[House Hearing, 107 Congress]
[From the U.S. Government Printing Office]




                               before the


                                 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

75-956                     WASHINGTON : 2001

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                     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
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
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
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 

                CHRISTOPHER SHAYS, Connecticut, Chairman
ADAM H. PUTNAM, Florida              DENNIS J. KUCINICH, Ohio
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          ------ ------

                               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

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



                          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 
    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 
    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.

                   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 
    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 
    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 
    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 
    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 
    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 
    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 




    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.

                       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 
    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 
    Mr. Putnam. Thank you very much. We appreciate your 
    [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 
    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 
    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 
    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. 
    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 
    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 
    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, 
    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 
    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 
    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 
    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 
    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 
    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. 
    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 
    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 
    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 
    Mr. Shays. Mr. Chairman, I'll come back. Thank you for your 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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. 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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.]