[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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WASHINGTON : 2003
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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
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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.]