA (Food Safety and Inspection Service) and has proposed projects for 
the prevention of and response to an intentional threat to the food 
supply.

                                SUMMARY

    FDA thorough it's aggressive program, has made significant progress 
in strengthening the safety and security of the Nation's food supply.
    Nearly 20% of all imports into the U.S. are food and food products. 
FDA anticipates that we will receive over 8 million food shipments from 
over 200,000 foreign manufacturers this year-a huge volume that 
continues to grow rapidly. To meet this challenge, FDA is providing a 
greater import presence. FDA has placed an additional 300 field 
personnel at U.S. ports of entry. FDA now has a presence at 90 ports of 
entry and quintupled the number of food import examinations it 
performed this year compared to 2001-FDA has exceeded its year-end goal 
of 48,000 by 14,000 food import examinations.
    FDA is using risk-based strategies to provide better information 
and in its collaborative efforts with other entities. This includes 
working with foreign authorities and manufacturers to improve 
production and shipping practices abroad as an alternative to detailed 
inspections at the boarder. FDA is using better information on imports 
to focus border checks on products that present significant potential 
risks and is working with producers to improve checks on the integrity 
of ingredients and to implement commonsense steps to reduce security 
risks.
    FDA is on schedule to publish four major new regulations in 
accordance with provisions of the Bioterrorism Act that provide the 
agency with most significant enhancements to FDA's statutory authority 
to keep food imports secure. The agency intends to publish two final 
rules in October of this year and two additional final rules by the end 
of this year.
    FDA has taken unprecedented steps to develop food security 
research, FDA has received $5 million in supplemental funding from OMB 
to support FDA's food security research initiative. FDA is using this 
supplemental funding to focus on three broad areas: development of 
prevention and mitigation technologies and strategies, elucidation of 
agent characteristics, and development of means for continuously 
assessing foods for contamination. FDA has redirected existing research 
staff to focus on key priority issues and has over 25 intramural 
research projects ongoing related to food security. FDA is developing a 
broader research agenda to address critical research needs to 
aggressively meet food security challenges including development of 
prevention and mitigation technologies/strategies, elucidation of agent 
characteristics needed to develop prevention technologies, and 
development of means for continuously assessing foods for 
contamination.
    FDA remains dedicated to ensuring the safety and security of the 
nation's food supply, Americans depend on FDA to keep food safe and 
secure, and FDA will keep doing all we can to fulfill this critical 
mission.

             Prepared Statement of Mark B. McClellan, M.D.

    Good morning, Mr. Chairman and other Members of the Committee. I am 
Dr. Mark B. McClellan, Commissioner of Food and Drugs in the Department 
of Health and Human Services (HHS). I am pleased to he here today with 
my colleagues from two of our sister agencies, Dr. Julie Gerberding of 
the Centers for Disease Control and Prevention (CDC) and Dr. Elias 
Zerhouni of the National Institutes of Health (NIH). The Food and Drug 
Administration (FDA or the Agency) appreciates the opportunity to 
discuss some of FDA's counterterrorism activities and to discuss the 
biodefense workforce issues raised in the recent report by the 
Partnership for Public Service entitled. Homeland Insecurity: Building 
the Expertise to Defend America from Bioterrorism.
    In my testimony today, I will first briefly describe FDA's role in 
counterterrorism activities. Second, I will address a significant 
omission in the report and describe the food safety and food security 
responsibilities of the FDA. Third, I will discuss the development and 
availability of countermeasures and the Administration's Project 
BioShield initiative. Finally, I will describe FDA's actions to improve 
our ability to recruit and retain the types and numbers of staff 
necessary to defend against terrorist attacks.

               FDA'S ROLE IN COUNTERTERRORISM ACTIVITIES

    FDA is the Federal agency that is responsible for ensuring that 80 
percent of the food supply, all foods except meat, poultry, and certain 
egg products, are safe and sanitary; that human and veterinary drugs, 
biological products, medical devices, and radiological products are 
safe and effective; and that cosmetics are safe. With more 
opportunities but more costs and complexity than ever in the 
development of better medicines and foods, FDA must increasingly focus 
on ways to reduce the cost, time, and uncertainty of the process of 
translating scientific breakthroughs into safe and effective products 
that can be produced reliably. FDA is also responsible for assuring 
that the health consequences of foods and medicines are accurately and 
honestly represented to the public, so that they can be used as 
effectively as possible to protect and improve the public health.
    FDA's primary mission is to protect the public health. Ensuring 
that FDA-regulated products are safe and secure is a vital part of that 
mission. FDA plays a central role in the nations defense against 
terrorism. First, terrorists could use an FDA-regulated product, such 
as food, as a vehicle for biological chemical, or radiological agents. 
Second, FDA-regulated products, such as human and animal drugs, 
vaccines, tissues, blood, and blood products, will play a central role 
in countering or preventing the effects of terrorism. It is FDA's 
responsibility, working closely within HHS and with other Federal 
agencies, state, and local governments, industry, and the public, to 
reduce the chance that an FDA-regulated product is misused to terrorize 
Americans and to help ensure that the nation's public health system is 
prepared to deter a potential threat and is ready to respond to an act 
of terrorism.

     FDA'S FOOD SAFETY AND SECURITY RESPONSIBILITIES AND ACTIVITIES

    Now, I would like to address a significant omission in the 
Partnership's report and describe FDA's food safety and food security 
programs.
    The section in the Partnership's report entitled ``The Threat to 
Our Food Supply'' fails to mention the FDA's significant 
responsibilities for safeguarding the food supply.
    FDA regulates 80 percent of the national food supply--practically 
everything we eat except for meat, poultry, and certain egg products, 
which are regulated by our colleagues at the U.S. Department of 
Agriculture (USDA) FDA's responsibility also extends to live food 
animals and animal feed.
    Food safety and food security continue to be top priorities for 
this administration. The events of September 11, the discovery of 
terrorist cells in Europe, the potential threat of a terrorist attack 
on the nation's critical infrastructure--all of this means that our 
mission must include protecting Americans from those who would harm us 
through our food supply. A terrorist attack on the food supply could 
pose both severe public health and economic impacts, while damaging the 
public's confidence in the food we eat.
    And so FDA's mission today is not only about food safety--it is 
fundamentally about food security as well. The changes in food security 
that we are implementing now amount to the most fundamental 
enhancements in our food safety activities in many years. Yesterday, 
Secretary Thompson and I issued a report entitled ``Ensuring the Safety 
and Security of the Nation's Food Supply.'' The report outlines a clear 
and comprehensive approach to protecting the safety and security of our 
food supply.
    In these new efforts, FDA has many partners. We are working closely 
with our Federal partners such as the U.S. Department of Agriculture 
(USDA), the new Department of Homeland Security, and the Homeland 
Security Council at the White House. I would like to call special 
attention to our close working relationships with CDC, our sister 
public health agency, Customs and Border Protection in the Department 
of Homeland Security, and USDA's Food Safety and Inspection Service, 
our counterpart agency responsible meat, poultry, and certain egg 
products. Some of our other Federal partners include USDA's Animal and 
Plant Health Inspection Service, USDA's Foreign Agriculture Service, 
Army Veterinary Services, Department of Commerce's National Oceanic and 
Atmospheric Administration, the Environmental Protection Agency, and 
the Department of Treasury's Alcohol and Tobacco Tax and Trade Bureau.

                 IMPLEMENTATION OF THE BIOTERRORISM ACT

    As you know, Title III of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) 
provided the Secretary of Health and Human Services with new authority 
to protect the nation's food supply against the threat of intentional 
contamination and other food-related emergencies. FDA is responsible 
for implementing these food security provisions. Let me commend you, 
Mr. Chairman, for your leadership, as well as that of the Ranking 
Member and other Members of the Committee, in enacting this landmark 
legislation.
    The Agency is working hard to implement this law effectively and 
efficiently. We have already published four proposed regulations to 
implement some of the provisions of the Bioterrorism Act. These 
regulations address four provisions of the law: registration of 
domestic and foreign food facilities, prior notice of imported food 
shipments, the establishment and maintenance of records, and 
administrative detention. We intend to publish final regulations on two 
of these provisions in October of this year and the remaining two in 
December. These new authorities will enable FDA to act quickly in 
responding to a threatened or actual terrorist attack.

                  VULNERABILITY AND THREAT ASSESSMENTS

    In addition to implementation of the Bioterrorism Act, FDA has been 
engaged in numerous other food security activities. As part of our 
efforts to anticipate threats to the food supply, we have conducted a 
scientific vulnerability assessment of different categories of food, 
determining the most serious risks of intentional contamination during 
various stages of food production and distribution. This assessment 
utilized an analytical framework called Operational Risk Management 
(ORM) that considers both the severity of the public health and 
economic impacts of a potential attack on our food supply and the 
likelihood of such an event taking place.
    FDA also awarded a task order to the Institute of Food 
Technologists (IFT) to conduct an indepth review of ORAI and provide a 
critique of its application to food security. This review validated 
FDA's vulnerability assessment and provided additional information on 
the public health consequences of a range of scenarios involving 
various products, agents, and processes. FDA also contracted with 
Battelle Memorial Institute to conduct a ``Food and Cosmetics, 
Chemical, Biological, and Radiological Threat Assessment,'' The 
assessment affirmed the findings of the ORM assessment. It also 
provided an additional decision-making tool for performing risk 
assessments, Further, the Battelle assessment made a number of 
recommendations that addressed research needs, the need for enhanced 
laboratory capability and capacity, and the need for enhanced 
partnerships between Federal, state, and local governments to ensure 
food security.
    FDA is conducting additional assessments regarding the 
vulnerability of FDA-regulated foods to intentional contamination with 
biological, chemical, and radiological agents. These assessments use 
processes adapted from techniques developed by the U.S. Department of 
Defense for use in assessing the vulnerabilities of military targets to 
asymmetric threats. Results of the assessments will be used to develop 
countermeasures, identify research needs, and provide guidance to the 
private sector.

                  EMERGENCY PREPAREDNESS AND RESPONSE

    FDA has established an Office of Crisis Management to coordinate 
the preparedness and emergency response activities within FDA and with 
our Federal, state, and local counterparts. Over the past two years, 
FDA has participated in and conducted multiple emergency response 
activities.
    Frequently, these exercises are coordinated with other Federal and 
state agencies. For example, FDA and USDA's Food Safety and Inspection 
Service have focused on strengthening their working relationships by 
the joint testing of several response plans in an exercise environment.
    In May of this year, FDA participated in the TOPOFF2 
counterterrorism exercise. This was a national, full-scale, fully 
functional exercise intended to simulate two separate terrorist 
attacks: detonation of a ``dirty bomb'' in Seattle and aerosol release 
of plague in Chicago. The ensuing response involved participation from 
17 Federal Departments and Agencies, the state governments of 
Washington and Illinois, the local governments of the affected cities, 
and the Canadian Government.
    FDA's response was coordinated from our Emergency Operations Center 
on an around-the-clock basis throughout the exercise. FDA performed 
duties as if this were a real event. At the Seattle venue, FDA's Center 
for Devices and Radiological Health (CDRH) monitored the dispersion of 
the radioactivity from the blast site. The Center for Food Safety and 
Applied Nutrition (CFSAN), in conjunction with other Federal and state 
officials, formulated a plan for sampling contaminated sites and 
developed recommendations regarding the shipment and consumption of 
potentially contaminated foods. In addition, the Center for Drug 
Evaluation and Research (CDER) provided guidance on the availability of 
medical countermeasures that would have been effective in this 
situation. The Center for Biologics Evaluation and Research (CBER) 
developed draft guidance on blood and tissue donor deferral for 
radiation exposure.
    In the TOPOFF2 Chicago venue, representatives from CBER and CDER 
worked with CDC to provide guidance on medical countermeasures and 
their availability. CDRH provided information on diagnostic kits for 
plague in addition to ventilator inventory information. FDA's Center 
for Veterinary Medicine (CVM) issued guidance on animal species 
susceptible to plague and worked with USDA's Animal and Plant Health 
Inspection Service to develop an emergency vaccine to prevent continued 
transmission of the disease.
    In September 2002, FDA led an exercise to test our draft biological 
and chemical agent response plan and to test our Agency's coordination 
and communication. In January 2002, FDA led another emergency response 
exercise with representatives from CDC, USDA, the Federal Bureau of 
Investigation, the Department of Defense, state agencies, and others. 
The purpose of this exercise was to improve coordination of responses 
among various agencies, so that those responses are smooth and 
appropriate and so that all needed parties are involved. Other 
exercises are being planned. We have also reviewed food security and 
rapid response and recovery procedures with industry groups and trade 
associations.

                        LABORATORY ENHANCEMENTS

    An additional step in enhancing our response capability is to 
improve our laboratory capacity. A critical component of controlling 
threats from deliberate food-borne contamination is the ability to 
rapidly test large numbers of samples of potentially contaminated foods 
for a broad array of biological, chemical, and radiological agents. We 
have been working with CDC to augment our ``surge capacity'' by working 
to expand the nationwide Laboratory Response Network and the Food 
Emergency Response Network (FERN) to include a substantial number of 
counterterrorism laboratories capable of analyzing foods. We are 
accomplishing this expansion in capacity through agreements with other 
Federal and state laboratories. As of June 2003, there were 63 
laboratories representing 27 states participating in FERN, including 
five Federal laboratories. Participation continues to grow. By working 
together with our Federal and State partners, we will have the ability 
to test a much higher than normal volume of samples. With CDC, we 
recently announced grants that states can use to buy special laboratory 
equipment and reagents and to develop skills to ensure there is a 
national network of laboratories that are ready to assess and respond 
to a food security emergency.
    We also are expanding Federal, state, and local involvement in our 
eLEXNET system by increasing the number of laboratories around the 
country that participate in this electronic data system. eLEXNET is a 
seamless, integrated network that allows multiple agencies engaged in 
food safety activities to compare, communicate, and coordinate findings 
of laboratory analyses. It enables health officials to assess risks and 
analyze trends, and it provides the necessary infrastructure for an 
early warning system that identifies potentially hazardous foods. At 
present, there are 95 laboratories representing 48 states that are part 
of the eLEXNET system. We are continuing to increase the number of 
participating laboratories.

                                RESEARCH

    We have embarked on an ambitious research agenda throughout the 
Agency to address potential terrorist threats. To enhance food 
security, FDA has significantly redirected existing research staff to 
ensure that appropriate resources are focused on priority food safety 
and security issues. For example, research sponsored by FDA's CFSAN is 
aimed at developing the tools essential for testing a broad array of 
food products for a multiple number of biological and chemical agents. 
We are actively working with our partners in government, industry, and 
academia to develop such methods. FDA's work with the Association of 
Official Analytical Chemists on validating analytical methods for the 
detection of biological, chemical, and radiological agents in foods is 
considered the ``gold standard'' against which other validations 
programs are judged. Likewise, the FDA's research on microbial genomics 
and analytical chemistry is widely recognized for its importance to 
other Federal agencies charged with forensic investigations of 
terrorism events. In compliance with Section 302 of the Bioterrorism 
Act, we will soon be submitting a report to this Committee that will 
provide additional details about the research that is underway.

             OPERATION LIBERTY SHIELD AND INDUSTRY GUIDANCE

    In March 2003, the Federal government launched Operation Liberty 
Shield to increase security and readiness at a time of elevated risk 
for terrorist attack. Operation Liberty Shield is a comprehensive 
national plan designed to increase protections for America's citizens 
and infrastructure while maintaining the free flow of goods and people 
across our border with minimal disruption to our economy and way of 
FDA's Office of Regulatory Affairs (ORA) conducted a number of targeted 
inspections of domestic and imported products as part of this 
initiative. ORA also increased joint activities with Federal, state, 
and local partners. Also as part of Operation Liberty Shield, we issued 
guidance documents for the food industry on the security measures it 
may take to minimize the risk that food under their control will be 
subject to tampering or other malicious, criminal, or terrorist 
actions. We have issued such guidance for food producers, processors, 
and transporters, for importers and filers, for retail food stores and 
food service establishments, and for cosmetic processors and 
transporters. In addition, we just recently issued specific security 
guidance for the milk industry.

                 ADDITIONAL COUNTERTERRORISM EMPLOYEES

    The Fiscal Year 2002 supplemental counterterrorism funds enabled 
FDA to hire about 800 employees. Most of these additional employees 
were hired by ORA to address food safety and security issues, primarily 
at the border. With these additional employees, we have expanded FDA's 
presence at ports of entry, increased surveillance of imported foods, 
increased domestic inspections, and enhanced our laboratory analysis 
capacity. More specifically, within the last two years, we have more 
than doubled the number of ports that have an FDA presence from 40 to 
90 ports. We have more than quintupled the number of food examinations 
at the border. So far this year, we have performed 62,000 food import 
examinations compared to 12,000 two years ago. We surpassed our goal of 
48,000 import examinations this year due to increased surveillance of 
imported food products during Operation Liberty Shield when the nation 
was at a heightened security alert status.

             MEDICAL COUNTERMEASURES AND PROJECT BIOSHIELD

    Today, the U.S. is better prepared than ever to meet the threat of 
terrorist attack with a biological, chemical, radiological, or nuclear 
agent. FDA plays a critical role in the response to a terrorist act. A 
primary responsibility is the expeditious development and licensing of 
products to diagnose, treat, or prevent outbreaks from exposure to 
bioterrorist agents.
    FDA scientists guide the products through the development and 
marketing application review processes, which include review of the 
manufacturing process, pre-clinical testing, clinical trials, and the 
licensing and approval process.
    FDA has been engaged in an accelerated effort to help to develop 
and make available better countermeasures. For example, in recent 
months, FDA has taken major steps to make available safe and effective 
treatments for certain nerve gases and radiological agents, and the 
Government has enhanced the national stockpiles of vaccines and 
treatments for smallpox and other possible agents of biowarfare. FDA 
also has sought data to provide the regulatory basis for defining the 
safety and efficacy of medical countermeasures. In addition, FDA has 
initiated collaborations with industry to utilize any additional data 
it may possess.
    In effect, FDA's actions eliminate preliminary steps in the 
approval process for certain medical countermeasures. For example, 
during the anthrax crisis in 2001, FDA reviewed available data and 
safety information to conclude that two approved drugs not typically 
considered indicated for treatment of anthrax exposure, doxycycline and 
procaine penicillin G, could be safely used to treat anthrax exposure 
without and additional clinical trials. More recently, FDA reviewed the 
data on treatments for radiation exposure and determined that Prussian 
Blue was safe and effective in treating people exposed to radioactive 
elements such as cesium-137. After a review of the published 
literature, FDA determined that 500 mg Prussian Blue capsules would be 
safe and effective for the treatment of patients with known or 
suspected internal contamination with radioactive thallium, non-
radioactive thallium, or radioactive cesium. FDA's guidance to industry 
and approved labeling for Prussian Blue products gives manufacturers 
critical information necessary for producing an FDA-approved product 
that will be an important medical countermeasure.
    In reviewing the lessons learned after the anthrax attacks, we 
identified the need for additional mechanisms for healthcare providers 
and the general public to report their outcomes or product-related 
adverse events to the FDA. To address this need, FDA and CDC have 
created a working group to define mechanisms, processes, and training 
needed to integrate Federal, state, and local follow-up activities. In 
addition, FDA participates in a number of interagency working groups to 
address laboratory surge capacity, prophylactic countermeasures, and 
novel pathogens.
    CBER is working closely with industry and other government agencies 
in an effort to assure an adequate supply of products for immunization 
against anthrax, smallpox, and other substances that might be used by 
terrorists and to evaluate adverse experiences reported after 
administration of anthrax vaccine in order to optimize its safe use. 
With the FY 2002 supplemental counterterrorism funds, CBER was able to 
hire 97 full-time equivalent (FTEs) employees to assist in the 
regulation of the development and licensure of new biological products 
including vaccines, blood, and blood products. Current workforce data 
indicate that CBER has approximately 200 FTEs dedicated toward 
counterterrorism activities.
    CDER has created a specific counterterrorism office to facilitate 
the product development of medical countermeasures. In addition to the 
numerous Center review staff, more than 30 employees are dedicated 
full-time to facilitating the identification of promising products.
    These employees assist both external and internal groups in 
defining and developing the science and databases necessary to move 
products toward full approval as a medical countermeasure.
    CDER has leveraged its science-based regulator mission by pooling 
its resources with other Federal agencies to fund homeland defense 
research to develop medical countermeasures. This research has 
addressed the need for drugs to treat plague, the safety of long-term 
antibiotic use, and the use of medical countermeasures in special 
populations, such as children, the elderly, and pregnant women. The 
research has also included the development of animal models to test 
drugs for biological threats. For example, working with other Federal 
agencies such as the Department of Defense, NIH, and CDC, FDA has 
developed the following research activities:
    Monkey studies involving numerous antibiotics for the treatment of 
plague;
    Human trials in plague-endemic areas; and
    Small animal models in viral hemorrhagic fevers.
    The pro-active approaches described above have facilitated the 
development and availability of safe and effective treatments. The 
national stockpile of medical countermeasures is large, and getting 
more extensive all the time, but more needs to be done.
    Earlier this year, President Bush proposed Project BioShield to 
enable the government to develop, procure, and make available 
countermeasures to chemical, biological, radiological, and nuclear 
agents for use in a public health emergence that affects national 
security. Enactment of the Project BioShield legislation is a priority 
for the Administration.
    Unfortunately, the medical treatments available for many pathogens 
have improved little in decades. For example, some treatments for 
radiation and chemical exposure have not changed much since the 1970's 
and some diseases, such as Ebola, have never had an effective medical 
countermeasure.
    Some diseases lack effective or modern treatment in part because 
there are no clear financial rewards for developing valuable new 
treatments that can save and improve lives. By contrast, the treatment 
of the vast majority of common, naturally occurring illnesses has 
improved dramatically as a result of continuing innovations from 
biomedical research and development. Heart attacks were often fatal in 
the 1970s, but they are much less likely to be fatal today. And better 
detection and therapeutic options have significantly improved survival 
rates for many kinds of cancer over the last 20 years. We must bring 
that sort of progress to the rare yet deadly threats posed by 
bioterrorists.
    Pharmaceutical research and development historically have focused 
on development of products likely to attract significant commercial 
interest. Many countermeasures for potential agents of terrorism 
realistically have no market other than the government and thus have 
not generated a great deal of manufacturer interest. Because the market 
for developing countermeasures is speculative, without government 
interest, private companies have not invested and engaged in developing 
the countermeasures that may he needed. However, in the vaccine 
development area, representatives of the pharmaceutical industry have 
stressed that they will meet the challenge if the Federal government 
can define its vaccine requirements and assure up front that the 
requisite funds will be available to purchase the vaccines.
    Project BioShield would speed up research and approval of vaccines 
and treatments and ensure a guaranteed funding source for their 
purpose. More specifically, the BioShield legislation would:
    Ensure that sufficient resources are available to procure the next 
generation of countermeasures;
    Accelerate NIH research and development by providing more 
flexibility in the contracting process, procurement authorities, and 
the issuance of grants for critical biodefense work; and
    Make promising treatments available more quickly for use in 
emergencies by establishing new emergency use authorization procedures 
at the FDA.

                            FDA'S WORKFORCE

    Now, I would like to respond to workforce issues raised in the 
recent report by the Partnership for Public Service. A key component of 
FDA's strategic plan is to assure a high-quality professional 
workforce. Capable personnel with the appropriate expertise are 
critical for the success of FDA and for the Agency's ability to 
maintain a high level of public trust in its activities. FDA's 
responsibilities require a very special workforce, one that can keep up 
with rapid changes in the industries that it regulates and that is 
capable of developing and implementing effective and innovative public 
health measures. Our workforce includes a solid cadre of experienced 
physicians, toxicologists, chemists, microbiologists, statisticians, 
mathematicians, biologists, pharmaeologists, veterinarians, and other 
highly qualified and dedicated professionals. FDA currently has 10,695 
employees. Of these, there are almost 1,500 professionals with Ph.D.'s 
and well over 400 with medical degrees. As FDA Commissioner, one of my 
foremost goals is to make sure that FDA's working environment attracts 
and retains top-quality scientists and encourages creativity, 
efficiency, and superior performance.
    Through training and education, FDA has expanded the scientific 
knowledge of its staff. For example, FDA has acquired and made 
available to its staff information on the characteristics of a wide 
range of biological, chemical, and radiological agents. FDA has hired 
additional personnel with specific expertise to assist us in our 
counterterrorism efforts. These areas of expertise include, but are not 
limited to, the use of select agents, law enforcement, intelligence, 
security, and risk assessment, FDA also has cross-trained existing 
scientists and consumer safety officers to meet the new challenges of 
food security and medical countermeasures. We have had to revise, 
expand and re-engineer investigation, laboratory, and compliance 
procedures and policies to bring them in line classified information 
gathering, facility and procedure security, and personnel security to 
accommplish these tasks. This new direction has also required the 
acquisition of secure storage and secure workstations. Further, FDA has 
redoubled its collaboration with Federal intelligence partners through 
our own Office of Criminal Investigations so that we are better 
prepared, are working on consistent priorities, and have regular and 
effective lines of communication with other law enforcement and 
intelligence agencies in the event of a biodefense situation.
    FDA began an Agency-wide strategic workforce alarming initiative in 
2001 to examine the workforce challenges of the future. In 2002, we 
expanded the initiative to identify the types and numbers of positions 
needed to enhance our counterterrorism readiness. The initiative also 
looked at the aging of the workforce, the attrition rate, succession 
planning, and leadership development. We identified ways to recruit, 
develop, and retain personnel. Two key outcomes of this initiative have 
been a heightened awareness among the FDA leadership of the importance 
of workforce planning and integration of workforce planning into the 
Agency's strategic planning process.
    For your information, our data indicate that 26 percent of our 
total workforce will be eligible to retire in the next five years. For 
some of our key occupations, 20 percent of our medical officers, 24 
percent of our microbiologists, and 16 percent of our chemists are 
eligible to retire in the next five years. Our data seem to conflict 
with the Partnership's report data that indicate 52 percent of medical 
field employees and 51 percent of employees in the biological sciences 
will be eligible for retirement in the next five years.
    FDA has created many new human resources policies to attract and 
keep high-caliber employees. I'd like to mention a few of these 
initiatives to recruit and retain staff:
    FDA has created a national program that allows academic and 
esteemed individuals to spend time at FDA to inject innovative thinking 
into the current regulatory science and review process.
    FDA has established partnerships with universities and colleges. 
These partnerships provide opportunities for joint research, for 
recruitment of students, and for sabbaticals for FDA employees.
    FDA has established occupational retention allowances for hard-to-
fill and hard-to-retain positions such as medical officers, clinical 
pharmacologists, and mathematical statisticians. We are able to pay 
employees in these categories an additional 10% of their salary.
    FDA has created a student loan repayment program. We can pay up to 
$6,000 a calendar year with a career maximum of $40,000 per employee.
    FDA has created a recruitment referral award for an employee who 
helps the Agency recruit new talent by referring external applicants. 
The cash awards range from $500 to $1,000 per referral for hard-to-fill 
positions.
    FDA has created a pay banding schedule for scientific, supervisory, 
and managerial positions. Using the flexibility offered by Title 42 of 
the U.S. Code, we are allowed to set salaries of up to $200,000 per 
year for our scientific workforce.
    In addition, employees can take advantage of flexible work 
schedules, including an ``any-80'' program that enables employees to 
work any 80-hour schedule over the two-week pay period so they may 
better balance their professional lives with their family lives. About 
one-fifth of our employees take advantage of our flexi-place program, 
which permits telecommuting. We also have a child-care subsidy program 
for lower-grade employees. We offer transit subsidies for employees who 
use public transportation.
    These measures seem to be working. In a recent survey conducted by 
the Office of Personnel Management to gauge how Federal employees feel 
about their jobs, FDA did very well compared to other agencies and the 
private sector. About 73 percent said they found FDA a friendly place 
to work, 82 percent said their supervisor supports their need to 
balance work and family issues, and 65 percent said they would 
recommend FDA as a place to work.
    In addition, a November 2001 report by the National Academy of 
Public Administration entitled ``A Work Experience Second to None: 
Impelling the Best to Serve'' cited FDA's flexible work environment as 
a successful employee retention practice in the competition for talent.
    To further assist in our recruitment efforts, FDA has taken steps 
to expedite the hiring process. FDA piloted the automated application 
system called Quick Hire. HHS has now adopted Quick Hire for the human 
resources consolidation effort. Quick Hire is a web-based on-line 
application system. The computer automatically rates and ranks the 
applicants based on pre-determined weighted questions developed by 
managers. In the past, we used a manual process of reviewing 
applications. Due to the pilot, we were able to hire 673 Consumer 
Safety Officers within the last fiscal year. We rated and ranked over 
5,000 applications for 90 different field locations and had the lists 
of the best-qualified candidates to the managers within two weeks; one 
month after the initial advertisement. Under the old manual system, 
this task would have taken several months to complete. Management 
officials have reported that they have been pleased with the quality of 
the applicants.
    FDA recently demonstrated its ability to hire, train, and utilize 
counterterrorism personnel quickly. The FY 2002 supplemental funding 
that Congress provided for counterterrorism activities enabled us to 
hire 800 additional personnel. Of these employees, 655 were hired by 
FDA's ORA. The remaining employees were hired by CDER, CBER, and the 
Office of the Commissioner to handle counterterrorism issues. Of the 
employees hired by ORA, 612 were hired as investigators and analysts, 
33 were hired as Special Agents in the Office of Criminal 
Investigations, and 10 were hired as supervisors and compliance 
officers. The majority of these were allocated for food safety and 
security activities. Using the Quick Hire automated system and other 
innovations, ORA was able to bring these additional employees on board 
in a short amount of time, less than a year. Through a new, more 
efficient, training program we were able to have the new hires doing 
``basic'' work within three months of employment and becoming fully 
operational within 12 months. These additional employees have improved 
our ability to detect and respond to terrorist threats and attacks.

                               CONCLUSION

    FDA plays a critical role in the nations defense against terrorism. 
Although we are better prepared than ever before, we are continuously 
working to improve our ability to detect and respond to terrorist 
threats.
    As part of this preparedness, we're building a strong workforce, 
and we intend to do even better. FDA has made significant progress in 
improving staffing for biological and medical sciences, and we will 
continue to do so. FDA has already implemented many of the suggestions 
in the Partnership report, we will continue to find additional 
innovative ways to support our workforce.
    Thank you for this opportunity to discuss some of FDA's 
counterterrorism activities and our efforts to attract and retain high-
quality personnel. I look forward to continuing to work with the 
Committee on security and workforce issues. I would be pleased to 
respond to any questions.

             Prepared Statement of Elias A. Zerhouni, M.D.

    Mr. Chairman and Members of the Committee, thank you for inviting 
me to discuss how the National Institutes of Health (NIH) is helping to 
increase national preparedness against terrorist threats. The events of 
September 11, 2001, and the anthrax attacks that followed changed 
forever our collective thinking about the Nation's vulnerability to 
terrorist attacks. In response, the NIH and our sister agencies in the 
Department of Health and Human Services (DHHS), the Centers for Disease 
Control and Prevention (CDC) and the Food and Drug Administration 
(FDA), have strengthened and expanded programs that will markedly 
enhance our ability to protect the American people against a broad 
range of potentially deadly terrorist threats. Indeed, many of these 
efforts have already borne fruit, and bioterrorism readiness stands at 
an all-time high. Nonetheless, we have more to do to develop the full 
complement of medical countermeasures and procedures that homeland 
security requires.
    Today, I will address how the NIH is contributing to the nation's 
capacity to counter bioterrorist threats. In Fiscal Years 2002 and 
2003, the NIH greatly accelerated and expanded its research program on 
dangerous microbes and their toxins, an emphasis that reflects the lead 
role of the NIH, and particularly the National Institute of Allergy and 
Infectious Diseases (NIAID), in federally supported research on human 
infectious diseases. For Fiscal Year 2003, the NIH received a budget 
appropriation of over $1.5 billion for biodefense research, an 
unprecedented amount for any single program in the history of NIH.
    More recently, the NIH has begun to identify next steps to 
implements its responsibility to develop a research agenda to address 
chemical and nuclear/radiological threats, as well as interventions to 
address the mental health impact of terrorism on individuals and 
society. The ultimate goal of these efforts is to develop an 
armamentarium of vaccines, therapeutics, and diagnostics that can 
protect the people of the United States against dangerous pathogens, 
toxins; chemicals, and radiological agents. Our bioterrorism-related 
research and development efforts are closely intertwined with the 
activities of the CDC, the FDA, and the Department of Defense (DoD).
    The success of our efforts to develop safe and effective biomedical 
countermeasures against terrorist threats depends on a balance of basic 
and product-driven research, sufficient infrastructure and resources, 
and the outstanding men and women whose expertise and commitment make 
the entire enterprise possible. With this emphasis in mind, my remarks 
today will focus on NIH's efforts to: (1) develop a broad range of 
medical countermeasures. including vaccines, against terrorist threats 
and emerging infectious diseases; (2) develop the necessary research 
infrastructure, including specialized laboratory facilities and 
equipment; (3) enhance collaborations with other federal agencies and 
the private sector, and (4) develop and sustain the human capital that 
is central to all our activities.

         DEVELOPING MEDICAL COUNTERMEASURES TO TERRORIST AGENTS

    As the United States confronts the threat of terrorism, it is 
imperative that the Federal government develop the means by which to 
protect its citizens. The NIH response to this challenge has been 
unprecedented in its swiftness and scope. Aggressively managed, 
milestone-driven, interagency-coordinated efforts, and enhanced 
partnerships with industry have already resulted in important progress 
in basic research and in the development of biodefense countermeasures.
    Last year, the NIH devised an intensive strategic planning process 
to shape its biodefense research program. These efforts resulted in the 
development of the NIAID Strategic Plan for Biodefense Research, as 
well as comprehensive research agendas for Category A agents, and 
Category B and C priority pathogens. Prepared in consultation with blue 
ribbon panels of experts, the research agendas delineate immediate, 
intermediate, and long-range plans for basic research and the 
development of vaccines, drugs, and diagnostics. Category A agents are 
considered to be the most serious bioterrorist threats. They include 
smallpox, anthrax, botulinum toxin. plague, tularemia, and hemorrhagic 
fever viruses such as Ebola. Category B and C priority pathogens 
include many food and Waterborne microbes such as those that cause 
cholera, typhoid fever, encephalitis, and certain forms of dysentery. 
In accord with the priorities outlined in its research agendas. NIAID 
developed a total of 46 biodefense initiatives in Fiscal Years 2002 and 
2003. The response from the scientific community was swift and strong; 
NIAID has seen a 30 percent increase in the number of grant 
applications, the vast majority of which are for biodefense.
    NIH has already advanced the development of vaccines and therapies 
for smallpox and anthrax. Last year, for example. NIH-supported 
scientists demonstrated that the existing U.S. supply of smallpox 
vaccine was still potent and could be diluted five-fold and retain the 
ability to stimulate the skin lesion ``take'' considered an indication 
of the vaccine's effectiveness. The discovery made it possible to 
Greatly expand the number of doses of smallpox vaccine in the United 
States. NIH is now developing and testing next-generation, attenuated 
smallpox vaccines such as modified vaccinia Ankara (MVA) that can be 
used safely in people whose immune systems are compromised, in pregnant 
women, in people with skin conditions such as eczema and atopic 
dermatitis, and in other vulnerable populations for whom the existing 
vaccine is not recommended. NIH is also testing antiviral compounds as 
potential therapies for smallpox, developing antibodies that could be 
used to treat complications caused by the current smallpox vaccine, and 
sequencing the genomes of smallpox and related poxviruses to identify 
potential molecular targets for new drug and vaccine development.
    Progress on anthrax is following a similar pattern of success. Last 
year, NIH-funded scientists identified the site on a human cell that 
binds the anthrax toxin and developed a compound that may block its 
lethal effects. The information gained through these and other studies 
will likely hasten the development of new drugs to treat anthrax. In 
May 2003, NIH-supported investigators at The Institute of Genomic 
Research in Rockville, MD, determined the complete genetic sequence of 
the strain of the anthrax microbe used in the 2001 mail attacks. In 
addition to providing valuable forensic information, this achievement 
may give scientists valuable clues about designing drugs and vaccines 
that capitalize on the bacterium's vulnerabilities. And as of July 
2003, four clinical trials of a next-generation, DNA-based vaccine for 
anthrax called recombinant Protective Antigen (rPA) are underway.
    Future NIH biodefense research will reveal more about the basic 
biology of these and other microbes, identify the mechanisms by which 
they cause disease, identify factors in the human innate and adaptive 
immune response to these microbes, and develop new and improved 
interventions that can prevent and treat diseases caused by Category A, 
B, and C agents. For example, NIH is developing and testing candidate 
vaccines for Ebola and is currently in the planning stages for 
initiation of a Phase I clinical trial to evaluate a candidate DNA 
vaccine for Ebola. Over a dozen more research initiatives are planned 
for Fiscal Year 2004, all of which will help accelerate the development 
of medical countermeasures against biological agents that could be used 
as weapons of terrorism.
    Over the past several months, NIH has also begun to examine several 
other areas of concern: nuclear/radiological terrorism, chemical 
terrorism, and the psychosocial impact of traumatic events. Earlier 
this year, we convened panels of experts in radiobiology and medical 
chemical defense to identify research opportunities in medical 
countermeasures. On February 26, 2003, NIH convened a meeting that 
included scientists of the NIAID, National Cancer Institute (NCI), the 
Armed Forces Radiobiology Research Institute, the National Academy of 
Sciences (NAS), other government agencies, and academia, to identify 
priorities in the development of medical countermeasures against 
nuclear/radiological terrorism. This meeting was a logical sequel to 
two NCI-sponsored workshops held in 2000 and 2002 that reviewed 
information on tissue damage from ionizing radiation and possible 
mechanisms of protection. On March 19, we convened a panel of experts 
that included representatives of the NAS, academia, industry, other 
federal agencies, including the DoD and the Army Medical Research 
Institute of Chemical Defense, the newly created Department of Homeland 
Security, and NIH Institutes and Centers. The panel was charged to 
identify gaps in scientific knowledge about chemical injury and repair, 
and to identify priorities for the research and development of medical 
countermeasures. These meetings have provided an excellent framework 
for new medical product development and greater homeland security.
    The National Institute of Mental Health (NIMH) has a program 
committed to research on mass casualties and trauma. Within several 
months of the attacks on the World Trade Center and Pentagon and the 
anthrax mailings, the NINTH expedited the award of grants to assess the 
mental health impact of these terrorist actions. The institute also 
convened, with other agencies, a major national workshop on mental 
health needs in disaster response. The NIMH is exploring additional 
behavioral/mental health research aimed at two problems, the treatment 
of trauma in individuals, and communication with the public during 
disasters and other traumatic events.

                 DEVELOPING THE RESEARCH INFRASTRUCTURE

    Continuing progress in our efforts to develop medical 
countermeasures against a broad range of terrorist agents also depends 
on the availability of specialized resources that enhance the NIH 
research infrastructure. hey among these resources is a nationwide 
network of Regional Centers of Excellence for Biodefense and Emerging 
Infectious Disease Research and the construction of the Regional and 
National Biocontainment Laboratories, all of which are being launched 
in Fiscal Year 2003. These facilities will serve as national resources 
for biodefense research and product development, as well as for the 
study of other infectious diseases such as SARS and the West Nile 
virus. which require specialized biocontainment laboratories for 
research. The new centers and laboratories will include a small number 
of Biosafety Level (BSL)-3 and BSL-4 laboratories, which have the 
containment safeguards necessary to study highly pathogenic organisms. 
Only four BSL-4 laboratories exist in the United States today, which 
limits the ability to conduct safe and efficient biodefense research; 
the new facilities will substantially increase our country's biodefense 
research capacity. Review of applications for the Regional Centers of 
Excellence and the Regional and National Biocontainment Laboratories 
programs is occurring now, and awards will be made this fall. In 
addition to these extramural facilities. NIH is planning the 
construction of new intramural facilities, which will include BSL-3 and 
4 laboratories at Fort Detrick and Rocky Mountain Laboratories, and 
BSL-3 laboratories at the NIH campus in Bethesda.
    NIH is also investing in other research resources necessary for 
meeting our biodefense goals. These include expanding our capacity for 
large-scale genome sequencing, developing new technologies to mine the 
wealth of data generated from genomic research, and establishing a 
national biodefense research reagent repository.

                        ENHANCING COLLABORATIONS

    Collaborations with other federal agencies, private industry, and 
academia have always been a cornerstone of NIH's programs of research 
and development to promote public health. For the past two years, we 
have expanded these collaborations in many directions to bring together 
the multidisciplinary expertise and make possible the rapid response 
required to address terrorist threats. These partnerships have 
contributed greatly to the progress in the biodefense enterprise to 
which I have already alluded. For example, our ability to initiate 
clinical trials to test the next-generation rPA vaccine for anthrax 
resulted largely from collaboration between NIH and DoD. NIH has also 
developed an interagency agreement with the U.S. Army Medical Research 
Institute of Infectious Diseases that allows for cross-utilization of 
resources and joint research projects of high national importance, such 
as next-generation vaccines against smallpox. NIH is also working 
closely with the FDA and DoD in the evaluation of antimicrobial drugs 
against high-threat agents such as plague and tularemia.
    Also critical to our continued success are partnerships with 
private industry. Unfortunately, many biodefense products provide 
insufficient incentive for private-sector engagement because there may 
be no viable commercial market. Within the limits of current statutory 
authority. NIH continues to develop new and innovative approaches to 
public-private partnerships to overcome such obstacles. The Project 
BioShield legislation now under consideration would provide significant 
funding for countermeasures against the highest priority threat agents. 
It would also greatly strengthen our ability to respond to the many 
challenges associated with biodefense research and development by 
providing streamlined authority, increased flexibility in awarding 
grants and cooperative agreements, expedited peer review procedures, 
bolstered authority for acquisition, construction, and renovation of 
facilities, and greater flexibility in hiring technical experts.
    Our plan is to work closely with colleagues elsewhere in 
government, including the Departments of Homeland Security, Defense, 
and Energy and the NAS to ensure that our efforts to develop chemical, 
biological, radiological, and nuclear countermeasures are successful.

                DEVELOPING AND SUSTAINING HUMAN CAPITAL

    A fundamental element in our ability to protect the American people 
against terrorist threats is personnel. We must hire, train, and retain 
the most highly qualified and dedicated men and women to form the core 
of the NIH research enterprise. Our current personnel levels have been 
sufficient to foster the progress in biodefense research that I have 
described.
    NIH is committed to the education and training of biomedical 
research scientists to meet future challenges. Recently, NIH initiated 
a number of programs to provide research training and career 
development opportunities in the area of biodefense. These 
opportunities, in the form of institutional training grants, individual 
pre- and postdoctoral fellowships, and career development awards in 
both basic and clinical research, will ensure a continuum of highly 
qualified men and women in this crucial area of research.
    We believe that the talent exists to conduct the necessary 
research. Our challenge across the federal government is to find more 
effective ways to attract, hire, nurture, and retain qualified, 
committed people into national service.

                               CONCLUSION

    Today, the United States faces a challenge that demands a rapid and 
coordinated scientific response. This challenge appears new and 
sinister because it arises from the deliberate use of deadly microbes, 
toxins, chemicals, and ionizing radiation as weapons against citizens. 
However, the tools and processes we need to combat these forms of 
terrorism are familiar to us. They include fundamental research to 
discover the mechanisms of injury and disease, investigations that lead 
us to a better understanding of how humans respond to these potential 
weapons, and the translation of that fundamental knowledge into safe 
and effective countermeasures. Indeed, the experience and expertise of 
the NIH places us in a unique position to accelerate the development of 
countermeasures needed by Americans and people around the world to 
protect them against the threat of terrorism in the 21st century.
    Mr. Chairman, this concludes my statement. I will be happy to 
answer any questions you and the other Members of the Committee might 
have.

    [Whereupon, at 11:31 a.m., the committee was adjourned.]

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