<DOC>
[107th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:76309.wais]
BIOTERRORISM AND PROPOSALS TO COMBAT BIOTERRORISM
=======================================================================
HEARING
before the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
NOVEMBER 15, 2001
__________
Serial No. 107-72
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
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COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas HENRY A. WAXMAN, California
FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia SHERROD BROWN, Ohio
STEVE LARGENT, Oklahoma BART GORDON, Tennessee
RICHARD BURR, North Carolina PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
GREG GANSKE, Iowa ANNA G. ESHOO, California
CHARLIE NORWOOD, Georgia BART STUPAK, Michigan
BARBARA CUBIN, Wyoming ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois TOM SAWYER, Ohio
HEATHER WILSON, New Mexico ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona GENE GREEN, Texas
CHARLES ``CHIP'' PICKERING, KAREN McCARTHY, Missouri
Mississippi TED STRICKLAND, Ohio
VITO FOSSELLA, New York DIANA DeGETTE, Colorado
ROY BLUNT, Missouri THOMAS M. BARRETT, Wisconsin
TOM DAVIS, Virginia BILL LUTHER, Minnesota
ED BRYANT, Tennessee LOIS CAPPS, California
ROBERT L. EHRLICH, Jr., Maryland MICHAEL F. DOYLE, Pennsylvania
STEVE BUYER, Indiana CHRISTOPHER JOHN, Louisiana
GEORGE RADANOVICH, California JANE HARMAN, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska
David V. Marventano, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
(ii)
C O N T E N T S
__________
Page
Testimony of:
Thompson, Hon. Tommy, Secretary, Department of Health and
Human Services; accompanied by Jeffrey P. Koplan, Director,
Centers for Disease Control and Prevention................. 51
Material submitted for the record by:
American Bakers Association, et al, letter dated November 14,
2001, to Hon. W.J. Tauzin.................................. 101
Cady, John R., President and CEO, National Food Processors
Association, prepared statement of......................... 103
Heinrich, Janet, Director, Health Care--Public Health Issues,
United States General Accounting Office, prepared statement
of......................................................... 108
Nelson, Philip E., President, Institutte of Food
Technologists, letter dated November 15, 2001, to Hon.
Billy Tauzin............................................... 107
Thornberry, Hon. Mac, a Representative in Congress from the
State of Texas, prepared statement of...................... 102
(iii)
BIOTERRORISM AND PROPOSALS TO COMBAT BIOTERRORISM
----------
THURSDAY, NOVEMBER 15, 2001
House of Representatives,
Committee on Energy and Commerce,
Washington, DC.
The committee met, pursuant to notice, at 10 a.m., in room
2123, Rayburn House Office Building, Hon. W.J. ``Billy'' Tauzin
(chairman) presiding.
Members present: Representatives Tauzin, Bilirakis, Upton,
Stearns, Gillmor, Greenwood, Cox, Deal, Burr, Whitfield,
Ganske, Norwood, Shimkus, Wilson, Shadegg, Fossella, Davis,
Bryant, Bass, Pitts, Bono, Walden, Terry, Dingell, Waxman,
Markey, Towns, Pallone, Brown, Deutsch, Rush, Eshoo, Stupak,
Engel, Sawyer, Wynn, Green, McCarthy, Strickland, DeGette,
Barrett, Luther, Capps, Doyle, and Harman.
Staff present: Alan Slobodin, majority counsel; Joe
Greenman, majority professional staff; Amit Sachdev, majority
counsel; Anne Esposito, policy coordinator; Vikki Riley,
assistant press secretary; Will Carty, legislative clerk; Bruce
M. Gwinn, minority counsel; Edith Holleman, minority counsel;
and Courtney Johnson, minority professional staff.
Chairman Tauzin. The committee will please come to order.
Let me ask our guests to take seats and we particularly want to
welcome the Secretary of Health and Human Services to the
committee today. Mr. Secretary, our customary procedure is to
allow the chairman and the chairman of the subcommittee and
ranking members to make opening statements before such an
important hearing and our usual procedure is to allow all
members' opening statements. We would ask unanimous consent
that in doing so that the rest of the members of the committee
would agree to limit their opening statements to 1 minute. Will
that be acceptable to all members? Without objection--Mr.
Waxman?
Mr. Waxman. Mr. Chairman, many of us came here because we
had something to say in an opening statement. Are we going to
have the chairman and the ranking member take more than 1
minute?
Chairman Tauzin. My understanding is that the 3 minutes
would be allowed to the chairman, Mr. Dingell, Mr. Bilirakis,
Mr. Brown and I'm asking unanimous consent that other members
limit their opening statements to a minute.
Mr. Waxman. I'm going to object. I think members might want
to do that, but I don't think we ought to be restricted to 1
minute.
Chairman Tauzin. The objection has been heard. The Chair
recognizes himself for the appropriate time. Today, the full
committee examines the threat of bioterrorism and proposals to
combat bioterrorism. With the recent anthrax attacks, the
spectrum of bioterrorism becomes a troubling reality which we
need to address vigorously and obviously quickly.
Prevention, preparedness and response to bioterrorism is a
priority, I believe, that Congress must critically evaluate and
this committee will take this task on this morning. Much of our
attention will focus on the Centers for Disease Control and
Prevention and the preeminent agency in the Federal
Government's public health infrastructure which provides so
much of our national leadership and illness detection, response
and indeed prevention, including what occurs as a result of
deliberate release of biological agents. We recently witnessed
its capabilities at work in detecting and reacting to the
anthrax outbreaks and I believe I speak for the vast majority
of Americans when I say that I am proud and comforted that we
created the CDC. Lives have been saved in New York and Trenton
and Florida and here in our Nation's capital because we have
invested in its capabilities.
Now our ability to improve the response to present and
future health threats depends upon our ability to look at the
recent events and determine which parts of our public health
apparatus have worked and which parts need to be enforced. In
recent weeks, members of the committee led by Vice Chairman
Burr, the chairman of the Subcommittee on Oversight and
Investigations, Mr. Greenwood, and the gentlelady from
Colorado, Ms. DeGette, have visited the CDC. Some found its
facilities woefully inadequate to do its work. And over the
past 3 years, the committee has reviewed certain aspects of the
CDC and found serious gaps in the law, in the resources and the
programs and the strategy relating to the CDC. With this
background, we're working to upgrade and to equip the Agency
much more properly and to make sure that it can assist our
country in the time of need.
We're seeking to address critical aspects for our public
health infrastructure. In light of this, I'm pleased today to
welcome two witnesses who have spent countless hours in recent
months helping to safeguard the public from these acts of
bioterrorism. The Honorable Tommy Thompson, Secretary of the
Department of Health and Human Services will discuss the
coordinated response to acts of bioterrorism. His insights into
what is needed to ensure that our Nation has taken every
practical step to protect its citizens from bioterror will be
extraordinarily valuable today.
As an aside, Mr. Secretary, I want to salute you for your
foresight and leadership on these matters. You hired a
bioterrorism advisor early in your tenure. You created a
bioterrorism committee and a commission before the anthrax
attacks and you've been ramping up production of the smallpox
vaccine very rapidly and for all those things, our Nation is
grateful.
We're also honored to have before us Dr. Jeffrey Koplan,
the Director of CDC. Dr. Koplan participated in one of the
greatest achievements in public health history, the eradication
of smallpox. Now you're leading one of the largest public
health investigations of all time and I'm eager to hear your
thoughts on how the CDC should be strengthened to meet the 21st
century health threats.
At present, the committee is working on draft legislation
in close coordination with the administration and through a
bipartisan process to improve our Nation's preparedness for
bioterrorism and other public health emergencies which include
disease outbreaks and health problems stemming from chemical
and radiological emergencies.
The key to doing this effectively is to use existing
programs and increase their coordination and communication so
we can get more money out of the States, to those States and
local governments as quickly as possible. We want to build on
the President's leadership in the efforts we've already seen.
We'll continue to urge our Senate colleagues to pass a bill
that this committee and the House passed overwhelmingly several
weeks ago which would tighten safety and security controls on
those deadly potential biological agents and impose stiff
penalties to those who would break those rules. I'm confident
this committee will produce a smart, strong, comprehensive
package, one that increases security of deadly agents at its
research facilities, strengthens our surveillance of the
Nation's abundant food supply, enhances drug safety and
reinforces the protection of our drinking waters. These will be
sensible measures to address threats we simply cannot ignore.
I want to thank the witnesses for taking time out of the
busy schedule to be with us and I look forward hearing your
testimony and discussing these very vital issues.
[The prepared statement of Hon. W.J. ``Billy'' Tauzin
follows:]
Prepared Statement of Hon. W.J. ``Billy'' Tauzin, Chairman, Committee
on Energy and Commerce
Today, the Full Committee examines the threat of bioterrorism and
proposals to combat bioterrorism.
With the recent anthrax attacks, the specter of bioterrorism became
a troubling reality, which we need to address vigorously. Prevention,
preparedness, and response to bioterrorism is a priority, I believe,
that Congress must critically evaluate. This Committee will take on
this task this morning.
Much of our attention will focus on The Centers for Disease Control
and Prevention (CDC). This preeminent agency in the federal
government's public health infrastructure provides national leadership
in illness detection, response and prevention, including what occurs as
a result of a deliberate release of biological agents. We recently
witnessed its capabilities at work--detecting and reacting to the
anthrax outbreaks. And I believe I speak for the vast majority of
Americans when I say that I am proud and comforted that we created the
CDC. Lives have been saved in New York, Trenton, Florida, and here in
our nation's capital because we have invested in its capabilities.
Now, our ability to improve the response to present and future
health threats depends upon our ability to look at recent events and
determine which parts of our public health apparatus have worked and
which parts need to be reinforced.
In recent weeks, Members of this Committee--led by the Vice
Chairman, Mr. Burr, the Chairman of the Subcommittee on Oversight and
Investigations, Mr. Greenwood, and the gentlelady from Colorado, Mrs.
DeGette--have visited the CDC. Some found its facilities woefully
inadequate to do its work. Over the past three years, this Committee
has also reviewed certain aspects of CDC and found serious gaps in law,
resources, programs, and strategy relating to the CDC.
With this background, we are working to upgrade and to equip the
agency properly to make sure it can assist our country in this time of
need. We are also seeking to address other critical aspects of our
public health infrastructure.
In light of this, I am pleased today to welcome two witnesses who
have spent countless hours in recent months helping to safeguard the
public from acts of bioterrorism. The Honorable Tommy Thompson,
Secretary of Department of the Health and Human Services, will discuss
the coordinated response to acts of bioterrorism. His insights into
what is needed to ensure that our nation has taken every practical step
to protect its citizens from bioterror will be extraordinarily
valuable.
As an aside, Mr. Secretary, I must salute you for your foresight
and leadership on these matters: you hired a bioterrorism advisor early
in your tenure, you created a bioterrorism commission before the
anthrax attack, and you've been ramping up production of the smallpox
vaccine.
We are also honored to have before us Dr. Jeffrey Koplan, the
Director of the CDC. Dr. Koplan participated in one of the greatest
achievements in public health history--the eradication of smallpox. Now
you are leading one of the largest public health investigations of all
time. I am eager to hear your thoughts on how the CDC should be
strengthened to meet 21st century health threats.
At present, the Committee is working on draft legislation--in close
coordination with the Administration and through a bipartisan process--
to improve our nation's preparedness for bioterrorism and other public
health emergencies, which include disease outbreaks and health problems
stemming from chemical and radiologic emergencies. The key to doing
this effectively is to use existing programs and increase their
coordination and communication, so that we can get more money out to
the States and local governments as quickly as possible. We want to
build on the President's leadership and the efforts we have already
seen.
And we will continue to urge our Senate colleagues to pass a bill
that this Committee and the House passed overwhelmingly several weeks
ago, which would tighten safety and security controls on the most
deadly potential biological agents and impose stiff criminal penalties
for those who break these new rules.
I'm confident this Committee will produce a smart, strong, and
comprehensive legislative package--one that increases the security of
deadly agents at our research facilities, strengthens our surveillance
of the nation's abundant food supply, enhances drug safety, and
reinforces protection of our drinking water. These will be sensible
measures to address threats we simply cannot ignore.
I thank our witnesses for taking time out of their very busy
schedules to be here, and I look forward to hearing your testimony and
discussing these vital issues.
Chairman Tauzin. Mr. Dingell is not here. The Chair will
recognize Mr. Brown for an opening statement.
Mr. Brown. I thank the chairman for scheduling this hearing
and especially thank my friends, Dr. Koplan and Secretary
Thompson for joining us.
I want to raise, briefly raise in the 3 minutes, a handful
of issues. First of all, I appreciate the efforts on the CDC on
antibiotic resistance, the links between antibiotic resistance
and bioterrorism are clear. We must isolate emerging antibiotic
resistance pathogens, track antibiotic overuse and misuse and
monitor the effectiveness of existing treatments over time. I
hope that the Secretary and that the CDC will work with us to
address the critical issue of antibiotic resistance before our
antibiotic stockpile is irreversibly compromised partly because
of the events of September 11 and the aftermath, partly because
of other problems we were obviously facing on that.
Second, I'm pleased the administration has requested
additional authority to safeguard our food supply as
conversations we've had in the past, Secretary Thompson. To
address the safety of food crossing our border, Congressman
Dingell and I introduced the Imported Foods Safety Act last
month to provide the FDA with a host of new authorities and
resources to inspect and detail food entering the United
States. As you know, budget constraints have reduced the
inspection--reduced ourselves to the level of inspecting only 1
percent of food crossing the border and because FDA lacks the
ability to conduct real time tests for microbial pathogens and
pesticides, very few shipments are actually tested.
Enactment of the Dingell-Brown bill would increase overall
resources, provide more inspectors and bring forward adoption
of technology to conduct ultra-rapid tests for contamination
unseen by the human eye.
Moving to the issue of public health preparedness, I have
serious concerns about the administration's funding proposal. I
have enormous respect for the CDC and the work they do for our
State and our local health departments. We're fortunate that
Dr. Koplan is at the helm. CDC was strained before September 11
and as a result since then they've had to shift personnel,
personnel they really are not able to shift in many ways in
terms of the work they need to do, key functions to respond to
anthrax. Before September 11, the administration proposed
decreasing CDC's funding from the previous year. Having
personally seen, as the chairman mentioned, and I know Mr.
Bilirakis has seen also the crumbling CDC facilities, knowing
the critical responsibility that that very, very important
agency fulfills, several of us on this committee have expressed
serious concerns about the administration's commitment to this
agency. I hope the events of September 11 have taught us how
important that agency is.
The most important step we can take in bioterrorism
preparedness is to stop neglecting CDC as our Government has
done too often, and stop neglecting State and local public
health departments that are the agency's partners in protecting
the Nation's health.
The last issue, Mr. Chairman, I'd like to raise is the
Cipro patent. You acknowledged that you had the right to
temporarily break Bayer's patent under imminent domain
authority, but argued the Government would face hefty costs if,
in fact, required to pay whatever price the patent holder
wanted to charge for a drug. I wanted to bring to your
attention legislation I've introduced that would address the
compensation issue and most importantly would preclude endless
court battles and not necessarily Government spending. My bill
would give you as the Secretary, compulsory licensing authority
in the event of a public health emergency which means you could
issue compulsory licenses to secure generic versions of a brand
name drug, as long as you followed the regulatory and the
statutory procedures established to ensure fair compensation
for the brand name drug company. There are already compulsory
licensing laws in place for the cable industry, for the air
pollution industry, for atomic energy and other products and
services. Unencumbered access to drugs is an essential element
in our response to bioterrorism. Establishing the statutory and
regulatory framework now to secure generic drugs on an
expedited and affordable basis, simply makes sense.
I'd like to work with you, Mr. Secretary, to ensure that
the tool of compulsory licensing is available to you which will
keep us away from the difficulties of another Cipro kind of
situation.
Mr. Chairman, I appreciate your holding this hearing. I
particularly appreciate Secretary Thompson and Dr. Koplan for
joining us. Thank you.
[The prepared statement of Hon. Sherrod Brown follows:]
Prepared Statement of Hon. Sherrod Brown, a Representative in Congress
from the State of Ohio
Mr. Chairman, Thank you for scheduling this hearing on bioterrorism
preparedness. Secretary Thompson, Dr. Koplan, welcome. It is always a
pleasure to have each of you here to testify before the Committee.
Mr. Secretary, in response to the emergent threat of bioterrorism,
your Department needs greater resources and authority to adequately
protect the public health.
During your prior visits here, we have agreed on the need for
improvements in several areas within your jurisdiction. I look forward
to continuing discussions with you and the Majority on this committee
to achieve consensus on these issues.
To fully prepare for potential bioterrorist attacks, we will have
to deal with a wide variety of public health issues, including
vaccinations, food safety, and government stockpiling of vaccines and
antibiotics.
In doing so--we must not forget the issue of antibiotic resistance.
The links between antibiotic resistance and bioterrorism are clear.
According to the Journal of the American Medical Association
(JAMA)--during the Cold War--Russian scientists engineered an anthrax
strain that was resistant to the tetracycline and penicillin.
We can only assume that anthrax, and other bacterial agents, could
also be engineered to resist antibiotics--including drugs like Cipro.
During the last couple of months, thousands of Americans have been
prescribed the antibiotic Cipro because of a legitimate risk of
exposure to Anthrax. Physicians tell us this use of antibiotics is
appropriate.
But thousands of other Americans have sought prescriptions for
Cipro without any indication of need or even a risk of infection.
If the U.S. and the rest of the world begins using drugs like Cipro
haphazardly, these drugs will eventually lose their effectiveness.
And when facing lethal diseases like Anthrax, it is important to
find an effective therapy quickly. Any delay can result in the death of
a patient--or in the case of a larger exposure--in the deaths of
thousands of individuals.
To adequately prepare for a bioterrorist attack, state and local
health departments must be equipped to rapidly identify and respond to
antibiotic-resistant strains of anthrax and other lethal agents.
We must isolate emerging antibiotic resistance pathogens, track
antibiotic overuse and misuse, and monitor the effectiveness of
existing treatments over time.
I hope you will work with me to address the critical issue of
antibiotic resistance before our antibiotic stockpile is irreversibly
compromised.
I'm pleased the Administration has requested additional authority
to safeguard our food supply.
The recent attacks on the United States have aroused concern that
food could be used as a weapon of bioterrorism.
Yet, the authorities and tools used to prevent, identify, and
intercept tainted shipments at our borders are not up to the job.
To address the safety of the food crossing our border, Congressman
Dingell and I introduced the ``Imported Food Safety Act'' last month to
provide the Food and Drug Administration with a host of new authorities
and resources to inspect and detain food entering the United States.
Budget constraints allow FDA to inspect less than 1% of all
imported food shipments.
And because FDA lacks the ability to conduct real time tests for
microbial pathogens and pesticides--very few shipments are tested for
these adulterants.
Enactment of the Dingell/Brown bill would increase overall
resources, provide more inspectors, and require adoption of technology
to conduct ultra rapid tests for contamination unseen by the human eye.
Moving to the issue of public health preparedness, I have serious
concerns about the Administration's funding proposal.
I have enormous respect for CDC and the work they do for our state
and local public health departments.
We are fortunate to have Dr. Koplan at the helm of CDC as we face
this unprecedented situation. CDC was strained before Sept. 11--the
agency doesn't have surplus staff waiting in the wings in the event of
a bioterrorist attack--and as a result they've had to shift personnel
from other key functions to respond to the anthrax attacks.
If I have any concerns, it is that CDC has not had more say in the
nation's response to this and future bioterrorist threats. I've had
credible sources tell me that CDC was not the first, or even the second
agency called in when anthrax was first detected. That worries me.
Before September 11, the Administration proposed decreasing CDC's
funding from the previous year. Having seen the crumbling CDC
facilities and knowing the critical responsibilities CDC fulfills,
several of us on this committee expressed serious concerns about the
Administration's commitment to this agency and its public health
mission.
Now, when the demands on CDC and its partners, the state and local
public health departments, have never been greater, the Administration
is not willing to provide enough resources to respond to a public
health crisis in even one state, much less 50.
Frankly, I don't understand it.
People and infrastructure are paramount to bioterrorism
preparedness. You can stockpile antibiotics and vaccines, but without
people on the ground to quickly identify and respond to threats, you
aren't prepared. That's what CDC, in conjunction with state and local
health departments, does.
CDC is the only agency that has infrastructure in all 50 states.
They have a relationship with state health departments and they train
these public health workers so they are prepared to respond at a
moments notice.
The most important step we can take in bioterrorism preparedness is
to stop neglecting CDC and the state and local public health
departments that are the agencies partners in protecting the nation's
health.
Mr. Secretary, In the dispute over the Cipro patent, you
acknowledged that you had the right to temporarily break Bayer's patent
under ``eminent domain'' authority, but argued that the government
could face hefty costs if required to pay whatever price the patent
owner wanted to charge for a drug. I wanted to bring to your attention
legislation I have since introduced that would address the compensation
issue, precluding endless court battles and unnecessary government
spending.
My bill would give you compulsory licensing authority in the event
of a public health emergency, which means you could issue compulsory
licenses to secure generic versions of a brand-name drug, as long as
you follow statutory and regulatory procedures established to ensure
fair compensation for the brand-name drug company.
There are already compulsory licensing laws in place for the cable
industry, air pollution prevention devices, atomic energy, and other
products and services.
The spread of anthrax has already taken a significant toll on the
nation's sense of security. Unencumbered access to drugs is an
essential element in our response to bioterrorism. Establishing the
statutory and regulatory framework now to secure generic drugs on an
expedited and affordable basis simply makes sense.
Taking that step now will help ensure that the priority of doing
what's best for the public is not subsumed by cost concerns, red tape,
or legal haggling.
I'd like to work with you to ensure you have this tool compulsory
licensing tool available to you before another ``Cipro situation''
arises.
Again, I appreciate your willingness to join us this morning, and
look forward to your testimony.
Chairman Tauzin. I thank the gentleman and I thank the
gentleman for his, and Mr. Dingell's, and the rest of the
members' extraordinary work with us as we attempt to fashion a
bipartisan package. The Chair is pleased to now welcome and
recognize for an opening statement, the chairman of the
committee's Health Subcommittee, the gentleman from Florida,
Mr. Bilirakis.
Mr. Bilirakis. Thank you, Mr. Chairman. I have a more
lengthy statement that I would submit for the record and in the
interest of time----
Chairman Tauzin. Let me make the unanimous consent that all
members have the ability to introduce their written statements
as part of the official record and without objection, it is so
ordered.
Mr. Bilirakis. I would also like to thank you, Mr.
Chairman, for holding this very important hearing. Bioterrorism
is an issue that our subcommittee has been examining for
several years now, but never as know, has the issue been as
timely as it is now. The world has changed dramatically and
it's imperative that we respond and prepare appropriately and
that's why we're all pleased that the Secretary and the
Director are here, along with Dr. Henderson. Mr. Chairman, you
said it, this has been a bipartisan effort from the beginning.
The staffs have been working in a bipartisan manner and I'm not
really sure how we're going to come out in the final analysis,
but the fact of the matter is we have not tried to steamroll a
piece of legislation through this committee. Thank you very
much, Mr. Chairman.
[The prepared statement of Hon. Michael Bilirakis follows:]
Prepared Statement of Hon. Michael Bilirakis, a Representative in
Congress from the State of California
Mr. Chairman, thank you, for holding this important hearing today
on the threat of bioterrorism. Bioterrorism is an issue the Health
Subcommittee has been examining for several years now, but never has
the issue been as timely as it is now. The world has changed
dramatically since September 11th and it is imperative that we respond
and prepare appropriately. That is why I am so pleased that Secretary
Thompson and CDC Director Koplan have taken the time to testify before
the Committee on these important issues.
On September 11th, America was brought into a war against
terrorism. I share the concerns of many Americans who are worried about
bioterrorism, including anthrax exposure and outbreaks of smallpox.
Bioterrorist threats have become real, and we must ensure that this
nation is ready to respond quickly and successfully in the event of
future bioterrorist attacks.
The Department of Health and Human Services, under Secretary
Thompson, is our national coordinator of public health surveillance and
protection while the Centers for Disease Control and Prevention (CDC)
are directly responsible for the nation's public health. Fortunately,
the CDC has been researching and planning responses to bioterrorism.
The CDC has established a Bioterrorism Program to ensure the rapid
development of federal, state and local capacity to address potential
bioterrorism threats. Security, communication, and infrastructure are
all important components of the CDC that need to be evaluated. I
believe it is important to ensure that the CDC is prepared for all
possible future public health emergencies.
Response to a bioterrorist attack will require rapid deployment of
public health resources. Public health threats come in many forms. We
can not know when or how a public health threat could occur and we must
be prepared to combat biological agents in every form. A vital part of
protecting the American population is guaranteeing a safe food and
water supply and water supply.
Today we will hear from the Secretary Thompson and Dr. Koplan
regarding the roles of CDC and other government agencies in combating
bioterrorism. These agencies, working closely with Congress, must make
certain that our public health infrastructure can detect disease
outbreaks and other possible threats. We must realize that this is a
long-term investment in our nation's public health that will require a
long term commitment by Congress and the federal government. The Health
Subcommittee will continue to look into bioterrorism and our national
response in the next year and the coming sessions as we make this firm
commitment to our public's health.
This is a time for the nation to unite. I personally thank and
honor those who are on the front lines fighting this war, domestic and
abroad. Again, thank you Mr. Chairman for holding this important
hearing and thanks again to Secretary Thompson and Director Koplan for
sharing their insights with us today.
Chairman Tauzin. I thank the gentleman. Further requests
for opening statements? When Mr. Dingell arrives, he's
entitled, obviously, to preference. The Chair will recognize
the gentleman, Mr. Waxman. Under our rules, members may give a
3-minute opening statement at this point.
Mr. Waxman.
Mr. Waxman. Thank you very much, Mr. Chairman. While we're
all very concerned of bioterrorism, this is not the first time
that our public health has seen a crisis. We saw the
Legionnaire's Disease, Toxic Shock Syndrome and most obviously,
we face the AIDS epidemic. It is not the first time as well
that experts have come to us and said that our public health
system is in disrepair. We've had warnings and reports from the
National Academy of Sciences, the Institute of Medicine for a
decade now. We should have been able to learn the lesson from
the previous disasters that we cannot short change our health
care system. The most obvious lesson was in the 1980's, we were
suddenly faced with the AIDS epidemic, so we require the
Centers for Disease Control to take people away from the work
they were doing to work on AIDS and now that we have to respond
to an anthrax threat, we're taking people away from working on
AIDS and other public health measures, to work on anthrax.
Now when we look at energy issues in this committee, we
plan for surge capacity so that power systems can deal with
unexpectedly high demands. We should learn some lessons to
apply for the CDC and the public health. We can't budget for
some sort of theoretical normalcy, that's not how the public
health works. It's not a predictable assembly line. We should
build in surge capacity for bioterrorism, epidemics and new
problems.
I would emphasize that we need to focus our spending on
systems and people, not just things. It's important to
stockpile vaccines and drugs, but that's not enough. We need
on-going epidemiology and disease surveillance. We need
communication systems that work. We need better labs and more
lab workers. We need people who can train and work with health
professionals during a crisis.
I'm concerned that the budget that we got from this
administration is insufficient to meet these needs. It relies
on moving CDC and public health professionals from job to job,
the same musical chairs that we saw with CDC when they had to
cope with AIDS 20 years ago. It also provides a drop in the
bucket for spending on public health systems and people and
spends largely on things. It is as if the administration were
building lots of fire stations and buying some fire trucks, but
not hiring fire fighters or installing alarm systems.
Now let me add, this is not an issue of being unable to
afford all the things we need to do to protect the public
health. What we have is a conscious decision that we ought to
use our money for tax cuts, especially for the wealthy,
especially for corporations, rather than have money available
to do the kinds of things that will protect all of the American
people when we have a public health emergency. It's the
clearest example of penny wise and pound foolish that I can
imagine. We can do better. We should learn from our previous
health problems and we shouldn't short change these efforts.
[The prepared statement of Hon. Henry A. Waxman follows:]
Prepared Statement of Hon. Henry A. Waxman, a Representative in
Congress from the State of California
While the threat of bioterrorism cannot be overstated, this is not
our first public health crisis. We have had Legionnaire's Disease and
Toxic Shock Syndrome and earthquakes and hurricanes. Most obviously, we
have had--and still have--the AIDS epidemic.
It is also not the first time that experts have told us that our
public health system is in disrepair. We have had warnings and reports
from the National Academy of Sciences and the Institute of Medicine for
a decade now.
We should be able to learn lessons from these disasters to help us
respond now.
The most obvious lesson is that we cannot shortchange the Centers
for Disease Control and public health agencies. During the Eighties,
CDC was so short of staff that it had to pull its professionals off of
their ongoing work to devote themselves to the emerging AIDS epidemic.
Just last month, CDC again had to pull its staff off of their other
work (this time including AIDS) so that they could respond to anthrax
and other threats.
When it works on energy issues, this Committee has learned that we
have to plan for ``surge capacity'' so that power systems can deal with
unexpectedly high demands. We should learn the same lesson for CDC and
public health. We cannot budget these programs for some sort of
theoretical ``normalcy.'' That's not how public health works; it's not
a predictable assembly line. We should build in ``surge capacity'' for
bioterrorism, epidemics, and new problems. Only with new FTE's and
contingency funds can we be prepared.
I would emphasize that we need to focus our spending on systems and
people, not just things. It's important to stockpile vaccines and
drugs, but it's not enough. We need ongoing epidemiology and disease
surveillance. We need communications systems that work. We need better
labs and more lab workers. We need people who can train and work with
health professionals during a crisis.
I'm concerned that the budget from the Administration is
insufficient to meet these needs. It relies on moving CDC and public
health professionals from job to job--the same musical chairs that CDC
had to cope with twenty years ago. It provides a drop in the bucket for
spending on public health systems and people and spends largely on
things. It is as if the Administration were building lots of fire
stations and buying some fire trucks, but not hiring fire fighters or
installing alarm systems.
And it is not a question of what we can afford to do for public
health. The Administration has consciously decided to spend its money
on tax cuts--tax cuts that benefit the wealthiest and corporations--and
not to spend the funding on public health preparedness.
This is the clearest example of penny-wise and pound-foolish that I
can imagine. We can do better. We should learn from our previous public
health problems. Now we know what to do, and we should not shortchange
the efforts.
Chairman Tauzin. The gentleman's time has expired. The
Chair asks are there requests for additional opening
statements? The gentleman from Michigan, Mr. Upton, is
recognized for an opening statement.
Mr. Upton. Thank you Mr. Chairman. The anthrax attacks have
brought home to each of us how important it is that we do all
that we can to be prepared to respond quickly and effectively
to bioterrorism. What was perhaps an abstract concern has now
become very, very real. I wanted to share some good news from
Michigan that I received this morning. We were granted a
weapons of mass destruction civil support team by the
Department of Defense. We're battling two fronts as we all
know, one a world away in Afghanistan and the other one at
home. It's a huge task to adequately protect our people,
infrastructure, and we're grateful for that help.
The anthrax attacks have thrown the spotlight not only upon
the vital role of the CDC, but also on the enormous challenges
that the FDA must take on and meet in combatting bioterrorism.
It has to be prepared to expedite the development, approval and
production of bioterrorism vaccines, drug therapies and
diagnostic tests to give us the weapons that we need to fight
new strains of anthrax, smallpox, ebola and anything else.
We must also step up to the plate with regard to
inspections of imports, whether of drugs and devices or
imported foods. By rights, the Commissioner of the FDA ought to
be at that table as well, but sadly, the FDA has gone into
battle without a general at its head and I'm deeply concerned
and I would urge the administration to quickly make that a top
priority to help us.
I yield back.
[The prepared statement of Hon. Fred Upton follows:]
Prepared Statement of Hon. Fred Upton, a Representative in Congress
from the State of Michigan
Mr. Chairman, thank you for convening today's hearing to continue
our committee's examination of bioterrorism and proposals to combat it.
I am pleased that Secretary Thompson and Dr. Koplan, the Director of
the CDC are here to give us an overview of their activities. The
anthrax attacks have brought home to each of us how important it is
that we do all that we can to be prepared to respond quickly and
effectively to bioterrorism. What was perhaps an abstract concern has
become very, very real.
First, I just want to share some very good news for Michigan that I
received this morning. We are being granted a Weapons of Mass
Destruction Civil Support Team by the U.S. Department of Defense. We're
battling on two fronts right now--one a world away in Afghanistan, the
other right here at home. It's a huge task to adequately protect our
people and infrastructure, and we are grateful for this help.
The anthrax attacks have thrown the spotlight not only upon the
vital role of the CDC, but also on the enormous challenges that the FDA
must take on and meet in combating bioterrorism. It must be prepared to
expedite the development, approval and production of bioterrorism
vaccines, drug therapies, and diagnostic tests to give us the weapons
we may need to fight new strains of anthrax, smallpox, Ebola, and other
agents of infection. The FDA must review and give approval to every
drug, therapeutic, vaccine and anti-toxin that is to be administered to
our population. It must work proactively with the NIH, the CDC, and the
pharmaceutical and medical device community from the outset. It must
significantly step up its inspections of imports, whether of drugs and
devices or of imported foods, plugging the gaps and holes in our
dangerously porous borders that could so easily be exploited by
terrorists.
By rights, the Commissioner of the FDA should be flanking Secretary
Thompson today, too. But we don't have a Commissioner. The FDA is going
into battle without a general at its head, and I am deeply concerned
about that. I want to stress in the strongest possible terms to
Secretary Thompson and the Administration the need to act swiftly to
nominate a new Commissioner who is well-prepared to lead the FDA into
battle.
In the short time I have this morning, I would also like to
highlight the vital role that telehealth networks can play. As chairman
of the Telecommunications and the Internet, I have seen firsthand the
potential of telehealth systems. We need to coordinate existing
networks and link them with the CDC, the NIH, the FDA and other
agencies joined in our war against bioterrorism. Such coordinated
networks could be used for timely disease surveillance and reporting,
for the rapid diagnosis of symptoms that could signal a bioterrorist
attack, for training health care professionals and first responders
even in the very rural areas of our country in the diagnosis and
treatment of anthrax, smallpox, and other deadly diseases, and for
linking the victims of attacks and those caring for them with the
sophisticated information and treatment available at major medical
centers.
That is why I was very disturbed to learn, Secretary Thompson, that
the Department of Health and Human Services has plans to eliminate the
Office for the Advancement of Telehealth and transfer its functions to
the HIV/AIDS Bureau. The Office is currently the focal point for
telehealth activities across federal agencies. It was instrumental in
the formation of the Joint Working Group on Telemedicine, for which it
provides both leadership and staffing. Rather than eliminating the
Office, which should consider charging it with taking the lead in
coordinating the telehealth networks currently in place and helping
them become effective partners on the frontlines across America in our
war on bioterrorism. Secretary Thompson, I hope you will give me a
commitment today to strengthen the role of this Office and deep six the
proposal to eliminate it.
Secretary Thompson, I look forward today to exploring these issues
further with you.
Chairman Tauzin. I thank the gentleman. Are there further
requests for opening statements? The gentleman from
Massachusetts, Mr. Markey, is recognized.
Mr. Markey. Thank you, Mr. Chairman, very much and we thank
our guests for coming here today. My concern in my very brief
opening statement is on the question of what happens if the
terrorists make a successful attack at a nuclear power facility
in the United States. Obviously, there would be a very large
release of radioactive iodine into the atmosphere. There would
be a population which would be at greatest risk that live
within the first 5 to 10 miles, but of course, it could go out
further, but especially within those near in closer areas. And
depending upon which way the wind was blowing, the radioactive
plume would carry that radioactivity toward tens of thousands
of Americans.
Now thus far the Nuclear Regulatory Commission has refused
to order the stockpiling of potassium iodide within the
communities that would be most likely affected across the
United States. It seems to me that this is a decision that
should not be made by Nuclear Regulatory Commission. It should
be made instead by the health officials which are going to have
responsibility for dealing with the consequences of a potential
health disaster. And it seems to me that since it only costs
between 3 to 5 cents to have a potassium iodide pill available,
at least in the schools that are within the vicinity of a
nuclear power plant, which is how they do it in other
countries, that it's a relatively inexpensive way of
stockpiling the needed antidote to the very great danger that
would be created and thus far the Nuclear Regulatory Commission
has refused to do it.
Now I believe that the Nuclear Regulatory Commission has
been negligent in refusing to mandate that precaution. It can
be stockpiled again, in schools. Children are the most
vulnerable population. Adults are not as much and in the course
of my questioning, Mr. Chairman, I am going to ask that our
experts, our health care experts here enlist in the effort to
put that kind of precaution in place. I thank you for holding
the hearing.
[The prepared statement of Hon. Edward J. Markey follows:]
Prepared Statement of Hon. Edward J. Markey, a Representative in
Congress from the State of Massachusetts
Mr. Chairman, good morning and thank you for holding this important
and timely hearing on bioterrorism. I join you and my colleagues in
welcoming Secretary Thompson and Director Koplan and I thank them for
being here today.
In 1998 Ashton Carter, John Deutch and Philip Zelikow spoke of the
impending threat of terrorists using weapons of mass destruction in a
Foreign Affairs magazine article called ``Catastrophic Terrorism''. The
article opens with the following prescient and chilling description:
``If the device that exploded in 1993 under the World Trade
Center had been nuclear, or had effectively dispersed a deadly
pathogen, the resulting horror and chaos would have exceeded
our ability to describe it. Such an act of catastrophic
terrorism would be a watershed event in American history. It
could involve loss of life and property unprecedented in
peacetime and undermine America's fundamental sense of
security, as did the Soviet atomic bomb test in 1949. Like
Pearl Harbor, this event would divide our past and future into
a before and after. The United States might respond with
draconian measures, scaling back civil liberties, allowing
wider surveillance of citizens, detention of suspects, and use
of deadly force. More violence could follow, either further
terrorist attacks or U.S. counterattacks. Belatedly, Americans
would judge their leaders negligent for not addressing
terrorism more urgently.''
September 11th and the subsequent Anthrax crisis have served as the
sonic boom of wake up calls that no one can ignore. Much as our nation
is using its military superiority to wage a war against Osama Bin Laden
in Afghanistan, we must rely upon our healthcare superiority to wage a
public health war against bioterrorism.
This war must include protecting dangerous bioagents from falling
into enemy hands. In 1996 I introduced the ``Biological Weapons Control
Act of 1996'' with former Representative John Kasich, and Senator
Hatch. The bill imposed requirements for the transfer of select agents
and was later signed into law as part of the Anti-terrorism and
Effective Death Penalty Act of 1996. If we had not passed this law, we
would be largely in the dark with respect to who possesses which
bioagents in this country. Last month the House took one more step in
the battle against bioterrorism by voting to expand the 1996 law to
require that all select agents be registered.
While there is no doubt that the United States has the resources
and capability to wage this war, in its current form, the public health
system is ill-prepared.
It is my hope that the Administration will agree to significantly
increase emergency funding to the CDC so that a strong force can be
deployed to combat bioterrorism . We will need the well prepared health
care ground troops pre-positioned by improving hospital ``surge''
capacity in the event of a bioterrorist attack or epidemic. We must
create the best command control center. This means providing the
resources necessary to upgrade States' preparedness, improve public
health laboratories and heighten disease surveillance and response and
communication between state, local and federal officials. And finally,
we need to provide the most sophisticated defensive weapons by
expanding our current stockpiles and encouraging the development of new
treatments.
And while the focus on stockpiling lately has been largely on
Cipro, and smallpox vaccines we cannot be negligent in addressing other
obvious and necessary protective measures.
For example, we are guilty of gross negligence for failure to
stockpile potassium iodide--the Cipro of Nuclear Exposure in localities
surrounding nuclear power plants. Potassium iodide is a cheap and
effective protection against the cancer-causing effects of radioactive
iodine on the thyroid gland. In the event of a terrorist attack on a
nuclear power plant, cancer-causing radioactive iodine could be
released into the surrounding area. In an urban setting it may take
hours to escape the area. During Hurricane Floyd, it took some drivers
8 hours to go 35 miles. Yet the radioactive plume can travel much
faster if the weather conditions permit.
In light of over 20 years of government inaction, I have introduced
a bill to require the stockpiling of Potassium Iodide within the
vicinity of all nuclear plants, HR 3279. Additionally, I thank you, Mr.
Chairman for agreeing to work with me to address my concerns in the
Commerce Bioterrorism Bill.
In closing, we've heard the clarion call to arms--we can't waste
time we must address our ailing public health system. We must act
responsibly lest we be judged negligent.
Chairman Tauzin. I thank my friend. The Chair again reminds
all members that their written statements are part of the
record and would now ask if there are further requests for
time. The gentleman from Florida, Mr. Stearns, is recognized
for 3 minutes.
Mr. Stearns. Mr. Chairman, thank you again for holding this
hearing. I thank as a member on the Oversight Subcommittee,
Chairman Greenwood, who ably conducted hearings on October 10
and November 1, in this area and I'm pleased we'll hear from
one of the architects, chief architect of the Federal effort of
striking back at bioterrorism, of course, which is Honorable
Secretary Thompson.
One of the questions I think all of us are concerned about
is should the public health system and the public safety and
intelligence community share a uniform approach to planning
against bioterrorism? Is that being done? If not, why? As we
know, all us Members of Congress, how bureaucracies work.
Sometimes there's no communication between them. I think that's
perhaps a key that Honorable Thompson will address, and should
CDC place greater emphasis on developing the front end of the
public health system to ensure the creation of a robust ability
to both detect and assess suspected bioterrorism incidents. And
last, how can the CDC best coordinate with State and local
health departments in an effort to assure that they have
completed adequate bioterrorism preparedness plants.
So Mr. Chairman, I commend you for opening these hearings.
This is a sobering high alert time and I think it's very
important to get the Secretary's insights and the witnesses',
and I yield back the balance of my time.
Chairman Tauzin. I thank my friend. I would like to
announce also for the benefit of our audience that Chairman
Greenwood had scheduled a bioterrorism hearing on September 11,
ironically, and we had to postpone it and held that hearing
just last week instead, but again, I do commend the chairman
for his comments and his good work.
Are there further requests for opening statements? The
gentleman from New York, Mr. Towns, is recognized for 3
minutes.
Mr. Towns. Thank you very much, Mr. Chairman. The events of
September 11 and the recent anthrax attacks have brought home
just how real the threat of bioterrorism can be. While we all
feel the need to take action, I would caution my colleagues to
remember that old adage, act in haste, repeat at your leisure.
For example, we're all concerned about the availability of
vaccines for smallpox, but should we risk the public health by
taking shortcuts in vaccine production which could create
serious side effects for hundreds of thousands of Americans and
ultimately not protect against the disease?
We have a public health system in this country which varies
greatly in terms of its sophistication and its ability to
access the most up to date information about bioterrorist
threat. Currently, only 13 States are connected to all of their
local health jurisdictions. How do we ensure that the other 37
States have the same communication links? How do we ensure that
our rural communities are as prepared as our urban areas to
deal with the bioterrorism threat? On that note, Mr. Chairman,
I yield back.
[The prepared statement of Hon. Edolphus Towns follows:]
Prepared Statement of Hon. Ed Towns, a Representative in Congress from
the State of New York
Mr. Chairman, I am pleased that this committee will indeed have an
opportunity to review the important issue of bioterrorism before we
adjourn this session.
The events of September 11th and the recent anthrax attacks against
the media and members of this body have brought home just how real the
threat of bioterrorism can be. While we all feel the need to take
action, Mr. Chairman, I would caution my colleagues to remember that
old adage: ``Act in haste repent at your leisure''.
For example, we are all concerned about the availability of
vaccines for smallpox. But should we risk the public health by taking
shortcuts in vaccine production which could create serious side effects
for hundreds of thousands for Americans and ultimately not protect
against the disease?
Within the approaching holiday season, we have concerns about the
security of our food supply. But are country-of-origin labeling
requirements practical and, more importantly, will they make our food
any safer?
And finally, Mr. Chairman, we have a public health system in this
country which varies greatly in terms of its sophistication and its
ability to access the most up-to-date information about a bioterrorist
threat. Currently, only 13 states are connected to all of their local
health jurisdictions. How do we ensure that the other 37 have the same
communication links? How do we ensure that our rural communities are as
prepared as our urban areas to deal with a bioterrorism threat?
These are concerns which must be addressed responsibly and not in a
hasty fashion just so that we can claim ``we did something'' before
Congress adjourns. This is one area, Mr. Chairman, where we may not
have the ability to leisurely repent our earlier decisions. I look
forward to hearing the testimony from our witnesses.
Chairman Tauzin. I thank my friend for his statement. Are
there further requests for opening statements on this side? The
vice chairman of the committee, Mr. Burr.
Mr. Burr. Thank you, Mr. Chairman.
Chairman Tauzin. I'm sorry, the gentleman from California,
Mr. Cox, is signalling and is recognized for 3 minutes for an
opening statement.
Mr. Cox. I thank you. In fact, I thought Mr. Greenwood was
going to ask for time which is the only reason I yielded. I
want to thank you, Mr. Chairman for----
Chairman Tauzin. Would the gentleman yield a second--Mr.
Greenwood is here. I think the committee ought to take great
pride in the subcommittee's work, Mr. Greenwood performed this
week, this last week, on the issue of charitable aid to the
victims of the catastrophe in New York and Washington and
Pennsylvania. As you know, the Red Cross just yesterday
announced it was reversing its course and directing the money.
Mr. Greenwood, a great job, sir.
There are lots of folks who will claim some credit for
that, including Mr. Bill O'Reilly on his show who did a great
deal to expose the problem early, but Mr. Greenwood and his
subcommittee did a great job, I think, in helping to educate
the Red Cross on the voices that we were hearing from America.
And I think the Red Cross is to be commended for correcting
that course and for dedicating itself to putting that money now
to the victims of the families of New York and Washington and
Pennsylvania.
Again, thank you, Mr. Greenwood. Mr. Cox is recognized for
3 minutes.
Mr. Cox. Thank you, Mr. Chairman, again, thank you for
holding this hearing on bioterrorism and I want to welcome
Secretary Thompson, add my welcome to those of my colleagues. I
know all of us on the committee appreciate the time that you're
taking away from your other responsibilities to testify before
us this morning. I would personally like to thank you as well
as Deputy Assistant Secretary Claude Allan and Dr. Donald
Henderson for meeting with the House Policy Committee to
discuss this exact topic over the last month.
This committee has dedicated itself for several years to
improving the resources and programs of the National Institutes
of Health, the Centers for Disease Control and the Food and
Drug Administration. Now we are taking additional steps to
improve the Nation's ability to respond and more importantly
prevent public health emergencies instigated by terrorists'
attacks. In the process of drafting the legislation that this
committee is currently considering, it's become clear that our
Nation's biomedical researchers and scientists are being
hindered by laws already on the books that constrain them from
developing products that could treat, detect and prevent
bioterrorist attacks. Some of these impediments are as simple
as our failure to make the R&D tax credit permanent, as a
result of which America's biomedical research has been
conducted in an atmosphere of uncertainty, financial
uncertainty.
The Food and Drug Administration still takes too long to
approve lifesaving products, although efforts have been and are
being made to improve and streamline the approval process and
our increasingly dysfunctional lawsuit system which imposes
exorbitant and easily avoidable costs on our health care
consumers and providers alike, has particularly deleterious
effects on the development and marketing of vaccines.
I know, Mr. Secretary, that you have been a leading
advocate of reform in all of these areas and I would
particularly like to commend you, the President and the rest of
the Bush Administration for your leadership at this time. Mr.
Chairman, I yield back.
Chairman Tauzin. I thank the gentleman for his statement.
Are there further requests on this side? Mr. Pallone from New
Jersey is recognized.
Mr. Pallone. Thank you, Mr. Chairman. On September 28, the
General Accounting Office published a report requested by
Senators Kennedy and Frist which stated that, in fact, our
health departments are ill-equipped, we are vulnerable to
bioterrorism and that our response to bioterrorism is poorly
coordinated and under funded on the Federal, State and local
level.
Mr. Chairman, I have to say I was disappointed in the
Federal Government's response to the chain of anthrax events.
The information that was presented about medications and doses
were inconsistent and in general, fear and confusion about the
power and limitations of anthrax were instilled in an already
panicked nation. For the future, our efforts need to focus on
preparing for similar threats, as well as more severe threats
of diseases that are highly contagious and deadly such as
smallpox.
Mr. Chairman, bioterrorism is not a partisan issue, but I
did want to mention that our Democratic caucus has spent a lot
of time since September 11 focusing on this issue. Last week,
the Democratic Health Care Task Force invited Janet Heinrich
and her team from the GAO, the comment on their report which,
as I said, cited bioterrorism and vulnerability. And this
presentation was very helpful in understanding the current gaps
in our public health infrastructure. Several proposals were
brought up during this meeting, namely H.R. 3255,
Representative Bob Menendez' bioterrorism bill which has been
introduced on behalf of the House Democratic Caucus and H.R.
3219, Representative Jane Harman's bill to fund the CDC
renovations. And the team from the GAO agreed that these
proposals would certainly be a good starting point for
improving our bioterrorism response and Mr. Secretary, I'm not
trying to be partisan in saying this, but I really believe that
and I know that you have looked at these proposals and I really
would commend them to you because I think that having taken
them out on the road and talked at Town Forums about them, they
really seem to be a good basis for dealing with the issue.
The first bill, the Menendez bill, H.R. 3255, proposes a
$3.5 billion package for public health preparedness, the
majority of which would be directed toward State and local
governments. Ms. Harman's bill, H.R. 3219, would provide $1.5
billion over the next 5 years for CDC renovation and this would
help speed up completion of the CDC's master building plan.
With regard to the CDC, I just wanted to mention, of the
$3.8 billion, fiscal year 2001 CDC budget, only $181 million
was devoted to bioterrorism, of which only $67 million went to
State and local governments. This year, $1.6 billion has been
proposed in the emergency supplemental. However, only a small
portion of that amount, $175 million would go to State and
local governments and we all know the importance of public
health on the State and local level and much more needs to be
done in terms of funding.
I'm just asking you, Mr. Secretary, if you would take these
two bills that I've just mentioned into serious consideration.
I'm getting a lot of feedback back from locals about what needs
to be done and I think the House Democrats, without being
partisan, really spent a lot of time getting feedback from
State and local governments and that these are the types of
things that are trying to be addressed in these two bills and I
hope that we can work together on a bipartisan basis to improve
our public health system as timely as possible, because this
is--the issue we're discussing today is the key issue that I
hear about in the District and at home. This is the thing that
most people care about as their priority right now.
Thank you, Mr. Chairman.
[The prepared statement of Hon. Frank Pallone, Jr.
follows:]
Prepared Statement of Hon. Frank Pallone, Jr., a Representative in
Congress from the State of New Jersey
Chairman Tauzin, Chairman Bilirakis, thank you for holding this
important hearing on proposals to combat bioterrorism.
As we saw just a month ago from the unfortunate anthrax incidents
on Capitol Hill and throughout the nation, the need for better
communication in response to bioterrorism threats is extremely
compelling. Immediate collaboration among federal, state and local
government and their medical communities; public health officials;
emergency management; and law enforcement is crucial.
When the terrorist attacks against the World Trade Center and
Pentagon took place on September 11th, shortly thereafter concerns
about biological or chemical warfare were voiced. The nation was given
the impression by Secretary Thompson that the United States was fully
prepared to combat terrorism and that there was no need for panic. On
September 28th, the General Accounting Office (GAO) published a report
requested by Senators Kennedy and Frist, which stated that in fact, our
health departments are ill-equipped, we are vulnerable to bioterrorism
and that our response to bioterrorism is poorly coordinated and under-
funded on the federal, state and local level.
As a result of this ill-preparedness, the response to anthrax found
in Senator Daschles office, and the chain of anthrax events that
followed, was decentralized, uncoordinated, and quite frankly,
confusing. The CDC unfortunately lacked leadership in presenting
information to the public and to key health departments. The
information that was presented about medications and doses were
inconsistent, and in general, fear and confusion about both the power
and limitations of anthrax were instilled in an already panicked
nation. It is unfortunate that 4 deaths were the result, but it is
important to keep in mind that this was anthrax, a substance that is
not contagious. Obviously our efforts need to focus on preparing for
future similar threats, as well as more severe threats of diseases that
are highly contagious and deadly, such as small pox.
We as a Committee and we as a Congress, want to help to improve
this current situation of bioterrorism unpreparedness. Far greater
challenges are headed our way, and it is our responsibility and
aspiration to provide what you need to ensure the publics safety.
Last week, the Health Care Task Force invited Janet Heinrich and
her team from the GAO to present to us on the report, which cited
bioterrorism vulnerability. This presentation was very helpful in
understanding the current gaps in our public health infrastructure.
Several proposals were brought up during this meeting, namely HR 3255:
Rep. Bob Menendezs bioterrorism bill introduced on behalf of the House
Homeland Security Task Force, and HR 3219: Rep. Jane Harmans bill to
fund CDC renovation. Our team from the GAO agreed that these proposals
would certainly be good starting points for improving our bioterrorism
response.
HR 3255, the Bioterrorism Preparedness Act of 2001, proposes a $3.5
billion package for public health preparedness, the majority of which
will be directed toward state and local governments. The main
highlights of the bill that address public health infrastructure and
response to bioterrorism are: 1) improving community emergency response
capacity and preparedness, 2) ensuring an adequate supply of vaccines
and treatments for all Americans, 3) enhancing community planning and
intergovernmental coordination and 4) enhancing surveillance, improving
communications and strengthening technology infrastructure. I feel that
this bill provides an excellent starting point for ensuring a strong
and organized response to bioterrorism.
In addition, several of my colleagues recently visited the CDC
campus and came back to report to Members that a substantial investment
in our public health system and CDC bioterrorism-related programs is
badly needed. The CDC is responsible for our national pharmaceutical
stockpile, our health alert network, our public health training
network, and many infectious disease labs. Of the $3.8 billion FY 2001
CDC budget, only $181 million was devoted to bioterrorism, of which,
only $67 million went to state and local governments. This year, $1.6
billion has been proposed in the Emergency Supplemental, however, only
a small portion of that amount, $175 million would go to state and
local governments. We all know the importance of public health on the
state and local level and much more needs to be done in terms of
funding.
One of the most striking comments made by my colleagues regarding
their visit to the CDC, was that the buildings and facilities were
badly in need of renovation. My colleague, Rep. Jane Harman, has
introduced a bill, HR 3219, that would provide $1.5 billion over the
next five years for CDC renovation. This will help speed up completion
of the CDCs master building plan, which is crucial at this time when
the CDC must have the ability to carry out vast communications and
maintain a high level of security.
Thank you, Secretary Thompson and Director Koplan, for coming
before our Committee to address this important issue of response to
bioterrorism. I hope that you will take these two bills that I have
just mentioned into consideration and I hope that we can work together
to improve our public health system as timely a fashion as possible.
Thank you.
Chairman Tauzin. I thank the gentleman. Further requests
for opening statements? The gentleman from North Carolina, the
vice chairman of the committee, Mr. Burr.
Mr. Burr. Thank you, Mr. Chairman. Let me take this
opportunity to welcome Secretary Thompson and Dr. Koplan. We've
tried to put this slate together several times and if it hadn't
been us that's messed it up, it's been the President, but we
excuse him for last week.
Mr. Chairman, let me reiterate something that you said and
that's that, in a bipartisan way, the committee staff has
worked aggressively for the last week or longer to address the
bioterrorism bill that I think members on both sides of the
aisle agree that we need to do. It will focus on two specific
areas, but not limited to those two, a rebuilding of our public
health infrastructure in America that I think all of us agree
needs to be done to respond successfully to any threat that we
might see in any community. And second, to accelerate the
facility upgrade of our CDC facilities which will be really the
nucleus of our ability to understand what's happening and what
we should do. Mr. Linder from Georgia, has worked aggressively
with the CDC. He, along with Ms. Harman, has introduced that
bill and it is the plans of this committee to incorporate that
acceleration in our bioterrorism bill where we would accelerate
a 10 year plan, Jeff, to a 5 year plan, and hopefully find
appropriators to go along with us. It is my hope that it won't
be too long before we have an opportunity to produce out of
this committee a bipartisan piece of legislation on
bioterrorism and I look forward to that.
Mr. Chairman, I yield back.
Chairman Tauzin. I thank the gentleman. Further requests
for time? The gentleman from Michigan, Mr. Dingell, is
recognized for 5 minutes.
Mr. Dingell. Mr. Chairman, I thank you. Mr. Secretary
Thompson and Director Koplan, thank you, for being here and
welcome. I particularly want to discuss proposals to address
possible acts of bioterrorism directed against our citizens. I
believe there are serious deficiencies in our public health
systems, inadequacy of budget and equipment at CDC, major
shortfalls in the capability of Food and Drug to address its
problems, antiquated facilities at CDC, and indeed, an overall
shortage in the ability of our hospitals and local units of
Government to respond to the serious challenges that can come
from these kinds of events.
We know how to fix our public health system. We know
increased funding is required, as well as improved Federal
direction and coordination. I believe it is now a simple and
direct question of political will, given greater urgency
because of recent and unfortunate terrorist events. We need
money for training, more nurses, more laboratory staff, for
developing new vaccines and antibiotics, for developing
stockpiles of pharmaceuticals and other medical supplies. We
need more money for public hospitals and community health
centers and we do need leadership from the Federal Government.
Second, the administration should be able to address and
fix the problems in the initial response to anthrax attacks. I
have attached to my statements for inclusion in the record, a
copy of the November 10 National Journal article entitled
``Contagious Confusion'' which discusses many of the lessons
learned. Legislation can help in some respects, but ultimately
the Secretary and the administration will have to be the ones
who ensure that Federal response improves and that State and
local authorities have the tools and the support that they
desperately need to do better; and I would note that in
discussions with my local officials, they find a massive
problem in term of inadequate Federal support for local
undertakings which are, after all, the front line of defense in
matters of this sort.
Third, there is a greater recognition that our general
level of preparedness is not adequate. For example, our food
safety system is not prepared to prevent international and
intentional adulteration from occurring, particularly with
imported food. We have neither the manpower at the borders, nor
the technology, to detect adulteration, intentional and
otherwise, or to direct it to proper hands so that it may be
scrutinized and the dangers detected.
When food arrives at U.S. ports of entry, there are an
inadequate number of people and inadequate inspection awaiting
it. It can come wherever the sender wishes it to go and there's
no way of channelling it into proper and necessary inquiries
into the safety of foods and other imported commodities of that
character. Even when imported food is sampled and tests are
conducted, it takes overlong. It takes days or weeks for labs
to process the tests. By that time, the food is long gone and
people have been significantly at risk for significant period
of time.
We in Congress must give Secretary Thompson the tools and
resources he needs to properly address the threat and he must
face up to the fact that he has great needs and speak honestly
of those needs to this Congress. And the administration must
not shy away from seeking what is needed to take the necessary
steps.
Mr. Secretary and Director Koplan, thank you for being here
and I look forward to your testimony and I thank you, Mr.
Chairman.
I yield back the balance of my time.
[The prepared statement of Hon. John D. Dingell follows:]
Prepared Statement of Hon. John D. Dingell, a Representative in
Congress from the State of Michigan
I welcome Secretary Thompson and CDC Director Koplan to this
Committee, particularly to discuss proposals to address possible acts
of bioterrorism directed against our citizens. We all know there are
serious deficiencies--in our public health system, in our initial
responses to the anthrax mail attacks, and in our general level of
preparedness. Our task now is to discuss them objectively and
constructively, and to craft solutions. This Committee has been engaged
in such an effort over the last two weeks, and although no agreement
has been reached, I commend the Chairman for undertaking this task.
Many other efforts in the Congress and the Administration are underway,
and the collective efforts should ultimately bear fruit.
First, we know how to fix our public health system. We know that
increased funding is required, as well as improved federal direction
and coordination. Now it is a simple and direct question of political
will, given greater urgency because of recent terrorist events. We need
money for training, for more nurses and laboratory staff, for
developing new vaccines and antibiotics, and for developing stockpiles
of pharmaceu-ticals and other medical supplies. We need money for
public hospitals and community health centers. And we need leadership
from the Federal Government.
Second, the Administration should be able to address and fix the
problems in the initial response to the anthrax attacks. I have
attached to my statement, for inclusion into the record, a November 10
National Journal article ``Contagious Confusion,'' which discusses many
of the lessons learned. Legislation can help in some respects, but
ultimately the Secretary and the Administration must work to ensure
that the Federal response improves, and that the state and local
authorities have the tools and support they need to do better. We must
have a clear, timely, and medically credible response at the Federal
level.
Third, there is greater recognition that our general level of
preparedness is not adequate. For example, our food safety system is
not prepared to prevent intentional adulteration from occurring,
particularly with imported food. We have neither the manpower at the
borders nor the technology to detect adulteration, intentional or
otherwise, of food when it arrives at U.S. ports of entry. Even when
imported food is sampled and tests are conducted, it takes days or
weeks for labs to process the tests--and the food is long gone. We in
Congress must give Secretary Thompson the tools and resources he needs
to properly address this threat, and the Administration must not shy
away from seeking what is needed.
I thank Secretary Thompson and Director Koplan for being here, and
I look forward to their testimony.
______
[Friday, Nov. 9, 2001--National Journal]
Contagious Confusion
By Sydney J. Freedberg Jr. and Marilyn Werber Serafini
In a way that the far bloodier September 11 attacks did not, the
anthrax assault has required unprecedented collaboration: among law
enforcement, emergency management, and public health officials; among
federal, state, and local government; and between government at all
levels and the medical community. If the attacks-by-mail did America
any kind of favor, it was to highlight how many weak links there are in
the chains that bind these agencies to each other in a crisis--links
that must be strengthened before a far heavier blow breaks them apart
completely.
Consider Clifford Ong, Indiana's new statewide counter-terrorism
coordinator, appointed two weeks into the crisis as the Hoosier version
of national Homeland Security chief Tom Ridge. Ong's office, intended
to be the state's central clearinghouse for anthrax information, first
learned about Indiana's most serious anthrax scare, not through
official channels, but from the media. Although about 600 miles from
any confirmed case of anthrax, Indianapolis happens to have one of the
only two facilities nationwide that repair and recycle post office
sorting machines--including a tainted printer from Trenton, N.J. State
authorities did not even know the repair plant was there until a
subcontractor called asking for advice about how to handle machinery
possibly exposed to anthrax. The state then tested for anthrax at the
repair plant, and the report came back negative. Ong relaxed. But he
didn't know that the main contractor at the plant had asked the U.S.
Postal Service to come and do its own test. This second test, performed
by an out-of-state lab, came back positive. Suddenly, there was anthrax
in Indiana, and yet state authorities weren't told. Reporters in
Washington were. Ong had to field the frantic calls.
``Our problem isn't locally,'' said Ong, who has long worked with
the local U.S. district attorney and the FBI field office. ``Washington
seems to respond within the Beltway to national media without any
concern that we have local media . . . It puts us in somewhat of a
defensive position.''
This snafu--just one of many--shows how vital information can fall
into the cracks between organizations, into blind spots where fear can
flourish like mold inside a wall. Considering that just four people
died of anthrax in one month, the average American was far more likely
to be struck by lightning, which kills 80 to 100 people every year,
than to contract the disease. The point is that anthrax is not
contagious--but fear is. ``The medical problem was actually pretty
small,'' said Jack Harrald, the director of the Institute for Crisis,
Disaster, and Risk Management at George Washington University in
Washington. ``The terror problem, in terms of managing people's fear,
was pretty huge--and not very well managed.''
The failure of government, medicine, and media to respond to fears
and ignorance about anthrax with real understanding led to millions of
dollars in losses--to businesses that had to find substitute mail
carriers or evacuate their workplaces for testing, as well as to local
governments that had to respond to every emergency anthrax scare. In
Los Angeles, where hazardous-materials responses increased 300 percent
in mid-October, ``we received a call from an employee at a doughnut
shop that there's a white, powdery substance on the floor,'' said
Deputy Chief Darrell Higuchi, of the Los Angeles County Fire
Department. The shop, of course, sold doughnuts with powdered sugar.
``Yet,'' said Higuchi, ``you feel for the callers, because they are
scared.''
Fear thrives on ignorance. But there is no effective,
authoritative, nationwide system to communicate information about
bioterror. Nor is there a single national spokesperson for the public's
health. Indeed, some have criticized the Bush Administration for
failing to designate someone as the voice of the anthrax crisis, even
acknowledging White House reluctance to call on Surgeon General David
Satcher, a leftover Clinton Administration appointee. Instead,
information has moved through dozens of parallel and poorly coordinated
channels of communication: The Centers for Disease Control and
Prevention talks to state health officers, the FBI to local sheriffs,
the Federal Emergency Management Agency to disaster officials, medical
associations to their members. But when people in different fields,
such as police and physicians, must work together, or when there simply
is no state or local counterpart to a federal agency, the channels are
less clear--as Ong found out in dealing with the Postal Service. The
system simply isn't set up to share information.
In fact, civil liberties laws often forbid necessary communication.
Said Lawrence Gostin, the director of the Center for Law and the
Public's Health, a joint project of Georgetown University and Johns
Hopkins University: ``The law thwarts vital information-sharing
vertically from federal to state, and horizontally between law
enforcement, emergency management, and public health.''
The biggest gap is between government and the medical community. A
CDC alert on bioterrorism, sent to state health officials just after
September 11, had still not reached many local emergency rooms a week
later. And the crucial linchpins between doctors and officials--local
public health offices--are notoriously overworked and short of funds.
As many as one in five public health offices do not even have e-mail,
said Sen. Bill Frist, R-Tenn., a physician. Many localities still
collect epidemiological data on disease outbreaks only by asking
doctors to send postcards through the mail--hardly an ideal approach in
any fast-moving outbreak, let alone one that strikes at the postal
system.
Anthrax has finally kick-started efforts to revive public health
systems, after decades of neglect. In North Carolina, for example, the
Legislature is about to allocate millions of dollars to replace
reporting by postcard with high-speed, highly secure electronic links.
Ultimately, the network will connect not only local officials, but also
every hospital, pharmacy, and doctor's office in the state.
New funding and new networks are essential first steps. But in a
country where almost all health care is provided by the private
sector--indeed, where most critical terrorist targets, from Internet
servers to nuclear plants to sports arenas, are privately owned--
defense against terrorism probably cannot be achieved by a new agency,
a new program, or a new technology. True ``homeland security,'' most
experts say, will require an overarching system that links not just
every level and agency of government, but also the private sector,
nonprofit groups, and the general public. Computers and the Internet
will be vital in helping to set up this new national network, but it
will be the intangible connections between people working together in a
common cause that will really make the new system work.
The Broken Linchpin
If it sometimes seems as if the world has turned upside down since
September 11, that's because it has. Terrorism has upset the
traditional pyramid of who protects Whom. No longer do the Pentagon's
armed troops bear the brunt of foreign blows. Whether the danger comes
from airliners-as-bombs or from anthrax envelopes, local firefighters,
medics, and police respond long before Washington can act. But even the
local emergency teams come second to the scene. In a terrorist attack,
the first responder is the ordinary citizen--the airline passenger who
decides to rush the hijackers, the mailroom clerk who notices a
suspicious package, or anyone who wonders whether these flu-like
symptoms they're feeling might be anthrax. It is their decisions,
prudent or paranoid, that trigger the government response. Said Peter
Probst, a former Pentagon and CIA official, ``The first line of defense
is an educated, engaged public.''
That word, ``educated,'' signals where things start breaking down.
Even those officials who should be best equipped to inform have
stumbled over their own statements, and each other's--and that includes
Surgeon General Satcher and Health and Human Services Secretary Tommy
G. Thompson.
``You've got Satcher saying one thing, Tommy Thompson saying
another, and the CDC saying a third,'' fumed one local official who
spoke with National Journal. One day the word is to put everyone on
Cipro, the next day not, the third day it's another antibiotic
altogether. ``There isn't a consistent message.''
With that confusion at the top, many officials, never mind ordinary
citizens, admit turning to the news media as their first source of
knowledge. But as reporters themselves grope in the dark for
information, and constantly face the pressure for round-the-clock, up-
to-the-minute coverage, they may magnify inconclusive clues, or even
outright rumors, into major scare stories. There was so much
misinformation about anthrax early on, said one congressional staffer
well versed in bioterror, ``the first few days, I was kicking the
television a lot.''
Many confused citizens dialed 911, just to be sure. Far more fell
back on the second line of defense: their doctors. Physicians are still
trusted more than most other professionals. And even though only a
handful of American doctors have ever seen a case of inhalation anthrax
(the last U.S. case was in 1978), most rushed to learn what they could.
Until recently, medical education on bioweapons has been minimal. But
after September 11, well before the first anthrax case in Florida,
sensitivity to terror of all kinds was so high that the major medical
associations quickly rallied to upload data to their Web sites and
downlink teleconferences to their members.
That information probably saved lives. Had Florida photo editor Bob
Stevens died in August, said Randall Larsen, director of the Anser
Institute for Homeland Security, a consulting group in Northern
Virginia, ``it's highly unlikely he would have been diagnosed as dying
with anthrax, because they weren't looking for it.'' Before September
11, when authorities sent anthrax samples to four medical laboratories
as a test of their bioterrorism alertness, three of the labs just threw
the samples out, mistaking the anthrax bacteria for contamination on
the slides.
In another test, out of a roomful of doctors at Johns Hopkins
medical center, just one recognized an X-ray of a strange chest
inflammation as characteristic of anthrax. Even after the September 11
attacks, HHS Secretary Thompson initially suggested that Stevens's
death was due to a freak natural cause. But doctors were on high enough
alert by then to spot the symptoms.
Although the professional medical associations could deluge their
members with basic references on anthrax, they lacked the quick
communications systems to collect and broadcast up-to-date data on the
ever-changing outbreak. In fact, since most associations serve only a
single medical specialty--and even the mighty American Medical
Association serves fewer than half of all doctors--they could not even
help share information among different types of doctors in a given
community.
The painstaking, county-by-county collation of data gathered from
individual physicians has always fallen to local public health
offices--the traditional American defensive line against disease. But
emergency officials, medical associations, and independent experts
alike all agree that the public health infrastructure has long been, to
quote one congressional staffer, ``the forgotten stepchild.'' These
local offices are perpetually short on funds, technology, and--above
all--personnel. They are burdened with laws written to guard against
19th-century scourges such as syphilis and tuberculosis, and few of
these laws even require doctors to report outbreaks of likely
bioweapons such as anthrax, much less the subtler indications of
spreading disease.
``Suppose there's a run on anti-diarrhea medication. How would we
know that? If there are a lot of absences from school or work, how
would we know that?'' said Georgetown University's Gostin. ``We need a
public health agency to be able to get information from the private
sector.''
New York City, considered a national model, does keep hourly tabs
on such things as sales of the anti-diarrheal Kaopectate. Los Angeles
hospitals are linked by computer to share diagnosis data. But most
areas lack such sophisticated ``disease surveillance'' systems, even in
states that have really tried. Virginia, for example, connects its
local health offices across the state by computer, said George
Foresman, a Virginia emergency management official, but the state's
effort to bring private practices into the network stalled because ``we
just had not been able to secure the funding.''
The problems are not only fiscal. Even with a $1.4 million federal
grant, Michigan found the private sector deeply reluctant to share
information. ``We've asked pharmacies if we could monitor what
antibiotics are going out,'' said Dr. Sandro Cinti, of the University
of Michigan medical center, ``but they didn't want to give away that
information.''
In the absence of even such imperfect electronic systems, most
public health officials collect data the old-fashioned way: slowly. In
some places, doctors' offices fill out and mail in forms to health
agencies; in other places, they call in, and local officials must
laboriously enter the information by hand, and then in turn mail
another piece of paper to the state health office. Conversely, when
Illinois authorities, who have invested heavily in linking public
health offices to local hospitals, wanted to send every physician in
the state advice on anthrax, they had to take the licensing board's
master list of addresses and mail every one of them a letter. There was
no comprehensive e-mail or electronic system.
``The information-gathering and decision-making loop isn't fast
enough,'' said Clark Staten, the executive director of the Emergency
Response & Research Institute in Chicago. ``The bad guys can move
faster than the good guys--at the present time.'' And during that lag,
fear can spread, and people can die.
More Than Medical
Even in a better-than-average flu season, doctors may run out of
vaccine and hospitals out of beds. In some cities last year, said Sen.
Edward Kennedy, D-Mass., ``they had sick patients that couldn't even be
treated in the emergency rooms--they were out in cars.''
Any major natural disease outbreak overtaxes American medicine. But
biological terrorism takes the complexity an octave higher. Each
scattering of spores is obviously a public health problem. But it is
also evidence of a crime--and of a hazardous material in the
environment. Anthrax not only requires close ``vertical'' cooperation
among federal, state, local, and private medical organizations, it also
cuts horizontally across functional lines. Ordinary disease can be
dropped neatly into an organizational box marked ``medical.''
Bioterrorism requires out-of-the-box cooperation among public health
professionals, private doctors, law enforcement agencies, firefighters,
emergency management systems, and even foreign intelligence agencies.
This kind of jurisdiction-crossing is so alien to American
government that it is often outright illegal. If the Central
Intelligence Agency had somehow found out beforehand about the anthrax-
laced letter addressed to Senate Majority Leader Thomas A. Daschle, for
example, it may not have been allowed to warn health officials until
after it was sent, according to James Hodge, the project director of
the Center for Law and Public's Health. To protect civil liberties,
said Hodge, ``there's a firewall between intelligence agencies and
public health.''
Even when there's no legal obstacle to collaboration, many of the
various agencies lack the experience, the contacts, or the procedures
to work together. Both the U.S. Postal Inspection Service and the
Centers for Disease Control are trying to track the anthrax letters to
their source. The two agencies share information, but they don't share
people: Instead of combining forces, detectives and doctors are on two
separate teams following different methods to reach the same goal.
Sometimes, the lack of coordination could have even worse
consequences. ``When I was the health commissioner of New York, I had
no clue who was the head of the FBI office, and he had no clue who I
was,'' said Margaret Hamburg, who went on to become HHS's top bioterror
official under President Clinton. ``The last thing they want to be
doing is exchanging business cards in the middle of a crisis.'' Yet,
that is just what often happened with the anthrax scare.
In the District of Columbia, for instance, where traditional
federal-local complications compounded all the other problems, the
initial confusion and inconsistencies in testing and treatment for
Capitol Hill staff versus postal workers boiled over into racially
tinged fury. One community forum turned, unfairly, into a pillorying of
D.C. public health chief Ivan Walks. Soon Dr. Walks and Mayor Anthony
Williams were holding joint press conferences with Postal Service
officials and the CDC. But those relationships had to be set up on the
spot--and the public health office still does not have a full-time
representative in the District's interagency Emergency Operations
Center.
D.C.'s problem is not uncommon. ``We somehow managed to leave the
public health system . . . outside the emergency system,'' said
Harrald, at D.C.'s George Washington University. Emergency managers,
firefighters, and police have largely overcome past problems of
coordination by planning and training together before disasters, and by
jointly staffing command posts during times of crisis. Such a combined
system cranked into action in New York City on September 11. ``The
federal government had thousands of people moving in the right
direction 20 minutes after the second tower was hit,'' Harrald said.
``We know how to do this. That's the good news.''
The bad news is that, in most places, no one told public health
officials the good news. In D.C., ``it took a long time before the
emergency room at [George Washington University] hospital and the
emergency room at Children's Hospital and the attending physician of
the Capitol and the CDC had the same picture of what they were dealing
with,'' Harrald said. ``I'm not throwing stones at individuals. The
problem is that we didn't set the systems up before the event.''
The American Answer
In the first month of anthrax attacks, the country's system of
defenses against bioterror often seemed to be no system at all, only
chaos. Fortunately, reality is more nuanced, and more heartening, than
that. True, there is no one coherent national system. But there are
systems--all partial, all imperfect, but needing mainly to be
strengthened and brought into an overarching structure. Senate Health,
Education, Labor, and Pensions Committee Chairman Kennedy and panel
member Frist last year co-sponsored the Public Health Threats and
Emergencies Act of 2000, which authorized $540 million a year to
strengthen the public health infrastructure and to better recognize and
respond to bioterrorism attacks. Congress has not yet funded the new
law, but already the two Senators have upped their request to $1.4
billion a year.
The final sum needed for homeland security will surely be much
higher. But ``we're not going to create a whole new Department of
Defense,'' with a $350 billion budget and staff of 3 million, said
David McIntyre of the Anser Institute. ``We're going to play with the
chips that are on the table.''
``The pieces are there,'' said Frist. The task is taking the pieces
that exist--federal, state, local, and private--``and coordinating them
in a seamless way. It can be done.'' In Frist's own field, transplant
surgery, moving precious organs quickly across the country and then
ensuring that patients' bodies do not reject the new tissue require
far-flung hospitals and diverse disciplines to work closely together--
and they do it, every day.
High on Capitol Hill's agenda is a massive reinvestment in the
nation's long-neglected public health system. Top priority is a secure,
high-speed electronic data-link for doctors and public health officials
who are now scrawling disease reports on postcards. The CDC already has
an electronic Epidemic Information Exchange system to share outbreak
alerts among federal, state, and local public health officials, as well
as the military. And long before September 11, the CDC had given all 50
states seed money to start work on a National Electronic Disease
Surveillance System to link all 2,000-plus local health offices around
the country. This network could automatically and swiftly share, for
example, the results of a crucial diagnostic test. Ultimately, it could
also tap into hospitals and even private practices. But for now, the
surveillance network does not actually exist. A bare-bones ``base
system'' is scheduled to begin in 20 states in 2002. That seemed plenty
fast--before September 11. Now, lawmakers are likely to hit the gas.
But strengthening public health is only half the battle, because
public health officials will still get their information from the
private sector. The real challenge is to track--from every hospital,
every doctor's office, and every pharmacy around the country--the
telltale upticks in certain symptoms, or prescriptions, that although
seemingly innocuous in isolation, could signal an impending crisis. It
is a daunting task.
Yet it is also mostly done already. Insurance companies routinely
require doctors to code each diagnosis and report it electronically for
reimbursement, keeping electronic tabs on everything from
pharmaceutical sales to major surgeries. The Health Insurance
Portability and Accountability Act of 1996 (HIPAA) made such reporting
systems mandatory nationwide, though a significant 43 percent of
doctors are not yet hooked up. In its patient-privacy rules, the act
also has a little-known exception that requires doctors to share data
on threats to public health.
Medical information companies are already on the Hill touting
software solutions. A properly designed system could tap into the
existing streams of data, strip off names and other individual
identifiers, and crunch the numbers into trends. To be sure, such an
early-warning system might well find false patterns. An upsurge in
sales of certain drugs might indicate an outbreak of disease, or it
could simply reflect effective advertising. Conversely, the system
might miss a real outbreak if doctors consistently misdiagnosed as flu
the ambiguous early symptoms of, say, anthrax--the reason why D.C.'s
Walks is currently working on a system that codes not just final
diagnoses but actual symptoms as well.
Still, the most sophisticated computer is only a tool. The most
important linkages are among people. And in small ways, that linking
process has already begun, too. Tom Ridge has held teleconferences with
all 50 state governors. Local officials and medical associations are
reaching out to one another, often through e-mail. And a FEMA program
called ``Project Impact'' gives local governments grants and training
to bring together different agencies, businesses, and community groups
for disaster planning. Mayor Susan Savage of tornado-prone Tulsa,
Okla., says that Project Impact simply but systematically asks, ``What
does the private sector bring to the table that can complement public
resources?'' On September 11, for example, when 800 airline passengers
were stranded at the Tulsa airport, the city mobilized everything from
public buses for transportation to local preachers for counseling,
pulling resources freely from the public, private, and nonprofit
sectors.
Officials, legislators, and experts increasingly agree that such
bottom-up approaches are the model for homeland security. Imposing a
single national system from the top down is not only impractical, it is
probably unwise. What makes more sense is a ``network of networks,'' an
overarching system that lets each local government or private group
tailor its approach to its own unique needs--within the overall
framework.
A prototype nationwide network of networks has actually already
been built. Unfortunately, it was promptly taken apart soon after. Late
in 1999, when the public and private sectors alike were fretting that
their computers might crash once the year hit ``00,'' then-Secretary of
State Madeleine K. Albright visited the national Y2K crisis center and
exclaimed, ``You could really run the world from here.''
Like a terrorist, the Y2K bug threatened to strike unpredictably at
any target: federal, state, local, or, in the vast majority of cases,
private. Imposing a topdown structure to address the potential threat
was impossible, recalled John Koskinen, Clinton's Y2K coordinator:
``You need to build off existing structures, and not create new ones.''
So Koskinen pulled together existing networks--government agencies,
corporations, trade associations, and industry groups--in a loose but
comprehensive confederation that reached into every threatened sector,
with himself as the lead spokesman.
``The year-2000 preparations were a pretty good dress rehearsal''
for the kind of coordination required since September 11, said David
Vaughan, a Texas public health official. JoAnne Moreau, the emergency
preparedness director of Baton Rouge, La., agreed: ``We developed
relationships with agencies and companies and factions that we never
knew would have some kind of role.''
The lesson that Y2K holds for homeland defense is that the federal
government cannot, need not, and probably should not, do everything. Of
course, without strong guidance from Washington, the thousands of
private and local government responses could create an irrational
tangle, like an ill-tended garden. The federal role is to fertilize the
growth and, when necessary, prune it back. ``There are 1,800 separate
legal jurisdictions in the United States, and the American people and
the Constitution like it that way,'' said David Siegrist of the Potomac
Institute for Policy Studies think tank. ``The federal government needs
to offer incentives . . . and set standards.''
In a shadow war with an amorphous foe, America can prevail only by
empowering individuals and small groups to innovate--because it is
they, and not any federal official, who will be on the front lines.
Thirty years ago, noted McIntyre, if a child showed up at school beaten
black and blue, teachers might think, ``Tough parents,'' and move on.
Today, they would report the possible abuse--and thereby set various
responses in motion. A public similarly well-educated to watch for
something genuinely wrong in their world would go a long way, not just
toward calming panic, but toward stopping terrorists before they
strike.
``We don't want to be people who watch each other. We want to be
people who watch out for each other,'' said McIntyre. ``It's the
distinction between a controlled society and a civil society. A civil
society requires citizens. And in good times, maybe we forgot that.''
We have certainly been reminded now.
Chairman Tauzin. The gentleman yields back the balance of
his time. Mr. Whitfield? Dr. Ganske, 5 minutes for an opening
statement.
Mr. Ganske. I thank you. I thank the chairman for calling
this hearing and I thank the Secretary for coming. I'm sure
that the Secretary, after all the additional study he's done on
microbiology should probably be awarded a master's or a Ph.D.
at the end of his tenure as Secretary.
I hope that this committee is able to come together on a
bipartisan agreement on a bioterrorism bill, Mr. Tauzin and Mr.
Dingell. I hope they're able to do that. To date, we haven't
seen an agreement. For the past month, I have been, you might
say in consultation with Senator Bill Frist, a physician in the
Senate, on the bill that he and Senator Kennedy have been
working on and have come to an agreement on in a bipartisan
way. In fact, I talked to Senator Grassley just a day or so ago
and he informed me that he thought that would be
noncontroversial and most likely we will see a nearly unanimous
vote in the Senate on that bill.
I've also had extensive discussions with Senator Chuck
Hagel on the food provisions in that bill which I think are
excellent. It is my intent to introduce that bill in a
bipartisan manner, either today or tomorrow. I do not feel that
the level of funding in the Senate bill is excessive,
considering the things that we need to do for the CDC, for
animal disease labs, for vaccines, and for supplies of drugs.
As a physician, I've been interested in this issue for a
long time. I'm happy to have worked with Congressman Brown on
issues related to antibiotic resistance. I've had some personal
experience with some serious infectious diseases, such as the
so-called flesh-eating infection, necrotizing faceitis. I've
also had personal experience with a very serious food infection
that became a case of encephalitis a few years ago when I was
on a surgical mission.
We recently got a phone call from a constituent because we
had sent her a letter in response to an inquiry. She phoned
back irate that we were potentially contaminating her household
with anthrax in sending her a letter from Washington. This is
really on a lot of people's minds. The bill that I will
introduce deals with a lot of things, but one of the things
that I think is a good item in the Frist-Kennedy bill is the
issue of block grants to States because it is clear that
whereas we need to do many things on the Federal level, the
States are in a lot of trouble financially. Secretary Thompson
knows that and they are frequently bound by balancing budget
amendments to their State constitutions. They need some
additional financial help to deal with the public health
aspects of this bioterrorist threat. I think that is one of the
advantages of the Kennedy-Frist, Frist-Kennedy bill which I
will be introducing. There are other aspects of that bill
particularly on food safety, and the threat to agriculture that
we need to address further than what we have done in Congress.
The economical blow to our agricultural sector from the
introduction of bioterrorist agent such as hoof and mouth
disease would be absolutely devastating.
So I am hopeful that this committee can come to a
bipartisan agreement, but if not, we will have an alternative
in the form of a companion bill to the Senate bill and I yield
back.
Chairman Tauzin. The gentleman's time has expired. Mr.
Deutsch.
Mr. Deutsch. Thank you, Mr. Chairman, and thank you, Mr.
Secretary for being here this morning.
Mr. Secretary, I know you have spent a great deal of time
and effort in terms of trying to have the smallpox vaccine
available in our stockpile in a number sufficient for all
Americans, and I'm very pleased that Mr. Henderson is here
today and actually, obviously, very pleased that you brought
him on board as part of your team.
This is really the first opportunity since September 11
that I have and this committee, even though we have
jurisdiction over CDC, to really talk to you specifically about
smallpox. And I would tell you that from my own perspective,
there is no more important issue that you can do as Secretary
than to get the vaccines available for Americans on the shelf.
And the reason why I'm taking the time in terms of the opening
statement is in this setting, which I have mentioned, is the
first hearing that we have had in over 2 months, specifically
on--or the opportunity to ask questions on smallpox. I only
have 5 minutes in that setting and hopefully, either in your
statement or in dialog we've had in other settings, to talk
about it, but i guess, I know that you're absolutely doing the
most you can possibly do. You're working the hardest. Your
intentions are the same intentions, but still we're more than 2
months down the road and we don't have a contract. We don't
have a specific plan to put smallpox vaccines on the shelf, in
our stockpile and I think Mr. Henderson, probably as much as
anyone in the world can talk about the disaster that would
occur if there was literally one case of smallpox that was
found int he United States of America. And unfortunately, it's
sort of the more you know, the more you don't want to know
situation and I think by this point you know far more than you
want to know, but what we all are aware is how even though
there are only two official stockpiles of smallpox in the
world, it is very clear that there is probably much more
smallpox that had been developed and was available for
terrorists in the world.
Three years ago, as you are well aware, less than 3 years
ago, was the last time we had inspectors in Iraq and by the
public domain information it appears very convincing that Iraq
had smallpox at that time. The same thing which we are well
aware that in the 1990's when the Soviet Union basically
disintegrated, it was not just one location where they were
developing smallpox, they were developing it in many locations
and just so that people are aware, to take smallpox and I'm not
an expert and Mr. Henderson really is the--Dr. Henderson is
really the world expert on this, but we're really talking about
a vial which could have kept a smallpox in a freeze-dried
state, could have been sent, just one vial. We're not talking
about a nuclear power plant. We're not talking about a reactor.
We're not talking about a plutonium facility. We're talking
about a vial and a vial potentially with one person could have
the destructive capability of ten hydrogen bombs. And I guess I
have a concern that as significant as all of our acknowledge
that that is the potential. The intensity and I know you're
doing as much as you possibly can do, but what I really have
had sought and asked for and really in the setting today is
really what more can we do, because the downside exposure of
smallpox is so severe that it's almost as if anything we can do
to get vaccine on the shelf is critical and I--at the opening
in terms of questions, I look forward to that and again I
appreciate your being here.
Chairman Tauzin. I thank the gentleman for his statement.
Further requests for opening statements? The gentleman from
Georgia, Mr. Norwood is recognized.
Mr. Norwood. Thank you, Mr. Chairman, I'll accept your
unanimous consent request for 1 minute out of respect for the
Secretary's time. Welcome, Mr. Secretary, we're glad you're
here.
Last week, I had the privilege of joining the President and
Secretary Thompson on the trip down to CDC. You don't have to
spend time there to realize the importance of their work to
national security. My Georgia colleagues, John Lender and Saxby
Chambliss recognize, as well. I'm happily a co-sponsor of their
bill, as is Ms. Harman and I sincerely hope this committee
accepts their work to make certain CDC has the appropriate
authorizations to accomplish their very important mission and I
hope we will work that into this committee's bioterrorism bill.
I also briefly want to commend your attention to Mr.
Thornberry's bill. It's very simple. In an emergency, frankly,
the difference between a for profit and a nonprofit hospital is
basically irrelevant and access to Federal funds in an
emergency should not be limited in my view, just to nonprofit
hospitals. I hope the committee will accept that simple fix as
well.
I appreciate you being here today, Mr. Secretary and Dr.
Koplan and we all look forward to your testimony.
I yield back, Mr. Chairman.
[The prepared statement of Hon. Charlie Norwood follows:]
Prepared Statement of Hon. Charlie Norwood, a Representative in
Congress from the State of Georgia
Thank you Mr. Chairman for holding this hearing this morning. Last
week I had the privilege of joining the President on his trip to the
CDC. You don't have to spend too much time there to realize the
importance of their work to our nation's security.
My Georgia colleagues, John Linder and Saxby Chambliss, recognize
this as well. I sincerely hope the Committee accepts their work to make
certain CDC has the appropriate authorizations to accomplish their very
important mission into the Committee bioterrorism bill.
I would also like to bring attention to Mr. Thornberry's bill as
well. In an emergency, the difference between a for-profit and a non-
profit hospital is irrelevant. Access to federal funds in an emergency
should not be limited to non-profit hospitals. I hope the Committee
accepts this very simple fix.
I appreciate your attendance today Secretary Thompson, Dr. Koplan
and look forward to your testimony. I yield back the balance of my
time.
Chairman Tauzin. I thank my friend. Further requests for
time on this side? The gentlelady from California, Ms. Eshoo,
is recognized.
Ms. Eshoo. Thank you, Mr. Chairman, for holding this all-
important hearing, and Secretary Thompson, it's wonderful to
see you again. Drs. Koplan and Henderson, welcome.
I have questions, obviously, that I would ask this morning,
but I want to welcome you, No. 1, and I can't help but think of
the time, the years in growing up and what my father would tell
me about World War II. He talked about the attack and then he
said our country went into high gear. And so I think as we're
shifting into high gear, we have to be mindful of what we can
do in our time, in our day.
We know that our public health service across the country
is absolutely key and central in this. We have outstanding
professionals in all of our communities, but we know that they
need more. We know that the CDC is superb, but we have a ways
to go in terms of upgrading that place being Ground Zero in
this preparation for us to respond, God forbid, to what we need
to respond to.
What are the medications that we need to have on the shelf?
These are all the thing that we need to be prepared for. That's
what this hearing is about. I don't think this is a Democrat
and Republican--this is not a partisan issue. This is where we
have to join ranks and not debate about the sums, but the
substance. The sums should be attached to the substance of what
we come up with and I also am very, very mindful that out of
this effort, out of this bioterrorism discussion that new
discoveries are going to come in terms of the drugs and the
research and the development of that research and that will
hold our Nation in good stead for years to come. So I look
forward, very sincerely, Mr. Secretary, with the chairman, with
all of my colleagues on this committee that is front and
central in this issue to coming up with those things that
generations to come, they will look over their shoulders and
say we did something noble and good in our time and in our day.
Thank you.
Chairman Tauzin. I thank the gentlelady. Further requests
for time? The gentleman from Illinois, Mr. Shimkus, is
recognized for 3 minutes.
Mr. Shimkus. Thank you, Mr. Chairman and thank you, Mr.
Secretary, for coming and I would just want to say this is a
national security issue. I think we all agree. We did have a
historical aspect of the influenza outbreak in 1918. It shows
us the risk we have. Had we had 5,000 casualties--had we had
5,000 injured people instead of approximately 5,000 dead, we
would have found out that we wouldn't have been able to contain
and treat those folks in New York City.
World War II and the cold war really had a good model. Our
civil defense plan was a pretty good model to nationalize civil
defense issues and I think it's time we kind of turned that
back, especially as we address bioterrorism and my big concern
is our front line responders, the fire departments, the police
officers. No matter what we do at the Federal level, they're
going to be the first ones there and we have to help them
prepare and then follow up with the surge capacity needed to
meet the needs early. We know that early intervention will be
the key and somehow we've got to find that great balance to
bring in our locals and prepare them to respond and they can do
the job if we're there to assist them and that will be my focus
and Mr. Chairman, thank you. I yield back.
[The prepared statement of Hon. John Shimkus follows:]
Prepared Statement of Hon. John Shimkus, a Representative in Congress
from the State of Illinois
Thank you Mr. Chairman for holding this hearing on the important
issue of bioterrorism. Now, more than ever, our country needs to be
prepared to deal with terrorist attacks of all kinds, including
bioterrorism.
I am especially concerned over the growing shortage of medical
laboratory personnel. These professionals are needed for the immediate
response to a bioterrorist situation.
Laboratory professionals must provide prompt and accurate
laboratory results so that a potential biological threat can be
detected. Considering the times, it is difficult to imagine how our
health delivery system would function without this needed laboratory
workforce. I am hopeful that any bioterrorism package that moves
forward would recognize this need.
In addition, I would like to mention the importance of community
health centers as a first line of detection for a bioterrorism attack.
Health centers are often located in isolated rural areas where they
are the only health care provider for miles. They are also often
expected to fulfill vital local public health functions because there
is no local health department or its resources are limited. I urge the
members of this committee and HHS to remember this important part of
our nation's health care delivery system as we craft this proposal.
Again, I would like to thank you Mr. Chairman, for holding this
important hearing today.
Chairman Tauzin. The Chair thanks the gentleman. Further
requests for time on this side? The gentleman from Ohio is
recognized. Mr. Rush, do you seek recognition? The gentleman
from Ohio is recognized.
Mr. Sawyer. Thank you, Mr. Chairman, for holding this
hearing and I thank our witnesses for your participation today.
I'd just like to make a couple of brief observations. First
of all, the CDC has made a good beginning. The strategic plan
is a good start and during the anthrax episode, health
officials in my District tell me that health alert network
functioned well in sharing timely information. That's
important.
The work entered into cooperative agreements with State and
major local health departments I think is an important element
in preparedness, because clearly and I think we would all agree
that in a crisis, all responses is local. It falls to our
cities and our counties first to be able to react and we've got
to make sure that they have the tools they need to react
appropriately.
That leads me to my second observation and that is that
that does not seem to be the case yet, that of the $8.7 billion
that OMB suggests we're spending in fighting terrorism, only
about 3.5 percent of that is reaching the local level in the
form of training, planning and equipment grants. I believe we
need to do better than that. I think we can do better than that
in the kind of environment that we've heard talked about by the
chairman and others. I'm confident that we will do that.
I yield back the balance of my time, Mr. Chairman.
[The prepared statement of Hon. Tom Sawyer follows:]
Prepared Statement of Hon. Tom Sawyer, a Representative in Congress
from the State of Ohio
Thank you Mr. Chairman and thank you for holding this hearing. I
would also like to thank the Secretary for testifying in front of the
committee today about ways the government can better protect the public
from bioterrorism.
In early October, when the first anthrax case was confirmed, the
threat of bioterrorism ceased being theoretical or distant. It became
real and immediate, regardless of its ultimate source. Subsequently, 22
cases have been confirmed by CDC and tragically, four people have died
as a result of anthrax inhalation. Clearly, the treatment of postal
workers who were exposed to anthrax was a disaster. The federal and
local governments must do a better job in responding because in the
future, the biological agents that terrorist use may be more contagious
and more deadly.
The CDC has made a good beginning in leading the nation's efforts
to prepare for a bioterrorism attack. As part of HHS's 1999
Bioterrorism initiative, the CDC took on this burden and has performed
admirably working with limited resources. Over a year ago, CDC issued a
well thought-out strategic plan to deal with bioterrorism and has
worked with State public health departments to strengthen planning, lab
capacity and communication. In conversations with heath officials in my
district, they have all told me that during the current anthrax
episode, the Health Alert Network has performed exceptionally well in
informing them about the latest developments and medical information.
In response to the bioterrorism initiative, CDC also began entering
into cooperative agreements with State and major local public health
departments to help them upgrade their preparedness and response
capabilities. These agreements focus on five areas: Preparedness
Planning and Readiness Assessment, Surveillance and Epidemiology, the
Health Alert Network, and Biologic and Chemical Agents Laboratory
Capacity. However, last year, the CDC was able to award only slightly
more than $50 million to all public health departments across all five
of these areas. Due to a lack of funding, all state public health
departments could not even access money in each of the grant
categories. In light of September 11 and the anthrax mailings, we need
to increase the funding substantially for these vitally important
programs.
During a crisis, all response is local. Police, firefighters,
health workers, EMTS and mayors are immediately responsible to react.
The federal government cannot meet these events as they occur.
Consequently, we must make sure that our local health care and safety
forces are prepared, and that bioterrorism funding is targeted
appropriately.
Unfortunately, this does not seem to be the case yet. An analysis
of OMB's figures shows that the federal government is spending about
$8.7 Billion to fight terrorism but only 3.5% of that is making it to
the local level in the form of training, planning and equipment grants.
We need to do better. We must ensure that bioterrorism proposals direct
resources to those who will be responding. I look forward to hearing
from the witnesses on how they believe that this can best be
accomplished.
Chairman Tauzin. Thank you, my friend. Further requests for
time on this side? The gentlelady from New Mexico, Ms. Wilson.
Ms. Wilson. Thank you, Mr. Chairman, Mr. Secretary, I
appreciate your being here today. All of us know that we have
to strengthen our capacity to respond to and detect biological
threats, but I think we also have to recognize that what we're
talking about here is only one part of a renewed focus on
health security. Many of the threats that we know we're going
to have to face include nuclear and chemical contaminants and
those are largely unaddressed thus far in the legislation
that's emerging certainly from the Senate and possibly also
here in the House.
We do know with respect to biological agents that there are
some things we have to do. We have to expand our laboratory
capacity which was overwhelmed by a relatively small incident
involving anthrax in three different communities. That regard
last year, the Congress established a national center for
infectious disease which a year ago the CDC did not recommend
for continuance and I hope that that's been reconsidered.
We need to research, develop and deploy low cost
technologies for real time detection of contaminants, whether
they are biological, nuclear or chemical. The idea that--the
visions that we've seen on our televisions of q-tips and petri
dishes and men in bunny suits are not where we should be. We
are within 3 to 5 years of the deployment of real time
detection of chemical and biological and nuclear contaminants
in water systems across the country and we should accelerate
that deployment and develop those technologies for the air, the
water and the food that we eat. We need to strengthen our
controls on hazardous biological agents and this committee has
already acted, the House has already acted in that regard. We
also need to develop really an encyclopedia of cultures of
those materials that we know exist and the genetic sequences of
those cultures so that if there is an outbreak, we're able to
find out who the parents were of that outbreak. And finally, we
need to protect our water systems and our food supply.
One of the things that we haven't addressed and really is
not within the realm of this committee is the role of the
National Guard, the Department of Defense and to some extent
our national laboratories in this effort. We need to move
beyond some of the stovepipe approaches and I know that you've
made efforts int hat regard to make sure there's a coordinated
Federal and national response to the challenges that we face.
There are capabilities developed for one purpose that now can
be applied to a completely different problem. I yield the
balance of my time.
Chairman Tauzin. I thank the gentlelady. Further requests
for time. The gentleman from Maryland, Mr. Wynn, is recognized.
Mr. Wynn. Thank you very much, Mr. Chairman. First of all,
I'd like to welcome the Secretary for being with us as well as
Dr. Koplan. Mr. Secretary, I just wanted to add my voice to the
chorus you've heard today calling for assistance to State and
local governments, the well renowned first responders, if you
will. I say this because I was distressed yesterday at
Appropriations Committee, at the urging of the administration,
amendments were defeated which would have provided additional
funding for homeland security. Included in that amendment was
money to help local governments at the county level, at the
municipal level, as well as at the State level.
Now it may be that the administration feels there's a more
appropriate vehicle and that's certainly the administration's
prerogative, but I certainly would hope that after hearing so
many voices say we need to help local governments, that the
administration will step up to the plate on the question of
providing additional funding to help those first responders, to
help our public health infrastructure.
Dr. Koplan, this week I attended the memorial service for
two postal workers who died of anthrax, and at that memorial
service, attended by over a thousand individuals, there was a
great deal of resentment. There was the sentiment that there is
a double standard between the treatment of postal workers and
the treatment of congressional staff. I know that's not true
and my point is not to point fingers because obviously, I'm
speaking with the clarity of hindsight. I guess we all are. I
would only say that in dealing with the welfare of service
industry personnel, whatever the situation, that we exercise
maximum caution on their behalf because after the fact, it's
obviously too late. I know you're in a very difficult
situation. Everyone looks to you for answers that may not be
available, but I would just, as I say, sound a cautionary note
with respect to the decisions you make that ultimately affect
the lives of thousands and thousands and thousands of people at
the blue collar level, that don't occupy these halls.
Thank you. I relinquish the balance of my time.
Chairman Tauzin. I thank the gentleman for yielding.
Further requests for time on this side? I see none for further
requests from this side. The gentleman from Texas, Mr. Green is
recognized.
Mr. Green. Thank you, Mr. Chairman, and I'll submit a
complete statement and I'll try to stay within a minute. I want
to welcome our Secretary again and also the medical experts who
are there with him.
September 11 in the resulting 2 months plus since then have
brought new territory for our country with bioterrorism. In
watching it over the last 2 months and particularly in the last
month because of the anthrax scare in mid-October, it seemed
like we had different information coming out from different
agencies. I know there's an effort in administration to
streamline that and I would hope that the CDC would be able to
do that, following my colleague from Maryland next to me, the
assistance to the local public health department. I'm from
Houston and we haven't had an anthrax infestation in a thousand
miles, but our emergency rooms are showing up, our first
responders are hearing from people and so we need to make sure
that even though it may not be Maryland or New York or Florida,
we're still having to respond locally. And the information that
CDC provides and HHS provides needs to be as succinct and speak
with one voice as we can.
With that, I would, like my colleagues, like to talk about
a bill that Congressman Quinn and I from New York has
introduced on staffing for fire and emergency response
personnel in first responders to deal with the problem, not
only from experience in New York, but all across the country
for the need for increase to first responders and thank you,
Mr. Chairman, I yield back my time.
[The prepared statement of Hon. Gene Green follows:]
Prepared Statement of Hon. Gene Green, a Representative in Congress
from the State of Texas
Mr. Chairman, thank you for holding this full committee hearing on
what is one of the most important issues our committee will discuss
this year.
Americans have been living in fear since September 11, not only of
major attacks like those at the World Trade Center and the Pentagon,
but also of a bioterrorist attacks like the anthrax outbreaks in
Florida, New York, New Jersey, and here in Washington.
These attacks are new territory for this country. We have never had
to deal with a bioterrorist attack like this. So in many ways, it is
understandable that we have had some missteps along the way.
But we must take stock of what we've learned so far.
We have learned that a bioterrorist attack is not always going to
be obvious. It might take several weeks before a pattern is noticed or
the public becomes aware of the threat.
In the case of Bob Stevens, the photo editor from Florida who was
the first anthrax victim after the September 11th attacks, Secretary
Thompson suggested that he probably died from a freak natural cause.
The CDC had many different spokesmen who often contradicted each
other, and other administration officials.
Now I'm not pointing fingers or casting blame. As I mentioned
earlier, we are all relatively new at this.
But we must identify ways that we can protect the public--not only
from a bioterrorist threat--but also from the kinds of confusion and
chaos we have witnessed so far.
We have also learned that our nation's public health system, which
has been neglected for decades now, is ill-prepared for any kind of
mass biological threat.
Many public health departments lack modern technological equipment,
such as computers, e-mail, Internet access, or even such outdated
devices as fax machines.
This inhibits their ability to communicate with the people on the
front lines--the doctors and nurses--about possible bioterrorist
attacks.
Since most of the health care in this country is provided through
private entities, we must develop a system where the public health
departments can have real time communications with physicians,
hospitals, clinics, pharmacies, schools, and other facilities, so that
we can immediately identify and track potential public health problems.
There is also dire shortage of health care professionals, such as
nurses, pharmacists, and laboratory personnel.
And many of the dedicated individuals who are currently working in
our hospitals and clinics lack the proper training to identify and
treat bioterrorist threats like anthrax and small pox.
I know that my colleague and friend Mrs. Capps has been working on
this issue for quite some time now, and is trying to secure funding so
that we can train a new generation of nurses and other health care
professionals.
I hope that the Administration and our friends in the majority will
work with her on this issue.
I would also like to point our that many of our communities suffer
a significant shortage of first responders, such as firefighters and
emergency medical personnel.
Firefighters play a central role in our terrorism preparedness
plan, and we must ensure that each community has an adequate number of
well-trained fire fighters who can respond to fires, emergencies, and
terrorist attacks, including chemical and biological attacks.
That is why I have introduced H.R. 3185, the Staffing for Adequate
Fire and Emergency Response (SAFER) Act of 2001, which is modeled after
the successful COPS program, and would to a long way to ensure that our
local fire departments are prepared for a bioterrorist attack.
The bottom line, Mr. Chairman, is that our states and localities
need resources in order to be prepared for a bioterrorist attack.
As this committee considers legislation to prevent and mitigate a
bioterrorist attack, I encourage the leadership to consider these
issues, and provide the resources necessary.
Thank you, Mr. Chairman, and I yield back the balance of my time.
Chairman Tauzin. I thank the gentleman. The gentleman from
Tennessee, Mr. Bryant, is recognized.
Mr. Bryant. Thank you, Mr. Chairman. I will be brief. Let
me thank you for holding this hearing and addressing a point,
my colleague from Texas, Mr. Green, just made. I've been going
back and forth between judiciary and here. We just passed out
of the full Judiciary Committee a bill which will clearly
criminalize the making of hoax, prank-type calls or letters and
at the Federal level and hopefully it will have some impact as
that word gets out that there should be quite a deterrent out
there for folks who would do this.
Second, I would echo the opening statement of my friend
from California, Mr. Cox. I agree with him and I think there
are certain areas that we have to look at as we prepare to turn
over to our pharmaceuticals the task of producing sufficient
vaccinations for the various possibilities of bioterrorism and
as a part of that, and some of this is outside the jurisdiction
of this committee, but clearly some relief in antitrust law
will be needed there to allow these companies to come together
and unite in the production for so many different reasons to
avoid duplication and so on.
Second, some relief in terms of liability that in today's
litigious world, at least the litigious United States,
companies have to have some protection there as we're going to
be going into areas that we've never been before with some of
these diseases.
And with that, Mr. Chairman, with respect to our Secretary,
I'd like to yield back the balance of my time and perhaps move
this along.
Chairman Tauzin. I thank the gentleman for yielding. The
gentlelady from Missouri, Ms. McCarthy, is recognized.
Ms. McCarthy. Thank you, Mr. Chairman. I too will excerpt
and submit my statement for the record. I welcome the Secretary
and his team here today, Dr. Koplan. Thank you for all you're
doing to help work, build our public health infrastructure and
Mr. Secretary, like most members, I've been having
conversations in my community with my first responders and
those in the line of fire, so to speak, about what we at the
Federal Government could be doing to help them do their job.
Obviously, all their budgets have been cut because of needs at
the local level and that's why I think like the Bioterrorism
Protection Act that's been referred to you earlier this morning
is worth your review and support.
First of all, two key sections in it address public health
infrastructure and response to bioterrorism and dedicate
Federal monies already allocated in the monies that we've
approved, to improve the community emergency response capacity
and preparedness and address some of the concerns about
hospital capacity and training of medical personnel and
increased nursing and clinical lab personnel and training to
the first responders.
In my community conversations, these are the real needs out
there in the heart of America. And the bill also enhances
community planning and intergovernmental coordination and
dedicates funds to those. And that's another concern. When you
have a metropolitan area like Greater Kansas City with a
regional council that crosses State lines, coordination is
absolutely essential. Getting results back from labs in a
timely way is important. Requiring States to submit medical
response plans to the Federal Government would aid you, I
think, in your work as well. So these kinds of issues are
addressed in this bill, as well as a whole section on
protecting our food and water and many of these issues have
been raised by others this morning, but I think you would find
these helpful and I know that the local governments would, as
well, keeping our water supply safe is certainly a concern we
all share.
So I look forward to working with you on legislation and
very much look forward to hearing your remarks today and I
yield back my time, Mr. Leader.
[The prepared statement of Hon. Karen McCarthy follows:]
Prepared Statement of Hon. Karen McCarthy, a Representative in Congress
from the State of Missouri
Mr. Chairman, thank you for scheduling this full committee hearing
on bioterrorism and proposals to combat it. I join my other colleagues
in welcoming Secretary Thompson. CDC Director, Dr. Koplan, and Dr. D.A.
Henderson, Director of the new Office of Public Health Preparedness,
and I thank you for your testimony.
The bioterrorism related programs of the Centers for Disease
Control and Prevention, such as the National Pharmaceutical Stockpile,
the Health Alert Network, the Epidemiology and Laboratory Capacity in
Infectious Diseases Program, and the Public Health Training network,
have been underfunded since the inception of bioterrorism funding in
fiscal year 1999. In the fiscal year 2001 CDC budget, less than half of
the available funds for bioterrorism preparedness reached the state or
local governments. Our local public health infrastructure is in need of
more resources in order to build the healthcare capacity to effectively
handle new bioterrorist threats.
Building our public health capacity at the state and local levels
should be the first step in a reinvestment in our healthcare
infrastructure. HR 3255, the Bioterrorism Preparedness Act of 2001,
also known as BioPAct, of which I am a cosponsor, is a comprehensive $7
billion package that strengthens our public health infrastructure,
including military and intelligence coordination with public health
agencies and first responders. The majority of these resources will be
earmarked for state and local governments and deal with anticipating
new bioterrorist threats and our capacity to prevent and manage any
that may occur. Half of the funds, $3.5 billion, are dedicated to
public health infrastructure preparation and response to bioterrorism
threats due to staffing shortages, proper training for hospital workers
and first responders, sufficient supplies of vaccines and antibiotics,
and the need to fully integrate a response to these threats into local
planning, emergency communication and disaster response systems.
Another $800 million is provided to help address viral and bacterial
threats to our food and water supply, including protecting our crops
and livestock.
Dr. Koplan, in a recent public health training network broadcast
sponsored by the Association of State and Territorial Health Officials
and the Department of Health and Human Services, CDC and the Food and
Drug Administration, you laid out seven priority areas for building the
public health infrastructure, and I wanted to highlight two here today
that are directly related to bioterrorism. During the broadcast, you
delineated the CDC's first priority as the public health workforce, as
this is the basis for our country's public health system. Without an
adequate supply of well trained and well staffed health care
facilities, our country cannot be prepared for a bioterrorist attack,
and our citizens cannot be protected.
Last month, Congressman Dennis Moore and I hosted a meeting at the
University of Kansas Medical Center focused on local preparedness for
bioterrorism. More than 250 doctors, hospital and health department
administrators, and representatives of area governing bodies, police,
fire, and ambulance services assembled to voice their concerns about
the level of preparedness in the wake of a chemical or biological
weapons attack. The consensus of these local leaders who would be on
the front line of any bioterrorist attack was that cost cutting has
left Greater Kansas City health care providers with few resources to
prepare for these emergencies. Health department officials spoke of the
need for additional staff to identify and investigate biological
attacks in their earliest and most treatable stages. Hospitals and
rescue workers need more training and resources to handle large numbers
of casualties.
While local public safety agencies have been preparing responses to
terrorist attacks for several years, their plans assume 500 to 1,000
victims, a number far less than what we witnessed on September 11. Dr.
Rex Archer, the Director of the Kansas City Health Department,
indicates that Kansas City needs an additional dozen public health
workers dedicated to solely investigating disease outbreaks. The
Bioterrorism Preparedness Act of 2001 will have a direct positive
effect on Greater Kansas City and other local communities as they
rebuild their local public health infrastructure.
Dr. Koplan, in that same public health training network broadcast,
you mentioned as a priority of the CDC the building of our country's
laboratory capacity to produce timely and accurate results for
diagnosis and investigation. Similar to other areas of the health care
industry, laboratories are trying to cope with a shortage of qualified
personnel. A strong and capable laboratory workforce is essential to
our public health infrastructure and to our nation's preparedness.
I am also pleased to be a cosponsor of Congressman Shimkus'
legislation, HR 1948, the Medical Laboratory Personnel Shortage Act of
2001. This bill would allow the Secretary of Health and Human Services
to assure an adequate supply of medical technologists and medical
laboratory technicians to provide primary health services in health
professional shortage areas by granting scholarships and loans for
health professional training under the National Health Service Corps'
scholarship and loan repayment program. An integral and timely section
of this legislation directs the Secretary to support programs that
train medical laboratory personnel in disciplines that recognize or
identify the resistance of pathogens and that recognize or identify a
potential biological agent.
At the bioterrorism roundtable I convened in Kansas City, several
of the participants, including Matt Shatto, a city public health
employee, stressed the need for increased staffing and resources for
our local laboratories. These front line workers realize that without
the laboratory resources needed to quickly detect bioterrorist agents
and recognize epidemiologic aberrations, our nation will not be
adequately protected. HR 1948 is important legislation in our fight
against bioterrorism and will contribute to our national and local
level of preparedness in the wake of a chemical or biological attack. I
urge the Chairman to take swift action on this bill.
Finally, no plan to protect our nation can be truly comprehensive
without the inclusion of the possible risks arising from our food
supply. Our esteemed Ranking Member, Mr. Dingell, has introduced HR
3075, the Imported Food Safety Act of 2001, a bill with the primary aim
of safeguarding our food supply. With the lack of security at our ports
of entry and a shortage of qualified food inspectors, our food supply
is a potential means of launching a bioterrorist attack, as it is an
open target for the spread of biological agents.
In order to protect the United States against future bioterrorist
attacks, the lack of security at ports of entry and the dearth of food
inspections needs to be addressed now. I hope that the CDC can play a
role in educating the public health workforce about the symptoms and
treatments for food borne illness. Secretary Thompson, I know that food
safety is one of your top priorities as you mentioned in a Women's
Caucus meeting, and I hope that you will be able to speak on this
issue.
I would like to reiterate my support for three bills that will have
a significant impact on bioterrorism preparedness: BioPAct, the Medical
Laboratory Personnel Shortage Act of 2001, and the Imported Food Safety
Act of 2001. I hope the Administration will support these measures as
well. Thank you Mr. Chairman for scheduling this hearing, and thank you
to Secretary Thompson and Dr. Koplan for taking the time to testify at
this hearing.
Chairman Tauzin. I thank the gentlelady. Further requests
for time? The gentleman, Mr. Pitts, is recognized for 3
minutes.
Mr. Pitts. Thank you, Mr. Chairman, for holding this
important hearing and thank you, Mr. Secretary for the great
job you've done responding to the anthrax threat. We're proud
of the work that the CDC is doing in trying to address our
Nation's bioterrorism crisis and threat and we need to make
sure that the CDC has adequate resources to defend our Nation
against this new threat.
I am concerned that some of the valuable CDC resources have
been wasted to promote questionable activities with little or
no proven effectiveness in the prevention of disease and I will
submit for the record documentation regarding some of these
questionable programs. I'd appreciate your looking into these
abuses and helping provide greater accountability in the CDC.
Thank you for your leadership.
I yield back the balance of my time.
[The prepared statement of Hon. Joseph R. Pitts follows:]
Prepared Statement of Hon. Joseph R. Pitts, a Representative in
Congress from the State of Pennsylvania
Mr. Chairman, the Centers for Disease Control is the nation's
foremost agency of public health.
The need for this important agency has been clearly demonstrated in
wake of September 11.
Before September 11 the threat of bioterrorism seemed remote to
most Americans.
Now we know all too well how serious and deadly bioterrorism can
be.
I understand that the CDC has worked hard to address our nation's
current bioterrorism crisis.
We need to make sure that the CDC has adequate resources to defend
our nation against this new threat.
But I am concerned that valuable CDC resources have been wasted.
CDC funds have been used to promote questionable activities that
encourage risky behavior and have little or no proven effectiveness in
the prevention of disease. T
hese expenditures represent a flagrant disregard for the moral
values of many Americans.
Taxpayer dollars should not be used to advertise for the Playboy
Foundation.
Taxpayer dollars should not be used to promote teen abortion.
Taxpayer dollars should not be used to fund sexually explicit
billboards, gay flirting classes or sex workshops.
Mr. Chairman, the examples that I have just cited are the tip of
the iceberg.
The rules of common decency do not permit me to describe many of
the other programs and activities currently supported by the CDC.
Even the titles of some of these programs are pornographic.
However, I will submit for the record documentation that describes
in detail the hedonistic excesses currently being supported by the CDC.
I was originally going to ask the Secretary to support a review by
the Inspector General on this misuse of funds, but I have just learned
that the Secretary has already requested an IG review. I want to thank
the Secretary for his quick action on this matter, and I look forward
to working with him to restore the credibility of the CDC by putting an
end to this outrage.
Mr. Chairman, please note that I do realize that these abuses were
allowed to flourish under the previous administration, and do I not
place blame on Secretary Thompson for the CDC's involvement in these
questionable programs. In fact, the President's nominee to head the CDC
has yet to be confirmed.
I am happy to work with you, Mr. Chairman, and Secretary Thompson,
to ensure that greater accountability is established at the CDC, and I
look forward to seeing him fill leadership posts at the CDC with
individuals who reflect the values and priorities of the new
Administration.
Attachment 1
[Sunday, September 9, 2001--Associated Press]
Fed Funds Used for Explicit Workshops
By Larry Margasak, Associated Press Writer
WASHINGTON (AP)--The advertisements addressed to gay men were
provocative: Learn to write racy stories about your sexual encounters,
choose toys ``for solo and partner sex'' or share tales of erotic
experiences.
All of it was done at government expense, in the name of preventing
AIDS.
These expenditures--along with other recent allegations of fraud
and abuse of federal money to fight AIDS--have upset some AIDS
activists and lawmakers.
``The tragic consequences are that people die when they don't get
their vital medical services,'' said Wayne Turner, spokesman for the
AIDS activist group Act Up in Washington. ``The days of the AIDS gravy
train are numbered.''
Added Iowa Sen. Charles Grassley, the senior Republican on the
Senate Finance Committee: ``We don't have money to bum when people are
suffering and dying.''
After learning of mismanagement of AIDS money, Grassley won a
commitment from the Health and Human Services inspector general for
increased audits of federal treatment funds.
The sexually provocative prevention programs run by San Francisco
AIDS groups are funded in part from the $387.7 million the federal
government is spending this year on AIDS prevention.
The government also spends $1.8 billion for medical treatment of
low-income victims of AIDS and $257 million for housing for low income
and homeless sufferers of the sexually transmitted disease that attacks
the body's immune system.
Allegations of mismanagement or poor administration of the AIDS
treatment funds have arisen in the Kansas City area, Indiana and the
District of Columbia. The housing assistance program was criticized in
Los Angeles. An AIDS clinic operator in Dallas was sentenced to prison
for using federal AIDS funds to pay a psychic.
Federal officials who administer the AIDS funds say they rely
primarily on state and local governments and--in the case of prevention
program content--citizen review boards to ensure the money is spent
properly.
Lisa Swenarski, spokeswoman for the Centers for Disease Control and
Prevention, said the sexually provocative materials ``have been brought
to our attention and we are looking into it.'' Under CDC guidelines,
prevention programs cannot promote or encourage sexual activity.
``We defend the process of having the local review panels make
those decisions,'' she said.
Douglas Morgan, a director in the AIDS bureau of the Health
Resources and Services Administration, said state and local governments
that receive AIDS prevention grants ``have been very good in
identifying these issues. We expect them to notify us'' of fraud and
abuse.
But those who run the federally funded workshops on writing sex
stories and using sex toys say that was the only way to draw gay men
into discussions about AIDS prevention.
``Many who are at risk experience AIDS-prevention burnout,'' said
Brian Byrnes, director of prevention services for the San Francisco
AIDS Foundation--the group that conducts the ``Hot Writing'' workshop.
``Like the marketing of any product, you need to find language that
will attract the target population: Men at high risk for HIV infection
or transmission,'' he said.
San Francisco officials, who distribute more than $40 million
annually in federal treatment and prevention funds to community AIDS
groups, agreed. ``If you put out a flier saying, 'Please come learn how
to prevent AIDS,' nobody shows up,'' said Steven Tierney, director of
HIV prevention for the city.
Community organizations say prevention experts participate in
events with sexually provocative themes, but promotions on the groups'
Internet sites give no hint of a disease-prevention program.
``It was a dark and steamy night,'' began the advertising for the
``Hot Writing'' seminar in San Francisco. ``This pens-on-paper workshop
is for guys who like to write or want to finally get that sexy story
down.''
Another advertisement welcomed interested gay men ``to our world of
toys. Learn how to choose, use and care for toys for solo and partner
sex.''
Gay men were invited in another program to ``share tales of
intercourse,'' part of a `` Sex in the City'' series. Other programs
focused on pleasing sex partners, meeting friends without paying cover
charges and making sex more erotic.
On the treatment side of the federal AIDS effort, recent
allegations of mismanagement of taxpayer funds have prompted
investigations across the country.
An AIDS task force appointed by Kansas City, Mo., Mayor Kay Barnes
is holding public meetings to determine whether funds were distributed
fairly, especially to minority groups.
In Dallas, AIDS clinic operator Mythe Kirven pleaded guilty to
paying $27,800 in federal funds to a self-proclaimed psychic. Kirven
was sentenced to 18 months in prison and ordered to pay $262,828 in
restitution.
California's state auditor found in 1999 that the Los Angeles
Housing Department had not spent $21.8 million of prior-year federal
housing funds for homeless and low-income AIDS victims.
Indiana officials terminated contracts last year with the company
that processes claims for AIDS treatment services after learning that
doctors, dentists and other providers were not paid. A new contractor
has been hired.
In the nation's capital, an audit found no documentation for almost
half the sampled disbursements of the HIV Community Coalition of
Metropolitan Washington. Sundiata Alaye, the group's new executive
director, said changes were made and ``we've got an excellent control
structure in place now.''
Attachment 2
[Thursday, September 20, 2001--St. Louis Post-Dispatch]
AIDS Awareness Billboards Start Coming Down, On Slay's Orders; Mayor
Says Photos Were Offensive
Mark Schlinkmann, Regional Political Correspondent
Workers began removing nine AIDS awareness billboards Wednesday at
Mayor Francis Slay's orders because he believed they included photos
that were offensive to some city residents.
Eight signs showed two bare-chested men embracing, one with his
head buried in the neck of his partner and the other with his hand on
the partner's shoulder. A condom was pictured on the ninth. Slay said
he didn't object to the goal of the ads, urging African-Americans to
get tested for AIDS. But he said the photos used ``would offend
families, people with children, a whole host of people.''
``You wouldn't see those in Creve Coeur. in Chesterfield, in other
areas of our community,'' Slay said in an interview.
The decision Tuesday by Slay and his acting health director,
Michael Thomas, angered members of a regional AIDS-HIV planning
committee that devised the ad campaign and is the grant recipient. The
group got a $64,000 federal grant, overseen by the city
Nine other signs with other photos passed muster with the mayor and
Thomas, who said be knew nothing of what photos were being used until
Tuesday. The signs went up Monday and Tuesday at sites across the city.
Attachment 3
[Bay Area Reporter, September 21, 2000]
KGO bans HIV prevention commercials from daytime TV
by Terry Beswick
Oprah would probably cope with it, and Rosie wouldn't bat an
eyelash, but programming officials at the local ABC/Disney television
affiliate are apparently squeamish about men with bare chests and about
a transgender with breasts.
KGO Channel 7 has rejected a new federally-sponsored ``HIV Stops
With Me'' commercial featuring seven HIV-positive ``spokesmodels''
arguing for taking responsibility for their personal health and for the
health of their community.
Based on a telephone survey of the viewing habits of gay and
bisexual men in San Francisco, the local social marketing firm that
produced the commercial wanted to air the ad during the Oprah and Rosie
O'Donnell talk shows, found to be the most popular shows on the ABC
network. The station countered with an offer to air the commercials
after 10 p.m.
``What KGO said is that children six or seven years old will see it
and ask their parents about it and they won't know what to say,'' said
Les Pappas, president of Better World Advertising [BWA], which produced
the ads and had offered the station $12,000 to air them during daytime
TV. ``It's outrageous.''
Targeted to HIV-positive gay men and transgenders in the Bay Area,
the ads are part of a $350,000 social marketing campaign subcontracted
to BWA, one component of a Department of Public Health $1,826,877
contract with the federal Centers for Disease Control and Prevention.
The CDC also awarded funds to five other cities for demonstration
projects designed to confine HIV within the HIV-positive community.
Attachment 4
--- Original Message ---
From: preventionews@cdcnpin.org [mailto:preventionews@cdcnpin.org]
Sent: Friday, October 26, 2001 6:08 PM
To: prevention-news@hattrick.qrc.com
Subject: [CDC News] HIV/STD/TB Funding Information 10/29/01
The following funding information has been recently added to the
CDC National Prevention Information Network's (NPIN) Funding Database
(http://www.cdcnpin.org/db/public/fundmain.htm). For more information
about HIV, STD, and TB funding opportunities, please contact the CDC
NPIN at 1-800-458-5231.
Fund Title: Reproductive Health and Rights: General Service
Foundation
Funder Name: General Service Foundation
Fund Description: Among other things, the General Service
Foundation makes grants in areas of Reproductive Health and Rights.
This program is dedicated to improving access to comprehensive
reproductive health care, including abortion, for women and
adolescents; and to supporting education efforts which increase
awareness and action around issues of reproductive health, sexuality,
and reproductive choices. Grants are made domestically for research
development, policy analysis, litigation, technical assistance,
advocacy, and outreach. The Foundation also funds organizations working
in Mexico whose work parallels the goals of the domestic agenda.
Generally, grants are not made for service delivery, or university-
based research, and the Foundation does not support local or state-
based organizations in the United States working within a limited
geographic range.
Inclusive Target Audience(s): 306--Adolescents. 390--Women
Fund Subject(s): Adolescents, Advocacy, Health care, Outreach,
Sexually transmitted diseases, Women
Application Deadline: February 1, 2002--Spring; September 1, 2002--
Fall
Fund Location (Eligibility): Location unrestricted. (United States)
Fund Location (Ineligibility): n/a
Fundee, Geographic Location (Eligibility): Location unrestricted.
(United States)
Fundee, Geographic Location (Ineligibility): n/a
Fundee, Other Eligibility: Priority is given to organizations
working with underserved communities and populations whose reproductive
health and rights are most impacted by poverty.
Fundee, Type of Support: Technical assistance
Fundee, Inclusive Target Organizations: CBO--Community Based
Organization
IRS--IRS 501 (c)(3) Organization
Application Technical info Person: Lani Shaw
www.generalservice.org
557 N Mill St, Ste 201
Aspen, CO 81611
970-920-6834
970-920-4578--FAX
lani@generalservice.org
Executive Director
Application, Type of Information Required: Review the Foundation's
Guidelines, and past years' grants lists to be sure the projects fits
within the Foundation's specific areas of interest by accessing the
Internet: www.generalservice.org; or contact Lani Shaw, Executive
Director and Program Officer for instructions.
If you have information about your organization's conference or
funding opportunities that you would like included in the NPIN
databases and/or in the weekly e-mail announcements, please send it via
e-mail to info@cdcnpin.org
The PreventioNews Mailing List is maintained by the National
Prevention Information Network (NPIN), part of the Centers for Disease
Control and Prevention's National Center for HIV, STD, and TB
Prevention. Regular postings include the Prevention News Update,
conference announcements, funding opportunities, select articles from
the Morbidity and Mortality Weekly Report series, and announcements
about new NPIN products and services.
Attachment 5
the cdc national prevention information network--oct 30, 2001
Playboy Foundation: General Fund Announcement.
Fund Description:
The Playboy Foundation seeks to foster social change by confining
its grants and other support to projects of national impact and scope
involved in fostering open communication about, and research into,
human sexuality; reproductive health and rights; protecting and
fostering civil rights and civil liberties in the United States for all
people, including women, people affected and impacted by HIV/AIDS, gays
and lesbians, racial minorities, the poor, and the disadvantaged; and
eliminating censorship and protecting freedom of expression. Recent
grantees include: the Gay Men's Health Crisis, for its public policy
work on behalf of people with HIV/AIDS; the AIDS Action Council, for
its efforts to advocate and lobby on behalf of community-based HIV/AIDS
organizations; and the AIDS Legal Referral Panel, to support its policy
work on issues affecting women with HIV/AIDS.
Inclusive Target Audience(s):
<bullet> Homosexuals
<bullet> Minorities
<bullet> Low Income Persons
<bullet> Lesbians
<bullet> Women
<bullet> Persons With AIDS
<bullet> HIV Positive Persons
Fund Subject(s):
<bullet> Advocacy
<bullet> Homosexuals
<bullet> Information exchange
<bullet> Policy development
<bullet> Public awareness
<bullet> Research
<bullet> Sexual behavior
Fundee, Inclusive Target Organizations:
<bullet> Community Based Organization
<bullet> IRS 501 (c)(3) Organization
<bullet> Non Profit
Fund Location (Eligibility):
General grants: Location unrestricted--U.S.
Fundee, Other Eligibility:
The Foundation is especially interested in projects where a small
grant can make a difference.
Fundee, Type of Support:
Program development
Playboy Foundation
Procedure Contact Person:
Unspecified
Executive Director
680 N. Lake Shore Dr.
(phone extension: x2667)
Chicago, IL 60611
(312) 751-8000
Fund Duration: Open ended.
Letter of Intent Date: n/a
Application Deadline: n/a
Intended Award Date(s): n/a
Project Start Date(s): na
Maximum Amount: $10,000.00
Minimum Amount: $5,000.00
Fund Identification Number: 988
Attachment 6
--- Original Message ---
From: preventionews@cdcnpin.org [mailto:preventionews@cdcnpin.org]
Sent: Friday, August 31, 2001 3: 1 0 PM
To: `prevention-news@hattrick.qrc.com'
Subject: [CDC News] HIV/STD/TB Funding Information 08/3 1/01
The following funding information has been recently added to the
CDC National Prevention Information Network's (NPIN) Funding Database
(http://www.cdcnpin.org/db/public/fundmain.htm). For more information
about HIV, STD, and TB funding opportunities, please contact the CDC
NPIN at 1-800-458-5231.
Fund Title: The David Bohnett Foundation: Fund Announcement Funder
Name: David Bohnett Foundation
Fund Description: The David Bohnett Foundation is a grant-making
organization formed in 1999 for the purpose of improving society
through social activism. Planned giving areas include: (1) the
promotion of the positive portrayal of lesbians and gay men in the
media, (2) the reduction and elimination of the manufacture and sale of
handguns in the US, (3) voter registration activities, (4) Community
based social services that benefit gays and lesbians, (5) animal
language research, animal companions, and eliminating rare animal
trade, and (6) the development of mass transit and nonfossil fuel
transportation.
Inclusive Target Audience(s): 338--Homosexuals, 386--Lesbians
Exclusive Target Audience(s): n/a
Fund Subject(s): Homosexuals, Lesbians, Social services
Application Deadline: October 31, 2001
Fund Location (Eligibility): California; Washington, DC; and other
major cities, such as Chicago.
Fund Location (Ineligibility): n/a
Fundee, Geographic Location (Eligibility): California; Washington,
DC; and other major cities, such as Chicago.
Fundee, Geographic Location (Ineligibility): n/a
Fundee, Other Eligibility: The Foundation encourages grants
proposals from nonprofit organizations with 501 C3 designations whose
mission and programs are closely aligned with the Foundation's giving
areas.
Fundee, Other Restrictions: n/a
Fund Products: n/a
Fundee, Type of Support: Capital Campaign, General/operating
support, Matching grants, Seed money
Fundee, Inclusive Target Organizations: IRS--IRS 501 (c)(3)
Organization
NPF--Non Profit
Fundee, Exclusive Target Organizations: n/a
Application Procedure Contact Person: Michael Fleming
www.bohnettfoundation.org
The David Bohnett Foundation
2049 Century Park East, Ste 2151
Los Angeles, CA 90067
310-277-4611
310-203-8111-FAX
mfpfleming@yahoo.com
Program Officer
Application, Type of Information Required: Contact funder for
application information.
Fund Identification Number: 1915
Chairman Tauzin. Further requests for time? The gentleman
from New York, Mr. Engel, is recognized for 3 minutes.
Mr. Engel. Thank you very much, Mr. Chairman. I appreciate
your efforts in calling this hearing today on this issue of
critical importance. Since I work in Washington, I live in New
York, I represent the District in New York City and the suburbs
that I think that I, as well as my other New York colleagues
have been uniquely affected by the incidents starting with
September 11 and continuing.
In the wake of the anthrax attacks, we must examine the
response by the Department of Health and Human Services and the
Centers for Disease Control during this crucial time. It's
imperative we learn from the things we did right, as well as
those we did wrong, and use that information to better prepare
for the future.
Many questions arise as we look back on CDC's response. Was
the information made available to the public accurately? Was it
delivered in a timely fashion? And did our Government officials
speak in a unified voice. We have to be diligent in examining
these issues. Our very lives, obviously may depend on what we
learn from the last few weeks and how we apply that information
to prevent and respond to future attacks.
While I appreciate the efforts of those in the difficult
position of responding to the anthrax attacks, I know we can do
better and we will. We must be sure that we prepare for any
scenario. The CDC and Congress needs to work together to
prevent and fight bioterrorism and we need to do it
proactively.
Our public health officials and health care providers must
be better educated about how to recognize and treat those
infected with biological agents. In addition, our hospitals
must be well equipped to treat the American public if we are
attacked again. Bioterrorism has the potential to inflict
enormous casualties on the public. As such, it's imperative
that we put forth the necessary resources to protect the
American public from this form of attack. On September 11, and
I was in New York City when the terrorists struck, the
unthinkable became reality and in the days following we faced
further biological attacks. The truth is we were unprepared for
such horrendous acts of hate and violence and we as a country,
of course, must never be unprepared again.
These are all issues that require our serious attention and
Mr. Chairman, I commend you for holding this hearing and I look
forward to working with you and Mr. Secretary to strengthen our
efforts to fight bioterrorism. I might also add that I can
think of no better witnesses than Secretary Thompson and Dr.
Koplan to come here this morning and I'm eagerly awaiting to
hear their testimony. I thank you both for attending and I
thank you, Mr. Chairman. I yield back.
Chairman Tauzin. I thank the gentleman. Further requests
for time on this side? Seeing none, are there further requests
for time? Mr. Rush is now requesting time and under our rules,
Mr. Rush is recognized for 3 minutes.
Mr. Rush. Thank you, Mr. Chairman. Mr. Chairman, I also
want to commend you for this hearing and I want to commend the
Secretary and thank him for this visit to this committee.
I want to say that I am engaging in this discussion and
looking forward to this hearing with a sense of caution and
concern and growing feeling of trepidation in that I see out in
my District and in my city and throughout urban areas, I see
the fact that we are confronted with a two-tiered public health
system and I want to join the course of concerns and comments
from my colleagues because they seem to all agree with the
ideal that our public health system does need to be supported,
does need to be enhanced and our public health system does need
to be built back up.
Mr. Secretary, as you know, you're from a neighboring State
and I'm sure you can recall the summer of 1995 when we had a
heat wave in the city of Chicago which resulted in
approximately 700 deaths of people, most of these individuals
were poor people, people who had no connection with the public
health system. As I look across my city and my State and as I
look across urban America, I see hospitals closing down
throughout America, retreating from inner city communities and
those kinds of locations. And what it tells me, frankly, is
that if, in fact, we were to have a significant bioterrorism
threat in a large urban area, then we will be hard pressed to
engage most of our public in terms of--even getting the basic
information out to them.
I look at our program, the S-chip program and I see across
America, literally millions of people who are eligible for the
S-chip program, but not being encouraged to sign up for the S-
chip program, not being involved in S-chip program at all and
therefore it seems to indicate that there's some kind of void,
there's some kind of a problem, there's some kind of a
brokenness that existed within our public health delivery
system and information system that prevents people in certain
poor and marginal communities from engaging fully in our public
health system.
So the question that I'm left with is if, in fact, there is
a significant bioterrorism threat, then what will happen to
these individuals? And I think that the response by the CDC and
by you, Mr. Secretary, is certainly warranted because to me I
think this is going to be a catastrophe, if, in fact, we are
confronted with either bioterrorism or any other kind of
natural disorder that might occur and at some point in time
would like for you to respond.
Mr. Chairman, I yield back.
Chairman Tauzin. The gentleman's time has expired. Further
requests on this side? Seeing none, the gentleman from Ohio,
Mr. Strickland is finally recognized.
Mr. Strickland. Thank you, Mr. Chairman. I have been
waiting patiently to say thank you to the Secretary. I gave you
a letter earlier today, sir. When you first appeared before our
committee, some months ago, I recall you saying that your goal
was to make your Agency more sensitive to the concerns and
needs of members and to our constituents and I have thanked you
in that letter for three issues in which you and your staff
have been very helpful. And I want to thank you for that.
I also want to associate myself with remarks of my
colleague, Mr. Deutsch, regarding the dangers that we face from
smallpox. I think the challenges faced by the companies that
produce vaccines and the importance of these vaccines to both
the public health and the national defense call for a national
vaccine authority. The National Academy of Sciences recommends
such an authority which could investigate the need for
Government production of vaccines, the overseeing of such
production, incentivizing of private vaccine development, and
the strategic funding of research into the vaccines that we
most need. And I hope we can move in this direction.
Mr. Secretary, I do thank you for what you've already done
and for what you're trying to do, but most of all, I thank you
for what you're going to do in the future to protect this great
Nation and the people who live within it.
Thank you very much and I yield back my time.
[The prepared statement of Hon. Ted Strickland follows:]
Prepared Statement of Hon. Ted Strickland, a Representative in Congress
from the State of Ohio
Mr. Chairman, thank you for convening this important hearing about
the challenges of bioterrorism. I look forward to hearing from both
Secretary Thompson and Dr. Koplan about the role and needs of the
Department of Health and Human Services and the Centers of Disease
Control and Prevention to best equip this country to respond to a
bioterror crisis.
I am hopeful that this Committee will craft bipartisan legislation
that doesn't shortchange any of the needs our public health system
requires to get up to speed in defending our country against
bioterrorist threats. There are many threats, including the need to
build an agile surveillance and communication system between the
federal government, local public health offices, and the doctors and
nurses who are on the front lines of treating any disease outbreak. We
need a better interface between the many federal agencies that have a
role in defending against a bioterror attack. We need to educate and
train health providers who will be the first to see the symptoms of
bioterror in emergency rooms and doctor's offices. We need to protect
our food and water supplies from contamination and we need to address
the already problematic nursing workforce shortage, which would be much
worse than it already is during a bioterror attack when many people are
in need of treatment from a limited number of health care
professionals.
One specific need that I have heard about from constituents in my
district is the need to ensure that we have enough vaccines and other
medications to treat those who are exposed to bioterror agents and to
prevent the spread of disease. The vaccine industry is not profitable,
and private manufacturers have trouble keeping effective and adequate
supplies of basic vaccinations, such as that for tentanus. In fact,
there are just four major vaccine makers in business, and only two of
those four are based in the United States. We already know what happens
when a vaccine manufacturer goes out of the vaccine business: last
year, a company stopped manufacturing the flu vaccine, leaving us with
a shortage and the need to ration the available vaccine. Obviously, a
shortage and rationing during a large scale bioterror attack could be
devastating.
The challenges faced by the companies that produce vaccines and the
importance of these vaccines to both the public health and national
defense call for a national vaccine authority. The National Academy of
Sciences recommends such an authority, which could investigate the need
for government production of vaccines, oversee such production,
incentivize private vaccine development, or strategically fund research
into the vaccines we most need.
The need for vaccines and the other needs of a strong bioterror
defense requires a commitment by this Committee to look closely at our
resources and how we must allocate those resources in the best interest
of public health. I look forward to hearing from Secretary Thompson and
Dr. Koplan about these issues.
Chairman Tauzin. The gentleman has completed his statement
and yields back. Further requests for statements on this side?
Then the gentlelady, Ms. DeGette, is recognized for 3 minutes.
Ms. DeGette. Thank you, Mr. Chairman. We all agree here
today that we have ignored an underfunded public health in this
country for over 25 years. While the CDC's efforts at early
identification at bioterrorism and most notably the recent
anthrax attacks is commendable. We can't simply sit here today
and put a bandaid over the issue of our outdated public health
system in this country.
In my visit to CDC 2 weeks ago with Congressman Greenwood,
for example, I saw freezers with biological agents in them
sitting in the hallways of the CDC. Now you'll be glad to know
that those freezers did not hold the most serious agents like
smallpox, anthrax, plague and the like. Still, this is an
indication of the symptom of decades of neglect of public
health issues. And it's not enough for us to just simply sit
here and talk about it. I know that many of my other colleagues
are talking about going to the CDC and I think it's important
that we see this for ourself, to see the tremendous constraints
that the Agency is trying to undertake their important role in
the coming years.
One final note that I would make also is that we can work
to identify biological or chemical warfare in its early stages
in our local health responders, but if we do not have beds for
the sick or isolation wards to keep the diseases at bay, we
will ultimately lose out as a society.
Let me give you an example. Denver Health is probably, as
Dr. Koplan and I discussed when I was at CDC, is probably one
of the most well-equipped local health agencies, probably one
of the three most well-equipped in the country to respond to an
attack. But if, for example, somebody released a communicable
disease agent like smallpox over Mile High Stadium during a
Bronco game, even though we could identify, we don't have beds
to put the sick in. We don't have isolation wards to put the
sick in to stop the disease from spreading and until we address
this very important issue at our local level, we will never be
completely safe as a country from biological warfare. I yield
back the balance of my time.
Chairman Tauzin. I thank the gentlelady. Further requests
for time? The gentleman, Mr. Luther, is recognized for 3
minutes.
Mr. Luther. Thank you, Mr. Chairman. I'll be brief as well.
Like others, I believe we need to examine our country's
shortcomings and develop a comprehensive plan to ensure that if
we are again confronted with bioterrorism, that we respond
quickly and effectively.
I'm pleased that in some ways my home State of Minnesota
may be ahead of the curve in preparedness because we do have a
strong public health system, as I know the Secretary is aware.
But I believe we need the strongest possible leadership at the
Federal level to protect Americans against this very serious
threat. I very much appreciate Secretary Thompson, from my
neighboring State and Drs. Henderson and Koplan, for being here
today. And I join others in asking each of you to do what is
necessary within the administration and outside the
administration, even if unpopular at times, to get the highest
priority placed on this matter, to ensure the safety and
security of all Americans. I think Americans expect that and I
yield back the balance of my time.
Chairman Tauzin. Further requests for time? The gentlelady,
Ms. Capps, is recognized.
Ms. Capps. Thank you, Mr. Chairman. The topic before us
today is critical to our Nation's public health and emergency
preparedness. Thank you, Secretary Thompson, Drs. Koplan and
Henderson for being with us. The cases of anthrax have caused
us to reevaluate the current practices and capabilities of our
public health infrastructure. Our health system may be able to
deal with the day by day health needs, but clearly lacks surge
capability. It would struggle to cope with the potentially
large number of patients that may require treatment after a
severe bioterrorist attack. Many public hospitals do not have
up to date medical equipment, adequate communications or proper
integration with other institutions across the country,
including our national health agencies. We must improve our
Nation's detection and surveillance capabilities. Public
hospitals must be able to identify and report cases that could
be significant and medical staff across the country, need to
know what to look for and who to report to. And of course, CDC
is an essential piece of this puzzle.
Unfortunately, we started this year off on the wrong foot
when the administration looked to cut $168 million from CDC's
budget. This kind of cut is unwise, even when we're not
particularly worried about major threats to our public health,
but it seems particularly short sighted given what we know
today. Clearly, some of the resources Congress has already
given to the administration need to be devoted to CDC. But I am
concerned that the administration's proposal to address
bioterrorism does not allocate enough resources to many of
these priorities, particularly as compared with the Senate's
bipartisan proposal and H.R. 3255, the Bioterrorism Protection
Act, for example, in development rapid detection of biological
weapons and research into vaccines and treatments.
I don't believe the public wants us to skimp in these
areas. These are important priorities that need to be addressed
in full. We also need to make sure that we have enough
personnel to deal with bioterrorist threats to our public.
As many on this committee know, we are facing a critical
shortage of properly trained nurses. The American Hospital
Association estimates that we need 126,000 more nurses right
now. The problem is only going to get worse and a significant
number of nurses are going to be retiring over the next decade.
We know that. And fewer nurses are entering the field. As this
situation occurs, we will face a massive shortfall of nurses in
all fields, just as the Baby Boom generation begins to retire
and to need more care. This directly relates to the short term
and long term threats of bioterrorism and terrorism in general
in the United States. We need to act now to address this
problem.
I have spoken with you, Mr. Secretary. I appreciate that.
And I appreciate your willingness to work on this topic and I
want to thank our Chairman and particularly, Mr. Bilirakis for
efforts to work with me on this issue. I appreciate your
willingness to make this a priority for this committee and hope
that we all would agree that the appropriateness of passing a
bioterrorism package must include efforts to address the
nursing work force situation.
Thank you.
[The prepared statement of Hon. Lois Capps follows:]
Prepared Statement of Hon. Lois Capps, a Representative in Congress
from the State of California
Thank you Mr. Chairman, it is so important for the Congress, and
this committee in particular, to address our nation's public health
preparedness.
I want to thank Secretary Thompson and Dr. Koplan for taking the
time to join us today and share their efforts and perspectives.
There is clearly a need for us to make sure that the federal and
state agencies tasked with protecting our health have the resources
they need.
The cases of Anthrax have caused us to reevaluate the current
practices and capabilities of our public health infrastructure.
What we seem to find when we look at it is a public health system
that may be able to deal with day to day health needs but lacks surge
capacity. It would struggle to cope with the potentially large number
of patients that may require treatment after a severe bioterrorist
attack.
Many public hospitals do not have up to date medical equipment,
adequate communications, or proper integration with other institutions
across the country, including the national health agencies that will
have important information in the case of bioterrorism.
We have to improve our nation's detection and surveillance
capabilities. Public Hospitals must be able to identify and report
cases that could be significant. And medical staff across the country
need to know what to look for and who to report to.
CDC is an essential piece of this puzzle. It has done a good job in
past years to address outbreaks of serious diseases and work with state
and local agencies.
Unfortunately we started this year off on the wrong foot when the
Administration looked to cut $168 million from the CDC's budget.
This kind of cut is unwise even when we were not particularly
worried about major threats to public health, but it seems particularly
short sighted given what we know today.
Clearly some of the resources Congress has already given the
Administration need to be devoted to CDC.1But I am concerned that the
Administration's proposal to address bioterrorism does not allocate
enough resources to many of these priorities.
As compared to the Senate's bipartisan proposal and HR 3255, the
Bioterrorism Protection Act, the administration's request does not go
far enough in helping state and local public health capacities and
hospital preparedness.
And both bills go further in developing rapid detection of
biological weapons and research into vaccines and treatments.
It is of course necessary for the government to continue on a
fiscally responsible path, but this is not the place to skimp. These
are important priorities that need to be addressed in full.
We also need to make sure that we have enough personnel to deal
with bioterrorist threats to our public health.
As many on this committee know, we are facing a critical shortage
of properly trained nurses.
The American Hospital Association estimates that we need 126,000
more nurses right now. And the problem is only going to get worse.
A significant number of nurses will be retiring over the next
decade, and fewer new nurses are entering the field.
As this contraction occurs, we will face a massive shortfall of
nurses in all fields just as the baby-boom generation begins to retire
and need more care.
This directly relates to the short term and long term threats of
terrorism and bioterrorism in the United States. We need to act now to
address this problem.
I have spoken before with Sec. Thompson about this issue and I
appreciate your willingness to work on it. And I want to thank you Mr.
Chairman, and Chairman Bilirakis, for your efforts to work with me on
this issue. I appreciate your willingness to make this a priority for
the committee.
I hope we all would agree that it would be best to include efforts
to address the nursing workforce situation a bioterrorism package.
I am eager to hear the comments of my colleagues and our
distinguished guests and I look forward to working with you on these
issues.
Chairman Tauzin. I thank the gentlelady. She's absolutely
on point in her statement. I recognize the gentlelady from
California, Ms. Harman, for an opening statement.
Ms. Harman. We're almost ready for your opening statements.
I thank you, Mr. Chairman. I would like tell you and our
witnesses that I come from a family of medical doctors. My late
father served three generations of patients in Los Angeles and
my brother was a resident at a public health service hospital
and is now an oncologist and hematologist and I have, I think,
a long standing appreciation for the importance of our public
health system.
Like Mr. Burr, I also serve on the House Intelligence
Committee and went to CDC a few weeks ago, learning what others
have learned about the talented people there working in shabby
conditions. I would just hold up a few of your pictures here
showing $500,000 equipment, pieces of equipment with plastic
covers to protect it from the rain, and important biological
culture and tissue samples in hallways in firetraps that were
built in the 1940's and that are still standing on your
Chamblee Campus.
I think that the Federal response to bioterrorist threats,
which are real and continuing has been good, at least there
have been good aspects to it, the best of them the great
people, the enormous talent that they possess and the selfless
dedication that they show. There have also been flaws revealed
in two areas. One, the lack of resources which everyone has
been talking about, and two, a lack of organization.
On the resources point, I want to commend you, Mr.
Chairman, and our vice chairman, Mr. Burr, for deciding to move
an important bipartisan piece of legislation that I cosponsor,
to accelerate infrastructure improvements at the CDC and cut in
half the time needed to improve these buildings where talented
people work in the shabbiest conditions. I think that that is a
critical thing we can do and I gather we will do it, so thank
you very much. That's one piece.
On organization, we've heard again from many who've spoken
before me about the vague lines of authority and some of the
muddled procedures that led to some of the gaps in our response
to the anthrax attacks. I realize that every witness here has
moved to correct those gaps. I think you will have a lot of
success in doing that. However, I continue to believe that the
new Office of Homeland Security in the White House needs to
have more authority, more statutory and budget authority, to
help you coordinate better. Without one voice, one threat
assessment, one national strategy, I believe we will continue
to have problems. And so I would urge us all to line up behind
bipartisan legislation to give statutory authority to Governor
Ridge, and I would tell the witnesses here that you are part of
the solution and I commend you for all the work that you've
been doing. Thank you, Mr. Chairman.
[The prepared statement of Hon. Jane Harman follows:]
Prepared Statement of Hon. Jane Harman, a Representative in Congress
from the State of California
Thank you, Mr. Chairman, and I would also like to thank Secretary
Thompson and Dr. Koplan for appearing before the Committee today.
Our nation's response to the anthrax attacks over the past month
has shown some of our government's great strengths, but also some of
our weaknesses. I am well aware of the Administration's existing
programs to combat bioterrorism and support the work you have done so
far with limited resources.
Unfortunately, we still have a long way to go before our nation
will truly be prepared for a bioterrorist attack. Vague lines of
authority and muddled procedures led to miscommunications and glaring
oversights, such as the delayed testing of postal workers. I do not
want to play the blame game--we are, after all, only beginning
understanding the science of an anthrax attack--but am glad for the
opportunity to begin to look at how we can improve our federal
response.
One lesson we learned is that there is no one quick fix that will
improve our bioterrorism response. Our domestic public health response
should be as strong and coordinated as the military campaign we are
waging in Afghanistan--if not stronger. We should have substantial and
diverse funds directed to local public health departments and hospitals
so that they can do everything from updating emergency response plans
for bioterrorism to establishing advanced surveillance systems that can
detect the outbreak of new diseases.
All of those who have spoken before me have mentioned useful--and
essential--ways to invest in our public health system. I would like to
mention one point that has not yet been raised--an investment in the
basic infrastructure at CDC.
I visited the Centers for Disease Control on October 22nd and saw
that the fight against bioterrorism is being waged by talented people
working in shabby conditions. Many of the CDC's laboratories are housed
in ``temporary'' structures, built in the 1940's, where the ceilings
leak and plastic sheeting covers sensitive equipment. Power outages,
cramped quarters and inadequate working facilities impair our abilities
to find breakthrough cures and treatments. I think you both agree that
we must provide our best scientists the resources to conduct research
and evaluate lab samples in a safe, secure environment. My colleagues
John Linder, Saxby Chambliss, and I introduced legislation to invest
$1.5 billion in CDC buildings and facilities over the next five years,
so that you, Dr. Koplan, will be able to upgrade laboratories and
essential for bioterrorism response and improve security at CDC.
I understand that the legislation the Commerce Committee is
drafting will include an authorization of funds for CDC buildings and
facilities. I would like to stress that a $300 million investment in
each of the next five years is essential to provide the steady stream
of funds CDC needs to build and renovate the facilities needed to meet
today's bioterrorist threat. 1Securing these facilities--as important
as that is--is one of a great many homeland security needs. Most of the
problems with our bioterrorism response activities cannot be solved by
throwing around money--to be sure, we do we have unlimited resources to
do this. What we do need is a unified threat assessment and a national
strategy to meet it.
At the federal level, the US government needs to eliminate the
communication gaps that led to confusion over the type of anthrax that
was sent to Senator Daschle's office. We must integrate the
bioterrorism research agenda of the Departments of Health and Human
Services and Defense. We must clarify who is responsible for managing
the investigation of a suspicious disease outbreak. Governor Ridge can
accomplish all of these tasks--and integrate these federal efforts with
our state and local response--but only if he has the statutory
authority to do his job. He should not be communicating our message on
anthrax--he should be the apex of a well-coordinated, multi-layered
system of bioterrorism response.
In a House Commerce Oversight and Investigations Subcommittee on
federal bioterrorism preparedness on October 10, seven assembled
witnesses agreed that Gov. Ridge must have budgetary authority. I would
hope that everyone gathered here would agree.
Chairman Tauzin. The gentlelady's time has expired. I'm
pleased to let the gentlelady know, I know she knows this. In
the draft bill, we're providing $300 million a year for 2 years
to upgrade those facilities.
[Additional statement submitted for the record follows:]
Prepared Statement of Hon. James Greenwood, a Representative in
Congress from the State of Pennsylvania
Mr. Chairman, I congratulate you for holding this hearing on
bioterrorism and for your work in moving a responsible and
comprehensive bioterrorism proposals for discussion. I am heartened
that this committee is galvanized by the dangers we face and is
committed to leading the effort to fight this new kind of war in a new
kind of way. And I also want to thank you for your personal commitment
of time and valuable full committee resources to support the work the
Subcommittee on Oversight and Investigation, which I chair, has done in
this area.
Both the hearing and recent passage of the Bioterrorism Enforcement
Act constitute full committee actions which, in large measure, are an
outgrowth of the discoveries we have made about the threat of bio-
terrorism as a result of a series of hearings held before the
Subcommittee on Oversight and Investigations.
And there is much work to do. Our traditional public health
surveillance system is the equivalent of relying on the pony express in
the age of the world wide web.
Many parts of the country still rely on doctors mailing in
postcards to their local public health departments. The traditional
system is too limited in what is reported, too slow in its reporting,
too late in the patient evaluation process, and too incomplete to meet
our country's emerging needs in this area.
In the last six weeks, the subcommittee has held hearings on such
critical issues as the effectiveness of Federal programs designed to
bolster the preparedness of States and local communities to deal with
bioterrorist attacks; building an early warning public health
surveillance system; and the physical security at the Centers for
Disease Control and Prevention (CDC) and the National Institutes of
Health. In addition, on October 23, this committee managed the House
passage of H.R. 3160, the ``Bioterrorism Enforcement Act of 2001,''
which imposes Federal controls on possession and use of certain
biological agents. This legislation addressed issues raised in previous
Oversight and Investigations Subcommittee hearings the provisions of
H.R. 3160 should be included in any proposed bioterrorism package.
From the subcommittee's bioterrorism oversight work my sense is the
committee should focus on several areas today.
First, there is a need for a better early warning system and rapid
response to biological attacks, especially the need to fund front line
first responders, establish universal protocols and enhance the State-
Federal partnership in this area through the existing grant structure.
Another area worthy of our immediate attention is one of Federal
preparedness and security. From my visit to the CDC facilities on
November 2 and the Oversight Subcommittee hearing on November 7, I note
that while the Secretary has correctly identified physical security as
a priority and the CDC is beginning to address some security concerns,
the agency is still faced with making a full transition to a post-
September 11 mindset. This includes not only the actions needed to
protect biological materials and certain deadly pathogens used in
research against theft, but also the very real need to carefully guard
any stockpiles of medicines and vaccines which may prove essential in
responding to an act of biological terrorism and which are in the
governments care. Third, there is a critical need for information
sharing and coordination at every level of government between public
health and traditional law enforcement and intelligence gathering
agencies. Meeting this need is particularly crucial to first
responders.
The antrhax investigation clearly demonstrated the need for this
kind of communication to occur, but this committee needs to identify
ways in which we can help nurture this flow of information.
I am delighted that the committee is working on legislation to
address these problems.
I welcome Secretary Thompson and Dr. Koplan. I look forward to the
Secretary's testimony and a constructive dialogue with the witnesses.
Chairman Tauzin. It's finally time for us to welcome our
witnesses and I certainly want to do so, but before I introduce
the Secretary, I have the very special honor of introducing to
all the members and our guests today and to the Americans who
may be viewing this hearing via television a real American hero
in the person of Dr. Donald Henderson. Dr. Henderson was
actually the head of the World Health Organization team which
eradicated smallpox which was such a scourge on this earth for
so long. I think he deserves our applause and our appreciation.
Mr. Brown. Mr. Chairman, I would add that Dr. Henderson was
a graduate of Oberlin College which actually won its first
football game 2 weeks ago, since Dr. Henderson graduated.
Chairman Tauzin. Pretty exciting. Mr. Secretary, we're
delighted to have you here and Dr. Koplan, on behalf of the
CDC, we deeply appreciate your presence. You've heard,
obviously, from a great number of our members today about how
seriously we take our responsibility here and I know you do too
and we welcome your testimony, sir.
STATEMENT OF HON. TOMMY THOMPSON, SECRETARY, DEPARTMENT OF
HEALTH AND HUMAN SERVICES; ACCOMPANIED BY JEFFREY P. KOPLAN,
DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION
Mr. Thompson. Thank you so very much, Chairman Tauzin, and
good morning and to ranking minority member----
Chairman Tauzin. Would the Secretary pull that mike a
little closer so that we----
Mr. Thompson. Thank you so very much. Let me just start off
by thanking all of you. It was music to my ears, as an advocate
of the public health system in America that on a bipartisan
basis individuals were talking about the importance, the need,
to invest in our public health system and let me just say thank
you to all of you.
I also learned a great deal this morning, especially the
fact that anytime I appear in front of your committee, I will
bring Dr. Henderson back in front and it was unprecedented and
it was a very precedent to start.
I want to start off by thanking you, Mr. Chairman, this
committee, for their leadership on this issue. Like me, all of
us have been working extremely hard on this issue, long before
the attacks on September 11. The Nation should be comforted by
your leadership on this committee for all that you've done so
far and what you continue to do in this very important area.
Thank you for inviting me to speak to you on the role of
the Department's Centers for Disease Control and Prevention
which played such a very important public health protection
led. I am joined by Dr. Jeffrey Koplan, who has just done an
outstanding job and I think he is one of those unsung heroes
and I thank him so very much for being here. He's the Director
of the Centers for Disease Control and Prevention and Dr.
Henderson who is our new head of our newly created Office of
Public Health Preparedness. I can't stop but just make a quick
observation in regards to the facilities at CDC Headquarters. I
came in front of this committee in June and talked to you about
the need for improving those facilities and I'm so appreciative
that all of you are talking about it. We have three campuses
down there and we still rent 25 other buildings around the
city. It doesn't make much sense and we need to improve it and
I thank you so much for your leadership.
The strength of our public health system is of the utmost
importance to the President and the Department of Health and
Human Services and also the Centers for Disease Control, as our
Nation's doctors, nurses, the EMTs and the other health
professionals who are on the front lines, as a lot of you have
indicated. And we must provide them the support and the
expertise they need to respond to public health causes. Let me
assure you that the response from the Federal, the State and
the local officials, to each and every unprecedented attack
over the last 2 months has been very strong, like our
counterparts at the State and the local levels.
We at the Department of Health and Human Services and the
CDC have faced and we have met new challenges. Just a month
ago, for example, our best information told us that inhalation
anthrax was up to 80 percent fatal. We never want to see
fatalities. And it truly is a tragedy that four people have
died. But the fatality for inhalation anthrax in these attacks
has been about 40 percent. And I am happy to report that the
last of those hospitalized went home yesterday. It's a
testament, I believe, to CDC's expertise that we have been able
to save lives, prevent countless people from becoming ill and
treat those who have fallen ill. And it's a testament to the
CDC and to the public health professionals on the front line
that people with inhalation anthrax are walking out of the
hospital. While our response has been strong, we must and we
will do more. WE must do more. The response to anthrax attacks
is an evolving science. We've learned so much over the last 6
weeks and we're learning more each and every day.
Winston Churchill once said, ``let our advance worrying
become advance thinking and planning.'' I think that's very
apropos for this discussion. We at the Department of Health and
Human Services have taken those words to heart on the
bioterrorism front. Since I arrived in Washington a short 8
months ago, we have assembled the greatest collection of
doctors and scientists in the world, I believe, from the CDC to
the National Institutes of Health, to the HHS Headquarters
downtown who are all advising the Government and strengthening
our Nation's preparedness.
Last spring, I named Dr. Scott Lillibridge my special
assistant for bioterrorism and his counsel has been invaluable.
And now that the threat of a bioterrorist attack has been
realized, I have strengthened our team even further by adding
Dr. Henderson as the head of the Office of Public Health
Preparedness, which will coordinate the Departmental to
responses to the public health emergencies.
As many of you all know and I'm very happy that you saluted
him, Dr. Henderson is the father of the eradication of
smallpox, having directed the World Health Organization's
Global Smallpox Eradication Campaign from 1966 to 1977. Dr.
Henderson brings a lifetime of preparation for the demands of
the job and I am personally grateful that he agreed to join me
in Washington to assist me, the Department and the Nation
during this time.
I am also very happy to report that we're in the process of
hopefully having Major General (Retired) Philip Russell who
comes on who is an expert in vaccines to come on and join with
Dr. Henderson, along with Dr. Michael Aster from California to
come, who's an expert on laboratories to also assist this team.
President Bush and I recognize, as you all do, the vital
role the CDC plays in protecting the homeland from bioterrorist
attacks. I spent several days last week, or 2 weeks ago working
at CDC and to see first hand the work that they are doing to
respond to the anthrax attacks and the number of great
scientists we have down there working overtime in their
laboratories, sometimes sleeping there, making sure they get
the analysis done properly and correctly and expeditiously.
President Bush and Governor Ridge and I also visited CDC
last week where he made major announcements. President Bush has
been keenly focused on preventing bioterrorism and the
coordination he has demanded and achieved of a far-reaching
Federal Government has been admirable coordination and
communication and I believe it's improving each day and it
needs to improve each day.
In the aftermath of September 11, the President requested
an additional $1.5 billion to strengthen our ability to prevent
and respond to a bioterrorism attack as part of the $40 billion
homeland defense package. The President has also asked for $600
million to strengthen FEMA's planning and response activities.
Our request includes $643 million to expand the national
pharmaceutical stockpile and $509 million to speed the purchase
of 300 million doses of smallpox and with these resources HHS
will expand its program capabilities to respond to an all
hazardous event.
In response to Congressman Deutsch, I'd like to point out
that we have accelerated--there was not going to be any
delivery of smallpox vaccine until 2004, 2005 and we hopefully
will now have all of the 300 million doses, in hand, on stock
within the next 12 months. And Dr. Henderson, I believe, is
going to come back this afternoon and also fill you in on some
further details.
With the additional resources, we will also add four more
push packs to the current aid already located across the
country, making more emergency supplies available and
augmenting our existing supplies of 400 tons by another 200
tons. The President and the Department are also committed to
the development and the approval of new vaccines and therapies.
The CDC, the Food and Drug Administration and the National
Institutes of Health, all agencies within HHS are collaborating
with the Department of Defense and other agencies to support
and encourage research to address scientific issues related to
bioterrorism. We also set up a scientific committee to take a
look at how we could accelerate new vaccines and new therapies
in the area of bioterrorism.
The capability to detect and counter bioterrorism depends
to a significant degree on the state of relevant medical
science. Our continuing research agenda and collaboration with
CDC, FDA, NIH and DOD is critical to our overall preparedness.
The President is calling for additional resources to expand
HHS's capacity to respond to terrorist incidents, Also included
in the amount is $20 million to support additional expert
epidemiology teams that can be sent to the States and cities to
help them respond quickly to infectious disease outbreaks as
well as other public health risks.
And let me reiterate something I said in front of this
committee in June--my conviction that every State should have
at least one federally funded epidemiologist who has graduated
from the CDC's Epidemic Intelligence Service Training Program
that would be very helpful to strengthen our local and State
public health system.
The President is also asking for $50 million to strengthen
the Metropolitan Medical Response System to increase the number
of large cities from 97 to 122 that are able to fully develop
their MMRS units and to spend more money getting our medical
response and emergency systems up to speed.
It is imperative that we work together in a bipartisan
basis with cities to ensure that their MMRS units have the
proper equipment and the proper training. We are also providing
$50 million to assist hospitals and emergency departments in
preparing for, and responding to, incidents requiring
immunization and treatment, and we are providing $10 million to
augment State and local preparedness by providing training to
the State health departments on bioterrorism, and, yes, on
emergency response.
The President is also requesting $40 million to support
early detection surveillance to identify potential bioterrorism
agents, which includes web-based disease notification to the
health community nationwide. This amount will provide for the
expansion of the Health Alert Network, which helps early
detection of disease, to 75 percent of the Nation's 3,000
counties. I believe it is important that we set as a goal to
have most of the counties connected in the coming years.
We are providing $15 million to support the increased
capacity in no less than 78 laboratories in 45 States. This
funding will enhance our ability to identify and be able to
detect all of the critical biological agents. And we are
implementing a new hospital preparedness effort to ensure that
our health facilities have the equipment and the training they
need to respond to mass casualty incidents.
In total, more than $300 million in additional funding is
being requested just for fiscal year 2002 for State and local
preparedness. This also means that we will have to come back in
front of this committee and the Congress in the years to come
for additional resources for our local and State public health
departments.
As to food safety, something that Congressman Dingell is
very much interested in and I salute him for it, I would like
to commend this committee--along with you, Chairman Tauzin, you
have been an absolute leader, and I thank you so very much--for
your leadership on one of my top priorities. I truly appreciate
the cooperation we have received from members of this
committee.
The President is requesting $61 million to enhance the
frequency and the quality of imported food inspections and to
modernize the import data system to enable us to detect tainted
food. This funding would also provide for 410 new FDA
inspectors to help ensure that our food is better protected.
In the past, additional resources for food safety have not
always been a priority, and the result is not enough of
America's food supply is currently being inspected. That is
unacceptable. We do need additional resources to enhance the
frequency and the quality of imported food inspections and to
be able to modernize the import data system.
But it is not simply a matter of money. We also need
enhanced authority to prevent potentially deadly foods from
entering into commercial channels. Let me mention several areas
that I think are important and are included in legislation we
have submitted to Congress.
Currently, the FDA cannot require the owner of food to hold
further distribution until a product's safety can be
determined. In a public health emergency, I believe that
authority to detain food is not only reasonable but vital to
protecting the American public. This administration has
requested that new authority in cases of emergency.
We also need to enable the FDA to prevent importers, who
have a history of repeated violations of our food safety laws,
from continuing to import food into this country. And we have
asked the food importers to be given and to give us advance
notice that their shipments are approaching our borders, so
that FDA will have time to gather information that it needs to
make quick, informed decisions about whether to allow that
entry into this country.
From the farm to the table, we owe it to all Americans to
protect the safety of the food supply. Some of these ideas that
I have presented are not new, and some of you on this committee
have supported these and other initiatives in the past, and I
commend you. We are committed to working with this committee to
see that legislation is enacted this year. We don't have much
longer to act, and this, to me, is a No. 1 priority.
It is my understanding that the committee may be including
universal product numbering language in the bioterrorism bill.
As you know, I am a strong supporter of technology that
improves the way that we do business, for improving the safety
and the quality of health care. I have said on several
occasions that bar coding technology has mass potential for
safeguarding against medical mistakes. And since September 11,
we are all the more aware of how critical it is to shore up and
expedite the health care supply chain and delivery function, so
we can have more lives saved. Products went in there that are
needed--especially in times of crisis.
Improving the health care technology is a critical building
block, Mr. Chairman, of the infrastructure we must erect to
ensure the utmost preparedness for bioterrorism and other
disasters.
Finally, I know members of this committee have expressed
concern about the overall security of the Nation's
laboratories, and I share their concerns. There has been, and
needs to be, a great deal of focus on the critical need for
additional resources in order to heighten security at CDC
facilities.
As many of you know, in 1996, there was an internal review
of the physical security at CDC facilities. The Office of
Inspector General recommended enhancing security measures at
CDC facilities. In response, the CDC has implemented several
new security improvements. A followup review conducted by the
OIG earlier this year indicated that CDC had taken several
positive steps to ensure the safety and security of the CDC
facilities, and that even more actions must be taken if
appropriately funded.
Additionally, immediately after September 11, I ordered
from the Department a rapid assessment of the Security
Department, which resulted in an additional $30 million of the
supplemental request to address core improvements of these
facilities. Included in this amount is $8 million for needs
that can be addressed immediately on our CDC campuses and $22
million for crucial upgrades that will tighten security at
facilities where dangerous pathogens are stored.
Further improvements remain one of my highest priorities in
our fight against bioterrorism, and I have assigned a member of
the Inspector General's staff to my command center to focus on
security at the labs across the country. And I have hired Jerry
Hower as a consultant to work with us to ensure our labs across
America are as secure as possible.
Jerry is one of our Nation's leading experts in
bioterrorism and has worked as a consultant to the Department.
His counsel has been, and will continue to be, invaluable.
Jerry is the former director of New York City's Office of
Emergency Management and was responsible for putting in place
much of the plan that enabled the city of New York to respond
so well to the terrorist attack on September 11. We should also
look at improving security at the private facilities as well.
I want to thank you, Mr. Chairman, and the members of this
committee for swiftly moving a proposal President Bush
requested that will give the Department new authority to
regulate the possession, the use, and the transfer of
biological agents and toxins at the many private laboratories
and institutions throughout our country.
Together we are building a stronger infrastructure that
will allow us to even more effectively respond to any public
health emergencies in the future.
Thank you, Mr. Chairman, for inviting me, Dr. Koplan, and
Dr. Henderson to testify on this very important topic. And now
I would be happy to take your questions.
[The prepared statement of Hon. Tommy Thompson follows:]
Prepared Statement of Hon. Tommy G. Thompson, Secretary, Department of
Health and Human Services
Good morning Mr. Chairman and Members of the Committee. Thank you
for the invitation to discuss my Department's role in protecting our
nation's public health and bioterrorism. I am accompanied today by Dr.
Jeffrey P. Koplan, Director of the Centers for Disease Control and
Prevention (CDC), and Dr. D.A. Henderson, the head of our newly created
Office of Public Health Preparedness, which will coordinate the
Department-wide respond to public health emergencies. Before I begin, I
would like to compliment this Committee for its foresight in working to
enact ``The Public Health Threats and Emergencies'' bill last year,
which was a landmark piece of legislation supporting improvements to
our nation's public health infrastructure. Through your hard work and
dedication, much of the infrastructure and tools to increase the public
health capacity to address bioterrorism and other public health
emergencies is already in place. Thank you.
The terrorist events of September 11th and later events related to
anthrax have been defining moments for all of us--and they have greatly
sharpened the Nation's focus on public health. Prior to the September
11th attack on the United States, CDC had made substantial progress in
defining and developing a nationwide framework to increase the
capacities of public health agencies at all levels--federal, state, and
local. Since September 11th, CDC has dramatically increased its level
of preparedness and is developing and implementing plans to increase it
even further. In recent weeks, I have spent considerable time at CDC--
and President Bush, Homeland Security Director Ridge and myself also
visited the CDC last week--witnessing first hand the efforts to address
the health threats this Nation currently faces and to prepare for
future needs to protect the Nation's health.
I know some critics are charging that our public health system is
not prepared to respond to a major bioterrorist attack. I know that
some state and local labs are feeling overwhelmed right now, but the
response from state and local authorities--to each and every threat--is
continuing and will continue. And we should be proud of how well we
have all responded to events that have broken our hearts even as they
have steeled our resolve.
Just a month ago, for example, our best information told us that
inhalation anthrax was 80 percent fatal. We never want to see
fatalities, and it truly is a tragedy that four people have died. But
the fatality rate for inhalation anthrax in these attacks has been 40
percent--and I am happy to report today that the last patient
hospitalized is now at home with his family. It's a testament to the
CDC's expertise that we have been able to save lives, prevent countless
people from becoming ill and treat those who have fallen ill. And it's
a testament to the CDC and public health professionals that people with
inhalation anthrax are walking out of the hospital. While our response
has been strong, we must--and we will--do more. The response to anthrax
attacks is an evolving science, one that is being rewritten with each
passing day.
The Department of Health and Human Services plays a vital role in
protecting our homeland from a bioterrorist attack, and an even more
important role in responding to the health consequences of such an
attack. In the aftermath of September 11th, President Bush has
requested an additional $1.5 billion to strengthen our ability to
prevent and respond to bioterrorism.
Let me outline several areas of this budget request that
specifically relate to the work performed by CDC.
FUNDING INITIATIVES
National Pharmaceutical Stockpile
The President's request includes $643 million to expand the
National Pharmaceutical Stockpile, which is managed by CDC. With these
resources, HHS will expand its program capabilities to respond to an
all-hazards event.
As you may know, there are currently 8 Push Packs available as part
of the Stockpile. Each one includes no less than 84 separate types of
supplies; things like antibiotics, needles and I-Vs, a tablet counting
machine and nerve agent antidotes. Each Push Pack provides a full
course of antibiotics and other medical supplies and is shipped to an
area within 12 hours to help state and local response efforts. These
Push Packs are complemented by large quantities of pharmaceuticals
stored in manufacturers' warehouses. This is called Vendor Managed
Inventory (VMI). The VMI and the 8 Push Packs combined have enough
drugs to treat 2 million persons for inhalation anthrax following
exposure.
I have directed that the Stockpile should be increased for anthrax
so that 12 million persons can be treated. CDC will reach that level of
response during Fiscal Year 2002. With the additional resources, we
will also add four more Push Packs to the current eight already located
across the country, making more emergency supplies available and
augmenting our existing supplies of 400 tons by another 200 tons.
Research
The Administration is also committed to the development and
approval of new vaccines and therapies. The CDC, the Food and Drug
Administration and the National Institutes of Health--all agencies
within HHS--are collaborating with the Defense Department and other
agencies to support and encourage research to address scientific issues
related to bioterrorism.
The capability to detect and counter bioterrorism depends to a
significant degree on the state of relevant medical science. This
continuing collaborative research agenda of CDC, FDA, NIH, and DOD is
critical to overall preparedness.
Laboratory Capability
The President is calling for an expansion of HHS's capacity to
respond to bioterrorist incidents, including $20 million for the CDC's
Rapid Response and Advance Technology and specialty labs, which provide
quick identification of suspected agents and technical assistance to
state labs. We're also providing $15 million to support increased
capacity in no less than 78 laboratories in 45 states. This funding
will enhance our ability to identify and detect critical biological
agents.
Surveillance, Communications, and Training
Also included in this amount is $20 million to support additional
expert epidemiology teams that can be sent to states and cities to help
them respond quickly to infectious disease outbreaks and other public
health risks. And let me reiterate my conviction that every state
should have at least one federally funded epidemiologist who has been
trained in the CDC's Epidemic Intelligence Service (EIS) training
program. The President's budget will accomplish this goal. Currently,
there are 42 EIS officers in 24 States.
The President is also requesting $40 million to support the
nation's Public Health communications infrastructure to facilitate
information sharing concerning potential bioterrorism agents, which
includes Web-based disease notification systems to the health community
nationwide. This amount will provide for the expansion of the Health
Alert Network, which will assist CDC in disseminating critical, time-
sensitive disease alerts to 75 percent of the nation's 3,000 counties,
and Epi-X, a secure web-based communications system that provides
information sharing capabilities to state and local health officials.
These expansions will encourage state and local health departments to
be vigilant in identifying public health threats. I intend to have all
counties connected in the coming year. One of our goals is to assist
state and local health departments achieve 24/7 capacity to receive and
act upon health alerts. And we're providing $10 million to augment
state and local preparedness by providing training and resources for
state health departments to develop readiness plans on bioterrorism and
emergency response.
Food Safety
The President is also requesting $61 million to enhance the
frequency and quality of imported food inspections and modernize the
import data system to enable us to detect tainted food. This funding
will also provide for 410 new FDA inspectors to help ensure that our
food is better protected.
Security for CDC Facilities
The Administration is also requesting an additional $30 million to
enhance the security of CDC and other critical facilities operated by
the Department. Members of this Committee have expressed concern about
the overall security of the nation's laboratories, and I share their
concerns. There has been--and needs to be--a great deal of focus on the
critical need for additional resources to heighten security at CDC
facilities. I have read a 1996 HHS Inspector General report that
recommended security at facilities be increased, and a recent review of
those findings. Progress has been made, but the Department must do
better.
Included in the amount requested by the President is $8 million for
needs that can be addressed immediately at our CDC campuses, and $22
million for crucial upgrades that will harden security at these
facilities that house some of the country's most dangerous pathogens.
These investments are important to our public health mission and our
fight against bioterrorism, and I implore you to fund this request.
LEGISLATIVE INITIATIVES
In legislation the President sent to Congress to strengthen the
Department's ability to respond to bioterrorism, much of the new
authority requested lies in the area of food safety. I am particularly
concerned about this issue.
As I have mentioned, too few resources have in the past been
dedicated to food safety. But it is not just a matter of money. The
Department--FDA--has for years needed enhanced authority to stop
potentially deadly food supplies from entering into commercial
channels.
Currently, the FDA cannot require that the owner of food hold
further distribution of that product into the stream of commerce until
a product's safety can be determined. In a public health emergency, FDA
needs the authority to detain food for a reasonable time so that it can
assess the hazard and not worry that goods are entering into commercial
channels. In the case of certain public health emergencies, this
limited new authority would be vital to protecting the American public.
Also included in the Administration's proposal is increased
maintenance and inspection of source and distribution records for
foods. Under current law, if the FDA suspected food was being used in a
biological attack, the Agency could not access the records of food
manufacturers, packers, distributors and others to identify the
location of a product or the source of that product. Such records might
not even be maintained. Requiring that records be kept, and that FDA
have the authority to inspect and copy these records is not
unreasonable in light of the serious health consequences that could
occur if our food supply became a vehicle for bioterrorism.
The President has also requested that the FDA be able to prevent
importers who have a history of repeated violations of our food safety
laws from continuing to import food into this country. And, the
Administration has asked that food importers give advanced notice that
their shipments are approaching our borders, so that FDA will have time
to gather information that it needs to make quick, informed decisions
about whether to allow entry into this country.
Also requested by the Administration are additional tools to
improve the security and safety of the many private laboratories
throughout this country that handle potentially deadly pathogens. The
possession, use and transfer of biological agents and toxins by these
facilities is an issue that concerns many not only in the public health
community, but also in the intelligence and defense communities. Under
the proposal, the Department would have the authority to regulate
entities handling these pathogens.
This Committee and the full House of Representatives, have already
recognized the importance of this issue, by passing legislation that
addresses this issue. Thank you, Mr. Chairman, and members of this
Committee, for swiftly moving the President's proposal.
CONCLUSION
In conclusion, the Department's top priority is to protect the
Nation's health. To do this, the Department, through the CDC, continues
to focus on building a solid public health infrastructure--with our
state and local partners--to protect the health of all citizens. As
recent events have shown so dramatically, we must be constantly
vigilant to protect our nation's health and security. The war on
terrorism is being fought on many fronts, and we must ensure a strong,
robust public health system to be on guard at all times to prevent and
respond to multiple and simultaneous terrorist acts. The arsenal of
terrorism may include biological, chemical, and radiological agents as
well as conventional and non-conventional weapons, as the attack on the
World Trade Center so vividly attests.
Regardless of the arsenal, the Department of Health and Human
Services is helping to build core public health capacities in this
country that will allow us to more effectively respond to any public
health emergency in the future.
At this time, I would be happy to answer questions from you and
Members of the Committee.
Chairman Tauzin. Thank you, Mr. Secretary. Let me first
recognize myself for 5 minutes, and members in order. Mr.
Secretary, this morning we learned on the national news that
the head of the Taliban, Mohammed Omar, announced that they are
planning--not Al-Qaeda, the Taliban, that they are planning the
destruction of the United States. And they are planning events
that are unimaginable to mankind, and one can only guess that
he is referring to determined attempts to inflict biological,
chemical, or even nuclear damage upon the United States.
This morning we also learned that the terrorist manuals
that we have been knowing about for a long time, the jihad
terrorist manuals operated by bin Ladin and his group, actually
now include new volumes, one on chemical and biological warfare
and one on nuclear bomb-making. They were discussed this
morning on the morning news. This is serious business.
And the first question I have for you is one some of the
members have related to already in their discussions with you.
And before I ask it, let me put on the record that we have now
an agreement that your office will share with us documents on
the report on security of the labs and CDC, which we had
requested, and also information on the agents. And I thank you
for that agreement.
The question I have for you is that you just now appointed
Dr. Henderson as your new Office of Public Health Preparedness
Director. You also have an Office of Emergency Preparedness.
You also have Scott Lillibridge as your Special Assistant for
National Security and Bioterrorism. In addition, you have a
Bioterrorism Preparedness and Response Program.
Now we know you are in charge. But with all of these
offices, how do we know, really, who is in charge and
responsible for what? How are you organizing this? How are you
coordinating this internally? And if I can ask a second
question quickly, how are you also coordinating this with the
Defense Department and other intelligence agencies that are
critical in this endeavor to protect our country?
Mr. Thompson. Mr. Chairman, what we have done is we have
taken a huge room across from the Secretary's office as an
intervention room. And in there we have set up a complete
command structure in which we get all of the information coming
in from CDC, the FBI, the CIA, the National Security Council,
on an hourly basis.
And in charge is Dr. Henderson, who is the overall command
general who collects the information and then advises me. And
Scott Lillibridge is the individual that is actually inside the
intervention room reporting to Dr. Henderson.
Chairman Tauzin. So Dr. Henderson will have overall
supervision of all of these other offices.
Mr. Thompson. That is correct.
Chairman Tauzin. And report I suppose also to Tom Ridge,
the Homeland Security Director, is that correct? As well as, of
course, to you first.
Mr. Thompson. And then we report to the White House on a
daily basis, in fact more frequently than on a daily basis, as
to what is going on. And then each morning NIH, CDC, and FDA,
and all of us have a morning telephone conference at 9 in the
morning with Dr. Koplan and Dr. Tony Fauci and Bernshwetz and
Dr. Henderson and myself.
Chairman Tauzin. Okay. That is the daily routine?
Mr. Thompson. That is the daily routine.
Chairman Tauzin. Can you also explain to us the status of
the national disaster medical system itself?
Mr. Thompson. Pardon?
Chairman Tauzin. The national disaster medical system
itself. Perhaps, Dr. Koplan, you can assist us here.
Mr. Thompson. The national----
Chairman Tauzin. Disaster medical system.
Mr. Thompson. That is under the Office of Emergency
Preparedness. That is headed up by Art Lawrence, and that
reports directly to the Assistant Secretary of Health, who has
been nominated but has not been approved.
Chairman Tauzin. Has not been appointed yet. That is right.
Mr. Thompson. And they report directly to me.
Chairman Tauzin. All right. Do you support the creation of
a new Office on Vaccines at HHS? We have been told that that is
a proposal being made.
Mr. Thompson. I don't think we need one because what we are
doing under Dr. Henderson, we are putting in an individual by
the name of Phil Russell, who is the former--he is the retired
Commandant at USAMRIID. And he is an expert in vaccines, and he
works with Dr. Henderson and makes any advice and any
suggestions possible. Plus, we have a Vaccine Advisory
Committee set up through NIH, CDC, FDA, which meets regularly.
They met all last week in regards to the----
Chairman Tauzin. NIH is vitally involved in this also.
Mr. Thompson. Very much so, on a daily basis.
Chairman Tauzin. Members have asked that question of me.
Would you mind, Mr. Secretary, passing the mike to Dr.
Henderson. I want to ask a question that I think is on the
minds of----
Mr. Thompson. Absolutely.
Chairman Tauzin. [continuing] most Americans and probably
most citizens of the world, Dr. Henderson. You oversaw the
enormously important work to eradicate smallpox as the disease
that kills so many people in this world. And yet our country
and the Soviet Union decided to keep that disease, to keep the
biological agents, and literally to experiment with them I
suppose over those years as potential weapons.
Could you comment on the rationale and the insanity of
those decisions?
Mr. Henderson. Thank you, Mr. Chairman. I am happy to do
so. May I say I appreciate very much the recognition. The
program of smallpox eradication was a major effort with a lot
of people, including Dr. Koplan, who spent a good bit of time
in the field himself. And it was a great achievement, but--and
certainly right now I would say we are more worried than we
have ever been before about smallpox returning.
The question of what to do with the smallpox virus is one
which was taken up by a World Health Organization committee
beginning as early as 1980. And in the course of this there was
the thought in mind that some day it might be possible to
destroy the virus. This was a difficult question to wrestle
with. Were we in a position to destroy a species?
Many efforts were made to identify the genetic material
that was involved with sequencing of the virus, with libraries
of fragments of the virus, and many organizations were
consulted about the advisability of doing this. In the
meantime, laboratories around the world were solicited about,
did they have the virus, and were persuaded, some with great
difficulty, to either destroy it themselves or transfer it to
one of the two laboratories which had been working with the
World Health Organization in this program, one at the Centers
for Disease Control and one in Russia.
As we moved along, it became clear that we had pretty good
cooperation. We couldn't absolutely be sure that every
laboratory had turned in their virus, and there was no way by
which you could verify this. The little vials are only about as
big as your finger. They can be lost in the bottom of a deep
freeze, and there is no way to inspect these things.
But countries I think made a good effort to get rid of the
virus, and I think there is--it is possible there is virus
elsewhere. We can't really say for sure. But we had doubts that
there were very many places at least.
As we came to move into the time of 1998 to year 2000, the
question came, would it be possible to develop a drug which
could be used in the treatment of smallpox? Some felt this
would be a good idea. Some felt irrespective of what we might
find it would be desirable to destroy the virus.
And so after much discussion, it was decided to retain the
virus, for the two countries with laboratories to review their
research programs regularly with a special World Health
Organization committee, for that committee to have oversight
and approve all research that was done, and to investigate to
be sure that there was very close watch kept on those stocks.
And so at this time there is research going on with regard
to smallpox, but it is focused on getting an antiviral drug.
The committee will be meeting in the first week of December
again to review this, and meanwhile the World Health Assembly
has agreed that the virus be retained up to but not later than
the year 2002. That is interpreted as December 31, 2002. And
that decision will be reviewed annually.
Chairman Tauzin. My time has expired, but I would love to
put you on the record with a very simple question. How certain,
how assured are you and the World Health Organization, today,
that we know where any of this virus may be located, and
whether anyone may have access to it who would do harm to the
people of this planet?
Mr. Henderson. Mr. Chairman, we cannot be sure. We do not
know how many places might have it. We know that it is almost
certainly in three places in Russia. There is a place--CDC, of
course, has it. And it is possible that there are other
countries. It has been suggested that Iraq may have it, that
North Korea may have it. The data on this are uncertain.
Chairman Tauzin. Thank you, sir.
The Chair recognizes the ranking minority member, Mr.
Dingell, for a round of questions.
Mr. Dingell. Mr. Chairman, thank you.
Mr. Secretary, welcome. I am going to--I have a lot of
questions, and I am going to ask you, to the degree you
possibly can, that you give me a yes or a no answer.
Mr. Secretary, which is the bigger contamination problem,
domestically produced food or imported food?
Mr. Thompson. Pardon?
Domestic or imported?
Mr. Dingell. Yes. Which is the greater source of risk for
contamination, domestically produced food or imported food?
Mr. Thompson. Yes.
Mr. Dingell. Pardon? Yes is fine but not responsive. We
have a Food and Drug Administration here. We don't have one
overseas.
Mr. Thompson. I think it has got to be imported food that I
am the biggest concerned about, Congressman.
Mr. Dingell. Thank you, Mr. Secretary. Now, Mr. Secretary,
food inspection officials in the State of New York have
informed the staff that 80 percent of the food recalls they
issued last year were contaminated imported food. Contamination
included pathogens, heavy metal, pesticides, illegal additives.
Is this a fair and a representative statement?
Mr. Thompson. I am not sure. I can tell you that last year
we had over 372,000 individuals that suffered from food
pathogens. Five thousand individuals were hospitalized and--
20,000 were hospitalized, 5,000 people died from food poisoning
in America. So it is possible, but I am not sure.
Mr. Dingell. Is there any information that you have that
refutes the findings that New York has communicated to us with
regard to the risk of contamination of imported food?
Mr. Thompson. I didn't hear the first part of that.
Mr. Dingell. I said is there any information you have about
recalls in other States that refutes the findings that New York
has communicated to my staff?
Mr. Thompson. Not that I know of, Congressman.
Mr. Dingell. Now, Mr. Secretary, is it true that only one--
rather, seven-tenths of a percent of imported food is inspected
by FDA?
Mr. Thompson. That is my understanding, and that is what
FDA tells me. We have 300 ports of entry that come into the
United States, 299 to be exact, and we have 150 inspectors. And
so it is pretty near impossible when you only have less than
one inspector per site where food is entering into the United
States to be able to inspect much.
Mr. Dingell. Now, Mr. Secretary, you have asked for
additional money, but most ports operate I note on 24 hours a
day, 7 days a week. Isn't that true?
Mr. Thompson. Most of them do, but a lot of the food coming
in is limited to 12 hours, from 9 until 8 in the evening.
Mr. Dingell. So I am going to submit you a question here
for the record that will involve how many in fact you really
can give full inspection to.
Now, Mr. Secretary, how many FDA inspectors would it take
to cover all 307 ports, or 299 ports, where food enters the
United States commerce on a 24-hour-a-day basis?
Mr. Thompson. We have 150.
Mr. Dingell. You have 150, which is probably about a sixth
the number you need. Is that right?
Mr. Thompson. We are requesting--we think that we can do a
much better job with an additional 200, so we would have 350.
And then with an additional 100 backup in the laboratories, we
think we could do an adequate job, not an excellent job but a
much better job than we are doing right now, Congressman.
Mr. Dingell. Not excellent, but better. Now, Mr. Secretary,
I note that USDA requires meat to be inspected at only 30
points of entry rather than the 307 ports where FDA-regulated
food enters U.S.
Mr. Thompson. That is correct.
Mr. Dingell. Do you have authority to stipulate that FDA
will inspect imported food at only certain ports as U.S.
Department of Agriculture has done?
Mr. Thompson. I do not have that authority.
Mr. Dingell. Would that be helpful to you in allocating
your resources?
Mr. Thompson. There are some big trade issues involved in
that. I have inquired about that, but there are some big trade
problems and trade issues for that. But it is something that I
am certainly willing to consider. The Department----
Mr. Dingell. Why would there be trade problems at FDA and
not trade problems at Department of Agriculture? Department of
Agriculture has communicated no such concerns to us.
Mr. Thompson. Because we have so much----
Mr. Dingell. Everybody seems to be happy, and yet you can't
control it, and you have got a big trade issue. What are you
telling us here?
Mr. Thompson. Well, Congressman, all I can tell you is that
the tradeoffice has indicated to me that there would be some
trade implications, some trade problems with it, and we have a
lot more food coming in than the Department of Agriculture.
They have 20 percent; we have about 80 percent of the food
coming into the United States.
And I am certainly willing to look at it. It is something
that I raised with you, Congressman, at a closed hearing once,
that this is something that we should consider.
Mr. Dingell. Mr. Secretary, my differences I don't think
are so much with you as they are with the administration. But
also, with some of the big food importers and processors who
don't seem to like the idea of being regulated. Now, I
understand----
Mr. Thompson. I am sure that is true.
Mr. Dingell. Now, Mr. Secretary, I understand FDA was
inspecting about 8 percent of all food imports in 1992, rather
than the seven-tenths of a percent it currently inspects. Is
that correct?
Mr. Thompson. That is my understanding.
Mr. Dingell. What caused that shift?
Mr. Thompson. Well, because of the expansion of food coming
into the United States and a complete cap on the number of
inspectors we had, Congressman. You can well imagine the
increased amount of food that has come into the United States
on a yearly basis since 1992. And when you have the same number
of inspectors, you are going to have less opportunity to
inspect food.
Mr. Dingell. Now, Mr. Secretary, I would----
Chairman Tauzin. The gentleman's time has expired. The
gentleman would ask additional time?
Mr. Dingell. No, Mr. Chairman. I would just like to get
this one little question in.
Chairman Tauzin. Get it in, Mr. Dingell.
Mr. Dingell. Just so we have a perspective. Mr. Secretary,
you asked for additional money. Did you get all that you
requested?
Mr. Thompson. I requested $61 million, and that is what----
Mr. Dingell. That is the amount you requested?
Mr. Thompson. That is right.
Mr. Dingell. And that is the amount you got?
Mr. Thompson. That is correct.
Mr. Dingell. You didn't request more money?
Mr. Thompson. I felt that I was--I was very appreciative to
get that much, Congressman, because I asked for it--I had asked
for it before and didn't get it.
Mr. Dingell. This is going to leave you able only, however,
to inspect----
Mr. Thompson. Pardon?
Mr. Dingell. This is going to leave you able, Mr.
Secretary, only to inspect 2 percent of the food and not have
other authorities.
Mr. Thompson. Well, we are hoping with the expanded
authorities that we are going to be able to have detention,
that we are going to be able to have notice, so that the
companies, the importers are going to have to notify us hours
before so we can get inspectors there, places we don't have
inspection.
We also are hoping to be able to have some of the other
authorities that we have put in there that is going to be
helpful, plus including an improved computer system called
OASIS, which is very important, plus an improved PulseNet,
which tracks down the pathogens and describes the DNA, and be
able to characterize and be able to find that, plus increased
laboratories' help by an additional 100 people, which would be
very helpful for the inspectors that are at the border.
Mr. Dingell. I appreciate that.
I have some other fine questions, Mr. Chairman. I will
defer further questioning.
Chairman Tauzin. I thank the gentleman. The record will, of
course, stay open after this hearing for the submission of
written questions, and the gentleman will be certainly welcome
to do so.
The Chair is now pleased to recognize the chairman of the
Health Subcommittee, from Florida, Mr. Bilirakis.
Mr. Bilirakis. Thank you, Mr. Chairman.
Mr. Thompson. Thank you, Mr. Chairman.
Well, I think there is some good news for you in terms of
our draft.
Mr. Thompson. Good. Thank you.
Mr. Bilirakis. Mr. Secretary, you made, in responding to
the questions asked by the chairman a few minutes ago, three
leading recommendations, and I just wanted to tell you that all
three were met in our draft--Sections 302, 303, and 305.
Mr. Thompson. Thank you so very much, all of you.
Mr. Bilirakis. Mr. Secretary--and I see that Ms. Capps is
not here, and I wish she had been--but there are others--Ms.
DeGette, Mr. Whitfield, Mr. Ehrlich, who is not here right at
this moment either--who have all been concerned about the
workforce problems.
Before the events of September 11, we heard a lot about
shortages of health care professionals in various areas,
including nursing, pharmacy, and medical technology. There has
been an ongoing debate over the ability of the market to
correct for these shortages and the role that government should
play.
I know that you have been concerned about this as well, Mr.
Secretary. You have taken action, for which we are grateful. In
late September, you announced $27.4 million to address the
emerging nursing shortage, for instance, and we thank you again
for seeing a need and responding swiftly and appropriately.
However, in the wake of September 11, there is a grave
concern that I know you share about the ability of our public
health system to respond to an emergency. There have been
questions about the effect that various workforce shortages may
have on our ability to respond as a nation, and it is important
that we are able to respond in all capacities.
The Department, through HRSA, the Health Resources and
Services Administration, has the ability to determine the
workforce necessary to respond to potential bioterrorism
attacks, and we have been talking to those people. They have
been very helpful and very cooperative.
Would providing additional monies through HRSA help the
Department determine where vital workforce shortages currently
occur and help train and educate individuals in those areas?
And, additionally, would a general approach such as this allow
the Department the flexibility to plan broadly for our public
health response to a possible emergency?
Mr. Thompson. Yes, it would.
Mr. Bilirakis. Are you familiar with workforce legislation?
Mr. Secretary--forgive me for interrupting you--regarding
particularly the nursing shortage and the other areas? And as
Ms. Capps has already said, we have been working--I mean, we
spent a lot of time with her and her staff trying to work out--
--
Mr. Thompson. I know you are working on a bipartisan bill.
Mr. Bilirakis. Yes.
Mr. Thompson. I know that my office has reviewed it. I
personally have not had the time to, but I know the gist of it,
and I am very supportive of it. I also would point out that the
Secretary of Labor, Elaine Chao; Secretary of Education, and
myself, are working on a joint cooperative effort between the
three departments of labor, education, and health and human
services, to determine the workforce problems in the health
care field, and to develop a concerted and coordinated plan to
try and come up with ways to get the dollars, get the
scholarships, and direct individuals who are trying to
encourage young people to get into the health care fields, not
only nursing, lab technicians, pharmacy, and dentistry, all
which need--which have big shortages.
Mr. Bilirakis. Mr. Secretary, how much legislation is
needed to be able to address these problems compared to what
the Department is able to do without legislation, and is in the
process of doing without it?
Mr. Thompson. How much money?
Mr. Bilirakis. Legislation.
Mr. Thompson. How much legislation?
Mr. Bilirakis. Authority.
Mr. Thompson. How much authority?
Mr. Bilirakis. Congressional authority, yes.
Mr. Thompson. The more discretionary, of course, the better
able we are to do our job, Congressman Bilirakis. And the
proposal, as I understand it, that you are working on with Ms.
Capps is one that gives us that authority and that discretion,
and that is the one that we would----
Mr. Bilirakis. I wish she were here, because I would want
her to hear your response, although I don't know what it is.
But I know one area that she feels very strongly about is
creating another national health service corps, only it would
be a national nursing health service corps.
How do you feel about that? And do you feel that it is
necessary to have an additional nursing service corps? Have you
studied that? I don't mean to put you on the spot here, but it
is important that we know these things. Can what we all want to
accomplish be done without creating an additional service
corps?
Mr. Thompson. Congressman, whatever we can do to encourage
young people to go into the nursing field is important. If it
is a nursing corps, fine, but it is--but I think what we have
to do is we have to start encouraging young people that this is
a great profession, and which it is, and one in which we need
more young people to go into. And I don't think we have done a
very good job of publicizing that and encouraging people to go
in that--to be the professional of choice.
And saying that, we also have to do the same thing for lab
technicians, for pharmacists, and for dentists. And these are
the shortages that we have right now that are going to be more
acute in the years to come. And if it is the nursing corps,
that is fine. I just know that we have to do a much better job
and be more aggressive in regards to recruiting young people to
get into it.
Mr. Bilirakis. All right. My time has expired. Thank you,
Mr. Secretary.
Chairman Tauzin. I thank the gentleman. The Chair is
pleased to recognize the gentleman from Massachusetts, Mr.
Markey, for a round of questions.
Mr. Markey. Thank you, Mr. Chairman, very much.
Today's New York Times reports that in Al-Qaeda
headquarters in Kabul blueprints for a Nagasaki-like nuclear
bomb have been found. And as we know, the Attorney General has
been consistently warning our country that terrorists consider
nuclear powerplants in the United States to be a target which
the terrorists would highly value if they could launch a
successful attack against it.
Now, I don't believe that bin Ladin as yet has access to
nuclear weapons capability. I believe that if he did he would
have already used them.
Mr. Thompson. I agree.
Mr. Markey. However, I do believe that we, as part of the
preparation which we make in our country, should be prepared to
protect our population in the event that they do gain access to
the materials or they launch a successful attack on a nuclear
powerplant somewhere in the United States.
So my question focuses in on that level of preparation.
Potassium iodide is something that was distributed in Poland
after the Chernobyl accident. They did not have it available in
the Soviet Union. Thousands of thyroid cancers as a result
occurred, especially in children, in that country.
So my question to you is this: notwithstanding the fact
that the Nuclear Regulatory Commission has made a decision to
allow each individual State to decide whether or not to
stockpile potassium iodide inside of the radius--let us just
say it is a 10-mile radius of a nuclear powerplant, although we
know depending upon the plume of a cloud that would--of an
accident that it could go far beyond 10 miles. But do you
believe that there should be a stockpiling inside of the most
vulnerable areas, especially in schools? Dr. Koplan or----
Mr. Thompson. Dr. Koplan will--let me start out, and then I
will have Dr. Koplan respond as well. First, I will thank you
for the question.
We are putting in the President's package $47 million for
chemical antidotes. That also includes potassium iodide. And
that is part of that package, and it--what you are saying I
think has a great deal of merit, and we certainly want to
review that.
Second, we have a review committee at CDC and NIH that
works with the Veterans Department that takes a look at what is
in our push packages. And we change periodically the kinds of
medicines and medical equipment that we put in these push
packages, and we are going to hopefully, in this bipartisan
package, have enough money to increase the number of push
packages from eight to 12, which would increase the number of
medical supplies from 400 tons to 600 tons. And of that, that
question about potassium iodide is being considered by the
committee and being able to place in our push packages.
Mr. Markey. Now, potassium iodide is the Cipro for nuclear
exposure.
Mr. Thompson. You are absolutely correct.
Mr. Markey. It would only cost $3.9 million to make it
available to all of the people who live within a 10-mile radius
of every nuclear powerplant in the United States. And I do
believe that the Nuclear Regulatory Commission is not the right
agency to be making the decision, as a precautionary measure,
as to whether or not that antidote should be made available.
And if I can just take it a step further, in the event that
there is an exposure, the national pharmaceutical stockpile, in
my opinion, should also include sulfhydryl compounds such as
amylphostine, which minimizes radiation damage to human cells
and could be used to protect emergency responders, so that
after the fact, if they are exposed, that there would be that
stockpile in place as well.
So I would ask for your reaction to the stockpiling of
those compounds as well, so that we do have the available means
of dealing with the effect on the public or the responders?
Mr. Thompson. We are reviewing all of those things,
Congressman, through Dr. Henderson and Dr. Koplan. And I think
a better person to respond to that would be Dr. Koplan.
Mr. Markey. Okay. Thank you.
Dr. Koplan?
Mr. Koplan. Thank you, Mr. Markey. As Secretary Thompson
said, we regularly review these compounds, and we would be glad
to talk some more with you and your staff about other ones you
might think would be useful and subject that to further review
and see what we can do.
We participate, as you have--as I am sure you know, as part
of the Federal radiologic emergency plan, with about 17 other
Federal agencies, and likely the leads would be, in an event
such as the type you described, either the Nuclear Regulatory
Commission, the Department of Defense, Department of Energy, or
EPA. But we, the Department of Health and Human Services, would
play a major public health role in that event. Because of that,
Secretary Thompson has had us beefing up our own capabilities
in response to that.
Mr. Markey. The reason that I am more recently concerned,
Doctor, is that in The Washington Post on October 30 there was
an interview with this captured Al-Qaeda member that the
Northern Alliance has had imprisoned for a number of years. And
it is just a full page interview with him in which he says
quite graphically in America there are more important places,
like atomic plants and reactors, that could be attacked.
So they are delivering the message to us, either in the
headquarters in Kabul, or we find evidence of attempts to make
nuclear weapons, or interviews with Al-Qaeda members that say
that nuclear powerplants would be targets. And so I would urge
you to ensure that potassium iodide and other antidotes are
available inside at least a 10-mile radius.
Chairman Tauzin. The gentleman's time has expired.
Mr. Markey. Thank you.
Chairman Tauzin. I thank the gentleman. The Chair
recognizes the gentleman, Mr. Upton, for a round of questions.
And Mr. Bilirakis will be in the Chair.
Mr. Upton. Thank you, Mr. Chairman.
Thank you, Mr. Secretary, for your testimony. This is
clearly a nightmare that is not going away. And as we look for
wins on the battlefield overseas, we obviously have to have
them here at home as well. And I know that all of us appreciate
your hard work and your commitment to make sure that that
nightmare somehow goes away.
I know that a number of our pharmaceutical companies have
offered to donate new antibiotic products that will help with
bioterrorism attacks--whether it be anthrax or anything else.
And I am curious to know where are we in terms of trying to
expedite and speed up the approval pipeline for some of those
drugs. And I am wondering if you need any more authority so
that we can help you in terms of the development and approval
process for some of these drugs.
Mr. Thompson. I think FDA is working extremely hard,
Congressman, in regards to this. Every morning we have a
teleconference with CDC and FDA and NIH, and probably a week
does not go by that we do not discuss the possibility and the
need for expediting drug approval. And FDA is putting more
resources into this as we speak.
Whether or not new authority would be helpful, I certainly
would like to look at it and get back to you after I have had a
chance to review it with FDA, as well as with the attorneys in
the Department of Health and Human Services. But I would
probably say, without seeing that language, that, yes,
additional authority for the Department would be advisable.
Mr. Upton. Over the last couple of weeks, I have sat down
with my local hospital administrators, emergency workers, and
police folks, and obviously they, at the State and local level,
are the first responders in case anything bad happens at home.
As chairman of the Telecommunications Subcommittee, too, I have
had plenty of presentations on telehealth and all of the
advantages of being able to communicate electronically with any
of those first responders.
I know that at an oversight hearing a couple of weeks ago,
there was a question that was posed to the CDC about the levels
of funding for State and local public health departments to
electronically connect them. And the response was, ``That is a
good question.'' In other words, it wasn't enough.
I note that the administration is planning to eliminate the
Office of the Advancement of Telehealth as well, and I am just
wondering if that is such a good idea in times like these. And
I am wondering maybe, Dr. Koplan, if you can respond to that,
and maybe Secretary Thompson as well.
Mr. Thompson. I believe it is just being moved. It is not
being eliminated.
Mr. Upton. It is not being eliminated? Okay. Well, that is
good news. That is good news.
Mr. Thompson. But can I respond a little bit? Just a little
bit in regards to communication to your local public health.
This has been something that CDC, through the Health Alert
Network, has really done an outstanding job on. And we need to
expand that. We need to get more information down to the
emergency wards and into the county health departments and to
regional and the State, and with up-to-date information, and we
have found that during this nightmare that we have gone through
for the last 6 weeks.
But the Health Alert Network has been extremely good, and
it has been a great investment. We just need to expand it and
be able to do it. Each week Dr. Koplan and I, for the last 3
weeks, we have had weekly conferences, teleconferences, with
the State health departments and with the State medical
departments and the emergency workers. And it has been
extremely well received by those individuals.
So what you are talking about is something that we are
doing. We would just like to be able to expand it, Congressman.
Mr. Upton. Well, that is exactly right, and that is why,
particularly as I look at the announcement this morning for
Michigan of this new support team that can integrate with our
State and local folks, how critical it is to have that
information online.
And even as we--there are a lot of news stories about our
own blackberries in terms of how we are able to communicate
here with each other, particularly when in time of a crisis.
Often cell phones go down and it is that type of communication
that our local folks have to have as they begin to think about
dealing with any emergency that might be out there.
The last question that I have--and you cited just a brief
reference to it in your testimony--good news about increasing
the amount of dosages to 300 million for smallpox, with a goal
to do that in the next year versus what was originally targeted
to be a 5- to 8-year process. How would we do this?
There was some talk of diluting it by up to, what, 20
percent, which would quintuple the amount of reserves. But tell
me--if you can tell us what your----
Mr. Thompson. Really, only after September 11, we sat
down--Dr. Henderson and with the FDA and with some other
individuals, and we have mapped out a plan on how we could
accelerate that. And then we called in ACAMBIS, who has the
contract to deliver 40 million doses, and they were not going
to start manufacturing until 2004 and delivery date was 2005.
We asked them--and we sat down with FDA, with CDC, NIH, and
with our Department, and we mapped out a plan under which they
will be able to start manufacturing next year and will start
delivering sometime in June, July, August of next year, of the
40 million. For that, we increased their contract from 40
million to 54 million doses, and they are to deliver next year
the 54 million doses.
Then, we put out a request for information to seven
companies to see whether or not they could come up and
accelerate, so that we could have some additional smallpox
vaccines up to the 300 million. Doing that, we had 10 companies
that came back, and now we are in the process of negotiating a
contract with some of those companies, and that process is
ongoing. And we are hoping to be able to complete it relatively
quickly.
Part of the terms are to be able to have the vaccines
delivered next year, and actually start manufacturing for the
preliminary doses sometime in the month of December. That is
how fast we are moving. And on top of that, we have asked NIH
to take a look at our existing stock of 15.4 million doses to
see if they could distill it down 5 to 1 and still have the
same kind of coverage rate.
And they are doing the studies and the research right now,
and we are expecting to have that analysis done sometime in
January, latter part of January, early part of February. And if
it comes back the way the preliminary analysis indicates, we
will have 77 million doses on hand in January or February of
this year of current stock, and then we will expand that to the
300 million doses, Congressman.
Mr. Bilirakis [presiding]. The gentleman's time has
expired. Good show, Mr. Secretary.
Mr. Brown, to inquire.
Mr. Brown. Thank you, Mr. Chairman.
Dr. Henderson, thank you especially for being here. You
really are a hero to a lot of us, and thank you for joining us.
Mr. Secretary, you noted several times in your negotiations
with Bayer on Cipro that your current authority to break
patents under imminent domain law poses financial risk.
Compensation to the brand-name company is determined after the
fact, according to law now based on vague criteria, creating
the possibility that the Federal Government would have to have
spent a great deal more money than we hoped for.
Putting a compulsory license in place would allow for
prospective determination of compensation. It would not require
wrangling in the courts the way present law would, to determine
fair compensation for the brand-name drug manufacturer in the
event of a public health emergency. What are your thoughts on
this? To give you the tools to do this without the threat of
government having to spend a great deal more money?
Mr. Thompson. I am not in favor, Congressman, of breaking
the patent law. And I felt that we were able to negotiate with
Bayer a very fair contract and saved over $50 million doing the
negotiations in regards to that. And I think within the patent
law we still can be able to drive down the costs of
pharmaceutical drugs in America. But I am more than happy to
look at your language and your legislation, which I haven't
personally reviewed yet, but I would be more than happy to, to
get back to you as our response.
Mr. Brown. Okay. I appreciate that. And you have always
done that in good faith in your time here. Beyond the cost--and
I think you did a good job negotiating. I don't think you had--
I think if you had had a better law to negotiate from you would
have had more of a position of strength to bring the price
closer to the 45 cents that some public hospitals have been
paying, but that is another issue.
But the supply problem is also an issue, and you were able
to reduce the goals for Cipro from I believe 1.2 billion to 100
million, in large part because of purchases of Doxycycline,
which is obviously a much less expensive Tetracycline class of
antibiotics.
Now, if there is a problem of antibiotic resistance to
Penicillin or Tetracycline, or a Tetracycline drug like
Doxycycline, we need to act--you are going to need to act fast,
and you are going to need to act fast within a budget or within
just the constraints of some number of dollars. Don't you think
you need at some point an ability to more quickly, in an
anticipatory way, be able to move--you can say break a patent,
but bring it--in this case I guess it is breaking a patent, but
it is in a public health emergency, to get these drugs made
quickly online at a relatively inexpensive price.
Mr. Thompson. Congressman Brown, I, along with Dr.
Henderson and a couple of other individuals from NIH, we have
met with the pharmaceutical companies, and they have indicated
that they will turn over their manufacturing concerns for any
type of an emergency in order to produce as many antibiotics as
necessary.
We have had also several companies that have indicated they
would like to donate for nothing antibiotics. Just yesterday
Phizer donated $2 million worth of Doxycycline to the
government to be used for any kind of emergency dealing with
anthrax whatsoever. And so other companies have done that as
well.
Did you want to say something, Dr. Henderson?
Mr. Henderson. I think we have felt that rather too much
emphasis has been placed on that Ciprofloxicin is virtually the
only answer for treatment, and this certainly is not so. In
fact, there are real--very powerful reasons of using
Doxycycline, which is a generic drug now and made by a number
of different companies. It is associated with fewer side
effects than the Cipro, and that certainly is an advantage. And
all of the strains are sensitive to this drug.
In addition, there are a number of other fluoroquinilones
which are drugs of this family of Ciprofloxicin, and those are
being tested, if you will, for comparability. We have every
reason to believe that they will be equally as effective as
Ciprofloxicin. So as one looks at the problem, we see at this
point in time that we have got enough drugs or access to enough
drugs to deal with this situation.
Mr. Brown. Okay. I appreciate that. Let me shift for a
moment. The administration has proposed spending $300 million
for State and local public health preparedness. State health
departments have told us that they need $250 million just for
anthrax, you know, worried well, whatever, preparedness.
The Wall Street Journal had an article today. Senator Sam
Nunn called for a new marshal plan separately. A bioterrorism
expert at Dr. Henderson's Johns Hopkins calculated America
needs to invest $30 billion to properly protect itself from
these dangers. I mean, I don't know if it is $30 billion. Who
knows? But is $300 million--and not just bioterrorism, but some
diseases like tuberculosis have little to do with bioterrorism.
Tuberculosis, which killed 5,500 people in the world on
September 11, 5,500 on September 12, 5,500 on September 13, and
every day since, is $300 million enough? Isn't the
administration trying to do this on the cheap?
Mr. Thompson. The answer would be no, if that is all that
was going to take place. But the administration is asking for
$300 million now, Congressman, plus an additional $100 million
for local and State public health efforts in the appropriation
bill for fiscal year 2002, which is $400 million to be spent
this year, in fiscal year 2002.
That is not the total story. We are going to have to come
back, and we are going to have to get more money for fiscal
year 2003 if we really want to do a job to strengthen and make
the local and State public health departments as effective as I
know you want to and as I want to and America. We are going to
have to invest more money in the future. But for fiscal year
2002, we think the $400 million, including the appropriation
bill, is an excellent start.
Mr. Brown. One more brief----
Mr. Bilirakis. The gentleman's time has expired.
Mr. Brown. [continuing] question. Dr. Koplan, could you----
Mr. Bilirakis. The gentleman's time has expired.
Mr. Brown. I will ask----
Mr. Bilirakis. Do it quick.
Mr. Brown. [continuing] real quick. How do you envision a
national antibiotic resistance surveillance network, Dr.
Koplan?
Mr. Thompson. My God, a quick----
Mr. Brown. That was a quick question. The answer is going
to be pretty long.
Mr. Thompson. Quick question, but not a quick answer.
Mr. Brown. And I can do that in writing, Mr. Chairman. I
will----
Mr. Bilirakis. Why don't we do that. Thank you. Appreciate
that.
Mr. Brown. Thank you.
Mr. Bilirakis. Mr. Greenwood, to inquire.
Mr. Greenwood. Thank you, Mr. Chairman. And thank you, Mr.
Secretary, for your service to the country at this time. It
is--we are very fortunate to have you at the helm at these very
trying times, and it is an extraordinary thing--process for the
country to go through this process of trying to contemplate
every imaginable vulnerability against an enemy that is--whose
intentions and whose capabilities are very difficult to
decipher.
But it is probably a good process. I think the country will
be safer in its health infrastructure and every other part of
our infrastructure for decades to come as a result of this
complicated process.
The vulnerability that I want to ask you about has to do
with how we protect some of our medicine, critical medicines.
Now, I know that--I am informed that the National Guard is
protecting the facility where anthrax vaccine will be
manufactured. Am I--is that correct?
Mr. Thompson. The National Guard, they are what? I am not
sure they are there today, but they were----
Mr. Greenwood. But they will be. That is the intention.
Okay.
Mr. Thompson. They were there. I don't know if they still
are, Congressman.
Mr. Greenwood. Okay. Okay.
Mr. Thompson. I know the security at Bioport has been
increased considerably.
Mr. Greenwood. Okay. I am interested in the security at the
facility where the smallpox vaccine is stored. And I would like
to discuss that with you. I have studied it. I have met with
the people in charge of it, and I think we need to strengthen
it. And I think we need to strengthen it with either National
Guard personnel and/or regular military personnel.
I don't think that that needs to be a permanent situation.
But I do think it is of immediate concern, and I would like to
have either one of you, any one of you, respond to--and I hope
in the next few minutes make a commitment to me that we will do
something in one of those ways.
Mr. Thompson. Thank you so very much for your comments. Dr.
Henderson is going to be back this afternoon to talk to some of
you in private about the smallpox, but right now I would ask
Dr. Koplan to respond.
Mr. Koplan. Thank you. Mr. Greenwood, we are--we currently
have security forces, people there. We are negotiating with the
company as we speak as to how that will transit and take place
over a longer period of time. But we will share all of that
information with you.
Mr. Greenwood. Okay. Well, for the record, and as I said I
have met with the security folks, and I have discussed their
capabilities and I know about these negotiations, but I am
persuaded that what we need there for the immediate future is
well-armed and well-trained military personnel. It is just--I
think it is a prudent thing to do. I don't think it needs to be
a massive force, but I think it needs to be done and done well.
Let me, while I have some time left, talk to the question
about liability protection for vaccine manufacturers. The
administration has asserted that it has authority to provide
liability protection under an Executive Order that is more than
40 years old. And the vaccine manufacturers tell us that they
don't think there is enough protection there, that there is
discretionary authority within the Executive Order, that it is
limited to activities that are ``unusually hazardous''--that is
a quote--or ``nuclear in nature.'' And it may require the
manufacturer to exhaust insurance coverage first.
If we are going to suddenly require vaccination of a large
percentage of the population as a result of a potential
smallpox breakout, for instance, there are going to be some
adverse consequences. We know that the statistics tell us that.
Should we--what is your recommendation in this regard? And do
you need additional--do you think we need additional
legislation to enhance and update and modernize the Executive
Order?
Mr. Thompson. I don't think it would hurt, Congressman
Greenwood. But right now we are in the process of, as you know,
negotiating with several companies dealing with the smallpox
vaccine. And this is going to be part of the negotiations that
will be ongoing over the course of the next several days.
So I don't think the legislation would be able to get
passed in time to have an impact whatsoever on the smallpox
vaccine. We are going to have to move ahead with that, and we
think the Executive Order gives us enough authority and
flexibility to negotiate that with the company or companies.
But future legislation, I certainly don't think it would be
harmful because I believe the Executive Order law was passed in
the 1950's. And I think any time that a law has been passed
that long ago there is no harm in----
Mr. Greenwood. Well, I think it was--it is not even
statutory. It is an Executive Order that is 40 years old.
Mr. Thompson. Right.
Mr. Greenwood. My time has expired.
Mr. Bilirakis. I thank the gentleman. Ms. DeGette, to
inquire.
Ms. DeGette. Thank you, Mr. Chairman. And I want to thank
my colleagues on the Democratic side for allowing me to
question before they did.
Mr. Towns--we are all really stretched in this time, and
Mr. Towns asked me if I would sub in for him at a hearing at 1
on cyber security as ranking member on Consumer Protection. So
we are all running around, and I do want to thank my colleagues
for their comity.
Secretary Thompson, I have a couple of questions for you
about an issue that we haven't talked about too much this
afternoon. That issue is drug reimportation. And I assume that
you know about the Oversight Subcommittee's investigation of
the adulterated, misbranded, and counterfeit drugs that are
entering our market and on which our subcommittee had a hearing
on June 7th. Are you aware of that issue and those hearings?
Mr. Thompson. Yes, I am somewhat. I don't know how detailed
you want to get into----
Ms. DeGette. Well, one thing we talked about, which I am
sure you are aware of, because there is a recent report about
that there are shipments now reaching the incredible level of 2
million entries into this country per year. A lot of these are
very dangerous counterfeit drugs, or substances that we don't
even know what they are. Are you aware of that?
Mr. Thompson. Yes, I am.
Ms. DeGette. And are you also aware that you and your
agency have the authority to stop those dangerous drugs from
coming into this country?
Mr. Thompson. I think FDA has attempted to do so,
Congresswoman.
Ms. DeGette. FDA has implemented a rule stopping the
reimportation?
Mr. Thompson. They are working on it, I know. I don't know
if----
Ms. DeGette. Okay. Well----
Mr. Thompson. They are working. I don't know if it has been
implemented yet. I can check that out and get back to you.
Ms. DeGette. Right. I mean, let me update you. On June 7th,
Mr. Hubbard, who is an FDA Commissioner, he was the witness,
and he told us that the FDA had recommended to you--that Mr.
Hubbard had recommended to you verbally and in writing that
these shipments be stopped. And then Mr. Greenwood, who is the
chairman of that subcommittee, asked for a public response
within 60 days. And we have not heard anything formal.
We did get a memo that was written recommending the halting
of these imports. Are you aware of that?
Mr. Thompson. I am aware of the fact that they have
submitted a plan and it is under review.
Ms. DeGette. Okay. What is the time table for
implementation of that plan?
Mr. Thompson. I would say hopefully very soon.
Ms. DeGette. All right. Well, the thing that we are
concerned about, obviously, you did order a halt of shipments
claiming to be Cipro, because you suspected that unscrupulous
exporters might be shipping in counterfeits of Cipro in light
of the recent anthrax attacks. Did you not order stopping those
drugs?
Mr. Thompson. I didn't order that. FDA did that on their
own.
Ms. DeGette. FDA did. Okay. So were you also concerned that
the terrorists might use the internet to advertise cheap Cipro
and then try to poison Americans by importing substances that
really were not Cipro?
Mr. Thompson. That is why FDA took the action they did.
Ms. DeGette. Now, it seems to me that if we are concerned
about importation of counterfeit drugs purporting to be Cipro
that aren't, that either are nothing or, worse, poison, we
should be concerned about all imports of drugs of that nature.
Mr. Thompson. We are.
Ms. DeGette. You are.
Mr. Thompson. Very much so.
Ms. DeGette. Okay. In that case, it seems to me, with all
due respect, Mr. Secretary, we should put implementation of the
FDA policy that we talked about back in June on a fast track
for implementation. Would you agree?
Mr. Thompson. It is on a fast track, Congresswoman.
Ms. DeGette. Okay. What kind of timeframe are we talking
about, then?
Mr. Thompson. I can get back to you this afternoon or
tomorrow exactly the time level, but I can assure you----
Ms. DeGette. I would appreciate that. And I am not--I am
quite concerned that----
Mr. Thompson. I understand that.
Ms. DeGette. [continuing] we had folks from our
subcommittee who went out to Dulles Airport and saw large piles
of substances that the FDA could not even identify what they
were. And the concern, of course, is if terrorist groups from
Iraq or Russia or other countries wanted to send in these
shipments under the guise that they were legitimate
medications, that this could be a real threat to the health of
our American citizens.
Mr. Thompson. Thank you very much.
Ms. DeGette. Would you agree with that?
Mr. Thompson. I agree with you.
Ms. DeGette. Great. So perhaps we can work, then, with your
office to find a deadline under which these rules could be
implemented.
Mr. Thompson. You can work with my office. You can work
with FDA. And we will get back to you relatively quickly.
Ms. DeGette. This afternoon, I would love to get some
timeframe from the FDA as to when we are going to implement the
recommendation. Thank you very much, and I yield back the
balance of my time.
Chairman Tauzin. I thank the gentlelady.
Mr. Thompson. I personally won't be able to get back to you
this afternoon. I am going to be on Capitol Hill. But I will
have somebody----
Ms. DeGette. That is fine.
Mr. Thompson. Okay.
Ms. DeGette. Thank you, Mr. Secretary.
Chairman Tauzin. I thank the gentlelady. The Chair
recognizes the vice chairman of the full committee, the
gentleman from Carolina, Mr. Burr.
Mr. Burr. Thank you, Mr. Chairman.
Mr. Secretary, before I ask questions, I want to thank you.
For the past several weeks, you have made many members of your
staff, as well as the White House staff, available to us as we
have tried to craft the bioterrorism legislation. It could not
have been done, and we couldn't complete it without the help of
folks from HHS and from the White House, as the Senate has
found out as they have gone through it as well. And my hope is
that we will be in a position very shortly to introduce that
legislation.
Dr. Koplan, let me cover something that I know----
Mr. Thompson. First, thank you for your comments.
Mr. Burr. Thank you. You spoke about--to us in Atlanta,
which I think Ms. Harmon and I found shocking at the time, was
that a third of our public health entities were not
technologically connected to the CDC. What challenge does that
cause to the Centers for Disease Control in our ability to
respond to potential threats and alerts?
Mr. Koplan. Thank you, Mr. Burr, and thank you for visiting
us recently. Communication, as has been discussed many times,
is a key part of public health responsiveness. And whether it
is food safety or a flu outbreak or a bioterrorist event, the
ability of people who know something about that event, whether
it is the first cases or a response to those cases or the fact
there are other cases elsewhere, need to share that
information, so that a county and a State needs to share it
with other counties in that State.
That State needs to share it with the other States around,
and then they need to get information back from whether it is a
Federal level or a State level. And so that is why that
communication network--and, indeed, some redundancy to that
communication network--is important. And it is important for us
to have all of our local and State health departments--we have
all of our State health departments, but all of the local
health departments within that jurisdiction linked up together
and communicating and do so easily and securely and on a
regular basis.
Mr. Burr. As this committee has learned in the past several
months as we have looked at bioterrorism and the attacks of the
11, we have also learned a lot about the health care data bases
that exist within the country today. In most cases, those data
bases within private entities that maintain and manage that
data base for certain purposes, how do you see the potential
use of those private data bases by the CDC, by the State
health--public health entities? And could we, if we
technologically connected all of the local public health
entities, could we plug them into that data base as well?
Mr. Koplan. I think those are very good points and ones
that we see bits and pieces of that taking place in some parts
of the country. An example would be some of the surveillance
activities that have been going on in New York and in the
Washington metro area in regards to the anthrax attacks have
included something we call symptom surveillance where we are
looking at clusters of symptoms and getting information it. And
that includes many private hospitals, public hospitals out
collecting the information together.
We are right now talking to a number of health care
companies, managed care plans, health systems, to see whether
some of that data that they have might be used in a way that
would be helpful for the type of surveillance you are talking
about--laboratory data from companies that just do laboratory
work. So I think it pays to both think outside the box and
think creatively, how can we use some of this other information
that is out there toward these ends?
Mr. Burr. Do you see some of that data potentially being
useful in identifying a potential biologic attack?
Mr. Koplan. Absolutely. An example would be--and when we
look at these clusters of symptoms, the earliest evidence of an
attack might be an unusual increase in persons with rash or
fever. It might be an unusual increase in certain pneumonia-
like entities which then, when inspected, one finds is a
bioterrorist attack. So these can be very important.
Mr. Burr. And with the passage of HIPAA, we limit the zip
code amount that these private entities can cover. But if they
were to contract with a Federal agency, like CDC, we can
actually include the entire nine-digit zip, then, because there
is a provision in HIPAA that allows us to get around that.
Which means that if you did have a release we could potentially
narrow it down to a city block within a given town. Is that
correct?
Mr. Koplan. I am not sure on that particular item. But our
goal is certainly to identify a locality in as fine an area as
we can, and usually within a household when we can do that.
Mr. Burr. Mr. Secretary, there has been much focus on
bioterrorism since September 11, and I think sometimes people
forget there are other real and maybe even more likely threats,
including chemical attacks or radiological attacks. Is
everything that the House and the Senate is working on at least
structurally in place that we could also handle chemical and
biologics, or should we put more concentration on chemical----
Chairman Tauzin. The gentleman's time has expired, but the
panel would be pleased to answer.
Mr. Thompson. I certainly think, Congressman, that we
should be beefing up our responses in chemical and
radiological. And the President's bill has an additional $47
million in it. The Senate proposal also has something, but I
know that you are also working on that. And I don't think that
you are off the mark. I think, in fact, you are right on the
mark in regards to that. I am sometimes more concerned about
those things happening than I am the biological.
Mr. Burr. Thank you very much.
Chairman Tauzin. I thank the gentleman. The two people I
want to thank before I recognize Mr. Deutsch--one of them is
the gentleman who just preceded me, Mr. Burr. The committee is
working on two paths, as you know, Mr. Secretary. One of them
is this path----
Mr. Thompson. Yes.
Chairman Tauzin. [continuing] the path of bioterrorism
legislation that we are trying to resolve in a bipartisan
fashion and hopefully file very soon. The second is the work of
the Oversight and Investigations Subcommittee in terms of very
privately, in closed hearings, examining such issues as
sensitive security issues and other issues.
I want to thank on a second level, Mr. Koplan, and
yourself, for assisting us in understanding those separate
issues as we work through the legislative path as well.
Mr. Thompson. Thank you, Mr. Chairman.
Chairman Tauzin. The Chair is pleased to recognize Mr.
Deutsch for a round of questions.
Mr. Deutsch. Thank you, Mr. Chairman.
Dr. Henderson, if you can, in a relatively compressed time,
give us a sense of what the destruction or the potential
destruction of America would be of, let us say, five self-
induced people getting--giving themselves smallpox and
purposely trying to infect the United States of America, if
that were to happen tomorrow.
Mr. Henderson. Well, I think if I may suggest the
likelihood of, let us say, people being infected with smallpox
and then wandering the country is I think a scenario that has
appeared in a number of publications. It seems a little
unlikely to us, very unlikely to us. What happens with
smallpox, there is an infection of the individual, and then for
10 to 12 days he will feel perfectly well, and he can't spread
the disease at all during this time.
Mr. Deutsch. Right. Until you are infected--or until you
actually show symptoms.
Mr. Henderson. And not only that, he has to have fever for
two or 3 days, and then begins to develop a rash. It is only
when the rash begins that he is able to transmit the disease.
Mr. Deutsch. Right.
Mr. Henderson. And at the time the rash develops the
individual is really pretty darn sick.
Mr. Deutsch. Right. Again--and I only have 5 minutes, so I
am going to just----
Mr. Henderson. Okay.
Mr. Deutsch. [continuing] try to dialog a little bit with
you, because I want to get to Secretary Thompson specifically.
I understand exactly what you are saying. I have read
extensively what you have written as well.
So we are relying upon the security of tens of millions,
potentially even 100 million Americans, on the fact that people
who we have already seen are suicidal are not willing to get up
when they are sick, and for that matter put makeup on, for that
matter, to cover smallpox and go on a plane and try to infect
100 people on a plane, 200 people on a plane. Is that our line
of defense?
Mr. Henderson. Well, it could be done. And could we do
something about it? Yes, I think we could. I think we could
move fairly quickly to----
Mr. Deutsch. And how would we move fairly quickly, since we
only have 15 million vaccines?
Mr. Henderson. Well, it is not 15. As the Secretary said, I
think the dilution of the vaccine by fivefold is there.
Mr. Deutsch. But we haven't done it. Is that correct?
Mr. Henderson. The vaccine sits in a vial, and it is dried.
And it depends on how much diluent you put in as to whether you
dilute it five-fold.
Mr. Deutsch. Dr. Henderson, I guess the point--and I think
it is serious enough--that, in fact, if there were five
suicidal people today who wanted to inflict catastrophic damage
on the United States of America, they could do it. And we are
talking about not thousands or even ten thousand lives, but
literally millions of lives. Do you think that is an accurate
statement?
Mr. Henderson. With all due respect, I do believe that
with--that we could respond quickly enough and with the vaccine
we have to head that off with----
Chairman Tauzin. Excuse me, sir. Whoever has the phone
ringing, would you please--is it out of the room now?
Mr. Deutsch. Dr. Henderson, let me just ask you one
question. And I can say it on a--I hate to personalize
questions. But if you were advising your family, if there was
one outbreak of smallpox tomorrow in America, what would you
advise them to do?
Mr. Henderson. I wouldn't advise them to be vaccinated at
that point.
Mr. Deutsch. I know that. But what would you advise them to
do?
Mr. Henderson. If there is an outbreak of smallpox----
Mr. Deutsch. One smallpox case in America tomorrow. What
would you advise your family to do?
Mr. Henderson. I don't think I would have any particular
advice to offer them.
Mr. Deutsch. I tell you what I would, I would say, ``Stay
in your home until you get vaccinated.'' And if that means a
year, if that means 2 years, if that means 3 years, literally
that would be the advice that I would give my family, my
children, my wife, and anyone who is listening to me. And I
think as you are shaking your head, that would probably be the
same advice that you would give as well.
Mr. Henderson. Let me just suggest, we have had a lot of
experience with smallpox and its ability to spread in a great
many countries. And it does not spread like influenza. I think
many people think of it spreading like a wildfire across the
country. It is not going to do that. With smallpox----
Mr. Deutsch. But our experience is with cases, not with
terrorists. And, again, the last case in the United States in
New York was a case that was controlled with hundreds of
thousands of vaccines, I guess in the 1940's. But that was a
case of, again, a person, not a terrorist.
Secretary Thompson, if I can follow up, when do you expect
to have a signed contract from one of the three drug companies
you are negotiating with?
Mr. Thompson. I hope, Congressman, that we will be able to
have a contract negotiated, I don't know if it will be signed,
by right after Thanksgiving.
Mr. Deutsch. So not until after Thanksgiving is the date
that you are telling us at this point. And that is negotiated,
not signed.
Mr. Thompson. Well, I don't know if we can get it signed or
not by that time.
Mr. Deutsch. When are we going to have a contract to
produce the 300 million or the 250 million vaccines that you
have said and you acknowledge that are necessary to have on the
stockpile for the United States of America?
Mr. Thompson. Congressman, I also would like to point out
that when we started a couple of months ago, there was not
supposed to be any smallpox delivered until 2005. And we have
accelerated that, and we should be able to have the 300 million
next year. We are working. We are moving faster. Dr. Tony Fauci
has said, and I quote him, that there has never been a contract
that has moved as rapidly in Department of Health and Human
Services in the 30 years that he has been there.
Mr. Deutsch. Okay.
Mr. Thompson. We are working almost around the clock in
order to get it done.
Mr. Deutsch. Mr. Secretary, can I just--and, again, and the
last sort of two things, can you say with very near certainty
that a contract will be signed that will allow for the
development of approximately 300 million doses of vaccine
within the next 12-month period?
Mr. Thompson. If we can reach an agreement, yes.
Mr. Deutsch. So you can't say with certainty that this is
going to happen.
Mr. Thompson. I can say with all probability we will have a
contract negotiated next week.
Mr. Deutsch. You know, if I can just close in 10 seconds to
say that what we have just described is the potentiality of
tens of millions of deaths, which is not an unhypothetical
reality. We have talked about--and Dr. Henderson directly
talked about a vial of smallpox being the size of less than a
thumb.
Mr. Thompson. I understand that.
Mr. Deutsch. Okay. We have just gone through a scenario
that could kill tens of millions of Americans, with hundreds of
billions of dollars, trillions of dollars of damage, and yet
this is the attitude that we have. I, you know, again talk
about that. I think we are totally missing the boat. I mean,
and, again, I know you----
Chairman Tauzin. The gentleman's time has expired. Would
the gentleman kindly----
Mr. Thompson. If I could just quickly respond. You don't
realize how hard we are working to get this thing done and how
far we have accelerated this. There has never been a contract
like this in over 30 years in the Department. In fact, in the
history of the Department, no contract has moved as rapidly as
the smallpox. No acceleration, no--we have got people from all
the agencies have come in for seven straight days to work this
thing out. It is a very complex thing.
I agree with you, it is a serious thing. And we want to be
able to respond. We want to get those 300 million. But I want
to tell you, we are not letting any stone unturned to get it
done as expeditiously and as correctly and as safely as we
possibly can.
Mr. Deutsch. And I----
Chairman Tauzin. The gentleman's time has expired. I have
got to honor the rules of the committee. The gentleman, Mr.
Whitfield, is recognized for 3 minutes, for 5 minutes rather.
Excuse me.
Mr. Whitfield. Thanks, Mr. Chairman. I am glad you didn't
cut me to 3 minutes, since I didn't make an opening statement
to help out on time.
Mr. Secretary, I also want to welcome you to this
committee, and want to commend you and the Department for the
good work that you are doing in trying to expedite the
availability of these vaccines. And I know that it is a
difficult issue.
One question that I wanted to ask is that the Vaccine
Injury Compensation Program, which is administered by HHS and,
I understand, the Department of Justice, has generally
benefited the national immunization policy of the U.S. And I
was just curious, do you believe that there should be a similar
program designed to compensate someone who has an adverse
reaction to a vaccine or a countermeasure administered in
response to a bioterrorism attack?
Mr. Thompson. Congressman, off the cuff, I would have to
say yes.
Mr. Whitfield. Yes.
Mr. Thompson. But I haven't dwelled on that, and I haven't
given it much consideration as of this point in time. And I
certainly think that you are raising a very valid question.
Mr. Whitfield. I would just ask, Dr. Henderson, if, say,
1,000 people were given a smallpox vaccine, what has been the
experience in the adverse reaction? What percent of people
would have an adverse reaction? Or do you know?
Mr. Henderson. How we define an adverse reaction is let us
say an adverse reaction can be very mild, and that does not
require----
Mr. Whitfield. Well, what about death?
Mr. Henderson. [continuing] anything like hospitalization.
Mr. Whitfield. What about death?
Mr. Henderson. If you are looking at 1,000 people, you are
probably looking at something like three or four at the most
adverse reactions.
Mr. Whitfield. Okay. All right.
Mr. Henderson. Not something that would put the people in
the hospital. But we must bear in mind that we do have--we
would expect a death rate of perhaps 3 or 4 persons per million
vaccinated.
Mr. Whitfield. Right.
Mr. Henderson. Now that doesn't seem like very many, but I
would say from the standpoint of the public reaction to this,
we have had a major reaction against one paralytic case of
polio per 3 million vaccinations. And so there is a perception
out there and a problem of how much risk do you take with a
vaccine like this versus what is the risk of the disease?
Mr. Whitfield. Right. And does Russia, at this time, have a
smallpox vaccine that--in large quantities or----
Mr. Henderson. We do not know what Russia has with regard
to quantities of vaccine. The question has been asked, but the
government has failed to respond.
Mr. Whitfield. Okay.
Mr. Henderson. There is a belief that they don't have very
much, if they have any reserve at all. But it is not very much,
so far as we know.
Mr. Whitfield. Okay. Mr. Secretary, any time we talk about
bioterrorism and the events that have happened on September 11
and since, we have this balancing act between privacy and
constitutional protection of freedoms versus trying to protect
the public.
And when we talk about food safety, I think that definitely
becomes an issue, and I know that you have asked for additional
authority for FDA to help deal with this problem, to detect
adulterated food, and so forth. In the bill that the committee
is coming forth with, there is a directive in there that the
Secretary take precautions that records of proprietary
information, formulas, so forth, are not inappropriately
released, which I know that you would not want to happen
anyway.
I mean, your goal is to protect the public, and that is
what our goal is. But you would not be opposed to that sort of
provision in our bill, would you? I don't think it was
specifically listed in your bill. And would you consider even
putting language like that, say, in the regulations?
Mr. Thompson. I don't have any difficulty with that. I
would like to see the language, Congressman.
Mr. Whitfield. Right.
Mr. Thompson. And work with you on the language.
Mr. Whitfield. Okay. Okay. Well, on this Section 319,
emergency authority that you have, it is my understanding that
you--have you already used that on one occasion?
Mr. Thompson. Yes, I have.
Mr. Whitfield. I am not sure I know what the background of
that was. Could you just briefly tell me?
Mr. Thompson. I used it immediately after the airplanes
went into the World Trade Center Towers, North and South. And
we decided that it was very necessary in order to move all of
the pharmaceutical drugs, the push packages, and so on, to
declare an emergency. We are still operating under that public
health emergency given the authority under Chapter 319.
Mr. Whitfield. Okay.
Mr. Thompson. And it is still in existence, and we have
used it very effectively in being able to get everybody alerted
to the difficulties. It was also helpful with CDC alerting all
of the State and local health departments--the fact that there
is an emergency. We also feel because of the anthrax that it is
important to keep the public health awareness emergency in
front of us.
Mr. Whitfield. And you are asking that that be expanded in
some ways, is that correct, the 319 authority?
Mr. Thompson. No. We are satisfied with it.
Mr. Whitfield. Okay. You are satisfied. Okay.
Chairman Tauzin. The gentleman's time has expired. The
Chair thanks the gentleman, and the Chair would recognize--who
is next, Mr. Sawyer? Ms. Eshoo? The gentlelady from California,
Ms. Eshoo, is recognized for 5 minutes.
Ms. Eshoo. Thank you, Mr. Chairman, again, for having this
hearing. And to our guests, thank you for your patience in
listening to all of the opening statements and your fortitude
in answering the questions.
I want to bring up three points, one about smallpox; one to
you, Mr. Secretary, about the UPL, which may seem like a side
bar issue, but it has everything to do with so many of the
things that you have presented today, where we strengthened our
public health system, the foundation that it sits on, and what
we have done in California and how we believe we need to
protect that; and a few words about food safety.
Let me start out with the issue of smallpox. It is my
understanding--and because I have read about it and heard about
this--and this is to you, to both of the doctors--about the
effort to build, obviously, a smallpox vaccine stockpile. What
I would like to know is if the CDC and the Department are
looking into medical treatments for smallpox other than
vaccines.
I am aware of cidofovir--excuse me if I am not pronouncing
it correctly--which has demonstrated promise in treating
smallpox. There is the before and there is the after. This
really deals with the after case. And I understand that the CDC
and the DOD are in the process of acquiring this drug for
Federal employees who work with smallpox.
So what I would like to know is, what are the steps that
the CDC is taking to add promising alternative treatments, such
as this--the one that I mentioned to our national
pharmaceutical stockpile?
And I also understand that in testimony, as they say over
in the other body, that Dr. Fauci spoke to this as well. So
could you comment on that?
Let me get just my questions out, and then--I don't think
the chairman is going to cut any of you off, but he will cut me
off.
So, you know, when you hang around here long enough, you
get to know the unwritten rules of the road.
The other----
Chairman Tauzin. You have learned well, I want to tell you.
Ms. Eshoo. Just at the foot of a master, Mr. Chairman.
On the UPL, the upper payment limit, Mr. Secretary, you
know the case very well. I think that we have an issue, or you
may have an issue, with obviously--and we all should--wherever
there is any kind of abuse or waste or misuse, misplacement of
Federal dollars.
But I am pleading with you, pleading with you, to recognize
that California and any other State that has followed the rules
of the road should not be made to bear the burden of any kind
of misuse or abuse by any other State or its lack of systems.
There is a post-September 11 case to be made here, and I don't
want to wrap those words around the case simply to heighten it.
I think it is just a pragmatic reality.
So I don't know when this proposed rule is going to come
out, but we need you to be an advocate for us. I think that
your voice would really count. If you want to say something
about it, I would welcome it.
And on the issue of food safety, you know, we are
considering things today that have been floating around the
Congress for a while. I introduced a food safety bill not to
penalize countries that want to trade with us, but, rather, to
protect the American people, what they put on the kitchen
table.
Mr. Secretary, you have a woefully inadequate workforce to
deal with this. You have got to get the money in order to
overhaul the system and to have the highest level of people
that are in charge of it. I would refer your staff back to
testimony that was given in the Senate in the last Congress.
This system has even been corrupted.
There was a witness there of--one of the food inspectors
that was--his trial--he had already been adjudicated. He was
going off to jail. But he was giving--he gave testimony as to
where all of the cracks were and what was going on. We have to
do much better in this country, and not just the pre-September
11, but upgrade it that much more. This is part of the army on
this issue and part of the war on it.
So I look forward to your telling me about it. Can you get
to the smallpox issue and comment about UPL? And are you going
to go for more? You don't have enough money to do the wonderful
things that you have talked about today, with all due respect.
I don't think you have the resources. But who wants to start,
and who wants to answer?
Mr. Koplan. Thank you.
Chairman Tauzin. The gentlelady's time has expired, but----
Ms. Eshoo. See, I told you. I told you. All right.
Chairman Tauzin. But if one of you would like to respond.
Dr. Koplan?
Mr. Koplan. I will respond to that briefly. On the issue of
antimicrobials for smallpox.
Congresswoman, I began my public health career testing a
reputed agent against smallpox, and that is where I first met
Dr. Henderson in Bangladesh in 1973. An issue with testing
antimicrobials for smallpox is--frequently you will find things
that look like they work in a laboratory, but don't work in
patients, when you go to put them, as with many other
medications.
In the last several months, as Dr. Henderson indicated, we
have been working with DoD and others looking at potential
antimicrobial agents against smallpox, and also trying to
improve diagnostic tests.
And there are promising agents there, and we will be
pursuing them, but I think that the mainstay of our defense is
a very effective vaccine, and we shouldn't hold out any great
hopes, or make any large investment I don't think, in agents
for treatment.
Ms. Eshoo. Thank you.
Mr. Thompson. Congresswoman, in regards to upper payment
limits, I think you should talk to OMB.
Ms. Eshoo. No, I want you to. I want you to be our
advocate.
Mr. Thompson. I have.
Ms. Eshoo. I understand that you have a problem, and we are
going to solve it.
Mr. Thompson. Second, in regards to food safety, I have
only been here for 8 months, but I immediately have recognized
an immediate problem with food safety. I can agree with you,
and I am passionate about it, that we need to do more.
We are doing a woefully inadequate job, and I have
testified in front of this committee before. I thanked the
Congressman, the chairman, and I thank you, and everybody else
who wants to upgrade the food safety system in America. It
needs to be done.
And 372,000 people got sick last year, and those are just
the ones that came in and said that I have got food poisoning.
You know, 20,000 ended up in the hospital, and 5,000 died. I
mean, that is----
Ms. Eshoo. That is not acceptable.
Chairman Tauzin. I thank the gentleman. I was one of those
that did not report to you in, but I had a bad case of it. The
Chair recognizes the gentleman from Iowa, Mr. Ganske----
Mr. Thompson. There is no food poisoning in Louisiana, Mr.
Chairman.
Chairman Tauzin. They have it in Florida actually. The
gentleman, Mr. Ganske, is recognized for 5 minutes.
Mr. Ganske. No food poisoning from any of that Canjun food
anyway, just good food. Mr. Secretary, I thank you for coming.
I know how busy you have been, and how hard you and our
department has been working, night and day basically, with an
unprecedented situation.
And I also wanted to thank you and the administration for
working hand-in-hand with Senator Frist and with Senator
Kennedy on their bill, as well as with our committee. I know
that you have been putting in a lot of time in consultation
with them on their bill.
Just a little while ago, Senator Frist, probably the
leading authority in the Senate on this issue of bioterrorism
said, ``Their bill,'' which is a bill that I and Congressman
Marion Berry will introduce this afternoon as a companion bill,
``authorizes approximately $3.2 billion in fiscal year 2002,
and it includes the administration's priorities.''
Senator Frist went on to say that the ``$3.2 billion in
funding in this bill takes us from an unprepared to a prepared
state. We believe that this is the money that we need to do
this job.''
And then both Senator Frist and Senator Kennedy said that
they have worked closely with you, appreciate that, and
appreciate the input from President Bush on this, and that,
``We expect to have administration support of our bill.''
So I have a proposal. Unfortunately, we have seen some
gridlock on Capitol Hill on the economic stimulus package. I am
told that as I am speaking we are having a conference meeting
on aviation security and so maybe something is happening in
that regard. I hope so. We have seen some gridlock on that.
But this issue of bioterrorism I think we should get past a
gridlocked situation, and so I would propose that the President
endorse the Frist-Kennedy bill today if possible. Thanksgiving
is coming up. Many items in this bill are going to take some
time for you to implement.
There are really good provisions that relate to food
safety, and earlier I had mentioned Senator Hagel, and I know
Senator Pat Roberts has had a great deal of input into those
food safety provisions. There are things in this bill, Mr.
Secretary, that I think would help you do your job as
Secretary.
Mr. Thompson. It would.
Mr. Ganske. And help coordinate the other Departments--for
instance, Defense, the USDA--in order to have a coordinated
approach. This is a well thought out bill, and I fear that
sometimes we end up with fingerpointing between the House and
the Senate.
And this is one issue that I think we can move on, because
I don't see anything in this bill that is as contentious as,
for instance, ``the Federalization'' of security screeners.
I think really what we are talking about are some funding
levels.
And one thing that I wanted to ask you about, because you
are a former Governor, but one of the advantages of what I see
of the Frist-Kennedy bill is that it does provide some support
to the States and the localities for the public health.
You as a former Governor know that the States are really
strapped right now, their public health departments in
particular, and I think they need that help. And I wondered if
you would make a comment on that particular item.
Mr. Thompson. Let me just start out, Congressman Ganske, by
thanking you, thanking you for your passion, and for public
health, and strengthening public health in America. It needs to
be done.
And I also want to thank Senators Frist and Kennedy,
because you and the chairman, and Senators Kennedy and Frist
have worked very closely with the Department and with the
administration to try and develop a really strong viable public
health bill for America.
The question is whether or not we need to do the full $3.2
billion immediately, or whether or not it can be spread over
several years. The administration feels that we have to live
within the $40 billion cap, and we certainly are complying with
that.
And we also recognize the importance, however, of
continuing to build on our public health system and come back
next year with another part of the funding necessary to make
that doable.
The programs that are outlined in the Kennedy-Frist-Ganske
bill, as well as Chairman Tauzin's mark, are very much in line
with what the administration wants. And in regards to block
grants, you know me.
I was the No. 1 Governor that was sort of a pain, because I
always talked about block granting everything to the States,
and there is no question that block grants would be very
helpful to the States.
My only proviso in the block granting, and please spare me
this little bit since I have been out here, to deviate a little
bit from my automatic universal support for block grants, is
that I want to make sure that that money is spent for local and
State public health systems.
It is so important. We have not invested the necessary
resource in the last 25 years in the State public health
system, and if there is going to be a good consequence of what
took place of the horrific acts of September 11, it may be a
renewed vigor on a bipartisan effort to come up with a strong,
stable, aggressive public health system. And I am very
appreciative of that effort on your part and the chairman's,
and this committee's part.
Chairman Tauzin. The gentleman's time has expired. The
Chair is pleased to recognize Mr. Stupak for a round of
questions for 5 minutes.
Mr. Stupak. Thank you, Mr. Chairman. Mr. Secretary, I am
pleased to hear you say that about getting it back to the local
level, because we have had a number of hearings here, and thus
far what we have heard in the last fiscal year is that
readiness on terrorism was $8.7 billion, but only $314 million
ever made it outside the Beltway.
So we have to do more to get it back to the local units of
government, public health and hospitals especially, no matter
where they are, in rural Northern Michigan where I am from, or
Wisconsin, where you are from, of course.
So you testified earlier that you have $300 million for
State and local preparedness. But what percentage is that of
your total budget for preparedness?
Mr. Thompson. I don't know the percentage. Are you talking
about the total Federal budget, or are you just talking about
the $1.6 billion?
Mr. Stupak. Okay. So of that $1.6 billion then, $300
million will go for local preparedness?
Mr. Thompson. That is correct.
Mr. Stupak. Will the rest of it stay within the Beltway
then?
Mr. Thompson. No. The rest of it is--there is $509 million
for the smallpox vaccine, and there is $643 million for
improving the antibiotics, the cipro and the other things
dealing with anthrax and so on. So that is about $1.2 billion
of the $1.6, and the 300 goes to the local and States.
Mr. Stupak. All right. Dr. Claire Broome testified on
November 1st about the NEDSS system, the National Electronic
Disease Surveillance System, and quite frankly there were about
three people on the panel, and she was the only one who was in
favor of it.
And once again the local units of government were saying
that we don't need another computer system which requires us to
hire people and put a room aside for this surveillance and
infrastructure that comes with it.
They would rather not see a NEDSS system. Again, that is a
lot of money, and we would rather see it back at a local level.
Mr. Thompson. I would like to have Dr. Koplan address that.
Mr. Stupak. Sure.
Mr. Koplan. I wasn't here, but my understanding was--and we
work closely, and I mean daily, hourly, with local and State
health organizations and their officials, and they are very
much in favor of the NEDSS. They have played a crucial role in
developing it.
This provides the highways in which we put the health of
our network to provide a secure up to date framework for the
infrastructure for our communication. What I think the local
health departments are not in favor of is having a lot of new
private--new construction of these things that they would have
to buy into.
The NEDSS system is one that they have contributed to. It
meets their standards, and it builds on what they have already
got. So I believe that at least in our regular communications
with them that they are very supportive.
Mr. Stupak. Well, when we asked the follow-up question,
like it is obvious from us up here after the panel got done
that there was not a lot of support for it because of the
costs.
I mean, you may help with the initial costs of getting the
system in place, but then that hospital or that public health
agency has to hire a person, and a constant update, and get the
computers, and things like this.
And quite frankly, they can't afford it. When Ms. DeGette
was asking you about or explained about releasing something
over Bronco Stadium up there during a Denver football game,
that was the example used.
And her people from Denver were testifying that they were
not in favor of the system. So I just wanted to make sure that
before we start pushing new systems that, No. 1, the locals are
covered for the costs; and, No. 2, they are in support of it,
because on November 1st, most people were not in favor of
NEDSS. That's the reason that I bring it up.
Mr. Secretary, what authority do you have to reprogram
monies and things like this? Since September 11, we have had
new concerns in this country called bioterrorism, and in
looking at the budget--and I don't mean that this isn't a good
program, but the AIDS and sexually transmitted disease has over
a billion dollars in it.
But in bioterrorism, we have only about 18 or 17 percent of
that budget, like $180 million. Do you have any authority, or
what authority do you need to reprogram, or call it block
granting within your own department, or however you want to
call it, but reprogram some of that money so when needs come up
we can move resources immediately within the existing
framework?
Mr. Thompson. Thank you so very much for that question. I
didn't think that I would ever get that question. I don't have
very much. I have less than most departments.
And I requested this year of going from 1 percent to 3
percent, and it was not universally received, and in fact
nobody but you have ever supported that. But I think, and
especially now, the Department certainly needs more
flexibility.
We have to scrimp and scrap from every place we can to get
Dr. Henderson on.
Mr. Stupak. Right.
Mr. Thompson. And it would be nice to be able to
redelegate, and to bring up with the notification of the
Congress what we are doing. But we don't have very much.
Mr. Stupak. Well, if you submit a proposal, I think many of
us up here would like to help you on that.
Mr. Thompson. Thank you.
Chairman Tauzin. The gentleman's time has expired. The
Chair recognizes Mr. Shimkus from Illinois for 5 minutes.
Mr. Shimkus. Thank you, Mr. Chairman, and again it has
really been enlightening, and we are glad to have you here. A
question that I was asked at another hearing, and I think it
was on the other side of the The Hill was did the U.S., or do
we know the number of laboratories that can weaponize anthrax.
And if we don't, why don't we, and should there be a
certification process, or some type of accounting for labs that
have or are doing research on that type of stuff.
Mr. Thompson. Congressman, we don't have the authority to
request that.
Mr. Shimkus. Would you like the authority?
Mr. Thompson. We are asking for it in this proposal.
Mr. Shimkus. Is that in the chairman's mark if you know?
Mr. Thompson. I hope it is. I don't know if it is. It is in
the proposal that we sent up here. We have the authority as a
department to set rules for the transportation of biological
agents, but not the possession, or the storing or the use of
them.
But we do have--I think there was a law passed in 1996 or
1998 that gave us the--'97--to give us the authority to
regulate the transportation, but not the possession or use, and
that just seems to me an oversight that needs to be done,
especially now. CDC needs that. Do you want to address that,
Joe?
Mr. Shimkus. I am being advised that we do have that in the
chairman's mark on the bill, and so I will follow up and see
what all that is.
Dr. Henderson, just a follow-up. I know that your expertise
is in smallpox, but just that scenario that the Federal
Government should probably have some accountability, and not
just on the transportation issue, but the location of
laboratories. You probably would think that would be a good
idea would you not?
Mr. Henderson. Yes, I think it would it would. I think we
have to be careful how we do it. We don't want to extend a
number of organisms to an extreme range, but I think it would
be good for a select number to have that.
Mr. Shimkus. Okay. Thank you. Mr. Secretary, I have a bill,
and I am sure that I will be followed by my friend, Lois Capps,
who will talk about her provisions. But you did address, and
Chairman Bilirakis mentioned shortages in personnel.
We have been addressing, or I have been working on a
laboratory tech shortage, which is just as great. And if we
expand laboratory facilities, and we don't have laboratory
technicians, then we are not going to get the work done.
I would hope that you would help us as we move legislation
and look at those provisions that help us staff up, and that
would encourage people to go into those fields to help provide
the needed expertise that we need in these areas.
Mr. Thompson. I certainly will and it needs to be done. I
mean, laboratory technicians are on par with nurses as it
relates to the shortage in America. And we are putting more
money into the laboratories, and to security, and to expansion,
which they badly need, but we need technicians also to be able
to be hired. And the CDC--Jeff, did you want to add something?
Mr. Koplan. I would just add that I agree with you. It is
hired, recruited, and retained. I think the retention of
people, because it is extraordinarily expensive to provide up
to date training in some new area.
And a good example is some of these agents we are concerned
about here is every year or so we get some new tests and there
is a new opportunity to train people. If those people then
leave the lab tech field to do so something else, you start
from zero again. So there needs to be an investment in keeping
these people happy and doing good work in the laboratory.
Mr. Shimkus. And I have been real surprised about how
technology has come into that field, too, and really allowed
people to do more with less, but then the need is going to be
greater.
Let me end up on this comment about one of the most
enjoyable things about being a Member of Congress--I have only
been serving now for 5 years--is my involvement with community
health centers, and the fact that in Illinois there is 25.
And since I have been a member, we have gotten three in my
district, and they provide a great benefit, especially those
uninsured, or those underinsured. Connecting them to the health
alert network and the national electronic disease surveillance
system aspect is critical, and I think that is probably going
to cost money with technology and stuff.
But they are on the front lines, and when I always get a
chance I like to promote the community health centers, and hope
that they are part of this equation of service in this era.
Mr. Thompson. Community health centers are absolutely
vital, and the proposal that is in our fiscal year 2002 budget
request, we are requesting an additional $125 million to expand
them.
We would like to grow from 3,200 community health centers
to 4,400 in America, and from serving 11 million people, to 20
million, and that is absolutely the front line of defense,
especially for the uninsured, and especially for minorities in
America. It is an investment that is badly needed, and it pays
many dividends to the American taxpayer.
Chairman Tauzin. The gentleman's time has expired. I want
to associate myself, however, with the gentleman's comments.
Electronically connecting those community health centers to the
emergency information system is critical, Dr. Koplan, and I
hope that is your goal.
Mr. Koplan. That is very much a goal of ours as well.
Chairman Tauzin. Thank you very much. You should also know
by the way that I think we have an agreement, Mr. Secretary, to
move the community health bill out of this committee, and we
are working on the final elements of it.
But I think we will be moving it out really quickly now,
and I thank you. The gentleman from Ohio, Mr. Sawyer, is
recognized for 5 minutes.
Mr. Sawyer. Thank you, Mr. Chairman. I just have to remark
on the last item. What looks like a small number of incidents
locally, when aggregated nationally, can look like an epidemic,
and the ability to recognize events as they are occurring in
real time is an extraordinary asset in all of this.
Mr. Secretary, you keep getting referred to as a former
Governor. I suspect that if you have ever been a Governor that
you are probably always a Governor, and that gives me great
comfort.
I used to be a mayor of a mid-range city, a quarter of a
million, in a community of a half-million, and I would like to
ask you a couple of management questions. I am glad you are
where you are.
I want to ask about how to get local funding to where it
needs to go and give you the flexibility to react in a highly
fluid environment, and to keep track of those dollars as we go.
You have put together cooperative agreements in five major
areas that deal with bioterrorism, and is incorporating this
into a larger bioterrorism bill that gives both that capacity
to flow dollars and to be accountable for them, is that the
best way to take advantage of the work that has gone on so far?
Mr. Thompson. I really think that the best way to do it is
to set up an Assistant Secretary for Bioterrorism, or health
care preparedness in America, and bring all these groups
together, and put them under one leader that then is
accountable to the Secretary, and to the administration, and to
Congress.
It seems to me that that makes a lot more sense. We really
have not addressed that particular question, Congressman, and I
am very happy that you are bringing it up, because it is a
management question, and getting money back to the local
municipal governments is usually by formula, and sometimes
those formulas don't work and don't meet the necessities.
Mr. Sawyer. There is a lot of jealously involved in that,
and it is not a criticism. It is just human nature.
Mr. Thompson. Right.
Mr. Sawyer. When you try and set up mutual assistance
packs, and you have fireworks with fire, and police with
police, but when you try to move across disciplines, and across
jurisdictions, it becomes enormously difficult.
You can play a critical role in establishing the kind of
cooperative command and control structures necessary to react
quickly in the event of the kinds of occurrences that we have
seen recently. I have gotten very good reports from my public
health people about the role that has been played by the health
alert network, and how good they have been in alerting the
professionals.
I have gotten a sense from the reports of my colleagues
that that has not always worked as well, in terms of public
communication across the country. It has worked well some
places and not well in others. Do you have any thoughts about
how best we can elevate that communication capacity with the
public and not just with the professionals?
Mr. Thompson. What we did, Mr. Sawyer, is we probably
should have done it right at the beginning. But what we are now
doing is that we have daily briefings from the Department, with
as many of the press people that wants to hook up.
And we usually have Dr. Koplan, or Dr. Falchiez, or the
Surgeon General, and we put that out. Dr. Koplan and I have
been having very regular meetings, and teleconferences with the
State health departments. I think we have had three so far.
We then had a teleconference with all the State
laboratories, and we had a teleconference with the Governors,
and we had a teleconference with the American Medical
Association, and American Hospital Association, the National
Conference of State Legislative Leaders.
Mr. Sawyer. We won't hold you responsible for that one.
Mr. Thompson. I guess I was. but we have been doing a lot
more research than we did at the beginning, and I think it has
paid a lot more dividends.
Mr. Sawyer. Let me mention ne in particular. My local
health director is the past president of the American
Association of Public Health Directors. So it is not as though
he is in a badly informed man. In fact, I think he is well
informed.
But virtually every health director in my district was only
marginally aware of the Center for Health Preparedness in my
own State of Ohio. It seems to me that integrated training
opportunities, while not immediate, represents an important
long term, on going effort.
Can you talk a little bit about how we might elevate that
into----
Mr. Thompson. I would really rather have Dr. Koplan talk
about that, because this is one of his expert areas.
Chairman Tauzin. Let me do something while Dr. Koplan does
that. Mr. Secretary, we are not grounded to these seats like
you are while you testify. If you would like to take a personal
break while Dr. Koplan testifies at this time, we would be
delighted to accommodate you.
Mr. Thompson. You are a gentleman and a scholar, sir. But I
think I will stick it out for a couple of more minutes.
Mr. Koplan. I was about to say how long do you want me to
talk. Ohio actually has a terrific health department. We have
Dick Baird, who is the head of it, has done a great job, and in
the course of just the last couple of years, once has seen a
transformation of--I guess it was about 2 years ago, and we
will have to check on the dates, but virtually none of the
county health departments were linked electronically to the
health alert network.
And today they all are and that makes a huge difference.
But you have identified one of several pieces of what makes for
a competent capacity for a health department. One of them is
communication capabilities. One of them is training
capabilities and staff.
And there is an interplay between this work force issue and
training capabilities, and getting people up to date. And then
there is surveillance, epidemiologic capability, and lab. And
unless all of those are at a level of competence, then that
local jurisdiction, whether it is a State or a county, really
is a weak link in the overall web of the system.
Now, what we are trying to do is upgrade all of those
components across the country to a level where we provide
safety to our neighbors about the virtue of our own competence
in that. Thank you very much.
Chairman Tauzin. The gentlelady from New Mexico is
recognized for 5 minutes.
Mrs. Wilson. Thank you, Mr. Chairman, and I appreciate you
staying here so long to answer questions today. Dr. Kaplan, how
many Level-4 labs are there in the country that are handling
the most dangerous toxins?
Mr. Koplan. There surely is just a couple. We have a major
Level-4 laboratory, and the Army has a Level-4 laboratory, and
there are other Level-3 plus laboratories that are capable of
doing fair numbers of things.
Mrs. Wilson. Do we need more of them?
Mr. Koplan. I think there is a tradeoff. As you add more,
then there is a lot of investment and energy that has to take
place around a Level-4 lab to keep it going. Its design is very
difficult, and the people that work in them have to take
extraordinary precautions, and are at considerable risk
themselves as they work in them. So there is value in having a
few, but there is also a tradeoff as you add these units.
Mrs. Wilson. As you look at the expansion of laboratory
capacity, which is one of the things that clearly we don't have
enough of, and I think you both acknowledged that we don't have
enough of, is there going to be a preference for funding
efforts that they themselves integrate things like the State
Epidemiologists that is trained by the CDC, and university
centers, and the crime and OMI laboratories, so that you are
not only pooling resources, but that brings together in the
same facility the experts that in any time of crisis you want
to be together?
Mr. Koplan. Very much so. I think that is a very good
point, and we have some very good examples of it. We have a
network of emerging infection laboratories that are often in
academic centers, but very closely tied up with local health
departments, State health departments, and the epidemiology
units.
And that combination of skills is extremely helpful and
effective toward early recognition of health problems, and then
early control or prevention of them.
Mrs. Wilson. I am very much encouraged, and particularly as
we work on this legislation, to--you know, sometimes the carrot
encourages things that the carrot of Federal assistance, or
matching funds, or participation, can encourage the expansion
of capacity in ways that makes sense in time of crisis, which
might not otherwise occur.
And I very much encourage you to explore and promote that
approach, and I certainly welcome a legislative point of view.
With respect to your ability to know who has these biological
agents, which Mr. Secretary, you do not have that authority now
and I understand that. You only deal with the transfer of them,
but you don't have authority for possession, storage, and use.
Do you have that authority with respect to the
transportation of materials held by other Federal agencies, or
should you have that authority over Federal labs that are
military, NASA, Department of Energy, laboratories, or do you
only have authority over private labs, Department of Health
labs, and those kinds of things? What is the extent of your
authority or your potential authority, that you are looking at?
Mr. Koplan. The select agent laws that are currently
written applies to all bodies, all laboratories, that have
these agents and ship them or receive them, including Federal.
Mrs. Wilson. So you currently have authority over the
military laws for that purpose?
Mr. Koplan. They have to register with us if they are
shipping or receiving.
Mrs. Wilson. Do they comply?
Mr. Koplan. I would have to check and make sure, but I
would think so. If we can get back to you on the details on
that.
Mrs. Wilson. With respect to the ideas that you have been
kicking around about registry of possession and use of storage,
is it also your concept to have cultures so that you can get
the genetic sequences of those materials, or just that a
university would say, yes, we have anthrax or certain bacillus?
Mr. Koplan. I am not sure whether there are plans to get
genetic breakdown of what everyone has. It would be more of a
listing of what they have got. That would take a considerable
investment, and some of these places have already characterized
what they have in stock.
Mrs. Wilson. Do you see an advantage in having a repository
of those sequences?
Mr. Koplan. I am not sure. I would have to think about it
some more and discuss it with some other people. I think it is
a complex issue. The issue of these laboratories and their
contents are complex in the sense that these are living
organisms, in the sense of security that comes around, and
knowing that they have some there can be a false one, in the
sense that those organisms can multiply, and you can have twice
as much at one point or half as much at another point.
Nevertheless, there is real value as you have indicated in
knowing which laboratories have which agents. A detailed
sequencing of individual agents is certainly worth looking
into.
Mrs. Wilson. With respect to research and development of
real time monitoring and getting away from the----
Chairman Tauzin. The gentlelady's time has expired. She can
complete that question.
Mrs. Wilson. Thank you, Mr. Chairman, and this will be my
last question. Mr. Chairman, I appreciate your tolerance. Q-
tips, and cultures, and moving beyond that to real time
monitoring, is there an effort, an interagency effort in the
Federal Government to identify technologies developed in other
agencies for other purposes to apply to this problem very
rapidly, and test and deploy those?
Mr. Thompson. It has not been very good in the past, but
since September 11 it has gotten much better.
Mrs. Wilson. Thank you, Mr. Chairman.
Chairman Tauzin. I thank the gentlelady. The gentleman from
New York, Mr. Engel, is recognized for 5 minutes.
Mr. Engel. Thank you, Mr. Chairman. Gentlemen, I want to
read a story that appeared in today's New York Post, and I
would like you to comment on it. It says, ``Deadly Nerve Gas is
a Phone Call Away.''
``For $130 almost anyone can order the chemicals needed to
develop deadly nerve gases a prominent chemist warns. If you
want to do it, you could just do it, Rice University organic
chemist, James Tour, told The Post.''
``After a Defense Department analyst tried to downplay the
problem to him last year, Tour said he was able to order enough
chemicals to make nearly 300 grams of serine, the nerve gas
used in attacks on Japan's subway system in 1995. It killed 12
people.''
``Tour said that is enough serine to kill 7,500 people in a
crowded subway system within 60 seconds, or 150 a minute in an
office building. After his secretary placed the order with
Sigma Aldrich, no one from the St. Louis-based company asked a
question, not even for verification that the professor was the
one ordering the chemicals.''
``The order simply arrived at his office in Houston a day
later. It is frightening said Tour, who served 2 years on a
Defense Department panel studying the possibility of chemical/
biological terrorism.''
``Tour said that he shared his concerns with Federal
officials, but claims to have been politely dismissed. Tour
said that the Federal Government should do background checks
and grant licenses to chemists who want to purchase chemicals
that can be used as weapons.''
``Some chemical industry officials say it would be onerous
for those who legitimately use the chemicals and would do
little to deter terrorists from getting them on the black
market. A Sigma Aldrich spokesman said it did not check on Tour
because of his reputation and his history with the company.''
``But Tour and other experts insist most suppliers do just
minimal screening of customers. Tour is calling on the Federal
Government to restrict the sale of chemicals that could be used
as deadly agents. Tour's concerns were first raised in the most
recent issue of Scientific American Magazine, which 2 weeks ago
was able to order the chemicals needed to mix Serine for
delivery to its New York city office.''
``Ron Kellier, a spokesman for Sigma Aldrich, said that his
company would support the tighter regulations Tour is
seeking.'' And I am wondering, Mr. Secretary, if you or anyone
else can comment on that, because to me it is frightening.
Mr. Henderson. I would say that it is welcome to the 21st
century. We have now a broader number of people educated in
more ways and have more access to the internet to do more
things than one can possibly imagine.
And I think the fact is that in the field of biology, we
are obviously going to have to effect more in the way of
controls than we had before, because people are able to do
recontaminant technology very simply in very many ways, and
very many places.
And I think that the same can be said with the chemical
agents as well, and we have not really given this much thought
up until now, and I think we are only beginning to explore
this, but it is a challenge, and I think it means some further
restrictions in freedoms if we are going to have a greater
security.
Mr. Thompson. Congressman, I think Dr. Henderson outlined
the difficulties, but let's face it. If we are going to be
secure, we are going to have to have background checks, and if
you are going to purchase gas, you are going to have to have
some investigations, and it is going to require some degree of
Federal authority, whether it be a Congressional law, or
Federal rule, or whatever the case may be.
But it seems to me that we have an opportunity now since
September 11 to be able to do a lot of things that is going to
make our homeland much more secure, and this is a particular
problem, and it is not the only problem out there facing us.
There are a lot of problems dealing with a lot of
chemicals, and a lot of agents that can cause a great deal of
harm top a lot of Americans. And if we are going to be secure,
we are going to have to start looking at ways to register and
doing background checks.
But it also is going to require the Congressional
delegation to make some tough decisions. How far do you want to
go. We will implement the laws that you pass.
Mr. Engel. Well, I would hope that we would hold hearings
on these things specifically, and I would certainly intend to
introduce legislation to deal with this, because I think that
this is obviously a time bomb that cannot wait. We need to act
on it immediately.
Mr. Thompson. The same thing with food pathogens and it is
the same thing as Congresswoman Wilson talked about in
laboratories dealing with biological agents.
Mr. Engel. On another matter----
Chairman Tauzin. The gentleman's time has expired.
Mr. Engel. Okay. I guess we will do another matter another
time, Mr. Chairman. Thank you.
Chairman Tauzin. I thank the gentleman. The Chair
recognizes the gentlelady from California, Ms. Capps.
Ms. Capps. Thank you, Mr. Chairman, and Mr. Secretary and
your colleagues, I commend you for your staying power. I am
very impressed with that you would hear each of us out, and I
also note with great interest your focus on the importance of
local resources in this whole topic. It is right on in my
opinion.
Mr. Thompson. Thank you.
Ms. Capps. And I want to thank my Chairman, Mr. Bilirakis,
for engaging you in a conversation earlier about the nursing
shortage, which if there is anything----
Mr. Thompson. He did an excellent job supporting you, and I
want you to know that.
Ms. Capps. I know that, and that's partly why I wanted to
follow up, because if there is anything local, more local than
nurses, I don't know what it is. And other health officials.
The work force that does man and staff our hospitals and
our public health facilities, and right now we are woefully
short, as I know that you are well aware. You mentioned
expanded resources, and expanding authorities, to address the
situation.
Many of these I have included in a bill introduced many
months ago, and it has a counterpart in the Senate of the Nurse
Investment Act. It has over 220 co-sponsors, and I called this
entity for lack of a better term, and it can be called
anything, but a National Service Nurse Service Corps.
Whatever it is that will give incentives and scholarships,
and loan forgiveness, to encourage people coming into the
field, who will then guarantee work, particularly in under-
served areas, for a time.
If you would expand on that even more if you will, and if
there is a way that we can do this, also keeping in mind the
need for a career ladder track if you will, harkening to what
Dr. Koplan said, that you train people and then there is new
technology, and you have got to train them further.
We want the basic education there, but we also want people
to have opportunity to go into advanced practice and into
public health.
Mr. Thompson. Congresswoman, I am speaking to the choir.
Ms. Capps. Yes, you are.
Mr. Thompson. And I applaud you and thank you for your
leadership on this effort. As you know, I handed out $27
million I think about 6 weeks ago out at the Georgetown Nursing
School toward nursing scholarship students, or several nursing
schools.
I think one thing we should do is put in--part of your
proposal should be to get to the high school counselors.
Ms. Capps. Yes.
Mr. Thompson. And do some PR to get out to a lot of
individuals, and also now that we are going to reauthorize
TANF, it would be a great opportunity for us to talk about the
need for educating single women in----
Ms. Capps. And men. And men.
Mr. Thompson. And men, absolutely. But individuals that are
still in TANF to be able to go into the health care field. And
it is not only nursing. It is the laboratory technicians are
probably No. 1, and nurses are probably No. 2. I am not
speaking of categories.
I am just telling you that we have got a shortage of a lot
of health care fields, and pharmacists, and so on, and all of
these individuals need to be taken care of, and we have got to
encourage more people, more young people, men and women, to get
involved in the health care fields.
And I think a public relations effort by you, by Congress,
by the Department, however we do it, on a bipartisan basis, is
to get out to our high school students that are going into
college and saying that these are the fields that are badly
needed. And they are great professions, and we need you to take
a look at them.
Ms. Capps. Thank you, and you being able to say this in the
context of combating bioterrorism makes a lot of sense and will
help us with this. I appreciate your leadership on it.
Mr. Thompson. Thank you very much.
Ms. Capps. Thank you. I yield back the balance of my time.
Chairman Tauzin. I thank the gentlelady. Mr. Secretary,
your staff has informed me that you have a meeting with Speaker
Hastert at some point?
Mr. Thompson. Yes, I do.
Chairman Tauzin. Are you late for that meeting now, sir?
Mr. Thompson. I am afraid so.
Chairman Tauzin. I know that we have several of the members
who would like to ask questions. What are your wishes here? I
don't want to unnecessarily delay the Secretary from his
meeting. Tim, can we do that, and then I will recognize you
again for questions to Dr. Koplan and Dr. Henderson. Mr.
Strickland, can we do this quickly?
Mr. Strickland. Yes. I have a very, very short question. I
have heard--and I apologize if this has been covered, but I
have heard from some doctors in my district who are concerned
that the emphasis on bioterrorism and being prepared for that
problem, and specifically the focus on smallpox vaccine could
mean that other, perhaps more basic, vaccines such as for
measles and the flu, will be left behind and we will have
resulting shortages. Is this a legitimate concern?
Mr. Thompson. First off, Congressman, thank you for your
lovely letter, and thank you for your wonderful comments about
me personally, and I appreciate that very much. I don't think
so.
What we have done is we have set up a scientific committee
composed of a bunch of scientists from the pharmaceutical
companies, and from NIH, and from CDC, headed by Dr. Henderson
to take a look at all vaccines.
Not only the existing vaccines, but also new vaccines that
we need. We need to develop some new vaccines for the plague,
and for the hemorrhagic viruses, and for emboli, and for all of
these that are out there.
We should be really doing more of a concerted effort to
develop the vaccines, and a lot of companies have gotten out of
the field of producing vaccines, and we are trying to find a
way to encourage them back into producing vaccines, not only
for measles and chicken pox, and now smallpox, but also anthrax
and so on.
Chairman Tauzin. Mr. Doyle and Ms. Harman, do you have a
question that you need to ask? If not, then with the--Mr.
Doyle, you had one brief one? If you will make it very quickly,
sir.
Mr. Doyle. Thank you. Mr. Secretary, thank you. A few years
ago, Congress, with the support for the Centers for Disease
Control, set up a program called the Centers for Public Health
Preparedness, and the goal was to use accredited schools of
public health, and provide a one-stop shop network of training
and professional resources for public health professionals,
primary and secondary health care providers, and the general
public.
Now, currently we have seven such centers funded at a total
of just over $2 million, which is sort of partial funding and
despite that rather modest investment, they have been able to
produce about a hundred training products for various aspects
of public health work force, which is very encouraging.
I understand that there is a move to put on eight
additional centers, and eight additional centers have been
approved, in addition to the seven that already exist. But
there is not anymore additional funding, and I am just
wondering with the $2 million budget how we intend to get these
15 centers off the ground, and are you asking for more
resources to do that?
Mr. Koplan. The centers are excellent, and they are very
effective. Just some recent examples is that there is center at
Columbia, at the Mellman School of Public Health, that has been
very prominent and been very helpful in the recent New York
disasters.
The centers in Florida have been very helpful to
identifying anthrax to physicians in health departments in
Florida, and they serve as a very important training base for a
variety of other activities.
The schools of public health are really an untapped
resource, because there are many more of them doing things. Dr.
Henderson has had this experience before at Hopkins. There are
a number of other places that could play a role. So I think it
is a fertile area for growth and expansion.
Mr. Doyle. But what is the status of these eight centers
that have been approved, but not funded? Are they in limbo now?
Mr. Koplan. When funds are available, they can be
supported. It is much like research grants, where you get a
larger number of things that have merit and could be approved,
but if the funding isn't there, you can't extend it to them.
Mr. Doyle. Have you asked for additional funding?
Mr. Koplan. I think additional funding is under
consideration in the coming budget years.
Mr. Doyle. Okay. Thank you, Mr. Chairman.
Chairman Tauzin. I thank the gentleman, and Secretary
Thompson, we deeply appreciate your appearance, and your
patience here today. I want to say something before you leave
though. I don't know if America fully appreciates how hard you
and your department are all working to protect our citizens. I
want them to know that today.
We are privy to very private briefings with you, and we
know perhaps even more deeply than this hearing has indicated
how hard you are working, and what you are doing to make sure
that we face these threats with as much security and as much
capacity as possible to protect American lives.
And American lives are truly in your hands, and I want to
commend you for understanding the seriousness of these threats
and for dealing with them as you are. You have this committee's
full support as you know in those efforts, and as your needs
become clearer as we go forward, you have many allies on this
committee, and we are prepared to help you, sir.
Mr. Thompson. Thank you.
Chairman Tauzin. Thank you very much, Secretary Thompson.
Mr. Thompson. Thank you very much, Congressmen.
Mr. Koplan. Mr. Chairman, thank you.
Chairman Tauzin. Thank you, sir. If Dr. Henderson and Dr.
Koplan will stay just a second, let me make sure. Do any
members have questions of either of these two gentlemen? Then I
thank you very much.
And before we adjourn, I have two items that I want to put
in to the record. One is a letter to the committee from the
various food and food processor associations in support of the
draft of language that we are preparing.
And a statement by Representative Mac Thornberry regarding
the Committee on Commerce's hearing today; and a General
Accounting Office GAO report on the Centers for Disease and
Control and Public Health Protection.
And without objection, all of these documents will be made
a part of the record. And again I want to express my
appreciation to the Department for its agreement to forward to
our Oversight and Investigations Subcommittee the documents on
CDC security which we requested, as well as the other
additional information on agents.
We will hold the record open for further questions and
further submittals for approximately 30 days, and if there is
no further business to come before the committee, with my
appreciation to the staff, and to the witnesses, the committee
stands adjourned.
[Whereupon, at 2:07 p.m., the committee was adjourned.]
[Additional material submitted for the record follows:]
November 14, 2001
The Honorable W. J. Tauzin
Chairman
House Energy and Commerce Committee
U.S. House of Representative
Washington DC 20510
Dear Mr. Chairman: As the Committee begins to address the issue of
bioterrorism, we appreciate your focus on enhancing food security
through additional resources targeting any new legal authorities to
well-defined risks.
The food industry supports a strong, effective regulatory system
that has sufficient resources to accomplish its core mission. As you
know, food safety and security have long been a top priority for the
food industry. Our industry has a proven track record of working
closely with the states, federal regulatory agencies and the Congress
to develop risk-and science-based solutions to food security
challenges. Because of these efforts of the food industry, Americans
enjoy the safest food supply in the world.
The federal government, through Food and Drug Administration (FDA)
and the U.S. Department of Agriculture (USDA), already have vast legal
authority and numerous enforcement tools to police our food safety
system. At a time when concerns are being raised about the security of
our food supply, both industry and government have increased their
vigilance. We support the appropriation of resources to enable federal
agencies to fully exercise their legal responsibilities. We applaud the
targeting of these new resources to improved systems and methods for
rapid detection of foodborne pathogens and other significant risks;
enhanced facilities, equipment and integrated information management
systems for effective food safety surveillance, inspection analysis;
and strengthened personnel resources and training, including for
inspection of imported foods.
While we are not fully convinced that new additional authorities
are necessary at this time, we appreciate your efforts to carefully
circumscribe new authorities to address well-defined risks to food
security. Specifically:
<bullet> Any additional detention authorities granted to the FDA should
be limited to those circumstances which present a genuine
public health emergency as declared under the Public Health
Services Act, and relate directly to an adulteration that
presents a threat of serious adverse health consequences.
<bullet> The Secretary of Health and Human Services should only have
the authority to debar individuals who are convicted of a
felony resulting from the importation of unsafe food into the
United States.
<bullet> Any additional authority expanding government access to
company records should be linked directly and strictly limited
to the documents needed to investigate the specific occurrence
of adulteration that poses a threat of serious adverse health
consequences. If a company treats a document as
``confidential'' so should the government, and steps should be
taken to ensure the protection of such information.
<bullet> Any new prior notice requirements for the importation of food
products should be designed to ensure that the free flow of
commerce is protected and to protect the U.S. food supply from
shortages from undue commercial disruptions.
<bullet> Any new grants made to state or territories for the purpose of
conducting food inspections should be confined to those
circumstances in which a genuine public health emergency
related to food adulteration has been declared under the Public
Health Services Act.
We believe your draft legislation is generally consistent with
these principles, and offer our assistance to you and the Committee in
the continuing effort to enhance consumer confidence in food safety
through science- and risk-based solutions to current and emerging
threats.
Several legislative initiatives exist that would vastly expand FDA
and USDA authorities over domestic and imported foods. These proposals
have little, if any relevance to addressing well defined risks to
public health and safety and are outside the parameters of current
legislative efforts to address bioterrorism. Aside from presenting
significant trade and regulatory concerns, we strongly believe that
they would not enhance food security.
Thank you for the thoughtful approach you have taken thus far and
for considering our concerns. Americans are continuing to count on both
the food industry and the government to ensure a safe, secure and
affordable food supply. Industry has a food safety infrastructure in
place today staffed by thousands of food scientists whose mission is to
focus exclusively on analyzing current and potential hazards to food.
We stand ready to assist in this effort in any way we can.
Sincerely,
American Bakers Association; American Feed Industry Association;
American Frozen Food Institute; Association of Food Industries,
Inc.; Associated New York State Food Processors; Cheese Importers
Association of America; Food Marketing Institute; Food Distributors
International; Grocery Manufacturers of America, Inc.;
International Dairy Foods Association; Missouri Food Processors
Association; National Council of Chain Restaurants; National
Fisheries Institute; National Food Processors Association; National
Grocers Association; National Renderers Association; National
Restaurant Association; National Soft Drink Association; Northwest
Food Processors Association; and the United Fresh Fruit and
Vegetable Association.
cc: The Honorable John D. Dingell, Ranking Member
______
Prepared Statement of Hon. Mac Thornberry, a Representative in Congress
from the State of Texas
I am pleased to provide this statement on proposals to combat
bioterrorism. As you may know, I--along with Rep. Wilson, Rep. Norwood,
and Rep. Gene Green--recently introduced H.R. 3239, a bill to amend the
Robert T. Stafford Disaster Relief and Emergency Assistance Act to
ensure continuity of medical care following a national disaster. This
bill, also cosponsored by Rep. Whitfield, Rep. Hayworth, Rep. Weller
and Rep Crane, makes private, for-profit medical facilities, including
hospitals and long term care facilities, eligible for federal disaster
assistance.
In many parts of the country, investor-owned health care hospitals
and long term care facilities are the only places for the public to
receive care. Now more than ever, we are trying to make sure that our
hospitals and other medical providers are able to give proper care and
treatment in the event of an emergency. Therefore, it makes sense for
all medical facilities to be afforded the same access to federal
disaster assistance so that wherever a disaster strikes, our entire
medical system can help those in need.
Currently, the 1974 Stafford Act precludes FEMA funds from
benefitting for-profit institutions--even if facilities owned by these
institutions treat patients. This preclusion is short-sighted. Disaster
strikes without respect to hospital or long term care facility
ownership. In many communities, for-profit hospitals serve as the
safety net or sole-community providers. The current law could have the
chilling effect of indirectly determining which community providers
will continue to operate following a disaster, without any direct
relationship to a community's particular needs. This simply does not
make sense. If a disaster occurs in or around a specific community,
every single health care facility in the area that provides care should
be able to access federal disaster funds if needed.
This bill is supported by the Federation of American Hospitals, the
American Hospital Association, the American Health Care Association, as
well as a number of state hospital associations around the country,
including: Arizona, California, Colorado, Florida, New Mexico,
Oklahoma, Pennsylvania, Texas, Kentucky, and Utah--just to name a few.
The current events relating to anthrax and September 11th
demonstrate the need for this Nation to prepare--and to prepare
quickly--for the possibility of large-scale bioterrorist attacks on our
homeland. However, we should also approach this issue in a thoughtful
and reasoned way.
It is my strong hope that any kind of package this Committee puts
together to address the emerging threats of bioterrorism will include
the provisions of H.R. 3239. My colleagues and I believe that this
bipartisan, budget-neutral proposal is sound policy to help reflect the
current state of medical care in our Nation.
I thank Chairman Tauzin and the Committee members for their efforts
to improve and strengthen our public health system. I look forward to
working with this Committee, the Congress and the Administration on
this important legislation, as well as additional ways to improve the
continuity of care available to communities affected by a national
disaster.
______
Prepared Statement of John R. Cady, President and CEO National Food
Processors Association
Thank you, Mr. Chairman, for the opportunity to submit this
testimony for your hearing today on various legislative proposals to
prevent and effectively respond to bioterrorist threats or incidences.
First, let me thank you and the distinguished ranking member of the
Committee, Representative Dingell, for holding this hearing and your
leadership on food safety issues. We encourage the House of
Representatives to fully exercise its legislative responsibilities in
order to send to the President legislation that reflects not only the
collective wisdom of the Congress, but helps achieve our goal of a
truly science- and risk-based food safety system.
NFPA is the largest food-only trade association in the United
States, representing the $500 billion U.S. food processing industry on
scientific and public policy issues involving food safety, nutrition,
technical and regulatory matters, consumer outreach and international
affairs. NFPA's members produce and package the branded and private-
label food and beverage products found in retail and wholesale stores
using a variety of processing and packaging technologies. With three
laboratory centers in the United States--including one just three
blocks from the White House--our mission is to provide the best
scientific and technical assistance to food processors, and translate
our unique food safety and food science expertise into sound public
policy.
Overview
There are a number of legislative vehicles that have been proposed
to grant additional federal enforcement powers as well as to authorize
or appropriate additional resources to the Food and Drug Administration
(FDA) to help prevent and respond to possible threats to our food
security. However, given the vast powers and numerous enforcement tools
already at the disposal of federal regulatory agencies, Congress should
first focus on providing adequate resources to meet any new potential
threats to our food security before exploring new legislative
authorities. These resources should be focused on helping the agency
prevent and detect possible threats. These resources should also
support crisis communication efforts between the agencies and industry
on how industry can better assist in combating and preparing for these
new threats. Additional resources are needed to upgrade and improve
FDA's information tracking system for imported foods, called OASIS
(Operational and Administrative System for Import Support), and enhance
testing at the border.
Food safety and security has long been a top priority for the food
industry. Our industry has a long history of working with regulatory
agencies and the Congress to develop risk- and science-based solutions
to food safety challenges. The food industry has a food safety
infrastructure in place today staffed by thousands of microbiologists,
chemists, food scientists and quality assurance experts whose mission
is to focus exclusively on analyzing current and potential hazards to
food. We and our member companies focus on food safety and food
security issues daily. Since September 11th our industry has come
together as never before to educate others and ourselves on how best to
redouble our efforts and ensure we are prepared for any potential
risks.
The federal government should have the resources and authorities
essential to continue to ensure the safety and security of our food
supply. It is vital that we maintain the highest consumer confidence in
our food supply, which is among the safest in the world. Likewise, our
food safety system, which is responsible for our nation's safe,
wholesome, abundant and affordable food supply stands as a model
throughout the world. That is why we have long supported additional
resources for the FDA to ensure that it can fulfill its core mission to
protect public health and safety. Any new authorities must be carefully
scrutinized and focused on giving the federal government germane and
defined powers that enable it to respond effectively in the event of a
public health emergency.
Millions of Americans are counting on both the food industry and
the government to continue to ensure a safe, yet abundant and
affordable food supply. It is essential that the changes being
considered regarding our industry be practical , and constructive,
while balancing the needs to enhance food security while ensuring our
economic health and the free flow of commerce, both between the United
States and other nations as well as within our own borders.
The Administration Proposal
Secretary of Health and Human Services, the Honorable Tommy
Thompson on October 18th transmitted to the Speaker the ``HHS
Bioterrorism Prevention and Emergency Response Act of 2001.'' Our views
of the food provisions of most concern follows.
Sec. 101. Emergency Administrative Detention
We believe existing authorities currently employed by states have
worked well and remain adequate. However, in the event of a public
health emergency that is declared under Section 319 of the Public
Health Service Act, we do not object to enhanced powers for the
Secretary to detain adulterated foods that pose the threat of serious
adverse health consequences to humans or animals.
The duration of detention as outlined under Sec. 101 (2)(A) should
be consistent with current detention authority for the US Department of
Agriculture, which is 20 days. We also urge insertion of the following
language (to provide an appeal option) before the quotation mark at
line 2, page 3: ``(B) The person may appeal the detention order to the
United States District Court in any district in which the detained
article is located.
Sec. 102. Tampering with Consumer Products: Emergency Administrative
Detention
We believe this section is redundant of Section 101 and should be
stricken.
Sec. 103 Debarment for Repeated or Serious Food Import Violations
To supplement the Secretary's substantial existing authorities, we
have no objection to additional authority that would permit the
Secretary to debar individuals who are convicted of a felony related to
importing a food into the United States. However, as currently drafted,
the Administration's provision would broadly permit debarment of a
person who ``repeatedly or deliberately'' imported or offered for
import adulterated or misbranded foods. Our concern is that the
severity of the offense is not adequately limited to those violations
of a public health significance. As drafted this section would include
such violations as misplaced commas on the nutrition facts label; the
appearance of unapproved synonyms on food labels; and economic
adulteration that does not involve any threat to public health or
safety--clearly issues well outside the scope of combating terrorism.
We suggest that authority to debar individuals based on a felony
conviction related to importing a food represents a strong ``one strike
and your out'' provision.
Sec. 104 Maintenance and Inspection of Records
We strongly oppose the Administration provision. The language
provides the Secretary with a very low threshold for access to the
private property of a food company and no problem with the existing
balance of authorities has been demonstrated. This provision is far
broader than needed to address potential bioterrorism threats. Any
authority expanding government access to company records should be
strictly limited to the documents needed to investigate a specific
occurrence of adulteration that poses a threat of serious adverse
health consequences. If a company treats a document as ``confidential''
so should the government, and steps should be taken to ensure the
protection of such information. Government access to the confidential
information of a person in the food business does not justify
government release or publication of that information.
Sec. 105 Prior Notice of Imported Food Shipments.
This provision is unnecessary due to 19 USC Sec. 1484, which
authorizes the Secretary of Treasury to specify time frames within
which import documents must be submitted to determine compliance with
applicable law. Moreover, no purpose for the prior notification is
stated to serve as an appropriate limitation on the exercise of the
proposed authority. Moreover, any new prior notice requirements for the
importation of food products should be designed to ensure that the free
flow of commerce is protected and to protect the U.S. food supply from
shortages from undue commercial disruptions.
Additional Proposals
The Honorable John Dingell, ranking member of the House Commerce
Committee, has introduced the HR 3075, the Imported Food Safety Act of
2001. While we greatly appreciate Representative's Dingell's long-
standing interest in strengthening our food security, we cannot support
his legislation as drafted. Here are our concerns about major
provisions in his legislation and others that we understand may at some
time be considered by the Committee.
FDA Prior Approval for Imported Foods Required
NFPA does not support this provision of HR 3075. Under current law,
FDA exercises its discretion in determining when an imported food must
be examined. FDA makes a determination as to whether a food should be
detained and sampled based upon whether it ``appears'' to be in
violation of the Federal Food, Drug and Cosmetic Act (FD&C Act). This
provision of H.R. 3075 would be much more burdensome if enacted because
the basis of denial of entry is so subjective that it would be
tantamount to complete agency discretion. If someone once imports a
food labeled with an unapproved synonym it could indicate that they
have a history of noncompliance and FDA could prohibit future entries
of foods offered for admission by the importer. Moreover, H.R. 3075
would require all food importers to wait in line for FDA's approval
before their product could be released into interstate commerce.
Finally, it is unclear how FDA approval would be given (e.g., whether
sampling of every imported food would be required).
Equivalence Requirements for Imported Food
NFPA strongly opposes this provision of the HR 3075. Efforts to
justify establishment of FDA equivalence authority by referencing to
the equivalence authority for meat and poultry products regulated by
USDA overlook the fundamental differences in the two regulatory
programs. Unlike USDA, FDA presently has a more rigorous standard for
imports than domestically produced foods. Under Section 801 of the FD&C
Act, a food product regulated by FDA may be refused entry if it appears
to be in violation of the Act, while domestic products are actionable
if they are in violation of the Act. Meat and poultry products in
commerce are actionable if they are in violation of the Act. Thus, FDA
now has a more rigorous standard for food imports than USDA. Moreover,
FDA implementation of an equivalence program of the sort employed by
USDA would be an undertaking of massive scope and expense that would
take many years (probably decades) to complete with no appreciable food
safety benefit. USDA regulates just meat and poultry, while FDA has
responsibility for the full range of other foods. There is economic
incentive to export meat or poultry products to the U.S. from only a
very limited number of countries. FDA regulated foods are imported from
the vast majority of the countries in the world. The time and expense
of FDA personnel that would be required to implement an equivalence
program for various foods from various countries would be a tremendous
distraction from meaningful food safety activities.
This provision of H.R. 3075 could invite retaliation by foreign
countries. Moreover, for countries without an equivalent regulatory
system or that deny U.S. inspection, H.R. 3075 would require testing
for pathogens and pesticides in all cases, regardless of the likelihood
such pesticides or pathogens would appear on or in the food.
Recall Authority
The FD&C Act does not provide FDA with mandatory recall authority
for foods. The recall provision of H.R. 3075 would permit FDA to
mandate a recall based solely on the belief that the imported food has
been intentionally adulterated. FDA would not have to establish
adulteration.. Therefore, FDA could require companies to undertake
massively expensive recalls when food has not been adulterated.NFPA has
opposed granting such recall authority to the FDA because the current
system for recalls works well. For more than ninety years, the
foundation of Federal food safety policy has been that food companies--
their executives and employees--are primarily responsible for the
safety of the food they process. Existing law provides strict penalties
for companies who market adulterated or misbranded food products. We
challenge the FDA to demonstrate instances where food companies have
not readily complied with a request by the agency to recall foods that
may post a threat of serious adverse health consequences. There is
simply no evidence that this new authority will enhance food safety.
Limits On Ports Of Entry
Under the HR 3075, FDA would be authorized to limit the ports of
entry into the U.S. for all or certain foods or from particular points
of origin or with particular chains of distribution, if FDA determines
that such action is necessary to carry out provisions of H.R. 3075.
NFPA opposes this provision.
The limits on ports of entry may raise constitutional issues, since
Article 1, section 9, clause 6 of the U.S. Constitution prohibits
preference to be given to the ports of one state over another and
states that vessels coming into one port shall not ``be obliged to
enter, clear, or pay duties in another.'' The only justification for
limiting ports of entry is due to the lack of personnel or other
resources to exercise the government's full legal authorities and
responsibilities--we believe this issue is best addressed through
additional appropriations to the agency, not through potentially
unconstitutional provisions such as these.
Country of Origin Labeling
H.R. 3075 would deem misbranded any food for which its retail
labeling does not indicate the country in which the food was grown,
prepared, packed, manufactured, or processed. Country-of-origin
labeling would not be required for foods sold at the retail level by
restaurants. For all imported foods that are packaged when sold at
retail this provision is redundant of existing Customs requirements.
However, H.R. 3075 would prohibit the current practice of marketing
unpackaged fruits and vegetables without country of origin marking. The
most significant effect of this provision would be to require country
of origin marking of domestically produced foods. There is no evidence
that such labeling mandates would advance food safety or enhance
prevention or response to bioterrorist threats or incidents. NFPA
strongly opposes this provision.
User Fees for Import Inspections
These provisions in HR 3075 would establish fees on persons because
they are subject to mandatory regulatory activities intended to protect
public health and welfare. Thus, they are not traditional user fees
imposed on persons who choose to avail themselves of a discretionary
government service to the user. In addition, these fee provisions
invite scrutiny under international trade agreements for their
discriminatory effect on food imports. Furthermore, this provision is
unrelated to the prevention and response to threats of bioterrorism.
NFPA strongly opposes these user fee provisions.
Physical Presence at the Ports
We also understand that consideration may be given to legislation
that would require the physical presence of an FDA inspector at the
ports. Currently, FDA is notified by Customs on every imported food
shipment, and the agency, based on the prior record of the importer,
type of food, and other priorities established by the agency,
determines whether the product should be sampled and tested and/or
detained. We believe a provision requiring a physical presence is
inconsistent with a science- and risk-based food safety inspection
system, and may arbitrarily take away the Secretary's discretion to
shift scarce resources to address actual threats to food security.
Therefore, we would strongly oppose such a provision.
Prohibiting Products from Terrorism Sponsoring Countries
We understand that legislation may be considered that would direct
the Secretary of Health and Human Services to deny approval for the
entry into the United States of any food from a country that the
Secretary of States determines has supported or otherwise ``aided or
abetted one or more acts of international terrorism.'' The President
already has authority to impose unilateral sanctions on state sponsors
of terrorism, including powers to bar commerce with such countries.
This provision takes the form of a trade sanction, rather than a food
safety regulatory measure. NFPA respectfully urges that efforts
intended to achieve food safety objectives should be risk-based
measures that respond to unique facts regarding a food. The
considerations regarding institution of trade sanctions are beyond the
scope of testimony we are prepared to present today.
Mr. Chairman and Representative Dingell, thank you again for your
leadership and this opportunity to comment on proposals to prevent and
respond to threats and incidences of bioterrorism. The food industry
stands ready to assist you in any way possible to advance the cause of
science- and risk-based solutions to current and emerging threats to
our food security.
______
Institute of Food Technologists
November 15, 2001
The Honorable Billy Tauzin
Chairman, House Committee on Energy and Commerce
2125 Rayburn House Office Building
United States House of Representatives
Washington, D.C. 20515-6115
Re: IFT's Role in Assisting the Continued Assurance of the Integrity of
the U.S. Food Supply
Dear Mr. Chairman: Anthrax, the deadly disease currently at the
forefront of American consciousness, is only one of dozens--
realistically hundreds--of biological diseases, chemical toxicants and
physically debilitating attacks that boast the potential of disabling
our nation's economy and threatening the collective health of its
citizens. Each could have crippling and devastating effects if
introduced into the U.S. food supply.
For this reason, the Institute of Food Technologists (IFT) has
established a cadre of highly qualified professionals with renowned
expertise in food microbiology, chemistry, engineering, packaging,
toxicology, food market manufacture and quality assurance, food service
and retail operations, food distribution and delivery systems, crisis
management, and risk communication to lead and direct IFT activities on
topics directly relating to food bioterrorism. As a non-profit society
with 28,000 individual members working in food science, technology, and
related professions in industry, academia, and government, IFT brings
sound science to the public discussion of food issues. IFT does so by
drawing on the breadth of expertise comprised within its vast
membership base. IFT has a proven record of assembling panels of
experts to evaluate and assess prescribed issues in food safety and
nutrition and delivering comprehensive reports and advice on a timely
basis. IFT respectfully requests that this document be entered as part
of the record of the full committee public hearing on November 15, 2001
to review federal Biosecurity Programs and Authorities. We are eager
for the House Committee on Energy and Commerce to be aware of the
efforts of the scientific community to contribute to protections
against bioterrorist activities, especially as they might be directed
toward the U.S. food supply.
IFT extends its nationally recognized expertise to provide services
that directly assist in risk characterization, the pursuit of objective
risk assessment, and risk communication. Furthermore, IFT offers its
assistance in identifying the potential magnitude of intentional
adverse events, should any occur, and the traceability required to
define raw materials and identify contamination sources. Additionally,
to deter potential catastrophic attacks and minimize their impact if
they occur, IFT offers: food safety education, critical to reducing the
risk of foodborne illness whether linked with normal, unintentional
contamination; human health hazard assessments, paramount to reducing
the risks to our populace; and, development of effective food security
assurance programs, critically important throughout the food system.
IFT's cadre of experts are in the unique position to provide
comprehensive assessments on microbiological, chemical, and physical
hazards that could detrimentally affect the safety of our supply.
Furthermore, IFT's group of experts can provide valuable insight to not
only prevent, but effectively control contamination of the food supply,
whether introduced during food product manufacture, distribution,
retail, or preparation in foodservice or the home.
In summation, the Institute of Food Technologists stands ready to
work in conjunction with--and in advisement to--federal safety and
security agencies, national and international food manufacturers,, and
national mass communications organizations to provide insight,
expertise, and advisement on the myriad of food security challenges
confronting the future health and well-being of our great nation and
its citizens.
Sincerely,
Philip E. Nelson, Ph.D.
President
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