Bioterrorism
The Centers for Disease Control and Prevention's Role in Public Health Protection Gao ID: GAO-02-235T November 15, 2001Federal research and preparedness activities related to bioterrorism center on detection; the development of vaccines, antibiotics, and antivirals; and the development of performance standards for emergency response equipment. Preparedness activities include (1) increasing federal, state, and local response capabilities; (2) developing response teams; (3) increasing the availability of medical treatments; (4) participating in and sponsoring exercises; (5) aiding victims; and (6) providing support at special events, such as presidential inaugurations and Olympic games. To coordinate their efforts to combat terrorism, federal agencies are developing interagency response plans, participating in various interagency work groups, and entering into formal agreements with other agencies to share resources and capabilities. However, coordination of federal terrorism research, preparedness, and response programs is fragmented, raising concerns about the ability of states and localities to respond to a bioterrorist attack. These concerns include insufficient state and local planning and a lack of hospital participation in training on terrorism and emergency response planning. This testimony summarizes a September 2001 report (GAO-01-915).
GAO-02-235T, Bioterrorism: The Centers for Disease Control and Prevention's Role in Public Health Protection
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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 Care”Public 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 Prevention‘s
(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 CDC‘s research and
preparedness activities on bioterrorism and augments our previous work
on combating terrorism. [Footnote 4] Specifically, we will focus on
CDC‘s 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 CDC‘s 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 CDC‘s
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 CDC‘s
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 ’first
responders“ 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: CDC‘s 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 nation‘s 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 agency‘s Bioterrorism Preparedness and Response
Program. The principal priority of CDC‘s 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.
CDC‘s Research and Preparedness Activities on Bioterrorism:
CDC is conducting a variety of activities related to research on and
preparedness for a bioterrorist attack. Since CDC‘s 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 CDC‘s response capacity,
preparedness and response planning, and building the National
Pharmaceutical Stockpile Program.
Trends in CDC‘s Funding for Bioterrorism Activities:
The funding for CDC‘s 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 CDC‘s 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 CDC‘s 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 CDC‘s
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: CDC‘s Bioterrorism Preparedness and Response Program Funding:
[See PDF for image]
This figure is a multiple line graph illustrating CDC‘s 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:
CDC‘s 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, CDC‘s 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 CDC‘s 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 departments‘
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 ’highway“ 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,
clinician‘s 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 CDC‘s 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 CDC‘s 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 CDC‘s
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 CDC‘s 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 department‘s FY 2002”FY 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 CDC‘s 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 CDC‘s 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
nation‘s 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 –
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 VA‘s 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 President‘s
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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