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United States General Accounting Office: 
GAO: 

Testimony: 

Before the Committee on Energy and Commerce, House of Representatives: 

For Release on Delivery: 
Expected at 10:00 a.m. 
Thursday, November 15, 2001: 

Bioterrorism: 

The Centers for Disease Control and Prevention's Role in Public Health 
Protection: 

Statement for the Record by Janet Heinrich: 
Director, Health CareóPublic Health Issues: 

GAO-02-235T: 

Mr. Chairman and Members of the Committee: 

I appreciate the opportunity to submit this statement for the record
discussing our work on the Centers for Disease Control and Preventionís
(CDC) activities to prepare the nation to respond to the public health 
and medical consequences of a bioterrorist attack. [Footnote 1] The 
country is now dealing with anthrax exposures resulting from the agent 
being sent through the mail and the consequences of dealing with even 
limited exposures have proven to be quite significant. Prior to the 
recent anthrax incidents, a domestic bioterrorist attack had been 
considered to be a low-probability event, in part because of the 
various difficulties involved in successfully delivering biological 
agents to achieve large-scale casualties. [Footnote 2] 

On September 28, 2001, we released a report [Footnote 3] that describes 
(1) the research and preparedness activities being undertaken by federal
departments and agencies to manage the consequences of a bioterrorist
attack, (2) the coordination of these activities, and (3) the findings 
of reports on the preparedness of state and local jurisdictions to 
respond to a bioterrorist attack. This statement will summarize our 
findings in the September report regarding CDCís research and 
preparedness activities on bioterrorism and augments our previous work 
on combating terrorism. [Footnote 4] Specifically, we will focus on 
CDCís research and preparedness activities on bioterrorism, and 
remaining gaps that could hamper the response to a bioterrorist event. 

In summary, CDC has a variety of ongoing research and preparedness
activities related to bioterrorism. Most of CDCís activities to counter
bioterrorism are focused on building and expanding public health
infrastructure [Footnote 5] at the federal, state, and local levels. 
These include funding research on anthrax and smallpox vaccines, 
increasing laboratory capacity, and building a national pharmaceutical 
stockpile of drugs and supplies to be used in an emergency. Since CDCís 
bioterrorism program began in 1999, funding increased 43 percent in 
fiscal year 2000 and an additional 12 percent in fiscal year 2001. 
While the percentage increases are substantial, they reflect only a $73 
million increase in overall spending because many of the activities 
initially received relatively small allocations. Gaps in CDCís 
activities could hamper the response to a bioterrorist attack. For 
instance, laboratories at all levels can quickly become overwhelmed 
with requests for tests. In addition, there is a notable lack of 
training focused on detecting and responding to bioterrorist threats. 

Background: 

Although many aspects of an effective response to bioterrorism are the
same as those for any form of terrorism, there are some unique features.
For example, if a biological agent is released covertly, it may not be
recognized for a week or more because symptoms may not appear for
several days after the initial exposure and may be misdiagnosed at 
first. In addition, some biological agents, such as smallpox, are 
communicable and can spread to others who were not initially exposed. 
These characteristics require responses that are unique to 
bioterrorism, including health surveillance, [Footnote 6] epidemiologic 
investigation, [Footnote 7] laboratory identification of biological 
agents, and distribution of antibiotics to large segments of the 
population to prevent the spread of an infectious disease. However, some
aspects of an effective response to bioterrorism are also important in
responding to any type of large-scale disaster, such as providing
emergency medical services, continuing health care services delivery, 
and, potentially, managing mass fatalities. 

The burden of responding to bioterrorist incidents falls initially on
personnel in state and local emergency response agencies. These ďfirst
respondersĒ include firefighters, emergency medical service personnel,
law enforcement officers, public health officials, health care workers
(including doctors, nurses, and other medical professionals), and public
works personnel. If the emergency requires federal disaster assistance,
federal departments and agencies will respond according to
responsibilities outlined in the Federal Response Plan. [Footnote 8] 

Under the Federal Response Plan, CDC is the lead Department of Health
and Human Services (HHS) agency providing assistance to state and local
governments for five functions: (1) health surveillance, (2) worker 
health and safety, (3) radiological, chemical, and biological hazard 
consultation, (4) public health information, and (5) vector control. 
[Footnote 9] Each of these functions is described in table 1. 

Table 1: CDCís Functions Under the Federal Response Plan: 

Function: Health surveillance; 
Description of function: Assist in establishing surveillance systems to 
monitor the general population and special high-risk population 
segments; carry out field studies and investigations; monitor injury 
and disease patterns and potential disease outbreaks; and provide 
technical assistance and consultations on disease and injury prevention 
and precautions. 

Function: Worker health and safety; 
Description of function: Assist in monitoring health and well-being of 
emergency workers; perform field investigations and studies; and 
provide technical assistance and consultation on worker health and 
safety measures and precautions. 

Function: Radiological, chemical, and biological hazard consultation; 
Description of function: Assist in assessing health and medical effects 
of radiological, chemical, and biological exposures on the general 
population and on high-risk population groups; conduct field 
investigations, including collection and analysis of relevant samples; 
advise on protective actions related to direct human and animal 
exposure, and on indirect exposure through radiologically, chemically, 
or biologically contaminated food, drugs, water supply, and other 
media; and provide technical assistance and consultation on medical
treatment and decontamination of radiologically, chemically, or 
biologically injured or contaminated victims. 

Function: Public health information; 
Description of function: Assist by providing public health and disease 
and injury prevention information that can be transmitted to members of 
the general public who are located in or near areas affected by a major 
disaster or emergency. 

Function: Vector control; 
Description of function: Assist in assessing the threat of vector-borne 
diseases following a major disaster or emergency; conduct field 
investigations, including the collection and laboratory analysis of 
relevant samples; provide vector control equipment and supplies; 
provide technical assistance and consultation on protective actions 
regarding vector-borne diseases; and provide technical assistance and 
consultation on medical treatment of victims of vector-borne diseases. 

Source: The Health and Medical Services Annex in the Federal Response 
Plan, April 1999. 

[End of table] 

HHS is currently leading an effort to work with governmental and
nongovernmental partners to upgrade the nationís public health
infrastructure and capacities to respond to bioterrorism. [Footnote 10] 
As part of this effort, several CDC centers, institutes, and offices 
work together in the agencyís Bioterrorism Preparedness and Response 
Program. The principal priority of CDCís program is to upgrade 
infrastructure and capacity to respond to a large-scale epidemic, 
regardless of whether it is the result of a bioterrorist attack or a 
naturally occurring infectious disease outbreak. The program was 
started in fiscal year 1999 and was tasked with building and enhancing 
national, state, and local capacity; developing a national 
pharmaceutical stockpile; and conducting several independent studies on
bioterrorism. 

CDCís Research and Preparedness Activities on Bioterrorism: 

CDC is conducting a variety of activities related to research on and
preparedness for a bioterrorist attack. Since CDCís program began 3 
years ago, funding for these activities has increased. Research 
activities focus on detection, treatment, vaccination, and emergency 
response equipment. Preparedness efforts include increasing state and 
local response capacity, increasing CDCís response capacity, 
preparedness and response planning, and building the National 
Pharmaceutical Stockpile Program. 

Trends in CDCís Funding for Bioterrorism Activities: 

The funding for CDCís activities related to research on and preparedness
for a bioterrorist attack has increased 61 percent over the past 2 
years. See table 2 for reported funding for these activities. 

Table 2: Reported Funding for CDCís Bioterrorism Preparedness and 
Response Program Activities (Dollars in millions): 
 
Fiscal year 1999: 
Fiscal year 2000: 
Fiscal year 2001: 

Program/initiative[A]: Research activities: Research and development; 
Fiscal year 1999: 0; 
Fiscal year 2000: $40.5; 
Fiscal year 2001: $42.9. 

Program/initiative[A]: Research activities: Independent studies[B]; 
Fiscal year 1999: $1.8; 
Fiscal year 2000: $7.7; 
Fiscal year 2001: $2.6. 

Program/initiative[A]: Research activities: Worker safety; 
Fiscal year 1999: 0; 
Fiscal year 2000: 0; 
Fiscal year 2001: $1.1. 

Program/initiative[A]: Preparedness activities: Upgrading state and 
local capacity; 
Fiscal year 1999: $55.0; 
Fiscal year 2000: $56.9; 
Fiscal year 2001: $66.7. 

Program/initiative[A]: Preparedness activities: Upgrading state and 
local capacity: Preparedness planning; 
Fiscal year 1999: $2.0; 
Fiscal year 2000: $1.9; 
Fiscal year 2001: $5.8. 

Program/initiative[A]: Preparedness activities: Upgrading state and 
local capacity: Surveillance and epidemiology; 
Fiscal year 1999: $12.0; 
Fiscal year 2000: $15.8; 
Fiscal year 2001: $16.1. 

Program/initiative[A]: Preparedness activities: Upgrading state and 
local capacity: Laboratory capacity; 
Fiscal year 1999: $13.0; 
Fiscal year 2000: $9.5; 
Fiscal year 2001: $12.8. 

Program/initiative[A]: Preparedness activities: Upgrading state and 
local capacity: Communications; 
Fiscal year 1999: $28.0; 
Fiscal year 2000: $29.7; 
Fiscal year 2001: $32.0. 

Program/initiative[A]: Upgrading CDC capacity: 
Fiscal year 1999: $12.0; 
Fiscal year 2000: $13.9; 
Fiscal year 2001: $20.4. 

Program/initiative[A]: Upgrading CDC capacity: Epidemiologic capacity; 
Fiscal year 1999: $2.0; 
Fiscal year 2000: $1.8; 
Fiscal year 2001: $4.0. 

Program/initiative[A]: Upgrading CDC capacity: Laboratory capacity; 
Fiscal year 1999: $5.0; 
Fiscal year 2000: $7.6; 
Fiscal year 2001: $11.4. 

Program/initiative[A]: Upgrading CDC capacity: Rapid toxic screening; 
Fiscal year 1999: $5.0; 
Fiscal year 2000: $4.5; 
Fiscal year 2001: $5.0. 

Program/initiative[A]: Preparedness and response planning; 
Fiscal year 1999: $1.0; 
Fiscal year 2000: $2.3; 
Fiscal year 2001: $9.2. 

Program/initiative[A]: Building the National Pharmaceutical Stockpile 
Program; 

Fiscal year 1999: $51.0; 
Fiscal year 2000: $51.8; 
Fiscal year 2001: $51.0. 

Program/initiative[A]: Total; 
Fiscal year 1999: $120.8; 
Fiscal year 2000: $173.1; 
Fiscal year 2001: $193.9. 

Note: We have not audited or otherwise verified the information 
provided. 

[A] CDC also received funding in fiscal year 1999, fiscal year 2000, 
and fiscal year 2001 for bioterrorism deterrence activities, such as 
implementing regulations restricting the importation of certain 
biological agents. That funding is not included here. 

[B] For instance, $1 million was specified in the fiscal year 2000 
appropriations conference report for the Carnegie Mellon Research 
Institute to study health and bioterrorism threats. 

Source: CDC. 

[End of table] 

Funding for CDCís Bioterrorism Preparedness and Response Program
grew approximately 43 percent in fiscal year 2000 and an additional 12
percent in fiscal year 2001. While the percentage increases are 
significant, they reflect only a $73 million increase because many of 
the programs initially received relatively small allocations. 
Approximately $45 million of the overall two-year increase was due to 
new research activities. 

Relative changes in funding for the various components of CDCís
Bioterrorism Preparedness and Response Program are shown in Figure 1.
Funding for research activities increased sharply from fiscal year 1999 
to fiscal year 2000, and then dropped slightly in fiscal year 2001. The 
increase in fiscal year 2000 was largely due to a $40.5 million 
increase in research funding for studies on anthrax and smallpox. 
Funding for preparedness and response planning, upgrading CDC capacity, 
and upgrading state and local capacity was relatively constant between 
fiscal year 1999 and fiscal year 2000 and grew in fiscal year 2001. For 
example, funding increased to upgrade CDC capacity by 47 percent and to 
upgrade state and local capacity by 17 percent in fiscal year 2001. The 
National Pharmaceutical Stockpile Program experienced a slight increase 
in funding of 2 percent in fiscal year 2000 and a slight decrease in 
funding of 2 percent in fiscal year 2001. 

Figure 1: CDCís Bioterrorism Preparedness and Response Program Funding: 

[See PDF for image] 

This figure is a multiple line graph illustrating CDCís Bioterrorism 
Preparedness and Response Program Funding. The vertical axis of the 
graph represents dollars in millions from 0 to 70. The horizontal axis 
of the graph represents fiscal years 1999, 2000, and 2001. The 
following data is approximated from the graph: 

Fiscal year: 1999; 
Research Activities: approximately $0; 
Upgrading State and Local Capacity: approximately $55 million; 
Upgrading CDC Capacity: approximately $12 million; 
Preparedness and Response Planning: approximately $0; 
National Pharmaceutical Stockpile Program: approximately $51 million. 

Fiscal year: 2000; 
Research Activities: approximately $48 million; 
Upgrading State and Local Capacity: approximately $57 million; 
Upgrading CDC Capacity: approximately $14 million; 
Preparedness and Response Planning: approximately $3 million; 
National Pharmaceutical Stockpile Program: approximately $53 million. 

Fiscal year: 2001; 
Research Activities: approximately $46 million; 
Upgrading State and Local Capacity: approximately $67 million; 
Upgrading CDC Capacity: approximately $21 million; 
Preparedness and Response Planning: approximately $9 million; 
National Pharmaceutical Stockpile Program: approximately $51 million. 

Source: GAO analysis of CDC data. 

[End of figure] 

Research Activities: 

CDCís research activities focus on detection, treatment, vaccination, 
and emergency response equipment. In fiscal year 2001, CDC was 
allocated $18 million to continue research on an anthrax vaccine and 
associated issues, such as scheduling and dosage. The agency also 
received $22.4 million in fiscal year 2001 to conduct smallpox 
research. In addition, CDC oversees a number of independent studies, 
which fund specific universities and hospitals to do research and other 
work on bioterrorism. For example, funding in fiscal year 2001 included 
$941,000 to the University of Findlay in Findlay, Ohio, to develop 
training for health care providers and other hospital staff on how to 
handle victims who come to an emergency department during a 
bioterrorist incident. Another $750,000 was provided to the University 
of Texas Medical Branch in Galveston, Texas, to study various viruses 
in order to discover means to prevent or treat infections by these and 
other viruses (such as Rift Valley Fever and the smallpox virus). For 
worker safety, CDCís National Institute for Occupational Safety and 
Health is developing standards for respiratory protection equipment used
against biological agents by firefighters, laboratory technicians, and 
other potentially affected workers. 

Preparedness Activities: 

Most of CDCís activities to counter bioterrorism are focused on building
and expanding public health infrastructure at the federal, state, and 
local levels. For example, CDC reported receiving funding to upgrade 
state and local capacity to detect and respond to a bioterrorist 
attack. CDC received additional funding for upgrading its own capacity 
in these areas, for preparedness and response planning, and for 
developing the National Pharmaceutical Stockpile Program. In addition 
to preparing for a bioterrorist attack, these activities also prepare 
the agency to respond to other challenges, such as identifying and 
containing a naturally occurring emerging infectious disease. 

Upgrading State and Local Capacity: 

CDC provides grants, technical support, and performance standards to
support bioterrorism preparedness and response planning at the state and
local levels. In fiscal year 2000, CDC funded 50 states and four major
metropolitan health departments for preparedness and response 
activities. CDC is developing planning guidance for state public health 
officials to upgrade state and local public health departmentsí 
preparedness and response capabilities. In addition, CDC has worked 
with the Department of Justice to complete a public health assessment 
tool, which is being used to determine the ability of state and local 
public health agencies to respond to release of biological and chemical 
agents, as well as other public health emergencies. Ten states 
(Florida, Hawaii, Maine, Michigan, Minnesota, Pennsylvania, Rhode 
Island, South Carolina, Utah, and Wisconsin) have completed the 
assessment, and others are currently completing it. 

States have received funding from CDC to increase staff, enhance 
capacity to detect the release of a biological agent or an emerging 
infectious disease, and improve communications infrastructure. In 
fiscal year 1999, for example, a total of $7.8 million was awarded to 
41 state and local health agencies to improve their ability to link 
different sources of data, such as sales of certain pharmaceuticals, 
which could be helpful in detecting a covert bioterrorist event. 

Rapid identification and confirmatory diagnosis of biological agents are
critical to ensuring that prevention and treatment measures can be
implemented quickly. CDC was allocated $13 million in fiscal year 1999 
to enhance state and local laboratory capacity. CDC has established a
Laboratory Response Network of federal, state, and local laboratories 
that maintain state-of-the-art capabilities for biological agent 
identification and characterization of human clinical samples such as 
blood. CDC has provided technical assistance and training in 
identification techniques to state and local public health 
laboratories. In addition, five state health departments received 
awards totaling $3 million to enhance chemical laboratory capabilities 
from the fiscal year 2000 funds. The states used these funds to 
purchase equipment and provide training. 

CDC is working with state and local health agencies to improve 
electronic infrastructure for public health communications for the 
collection and transmission of information related to a bioterrorism 
incident as well as other events. For example, $21 million was awarded 
to states in fiscal year 1999 to begin implementation of the Health 
Alert Network, which will support the exchange of key information over 
the Internet and provide a means to conduct distance training that 
could potentially reach a large segment of the public health community. 
Currently, 13 states are connected to all of their local jurisdictions. 
CDC is also directly connected to groups such as the American Medical 
Association to reach healthcare providers. 

CDC has described the Health Alert Network as a ďhighwayĒ on which
programs, such as the National Electronic Disease Surveillance System
(NEDSS) and the Epidemic Information Exchange (Epi-X), will run.
NEDSS is designed to facilitate the development of an integrated, 
coherent national system for public health surveillance. Ultimately, it 
is meant to support the automated collection, transmission, and 
monitoring of disease data from multiple sources (for example, 
clinicianís offices and laboratories) from local to state health 
departments to CDC. This year, a total of $10.9 million will go to 36 
jurisdictions for new or continuing NEDSS activities. Epi-X is a 
secure, Web-based exchange for public health officials to rapidly 
report and discuss disease outbreaks and other health events 
potentially related to bioterrorism as they are identified and 
investigated. 

Upgrading CDC Capacity: 

CDC is upgrading its own epidemiologic and disease surveillance 
capacity. It has deployed, and is continuing to enhance, a surveillance 
system to increase surveillance and epidemiological capacities before, 
during, and after special events (such as the 1999 World Trade 
Organization meeting in Seattle). Besides improving emergency response 
at the special events, the agency gains valuable experience in 
developing and practicing plans to combat terrorism. In addition, CDC 
monitors unusual clusters of illnesses, such as influenza in June. 
Although unusual clusters are not always a cause for concern, they can 
indicate a potential problem. The agency is also increasing its 
surveillance of disease outbreaks in animals. 

CDC has strengthened its own laboratory capacity. For example, it is
developing and validating new diagnostic tests as well as creating 
agent-specific detection protocols. In collaboration with the 
Association of Public Health Laboratories and the Department of 
Defense, CDC has started a secure Web-based network that allows state, 
local, and other public health laboratories access to guidelines for 
analyzing biological agents. The site also allows authenticated users 
to order critical reagents [Footnote 11] needed in performing 
laboratory analysis of samples. 

The agency has also opened a Rapid Response and Advance Technology
Laboratory, which screens samples for the presence of suspicious
biological agents and evaluates new technology and protocols for the
detection of biological agents. These technology assessments and
protocols, as well as reagents and reference samples, are being shared
with state and local public health laboratories. 

Preparedness and Response Planning: 

One activity CDC has undertaken is the implementation of a national
bioterrorism response training plan. This plan focuses on preparing CDC
officials to respond to bioterrorism and includes the development of
exercises to assess progress in achieving bioterrorism preparedness at 
the federal, state, and local levels. The agency is also developing a 
crisis communications/media response curriculum for bioterrorism, as 
well as core capabilities guidelines to assist states and localities in 
their efforts to build comprehensive anti-bioterrorism programs. 

CDC has developed a bioterrorism information Web site. This site 
provides emergency contact information for state and local officials in 
the event of possible bioterrorism incidents, a list of critical 
biological and chemical agents, summaries of state and local 
bioterrorism projects, general information about CDCís bioterrorism 
initiative, and links to documents on bioterrorism preparedness and 
response. 

Building the National Pharmaceutical Stockpile Program: 

The National Pharmaceutical Stockpile Program maintains a repository of
life-saving pharmaceuticals, antidotes, and medical supplies, known as 
12-Hour Push Packages, that could be used in an emergency, including a
bioterrorist attack. The packages can be delivered to the site of a
biological (or chemical) attack within 12 hours of deployment for the
treatment of civilians. The first emergency use of the National
Pharmaceutical Stockpile occurred on September 11, 2001, when in
response to the terrorist attack on the World Trade Center, CDC released
one of the eight Push Packages. 

The National Pharmaceutical Stockpile also includes additional 
antibiotics, antidotes, other drugs, medical equipment, and supplies,
known as the Vendor Managed Inventory, that can be delivered within 24
to 36 hours after the appropriate vendors are notified. Deliveries from 
the Vendor Managed Inventory can be tailored to an individual incident. 
The program received $51.0 million in fiscal year 1999, $51.8 million 
in fiscal year 2000, and $51.0 million in fiscal year 2001. CDC and the 
Office of Emergency Preparedness (another agency in HHS that also 
maintains a stockpile of medical supplies) have encouraged state and 
local representatives to consider stockpile assets in their emergency 
planning for a biological attack and have trained representatives from 
state and local authorities in using the stockpile. The stockpile 
program also provides technical advisers in response to an event to 
ensure the appropriate and timely transfer of stockpile contents to 
authorized state representatives. [Footnote 12] Recently, individuals 
who may have been exposed to anthrax through the mail have been given 
antibiotics from the Vendor Managed Inventory. 

Gaps in CDCís Research and Preparedness Activities for Bioterrorism: 

While CDC has funded research and preparedness programs for 
bioterrorism, a great deal of work remains to be done. CDC and HHS have
identified gaps in bioterrorism research and preparedness that need to 
be addressed. In addition, some of our work on naturally occurring 
diseases also also indicates gaps in preparedness that would be 
important in the event of a bioterrorist attack. 

Research Activities: 

Gaps in research activities center on vaccines and field testing for
infectious agents. CDC has reported that it needs to continue the 
smallpox vaccine development and production contract begun in fiscal 
year 2000. This includes clinical testing of the vaccine and submitting 
a licensing application to the Food and Drug Administration for the 
prevention of smallpox in adults and children. [Footnote 13] CDC also 
plans to conduct further studies of the anthrax vaccine. This research 
will include studies to better understand the immunological response 
that correlates with protection against inhalation anthrax and risk 
factors for adverse events as well as investigating modified 
vaccination schedules that could maintain protection and result in 
fewer adverse reactions. The agency has also indicated that it needs to 
continue research in the area of rapid assay tests to allow field 
diagnosis of a biological or chemical agent. 

Preparedness Activities: 

Gaps remain in all of the areas of preparedness activities under CDCís
program. In particular, there are many unmet needs in upgrading state 
and local capacity to respond to a bioterrorist attack. There are also 
further needs in upgrading CDCís capacity, preparedness and response 
planning, and building the National Pharmaceutical Stockpile. 

Upgrading State and Local Capacity: 

Health officials at many levels have called for CDC to support 
bioterrorism planning efforts at the state and local level. In a series 
of regional meetings from May through September 2000 to discuss issues 
associated with developing comprehensive bioterrorism response plans, 
state and local officials identified a need for additional federal 
support of their planning efforts. This includes federal efforts to 
develop effective written planning guidance for state and local health 
agencies and to provide on-site assistance that will ensure optimal 
preparedness and response. 

HHS has noted that surveillance capabilities need to be increased. In
addition to enhancing traditional state and local capabilities for 
infectious disease surveillance, HHS has recognized the need to expand 
surveillance beyond the boundaries of the public health departments. In 
the departmentís FY 2002óFY 2006 Plan for Combating Bioterrorism, HHS
notes that potential sources for data on morbidity trends include 911
emergency calls, reasons for emergency department visits, hospital bed
usage, and the purchase of specific products at pharmacies. Improved
monitoring of food is also necessary to reduce its vulnerability as an
avenue of infection and of terrorism. Other sources beyond public health
departments can provide critical information for detection and
identification of an outbreak. For example, the 1999 West Nile virus
outbreak showed the importance of links with veterinary surveillance. 
[Footnote 14] Initially there were two separate investigations: one of 
sick people, the other of dying birds. Once the two investigations 
converged, the link was made, and the virus was correctly identified. 

HHS has found that state and local laboratories need to continue to
upgrade their facilities and equipment. The department has stated that 
it would be beneficial if research, hospital, and commercial 
laboratories that have state-of-the-art equipment and well-trained 
staff were added to the National Laboratory Response Network. 
Currently, there are 104 laboratories in the network that can provide 
testing of biological samples for detection and confirmation of 
biological agents. Based on the 2000 regional meetings, CDC concluded 
that it needs to continue to support the laboratory network and 
identify opportunities to include more clinical laboratories to provide 
additional surge capacity. 

CDC also concluded from the 2000 regional meetings that, although it has
begun to develop information systems, it needs to continue to enhance
these systems to detect and respond to biological and chemical 
terrorism. HHS has stated that the work that has begun on the Health 
Alert Network, NEDSS, and Epi-X needs to continue. One aspect of this 
work is developing, testing, and implementing standards that will permit
surveillance data from different systems to be easily shared. 

During the West Nile virus outbreak, while a secure electronic 
communication network was in place at the time of the initial outbreak,
not all involved agencies and officials were capable of using it at the 
same time. For example, because CDCís laboratory was not linked to the 
New York State network, the New York State Department of Health had to 
act as an intermediary in sharing CDCís laboratory test results with 
local health departments. CDC and the New York State Department of 
Health laboratory databases were not linked to the database in New York 
City, and laboratory results consequently had to be manually entered 
there. These problems slowed the investigation of the outbreak. 

Moreover, we have testified that there is also a notable lack of 
training focused on detecting and responding to bioterrorist threats. 
[Footnote 15] Most physicians and nurses have never seen cases of 
certain diseases, such as smallpox or plague, and some biological 
agents initially produce symptoms that can be easily confused with 
influenza or other, less virulent illnesses, leading to a delay in 
diagnosis or identification. Medical laboratory personnel require 
training because they also lack experience in identifying biological 
agents such as anthrax. 

Upgrading CDC Capacity: 

HHS has stated that epidemiologic capacity at CDC also needs to be
improved. A standard system of disease reporting would better enable
CDC to monitor disease, track trends, and intervene at the earliest 
sign of unusual or unexplained illness. 

HHS has noted that CDC needs to enhance its in-house laboratory
capabilities to deal with likely terrorist agents. CDC plans to develop
agent-specific detection and identification protocols for use by the
laboratory response network, a research agenda, and guidelines for
laboratory management and quality assurance. CDC also plans further
development of its Rapid Response and Advanced Technology Laboratory. 

As we reported in September 2000, even the West Nile virus outbreak,
which was relatively small and occurred in an area with one of the 
nationís largest local public health agencies, taxed the federal, 
state, and local laboratory resources. Both the New York State and the 
CDC laboratories were quickly inundated with requests for tests during 
the West Nile virus outbreak, and because of the limited capacity at 
the New York laboratories, the CDC laboratory handled the bulk of the 
testing. Officials indicated that the CDC laboratory would have been 
unable to respond to another outbreak, had one occurred at the same 
time. 

Preparedness and Response Planning: 

CDC plans to work with other agencies in HHS to develop guidance to
facilitate preparedness planning and associated investments by local-
level medical and public health systems. The department has stated that 
to the extent that the guidance can help foster uniformity across local 
efforts with respect to preparedness concepts and structural and 
operational strategies, this would enable government units to work more 
effectively together than if each local approach was essentially 
unique. More generally, CDC has found a need to implement a national 
strategy for public health preparedness for bioterrorism, and to work 
with federal, state, and local partners to ensure communication and 
teamwork in response to a potential bioterrorist incident. 

Planning needs to continue for potential naturally occurring epidemics 
as well. In October 2000, we reported that federal and state influenza
pandemic plans are in various stages of completion and do not completely
or consistently address key issues surrounding the purchase, 
distribution, and administration of vaccines and antiviral drugs. 
[Footnote 16] At the time of our report, 10 states either had developed 
or were developing plans using general guidance from CDC, and 19 more 
states had plans under development. Outstanding issues remained, 
however, because certain key federal decisions had not been made. For 
example, HHS had not determined the proportion of vaccines and 
antiviral drugs to be purchased, distributed, and administered by the 
public and private sectors or established priorities for which 
population groups should receive vaccines and antiviral drugs first 
when supplies are limited. As of July 2001, HHS continued to work on a 
national plan. As a result, policies may differ among states and 
between states and the federal government, and in the event of a 
pandemic, these inconsistencies could contribute to public confusion 
and weaken the effectiveness of the public health response. 

Building the National Pharmaceutical Stockpile: 

The recent anthrax incidents have focused a great deal of attention on 
the national pharmaceutical stockpile. Prior to this, in its FY2002 Ė 
FY 2006 Plan for Combating Bioterrorism, HHS had indicated what actions 
would be necessary regarding the stockpile over the next several years. 
These included purchasing additional products so that pharmaceuticals 
were available for treating additional biological agents in fiscal year 
2002, and conducting a demonstration project that incorporates the 
National Guard in planning for receipt, transport, organization, 
distribution, and dissemination of stockpile supplies in fiscal year 
2003. CDC also proposed providing grants to cities in fiscal year 2004 
to hire a stockpile program coordinator to help the community develop a 
comprehensive plan for handling the stockpile and organizing volunteers 
trained to manage the stockpile during a chemical or biological event. 
Clearly, these longer range plans are changing, but the need for these 
activities remains. 

Contact and Acknowledgments: 

For further information about this statement, please contact me at (202)
512-7118. Robert Copeland, Marcia Crosse, Greg Ferrante, David Gootnick,
Deborah Miller, and Roseanne Price also made key contributions to this
statement. 

[End of testimony] 

Related GAO Products: 

Homeland Security: A Risk Management Approach Can Guide Preparedness 
Efforts (GAO-02-208T, Oct. 31, 2001). 

Terrorism Insurance: Alternative Programs for Protecting Insurance
Consumers (GAO-02-199T, Oct. 24, 2001). 

Terrorism Insurance: Alternative Programs for Protecting Insurance
Consumers (GAO-02-175T, Oct. 24, 2001). 

Combating Terrorism: Considerations for Investing Resources in Chemical 
and Biological Preparedness (GAO-02-162T, Oct. 17, 2001). 

Homeland Security: Need to Consider VAís Role in Strengthening Federal
Preparedness (GAO-02-145T, Oct. 15, 2001). 

Homeland Security: Key Elements of a Risk Management Approach (GAO-02-
150T, Oct. 12, 2001). 

Bioterrorism: Review of Public Health Preparedness Programs (GAO-02-
149T, Oct. 10, 2001). 

Bioterrorism: Public Health and Medical Preparedness (GAO-02-141T,
Oct. 9, 2001). 

Bioterrorism: Coordination and Preparedness (GAO-02-129T, Oct. 5, 
2001). 

Bioterrorism: Federal Research and Preparedness Activities (GAO-01-915, 
Sept. 28, 2001). 

Combating Terrorism: Selected Challenges and Related Recommendations 
(GAO-01-822, Sept. 20, 2001). 

Combating Terrorism: Comments on H.R. 525 to Create a Presidentís 
Council on Domestic Terrorism Preparedness (GAO-01-555T, May 9, 2001). 

Combating Terrorism: Accountability Over Medical Supplies Needs Further 
Improvement (GAO-01-666T, May 1, 2001). 

Combating Terrorism: Observations on Options to Improve the Federal 
Response (GAO-01-660T, Apr. 24, 2001). 

Combating Terrorism: Accountability Over Medical Supplies Needs Further 
Improvement (GAO-01-463, Mar. 30, 2001). 

Combating Terrorism: Comments on Counterterrorism Leadership and 
National Strategy (GAO-01-556T, Mar. 27, 2001). 

Combating Terrorism: FEMA Continues to Make Progress in Coordinating 
Preparedness and Response (GAO-01-15, Mar. 20, 2001). 

Combating Terrorism: Federal Response Teams Provide Varied 
Capabilities; Opportunities Remain to Improve Coordination (GAO-01-14, 
Nov. 30, 2000). 

Influenza Pandemic: Plan Needed for Federal and State Response (GAO-01-
4, Oct. 27, 2000). 

West Nile Virus Outbreak: Lessons for Public Health Preparedness 
(GAO/HEHS-00-180, Sept. 11, 2000). 

Combating Terrorism: Linking Threats to Strategies and Resources (GAO/T-
NSIAD-00-218, July 26, 2000). 

Chemical and Biological Defense: Observations on Nonmedical Chemical 
and Biological R&D Programs (GAO/T-NSIAD-00-130, Mar. 22, 2000). 

Combating Terrorism: Need to Eliminate Duplicate Federal Weapons of 
Mass Destruction Training (GAO/NSIAD-00-64, Mar. 21, 2000). 

Combating Terrorism: Chemical and Biological Medical Supplies Are 
Poorly Managed (GAO/T-HEHS/AIMD-00-59, Mar. 8, 2000). 

Combating Terrorism: Chemical and Biological Medical Supplies Are 
Poorly Managed (GAO/HEHS/AIMD-00-36, Oct. 29, 1999). 

Food Safety: Agencies Should Further Test Plans for Responding to 
Deliberate Contamination (GAO/RCED-00-3, Oct. 27, 1999). 

[End of section] 

Footnotes: 

[1] Bioterrorism is the threat or intentional release of biological 
agents (viruses, bacteria, or their toxins) for the purposes of 
influencing the conduct of government or intimidating or coercing a 
civilian population. 

[2] See Combating Terrorism: Need for Comprehensive Threat and Risk 
Assessments of Chemical and Biological Attacks (GAO/NSIAD-99-163, Sept. 
14, 1999), pp. 10-15, for a discussion of the level of difficulty a 
terrorist would face in attempting to cause mass casualties by making 
or using chemical or biological agents without the assistance of a
state-sponsored program. 

[3] See Bioterrorism: Federal Research and Preparedness Activities (GAO-
01-915, Sept. 28, 2001). This report was mandated by the Public Health 
Improvement Act of 2000 (P.L. 106-505, sec. 102). We conducted 
interviews with and obtained information from the Departments of 
Agriculture, Commerce, Defense, Energy, Health and Human Services 
(including CDC), Justice, Transportation, the Treasury, and Veterans 
Affairs; the Environmental Protection Agency; and the Federal Emergency 
Management Agency. 

[4] See the list of related GAO products at the end of this statement. 

[5] The public health infrastructure is the underlying foundation that 
supports the planning, delivery, and evaluation of public health 
activities and practices. 

[6] Health surveillance systems provide for the ongoing collection, 
analysis, and dissemination of data to prevent and control disease. 

[7] Epidemiological investigation is the study of patterns of health or 
disease and the factors that influence these patterns. 

[8] The Federal Response Plan, originally drafted in 1992 and updated 
in 1999, is authorized under the Robert T. Stafford Disaster Relief and 
Emergency Assistance Act (Stafford Act; P.L. 93-288, as amended). The 
plan outlines the planning assumptions, policies, concept of 
operations, organizational structures, and specific assignment of 
responsibilities to lead departments and agencies in providing federal 
assistance once the President has declared an emergency requiring 
federal assistance. 

[9] A vector is a carrier, such as an insect, that transmits the 
organisms of disease from infected to noninfected individuals. 

[10] Beyond CDC, other offices and agencies within HHS are involved in 
this effort, including the Agency for Healthcare Research and Quality, 
the Food and Drug Administration, the National Institutes of Health, 
and the Office of Emergency Preparedness. 

[11] A reagent is a substance used to detect the presence of another 
substance. 

[12] For more information on the National Pharmaceutical Stockpile 
Program, see Combating Terrorism: Accountability Over Medical Supplies 
Needs Further Improvement (GAO-01-463, Mar. 30, 2001). 

[13] Previous plans were for 40 million doses of the vaccine to be 
produced initially, with expected delivery of the first full-scale 
production lots in 2004. The department now plans to expand and 
accelerate production significantly. 

[14] See West Nile Virus Outbreak: Lessons for Public Health 
Preparedness (GAO/HEHS-00-180, Sept. 11, 2000). 

[15] See Bioterrorism: Review of Public Health Preparedness Programs 
(GAO-02-149T, Oct. 12, 2001). 

[16] See Influenza Pandemic: Plan Needed for Federal and State Response 
(GAO-01-4, Oct. 27, 2000). 

[End of section] 

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