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75–956 PDF 2001

COMBATING TERRORISM: MANAGEMENT OF

MEDICAL SUPPLIES

HEARING

BEFORE THE

SUBCOMMITTEE ON NATIONAL SECURITY,

VETERANS AFFAIRS AND INTERNATIONAL

RELATIONS

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SEVENTH CONGRESS

FIRST SESSION

MAY 1, 2001

Serial No. 107–17

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

BOB BARR, Georgia

DAN MILLER, Florida

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

DAVE WELDON, Florida

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

C.L. ‘‘BUTCH’’ OTTER, Idaho

EDWARD L. SCHROCK, Virginia

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

JANICE D. SCHAKOWSKY, Illinois

WM. LACY CLAY, Missouri

——— ———

——— ———

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

JAMES C. WILSON, Chief Counsel

ROBERT A. BRIGGS, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS AND INTERNATIONAL

RELATIONS

CHRISTOPHER SHAYS, Connecticut, Chairman

ADAM H. PUTNAM, Florida

BENJAMIN A. GILMAN, New York

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEVEN C. LATOURETTE, Ohio

RON LEWIS, Kentucky

TODD RUSSELL PLATTS, Pennsylvania

DAVE WELDON, Florida

C.L. ‘‘BUTCH’’ OTTER, Idaho

EDWARD L. SCHROCK, Virginia

DENNIS J. KUCINICH, Ohio

BERNARD SANDERS, Vermont

THOMAS H. ALLEN, Maine

TOM LANTOS, California

JOHN F. TIERNEY, Massachusetts

JANICE D. SCHAKOWSKY, Illinois

WM. LACY CLAY, Missouri

——— ———

——— ———

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

(III)

C O N T E N T S

Page

Hearing held on May 1, 2001 ................................................................................. 1

Statement of:

Calbom, Linda M., Director, Financial Management and Assurance, General Accounting Office, accompanied by Alana B. Stanfield, Assistant

Director, Financial Management and Assurance; and Louise Beck ......... 3

Mather, Susan, Chief, Public Health and Environmental Hazards Office,

Department of Veterans Affairs, accompanied by John Ogden, Chief

Consultant, Pharmacy Benefits Management Strategic Health Group;

and Kristi L. Koenig, Chief Consultant, Emergency Management Strategic Healthcare Group; Robert F. Knouss, Director, Office of Emergency Preparedness, Public Health Service, Department of Health and

Human Services, accompanied by Mark Gnitzke, Chief Pharmacist;

and Terry Wagner, Finance Officer; James M. Hughes, Director, National Center for Infectious Diseases, Centers for Disease Control and

Prevention, accompanied by Steven D. Bice, Director, National Pharmaceutical Stockpile Program, National Center for Environmental Health;

and Colonel Carlos R. Hollifield, Commanding Officer, Chemical Biological Incident Response Force [CBIRF], U.S. Marine Corps, Department of Defense, accompanied by Commander Corley Puckett, Second

Marine Expeditionary Force Sergeant’s Office ........................................... 29

Letters, statements, etc., submitted for the record by:

Calbom, Linda M., Director, Financial Management and Assurance, General Accounting Office, prepared statement of ........................................... 6

Hollifield, Colonel Carlos R., Commanding Officer, Chemical Biological

Incident Response Force [CBIRF], U.S. Marine Corps, Department of

Defense, prepared statement of ................................................................... 62

Hughes, James M., Director, National Center for Infectious Diseases,

Centers for Disease Control and Prevention, prepared statement of ....... 47

Knouss, Robert F., Director, Office of Emergency Preparedness, Public

Health Service, Department of Health and Human Services, prepared

statement of ................................................................................................... 40

Kucinich, Hon. Dennis J., a Representative in Congress from the State

of Ohio, prepared statement of .................................................................... 26

Mather, Susan, Chief, Public Health and Environmental Hazards Office,

Department of Veterans Affairs, prepared statement of ........................... 32

Shays, Hon. Christopher, a Representative in Congress from the State

of Connecticut, prepared statement of ........................................................ 23

(1)

COMBATING TERRORISM: MANAGEMENT OF

MEDICAL SUPPLIES

TUESDAY, MAY 1, 2001

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS

AFFAIRS AND INTERNATIONAL RELATIONS, COMMITTEE ON GOVERNMENT REFORM, Washington, DC.

The subcommittee met, pursuant to notice, at 2 p.m., in room

2247, Rayburn House Office Building, Hon. Adam Putnam (acting

chairman of the subcommittee) presiding.

Present: Representatives Putnam, Kucinich, Platts, Shays, and

Tierney.

Staff present: Lawrence J. Halloran, staff director and counsel;

Kristine McElroy, professional staff member; Alex Moore, fellow;

Jason M. Chung, clerk; Michael Yang, minority counsel; and Teresa

Coufal, minority staff assistant.

Mr. PUTNAM. The Subcommittee on National Security, Veterans

Affairs and International Relations hearing entitled, ‘‘Combatting

Terrorism: Management of Medical Supplies’’ is called to order.

Welcome, Congressman Platts. Thank you for being here. I know

that your constituents have a major issue going on upstairs.

I’ll begin with the opening statement, standing in for Chairman

Shays.

In the event of mass casualties inflicted through the use of chemical, biological, or radiological weapons, State and local public

health officials will need help. They will look for timely access to

Federal stockpiles of the antidotes, antibiotics, and vaccines necessary to save lives. Will those critical medicines get there in time?

Last year we could not be certain. Weak internal controls, lax security, and sloppy inventory management practices increased the

risks of stockpiling the wrong medicines, expired medicines, or not

enough of the medicines needed to meet the consequences of a terrorist attack.

Today the General Accounting Office releases a report requested

by this subcommittee on steps taken to address those weaknesses.

According to GAO, the Department of Health and Human Services’ Office of Emergency Preparedness and the Centers for Disease

Control and Prevention have made substantial improvements in

both purchasing and stockpile management practices. As a partner

with OEP and CDC, the Department of Veterans Affairs has simplified stockpile storage.

The Marine Corps’ Chemical Biological Incident Response Force

has formalized its medical equipment list and upgraded inventory

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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.

3

STATEMENT OF LINDA M. CALBOM, DIRECTOR, FINANCIAL

MANAGEMENT AND ASSURANCE, GENERAL ACCOUNTING

OFFICE, ACCOMPANIED BY ALANA B. STANFIELD, ASSISTANT DIRECTOR, FINANCIAL MANAGEMENT AND ASSURANCE;

AND LOUISE BECK

Ms. CALBOM. Mr. Chairman, I am pleased to be here today to

discuss the status of agencies’ actions taken to establish effective

internal control over the Federal medical stockpiles that can be

used to treat victims of a chemical or biological terrorist attack.

We originally testified before this subcommittee in March of last

year on the need to establish effective control over the stockpiles,

which was also the subject of a report that we issued in October

1999. That work resulted in several initiatives by the Office of

Emergency Preparedness, the Centers for Disease Control and Prevention, and the Department of Veterans Affairs, as well as the

Marine Corps’ Chemical Biological Incident Response Force that I’ll

refer to as CBIRF.

The responsibility areas for each of these agencies are actually

shown on this chart, which I know is also hard to see, but it is also

an attachment to my written testimony, which is in your folder. It’s

the last page of the testimony.

Today I will focus on responding to the committee’s request that

we followup on the status of corrective actions taken by the responsible agencies to address the recommendations in our prior report.

A detailed discussion of our findings is included in our report that

is being issued here today. I would like to just spend a few minutes

talking about the issues that we came up with in that followup review.

The first area of followup had to do with risk assessments. In the

October 1999 report we reported that neither OEP, VA, nor CBIRF

had determined the risk that faced their stockpiles, assessed the

likelihood of each risk’s occurrence, and established plans to detect

and mitigate the risk.

Since our last review, each agency has prepared a risk assessment. In fact, CBIRF not only completed a risk assessment, it also

implemented controls to mitigate the risks identified in that assessment.

However, for CDC and OEP we found instances where the risk

assessments were not sufficiently comprehensive or where actions

identified to mitigate the risks had not been fully implemented. For

example, neither agency had addressed all of the risks posed by

delegating key storage, management, and transport responsibilities

to other entities.

The next area we looked at was inventory accuracy. Our prior reviews showed large discrepancies between the data recorded in

CBIFR’s and OEP’s inventory systems and the actual physical

counts of their inventories. In our most recent review, we noted

that, while some discrepancies did still exist, the accuracy of both

CBIRF and OEP inventory records had improved significantly.

However, we found that OEP lacks certain detailed written inventory procedures necessary to help ensure the overall reliability of

their inventory records.

In addition, while we found that CBIRF had developed an inventory requirements list, which they didn’t have at the time of our

4

last review, it did not have on hand all the items included in the

list.

We also found that OEP had not updated its requirements list

to reflect changes to the composition of its stockpile.

And, finally, we found that, while CDC had established requirements list for its national pharmaceutical stockpile, the requirements were not completely filled by the end of our field work.

The next area we followed up on was inventory tracking systems.

We previously reported that the responsible agencies’ inventory

systems did not adequately track inventory items, and we recommended that they implement tracking systems that retain complete documentation for all supplies they have ordered, received,

and destroyed.

The current inventory systems used by OEP, VA, CDC, and

CBIRF still lack certain fundamental information which impedes

their ability to comprehensively track their pharmaceutical and

medical supplies; however, each agency is currently in the process

of replacing its current system with one that is expected to be able

to track medical supplies from the time an order is placed until the

time it is consumed or otherwise disposed of.

The last area we looked at was rotation. We previously reported

that the agencies’ inventories included items that had expired but

not been replaced, and therefore we recommended that they properly rotate these supplies. In response to our report, we found that

all of the agencies have developed policies and procedures related

to rotating stock in their inventories; however, in some cases

planned approaches were not completely implemented. For example, during our October 2000, counts at CBIRF we found 161 medical supply items had expired but not been replaced.

In addition, at the time of our review CDC had not finalized

agreements with a private sector partner to implement a cost-saving strategy to rotate soon-to-expire pharmaceuticals into the commercial marketplace and replace them with fresh stock.

Just to sum up, in completing our most recent work, we did find

that all of the agencies have made significant progress toward implementing our October 1999, recommendations. Management in

each of the agencies has given priority to and placed emphasis on

strengthening internal control over the stockpiles. As a result, corrective actions have reduced inventory discrepancy rates and improved accountability.

At the same time, we found that, in all of the areas associated

with our prior recommendations, additional steps should be taken

to ensure that the medical and pharmaceutical supplies are current, accounted for, and readily available for use.

Our current report includes several additional recommendations

to address these issues. We do understand that since the completion of our review some actions have been taken by the agencies

in response to our recent findings.

That concludes my statement, Mr. Chairman. We’d be happy to

answer any questions at this time.

5

Mr. PUTNAM. Thank you very much.

[NOTE.—The GAO report entitled, ‘‘Combating Terrorism, Accountability Over Medical Supplies Needs Further Improvement,’’ GAO–01–463, may be found in subcommittee files.]

[The prepared statement of Ms. Calbom follows:]

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Mr. PUTNAM. To what extent have the agencies responded to the

13 new recommendations?

Ms. CALBOM. They’ve done actually quite a bit already. In the

course of our review I think, you know, they were aware of our

findings as we came across them. They have put into place some

of the agreements with third parties that we talk about in our report. For instance, I know OEP has completed its agreements with

VA. I believe that CDC has completed a lot of its agreements with

its wholesale distributor. There are still a couple areas where we

have concerns. For instance, CDC has not completed all of its

agreements, or at least last that we knew of, with some of its carriers to ensure proper transport of these supplies, which we think

is very important.

I’ll ask Ms. Stanfield if she’d like to add on to some of the areas

that perhaps improvements have been made.

Ms. STANFIELD. Actually, a couple areas where the recommendations are still open—as you know, in our report we talk about one

of the locations, the central location at OEP, where the goods were

stored at temperatures at 95 degrees or above, and also at that

same location there were security issues. There was not an alarm

on the cage.

And, as we understand it, they do plan to move that cache to a

new location some time. They had originally planned to move it in

April, but they will be moving that in the May/June timeframe instead. So that’s one area that is open.

We are particularly, on the positive side, pleased with the improvements in the inventory discrepancy rates, and those have improved.

At CBIRF the one open recommendation, which I’m sure they

will discuss, too, is the fact that there is a new authorized medical

allowance list, and we have recommended that they stock up to

that list, and they have not yet done so, but they will probably provide you some updates on that.

Mr. PUTNAM. Is there a single inventory management system

that CBIRF and the other agencies are using so that there is some

uniformity to the categorization and cataloging of the pharmaceuticals?

Ms. CALBOM. Well, Mr. Chairman, all three of the agencies are

working on getting the inventory systems in place. CDC is taking

the lead as far as the HHS side of things, and I believe their system is due to be in place in May or June, which I’m sure they’ll

update us on. That same system will be used by OEP, and then

CBIRF has its own system that it is putting in place, and I believe

we were just told that may be delayed until September.

Mr. PUTNAM. So everybody is on the same page then except

CBIRF?

Ms. CALBOM. Yes. And, of course, CBIRF is a little bit different,

you know. Their inventory is really more of a self-contained inventory. Their mission is a bit different. They really aren’t in the business of having in place a stockpile to treat the masses, as OEP and

CDC are. CBIRF’s stockpile is really more or less to treat their own

troops or civilians that happen to be in the area where they are

carrying out their mission.

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Mr. PUTNAM. Would you elaborate a little bit on the difficulty

that they’ve had in making arrangements with transport and mobilization contractors? You know, contemplating the scenario where

we would need to have those arrangements in place, who is the

ideal subcontractor to deliver that kind of a supply, enter that kind

of a hot zone? What avenues have been explored? What current arrangements are in place as it relates to that?

Ms. CALBOM. I guess, as far as who is the ideal person, I don’t

know that we can answer that. That’s not something that we’ve

really done an assessment of. But Alana may want to expand on

what kind of arrangements are currently in place.

Ms. STANFIELD. Currently they do have arrangements with two

transport companies. They are interim arrangements. Those, as of

the end of our field work, though, had not been finalized, but they

do have arrangements with two transport companies that are very

well known.

Mr. PUTNAM. And, finally, the mobile stockpile that is available

for special events such as the Olympics, what other instances or

gatherings are appropriate uses for the mobilization of that stockpile? And is that limited to the United States or is that international events abroad, as well?

Ms. STANFIELD. Another example of an event would be like the

inauguration. I believe it is just for domestic events, but you might

want to check with them just to make sure.

Mr. PUTNAM. OK.

Ms. STANFIELD. But I’m pretty sure it is just for domestic.

Mr. PUTNAM. We welcome Chairman Shays.

Mr. SHAYS. Thank you, Mr. Chairman. I’m very apologetic to

have missed the testimony of the first panel.

I have no questions. I just want to say that I lost a good friend

of mine, Barbara Bate, and her husband was a State legislator, and

we got elected in 1974, and I just learned about it today, so I wanted to make sure I went to see him back in Connecticut, but I will

be ready for the next panel.

I thank you very much.

[The prepared statement of Hon. Christopher Shays follows:]

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Mr. PUTNAM. Thank you, Mr. Chairman.

And that concludes the questions for the first panel. We appreciate your hard work and diligence on this issue, and we look forward to hearing from panel two.

Ms. CALBOM. Thank you.

Mr. PUTNAM. Thank you.

While we’re setting up for the second panel, I ask unanimous

consent that all members of the subcommittee be permitted to

place any opening statement into the record and that the record remain open for 3 days for that purpose.

Without objection, so ordered.

[The prepared statement of Hon. Dennis J. Kucinich follows:]

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Mr. PUTNAM. I ask further unanimous consent that all witnesses

be permitted to include their written statements in the record.

Without objection, so ordered.

Pursuant to House rules and committee rules I note for the

record that the subcommittee requested and all witnesses appearing at this hearing in a non-governmental capacity have provided

a resume and a disclosure of Federal grants and contractor receipt.

With that, we welcome the second panel: Dr. Susan Mather, Dr.

Robert Knouss, Dr. James Hughes, Mr. Steven Bice, and Colonel

Carlos Hollifield.

If you would, please stand, raise your right hands, and any other

persons accompanying the witnesses who may be called upon to answer a question, please stand and raise your right hand.

[Witnesses sworn.]

Mr. PUTNAM. Note for the record that the witnesses responded in

the affirmative.

Mr. SHAYS. I’d just like to note, Mr. Chairman, I was going

through withdraw. When you stood up, I felt I should have stood

up, as well. [Laughter.]

Mr. PUTNAM. With that, Dr. Susan Mather, if you would please

begin with your testimony. Welcome to the committee.

STATEMENT OF SUSAN MATHER, CHIEF, PUBLIC HEALTH AND

ENVIRONMENTAL HAZARDS OFFICE, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY JOHN OGDEN, CHIEF

CONSULTANT, PHARMACY BENEFITS MANAGEMENT STRATEGIC HEALTH GROUP; AND KRISTI L. KOENIG, CHIEF CONSULTANT, EMERGENCY MANAGEMENT STRATEGIC

HEALTHCARE GROUP; ROBERT F. KNOUSS, DIRECTOR, OFFICE OF EMERGENCY PREPAREDNESS, PUBLIC HEALTH

SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES,

ACCOMPANIED BY MARK GNITZKE, CHIEF PHARMACIST;

AND TERRY WAGNER, FINANCE OFFICER; JAMES M.

HUGHES, DIRECTOR, NATIONAL CENTER FOR INFECTIOUS

DISEASES, CENTERS FOR DISEASE CONTROL AND PREVENTION, ACCOMPANIED BY STEVEN D. BICE, DIRECTOR, NATIONAL PHARMACEUTICAL STOCKPILE PROGRAM, NATIONAL CENTER FOR ENVIRONMENTAL HEALTH; AND COLONEL CARLOS R. HOLLIFIELD, COMMANDING OFFICER,

CHEMICAL BIOLOGICAL INCIDENT RESPONSE FORCE

[CBIRF], U.S. MARINE CORPS, DEPARTMENT OF DEFENSE,

ACCOMPANIED BY COMMANDER CORLEY PUCKETT, SECOND

MARINE EXPEDITIONARY FORCE SERGEANT’S OFFICE

Dr. MATHER. Thank you, Mr. Chairman and members of the subcommittee. I am pleased to have this opportunity to address the

significant progress that VA has made in response to GAO’s October 1999, report concerning management of chemical and biological

medical supplies.

I am accompanied by Dr. Kristi Koenig, chief consultant of the

Emergency Management Strategic Healthcare Group [MSHG], and

Mr. John Ogden, chief consultant of the Pharmacy Benefits Management strategic Health Group.

VA is a partner with HHS’ Office of Emergency Preparedness in

assuring the availability of medical supplies that may be needed by

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the national medical response teams to treat victims where weapons of mass destruction have been used.

OEP officials determine the contents of the inventories; provide

funding for the procurement, maintenance, and deployment of the

medical supplies; and determine the location of the stockpiles at

sites across the United States.

The partnership between OEP and VA began late in 1995 and

evolved to a formal interagency agreement in April 1997. MSHG

has overall VA responsibility for emergency management activities

while VA’s emergency pharmacy service is directly responsible for

managing the pharmaceutical and medical supply stockpiles and

works in coordination with MSHG.

I am pleased to describe VA’s actions to address each of the four

recommendations from the 1999 GAO report.

First, GAO recommended that all the agencies, including VA, establish sufficient systems of internal control over management of

their chemical and biological stockpiles so that the stockpiles could

be provided, as planned.

To implement this recommendation, OEP contracted with Logistics Management Institute to evaluate the program, conduct a risk

assessment, and advise us on areas for improvement. MLI reviewed

the program from April to August 2000, and reported their findings

to EOP in December 2000.

Concurrently, the Emergency Pharmacy Service implemented numerous improvements to simplify the inventory process, refine the

inventory data base, improve cache security, color code all inventory categories, monitor storage temperatures, and improve inventory results. LMI noted many of these improvements in their reports and recommended adding an inventory management system

with bar codes. OEP has selected a computer package that will be

implemented during the summer of 2001.

Second, GAO recommended that the agencies arrange for periodic independent inventories of the stockpiles. The results of each

inventory showed improvement over the previous, including a less

than 1 percent discrepancy rate from the November inventory. Inventories will be continuing in 2001.

Third, GAO recommended that VA implement a tracking system

that retains complete documentation for all supplies that have been

ordered, received, or destroyed. In January 2000, VA began using

an enhanced inventory management system. The resulting data

base was verified during the April 2000, inventories. LMI reviewed

this inventory management system and recommended that it be replaced by a commercial system that would provide additional enhancements. OEP decided we would use the same inventory management system CDC selected for use with the national pharmaceutical stockpile, and training will begin this month.

Fourth, GAO recommended that supplies be rotated properly,

and this is now being done. The current inventory management

system allows for the necessary planning for ordering, receiving,

shipping, and rotating stock at each location on a timely basis. No

outdated drugs or supplies were found in the caches at the August

and November 2000, inventories. The new inventory management

system should enhance this capability.

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Mr. Chairman, I would like to close with a description of additional actions taken since the testimony provided you in March

2000.

First, GAO conducted a followup review of this program from August to November 2000. The draft report of this visit indicates that

GAO was pleased with the progress VA has made.

Second, VA moved the one cache that was stored outside VA control into a VA warehouse location. Both LMI and GAO have favorably reviewed this site.

Third, VA placed refrigerator units with a self-contained battery

pack at all sites that will maintain refrigeration of stockpile when

deployed or when there is a power failure.

Fourth, VA replaced all products at the central—will replace all

products at the central cache that may be heat sensitive as soon

as the cache is moved to the new storage location. The new storage

location has been selected. Plans have been approved for the necessary construction, and the contractor has been chosen. The move

is currently targeted for June 2001.

Fifth, an update to the 2000 MOA between OEP and VA further

defining expectations and responsibilities has been developed and

is in the clearance process with MVA.

Sixth, VA initiated an internal risk assessment group, including

members with financial security, emergency management, and risk

assessment expertise. The group is charged with conducting a new

risk assessment and reporting findings to VA officials and ultimately OEP later this year.

Seventh, to improve security at each cache, installation of locking

devices at the access point is underway. These devices will record

date, time, and the individual gaining access.

Eight and finally, all the caches were successfully deployed and

then returned to storage.

Mr. Chairman, the management of the emergency supplies has

greatly improved since the first GAO review. We appreciate the

benefits of GAO’s work on the Congress’ behalf. Should incidents

involving the use of weapons of mass destruction occur, we are prepared to meet our responsibilities as part of the Nation’s readiness

capability.

Dr. Koenig, Mr. Ogden, and I would be happy to respond to questions.

Mr. PUTNAM. Thank you very much. We appreciate your testimony.

[The prepared statement of Dr. Mather follows:]

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Mr. PUTNAM. Dr. Robert Knouss, Director, Office of Emergency

Preparedness, Department of Health and Human Services, welcome to the committee. You are recognized.

Dr. KNOUSS. Thank you very much, Mr. Chairman. It is a pleasure to be able to be back here again testifying about these programs.

I’m also accompanied today by my chief pharmacist, Mark

Gnitzke, and my finance officer, Terry Wagner.

I appeared here last year before the committee to discuss the

original GAO report about our specialized pharmaceutical caches,

and I’m pleased to be back here again to be able to discuss with

you the improvements that have been made since those initial

hearings.

These pharmaceutical stockpiles were designed to be deployed

with our NMRTs, or national medical response teams, in responding to a weapon of mass destruction event and providing medical

care to its victims.

Three of the teams—one on the West Coast, one in the central

part of the country, and one on the East Coast—can be deployed

anywhere in the country. The middle Atlantic team is committed

to responding to incidents in Washington, DC, including the U.S.

Capitol, and I would just like to mention that it is pre-positioned

here when we have the State of the Union event or the inauguration or other major events here at the capital.

The stockpiles associated with each of these four teams contains

specialized pharmaceuticals to treat up to 5,000 victims of a chemical exposure to nerve agents such as sarin and VX, to vesicants

such as mustard gas, and to pulmonary agents such as phosgene.

In addition, each stockpile has medicines to provide the initial care

at the scene for these victims, stabilizing them medically until they

arrive at a health care facility.

In the original report on the status of the stockpiles, GAO raised

concerns about the manner in which the caches were managed and

the oversight provided by OEP.

We have appreciated GAO’s comments, suggestions, and insights,

and have been working diligently with the VA to correct problems,

improve internal controls, and tighten our management practices.

We have made a great deal of progress in these areas. We’ve ensured appropriate storage and physical security of the stockpiles;

strengthened internal controls, including 100 percent inventories of

all the caches, as well as independent reviews; established regular

communications with the VA; conducted risk assessments; ensured

regular and recurring management oversight; approved operational

plans for each location; and ensured that an improved, updated inventory requirement list is maintained.

However, we still have a number of things to do. GAO recently

completed its final report on the stockpiles, and we appreciate that

they noted the significant progress that we’ve made to bring these

caches into compliance with all the regulations and appropriate internal control procedures.

In its recently released report, GAO commented on some of the

progress that still needed to be made and made some additional

recommendations to OEP. At this time I’d like to address these recommendations and discuss what we still are doing to complete the

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activities, to ensure the stockpiles meet all requirements, and to be

able to deploy them in a timely and effective response.

Within the next month or two, we’ll be moving our central cache

to a new location in order to ensure that appropriate physical security and safeguards are in place, as well as to ensure that temperature controls are maintained. This action will mitigate problems

that have occurred at the current location, with some of the cache

being exposed to higher-than-acceptable temperatures.

We do not believe that the observed temperature fluctuation degraded the effectiveness of the pharmaceuticals; however, we will

be replacing all of the affected drugs when the cache is moved.

While the GAO report notes that the items that were exposed to

the higher temperature may not be effective in the event of a terrorist incident, we’d note that we have three other caches that can

be moved, if necessary.

GAO noted that OEP lacked detailed, written inventory procedures necessary to help ensure overall reliability of inventory

records. They also said that OEP had not updated its requirements

list for significant increases to its stockpile. Both of these issues

have subsequently been addressed and detailed inventory procedures and operating plans have been approved for each cache location, and detail requirement lists have been updated and transmitted to the VA.

GAO also stated that there were no published discrepancy rates,

and that in the absence of this information there were no data with

which to measure the inventory results. Error rates have been discussed with the VA. We have a zero tolerance error rate for controlled substance and an error rate of 3 to 5 percent for low-cost

items.

Finally, GAO expressed concern about the lack of training for VA

personnel involved in stockpile management, and later this month

we will be bringing VA personnel, in addition to other public service teams, to the Noble Training Center in Anniston, AL, to conduct training in conjunction with CDC. We will be providing Oracle

software training to VA staff for managing cache inventories, and

we recently provided HAZMAT training for their staff at the

NDMS conference that was held in Dallas.

Mr. Chairman, OEP has been working diligently to ensure that

all internal control procedures are met, that the stockpiles are current and adequately safeguarded, and that we can deploy them

quickly. It is my sincere hope that these stockpiles will never have

to be used, but we will continue to assure our readiness to respond,

if necessary.

That, sir, concludes my prepared remarks, and I obviously would

be pleased to answer any questions you may have.

Mr. PUTNAM. Thank you very much, sir.

[The prepared statement of Dr. Knouss follows:]

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Mr. PUTNAM. We now look forward to hearing from Dr. James

Hughes, the Director of the National Center for Infectious Diseases, Centers for Disease Control and Prevention, Department of

Health and Human Services.

Never a dull moment in your line of work, is there?

Dr. HUGHES. That’s true, sir.

Mr. PUTNAM. Welcome to the committee.

Dr. HUGHES. Thank you very much, Mr. Chairman. Good afternoon.

I am accompanied by Mr. Steven Bice, Director of CDC’s National Pharmaceutical Stockpile Program in our National Center

for Environmental Health.

CDC appreciates the opportunity to discuss the national pharmaceutical stockpile, one component of our overall public health response to the threat of bioterrorism.

CDC provides leadership to detect, diagnose, respond to, and prevent illnesses, including those resulting from bioterrorism. In 1998

we issued ‘‘Preventing Emerging Infectious Diseases: A Strategy for

the 21st Century,’’ our plan to prevent emerging diseases. This

plan emphasizes the need to be prepared for the unexpected,

whether it be a naturally occurring influenza pandemic or the deliberate release of anthrax spores by a terrorist.

CDC is continuing to build on these efforts. One example is the

public health strategy that we are developing with our partners to

define priorities to prepare the country to respond to bioterrorism.

We have moved aggressively in multiple areas, including preparedness planning, laboratory diagnostics, strengthened surveillance

and epidemiologic investigative capacity, and enhanced communications.

Another integral component of public health preparedness has

been developing a national pharmaceutical stockpile or NPS which

can be mobilized in response to an episode caused by a biological

or chemical agent.

The goal of CDC’s NPS is to ensure the availability of lifesaving

pharmaceuticals and medical supplies for delivery to the site of a

biological or chemical terrorism event.

The NPS has two basic components: eight pre-assembled sets of

supplies called ‘‘12-hour push packages’’ that can be delivered to

the scene of a terrorism event within 12 hours of activation; and

vendor-managed inventory, which consists of additional pharmaceuticals and supplies that can be tailored to a specific threat agent

and will arrive at the scene within 24 to 36 hours after activation.

CDC provides guidance and oversight of all aspects of the NPS.

We have chosen the Department of Veterans Affairs National Acquisition Center as our acquisition partner. An electronic inventory

management system has been purchased and will allow for efficient

and accurate inventory tracking, ordering, receipt, and scheduled

rotation of stock. We have instituted a rigorous quality assurance

program to ensure the integrity of the NPS.

I will now comment briefly on the GAO report released today,

specifically on its recommendations pertaining to CDC.

We very much appreciate GAO’s ongoing contributions to assure

that the NPS functions to protect the American people. First, GAO

recommends executing written agreements with all NPS program

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partners covering storage, management, stock rotation, and transportation. We have final written agreements with our principal

commercial partners for storage and rotation, and interim agreements with our transportation partners.

Our partners in storage sites were selected based on their known

good business practices, security measures, and procedural methods for handling large pharmaceutical and supply inventories.

These strengths enable the NPS to ensure the integrity of the inventory and to maintain readiness.

GAO’s second recommendation to CDC is to issue written security guidance to private storage warehouses. Each NPS storage

partner has procedures in place to admit only authorized individuals to the facilities. We are updating the standard operating procedures to include controlled access to NPS inventory and guidelines for stock rotation. The first quantity of stock has been successfully rotated.

Finally, GAO recommends installing proper fencing to physically

secure the NPS inventory. Although fencing does provide an additional level of security, it was also intended to separate NPS assets

from other materials within a larger warehouse.

The facilities chosen to store the push packages are bonded, licensed by the Food and Drug Administration, or approved by the

Drug Enforcement Administration and operate under strict security controls to ensure the environmental and physical safety of

pharmaceuticals. Fencing has been installed at all locations for

which it was intended.

In summary, the NPS involves direct coordination and management by CDC staff, ongoing monitoring, quality assurance, and

evaluation, and collaboration with partners.

Through our NPS program, we will continue to ensure the rapid

availability of life-saving pharmaceuticals and medical supplies to

the Nation in the event of a biological or chemical terrorism incident.

Mr. Chairman, this concludes my testimony. Mr. Bice and I will

be happy to answer any questions you or members of the subcommittee may have.

Mr. PUTNAM. Thank you very much, Dr. Hughes.

[The prepared statement of Dr. Hughes follows:]

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Mr. PUTNAM. The committee also welcomes Colonel Carlos

Hollifield, Commanding Officer, Chemical Biological Incident Response Force, U.S. Marine Corps. Welcome. You are recognized.

Colonel HOLLIFIELD. Thank you. Good afternoon, Mr. Chairman.

With me today is Commander Corley Puckett from the Second

Marine Expeditionary Force Sergeant’s Office, which is my higher

headquarters. I’m honored to again have the privilege to appear before this subcommittee and want to be thankful for the opportunity

to update you on the actions that we’ve taken to improve internal

control over the medical supply working stocks that we hold in the

Marine Corps’ Chemical Biological Incident Response Force.

You invited me here today simply to talk about the management

of our medical supplies, and I’m pleased to tell you that the status

of our medical supply count has vastly improved since I last appeared before this subcommittee. We pursued multiple courses of

action, and significant progress has been made, resulting in a

stronger internal control environment.

I’d like to highlight the key actions that we’ve taken, specifically

as they pertain to the two recommendations in the recent GAO

followon report.

When GAO visited my unit in 1999, we had a fundamental problem—that the unit had no authorized medical allowance list of

those items it was authorized to hold and maintain. Specifically, we

refer to this as an authorized medical allowance list [AMAL]. None

had ever been developed or approved for a chemical or biological

unit such as the CBIRF. This resulted in the absence of a basic

foundation upon which to establish fundamental internal control

procedures and to gauge the effectiveness of inventory management

practices.

We’ve worked diligently to fix this problem. As an interim measure, we developed an internal allowance list of the medical supplies

that were necessary to meet our unit’s mission. Concurrently, we

requested that a CBIRF-specific authorized medical allowance list

be developed and approved, and today I’m proud to report that

problem is nearing resolution as the Navy Medical Logistics Command published a chemical biological authorized medical allowance

list for my unit in October 2000.

The Marine Corps Systems Command, in its capacity as the program manager for medical material within the Marine Corps, has

finalized the configuration of those AMAL contents, and we will

work with the Marine Corps Systems Command to acquire the necessary supplies to bring my working stock into compliance with the

recently approved AMAL standards.

The filling of the standardized AMAL will provide a solid basis

for accountability, as well as inventory control of medical supplies,

and will permit me to be able to fully comply with GAO’s first recommendation made as a result of their October 2000, visit.

Inventory discrepancies were further reduced in my organization

from 26 percent in 1999 to 10 percent during the recent October

visit. In this 14-month period, this represents a 16 percent reduction in inventory variance rates. My supply personnel since October

have researched all inventory discrepancies noted by the GAO during their October count, and all accounting records were adjusted

in January 2001.

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The upcoming implementation of a new supply management data

base will enhance asset visibility and improve our ability to minimize inventory discrepancies. The Marine Corps is currently filling

an upgrade to the asset tracking for logistics and supply system

[ATLASS], an automated supply management data base. This upgrade, known as ATLASS-II+ will improve CBIRF’s ability to do inventory management, as well as enable us to overcome existing

data base shortfalls which the GAO has highlighted.

I’m pleased to report that implementation of ATLASS-II+ is currently underway, having commenced yesterday, and will be completed late this summer. This will permit all CBIRF medical supplies and my working stock to be entered into the ATLASS-II+ data

base not later than the commencement of the new fiscal year on

October 1st.

GAO noted that during their October 2000, counts they identified

161 expired items on hand. This number of expired items represents less than 1 percent of the working stock of medical supplies

that my unit maintains. All expired items had been clearly identified, were labeled as being expired, and were segregated from active medical supplies prior to GAO’s inventory in October in order

to preclude their reissuance. These expired items were pending disposal at the time of GAO’s visit.

As you may be aware, CBIRF executed a significant undertaking

during the period between the two GAO visits. From May through

August 2000, the entire unit relocated from Camp Lejeune, NC, to

Indian Head, MD. Accordingly, procedures for the exposure of expired medications at our new location had not been finalized when

the GAO visited in October 2000. The expired items noted by the

GAO were reviewed to ensure that none were subject to shelf life

extensions, and all disposal actions were completed in December

2000.

To better manage disposal actions in the future, we are currently

evaluating the feasibility of disposing the expired medications

through the use of a pharmaceutical return program. This program

may offer me the ability to dispose of expired medications in a

more timely and cost-effective manner.

Implementation of the ATLASS-II+ upgrade, use of the pharmaceutical return program, and acquisition of those necessary items

to bring my working stock up to the levels of the AMAL approval

standards will all strengthen internal management within my medical supply block that I hold.

These actions will also ensure that we fully comply with both the

recommendations and the GAO’s recent followon report.

In addition to these key areas, we have taken many other measures to help VA’s strong internal control environment. I have provided details on these in my statement for the record.

All recommendations made by the General Accounting Office as

a result of their visits to my unit have been fully acted upon, and

I believe the resulting measures have yielded positive results; however, I would be extremely remiss if I did not point out that the

progress that we have achieved to date is a direct result of the

dedication and professionalism of the young enlisted marines and

sailors that I’m blessed to lead.

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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?

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Is it—just describe to me how we should view chemical versus biological. I throw it open to the floor, whoever.

Dr. HUGHES. Well, perhaps I can begin with it.

Mr. PUTNAM. Sure.

Dr. HUGHES. I’m sure the others will want to add.

For a biological agent, we have to deal with what is known as

an ‘‘incubation period.’’ That’s the time from exposure to the time

of onset of illness, which can range, depending on agent, from several hours—— Mr. SHAYS. Right.

Dr. HUGHES [continuing]. To several days, and in some cases several weeks. It is that difference that is very important in terms of

a biological event requiring for recognition good disease surveillance, because people will be widely dispersed from their site of exposure.

Mr. SHAYS. But this is one reason why we contact hospitals in

urban areas every day to see if they have a particular outbreak of

a problem—it’s one of the reasons. They may have an outbreak of

a natural cause, or it may be terrorist induced.

Dr. HUGHES. That’s right. In the absence of an overt claim by a

terrorist, a bioterrorism event will present as any complicated infectious disease outbreak that requires alert health care workers

and a vigilant public health system to recognize problems.

Mr. SHAYS. And it grows geometrically.

Dr. HUGHES. Yes, it can. It certainly can.

Mr. SHAYS. Whereas chemical, it will be a little more instant and

spread, but not necessarily in the same way.

Dr. HUGHES. Well, for many chemicals there will be a much

shorter interval from exposure to onset of illness.

Mr. SHAYS. And not contagious.

Dr. HUGHES. Well, not directly contagious the way some infections are, but a victim may be contaminated with the chemical, so

it is possible for a victim of a chemical exposure to expose people

who are caring for that individual.

Mr. SHAYS. OK. So it can spread.

Dr. HUGHES. On a limited basis.

Mr. SHAYS. Right. And then it goes many places. So describe to

me how the system would work. It is, you know—and the location

of these stockpiles is not something we advertise, but let’s just say

the stockpile is in a particular place and it needs to go 200 miles

to Columbus. Describe for me what happens. How does this system

work?

Dr. HUGHES. Well, we, in an event like the where an episode was

recognized and characterized and a decision was made that it was

appropriate to mobilize the stockpile, a push-pack, one of these

push-packs that I mentioned would be mobilized either by air or by

land, depending on its proximity to its ultimate destination, and

can be moved within 12 hours to such a site, and in many

cases—— Mr. SHAYS. And who is responsible for making sure that gets

there?

Dr. HUGHES. Well, that would be the CDC response for our stockpile for those push-packs. It would be our responsibility.

Mr. SHAYS. Colonel, tell me how you fit into that process.

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Colonel HOLLIFIELD. Sir, I don’t really fit into that push-pack

process at all. We maintain a limited amount of medical supplies,

primarily to provide care for our own first responders. My unit’s

role is to provide assistance to the lead Federal agency when

tasked to do so.

Mr. SHAYS. OK. Walk me through this a bit. I mean, we had an

exercise in Connecticut—— Colonel HOLLIFIELD. Yes.

Mr. SHAYS [continuing]. And that was fascinating, but just walk

me through. We have an outbreak. The first responders didn’t survive. Sometimes the firemen tell us the police are the canary in the

field. So let’s say a few policemen have died. We’re trying to determine what the cause is. Is that your job, Dr. Hughes, or are you

just responding to whatever you’re asked for?

Dr. HUGHES. No. The stockpile is only one component of the CDC

and the public health.

Mr. SHAYS. Right.

Dr. HUGHES. There’s detection, diagnosis, assessment of risk factors, definition of the—— Mr. SHAYS. You just have to get it there, whatever you’re asked

for? You have to get the supplies there to the site?

Dr. HUGHES. Well, the mobilization of the stockpile is one

component—— Mr. SHAYS. Right.

Dr. HUGHES [continuing]. Of what we would be doing, but we

would be responsible for ensuring that the stakeholder is moved

using our transportation partners to the site or sites where it is

needed.

Dr. KNOUSS. May I step in, please?

Mr. SHAYS. Yes, please.

Dr. KNOUSS. Just with a context, because I think that there is

an entire context of a Federal response plan in the event that we

have one of these emergencies. The difficulty with a biological

event that looks like it is just a regular—let’s say like West Nile

did in New York where it is a naturally occurring disease that is

being transmitted and spread from Europe. There was no indication as to whether or not that was a human-caused or a naturally

occurring disease. But in the event of a terrorist attack, that would

be a—that might be appearing originally as a naturally occurring

disease and then all of a sudden becomes apparent that it is a terrorist attack.

But when we know that there is a chemical event or a terrorist

attack with a biological agent, there is a Federal response plan

that really mobilizes the whole of the Federal Government.

Mr. SHAYS. And you would be responding whether it is a terrorist

attack, or not? You would be responding either way?

Dr. KNOUSS. We would be responding either way.

Mr. SHAYS. Yes.

Dr. KNOUSS. If it’s a mass—actually, we have enormous numbers

of resources to be able to respond to mass casualty situations in the

United States, and this is just one other way of getting to a mass

casualty situation.

Mr. SHAYS. I just—I guess what I maybe need to do is just—because my time is running out here—I just want to appreciate obviVerDate 11-MAY-2000 10:49 Nov 27, 2001 Jkt 000000 PO 00000 Frm 00076 Fmt 6633 Sfmt 6633 C:\DOCS\75956.TXT HGOVREF1 PsN: HGOVREF1
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ously how we maintain these—this medicine and these antidotes is

one issue, but how we get it to the field—and I’m just trying to understand that basic point.

And I just heard the word ‘‘scene’’ more than I was comfortable,

instead of ‘‘scenes.’’ So it is in Columbus, and, guess what, it is in

Dayton and it is in Chicago and, my god, it’s down in Miami all

of a sudden. I just want to know who in this group responds and

how you respond when that happens, and then, thank you, Mr.

Chairman, I’ll come back for a second round.

Dr. KNOUSS. That’s a very complicated question, but basically we

all respond and there are prescribed procedures that we use to respond.

Mr. SHAYS. It’s not classified, is it?

Dr. KNOUSS. No. It’s the Federal response plan that we use. It’s

for emergencies.

Mr. SHAYS. OK. So just walk me through it.

Dr. KNOUSS. And the bioterrorism—or the terrorism annex to

that plan.

If there is an event that occurs and the FBI is notified or law

enforcement notifies, the initial response is going to be a local response.

Mr. SHAYS. OK.

Dr. KNOUSS. That’s one of the reasons why we are trying to improve local resources around the country. Both CDC, both the local

and State level, and we, in terms of the health systems at the metropolitan level, and we are now active in over 100 major metropolitan—about 100 major metropolitan areas.

So if it happens in one of those areas, plans are being developed

now for the initial local response, including the stockpiling of antidotes and some antibiotics.

Mr. SHAYS. And we don’t have stockpile like at Pearl Harbor

where we put all our ships?

Dr. KNOUSS. No, sir.

Mr. SHAYS. They’re all around the country.

Dr. KNOUSS. They’re all around the country. And we’re doing two

things for chemicals. We’re buying some stockpile to put in our

major metropolitan areas because of the rapidity of the responses

needed, so that our first responders have immediately at their disposal enough stockpile to take care of anywhere from 1,000 to 6,000

people, and for some of our larger cities even more than that.

Mr. SHAYS. And chemical has a longer shelf life?

Dr. KNOUSS. No. It all depends on——

Mr. SHAYS. So we’re constantly having to update.

Dr. KNOUSS. That’s correct.

Mr. SHAYS. If you don’t mind, Mr. Chairman, since there are only

two of us——

Mr. PUTNAM. There’s nobody else to go.

Mr. SHAYS. Let me just appreciate—I’m pleased the others

jumped in, but I just want to have—maybe this is so redundant for

you that you don’t want to keep talking about it. I get tired of talking about campaign finance reform. You can get tired of talking

about this.

Dr. KNOUSS. Well, hopefully this is not in the same category.

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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.

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I’m still not really getting a great answer from my standpoint.

I know that you’re going to be going to a site. I want to ask—— Colonel HOLLIFIELD. If I could draw an analogy, Mr. Chairman?

Mr. SHAYS. Sure.

Colonel HOLLIFIELD. I’m kind of like the ambulance guy, you

know. I have some limited medical supplies.

Mr. SHAYS. Right.

Colonel HOLLIFIELD. I’m the ambulance. I show up at the scene

and I provide some stabilization care so that these agencies and

the medical supplies they provide the local responders can take

over that surge of patients and be able to follow on and provide the

long-term care.

Mr. SHAYS. It’s just basically you’re a one-scene primarily focus,

so I sure as heck we know soon enough to get you there before we

see the chemical contamination spread or the biological agents.

Colonel HOLLIFIELD. We try to preclude that, sir, by two methods. One is we look and rely very heavily on intelligent information.

Mr. SHAYS. Right.

Colonel HOLLIFIELD. So if we anticipate that there is a credible

threat for a major event, we can pre-stage forces at that scene,

which we have done repeatedly in the past.

But, more importantly, we keep about one-third of the unit on a

1-hour tether, 365 days a year, which means if something happens,

within 1 hour we can recall that response force in. All their equipment is pre-stage packed and mobile loaded. And then it’s just a

matter of air lift and getting us to the destination before we can

have impact.

Mr. SHAYS. Thank you. Now, the national medical response

teams, how many do we have?

Dr. KNOUSS. Four.

Mr. SHAYS. So does that mean that we could get to those four

sites?

Dr. KNOUSS. At the beginning what’s going to happen is that the

State of Ohio is going to be responding, and, in fact, we are developing systems in those cities, so—and we’ve also worked with the

State to link those cities in a network so that we have some response capability in the State of Ohio to begin with, which was the

example you started with.

Then we have the opportunity to move those four teams. The

first three teams would be the ones positioned on the west and the

central and the East Coast. The one here in Washington, DC, will

probably stay here in the event that we have a continuing or

additional——

Mr. SHAYS. Right.

Dr. KNOUSS [continuing]. Threat here in the Nation’s Capital.

We have constructed our stockpiles so that we can split each one

into four pieces, and that means that we can move—we actually

have a great deal of mobility. Obviously, at some point the response may require such a large requirement that it is going to exceed what we have pre-positioned, but we think we have a very

substantial capability when it comes to chemical victims.

Mr. SHAYS. Mr. Chairman, I’ll come back. Thank you for your patience.

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Mr. PUTNAM. You’re certainly welcome, Mr. Chairman.

Dr. Mather, your testimony states that the caches have been successfully deployed and returned to storage. Why were they deployed?

Dr. MATHER. As a test case. We did deploy the capital—the cache

here for the inauguration and the State of the Union address, as

you are aware.

Mr. PUTNAM. OK. And do we have any mobile stockpiles overseas?

Dr. KNOUSS. We do not, not for any of the programs that we operate. Those are all domestic and really have been committed to domestic uses. That question has come up on a frequent occasion.

Now, there are some instances in which we have assisted AID in

actually purchasing some additional pharmaceuticals for other governments, but it has really been part of a foreign assistance package and not as a part of our immediate response capability.

The one thing that we can do that is new is that, in response to

the bombings that took place in Nairobi and Dar es Salaam, we

now have a capability of immediately deploying a civilian team

from a very fine surgical care institution in Massachusetts that we

can use to stabilize U.S. employees that may be immediately at

risk from those kinds of events again.

Mr. PUTNAM. When an event or evidence of an event begins to

pour in to CDC and HHS, who makes the final call? Who is ultimately responsible for identifying this scenario as an event and

therefore triggering your response plan?

Dr. KNOUSS. Well, the initial event would be the FBI and FEMA.

In terms of the actual response in terms of management within our

department, our current Secretary has made it very clear that he

is going to be directly responsible for the responses of the Department of Health and Human Services.

Mr. PUTNAM. So when you are communicating with urban hospitals and first responders and reports begin to come in, and, as

we’ve heard earlier, everything looks like the flu in the beginning,

it’s up to the FBI to determine what they’re really looking at?

Dr. KNOUSS. No, that’s when it’s looking like an emerging infectious disease, and that’s a public health problem, and that really

is a CDC issue. It’s once it becomes clear that it is a terrorist incident that the lead agency is the Department of Justice and the

Federal Bureau of Investigation.

Mr. PUTNAM. But I guess in this murky world that we live in it

may not be clear that it is a terrorist incident, and that’s why I

asked who sifts through the data and makes the recommendation

that it is—it looks enough like a terrorist attack to deploy your

plan? Is that you, Dr. Hughes?

Dr. HUGHES. Well, that’s where the Nation’s public health system comes into plan and its linkage with clinicians, health care

providers who—in a biological event, it is the health care providers

that are going to initially see these patients. They need to have a

high index of suspicion, if they’re seeing one or two patients, that

this may be part of a much larger event occurring in their community or maybe in many communities. So an index of suspicion,

prompt recognition, notification of local and State public health authorities who would then, in turn, notify us at the national level.

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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 midsized midwestern city like Oklahoma City, why would they think

that anthrax is in their community? What training or preparation

would they have had given them that would alert them to look for

and consider such an outlandishly sounding eventuality?

Dr. HUGHES. I think the good news is they’re more likely to consider that possibility today than 2 to 3 years ago, with the publicity, the heightened awareness, the efforts at training, the establishment of strengthened surveillance in laboratory networks, and dissemination of information about the clinical nature of anthrax.

Anthrax is a disease that should not occur at all in the United

States in humans, so a single case should raise the possibility of

a terrorism event. It doesn’t mean a single case will be the result

of a terrorist event, but a single case should raise a red flag.

I think, although we have a long way to go, that’s more likely

to happen today than it was 2 to 3 years ago.

Mr. PUTNAM. Who decides—in these stockpiles that are around

the country, who decides what eventualities those stockpiles need

to be prepared for? And how often does that threat analysis

change, or how often is it reviewed to make sure that we’re prepared for the proper eventualities?

Dr. KNOUSS. There are a variety of different processes that we

go through to do that. I think Dr. Hughes is in a position to describe a lot of the things that CDC does to decide what is the most

likely mass-casualty-producing organisms that might be used and

that we have to be prepared to respond to.

From a chemical standpoint, we rely a good deal on what DOD

has decided are some of our most important chemical weapons

threats, and it boils down to some things that really have a lot of

common antidotes to them so that we use that as the basis for the

stockpile.

Mr. PUTNAM. Dr. Hughes.

Dr. HUGHES. Roughly 2 years ago we assembled an expert group

of individuals representing the private sector, the Department of

Health and Human Services, the intelligence community, and we

talked about candidate agents. The Department of Defense had

representatives at that, as well. We talked about candidate agents

that we should be most concerned about, considered a number of

parameters, one of which is the ability that we’ve alluded to already of an organism to spread from person to person, cause severe

disease, have a high mortality rate. Those kind of things went into

the equation.

It was that process that led us to definition of what we call ‘‘category A’’ agents that are the ones that we are most concerned

about because of their potential catastrophic impact.

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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 vendormanaged inventory, the push-packs currently are supplied to adequately deal with plague and with tularemia. More work needs to

be done to get them fully up to the level they should be to deal

with anthrax.

And, of course, when you get to smallpox and the viral hemorrhagic fevers, there aren’t effective therapies currently available for

those so that becomes a research issue. So it’s very complicated.

Dr. KNOUSS. Could I just add to that, though, that the stockpile

that we do have in terms of antibiotics includes what are called

‘‘broad spectrum antibiotics,’’ and they can be used against a large

number of different organisms that might be susceptible. So what

we are now putting in the stockpile is not necessarily limited to

treating just plague or tularemia or anthrax, it can be used for a

variety of other illnesses, bacterially caused illnesses, as well.

Mr. PUTNAM. Let me get back to what we were discussing earlier

in terms of the line of authority, the chain of command. To followup on the chairman’s line, there is a disturbing amount of evidence

emanating from the Chicago metropolitan area and in Dayton and

in Cincinnati, so you all move into action and begin to deploy assets to that area. Who makes the determination of holding back assets or preparing for a second outbreak or a far-removed outbreak

in Miami or New York or San Francisco so that we’re not deploying

all of our assets to the first line of attack and, in effect, depleting

our ability to respond to the secondary effects? Who handles all of

that decisionmaking? Does that make sense?

Dr. KNOUSS. Yes. I’m not aware of any situation in which we’ve

actually said, ‘‘We’re going to keep a reserve force that’s going to

be available in case there’s another incident,’’ with the one exception that here in Washington, DC, we are committed to keeping

specific kinds of resources available here in case this—I mean, I

just consider this as a secondary target, regardless of where something else may be happening.

But it is like everything else. When you see a particular threat—

if we are faced with—and this is a highly theoretical kind of discussion at this point—I don’t think there is any formula for good judgment as to what you can commit to one kind of incident or another

incident, and every one of those incidents—and we’ve been involved

in a variety of responses to rather cataclysmic natural disasters, as

well as pre-positioning resources for some kinds of these incidents,

potential threats. There’s no exchange for good judgment and there

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is no formula for what has to be kept in reserve and what needs

to be committed.

Dr. HUGHES. Let me pick up on this a little bit, and maybe Mr.

Bice.

Mr. SHAYS. You know what I’d like to suggest, if I could, Mr.

Chairman?

Mr. PUTNAM. Certainly.

Mr. SHAYS. That anyone who wants to participate, if they have

been accompanying, if they just sit right on the side up here where

the mics are. Just come on up here, anyone else who would like to

add to this dialog. So you can just wait, but anybody else.

I’m sorry.

Dr. HUGHES. I know that Mr. Bice will want to amplify on this,

but, from the CDC standpoint, in terms of the stockpile, we have— it’s a two-component situation where we have these push-packs.

There are seven right now. There will be an eighth this summer.

But obviously—— Mr. PUTNAM. Is that enough? Let me just stop you right there.

Dr. HUGHES. Well, It depends on the magnitude of the situation.

If the situation that we’re talking about occurs in 20 different cities, obviously the eight push-packs wouldn’t cover 20 cities.

There’s a second component, though, to the CDC stockpile, and

it’s what we call the ‘‘vendor-managed inventory,’’ which can’t be

mobilized as rapidly but it can be mobilized within 24 to 36 hours

of activation.

In contrast to the push-packs, which are an attempt to be all

things to all agents, the vendor-managed inventory can actually be

tailored so that if you know you’re dealing with anthrax you can

call on the medications and supplies that you need to deal specifically with cases of anthrax.

Mr. PUTNAM. Mr. Bice, I think you wanted to followup on that?

Mr. BICE. Yes. Thank you, Mr. Chairman. I just wanted to ensure that all understand that, while there’s no magic to eight, we

dealt specifically with Defense Intelligence Agency, Central Intelligence, FBI, our own colleagues in our own department and other

departments who are experienced with strategies for defense and

response. There is no magic to eight, but the fact that each of the

push packages can treat in the hundreds of thousands of people for

a week or thereabouts gives us breathing room to mobilize the prodigious amount of supplies and equipment that we have held back

in the vendor warehouses across the United States.

So therein is our tactical scenario that we play out, we exercise

according to that plan. So we would never commit all eight push

packages, for example, to Dayton or to any one location. They

would stage according to what we would see as evidence by laboratory and epidemiologic evidence the need for those.

And one other caution. None of what we do is to respond—none

of what the national pharmaceutical stockpile is to do, we’re not a

first response element. We would only go when Governors of States

requested assistance, and in that sense we’re not a primary or first

response element.

Mr. SHAYS. But it conjures up this concept of the scene. I mean,

the scene that I visualize, unless the technology isn’t there for terrorists to do, is Atlanta Delta flights. All of a sudden, you know,

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there’s some contamination at the airport and there’s all these—if

you’ve ever been there—you’ve been there.

Dr. HUGHES. I have the pleasure of constantly, sir.

Mr. SHAYS. And so there could be potentially 40 sites like that.

So I’m not comforted that somehow the national government

doesn’t—you know, is kind of responding in invitation. I mean, I

could see a for instance where we literally have to say, ‘‘No flights.

No one is allowed to get on the highway. No one is allowed to move

from their office to home. You have to be stationary.’’ I mean, I can

see that. Is that an unrealistic—— Dr. HUGHES. That’s very realistic. Let me just comment. In the

Operation Top Off exercise that occurred last year that involved

three components, the most complicated one was the plague outbreak that was said to have occurred in Denver, exposing a very

large number of people, and all of these issues that you’ve brought

out and many more came up.

There was thinking in terms of when Colorado asked for a pushpack 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

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interstate quarantine authorities, looking at State laws for quarantine of infected individuals. It has raised many, many questions.

Dr. KNOUSS. I’m not sure that we’re the best people to answer

that question. The people to answer that question that have been

working on it and chairing the task forces looking at those issues

has been the Department of Justice.

When we’re talking about the quarantine issues and looking at

quarantine laws at the present time, a lot of them are dependent

on exactly what State law is and they vary from State to State.

Mr. SHAYS. It’s just that, you know, we have this comfort level

that, you know, you’re the group that’s going to be responding, and

I had this sense before I came to this hearing that this is kind of

a complete picture, and I hear ‘‘scene’’ rather ‘‘scenes.’’ I have a

sense that we will try to catch up to the contagious elements and

we’ll be—you know, if it’s nice and neat and pretty we’ll be doing

fine, but otherwise we’ll have some—— Dr. KNOUSS. Mr. Chairman, I think that we’re just one part of

a very large response that is going to be taking place, and that’s

what I was trying to allude to at the very beginning in terms of

this being one part of the Federal response plan and the issues

that will be tackled really at the highest level of our government.

Mr. SHAYS. Then let me just make this statement—did you want

to say something, Dr. Hughes, first?

Dr. HUGHES. I was just going to say that your comments I think

are very well taken. One thing they bring out is the urgency and

the importance of having surveillance systems in place, strong public health surveillance, so that an event can be very rapidly recognized because things can spin out of control very, very quickly potentially.

Mr. SHAYS. Yes. I mean, I’m left with the feeling that, just as it

relates to all of you and the wonderful work you’re doing and the

efforts you’re making, you could potentially never get caught up to

it. It will be identified too late, it will have spread too quickly, and

we won’t have the resources, even though it seems like we might.

If I could, could I ask about smallpox?

Mr. PUTNAM. Certainly.

Mr. SHAYS. Why don’t I—— Mr. PUTNAM. Well, I just wanted to—I think that your line of

questioning highlights the theme of this subcommittee since January, which is, when it comes to homeland security, Department of

Justice points to the CDC, the CDC points to the Department of

Justice, and there really isn’t anybody willing to stand up and say, ‘‘I’m in charge here,’’ and that reflects sort of an institutional crisis

of identifying how to respond to these types of threats.

I would hope that you all would recognize the threat before a lot

of Governors would, much less have to wait on the Governors to

type up the proclamation to invite you down for tea.

I think what this highlights is that it reinforces the need for us

to have a better-integrated system of homeland defense and address the questions of when it is appropriate for CBIRF or equivalent or similar type units to be deployed domestically and respond

to these types of crises and have pre-positioned stockpiles in the

right places, in the right amounts and things of that nature.

That’s all I wanted to say, Mr. Chairman.

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Mr. SHAYS. Just quickly about smallpox, the ‘‘Stars and Stripes’’

had a story on the 26th that we’re going to get 40 million doses

of vaccine against smallpox. Who would respond to that? Is that

you, Dr. Hughes?

Dr. HUGHES. Yes.

Mr. SHAYS. OK. Tell me the genesis of why that decision was

made. The stories that preceded it, to my knowledge, is that the

United States has the last and the Soviet Union, and we don’t

know quite what the Soviet Union has and who it could give it to.

What do you know that we don’t know that’s not classified?

Dr. HUGHES. OK. You’ve asked several questions.

Mr. SHAYS. Right. We want to give you a range of choices.

Dr. HUGHES. Let me start and you guide me and I’ll do the best

I can.

Mr. SHAYS. OK.

Dr. HUGHES. There are two authorized supplies of smallpox virus

in the world. One of those—or stocks, I meant. One of those is

stored at CDC. The other is stored at the Institute Vector in——

Mr. SHAYS. And this is the disease, not the vaccine?

Dr. HUGHES. This is the virus that causes the disease.

Mr. SHAYS. Right.

Dr. HUGHES. Correct.

Mr. SHAYS. Yes.

Dr. HUGHES. There are concerns in the intelligence community

about given the fact that the Soviet Union, from all we know, clearly had a very aggressive offensive biological warfare program. They

included development of smallpox virus as a weapon.

Mr. SHAYS. Right.

Dr. HUGHES. There are concerns that perhaps all the remaining

smallpox virus that the former Soviet Union had is not currently

stored in the facility in Novo Severe. So that leaves—there is the

possibility——

Mr. SHAYS. At least you can’t be certain of it.

Dr. HUGHES. We can’t be absolutely certain.

Mr. SHAYS. OK.

Dr. HUGHES. But the officially declared stocks and the ones that

come up when you hear talk about destruction, discussions related

to future destruction of known stocks, the virus, those relate to the

virus stocks at CDC and the ones at Vector and Novo Severe.

Mr. SHAYS. And can I make an assumption at CDC it’s strongly

guarded?

Dr. HUGHES. It’s stored in a secure—under secure conditions.

Yes.

Mr. SHAYS [ASSUMING CHAIR]. I feel rudderless at the moment,

here. The gavel is over there and I’m here. You could really abuse

me here. [Laughter.]

Dr. HUGHES. The storage conditions at both——

Mr. SHAYS. I’m in charge here now.

Dr. HUGHES. I sensed that. The storage conditions at both institutions, both CDC and Vector, have been reviewed by a team of experts from WHO and have been deemed to be adequate.

Mr. SHAYS. And what would happen if we saw an outbreak? We

would try to vaccinate as many people in the area as possible?

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Dr. HUGHES. Well, if we saw an outbreak of febrile illness with

skin lesions consistent with smallpox, the first thing we would do

is try to rapidly confirm the diagnosis.

Mr. SHAYS. Right.

Dr. HUGHES. And because of ongoing research programs we have

pretty good molecular diagnostic tools now, better than we would

have had a year or two ago, to make the diagnosis. Once the diagnosis is made, here’s a good example of agent. I mean, if we see

cases of smallpox, either that’s a lab escape or that’s a terrorist infecting himself by manipulating the virus that he had, or it’s a terrorism event, so that gets you very—that would get you very quickly into the terrorism arena.

In terms of what you would do, you would mobilize stocks of

smallpox vaccine, which is not smallpox virus, you know, it’s the

smallpox vaccine.

Mr. SHAYS. You don’t need the virus to make the vaccine?

Dr. HUGHES. That’s correct. The current vaccine and the next

generation that’s currently being developed involves a related pox

virus called ‘‘vaccinia.’’ It’s the——

Mr. SHAYS. But in creating the vaccine you aren’t creating the

potential for the disease?

Dr. HUGHES. No. The other thing that you would be rapidly

doing is characterizing this smallpox virus that these hypothetical

patients are infected with because there would be concerns about

the possibility that this virus might have been genetically modified

by people who were interested in having——

Mr. SHAYS. Weaponizing it.

Dr. HUGHES. Weaponizing it and having it be able to work

around the existing vaccine.

Mr. SHAYS. And so that’s a crap shoot. OK.

Dr. HUGHES. I mean, you can imagine scenarios that are beyond

the capacity to manage.

Mr. SHAYS. How about with anthrax? If we think our military

personnel need to be protected, are we stockpiling anthrax for civilians?

Dr. HUGHES. Well, we—the colonel might want to comment here

also.

Mr. SHAYS. Don’t feel you have to, Colonel. It’s dangerous. You

know what a mine field is like.

Colonel HOLLIFIELD. I’m current on my anthrax vaccines, Mr.

Chairman.

Mr. SHAYS. You don’t want to get in this debate, Colonel.

Colonel HOLLIFIELD. Thank you, sir.

Mr. SHAYS. It’s not a pleasant conversation.

Dr. Hughes, are we developing or stockpiling anthrax vaccines in

case the public is exposed to anthrax?

Dr. HUGHES. What we’re doing with anthrax vaccine, at CDC we

actually have an ongoing research program looking at the currently

available anthrax vaccine, looking to see if it can be given in fewer

doses, looking if it can be given by a different route of administration that might result in a——

Mr. SHAYS. To develop a new——

Dr. HUGHES [continuing]. In less side effects.

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Mr. SHAYS. To do what we asked the military to do, which is to

develop a modern generation of vaccine, anthrax vaccine?

Dr. HUGHES. Well, there’s ongoing research, not research that

we’re doing, but there is ongoing research looking at improved anthrax vaccines, but what we’re trying to do is look at the available

vaccine, see if it can be given in fewer doses, different route, and

then assessing its—— Mr. SHAYS. Right.

Dr. HUGHES [continuing]. Effectiveness to prevent inhalation anthrax in non-human primates that are exposed.

Mr. SHAYS. Don’t you see a gigantic disconnect? The military, to

my knowledge, isn’t focused on giving a smallpox vaccine to its

military, but it has decided, in its wisdom, and based on the facts

as they see it, to have anthrax, and yet domestically you all are

saying we’re going to look at smallpox and you’re not—we don’t

have developed anthrax. So it just to me calls into question the

wisdom of what the military is doing. Either the military is right

and you’re wrong or you’re right and they’re wrong. They don’t jibe.

It’s not a trick question; it’s just an observation that we’ve had 4

years or 3 to 4 years of very frustrating dialog with the military

about this.

It is hard for me to imagine how, if we think we need to protect

our military forces from anthrax, we don’t think we need to protect

the public. I’d just make—I throw it out there and it will dangle

out there for a future hearing.

I’d be happy to have the counsel ask some questions.

Mr. HALLORAN. Just to clean up the record a little bit here, Colonel Hollifield, has anybody in your unit read your AMAL kind of

side-by-side with the contents of the push packages or the stockpiles to look and see what’s the same, what’s different? And let me

ask all of you, in terms of the transparency of these things, in

terms of if he’s there first, you fall in after, are you going to be giving the same material—bringing the same material and the same

doses in the same color packages, or are we going to have some

kind of a bridging transition problem as each asset arrives?

Colonel HOLLIFIELD. I don’t think there’s been any attempt, to

my knowledge at least, to compare the AMAL contents with anything that’s a part of the national pharmaceutical stockpile program.

In the military the authorized medical allowance list is basically

what I would call ‘‘type specific.’’ Each type of military organization, be it an infantry unit, mechanized unit, or an aviation unit,

has a specific authorized medical allowance that is tailored to its

unit’s mission. If you look at the quantity of the medications that

we have and the number of victims that we’re designed to be able

to render care for, which are primarily the size of own force, and

compare that with the scope and depth of what the other agencies

have in the stockpile program, you know, we’re very, very minuscule.

So I’m not so sure that there is a necessity to do that. I understand that it would be nice that if we’re all showing up, we’re

showing up with the same type of items and supplies, but our missions are different, so the care items that I have are really designed to provide protection for my people who go into the contamiVerDate 11-MAY-2000 10:49 Nov 27, 2001 Jkt 000000 PO 00000 Frm 00088 Fmt 6633 Sfmt 6633 C:\DOCS\75956.TXT HGOVREF1 PsN: HGOVREF1
85

nated environment and risk exposure, and I have very limited

quantities.

So I don’t think there is a connection. I’m not necessarily sure

that—and maybe they can comment in terms of what type of supplies the national medical response team has and if they’re similar,

but I’m sure that the vaccines and stuff that we carry for care are

all similar in nature, whether they’re manufactured or the process

by how we acquire them are the same.

Dr. KNOUSS. I’d like to just mention that for the pharmaceutical

purchases for the cities, as well as those that we make for our

teams, that we want to review all those purchases before we actually support them at the city level, and we have an interagency

group that looks at that so that we try to achieve as much consistency as we can, as well as the fact that our teams and our cities

know what we have in our stockpiles for chemical responses.

So it’s not true for—that we do not do that with the Marine

Corps’ stockpile, but we do try to do that with all of the metropolitan stockpiles and the ones that we hold for our teams.

Mr. HALLORAN. OK. That brings me to—there’s a reference we

have to metropolitan medical strike teams, which are not on the

GAO chart, but yet they seem to be an HHS-funded asset; is that

correct?

Dr. KNOUSS. Well, what we have done is that term is somewhat

obsolete at this point—— Mr. HALLORAN. I see.

Dr. KNOUSS [continuing]. Because we’ve migrated to some new

concepts. That was a concept maybe 5 years ago, 4 or 5 years ago.

But what had then been called a ‘‘metropolitan medical strike

team’’ has become now our four national medical response teams,

because they are the Federal teams, the civilian Federal teams.

The metropolitan medical strike team concept at the city level

has become really a response system concept because we’re looking

at not just a few people trained to respond; we’re looking at the entire capability of the cities’ public safety, public health, and health

services communities to be able to respond to one of these massive

events. And so we’re really looking at this from a systems point of

view, not a team point of view.

Mr. HALLORAN. Yes.

Dr. KNOUSS. So we’ve migrated far beyond that original concept

that we held in 1996 and 1997.

Mr. HALLORAN. But do you have the same kind of attempt at

consistency and transparency with what they might acquire? I

mean, the question arises—I was reading through their—I guess it

is old now, but their field operations guide, and they give fairly

specific instructions about packaging and color coding of what they

bring, so is everybody bringing antibiotics to a scene going to have

them in red packages, or are they going to open them up and figure

out what’s inside?

Dr. KNOUSS. No. I think we’re trying to standardize that now.

One of the things that we’re doing, for example, on our chemical

push packages, we’re putting them in the same kind of containers

that CDC is using for its eight stockpiles. We are giving diagrams

to the cities and to the teams as to where in each one of those containers they can find what chemicals. So it’s not just a matter of,

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‘‘Here’s what’s the content of the stockpile,’’ but here, in a threedimensional diagram, is where, in our material that we’re sending

out to you, you can actually find each one of these products. So

we’re getting far more specific and far more user friendly in what

we’re sending out there so that we can—I mean, we’re very sensitive to the time issues. I’m not sure we’ve solved all the time

problems, but we’re very sensitive to the fact about the sooner we

can respond the more lives we can potentially save.

Mr. HALLORAN. Yes.

Dr. HUGHES. From the standpoint of CDC, let me ask Mr. Bice

to comment on that.

Mr. BICE. The standardization amongst the eight push-packages

is, as you can well imagine, very, very consistent. As we go to

standardize and mirror what locals have, we come prepared to deliver in bulk and oftentimes locals will deliver or have at their access smaller doses. They won’t exactly look alike, but the basic

medications will be the same. They’ll be the same general medication types, so in that sense that’s the answer that we would give.

Mr. HALLORAN. Back to the chairman’s question, once the bulk

push package arrives, who decides how to break it out and disburse

it?

Mr. BICE. We send a technical advisory response unit with each

of the push packages. They assist the locals on the scene as for

points of distribution, how much needs to be broken down and for

how many victims or potential victims.

Dr. KNOUSS. As we enter into our contracts, if I could just add

to that, at the local level we are trying to encourage every metropolitan area that we’re working with to develop a specific distribution plan, both in terms of location, as to where they would receive

the material, and how they would actually do points of distribution

for the affected population.

That’s a very extensive planning process and a lot is dependent

on what the organizational arrangements are at the local level, as

Mr. Bice was saying.

Mr. HALLORAN. Was Top Off the first time that the biological scenario was exercised down to that level?

Dr. KNOUSS. I can’t think of another time in which it was done

like that.

Mr. HALLORAN. OK. And then, finally, the GAO report referenced

17,897 expired items in your inventory that you were looking for

FDA shelf life extensions on, so my question is: to what extent do

you believe your entire inventory could be subject to that kind of

extension activity? And do you inventory systems, are they

equipped to account for that? You’ve put in shelf life. You’ve put

in expiration date. DY have—just reset the expiration date, or do

you set the new one, or is there a penultimate one? How do you

track extensions?

Dr. KNOUSS. I’m not sure exactly which particular products

they’re referring to, but there are a variety of shelf life requirements. Our involvement with FDA on the chemical stockpiles has

been really to identify and work with them to look at whether or

not any of the things that were temperature damaged might be

able to be kept, and we’ve made a decision, because GAO is referring to the stockpiles in the midwest or central locations, specifiVerDate 11-MAY-2000 10:49 Nov 27, 2001 Jkt 000000 PO 00000 Frm 00090 Fmt 6633 Sfmt 6633 C:\DOCS\75956.TXT HGOVREF1 PsN: HGOVREF1
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cally, 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

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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.]

Æ