[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
COMBATING TERRORISM: MANAGEMENT OF MEDICAL SUPPLIES
=======================================================================
HEARING
before the
SUBCOMMITTEE ON NATIONAL SECURITY,
VETERANS AFFAIRS AND INTERNATIONAL
RELATIONS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
MAY 1, 2001
__________
Serial No. 107-17
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
U.S. GOVERNMENT PRINTING OFFICE
75-956 WASHINGTON : 2001
____________________________________________________________________________
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COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California PATSY T. MINK, Hawaii
JOHN L. MICA, Florida CAROLYN B. MALONEY, New York
THOMAS M. DAVIS, Virginia ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
BOB BARR, Georgia ROD R. BLAGOJEVICH, Illinois
DAN MILLER, Florida DANNY K. DAVIS, Illinois
DOUG OSE, California JOHN F. TIERNEY, Massachusetts
RON LEWIS, Kentucky JIM TURNER, Texas
JO ANN DAVIS, Virginia THOMAS H. ALLEN, Maine
TODD RUSSELL PLATTS, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
DAVE WELDON, Florida WM. LACY CLAY, Missouri
CHRIS CANNON, Utah ------ ------
ADAM H. PUTNAM, Florida ------ ------
C.L. ``BUTCH'' OTTER, Idaho ------
EDWARD L. SCHROCK, Virginia BERNARD SANDERS, Vermont
------ ------ (Independent)
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
James C. Wilson, Chief Counsel
Robert A. Briggs, Chief Clerk
Phil Schiliro, Minority Staff Director
Subcommittee on National Security, Veterans Affairs and International
Relations
CHRISTOPHER SHAYS, Connecticut, Chairman
ADAM H. PUTNAM, Florida DENNIS J. KUCINICH, Ohio
BENJAMIN A. GILMAN, New York BERNARD SANDERS, Vermont
ILEANA ROS-LEHTINEN, Florida THOMAS H. ALLEN, Maine
JOHN M. McHUGH, New York TOM LANTOS, California
STEVEN C. LaTOURETTE, Ohio JOHN F. TIERNEY, Massachusetts
RON LEWIS, Kentucky JANICE D. SCHAKOWSKY, Illinois
TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri
DAVE WELDON, Florida ------ ------
C.L. ``BUTCH'' OTTER, Idaho ------ ------
EDWARD L. SCHROCK, Virginia
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Lawrence J. Halloran, Staff Director and Counsel
Kristine McElroy, Professional Staff Member
Jason Chung, Clerk
Michael Yang, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on May 1, 2001...................................... 1
Statement of:
Calbom, Linda M., Director, Financial Management and
Assurance, General Accounting Office, accompanied by Alana
B. Stanfield, Assistant Director, Financial Management and
Assurance; and Louise Beck................................. 3
Mather, Susan, Chief, Public Health and Environmental Hazards
Office, Department of Veterans Affairs, accompanied by John
Ogden, Chief Consultant, Pharmacy Benefits Management
Strategic Health Group; and Kristi L. Koenig, Chief
Consultant, Emergency Management Strategic Healthcare
Group; Robert F. Knouss, Director, Office of Emergency
Preparedness, Public Health Service, Department of Health
and Human Services, accompanied by Mark Gnitzke, Chief
Pharmacist; and Terry Wagner, Finance Officer; James M.
Hughes, Director, National Center for Infectious Diseases,
Centers for Disease Control and Prevention, accompanied by
Steven D. Bice, Director, National Pharmaceutical Stockpile
Program, National Center for Environmental Health; and
Colonel Carlos R. Hollifield, Commanding Officer, Chemical
Biological Incident Response Force [CBIRF], U.S. Marine
Corps, Department of Defense, accompanied by Commander
Corley Puckett, Second Marine Expeditionary Force
Sergeant's Office.......................................... 29
Letters, statements, etc., submitted for the record by:
Calbom, Linda M., Director, Financial Management and
Assurance, General Accounting Office, prepared statement of 6
Hollifield, Colonel Carlos R., Commanding Officer, Chemical
Biological Incident Response Force [CBIRF], U.S. Marine
Corps, Department of Defense, prepared statement of........ 62
Hughes, James M., Director, National Center for Infectious
Diseases, Centers for Disease Control and Prevention,
prepared statement of...................................... 47
Knouss, Robert F., Director, Office of Emergency
Preparedness, Public Health Service, Department of Health
and Human Services, prepared statement of.................. 40
Kucinich, Hon. Dennis J., a Representative in Congress from
the State of Ohio, prepared statement of................... 26
Mather, Susan, Chief, Public Health and Environmental Hazards
Office, Department of Veterans Affairs, prepared statement
of......................................................... 32
Shays, Hon. Christopher, a Representative in Congress from
the State of Connecticut, prepared statement of............ 23
COMBATING TERRORISM: MANAGEMENT OF MEDICAL SUPPLIES
----------
TUESDAY, MAY 1, 2001
House of Representatives,
Subcommittee on National Security, Veterans Affairs
and International Relations,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 2 p.m., in
room 2247, Rayburn House Office Building, Hon. Adam Putnam
(acting chairman of the subcommittee) presiding.
Present: Representatives Putnam, Kucinich, Platts, Shays,
and Tierney.
Staff present: Lawrence J. Halloran, staff director and
counsel; Kristine McElroy, professional staff member; Alex
Moore, fellow; Jason M. Chung, clerk; Michael Yang, minority
counsel; and Teresa Coufal, minority staff assistant.
Mr. Putnam. The Subcommittee on National Security, Veterans
Affairs and International Relations hearing entitled,
``Combatting Terrorism: Management of Medical Supplies'' is
called to order.
Welcome, Congressman Platts. Thank you for being here. I
know that your constituents have a major issue going on
upstairs.
I'll begin with the opening statement, standing in for
Chairman Shays.
In the event of mass casualties inflicted through the use
of chemical, biological, or radiological weapons, State and
local public health officials will need help. They will look
for timely access to Federal stockpiles of the antidotes,
antibiotics, and vaccines necessary to save lives. Will those
critical medicines get there in time? Last year we could not be
certain. Weak internal controls, lax security, and sloppy
inventory management practices increased the risks of
stockpiling the wrong medicines, expired medicines, or not
enough of the medicines needed to meet the consequences of a
terrorist attack.
Today the General Accounting Office releases a report
requested by this subcommittee on steps taken to address those
weaknesses. According to GAO, the Department of Health and
Human Services' Office of Emergency Preparedness and the
Centers for Disease Control and Prevention have made
substantial improvements in both purchasing and stockpile
management practices. As a partner with OEP and CDC, the
Department of Veterans Affairs has simplified stockpile
storage.
The Marine Corps' Chemical Biological Incident Response
Force has formalized its medical equipment list and upgraded
inventory controls. The GAO remains concerned. The extent and
pace of improvements continue to pose risks to the adequacy and
quality of the stockpiles. Agreements with critical supply and
transportation contractors are still incomplete or are vague.
Security standards are not yet uniform. Temperature monitoring
at some storage facilities may be inadequate to protect
sensitive supplies from damage. Operational plans and training
are not well developed.
The threat of domestic terrorism demands we amass and pre-
position costly perishable medical supplies we hope never to
use, but when called upon to stem the toll of a terrorist
attack the stockpiles must arrive at the right place at the
right time containing the types and amounts of medicines needed
to save lives.
Testimony today from the GAO and from those responsible for
maintaining Federal medical stockpiles and reserves will
describe tangible progress toward that goal. We welcome their
testimony and look forward to a discussion of how they plan to
meet the substantial challenges of preparing for medical
contingencies on an unprecedented, almost unthinkable scale.
We begin with our first panel, Ms. Linda Calbom, Director,
Financial Management and Assurance, General Accounting Office,
who is accompanied by Ms. Alana Stanfield, Assistant Director
of Financial Management and Assurance, also with GAO.
We welcome you ladies here, and if you would, please rise
and raise your right hand to be sworn in.
Mr. Platts. Mr. Chairman, just before you get into the
panel, if I can just make a brief statement.
Mr. Putnam. Absolutely. I apologize. Congressman Platts.
Mr. Platts. Thank you, Mr. Chairman. I appreciate Chairman
Shays and yourself holding this important hearing, and will
apologize to not hear the testimony in person. There is a
subcommittee hearing regarding the downing of the missionary
plane in Peru 11 days ago, and that association of missionary
individuals is based in my District, so I will be returning to
that, but I do appreciate the written testimony by our first
panel, as well as the other panelists, and will be giving close
scrutiny to that. I apologize I won't be able to stay.
Hopefully I'll get back, but time will tell.
Thank you, Mr. Chairman.
Mr. Putnam. Thank you, and we certainly understand.
Ms. Calbom. Mr. Chairman, we'd also like to have Ms. Louise
Beck be sworn in in case we need to have her confer at the
table, if that's all right.
Mr. Putnam. Fine with me.
Ms. Calbom. OK.
Mr. Putnam. Thank you.
[Witnesses sworn.]
Mr. Putnam. Thank you. A note for the record that the
witnesses have responded in the affirmative. Who would like to
begin? Ms. Calbom.
Ms. Calbom. Yes. I'll read the oral statement, and Ms.
Stanfield is here to assist me in answering questions.
Mr. Putnam. You are recognized. Thank you.
STATEMENT OF LINDA M. CALBOM, DIRECTOR, FINANCIAL MANAGEMENT
AND ASSURANCE, GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY ALANA
B. STANFIELD, ASSISTANT DIRECTOR, FINANCIAL MANAGEMENT AND
ASSURANCE; AND LOUISE BECK
Ms. Calbom. Mr. Chairman, I am pleased to be here today to
discuss the status of agencies' actions taken to establish
effective internal control over the Federal medical stockpiles
that can be used to treat victims of a chemical or biological
terrorist attack.
We originally testified before this subcommittee in March
of last year on the need to establish effective control over
the stockpiles, which was also the subject of a report that we
issued in October 1999. That work resulted in several
initiatives by the Office of Emergency Preparedness, the
Centers for Disease Control and Prevention, and the Department
of Veterans Affairs, as well as the Marine Corps' Chemical
Biological Incident Response Force that I'll refer to as CBIRF.
The responsibility areas for each of these agencies are
actually shown on this chart, which I know is also hard to see,
but it is also an attachment to my written testimony, which is
in your folder. It's the last page of the testimony.
Today I will focus on responding to the committee's request
that we followup on the status of corrective actions taken by
the responsible agencies to address the recommendations in our
prior report. A detailed discussion of our findings is included
in our report that is being issued here today. I would like to
just spend a few minutes talking about the issues that we came
up with in that followup review.
The first area of followup had to do with risk assessments.
In the October 1999 report we reported that neither OEP, VA,
nor CBIRF had determined the risk that faced their stockpiles,
assessed the likelihood of each risk's occurrence, and
established plans to detect and mitigate the risk.
Since our last review, each agency has prepared a risk
assessment. In fact, CBIRF not only completed a risk
assessment, it also implemented controls to mitigate the risks
identified in that assessment.
However, for CDC and OEP we found instances where the risk
assessments were not sufficiently comprehensive or where
actions identified to mitigate the risks had not been fully
implemented. For example, neither agency had addressed all of
the risks posed by delegating key storage, management, and
transport responsibilities to other entities.
The next area we looked at was inventory accuracy. Our
prior reviews showed large discrepancies between the data
recorded in CBIFR's and OEP's inventory systems and the actual
physical counts of their inventories. In our most recent
review, we noted that, while some discrepancies did still
exist, the accuracy of both CBIRF and OEP inventory records had
improved significantly. However, we found that OEP lacks
certain detailed written inventory procedures necessary to help
ensure the overall reliability of their inventory records.
In addition, while we found that CBIRF had developed an
inventory requirements list, which they didn't have at the time
of our last review, it did not have on hand all the items
included in the list.
We also found that OEP had not updated its requirements
list to reflect changes to the composition of its stockpile.
And, finally, we found that, while CDC had established
requirements list for its national pharmaceutical stockpile,
the requirements were not completely filled by the end of our
field work.
The next area we followed up on was inventory tracking
systems. We previously reported that the responsible agencies'
inventory systems did not adequately track inventory items, and
we recommended that they implement tracking systems that retain
complete documentation for all supplies they have ordered,
received, and destroyed.
The current inventory systems used by OEP, VA, CDC, and
CBIRF still lack certain fundamental information which impedes
their ability to comprehensively track their pharmaceutical and
medical supplies; however, each agency is currently in the
process of replacing its current system with one that is
expected to be able to track medical supplies from the time an
order is placed until the time it is consumed or otherwise
disposed of.
The last area we looked at was rotation. We previously
reported that the agencies' inventories included items that had
expired but not been replaced, and therefore we recommended
that they properly rotate these supplies. In response to our
report, we found that all of the agencies have developed
policies and procedures related to rotating stock in their
inventories; however, in some cases planned approaches were not
completely implemented. For example, during our October 2000,
counts at CBIRF we found 161 medical supply items had expired
but not been replaced.
In addition, at the time of our review CDC had not
finalized agreements with a private sector partner to implement
a cost-saving strategy to rotate soon-to-expire pharmaceuticals
into the commercial marketplace and replace them with fresh
stock.
Just to sum up, in completing our most recent work, we did
find that all of the agencies have made significant progress
toward implementing our October 1999, recommendations.
Management in each of the agencies has given priority to and
placed emphasis on strengthening internal control over the
stockpiles. As a result, corrective actions have reduced
inventory discrepancy rates and improved accountability.
At the same time, we found that, in all of the areas
associated with our prior recommendations, additional steps
should be taken to ensure that the medical and pharmaceutical
supplies are current, accounted for, and readily available for
use.
Our current report includes several additional
recommendations to address these issues. We do understand that
since the completion of our review some actions have been taken
by the agencies in response to our recent findings.
That concludes my statement, Mr. Chairman. We'd be happy to
answer any questions at this time.
Mr. Putnam. Thank you very much.
[Note.--The GAO report entitled, ``Combating Terrorism,
Accountability Over Medical Supplies Needs Further
Improvement,'' GAO-01-463, may be found in subcommittee files.]
[The prepared statement of Ms. Calbom follows:]
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Mr. Putnam. To what extent have the agencies responded to
the 13 new recommendations?
Ms. Calbom. They've done actually quite a bit already. In
the course of our review I think, you know, they were aware of
our findings as we came across them. They have put into place
some of the agreements with third parties that we talk about in
our report. For instance, I know OEP has completed its
agreements with VA. I believe that CDC has completed a lot of
its agreements with its wholesale distributor. There are still
a couple areas where we have concerns. For instance, CDC has
not completed all of its agreements, or at least last that we
knew of, with some of its carriers to ensure proper transport
of these supplies, which we think is very important.
I'll ask Ms. Stanfield if she'd like to add on to some of
the areas that perhaps improvements have been made.
Ms. Stanfield. Actually, a couple areas where the
recommendations are still open--as you know, in our report we
talk about one of the locations, the central location at OEP,
where the goods were stored at temperatures at 95 degrees or
above, and also at that same location there were security
issues. There was not an alarm on the cage.
And, as we understand it, they do plan to move that cache
to a new location some time. They had originally planned to
move it in April, but they will be moving that in the May/June
timeframe instead. So that's one area that is open.
We are particularly, on the positive side, pleased with the
improvements in the inventory discrepancy rates, and those have
improved.
At CBIRF the one open recommendation, which I'm sure they
will discuss, too, is the fact that there is a new authorized
medical allowance list, and we have recommended that they stock
up to that list, and they have not yet done so, but they will
probably provide you some updates on that.
Mr. Putnam. Is there a single inventory management system
that CBIRF and the other agencies are using so that there is
some uniformity to the categorization and cataloging of the
pharmaceuticals?
Ms. Calbom. Well, Mr. Chairman, all three of the agencies
are working on getting the inventory systems in place. CDC is
taking the lead as far as the HHS side of things, and I believe
their system is due to be in place in May or June, which I'm
sure they'll update us on. That same system will be used by
OEP, and then CBIRF has its own system that it is putting in
place, and I believe we were just told that may be delayed
until September.
Mr. Putnam. So everybody is on the same page then except
CBIRF?
Ms. Calbom. Yes. And, of course, CBIRF is a little bit
different, you know. Their inventory is really more of a self-
contained inventory. Their mission is a bit different. They
really aren't in the business of having in place a stockpile to
treat the masses, as OEP and CDC are. CBIRF's stockpile is
really more or less to treat their own troops or civilians that
happen to be in the area where they are carrying out their
mission.
Mr. Putnam. Would you elaborate a little bit on the
difficulty that they've had in making arrangements with
transport and mobilization contractors? You know, contemplating
the scenario where we would need to have those arrangements in
place, who is the ideal subcontractor to deliver that kind of a
supply, enter that kind of a hot zone? What avenues have been
explored? What current arrangements are in place as it relates
to that?
Ms. Calbom. I guess, as far as who is the ideal person, I
don't know that we can answer that. That's not something that
we've really done an assessment of. But Alana may want to
expand on what kind of arrangements are currently in place.
Ms. Stanfield. Currently they do have arrangements with two
transport companies. They are interim arrangements. Those, as
of the end of our field work, though, had not been finalized,
but they do have arrangements with two transport companies that
are very well known.
Mr. Putnam. And, finally, the mobile stockpile that is
available for special events such as the Olympics, what other
instances or gatherings are appropriate uses for the
mobilization of that stockpile? And is that limited to the
United States or is that international events abroad, as well?
Ms. Stanfield. Another example of an event would be like
the inauguration. I believe it is just for domestic events, but
you might want to check with them just to make sure.
Mr. Putnam. OK.
Ms. Stanfield. But I'm pretty sure it is just for domestic.
Mr. Putnam. We welcome Chairman Shays.
Mr. Shays. Thank you, Mr. Chairman. I'm very apologetic to
have missed the testimony of the first panel.
I have no questions. I just want to say that I lost a good
friend of mine, Barbara Bate, and her husband was a State
legislator, and we got elected in 1974, and I just learned
about it today, so I wanted to make sure I went to see him back
in Connecticut, but I will be ready for the next panel.
I thank you very much.
[The prepared statement of Hon. Christopher Shays follows:]
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Mr. Putnam. Thank you, Mr. Chairman.
And that concludes the questions for the first panel. We
appreciate your hard work and diligence on this issue, and we
look forward to hearing from panel two.
Ms. Calbom. Thank you.
Mr. Putnam. Thank you.
While we're setting up for the second panel, I ask
unanimous consent that all members of the subcommittee be
permitted to place any opening statement into the record and
that the record remain open for 3 days for that purpose.
Without objection, so ordered.
[The prepared statement of Hon. Dennis J. Kucinich
follows:]
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Mr. Putnam. I ask further unanimous consent that all
witnesses be permitted to include their written statements in
the record.
Without objection, so ordered.
Pursuant to House rules and committee rules I note for the
record that the subcommittee requested and all witnesses
appearing at this hearing in a non-governmental capacity have
provided a resume and a disclosure of Federal grants and
contractor receipt.
With that, we welcome the second panel: Dr. Susan Mather,
Dr. Robert Knouss, Dr. James Hughes, Mr. Steven Bice, and
Colonel Carlos Hollifield.
If you would, please stand, raise your right hands, and any
other persons accompanying the witnesses who may be called upon
to answer a question, please stand and raise your right hand.
[Witnesses sworn.]
Mr. Putnam. Note for the record that the witnesses
responded in the affirmative.
Mr. Shays. I'd just like to note, Mr. Chairman, I was going
through withdraw. When you stood up, I felt I should have stood
up, as well. [Laughter.]
Mr. Putnam. With that, Dr. Susan Mather, if you would
please begin with your testimony. Welcome to the committee.
STATEMENT OF SUSAN MATHER, CHIEF, PUBLIC HEALTH AND
ENVIRONMENTAL HAZARDS OFFICE, DEPARTMENT OF VETERANS AFFAIRS,
ACCOMPANIED BY JOHN OGDEN, CHIEF CONSULTANT, PHARMACY BENEFITS
MANAGEMENT STRATEGIC HEALTH GROUP; AND KRISTI L. KOENIG, CHIEF
CONSULTANT, EMERGENCY MANAGEMENT STRATEGIC HEALTHCARE GROUP;
ROBERT F. KNOUSS, DIRECTOR, OFFICE OF EMERGENCY PREPAREDNESS,
PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES,
ACCOMPANIED BY MARK GNITZKE, CHIEF PHARMACIST; AND TERRY
WAGNER, FINANCE OFFICER; JAMES M. HUGHES, DIRECTOR, NATIONAL
CENTER FOR INFECTIOUS DISEASES, CENTERS FOR DISEASE CONTROL AND
PREVENTION, ACCOMPANIED BY STEVEN D. BICE, DIRECTOR, NATIONAL
PHARMACEUTICAL STOCKPILE PROGRAM, NATIONAL CENTER FOR
ENVIRONMENTAL HEALTH; AND COLONEL CARLOS R. HOLLIFIELD,
COMMANDING OFFICER, CHEMICAL BIOLOGICAL INCIDENT RESPONSE FORCE
[CBIRF], U.S. MARINE CORPS, DEPARTMENT OF DEFENSE, ACCOMPANIED
BY COMMANDER CORLEY PUCKETT, SECOND MARINE EXPEDITIONARY FORCE
SERGEANT'S OFFICE
Dr. Mather. Thank you, Mr. Chairman and members of the
subcommittee. I am pleased to have this opportunity to address
the significant progress that VA has made in response to GAO's
October 1999, report concerning management of chemical and
biological medical supplies.
I am accompanied by Dr. Kristi Koenig, chief consultant of
the Emergency Management Strategic Healthcare Group [MSHG], and
Mr. John Ogden, chief consultant of the Pharmacy Benefits
Management strategic Health Group.
VA is a partner with HHS' Office of Emergency Preparedness
in assuring the availability of medical supplies that may be
needed by the national medical response teams to treat victims
where weapons of mass destruction have been used.
OEP officials determine the contents of the inventories;
provide funding for the procurement, maintenance, and
deployment of the medical supplies; and determine the location
of the stockpiles at sites across the United States.
The partnership between OEP and VA began late in 1995 and
evolved to a formal interagency agreement in April 1997. MSHG
has overall VA responsibility for emergency management
activities while VA's emergency pharmacy service is directly
responsible for managing the pharmaceutical and medical supply
stockpiles and works in coordination with MSHG.
I am pleased to describe VA's actions to address each of
the four recommendations from the 1999 GAO report.
First, GAO recommended that all the agencies, including VA,
establish sufficient systems of internal control over
management of their chemical and biological stockpiles so that
the stockpiles could be provided, as planned.
To implement this recommendation, OEP contracted with
Logistics Management Institute to evaluate the program, conduct
a risk assessment, and advise us on areas for improvement. MLI
reviewed the program from April to August 2000, and reported
their findings to EOP in December 2000.
Concurrently, the Emergency Pharmacy Service implemented
numerous improvements to simplify the inventory process, refine
the inventory data base, improve cache security, color code all
inventory categories, monitor storage temperatures, and improve
inventory results. LMI noted many of these improvements in
their reports and recommended adding an inventory management
system with bar codes. OEP has selected a computer package that
will be implemented during the summer of 2001.
Second, GAO recommended that the agencies arrange for
periodic independent inventories of the stockpiles. The results
of each inventory showed improvement over the previous,
including a less than 1 percent discrepancy rate from the
November inventory. Inventories will be continuing in 2001.
Third, GAO recommended that VA implement a tracking system
that retains complete documentation for all supplies that have
been ordered, received, or destroyed. In January 2000, VA began
using an enhanced inventory management system. The resulting
data base was verified during the April 2000, inventories. LMI
reviewed this inventory management system and recommended that
it be replaced by a commercial system that would provide
additional enhancements. OEP decided we would use the same
inventory management system CDC selected for use with the
national pharmaceutical stockpile, and training will begin this
month.
Fourth, GAO recommended that supplies be rotated properly,
and this is now being done. The current inventory management
system allows for the necessary planning for ordering,
receiving, shipping, and rotating stock at each location on a
timely basis. No outdated drugs or supplies were found in the
caches at the August and November 2000, inventories. The new
inventory management system should enhance this capability.
Mr. Chairman, I would like to close with a description of
additional actions taken since the testimony provided you in
March 2000.
First, GAO conducted a followup review of this program from
August to November 2000. The draft report of this visit
indicates that GAO was pleased with the progress VA has made.
Second, VA moved the one cache that was stored outside VA
control into a VA warehouse location. Both LMI and GAO have
favorably reviewed this site.
Third, VA placed refrigerator units with a self-contained
battery pack at all sites that will maintain refrigeration of
stockpile when deployed or when there is a power failure.
Fourth, VA replaced all products at the central--will
replace all products at the central cache that may be heat
sensitive as soon as the cache is moved to the new storage
location. The new storage location has been selected. Plans
have been approved for the necessary construction, and the
contractor has been chosen. The move is currently targeted for
June 2001.
Fifth, an update to the 2000 MOA between OEP and VA further
defining expectations and responsibilities has been developed
and is in the clearance process with MVA.
Sixth, VA initiated an internal risk assessment group,
including members with financial security, emergency
management, and risk assessment expertise. The group is charged
with conducting a new risk assessment and reporting findings to
VA officials and ultimately OEP later this year.
Seventh, to improve security at each cache, installation of
locking devices at the access point is underway. These devices
will record date, time, and the individual gaining access.
Eight and finally, all the caches were successfully
deployed and then returned to storage.
Mr. Chairman, the management of the emergency supplies has
greatly improved since the first GAO review. We appreciate the
benefits of GAO's work on the Congress' behalf. Should
incidents involving the use of weapons of mass destruction
occur, we are prepared to meet our responsibilities as part of
the Nation's readiness capability.
Dr. Koenig, Mr. Ogden, and I would be happy to respond to
questions.
Mr. Putnam. Thank you very much. We appreciate your
testimony.
[The prepared statement of Dr. Mather follows:]
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Mr. Putnam. Dr. Robert Knouss, Director, Office of
Emergency Preparedness, Department of Health and Human
Services, welcome to the committee. You are recognized.
Dr. Knouss. Thank you very much, Mr. Chairman. It is a
pleasure to be able to be back here again testifying about
these programs.
I'm also accompanied today by my chief pharmacist, Mark
Gnitzke, and my finance officer, Terry Wagner.
I appeared here last year before the committee to discuss
the original GAO report about our specialized pharmaceutical
caches, and I'm pleased to be back here again to be able to
discuss with you the improvements that have been made since
those initial hearings.
These pharmaceutical stockpiles were designed to be
deployed with our NMRTs, or national medical response teams, in
responding to a weapon of mass destruction event and providing
medical care to its victims.
Three of the teams--one on the West Coast, one in the
central part of the country, and one on the East Coast--can be
deployed anywhere in the country. The middle Atlantic team is
committed to responding to incidents in Washington, DC,
including the U.S. Capitol, and I would just like to mention
that it is pre-positioned here when we have the State of the
Union event or the inauguration or other major events here at
the capital.
The stockpiles associated with each of these four teams
contains specialized pharmaceuticals to treat up to 5,000
victims of a chemical exposure to nerve agents such as sarin
and VX, to vesicants such as mustard gas, and to pulmonary
agents such as phosgene. In addition, each stockpile has
medicines to provide the initial care at the scene for these
victims, stabilizing them medically until they arrive at a
health care facility.
In the original report on the status of the stockpiles, GAO
raised concerns about the manner in which the caches were
managed and the oversight provided by OEP.
We have appreciated GAO's comments, suggestions, and
insights, and have been working diligently with the VA to
correct problems, improve internal controls, and tighten our
management practices.
We have made a great deal of progress in these areas. We've
ensured appropriate storage and physical security of the
stockpiles; strengthened internal controls, including 100
percent inventories of all the caches, as well as independent
reviews; established regular communications with the VA;
conducted risk assessments; ensured regular and recurring
management oversight; approved operational plans for each
location; and ensured that an improved, updated inventory
requirement list is maintained.
However, we still have a number of things to do. GAO
recently completed its final report on the stockpiles, and we
appreciate that they noted the significant progress that we've
made to bring these caches into compliance with all the
regulations and appropriate internal control procedures.
In its recently released report, GAO commented on some of
the progress that still needed to be made and made some
additional recommendations to OEP. At this time I'd like to
address these recommendations and discuss what we still are
doing to complete the activities, to ensure the stockpiles meet
all requirements, and to be able to deploy them in a timely and
effective response.
Within the next month or two, we'll be moving our central
cache to a new location in order to ensure that appropriate
physical security and safeguards are in place, as well as to
ensure that temperature controls are maintained. This action
will mitigate problems that have occurred at the current
location, with some of the cache being exposed to higher-than-
acceptable temperatures.
We do not believe that the observed temperature fluctuation
degraded the effectiveness of the pharmaceuticals; however, we
will be replacing all of the affected drugs when the cache is
moved.
While the GAO report notes that the items that were exposed
to the higher temperature may not be effective in the event of
a terrorist incident, we'd note that we have three other caches
that can be moved, if necessary.
GAO noted that OEP lacked detailed, written inventory
procedures necessary to help ensure overall reliability of
inventory records. They also said that OEP had not updated its
requirements list for significant increases to its stockpile.
Both of these issues have subsequently been addressed and
detailed inventory procedures and operating plans have been
approved for each cache location, and detail requirement lists
have been updated and transmitted to the VA.
GAO also stated that there were no published discrepancy
rates, and that in the absence of this information there were
no data with which to measure the inventory results. Error
rates have been discussed with the VA. We have a zero tolerance
error rate for controlled substance and an error rate of 3 to 5
percent for low-cost items.
Finally, GAO expressed concern about the lack of training
for VA personnel involved in stockpile management, and later
this month we will be bringing VA personnel, in addition to
other public service teams, to the Noble Training Center in
Anniston, AL, to conduct training in conjunction with CDC. We
will be providing Oracle software training to VA staff for
managing cache inventories, and we recently provided HAZMAT
training for their staff at the NDMS conference that was held
in Dallas.
Mr. Chairman, OEP has been working diligently to ensure
that all internal control procedures are met, that the
stockpiles are current and adequately safeguarded, and that we
can deploy them quickly. It is my sincere hope that these
stockpiles will never have to be used, but we will continue to
assure our readiness to respond, if necessary.
That, sir, concludes my prepared remarks, and I obviously
would be pleased to answer any questions you may have.
Mr. Putnam. Thank you very much, sir.
[The prepared statement of Dr. Knouss follows:]
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Mr. Putnam. We now look forward to hearing from Dr. James
Hughes, the Director of the National Center for Infectious
Diseases, Centers for Disease Control and Prevention,
Department of Health and Human Services.
Never a dull moment in your line of work, is there?
Dr. Hughes. That's true, sir.
Mr. Putnam. Welcome to the committee.
Dr. Hughes. Thank you very much, Mr. Chairman. Good
afternoon.
I am accompanied by Mr. Steven Bice, Director of CDC's
National Pharmaceutical Stockpile Program in our National
Center for Environmental Health.
CDC appreciates the opportunity to discuss the national
pharmaceutical stockpile, one component of our overall public
health response to the threat of bioterrorism.
CDC provides leadership to detect, diagnose, respond to,
and prevent illnesses, including those resulting from
bioterrorism. In 1998 we issued ``Preventing Emerging
Infectious Diseases: A Strategy for the 21st Century,'' our
plan to prevent emerging diseases. This plan emphasizes the
need to be prepared for the unexpected, whether it be a
naturally occurring influenza pandemic or the deliberate
release of anthrax spores by a terrorist.
CDC is continuing to build on these efforts. One example is
the public health strategy that we are developing with our
partners to define priorities to prepare the country to respond
to bioterrorism. We have moved aggressively in multiple areas,
including preparedness planning, laboratory diagnostics,
strengthened surveillance and epidemiologic investigative
capacity, and enhanced communications.
Another integral component of public health preparedness
has been developing a national pharmaceutical stockpile or NPS
which can be mobilized in response to an episode caused by a
biological or chemical agent.
The goal of CDC's NPS is to ensure the availability of
lifesaving pharmaceuticals and medical supplies for delivery to
the site of a biological or chemical terrorism event.
The NPS has two basic components: eight pre-assembled sets
of supplies called ``12-hour push packages'' that can be
delivered to the scene of a terrorism event within 12 hours of
activation; and vendor-managed inventory, which consists of
additional pharmaceuticals and supplies that can be tailored to
a specific threat agent and will arrive at the scene within 24
to 36 hours after activation.
CDC provides guidance and oversight of all aspects of the
NPS. We have chosen the Department of Veterans Affairs National
Acquisition Center as our acquisition partner. An electronic
inventory management system has been purchased and will allow
for efficient and accurate inventory tracking, ordering,
receipt, and scheduled rotation of stock. We have instituted a
rigorous quality assurance program to ensure the integrity of
the NPS.
I will now comment briefly on the GAO report released
today, specifically on its recommendations pertaining to CDC.
We very much appreciate GAO's ongoing contributions to
assure that the NPS functions to protect the American people.
First, GAO recommends executing written agreements with all NPS
program partners covering storage, management, stock rotation,
and transportation. We have final written agreements with our
principal commercial partners for storage and rotation, and
interim agreements with our transportation partners.
Our partners in storage sites were selected based on their
known good business practices, security measures, and
procedural methods for handling large pharmaceutical and supply
inventories. These strengths enable the NPS to ensure the
integrity of the inventory and to maintain readiness.
GAO's second recommendation to CDC is to issue written
security guidance to private storage warehouses. Each NPS
storage partner has procedures in place to admit only
authorized individuals to the facilities. We are updating the
standard operating procedures to include controlled access to
NPS inventory and guidelines for stock rotation. The first
quantity of stock has been successfully rotated.
Finally, GAO recommends installing proper fencing to
physically secure the NPS inventory. Although fencing does
provide an additional level of security, it was also intended
to separate NPS assets from other materials within a larger
warehouse.
The facilities chosen to store the push packages are
bonded, licensed by the Food and Drug Administration, or
approved by the Drug Enforcement Administration and operate
under strict security controls to ensure the environmental and
physical safety of pharmaceuticals. Fencing has been installed
at all locations for which it was intended.
In summary, the NPS involves direct coordination and
management by CDC staff, ongoing monitoring, quality assurance,
and evaluation, and collaboration with partners.
Through our NPS program, we will continue to ensure the
rapid availability of life-saving pharmaceuticals and medical
supplies to the Nation in the event of a biological or chemical
terrorism incident.
Mr. Chairman, this concludes my testimony. Mr. Bice and I
will be happy to answer any questions you or members of the
subcommittee may have.
Mr. Putnam. Thank you very much, Dr. Hughes.
[The prepared statement of Dr. Hughes follows:]
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Mr. Putnam. The committee also welcomes Colonel Carlos
Hollifield, Commanding Officer, Chemical Biological Incident
Response Force, U.S. Marine Corps. Welcome. You are recognized.
Colonel Hollifield. Thank you. Good afternoon, Mr.
Chairman.
With me today is Commander Corley Puckett from the Second
Marine Expeditionary Force Sergeant's Office, which is my
higher headquarters. I'm honored to again have the privilege to
appear before this subcommittee and want to be thankful for the
opportunity to update you on the actions that we've taken to
improve internal control over the medical supply working stocks
that we hold in the Marine Corps' Chemical Biological Incident
Response Force.
You invited me here today simply to talk about the
management of our medical supplies, and I'm pleased to tell you
that the status of our medical supply count has vastly improved
since I last appeared before this subcommittee. We pursued
multiple courses of action, and significant progress has been
made, resulting in a stronger internal control environment.
I'd like to highlight the key actions that we've taken,
specifically as they pertain to the two recommendations in the
recent GAO followon report.
When GAO visited my unit in 1999, we had a fundamental
problem--that the unit had no authorized medical allowance list
of those items it was authorized to hold and maintain.
Specifically, we refer to this as an authorized medical
allowance list [AMAL]. None had ever been developed or approved
for a chemical or biological unit such as the CBIRF. This
resulted in the absence of a basic foundation upon which to
establish fundamental internal control procedures and to gauge
the effectiveness of inventory management practices.
We've worked diligently to fix this problem. As an interim
measure, we developed an internal allowance list of the medical
supplies that were necessary to meet our unit's mission.
Concurrently, we requested that a CBIRF-specific authorized
medical allowance list be developed and approved, and today I'm
proud to report that problem is nearing resolution as the Navy
Medical Logistics Command published a chemical biological
authorized medical allowance list for my unit in October 2000.
The Marine Corps Systems Command, in its capacity as the
program manager for medical material within the Marine Corps,
has finalized the configuration of those AMAL contents, and we
will work with the Marine Corps Systems Command to acquire the
necessary supplies to bring my working stock into compliance
with the recently approved AMAL standards.
The filling of the standardized AMAL will provide a solid
basis for accountability, as well as inventory control of
medical supplies, and will permit me to be able to fully comply
with GAO's first recommendation made as a result of their
October 2000, visit.
Inventory discrepancies were further reduced in my
organization from 26 percent in 1999 to 10 percent during the
recent October visit. In this 14-month period, this represents
a 16 percent reduction in inventory variance rates. My supply
personnel since October have researched all inventory
discrepancies noted by the GAO during their October count, and
all accounting records were adjusted in January 2001.
The upcoming implementation of a new supply management data
base will enhance asset visibility and improve our ability to
minimize inventory discrepancies. The Marine Corps is currently
filling an upgrade to the asset tracking for logistics and
supply system [ATLASS], an automated supply management data
base. This upgrade, known as ATLASS-II+ will improve CBIRF's
ability to do inventory management, as well as enable us to
overcome existing data base shortfalls which the GAO has
highlighted.
I'm pleased to report that implementation of ATLASS-II+ is
currently underway, having commenced yesterday, and will be
completed late this summer. This will permit all CBIRF medical
supplies and my working stock to be entered into the ATLASS-II+
data base not later than the commencement of the new fiscal
year on October 1st.
GAO noted that during their October 2000, counts they
identified 161 expired items on hand. This number of expired
items represents less than 1 percent of the working stock of
medical supplies that my unit maintains. All expired items had
been clearly identified, were labeled as being expired, and
were segregated from active medical supplies prior to GAO's
inventory in October in order to preclude their reissuance.
These expired items were pending disposal at the time of GAO's
visit.
As you may be aware, CBIRF executed a significant
undertaking during the period between the two GAO visits. From
May through August 2000, the entire unit relocated from Camp
Lejeune, NC, to Indian Head, MD. Accordingly, procedures for
the exposure of expired medications at our new location had not
been finalized when the GAO visited in October 2000. The
expired items noted by the GAO were reviewed to ensure that
none were subject to shelf life extensions, and all disposal
actions were completed in December 2000.
To better manage disposal actions in the future, we are
currently evaluating the feasibility of disposing the expired
medications through the use of a pharmaceutical return program.
This program may offer me the ability to dispose of expired
medications in a more timely and cost-effective manner.
Implementation of the ATLASS-II+ upgrade, use of the
pharmaceutical return program, and acquisition of those
necessary items to bring my working stock up to the levels of
the AMAL approval standards will all strengthen internal
management within my medical supply block that I hold.
These actions will also ensure that we fully comply with
both the recommendations and the GAO's recent followon report.
In addition to these key areas, we have taken many other
measures to help VA's strong internal control environment. I
have provided details on these in my statement for the record.
All recommendations made by the General Accounting Office
as a result of their visits to my unit have been fully acted
upon, and I believe the resulting measures have yielded
positive results; however, I would be extremely remiss if I did
not point out that the progress that we have achieved to date
is a direct result of the dedication and professionalism of the
young enlisted marines and sailors that I'm blessed to lead.
My supply warehousemen and Navy corpsmen worked many long
and demanding hours in an effort to improve our medical supply
operations. The tasks that they were completed were
accomplished in the face of tremendous obstacles--obstacles
presented by the unit's relocation--transfer of families, the
packing and shipping of all equipment and supplies, loss of
experienced personnel as a result of the move, and the need to
train newly joined personnel, delays in construction and
subsequent impact upon the occupancy of new facilities, and the
requirement to maintain a viable operational response
capability throughout the entire unit movement.
They did this not simply because I told them to; they did
this because they take pride in the uniforms they wear and
because they realize the gravity of the threat that confronts
us. They know that when our Nation is least prepared they've
got to be most prepared.
So I would like to express my sincere appreciation for this
committee's leadership in addressing the threat posed by
weapons of mass destruction. I want to tell you I'm equally
grateful for the support of the Marines and sailors that
comprise your CBIRF team.
Once again I thank you and I am prepared to answer any
questions you may have.
Mr. Putnam. Thank you very much, Colonel. We appreciate the
hard work that your Marines and sailors put in, as well.
[The prepared statement of Colonel Hollifield follows:]
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Mr. Putnam. I'd like to recognize or acknowledge that the
gentleman from Massachusetts, Mr. Tierney, has joined our
subcommittee, and I would ask our chairman, Mr. Shays, to lead
off with the questions.
Mr. Shays, you are recognized.
Mr. Shays. Thank you, Mr. Chairman.
Mr. Chairman, first I want to again thank the GAO for their
testimony and also our witnesses on this panel, and, with no
disrespect to the other panelists, just particularly thank you,
Colonel Hollifield, for your cooperation with the committee. We
felt cooperation with all, but the site visit was appreciated
by our staff.
Also, to say like a true Marine you are here--evidently,
your wife's father, Robert Cobb, passed away and you will be
going back down there to make arrangements, and it is just very
thoughtful of you to be here. Thank you.
Colonel Hollifield. Thank you, sir.
Mr. Shays. This chart is an accurate chart of the flow of
responsibility? There's no disagreement with this chart on the
part of all four of you?
Colonel Hollifield. No disagreement, Mr. Chairman, but a
point of clarification. I think we established this the last
time that I appeared. You know, we--you acknowledged at our
last hearing, sir, that our unit is somewhat different from the
other agencies that sit at the table with us. We are not a part
of the--formal part of the pharmaceutical stockpile program,
but we do have a responsibility.
Mr. Shays. I see the line of authority coming straight down
from the Department of Defense, and that's accurate?
Colonel Hollifield. Yes, sir.
Mr. Shays. And basically I get the sense that HHS is using
the Department of Veterans Affairs to contract. Dr. Knouss and
also Dr. Hughes, is that an accurate description? Are you--is
the Department of Veterans Affairs basically the contractor
by--the partner? Tell me the relationship between HHS
coordinates and medical services, medical assistance, and what
your role is, Dr. Mather.
Dr. Mather. We consider ourselves to be a partner with HHS,
and there are essentially two functions, the one being the
stockpiles that Dr. Knouss described, and in that case we
actually house the stockpiles and manage them on the site so
that they are ready when the national medical response teams
are activated and can pick up the stockpile.
Mr. Shays. Do you have oversight responsibility to the
Office of Emergency Preparedness and the Centers for Disease
Control and Prevention?
Dr. Mather. No.
Mr. Shays. So you basically contract with them in----
Dr. Mather. We are a contractor with the Office of
Emergency Preparedness, and then VA also functions in a--for
acquisition of the stock or the pharmaceutical supplies that
CDC has on hand.
Mr. Shays. What I'd like to wrestle with a bit, I heard the
concept of the scene, and I've never thought of it as a scene.
My sense is that it rapidly becomes many scenes.
If you will, if I could just get a sense of, first, the
antidote for a chemical versus a biological agent. Is the
antidote as effective? Is it--just describe to me how we should
view chemical versus biological. I throw it open to the floor,
whoever.
Dr. Hughes. Well, perhaps I can begin with it.
Mr. Putnam. Sure.
Dr. Hughes. I'm sure the others will want to add.
For a biological agent, we have to deal with what is known
as an ``incubation period.'' That's the time from exposure to
the time of onset of illness, which can range, depending on
agent, from several hours----
Mr. Shays. Right.
Dr. Hughes [continuing]. To several days, and in some cases
several weeks. It is that difference that is very important in
terms of a biological event requiring for recognition good
disease surveillance, because people will be widely dispersed
from their site of exposure.
Mr. Shays. But this is one reason why we contact hospitals
in urban areas every day to see if they have a particular
outbreak of a problem--it's one of the reasons. They may have
an outbreak of a natural cause, or it may be terrorist induced.
Dr. Hughes. That's right. In the absence of an overt claim
by a terrorist, a bioterrorism event will present as any
complicated infectious disease outbreak that requires alert
health care workers and a vigilant public health system to
recognize problems.
Mr. Shays. And it grows geometrically.
Dr. Hughes. Yes, it can. It certainly can.
Mr. Shays. Whereas chemical, it will be a little more
instant and spread, but not necessarily in the same way.
Dr. Hughes. Well, for many chemicals there will be a much
shorter interval from exposure to onset of illness.
Mr. Shays. And not contagious.
Dr. Hughes. Well, not directly contagious the way some
infections are, but a victim may be contaminated with the
chemical, so it is possible for a victim of a chemical exposure
to expose people who are caring for that individual.
Mr. Shays. OK. So it can spread.
Dr. Hughes. On a limited basis.
Mr. Shays. Right. And then it goes many places. So describe
to me how the system would work. It is, you know--and the
location of these stockpiles is not something we advertise, but
let's just say the stockpile is in a particular place and it
needs to go 200 miles to Columbus. Describe for me what
happens. How does this system work?
Dr. Hughes. Well, we, in an event like the where an episode
was recognized and characterized and a decision was made that
it was appropriate to mobilize the stockpile, a push-pack, one
of these push-packs that I mentioned would be mobilized either
by air or by land, depending on its proximity to its ultimate
destination, and can be moved within 12 hours to such a site,
and in many cases----
Mr. Shays. And who is responsible for making sure that gets
there?
Dr. Hughes. Well, that would be the CDC response for our
stockpile for those push-packs. It would be our responsibility.
Mr. Shays. Colonel, tell me how you fit into that process.
Colonel Hollifield. Sir, I don't really fit into that push-
pack process at all. We maintain a limited amount of medical
supplies, primarily to provide care for our own first
responders. My unit's role is to provide assistance to the lead
Federal agency when tasked to do so.
Mr. Shays. OK. Walk me through this a bit. I mean, we had
an exercise in Connecticut----
Colonel Hollifield. Yes.
Mr. Shays [continuing]. And that was fascinating, but just
walk me through. We have an outbreak. The first responders
didn't survive. Sometimes the firemen tell us the police are
the canary in the field. So let's say a few policemen have
died. We're trying to determine what the cause is. Is that your
job, Dr. Hughes, or are you just responding to whatever you're
asked for?
Dr. Hughes. No. The stockpile is only one component of the
CDC and the public health.
Mr. Shays. Right.
Dr. Hughes. There's detection, diagnosis, assessment of
risk factors, definition of the----
Mr. Shays. You just have to get it there, whatever you're
asked for? You have to get the supplies there to the site?
Dr. Hughes. Well, the mobilization of the stockpile is one
component----
Mr. Shays. Right.
Dr. Hughes [continuing]. Of what we would be doing, but we
would be responsible for ensuring that the stakeholder is moved
using our transportation partners to the site or sites where it
is needed.
Dr. Knouss. May I step in, please?
Mr. Shays. Yes, please.
Dr. Knouss. Just with a context, because I think that there
is an entire context of a Federal response plan in the event
that we have one of these emergencies. The difficulty with a
biological event that looks like it is just a regular--let's
say like West Nile did in New York where it is a naturally
occurring disease that is being transmitted and spread from
Europe. There was no indication as to whether or not that was a
human-caused or a naturally occurring disease. But in the event
of a terrorist attack, that would be a--that might be appearing
originally as a naturally occurring disease and then all of a
sudden becomes apparent that it is a terrorist attack.
But when we know that there is a chemical event or a
terrorist attack with a biological agent, there is a Federal
response plan that really mobilizes the whole of the Federal
Government.
Mr. Shays. And you would be responding whether it is a
terrorist attack, or not? You would be responding either way?
Dr. Knouss. We would be responding either way.
Mr. Shays. Yes.
Dr. Knouss. If it's a mass--actually, we have enormous
numbers of resources to be able to respond to mass casualty
situations in the United States, and this is just one other way
of getting to a mass casualty situation.
Mr. Shays. I just--I guess what I maybe need to do is
just--because my time is running out here--I just want to
appreciate obviously how we maintain these--this medicine and
these antidotes is one issue, but how we get it to the field--
and I'm just trying to understand that basic point.
And I just heard the word ``scene'' more than I was
comfortable, instead of ``scenes.'' So it is in Columbus, and,
guess what, it is in Dayton and it is in Chicago and, my god,
it's down in Miami all of a sudden. I just want to know who in
this group responds and how you respond when that happens, and
then, thank you, Mr. Chairman, I'll come back for a second
round.
Dr. Knouss. That's a very complicated question, but
basically we all respond and there are prescribed procedures
that we use to respond.
Mr. Shays. It's not classified, is it?
Dr. Knouss. No. It's the Federal response plan that we use.
It's for emergencies.
Mr. Shays. OK. So just walk me through it.
Dr. Knouss. And the bioterrorism--or the terrorism annex to
that plan.
If there is an event that occurs and the FBI is notified or
law enforcement notifies, the initial response is going to be a
local response.
Mr. Shays. OK.
Dr. Knouss. That's one of the reasons why we are trying to
improve local resources around the country. Both CDC, both the
local and State level, and we, in terms of the health systems
at the metropolitan level, and we are now active in over 100
major metropolitan--about 100 major metropolitan areas.
So if it happens in one of those areas, plans are being
developed now for the initial local response, including the
stockpiling of antidotes and some antibiotics.
Mr. Shays. And we don't have stockpile like at Pearl Harbor
where we put all our ships?
Dr. Knouss. No, sir.
Mr. Shays. They're all around the country.
Dr. Knouss. They're all around the country. And we're doing
two things for chemicals. We're buying some stockpile to put in
our major metropolitan areas because of the rapidity of the
responses needed, so that our first responders have immediately
at their disposal enough stockpile to take care of anywhere
from 1,000 to 6,000 people, and for some of our larger cities
even more than that.
Mr. Shays. And chemical has a longer shelf life?
Dr. Knouss. No. It all depends on----
Mr. Shays. So we're constantly having to update.
Dr. Knouss. That's correct.
Mr. Shays. If you don't mind, Mr. Chairman, since there are
only two of us----
Mr. Putnam. There's nobody else to go.
Mr. Shays. Let me just appreciate--I'm pleased the others
jumped in, but I just want to have--maybe this is so redundant
for you that you don't want to keep talking about it. I get
tired of talking about campaign finance reform. You can get
tired of talking about this.
Dr. Knouss. Well, hopefully this is not in the same
category.
Mr. Shays. Tell me how--we've got Columbus, we've got
Dayton, we've got Chicago, we've got Miami, and you're on the
phone. You may be--tell me--and then, Colonel, I just need to
know how you interface since you're not part of the system. I
don't want to leave a void here. You can jump in.
Colonel Hollifield. Let me tell you how I fit into the
system, sir, how my unit responds.
First of all, we are outlined in the emergency Federal
response plan. Specifically, we are tasked to support emergency
support function eight, and we don't do that in a vacuum. We
only do that when a lead Federal agency has come in and asked
DOD specifically for support. And that may be my unit or it may
be some other entity within the Department of Defense.
Typically, if we are tasked and employed to provide
support, we may be working in close conjunction with one of
these other agencies, such as providing support for the Public
Health Service.
Mr. Shays. Let me ask you, are there other units like
yours? I mean, I'm really showing my ignorance.
Colonel Hollifield. There is no unit exactly like mine,
sir, at the Federal level. The National Guard is sending up
units, the civil support teams.
Mr. Shays. The response teams, and so on.
Colonel Hollifield. Yes, sir. But they are designed to
provide the support for the State and local response under the
State adjutant general.
My unit comes in and provides support specifically focused
on chemical and biological, in addition to the medical
stabilization piece that we could bring to the table.
Mr. Putnam. We don't want to go to the Army or the Air
Force to do this, we're going to your unit to do it, aren't we?
Colonel Hollifield. Yes, sir, and other--there are other
entities. The Air Force has a radiological assessment team that
provides support.
Mr. Shays. Right, for radiologic.
Colonel Hollifield. Yes, sir.
Mr. Shays. OK.
Colonel Hollifield. We have an oversight and coordination
command and control coordination structure in place with the
joint task forces that we'll support.
Mr. Kucinich. And you have the capability to now go to
Dayton and--excuse me, Columbus and Dayton and Chicago and
Miami? Or can we only be at one place?
Colonel Hollifield. Sir, I have the capability to provide
an initial response primarily to a single location; however, I
could provide a followon response to another location. But I
only have 372 personnel in my unit, so the level and depth of
what we can do is limited.
Mr. Shays. I just don't want to have an over-expectation of
what we have available.
I think this issue is huge. I mean, I truly do. I think it
is kind of like everybody will be asleep. You all aren't, but
the general public and the lot may not fully realize that there
will be a chemical or biological attack some time, maybe
nuclear, and that's why you all are doing what you're doing.
I'm still not really getting a great answer from my
standpoint. I know that you're going to be going to a site. I
want to ask----
Colonel Hollifield. If I could draw an analogy, Mr.
Chairman?
Mr. Shays. Sure.
Colonel Hollifield. I'm kind of like the ambulance guy, you
know. I have some limited medical supplies.
Mr. Shays. Right.
Colonel Hollifield. I'm the ambulance. I show up at the
scene and I provide some stabilization care so that these
agencies and the medical supplies they provide the local
responders can take over that surge of patients and be able to
follow on and provide the long-term care.
Mr. Shays. It's just basically you're a one-scene primarily
focus, so I sure as heck we know soon enough to get you there
before we see the chemical contamination spread or the
biological agents.
Colonel Hollifield. We try to preclude that, sir, by two
methods. One is we look and rely very heavily on intelligent
information.
Mr. Shays. Right.
Colonel Hollifield. So if we anticipate that there is a
credible threat for a major event, we can pre-stage forces at
that scene, which we have done repeatedly in the past.
But, more importantly, we keep about one-third of the unit
on a 1-hour tether, 365 days a year, which means if something
happens, within 1 hour we can recall that response force in.
All their equipment is pre-stage packed and mobile loaded. And
then it's just a matter of air lift and getting us to the
destination before we can have impact.
Mr. Shays. Thank you. Now, the national medical response
teams, how many do we have?
Dr. Knouss. Four.
Mr. Shays. So does that mean that we could get to those
four sites?
Dr. Knouss. At the beginning what's going to happen is that
the State of Ohio is going to be responding, and, in fact, we
are developing systems in those cities, so--and we've also
worked with the State to link those cities in a network so that
we have some response capability in the State of Ohio to begin
with, which was the example you started with.
Then we have the opportunity to move those four teams. The
first three teams would be the ones positioned on the west and
the central and the East Coast. The one here in Washington, DC,
will probably stay here in the event that we have a continuing
or additional----
Mr. Shays. Right.
Dr. Knouss [continuing]. Threat here in the Nation's
Capital.
We have constructed our stockpiles so that we can split
each one into four pieces, and that means that we can move--we
actually have a great deal of mobility. Obviously, at some
point the response may require such a large requirement that it
is going to exceed what we have pre-positioned, but we think we
have a very substantial capability when it comes to chemical
victims.
Mr. Shays. Mr. Chairman, I'll come back. Thank you for your
patience.
Mr. Putnam. You're certainly welcome, Mr. Chairman.
Dr. Mather, your testimony states that the caches have been
successfully deployed and returned to storage. Why were they
deployed?
Dr. Mather. As a test case. We did deploy the capital--the
cache here for the inauguration and the State of the Union
address, as you are aware.
Mr. Putnam. OK. And do we have any mobile stockpiles
overseas?
Dr. Knouss. We do not, not for any of the programs that we
operate. Those are all domestic and really have been committed
to domestic uses. That question has come up on a frequent
occasion.
Now, there are some instances in which we have assisted AID
in actually purchasing some additional pharmaceuticals for
other governments, but it has really been part of a foreign
assistance package and not as a part of our immediate response
capability.
The one thing that we can do that is new is that, in
response to the bombings that took place in Nairobi and Dar es
Salaam, we now have a capability of immediately deploying a
civilian team from a very fine surgical care institution in
Massachusetts that we can use to stabilize U.S. employees that
may be immediately at risk from those kinds of events again.
Mr. Putnam. When an event or evidence of an event begins to
pour in to CDC and HHS, who makes the final call? Who is
ultimately responsible for identifying this scenario as an
event and therefore triggering your response plan?
Dr. Knouss. Well, the initial event would be the FBI and
FEMA. In terms of the actual response in terms of management
within our department, our current Secretary has made it very
clear that he is going to be directly responsible for the
responses of the Department of Health and Human Services.
Mr. Putnam. So when you are communicating with urban
hospitals and first responders and reports begin to come in,
and, as we've heard earlier, everything looks like the flu in
the beginning, it's up to the FBI to determine what they're
really looking at?
Dr. Knouss. No, that's when it's looking like an emerging
infectious disease, and that's a public health problem, and
that really is a CDC issue. It's once it becomes clear that it
is a terrorist incident that the lead agency is the Department
of Justice and the Federal Bureau of Investigation.
Mr. Putnam. But I guess in this murky world that we live in
it may not be clear that it is a terrorist incident, and that's
why I asked who sifts through the data and makes the
recommendation that it is--it looks enough like a terrorist
attack to deploy your plan? Is that you, Dr. Hughes?
Dr. Hughes. Well, that's where the Nation's public health
system comes into plan and its linkage with clinicians, health
care providers who--in a biological event, it is the health
care providers that are going to initially see these patients.
They need to have a high index of suspicion, if they're seeing
one or two patients, that this may be part of a much larger
event occurring in their community or maybe in many
communities. So an index of suspicion, prompt recognition,
notification of local and State public health authorities who
would then, in turn, notify us at the national level. There is
a need for alertness and rapid communication at all levels, as
is the case in recognition of any infectious disease outbreak.
There then needs to be an index of suspicion, depending on
the nature of the illness, the initial clues related to the
epidemiology of the event. There are certain triggers that
would alert you to the possibility that you might be dealing
with a terrorist event.
Mr. Putnam. What is the level of awareness in the local
health care community of--why would a public health official in
a mid-sized midwestern city like Oklahoma City, why would they
think that anthrax is in their community? What training or
preparation would they have had given them that would alert
them to look for and consider such an outlandishly sounding
eventuality?
Dr. Hughes. I think the good news is they're more likely to
consider that possibility today than 2 to 3 years ago, with the
publicity, the heightened awareness, the efforts at training,
the establishment of strengthened surveillance in laboratory
networks, and dissemination of information about the clinical
nature of anthrax.
Anthrax is a disease that should not occur at all in the
United States in humans, so a single case should raise the
possibility of a terrorism event. It doesn't mean a single case
will be the result of a terrorist event, but a single case
should raise a red flag.
I think, although we have a long way to go, that's more
likely to happen today than it was 2 to 3 years ago.
Mr. Putnam. Who decides--in these stockpiles that are
around the country, who decides what eventualities those
stockpiles need to be prepared for? And how often does that
threat analysis change, or how often is it reviewed to make
sure that we're prepared for the proper eventualities?
Dr. Knouss. There are a variety of different processes that
we go through to do that. I think Dr. Hughes is in a position
to describe a lot of the things that CDC does to decide what is
the most likely mass-casualty-producing organisms that might be
used and that we have to be prepared to respond to.
From a chemical standpoint, we rely a good deal on what DOD
has decided are some of our most important chemical weapons
threats, and it boils down to some things that really have a
lot of common antidotes to them so that we use that as the
basis for the stockpile.
Mr. Putnam. Dr. Hughes.
Dr. Hughes. Roughly 2 years ago we assembled an expert
group of individuals representing the private sector, the
Department of Health and Human Services, the intelligence
community, and we talked about candidate agents. The Department
of Defense had representatives at that, as well. We talked
about candidate agents that we should be most concerned about,
considered a number of parameters, one of which is the ability
that we've alluded to already of an organism to spread from
person to person, cause severe disease, have a high mortality
rate. Those kind of things went into the equation.
It was that process that led us to definition of what we
call ``category A'' agents that are the ones that we are most
concerned about because of their potential catastrophic impact.
The category A agents include smallpox, anthrax, plague,
tularemia, botulism, and several of the viral hemorrhagic
fevers such as ebola.
So we have a pretty good idea of those agents that would
have the most devastating consequences. The two bioterrorism
incidents, though, that have been perpetrated in the past in
the United States successfully involved common diarrheal
pathogens--salmonella in one case and shugella in another. So
you've got to be prepared for a broad range of possibilities.
Mr. Putnam. And how many eventualities does our stockpile
prepare us for?
Dr. Hughes. Well, I can speak to the CDC stockpile
currently. What we've done is focus on the category A agents
that I mentioned. In those push-packs that I mentioned and in
the vendor-managed inventory, the push-packs currently are
supplied to adequately deal with plague and with tularemia.
More work needs to be done to get them fully up to the level
they should be to deal with anthrax.
And, of course, when you get to smallpox and the viral
hemorrhagic fevers, there aren't effective therapies currently
available for those so that becomes a research issue. So it's
very complicated.
Dr. Knouss. Could I just add to that, though, that the
stockpile that we do have in terms of antibiotics includes what
are called ``broad spectrum antibiotics,'' and they can be used
against a large number of different organisms that might be
susceptible. So what we are now putting in the stockpile is not
necessarily limited to treating just plague or tularemia or
anthrax, it can be used for a variety of other illnesses,
bacterially caused illnesses, as well.
Mr. Putnam. Let me get back to what we were discussing
earlier in terms of the line of authority, the chain of
command. To followup on the chairman's line, there is a
disturbing amount of evidence emanating from the Chicago
metropolitan area and in Dayton and in Cincinnati, so you all
move into action and begin to deploy assets to that area. Who
makes the determination of holding back assets or preparing for
a second outbreak or a far-removed outbreak in Miami or New
York or San Francisco so that we're not deploying all of our
assets to the first line of attack and, in effect, depleting
our ability to respond to the secondary effects? Who handles
all of that decisionmaking? Does that make sense?
Dr. Knouss. Yes. I'm not aware of any situation in which
we've actually said, ``We're going to keep a reserve force
that's going to be available in case there's another
incident,'' with the one exception that here in Washington, DC,
we are committed to keeping specific kinds of resources
available here in case this--I mean, I just consider this as a
secondary target, regardless of where something else may be
happening.
But it is like everything else. When you see a particular
threat--if we are faced with--and this is a highly theoretical
kind of discussion at this point--I don't think there is any
formula for good judgment as to what you can commit to one kind
of incident or another incident, and every one of those
incidents--and we've been involved in a variety of responses to
rather cataclysmic natural disasters, as well as pre-
positioning resources for some kinds of these incidents,
potential threats. There's no exchange for good judgment and
there is no formula for what has to be kept in reserve and what
needs to be committed.
Dr. Hughes. Let me pick up on this a little bit, and maybe
Mr. Bice.
Mr. Shays. You know what I'd like to suggest, if I could,
Mr. Chairman?
Mr. Putnam. Certainly.
Mr. Shays. That anyone who wants to participate, if they
have been accompanying, if they just sit right on the side up
here where the mics are. Just come on up here, anyone else who
would like to add to this dialog. So you can just wait, but
anybody else.
I'm sorry.
Dr. Hughes. I know that Mr. Bice will want to amplify on
this, but, from the CDC standpoint, in terms of the stockpile,
we have--it's a two-component situation where we have these
push-packs. There are seven right now. There will be an eighth
this summer. But obviously----
Mr. Putnam. Is that enough? Let me just stop you right
there.
Dr. Hughes. Well, It depends on the magnitude of the
situation. If the situation that we're talking about occurs in
20 different cities, obviously the eight push-packs wouldn't
cover 20 cities.
There's a second component, though, to the CDC stockpile,
and it's what we call the ``vendor-managed inventory,'' which
can't be mobilized as rapidly but it can be mobilized within 24
to 36 hours of activation.
In contrast to the push-packs, which are an attempt to be
all things to all agents, the vendor-managed inventory can
actually be tailored so that if you know you're dealing with
anthrax you can call on the medications and supplies that you
need to deal specifically with cases of anthrax.
Mr. Putnam. Mr. Bice, I think you wanted to followup on
that?
Mr. Bice. Yes. Thank you, Mr. Chairman. I just wanted to
ensure that all understand that, while there's no magic to
eight, we dealt specifically with Defense Intelligence Agency,
Central Intelligence, FBI, our own colleagues in our own
department and other departments who are experienced with
strategies for defense and response. There is no magic to
eight, but the fact that each of the push packages can treat in
the hundreds of thousands of people for a week or thereabouts
gives us breathing room to mobilize the prodigious amount of
supplies and equipment that we have held back in the vendor
warehouses across the United States.
So therein is our tactical scenario that we play out, we
exercise according to that plan. So we would never commit all
eight push packages, for example, to Dayton or to any one
location. They would stage according to what we would see as
evidence by laboratory and epidemiologic evidence the need for
those.
And one other caution. None of what we do is to respond--
none of what the national pharmaceutical stockpile is to do,
we're not a first response element. We would only go when
Governors of States requested assistance, and in that sense
we're not a primary or first response element.
Mr. Shays. But it conjures up this concept of the scene. I
mean, the scene that I visualize, unless the technology isn't
there for terrorists to do, is Atlanta Delta flights. All of a
sudden, you know, there's some contamination at the airport and
there's all these--if you've ever been there--you've been
there.
Dr. Hughes. I have the pleasure of constantly, sir.
Mr. Shays. And so there could be potentially 40 sites like
that. So I'm not comforted that somehow the national government
doesn't--you know, is kind of responding in invitation. I mean,
I could see a for instance where we literally have to say, ``No
flights. No one is allowed to get on the highway. No one is
allowed to move from their office to home. You have to be
stationary.'' I mean, I can see that. Is that an unrealistic--
--
Dr. Hughes. That's very realistic. Let me just comment. In
the Operation Top Off exercise that occurred last year that
involved three components, the most complicated one was the
plague outbreak that was said to have occurred in Denver,
exposing a very large number of people, and all of these issues
that you've brought out and many more came up.
There was thinking in terms of when Colorado asked for a
push-pack to provide initial treatment to people that were
initially felt to have and then confirmed to have plague. A
push-pack was notionally sent.
There were reports of other States who were concerned about
potential exposures of their population, requesting a push-pack
to be sent, and the decision was made not to send it along the
lines of not spreading one's assets too thin.
But then all the questions that you are just alluding to
immediately came up, as well--issues related to quarantine,
stopping interstate movement, closing the airport. Actually, we
recommended that Denver International Airport be closed in the
exercise, and then we recognized that caused problems in terms
of mobilizing the push-pack, which had to be flown into Denver.
So these are very real concerns.
Mr. Shays. Right, they are, and this committee has been
working on this for years--correction, we have been involved in
this process for years and trying to get caught up to speed,
and I feel like I have a long way to go, but I don't have a
terrorist mind. But you closed the Denver Airport too late.
That's another hub, I believe, and so planes are everywhere.
I could see that the first indication is you had some of
the ticket agents who all of a sudden came down with an illness
and died, and you all are trying to sort it out. Do we have the
authority--do any of you have the authority to recommend to the
President or someone the ability to just shut down all traffic,
to close everything down, to ask for no movement whatsoever so
this doesn't spread?
Dr. Hughes. Of course we could recommend such a thing. In
terms of authorities, I can't speak to----
Mr. Shays. But who would--I want to identify. I'm not
playing a game here. I want to identify who most likely would
be--you know, I have this vision of a former Secretary of State
saying, ``I'm in charge here.'' I want to know who ultimately
is accountable for that recommendation.
Dr. Hughes. Well, I cannot definitively answer your
question, but I can say that in the aftermath of the Operation
Top Off and lessons learned there is an ongoing review as we
speak looking at interstate quarantine authorities, looking at
State laws for quarantine of infected individuals. It has
raised many, many questions.
Dr. Knouss. I'm not sure that we're the best people to
answer that question. The people to answer that question that
have been working on it and chairing the task forces looking at
those issues has been the Department of Justice.
When we're talking about the quarantine issues and looking
at quarantine laws at the present time, a lot of them are
dependent on exactly what State law is and they vary from State
to State.
Mr. Shays. It's just that, you know, we have this comfort
level that, you know, you're the group that's going to be
responding, and I had this sense before I came to this hearing
that this is kind of a complete picture, and I hear ``scene''
rather ``scenes.'' I have a sense that we will try to catch up
to the contagious elements and we'll be--you know, if it's nice
and neat and pretty we'll be doing fine, but otherwise we'll
have some----
Dr. Knouss. Mr. Chairman, I think that we're just one part
of a very large response that is going to be taking place, and
that's what I was trying to allude to at the very beginning in
terms of this being one part of the Federal response plan and
the issues that will be tackled really at the highest level of
our government.
Mr. Shays. Then let me just make this statement--did you
want to say something, Dr. Hughes, first?
Dr. Hughes. I was just going to say that your comments I
think are very well taken. One thing they bring out is the
urgency and the importance of having surveillance systems in
place, strong public health surveillance, so that an event can
be very rapidly recognized because things can spin out of
control very, very quickly potentially.
Mr. Shays. Yes. I mean, I'm left with the feeling that,
just as it relates to all of you and the wonderful work you're
doing and the efforts you're making, you could potentially
never get caught up to it. It will be identified too late, it
will have spread too quickly, and we won't have the resources,
even though it seems like we might.
If I could, could I ask about smallpox?
Mr. Putnam. Certainly.
Mr. Shays. Why don't I----
Mr. Putnam. Well, I just wanted to--I think that your line
of questioning highlights the theme of this subcommittee since
January, which is, when it comes to homeland security,
Department of Justice points to the CDC, the CDC points to the
Department of Justice, and there really isn't anybody willing
to stand up and say, ``I'm in charge here,'' and that reflects
sort of an institutional crisis of identifying how to respond
to these types of threats.
I would hope that you all would recognize the threat before
a lot of Governors would, much less have to wait on the
Governors to type up the proclamation to invite you down for
tea.
I think what this highlights is that it reinforces the need
for us to have a better-integrated system of homeland defense
and address the questions of when it is appropriate for CBIRF
or equivalent or similar type units to be deployed domestically
and respond to these types of crises and have pre-positioned
stockpiles in the right places, in the right amounts and things
of that nature.
That's all I wanted to say, Mr. Chairman.
Mr. Shays. Just quickly about smallpox, the ``Stars and
Stripes'' had a story on the 26th that we're going to get 40
million doses of vaccine against smallpox. Who would respond to
that? Is that you, Dr. Hughes?
Dr. Hughes. Yes.
Mr. Shays. OK. Tell me the genesis of why that decision was
made. The stories that preceded it, to my knowledge, is that
the United States has the last and the Soviet Union, and we
don't know quite what the Soviet Union has and who it could
give it to. What do you know that we don't know that's not
classified?
Dr. Hughes. OK. You've asked several questions.
Mr. Shays. Right. We want to give you a range of choices.
Dr. Hughes. Let me start and you guide me and I'll do the
best I can.
Mr. Shays. OK.
Dr. Hughes. There are two authorized supplies of smallpox
virus in the world. One of those--or stocks, I meant. One of
those is stored at CDC. The other is stored at the Institute
Vector in----
Mr. Shays. And this is the disease, not the vaccine?
Dr. Hughes. This is the virus that causes the disease.
Mr. Shays. Right.
Dr. Hughes. Correct.
Mr. Shays. Yes.
Dr. Hughes. There are concerns in the intelligence
community about given the fact that the Soviet Union, from all
we know, clearly had a very aggressive offensive biological
warfare program. They included development of smallpox virus as
a weapon.
Mr. Shays. Right.
Dr. Hughes. There are concerns that perhaps all the
remaining smallpox virus that the former Soviet Union had is
not currently stored in the facility in Novo Severe. So that
leaves--there is the possibility----
Mr. Shays. At least you can't be certain of it.
Dr. Hughes. We can't be absolutely certain.
Mr. Shays. OK.
Dr. Hughes. But the officially declared stocks and the ones
that come up when you hear talk about destruction, discussions
related to future destruction of known stocks, the virus, those
relate to the virus stocks at CDC and the ones at Vector and
Novo Severe.
Mr. Shays. And can I make an assumption at CDC it's
strongly guarded?
Dr. Hughes. It's stored in a secure--under secure
conditions. Yes.
Mr. Shays [assuming Chair]. I feel rudderless at the
moment, here. The gavel is over there and I'm here. You could
really abuse me here. [Laughter.]
Dr. Hughes. The storage conditions at both----
Mr. Shays. I'm in charge here now.
Dr. Hughes. I sensed that. The storage conditions at both
institutions, both CDC and Vector, have been reviewed by a team
of experts from WHO and have been deemed to be adequate.
Mr. Shays. And what would happen if we saw an outbreak? We
would try to vaccinate as many people in the area as possible?
Dr. Hughes. Well, if we saw an outbreak of febrile illness
with skin lesions consistent with smallpox, the first thing we
would do is try to rapidly confirm the diagnosis.
Mr. Shays. Right.
Dr. Hughes. And because of ongoing research programs we
have pretty good molecular diagnostic tools now, better than we
would have had a year or two ago, to make the diagnosis. Once
the diagnosis is made, here's a good example of agent. I mean,
if we see cases of smallpox, either that's a lab escape or
that's a terrorist infecting himself by manipulating the virus
that he had, or it's a terrorism event, so that gets you very--
that would get you very quickly into the terrorism arena.
In terms of what you would do, you would mobilize stocks of
smallpox vaccine, which is not smallpox virus, you know, it's
the smallpox vaccine.
Mr. Shays. You don't need the virus to make the vaccine?
Dr. Hughes. That's correct. The current vaccine and the
next generation that's currently being developed involves a
related pox virus called ``vaccinia.'' It's the----
Mr. Shays. But in creating the vaccine you aren't creating
the potential for the disease?
Dr. Hughes. No. The other thing that you would be rapidly
doing is characterizing this smallpox virus that these
hypothetical patients are infected with because there would be
concerns about the possibility that this virus might have been
genetically modified by people who were interested in having--
--
Mr. Shays. Weaponizing it.
Dr. Hughes. Weaponizing it and having it be able to work
around the existing vaccine.
Mr. Shays. And so that's a crap shoot. OK.
Dr. Hughes. I mean, you can imagine scenarios that are
beyond the capacity to manage.
Mr. Shays. How about with anthrax? If we think our military
personnel need to be protected, are we stockpiling anthrax for
civilians?
Dr. Hughes. Well, we--the colonel might want to comment
here also.
Mr. Shays. Don't feel you have to, Colonel. It's dangerous.
You know what a mine field is like.
Colonel Hollifield. I'm current on my anthrax vaccines, Mr.
Chairman.
Mr. Shays. You don't want to get in this debate, Colonel.
Colonel Hollifield. Thank you, sir.
Mr. Shays. It's not a pleasant conversation.
Dr. Hughes, are we developing or stockpiling anthrax
vaccines in case the public is exposed to anthrax?
Dr. Hughes. What we're doing with anthrax vaccine, at CDC
we actually have an ongoing research program looking at the
currently available anthrax vaccine, looking to see if it can
be given in fewer doses, looking if it can be given by a
different route of administration that might result in a----
Mr. Shays. To develop a new----
Dr. Hughes [continuing]. In less side effects.
Mr. Shays. To do what we asked the military to do, which is
to develop a modern generation of vaccine, anthrax vaccine?
Dr. Hughes. Well, there's ongoing research, not research
that we're doing, but there is ongoing research looking at
improved anthrax vaccines, but what we're trying to do is look
at the available vaccine, see if it can be given in fewer
doses, different route, and then assessing its----
Mr. Shays. Right.
Dr. Hughes [continuing]. Effectiveness to prevent
inhalation anthrax in non-human primates that are exposed.
Mr. Shays. Don't you see a gigantic disconnect? The
military, to my knowledge, isn't focused on giving a smallpox
vaccine to its military, but it has decided, in its wisdom, and
based on the facts as they see it, to have anthrax, and yet
domestically you all are saying we're going to look at smallpox
and you're not--we don't have developed anthrax. So it just to
me calls into question the wisdom of what the military is
doing. Either the military is right and you're wrong or you're
right and they're wrong. They don't jibe. It's not a trick
question; it's just an observation that we've had 4 years or 3
to 4 years of very frustrating dialog with the military about
this.
It is hard for me to imagine how, if we think we need to
protect our military forces from anthrax, we don't think we
need to protect the public. I'd just make--I throw it out there
and it will dangle out there for a future hearing.
I'd be happy to have the counsel ask some questions.
Mr. Halloran. Just to clean up the record a little bit
here, Colonel Hollifield, has anybody in your unit read your
AMAL kind of side-by-side with the contents of the push
packages or the stockpiles to look and see what's the same,
what's different? And let me ask all of you, in terms of the
transparency of these things, in terms of if he's there first,
you fall in after, are you going to be giving the same
material--bringing the same material and the same doses in the
same color packages, or are we going to have some kind of a
bridging transition problem as each asset arrives?
Colonel Hollifield. I don't think there's been any attempt,
to my knowledge at least, to compare the AMAL contents with
anything that's a part of the national pharmaceutical stockpile
program.
In the military the authorized medical allowance list is
basically what I would call ``type specific.'' Each type of
military organization, be it an infantry unit, mechanized unit,
or an aviation unit, has a specific authorized medical
allowance that is tailored to its unit's mission. If you look
at the quantity of the medications that we have and the number
of victims that we're designed to be able to render care for,
which are primarily the size of own force, and compare that
with the scope and depth of what the other agencies have in the
stockpile program, you know, we're very, very minuscule.
So I'm not so sure that there is a necessity to do that. I
understand that it would be nice that if we're all showing up,
we're showing up with the same type of items and supplies, but
our missions are different, so the care items that I have are
really designed to provide protection for my people who go into
the contaminated environment and risk exposure, and I have very
limited quantities.
So I don't think there is a connection. I'm not necessarily
sure that--and maybe they can comment in terms of what type of
supplies the national medical response team has and if they're
similar, but I'm sure that the vaccines and stuff that we carry
for care are all similar in nature, whether they're
manufactured or the process by how we acquire them are the
same.
Dr. Knouss. I'd like to just mention that for the
pharmaceutical purchases for the cities, as well as those that
we make for our teams, that we want to review all those
purchases before we actually support them at the city level,
and we have an interagency group that looks at that so that we
try to achieve as much consistency as we can, as well as the
fact that our teams and our cities know what we have in our
stockpiles for chemical responses.
So it's not true for--that we do not do that with the
Marine Corps' stockpile, but we do try to do that with all of
the metropolitan stockpiles and the ones that we hold for our
teams.
Mr. Halloran. OK. That brings me to--there's a reference we
have to metropolitan medical strike teams, which are not on the
GAO chart, but yet they seem to be an HHS-funded asset; is that
correct?
Dr. Knouss. Well, what we have done is that term is
somewhat obsolete at this point----
Mr. Halloran. I see.
Dr. Knouss [continuing]. Because we've migrated to some new
concepts. That was a concept maybe 5 years ago, 4 or 5 years
ago. But what had then been called a ``metropolitan medical
strike team'' has become now our four national medical response
teams, because they are the Federal teams, the civilian Federal
teams.
The metropolitan medical strike team concept at the city
level has become really a response system concept because we're
looking at not just a few people trained to respond; we're
looking at the entire capability of the cities' public safety,
public health, and health services communities to be able to
respond to one of these massive events. And so we're really
looking at this from a systems point of view, not a team point
of view.
Mr. Halloran. Yes.
Dr. Knouss. So we've migrated far beyond that original
concept that we held in 1996 and 1997.
Mr. Halloran. But do you have the same kind of attempt at
consistency and transparency with what they might acquire? I
mean, the question arises--I was reading through their--I guess
it is old now, but their field operations guide, and they give
fairly specific instructions about packaging and color coding
of what they bring, so is everybody bringing antibiotics to a
scene going to have them in red packages, or are they going to
open them up and figure out what's inside?
Dr. Knouss. No. I think we're trying to standardize that
now. One of the things that we're doing, for example, on our
chemical push packages, we're putting them in the same kind of
containers that CDC is using for its eight stockpiles. We are
giving diagrams to the cities and to the teams as to where in
each one of those containers they can find what chemicals. So
it's not just a matter of, ``Here's what's the content of the
stockpile,'' but here, in a three-dimensional diagram, is
where, in our material that we're sending out to you, you can
actually find each one of these products. So we're getting far
more specific and far more user friendly in what we're sending
out there so that we can--I mean, we're very sensitive to the
time issues. I'm not sure we've solved all the time problems,
but we're very sensitive to the fact about the sooner we can
respond the more lives we can potentially save.
Mr. Halloran. Yes.
Dr. Hughes. From the standpoint of CDC, let me ask Mr. Bice
to comment on that.
Mr. Bice. The standardization amongst the eight push-
packages is, as you can well imagine, very, very consistent. As
we go to standardize and mirror what locals have, we come
prepared to deliver in bulk and oftentimes locals will deliver
or have at their access smaller doses. They won't exactly look
alike, but the basic medications will be the same. They'll be
the same general medication types, so in that sense that's the
answer that we would give.
Mr. Halloran. Back to the chairman's question, once the
bulk push package arrives, who decides how to break it out and
disburse it?
Mr. Bice. We send a technical advisory response unit with
each of the push packages. They assist the locals on the scene
as for points of distribution, how much needs to be broken down
and for how many victims or potential victims.
Dr. Knouss. As we enter into our contracts, if I could just
add to that, at the local level we are trying to encourage
every metropolitan area that we're working with to develop a
specific distribution plan, both in terms of location, as to
where they would receive the material, and how they would
actually do points of distribution for the affected population.
That's a very extensive planning process and a lot is
dependent on what the organizational arrangements are at the
local level, as Mr. Bice was saying.
Mr. Halloran. Was Top Off the first time that the
biological scenario was exercised down to that level?
Dr. Knouss. I can't think of another time in which it was
done like that.
Mr. Halloran. OK. And then, finally, the GAO report
referenced 17,897 expired items in your inventory that you were
looking for FDA shelf life extensions on, so my question is: to
what extent do you believe your entire inventory could be
subject to that kind of extension activity? And do you
inventory systems, are they equipped to account for that?
You've put in shelf life. You've put in expiration date. DY
have--just reset the expiration date, or do you set the new
one, or is there a penultimate one? How do you track
extensions?
Dr. Knouss. I'm not sure exactly which particular products
they're referring to, but there are a variety of shelf life
requirements. Our involvement with FDA on the chemical
stockpiles has been really to identify and work with them to
look at whether or not any of the things that were temperature
damaged might be able to be kept, and we've made a decision,
because GAO is referring to the stockpiles in the midwest or
central locations, specifically, but we have made a decision
that we're just going to replace materials and we're not going
to look for a lot of shelf life extension.
For the CDC's stockpile, if I may just add, a lot of the--
as you saw in the report, is that there's actually a pre-
planned rotation to cut costs to the stockpile, and I think Mr.
Bice might want to describe specifically those activities.
We don't have the same luxury for the chemical stockpiles
because the products that we use, like atropine and pralodoxime
just do not have the same quantities used in the civilian
sector except in these kinds of dire circumstances, so there
isn't the opportunity for rotation and re-entry into the
commercial sector.
Mr. Bice might want to comment further.
Mr. Bice. Dr. Knouss, I'll just add that we are pioneering
a concept we call ``rotation in place.'' It is through our
private sector colleagues that we've learned that technique,
and we are applying it, and I believe you would have to agree
that it's successful since we are at least able to rotate
product currently.
There are products in all pharmaceutical stockpiles which
are not--that don't lend themselves to rotation or that, in the
sense of military-unique items, such as mark one auto
injectors, we work very closely with our DOD colleagues.
Actually, they pioneered the whole swapping out and extension
and working with the private manufacturer of those items to
reconstitute. While there's a new auto injector on the market
and some of this rotation will not be possible, we're looking
at all avenues to mitigate against actually having to destroy
product. I mean, that's the bottom line. That's the most
terrible thing that we could do. But in some cases,
unfortunately, that will probably be the case, but at very
minimal amounts.
Mr. Halloran. And, Colonel, on that same thing, you
mentioned the pharmaceutical return program. Could you
elaborate on that a little bit?
Colonel Hollifield. Yes, sir. The pharmaceutical return
program is a program that we just recently became aware of. Our
medical logistics company at Camp Lejeune has been using this
for some time now, and it has worked out very well. It is
basically a vendor-managed type program where the medical
supplies that you acquire through that vendor program, once
they reach a certain mark toward disposal and shelf life
expiration, can be returned and put back into the system. As a
result of that, the purchaser receives a credit, so you no
longer realize an opportunity to let the vendor do your
disposal action for you. As well, you realize some cost savings
in terms of reorder.
Mr. Halloran. And ATLASS-II can track and mark this kind of
early ship-back date?
Colonel Hollifield. Yes, sir, ATLASS-II+ should give us the
capability not only to look at what our current inventory is
but to see shipping status on replenishment supplies, as well.
Mr. Halloran. Thank you.
Mr. Shays. I thank you. I think we'll conclude here. I
would like to just say that it is obviously easy for us to look
at what all of you are doing from the outside and see ways that
you might be able to break through the system, and it may look
like we're kind of throwing stones here, but I feel the
responsibility of this committee is to look at all the
different parts in place and to just use our imagination to
see, you know, what has happened.
I always in my office put someone in charge of everything
so if something goes on we actually--someone knows if it goes
wrong it is really their responsibility. I see--I think our
committee could make a constructive role in trying to learn
from what you're telling us and see where there seems to be
some areas of concern.
The concern that I clearly have is that there won't be one
scene, one site, there will be many, and that I do see the
Federal Government needing to step in and maybe shutting down
the regions of the country until you all get a handle as to how
far the disease or the chemical agents have spread.
But I know that you all are working overtime to try to deal
with this issue, and I'm certain that you all realize that what
you're doing is for real and that some day you may be on CNN
responding to TV questions about how we're dealing with a
particular crisis, and hopefully we'll be able to feel like
we've done a good job.
Colonel, we want you to get on your way to your family.
Thank you again for being here. Thank all of you. Thank our
previous panel.
With the power vested in me, I'll close this hearing. Thank
you all.
Excuse me, I haven't hit the gavel yet. I do want to make
sure there's not a question we should have asked that you had
prepared for that needed to be asked, or something in the
course of this hearing that you think you need to make a
statement about? I'd welcome any of those who have accompanied
you if you want to.
[No response.]
Mr. Shays. It's a sincere invitation. Is there any last
comment from anyone?
[No response.]
Mr. Shays. OK. Well, with that we'll close the hearing.
Thank you.
Are you all set?
Dr. Hughes. Well, I was tempted. Prevention is key. CDC is
the Nation's prevention agency. But I think this discussion has
brought out the complexity of dealing with the--some of these
scenarios, so prevention is key and, absent prevention, early
rapid recognition and response is absolutely critical.
Mr. Shays. It sure is.
Thank you very much. This hearing is adjourned.
[Whereupon, at 3:55 p.m., the subcommittee was adjourned,
to reconvene at the call of the Chair.]