United States General Accounting Office

GAO Testimony

Before the Committee on Veterans’ Affairs, U.S. Senate

For Release on Delivery

Expected at

10:00 a.m., EST

Tuesday,

March 17, 1998

CHEMICAL AND

BIOLOGICAL DEFENSE

Observations on DOD’s

Plans To Protect U.S. Forces

Statement of Mark E. Gebicke, Director, Military

Operations and Capabilities Issues, National Security and

International Affairs Division

GAO/T-NSIAD-98-83

Mr. Chairman and Members of the Committee:

We are pleased to be here today to discuss the Department of Defense’s

(DOD) continuing efforts to protect U.S. military forces against chemical

and biological weapons, including its plan to inoculate all U.S. military

forces against anthrax. As we learned from the Gulf War, U.S. forces were

inadequately prepared for surviving and operating in a chemically or

biologically contaminated environment. More recently, we found that

deficiencies in medical record-keeping have hampered the conduct of

epidemiological research to the point that DOD cannot provide precise,

accurate, and conclusive answers regarding the causes of Gulf War

veterans’ illness.

Today, we will first briefly discuss the fundamental shortcomings in DOD’s

protection of its forces against chemical and biological warfare.1

 Then, we

will discuss DOD’s proposed anthrax immunization program.

Summary In examining DOD’s experience in preparing its forces to defend against

potential chemical and biological agent attacks during the Gulf War, we

identified numerous problems. Specifically, we found shortages in

individual protective equipment, inadequate chemical and biological agent

detection devices, inadequate command emphasis on chemical and

biological capabilities, and deficiencies in medical personnel training and

supplies.

While many deficiencies noted during the Gulf War remain unaddressed

today, DOD has increasingly acknowledged and accepted the urgency of

developing a capability to deal with the chemical and biological threat to

its forces. Both the Congress and DOD have acted to provide greater

protection for U.S. forces. Their actions have resulted in increased

funding, and the fielding of more and better chemical and biological

defense equipment. DOD must address remaining critical deficiencies if

U.S. forces are to be provided with the resources necessary to better

protect themselves. For example, DOD needs to decide on major policy and

doctrine issues, improve and increase its capability to detect toxic agents,

provide forces with improved and sufficient numbers of individual

protective equipment, and deal with problems of collective protection and

decontamination.

1

Appendix I provides a list of the unclassified GAO reports on DOD’s chemical and biological

capabilities. We have also issued three classified reports on this topic.

Page 1 GAO/T-NSIAD-98-83
DOD is now embarking on a major effort to protect U.S. forces from the

threat of the deadly biological agent anthrax. Its program to immunize

millions of active and reserve forces against anthrax, ensuring that each

receives the prescribed vaccinations in the proper time sequence, will be a

challenge. However, if DOD considers lessons learned from previous,

smaller-sized immunization programs and from the medical

record-keeping errors in the Gulf War and in Bosnia in formulating

detailed implementation plans, it can reduce the risks and improve the

prospects for successfully managing the program.

Protecting Forces

Against Chemical and

Biological Agents

Poses Continuing

Challenges

In 1996, we reported that military units then designated for early

deployment faced many of the same chemical and biological defense

problems that Gulf War veterans had experienced.2

 During the Gulf War,

units and individuals deployed to the theater without all of the chemical

and biological detection, decontamination, and protective equipment

needed to operate in a contaminated environment. Some units did not

have sufficient quantities or the needed sizes of protective clothing, and

chemical detector paper, and decontamination kits in some instances had

passed their expiration dates. While the 6-month Operation Desert Shield

buildup time allowed DOD to correct some of these problems, had chemical

or biological weapons been used during this period, some units might have

suffered significant, unnecessary casualties.

We further reported that DOD’s progress in chemical and biological

research and development was slower than planned, training of Army and

Marine Corps forces was inadequate, there was little evidence that joint

training and exercises included chemical and biological defense elements,

stocks of vaccines for biological agents were in short supply, and medical

units lacked necessary chemical and biological defense equipment and

training. We believe these deficiencies were a result of, and would not be

corrected without, changes in emphasis on the part of senior military

leadership.

We have also reviewed DOD’s ability to protect critical ports and airfields

overseas. Although I cannot fully discuss our findings in this open hearing

because of their sensitive nature, I can say that there are deficiencies in

doctrine, policy, equipment, and training for the defense of critical ports

and airfields.

2

Chemical and Biological Defense: Emphasis Remains Insufficient to Resolve Continuing Problems

(GAO/NSIAD-96-103, March 29, 1996).

Page 2 GAO/T-NSIAD-98-83
The Congress and DOD have taken action that has improved U.S. forces’

ability to survive and operate if chemical and biological agents are used

against them. For example, DOD has requested and the Congress has

approved increased funding for chemical and biological defense.

Numerous efforts are currently underway that should provide our

servicemembers with new chemical and biological defense equipment and

capabilities over the next 5 years. These include the production and

fielding of improved protective masks, body garments, and systems to

better detect biological and chemical agents. In addition, several

commanders in chief recently increased their emphasis on various aspects

of chemical and biological defense by, for example, increasing stocks of

chemical defense equipment and incorporating more chemical and

biological defense scenarios in major military exercises.

Still, DOD must address remaining critical deficiencies that affect its ability

to protect forces from chemical and biological attack. DOD’s doctrine and

policy are inadequate regarding responsibility for the chemical and

biological defense of overseas airfields and ports critical to the

deployment, reinforcement, and logistical support of U. S. forces in the

event of a conflict. As a result, questions are unresolved regarding the

provision of the force structure and equipment needed to protect these

facilities. Also, unresolved doctrinal, policy, and equipment questions

persist regarding the return of chemically or biologically contaminated

strategic lift aircraft and ships and the protection of both essential and

nonessential civilians in high-threat areas overseas. Moreover, DOD has

insufficient quantities of biological agent vaccines to protect U.S. forces,

and servicemembers deployed in high-threat areas overseas normally have

no biological agent detection capability. Also, collective protection

facilities and equipment and agent detection systems are generally

insufficient to protect the force.

DOD’s Program to

Immunize Forces

Against Anthrax

Anthrax is an infectious disease that afflicts certain animals, especially

cattle and sheep. The anthrax vaccine was licensed by the Food and Drug

Administration (FDA) in 1970 to protect veterinarians, meat packers, wool

workers, and health officials who might come in contact with anthrax.

(FDA licensure of a vaccine means that it has been tested and proven to be

safe and effective in humans.) The vaccine has been routinely

administered to populations at risk for several years.

The Chairman of the Joint Chiefs of Staff considers anthrax to be the

greatest biological weapons threat to U.S. military forces. After a 3-year

Page 3 GAO/T-NSIAD-98-83
study, the Secretary of Defense concluded that vaccination is the safest

way to protect U.S. forces against a threat that is 99-percent lethal to

unprotected individuals. Accordingly, in December 1997, DOD announced

plans to vaccinate all U.S. military personnel (including active, reserve,

and national guard servicemembers) against the biological warfare agent

anthrax. The Michigan Biologic Products Institute is under contract with

DOD to supply the vaccine for the DOD immunization program.

While the vaccine will be centrally procured, administering the

vaccinations will be decentralized at multiple DOD facilities worldwide.

Initially, DOD planned to begin administering the program in the summer of

1998 to about 165,000 servicemembers and DOD mission-essential

personnel located in Southwest Asia and Northeast Asia, which are the

areas with the greatest biological warfare threat from anthrax. Prior to

beginning the immunizations, DOD wanted time to (1) perform testing of

the vaccine to ensure its sterility, safety, potency, and purity;

(2) implement a system to track personnel who receive the vaccinations;

(3) approve plans to administer the immunizations and inform military

personnel of the program; and (4) have the program reviewed by an

independent expert. However, DOD accelerated the anthrax vaccination

schedule. In March 1998, DOD began immunizing forces stationed in the

Persian Gulf because of the possibility of hostilities occurring in that

region. DOD plans to vaccinate the remaining active and reserve force over

the next several years. In addition, DOD plans to decide whether the

program should be extended to others, such as host nation personnel,

civilian contractors, and dependents.

In accordance with the FDA licensure regimen for this vaccine, DOD plans to

provide an initial series of three vaccinations at 2-week intervals, a second

series of three vaccinations at 6-month intervals, and annual booster

vaccinations to maintain immunity against anthrax. DOD recognizes that

immunizing the entire force with multiple vaccinations will be difficult and

involves significant administrative and logistical issues. DOD’s program will

involve administering anthrax vaccinations to about 2.4 million personnel

around the world—a total of about 14.4 million vaccinations for the

current force. In addition, personnel entering military service will also be

immunized. Thus, DOD envisions the program to continue indefinitely.

Page 4 GAO/T-NSIAD-98-83
Personnel Data Systems to

Identify Servicemembers

Requiring Vaccinations

Must Be Accurate

To ensure that all servicemembers receive the required vaccinations, it is

important for DOD to have accurate and reliable personnel data systems

showing where all servicemembers are located, especially those deployed

to overseas locations.

Our work in examining the Operation Joint Endeavor medical surveillance

program in Bosnia surfaced concerns about the accuracy of the

deployment database used for determining which servicemembers

required postdeployment medical assessments. More specifically, DOD

officials expressed concerns about the accuracy of the DOD-wide database

that was used to identify Air Force and Navy personnel who deployed to

Bosnia. Air Force officials told us that the Air Force had supplied

information to DOD’s database on servicemembers it planned to deploy but

that many of them never deployed and the database was not corrected. We

were also told that data on servicemembers assigned to two Navy

construction battalions that deployed to Bosnia did not appear in the

database. DOD officials told us that they were concerned about the

accuracy of the deployment database and planned to address the problem.

Sufficient Command

Emphasis Needed to

Ensure Program

Implementation

Because DOD plans to administer anthrax vaccinations in a decentralized

manner at multiple locations involving both operational and medical

personnel, high-level commanders need to emphasize the importance of

the program to ensure that it is carried out within the time schedule for

administering the vaccinations. Careful attention to the administration of

vaccines is critical because the vaccinations must be given at specific

intervals over an 18-month period to achieve maximum protection.

In the past, a lack of command emphasis hindered DOD’s successful

implementation of medical programs. For example, we found that the

Army had not done many postdeployment medical assessments of active

duty personnel who had deployed to Bosnia. We also found that

assessments done were, on average, not done within the 30-day time frame

DOD established. Our work disclosed that it took an average of 98 days to

complete the assessments.

In addition, the Bosnia medical surveillance plan also required

servicemembers to undergo a tuberculin test at about 90 days following

departure from the theater. Our work disclosed that the test took an

average of 142 days.

Page 5 GAO/T-NSIAD-98-83
These problems occurred because command officials did not emphasize

the importance of the assessments and medical personnel did not have the

authority to require servicemembers to go to medical clinics for

assessments. Reliance upon unit commanders to require servicemembers

to get the assessments was not effective for the Bosnia deployment.

Medical Records

Documenting Vaccinations

Must Be Complete

Medical records documenting all care (including vaccinations) for

servicemembers are essential for the delivery of high-quality medical care.

DOD regulations require documentation in a servicemember’s permanent

medical record of all immunizations and visits made to health units.

The Presidential Advisory Committee on Persian Gulf War Veterans’

Illnesses and the Institute of Medicine reported problems concerning the

completeness and accuracy of medical record-keeping during the Gulf

War. Research efforts to determine the causes of what has become known

as veterans’ Gulf War illnesses have been hampered by, among other

things, incomplete medical records showing immunizations and other

health services provided to servicemembers while deployed. The Institute

of Medicine characterized DOD’s medical records as fragmented,

disorganized, and incomplete.

We tested the completeness of medical records for selected active duty

Army servicemembers who had deployed under Operation Joint Endeavor.

We found that many of the medical records were incomplete in that they

lacked documentation on (1) medical surveillance assessments conducted,

(2) tick-borne encephalitis vaccinations given, and (3) visits made to

in-theater health units. More specifically, we found that 19 percent of the

postdeployment in-theater medical assessments and 9 percent of the

postdeployment home unit medical assessments were not documented in

the medical records. These documentation problems were attributed to

the fact that this was a paper-based system that relied upon

servicemembers to hand carry assessment forms from the theater to their

home unit, which maintained the permanent medical record.

Regarding the documentation of tick-borne encephalitis vaccine in Bosnia,

servicemembers deploying to regions where the threat of this disease was

prevalent were given the choice of being inoculated with this

investigational drug vaccine.3

 We found that 141 (24 percent) of the 588

3

An investigational drug is a new drug or product regulated by FDA that has not been licensed for

general use in the United States.

Page 6 GAO/T-NSIAD-98-83
medical records reviewed for servicemembers who had received the

vaccine lacked required documentation.

Our tests of the completeness of the permanent medical records for

servicemembers’ visits made to battalion aid stations in Bosnia showed

similar problems. Specifically, we found that there was no documentation

in the medical records for 44 (29.3 percent) of the 150 visits we reviewed.

Army officials mentioned that permanent medical records were still

paper-based and that information was subject to being misfiled or lost.

They also pointed out that servicemembers had deployed to the theater

with only an abstract of their permanent medical records and that any

medical documentation generated in the theater was to have been routed

back to the servicemembers’ home units for inclusion into their medical

records.

DOD officials told us that a solution to these documentation problems

would be the development of a deployable, computerized patient record.

DOD has a project underway to have a paperless computerized medical

record for every active duty servicemember by fiscal year 2000.

Centralized Database for

Monitoring Program

Implementation Must Be

Accurate

Without an adequate centralized monitoring system, DOD will not have

reasonable assurances that the program is being implemented as planned.

For Operation Joint Endeavor, DOD established a centralized database to

track the services’ progress in implementing its medical surveillance

program. Medical units processing medical assessments were required to

send copies of assessment forms to the DOD office maintaining the

centralized database in the United States.

In testing the completeness of the centralized database for in-theater and

home unit postdeployment medical assessments conducted for 618

servicemembers, we found that the database understated the number of

assessments done. More specifically, it omitted 12 percent of the in-theater

medical assessments and 52 percent of the home unit medical

assessments.

DOD officials told us that they plan to use a new automated system for

tracking implementation of the anthrax immunization program from

locations around the world. The automated system is still being developed.

Page 7 GAO/T-NSIAD-98-83
Efficient Inventory

Controls Are Necessary to

Ensure Sufficiency of

Vaccine Supply

To ensure that military personnel will receive vaccinations in a timely

manner and to effectively manage the program, it is important for DOD to

maintain an efficient inventory control system. This system is needed to

ensure that (1) sufficient supplies of vaccines will be available at the

various worldwide immunization sites; (2) vaccines that are older than

their 1-year shelf life are destroyed; and (3) records of vaccines received,

administered, and destroyed are kept to allow for monitoring and tracking.

For the Bosnia deployment, DOD experienced problems in accounting for

the inventory of the tick-borne encephalitis vaccine. DOD had to comply

with strict FDA regulations regarding its use because it was still being

tested as an investigational new drug. Regulations required DOD to fully

account for vaccine inventories, including the number of doses

administered and the number of doses destroyed.

In the spring of 1996, officials from the U.S. Army Medical Research

Institute of Infectious Diseases (USAMRIID) went to Bosnia to review the

procedures being used to administer the tick-borne encephalitis vaccine.

These officials found that no record of vaccine disposition was being

maintained and recommended that all vaccination sites perform a physical

inventory and maintain data on vaccines on hand, used, and destroyed.

USAMRIID officials met with considerable resistance from some medical

personnel responsible for administering the vaccine about the need to

keep proper records. They told us that some of the personnel seemed

more interested in administering the vaccine than in keeping necessary

records.

Our work on the Bosnia deployment in 1997 showed that the problems

identified by USAMRIID had not been corrected. More specifically, DOD could

not account for more than 3,000 (20 percent) of the total number of doses

sent to Bosnia. Since our report was issued in April 1997, officials from the

Office of the Army Surgeon General informed us that most of the missing

doses had been destroyed and only 242 doses remained unaccounted for.

Conclusions In conclusion, we believe that DOD has moved in the right direction in

increasing its emphasis on improving its chemical and biological defense

capabilities. Increased emphasis by the commanders in chief in their areas

of responsibility, a DOD-wide spending increase leading to increased

numbers of fielded chemical and biological detection and protective

equipment, and planned procurements of equipment over the next several

years will make U.S. forces better prepared to deal with chemical and

Page 8 GAO/T-NSIAD-98-83
biological weapons than in the past. However, greater diligence and more

action is needed by DOD to maintain progress toward achieving a level of

protection for our forces that will enable us to achieve wartime objectives.

This latest initiative to immunize the forces against anthrax represents a

clear recognition of this threat to U.S. servicemembers. But DOD must

overcome past deficiencies in its medical record-keeping practices and

make sure supplies of vaccine are available if this new program is to be

successful. In this regard, we reiterate that DOD needs to have the means to

(1) identify those servicemembers that require immunization, (2) ensure

sufficient command emphasis to guarantee that those identified for

immunization are immunized, (3) maintain an accurate medical record of

immunizations for each servicemember, (4) manage large-scale

immunizations through accurate central databases, and (5) ensure that

vaccine inventories are appropriately controlled to ensure that sufficient

supplies are on hand.

This concludes my prepared remarks. We would be happy to respond to

any questions the Committee may have.

Page 9 GAO/T-NSIAD-98-83
Page 10 GAO/T-NSIAD-98-83
Page 11 GAO/T-NSIAD-98-83
Related GAO Reports on Chemical and

Biological Defense

Gulf War Illnesses: Public and Private Efforts Relating to Exposures of

U.S. Personnel to Chemical Agents (GAO/NSIAD-98-27, Oct. 15, 1997) .

Combating Terrorism: Status of DOD Efforts to Protect Its Forces Overseas

(GAO/NSIAD-97-207, July 21, 1997).

Gulf War Illnesses: Improved Monitoring of Clinical Progress and

Reexamination of Research Emphasis Are Needed (GAO/NSIAD-97-163,

June 23, 1997).

Defense Health Care: Medical Surveillance Improved Since Gulf War, but

Mixed Results in Bosnia (GAO/NSIAD-97-136, May 13, 1997).

Chemical and Biological Defense: Emphasis Remains Insufficient to

Resolve Continuing Problems (GAO/NSIAD-96-103, Mar. 29, 1996).

(703231) Page 12 GAO/T-NSIAD-98-83
Ordering Information

The first copy of each GAO report and testimony is free.

Additional copies are $2 each. Orders should be sent to the

following address, accompanied by a check or money order

made out to the Superintendent of Documents, when

necessary. VISA and MasterCard credit cards are accepted, also.

Orders for 100 or more copies to be mailed to a single address

are discounted 25 percent.

Orders by mail:

U.S. General Accounting Office

P.O. Box 37050

Washington, DC 20013

or visit:

Room 1100

700 4th St. NW (corner of 4th and G Sts. NW)

U.S. General Accounting Office

Washington, DC

Orders may also be placed by calling (202) 512-6000 

or by using fax number (202) 512-6061, or TDD (202) 512-2537.

Each day, GAO issues a list of newly available reports and

testimony. To receive facsimile copies of the daily list or any

list from the past 30 days, please call (202) 512-6000 using a

touchtone phone. A recorded menu will provide information on

how to obtain these lists.

For information on how to access GAO reports on the INTERNET,

send an e-mail message with "info" in the body to:

info@www.gao.gov

or visit GAO’s World Wide Web Home Page at:

http://www.gao.gov

PRINTED ON RECYCLED PAPER
United States

General Accounting Office

Washington, D.C. 20548-0001

Official Business

Penalty for Private Use $300

Address Correction Requested

Bulk Rate

Postage & Fees Paid

GAO

Permit No. G100