Bioterrorism: Federal Research and Preparedness Activities	 
(28-SEP-01, GAO-01-915).					 
								 
Federal research and preparedness activities related to the	 
public health and medical consequences of bioterrorism focus on  
biological agents used as weapons of terrorism; detection of such
agents; development of new or improved vaccines, antibiotics, and
antivirals; and 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 activities to combat terrorism. federal departments and	 
agencies are developing interagency response plans, participating
in a variety of 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 preparedness of states and local units
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.							 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-01-915 					        
    ACCNO:   A02065						        
    TITLE:   Bioterrorism: Federal Research and Preparedness          
             Activities                                                       
     DATE:   09/28/2001 
  SUBJECT:   Biological warfare 				 
	     Emergency preparedness				 
	     Federal funds					 
	     Funds management					 
	     Interagency relations				 
	     Terrorism						 
	     CDC National Pharmaceutical Stockpile		 
	     Program						 								 
             FEMA Federal Response Plan                          
	     HHS Metropolitan Medical Response System		 
	     National Disaster Medical System			 
	     United States Interagency Domestic 		 
	     Terrorism Concept of Operations Plan		 
								 

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GAO-01-915
     
A

Report to Congressional Committees

September 2001 BIOTERRORISM Federal Research and Preparedness Activities

GAO- 01- 915

Letter 1 Results in Brief 4 Background 5 Departments and Agencies Reported a
Variety of Actions and

Funding for Research and Preparedness Activities 7 Despite Efforts to
Coordinate Federal Programs, Fragmentation

Remains 14 Despite Federal Efforts, Concerns Exist Regarding Preparedness at
State and Local Levels 20

Agency Comments 23 List of Committees 26

Appendixes

Appendix I: Biological Agents and Pathogens Mentioned in This Report 28

Appendix II: Scope and Methodology 30

Appendix III: Summaries of Selected Federal Policy and Planning Documents 32
Federal Response Plan With Terrorism Incident Annex 32 Presidential Decision
Directive 39, U. S. Policy on Counterterrorism

33 Presidential Decision Directive 62, Combating Terrorism 33 U. S.
Government Interagency Domestic Terrorism Concept of Operations Plan 34

Appendix IV: Department of Agriculture 35 Office of Crisis Planning and
Management 35 Agricultural Research Service 36 Animal and Plant Health
Inspection Service 36 Food Safety Inspection Service 37

Appendix V: Department of Commerce 38 Office of Law Enforcement Standards 38

Appendix VI: Department of Defense 39 Defense Advanced Research Projects
Agency 40 Joint Task Force for Civil Support 41 National Guard 41 U. S. Army
42

Appendix VII: Department of Energy 46 The Office of Defense Nuclear
Nonproliferation 46

Appendix VIII: Department of Health and Human Services 48 Agency for
Healthcare Research and Quality 48 Centers for Disease Control and
Prevention 48 Food and Drug Administration 54 National Institutes of Health
60 Office of Emergency Preparedness 62

Appendix IX: Department of Justice 67 Office of Justice Programs 68 Federal
Bureau of Investigation 70

Appendix X: Department of Transportation 72 Research Activities 72
Preparedness Activities 72

Appendix XI: Department of the Treasury 74 U. S. Secret Service 74

Appendix XII: Department of Veterans Affairs 75 Preparedness Activities 75

Appendix XIII: Environmental Protection Agency 76 Research Activities 76
Preparedness Activities 77

Appendix XIV: Federal Emergency Management Agency 78 Preparedness Activities
78

Appendix XV: Comments From the Department of Commerce 81

Appendix XVI: Comments From the Department of Defense 83

Appendix XVII: Comments From the Department of Health and Human Services 84

Appendix XVIII: Comments From the Department of Justice 87

Appendix XIX: GAO Contacts and Staff Acknowledgments 88 Related GAO Products
89 Tables Table 1: Total Reported Funding for Research on Bioterrorism and

Terrorism by Federal Departments and Agencies, Fiscal Year 2000 and Fiscal
Year 2001 (Dollars in millions) 8 Table 2: Total Reported Funding for
Preparedness Activities on

Bioterrorism and Terrorism by Federal Departments and Agencies, Fiscal Year
2000 and Fiscal Year 2001 (Dollars in millions) 10

Table 3: Selected Federal Activities Providing Assistance to State and Local
Governments for Emergency Planning Relevant to a Bioterrorist Attack 17
Table 4: Reported Funding for Activities on Bioterrorism at USDA

(Dollars in millions) 35 Table 5: Reported Funding for Activities on
Domestic Terrorism at DOD (Dollars in millions) 40

Table 6: Reported Funding for Activities on Terrorism at DOE (Dollars in
millions) 46 Table 7: Reported Funding for Activities on Bioterrorism at CDC

(Dollars in millions) 50 Table 8: Reported Funding for Activities on
Bioterrorism at FDA

(Dollars in millions) 55 Table 9: Reported Funding for Activities on
Bioterrorism at NIH

(Dollars in millions) 61 Table 10: Reported Funding for Activities on
Terrorism at OEP

(Dollars in millions) 62 Table 11: Reported Funding for Activities on
Bioterrorism at DOJ (Dollars in millions) 67

Table 12: Reported Funding for Activities on Bioterrorism at EPA (Dollars in
millions) 76 Table 13: Reported Funding for Activities on Terrorism at FEMA

(Dollars in millions) 78

Abbreviations

AHRQ Agency for Healthcare Research and Quality CDC Centers for Disease
Control and Prevention CONPLAN U. S. Government Interagency Domestic
Terrorism

Concept of Operations Plan DOD Department of Defense DOE Department of
Energy DOJ Department of Justice DOT Department of Transportation EPA
Environmental Protection Agency FBI Federal Bureau of Investigation FDA Food
and Drug Administration FEMA Federal Emergency Management Agency HHS
Department of Health and Human Services NIAID National Institute of Allergy
and Infectious Diseases NIH National Institutes of Health OEP Office of
Emergency Preparedness OJP Office of Justice Programs TOPOFF 2000 Top
Officials 2000 exercise USDA U. S. Department of Agriculture VA Department
of Veterans Affairs WMD weapon of mass destruction

Lett er

September 28, 2001 Congressional Committees A number of incidents involving
biological agents, including at least one completed bioterrorist act and
numerous threats and hoaxes, 1 have occurred domestically. In 1984, a group
intentionally contaminated salad

bars in local restaurants in Oregon with salmonella bacteria 2 to prevent
people from voting in a local election. 3 Although no one died, 751 people
were diagnosed with foodborne illness. As was the case with this incident,
determining whether an outbreak occurred naturally or was the product of an
intentional release may be difficult unless someone announces the

release beforehand or claims responsibility for it. Given the terrorist
attacks of September 11, 2001, in addition to the terrorist bombings in New
York City in 1993 and in Oklahoma City in 1995, some experts predict that

domestic bioterrorist attacks are likely to occur. Others consider the
likelihood of bioterrorist attacks to be low because of various
difficulties, including those involved in processing the biological agents
into lethal forms and successfully delivering them to achieve large- scale
casualties.

However, the ease with which these agents can be concealed and their
potential to affect large segments of the population beyond those initially
exposed may increase their appeal to terrorists. Bioterrorism is the threat
or intentional release of biological agents (viruses, bacteria, or their
toxins) for the purpose of influencing the conduct of government, or
intimidating or coercing a civilian population.

These agents can be released by way of the air (as aerosols), food, water,
or insects. The intentional release of a biological agent may not be
recognized for several days, if ever, during which time a communicable
biological agent (such as smallpox) can spread to others who were not
initially exposed. Some biological agents (such as anthrax and plague)
produce

symptoms that can be easily confused with influenza or other, less virulent
1 For example, in January 2000, threatening letters were sent to a variety
of recipients, including the Planned Parenthood office in Naples, Florida,
warning of the release of anthrax. Federal authorities found no signs of
anthrax or any other traces of harmful substances and determined these
incidences to be hoaxes. 2 See app. I for a description of salmonella and
other biological agents and pathogens mentioned in this report. 3 See Food
Safety: Agencies Should Further Test Plans for Responding to Deliberate
Contamination (GAO/ RCED- 00- 3, Oct. 27, 1999), p. 4.

illnesses, leading to a delay in diagnosis or identification. In addition to
widespread medical consequences, a bioterrorist attack also could bring
about behavioral, social, economic, and psychological consequences, such as
mass panic. Health care providers could be the first authorities to see
victims as they seek treatment of their symptoms. If large numbers of people
are affected, local and state officials may turn to the federal government
for assistance with disease surveillance, 4 epidemiologic investigation, 5
health care delivery, quarantine management, remediation, and mass fatality
management.

Many federal departments and agencies, including the Departments of Health
and Human Services (HHS) and Justice (DOJ), would have roles in responding
to a domestic bioterrorist attack against the U. S. population. These
departments and agencies are involved in a range of activities related to
the public health and medical consequences of a bioterrorist attack on the
civilian population. 6 These activities are part of the federal government?s
overall effort to combat terrorism.

Because of the concerns about bioterrorism, the Public Health Improvement
Act of 2000 (P. L. 106- 505, sec. 102) mandates that we describe federal
activities related to the public health and medical consequences of a
bioterrorist attack against the civilian population. We are therefore
providing information on (1) federal activities and funding related to the
public health and medical consequences of a bioterrorist attack against the
civilian population, (2) how these activities are coordinated among federal
agencies and whether there are any shortcomings in the current coordination
structure, and (3) existing evaluations of the effectiveness of

these activities in preparing state and local authorities. 4 Disease
surveillance systems provide for the ongoing collection, analysis, and
dissemination of data to prevent and control disease. 5 Epidemiological
investigation is the study of patterns of health or disease and the factors
that influence these patterns.

6 Public health and medical consequences refers to the effects of a
biological agent on the population as well as on the individual. See app. I
for the medical effects of the biological agents and pathogens mentioned in
this report.

In carrying out our work, we relied on federal departments and agencies to
identify relevant programs and provide budget information. 7 We have not
audited or otherwise verified the information provided. We interviewed
agency officials, obtained documents, and reviewed reports prepared by
others (such as Ataxia: The Chemical and Biological Terrorism Threat and the
U. S. Response 8 and Toward a National Strategy for Combating Terrorism 9 ),
as well as our previous reports (see Related GAO Products at the end of this
report). Although there are generally no specific

appropriations for activities on bioterrorism, some departments and agencies
did provide estimates of the funds they were devoting to activities on
bioterrorism. Other departments and agencies provided estimates for

overall terrorism activities but were unable to provide funding amounts for
activities on bioterrorism specifically. Still others stated that their
activities were relevant for bioterrorism, but they were unable to specify
the funding amounts. As a result, departments and agencies provided funding

information in various forms- appropriations, obligations, expenditures. For
a given fiscal year, this information is not necessarily additive across
agencies. 10 For this reason, we have summarized funding by agency, but not
across the federal government. 11 (See app. II for details regarding our
scope and methodology.) We conducted our work from January through

September 2001 in accordance with generally accepted government auditing
standards.

7 We conducted interviews with and obtained information from the Departments
of Agriculture, Commerce, Defense, Energy, Health and Human Services,
Justice, Transportation, the Treasury, and Veterans Affairs; the
Environmental Protection Agency;

and the Federal Emergency Management Agency. 8 Amy Smithson and Leslie- Ann
Levy, Ataxia: The Chemical and Biological Terrorism Threat and the U. S.
Response (Washington, DC: The Henry L. Stimson Center, Oct. 2000). 9
Advisory Panel to Assess Domestic Response Capabilities for Terrorism
Involving Weapons of Mass Destruction, Toward a National Strategy for
Combating Terrorism, Second Annual Report (Arlington, VA: RAND, Dec. 15,
2000).

10 For example, an agency providing appropriations is not necessarily
indicating the level of its commitments (that is, obligations) or
expenditures for that year- only the amount of budget authority made
available to it by the Congress. Similarly, an agency which provided
expenditure information for fiscal year 2000 may have obligated the funds in
fiscal year 1999 based on an appropriation for fiscal year 1998. To simplify
presentation, we generally refer to the budget data we received from
agencies as ?reported funding? and report this information for the agencies
separately. 11 Funding levels for activities on terrorism, including
bioterrorism, were reported for activities prior to September 11, 2001 and
do not include any funds approved by the Congress after that date.

Results in Brief A variety of federal research and preparedness activities
related to the public health and medical consequences of a bioterrorist
attack are under

way. Research activities focus on various biological agents that could be
used as weapons of terrorism; detection of such agents; development of new
or improved vaccines, antibiotics, and antivirals; and performance standards
for emergency response equipment. Preparedness activities include increasing
state and local response capabilities, improving federal response capacity,
developing response teams, increasing the availability of medical
treatments, participating in and sponsoring exercises, aiding

victims, and providing support at special events, such as presidential
inaugurations and Olympic games. Activities in many departments and agencies
have a dual use, being not only relevant for bioterrorism but also for other
types of terrorism, emergencies, and infectious disease surveillance. For
example, the Federal Emergency Management Agency (FEMA) has a broad
emergency and terrorist response system, which includes a bioterrorist
response system. HHS has programs on emerging infectious diseases that
benefit its activities on bioterrorism as well as research endeavors such as
research on diagnoses, vaccines, and new therapies.

Federal departments and agencies use a variety of methods to coordinate
their activities to combat terrorism. Departments and agencies are
developing interagency response plans, participating in a variety of
interagency work groups, and entering into formal agreements with other
agencies to share resources and capabilities in order to improve
coordination. However, coordination of federal terrorism research,
preparedness, and response programs is fragmented, as we have discussed in a
previous report. 12 As we noted, several different agencies are responsible
for various coordination functions, which limits accountability and hinders
unity of effort. For bioterrorism, different agencies have developed
separate threat lists of biological agents, several agencies have

not been included in bioterrorism- related policy and response planning, and
agencies have developed programs to provide assistance to state and local
governments that are similar and potentially duplicative. However, the
Office of Management and Budget and the National Security Council have
created a process to reduce overlap and improve coordination as part of the
annual budget cycle. In addition, the Vice President was asked by the

12 See Combating Terrorism: Selected Challenges and Related Recommendations
(GAO- 01822, Sept. 20, 2001), p. 40.

President in May 2001 to lead an interagency effort to improve coordination.
Also, on September 20, 2001, the President announced the creation of the
Office of Homeland Security to lead, oversee, and coordinate a comprehensive
national strategy to safeguard the country against terrorism.

The reports that we reviewed identified concerns about the preparedness of
states and local areas to respond to a bioterrorist attack. These concerns
include insufficient state and local planning for response to terrorist
events and a lack of hospital participation in training on terrorism and
emergency response planning. Some federal programs have begun to provide
funding

to state and local governments to improve preparedness. We provided a draft
of this report to the eleven departments and agencies for their review in
August 2001. HHS stated that many of the services needed in response to a
bioterrorist attack would be needed to respond to other emergencies,
including natural disasters and other types of terrorist attacks, and we
added this information to the report. We also modified the

report in response to a DOJ comment that it is appropriate for different
agencies to maintain separate lists of biological threats, noting that such
lists may have different purposes. Most agencies provided technical
comments.

Background Although the probability of a domestic bioterrorist attack has
been considered to be low, some characteristics of biological agents may
make them appealing to terrorists. The information for the production of
agents is readily available on the Internet, and the agents are relatively
easy to

grow and conceal. According to intelligence agencies, the possibility that
terrorists may use chemical or biological materials may increase over the
next decade. 13 However, other characteristics of biological agents may
limit their appeal to terrorists. For example, they are difficult to obtain,
process into a lethal form, and deliver to achieve large- scale casualties.
Processing biological agents into the right particle size and delivering
them effectively require

expertise in a wide range of scientific disciplines. Additional hurdles to
deployment include disruptions caused by environmental and 13 See Combating
Terrorism: Need for Comprehensive Threat and Risk Assessments of Chemical
and Biological Attacks (GAO/ NSIAD- 99- 163, Sept. 14, 1999), p. 17.

meteorological conditions. For example, if wind conditions are too strong or
erratic, agents released as aerosols might dissipate rapidly or fail to
reach the desired area. With any emergency, including natural disasters and
terrorist attacks, states can call upon services related to emergency
management, public safety, emergency medical services, health care delivery,
and fatality management. Most states rely on local public health agencies to
identify

and respond to naturally occurring disease outbreaks, and these are the same
agencies that are responsible for bioterrorism preparedness and response.
Just as in naturally occurring outbreaks, a bioterrorist attack could
involve public health officials in disease surveillance, epidemiologic
investigation, health care delivery, quarantine management, remediation,

and mass fatality management. Unless a terrorist announces the release of a
biological agent, the cause of an outbreak might be detected only after an
epidemiologic investigation and laboratory identification. Officials from
the Centers for Disease Control and Prevention (CDC) and the National
Association of County and City Health Officials have stated that the
capacities needed by local public health agencies to prepare for a
bioterrorist incident should be built on the systems used to respond to
naturally occurring disease outbreaks. Such a

?dual- use? response infrastructure improves the capacity of local public
health agencies to respond to all hazards. In response to past domestic
terrorist events and bioterrorism cases, including hoaxes, the federal
government has become more involved in bioterrorism preparedness. From 1989
through 1996, Congress passed

several laws aimed at preventing the acquisition and use of chemical or
biological weapons by groups or individuals. In addition, the National
Defense Authorization Act for Fiscal Year 1997 (P. L. 104- 201) authorized
$97 million for domestic emergency assistance programs, including the
implementation of programs providing advice, training, and the loan of
equipment to state and local emergency response agencies and assistance to
major cities in establishing medical strike teams. The act also authorized
the Department of Defense (DOD) to establish military domestic terrorism
rapid response teams. In the event of a bioterrorist attack against the
civilian population, DOD will use these teams to provide support to the
primary federal agency as defined under the Federal Response Plan.

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 lays out
the manner in which the federal government responds to domestic situations
in which the President has declared an emergency requiring federal disaster
assistance. Presidential Decision Directive 39, which was issued after the
Oklahoma City bombing in 1995, provides a framework for how the federal
government will respond to weapons of mass destruction

(WMD) 14 terrorism within the United States, reaffirming the Federal
Response Plan. The plan is an ?all- hazards? (that is, for any emergency or
disaster) approach document, with an annex specific to terrorism, which was
added by FEMA in 1997. In 1998, Presidential Decision Directive 62 was
issued, which describes federal agency roles in preparing for and

responding to WMD terrorism. In 2001, the U. S. Government Interagency
Domestic Terrorism Concept of Operations Plan was issued, which explains
agencies? responsibilities under Presidential Decision Directives

39 and 62 in more detail. HHS is currently developing a bioterrorism annex
to this plan. (See app. III for more information on these federal policy and
planning documents.)

Departments and The federal government is conducting a variety of activities
related to Agencies Reported a

research on and preparedness for the public health and medical consequences
of a bioterrorist attack against the civilian population. Variety of Actions
and Research activities focus on detection, treatment, vaccination, and
Funding for Research

emergency response equipment. Preparedness efforts include increasing and
Preparedness

state and local response capabilities, improving federal response capacity,
developing response teams, increasing availability of medical treatments,
Activities participating in and sponsoring exercises, planning for victim
aid, and providing support during special events such as presidential
inaugurations and Olympic games.

Research Activities Focus The federal government is involved in a range of
research activities related

on Detection, Treatment, to the public health and medical consequences of a
bioterrorist attack on Vaccination, and Equipment

the civilian population. Studies are currently being done to enable the
rapid identification of biological agents in a variety of settings; develop
new or improved vaccines, antibiotics, and antivirals to improve treatment
and

14 Throughout this report, we use the term WMDs to refer to chemical,
biological, radiological, or nuclear agents or weapons. Some agencies define
it to include large conventional explosives as well.

vaccination for infectious diseases caused by biological agents; and develop
and test emergency response equipment. Table 1 provides information on the
total reported funding for all the departments and agencies carrying out
research and examples of this research for these departments and agencies.
In addition, DOD and the Department of Transportation (DOT) have some
relevant research activities, but were not able to specify the associated
funding. More detail on each department?s

and agency?s activities is provided in appendixes IV through XIV.

Table 1: Total Reported Funding for Research on Bioterrorism and Terrorism
by Federal Departments and Agencies, Fiscal Year 2000 and Fiscal Year 2001
(Dollars in millions)

Fiscal year Fiscal year

Department or agency 2000 funding 2001 funding Sample activities

U. S. Department of 0 $0.5 Improving detection of biological agents
Agriculture- Agricultural Research Service

Department of Energy $35.5 $39. 6 Developing technologies for detecting and
responding to a bioterrorist attack

Developing models of the spread of and exposure to a biological agent after
release HHS- Agency for

$5.0 0 Examining clinical training and ability of front- line medical staff
to Healthcare Research and detect and respond to a bioterrorist threat
Quality

Studying use of information systems and decision support systems to enhance
preparedness for medical care in the event of a bioterrorist event HHS- CDC
$48.2 $46. 6 Developing equipment performance standards

Conducting research on smallpox and anthrax viruses and therapeutics

HHS- Food and Drug $8.8 $9.1 Licensing of vaccines for anthrax and smallpox
Administration Determining procedures for allowing use of not yet approved
drugs and specifying data needed for approval and labeling

HHS- National Institutes of $43. 0 $49. 7 Developing new therapies for
smallpox virus Health Developing smallpox and bacterial antigen detection
system

HHS- Office of Emergency 0 $4.6 Overseeing a study on response systems
Preparedness DOJ- Office of Justice $0.7 $4.6 Developing a biological agent
detector

Programs DOJ- Federal Bureau of 0 $1.1 Conducting work on detection and
characterization of biological Investigation materials

(Continued From Previous Page)

Fiscal year Fiscal year

Department or agency 2000 funding 2001 funding Sample activities

Department of the 0 $0.5 Developing a biological agent detector Treasury-
Secret Service Environmental Protection 0 $0.5 Improving detection of
biological agents

Agency Note: Total reported funding refers to budget data we received from
agencies. Agencies reported appropriations, actual or estimated obligations,
or actual or estimated expenditures. An agency providing appropriations is
not necessarily indicating the level of its commitments (that is,
obligations) or expenditures for that year- only the amount of budget
authority made available to it by the Congress. Similarly, an agency which
provided expenditure information for fiscal year 2000 may have obligated the
funds in fiscal year 1999 based on an appropriation for fiscal year 1998.
Source: Information obtained from departments and agencies.

The U. S. Department of Agriculture (USDA), DOD, Department of Energy (DOE),
HHS, DOJ, Department of the Treasury, and the Environmental Protection
Agency (EPA) have all sponsored or conducted projects to improve the
detection and characterization of biological agents. These

detection devices and tests are designed to identify biological agents in
food, the environment, and clinical samples (such as blood). For example,
EPA is sponsoring research to improve its ability to detect biological
agents in the water supply.

Departments and agencies are also conducting or sponsoring studies to
improve treatment and vaccination for diseases caused by biological agents.
These projects include basic research to develop drugs and diagnostics and
applied research to improve health care delivery systems. Several agencies
also reported working to develop vaccines to prevent infection caused by
biological agents. For example, HHS funded research to determine if the
currently available stock of smallpox vaccine could be extended by dilution
and yet remain effective. HHS is also developing a new vaccine for smallpox
and collaborating with DOD on the development of a new anthrax vaccine.

In addition, several agencies are conducting research that focuses on
developing performance standards and methods for testing the performance of
emergency response equipment, such as respirators, personal protective
equipment, and chemical and biological agent detectors and decontamination
equipment.

Preparedness Efforts Departments and agencies are undertaking activities to
increase Include Multiple Actions

preparedness for the public health and medical consequences of a
bioterrorist attack. Preparing for a bioterrorist attack includes activities
such as planning, purchasing equipment, training, and participating in
exercises simulating a bioterrorist attack. Federal departments and

agencies have undertaken the following preparedness activities: increasing
state and local response capabilities, improving federal response capacity,
developing response teams, increasing availability of medical treatments,
participating in and sponsoring exercises, planning for victim aid, and
providing support during special events. Table 2 contains information on

total reported funding for all the departments and agencies with
bioterrorism preparedness activities in fiscal year 2000 and fiscal year
2001 and examples of preparedness activities for these departments and
agencies. In addition, the Department of the Treasury has some relevent
preparedness activities, but was not able to specify the associated funding.
More information on these activities is given in appendix IV through
appendix XIV.

Table 2: Total Reported Funding for Preparedness Activities on Bioterrorism
and Terrorism by Federal Departments and Agencies, Fiscal Year 2000 and
Fiscal Year 2001 (Dollars in millions)

Fiscal year Fiscal year

2000 2001

Department or agency funding

funding Sample activities

USDA- Animal and Plant 0 $0.2 Developing educational materials and training
programs Health Inspection Service specifically dealing with bioterrorism

DOD- Joint Task Force for Civil $3.4 $8.7 Planning, and when directed,
commanding and controlling DOD?s

Support WMD and high- yield explosive consequence management capabilities in
support of FEMA

DOD- National Guard $70.0 $93. 3 Managing response teams that would enter a
contaminated area to gather samples for on- site evaluation DOD- U. S. Army
$29.5 $11. 7 Maintaining a repository of information about chemical and

biological weapons and agents, detectors, and protection and decontamination
equipment HHS- CDC $124.9 $147.3 Awarding planning grants to state and local
health departments

to prepare bioterrorism response plans Improving surveillance methods for
detecting disease outbreaks Increasing communication capabilities in order
to improve the gathering and exchanging of information related to
bioterrorist incidents

(Continued From Previous Page)

Fiscal year Fiscal year

2000 2001

Department or agency funding

funding Sample activities

HHS- Food and Drug $0.1 $2.1 Improving capabilities to identify and
characterize foodborne Administration pathogens Identifying biological
agents using animal studies and microbiological surveillance

HHS- Office of Emergency $35.3 $46. 1 Providing contracts to increase local
emergency response Preparedness capabilities Developing and managing
response teams that can provide support at the site of a disaster

DOJ- Office of Justice $7.6 $5.3 Helping prepare state and local emergency
responders through Programs training, exercises, technical assistance, and
equipment programs Developing a data collection tool to assist states in
conducting their threat, risk, and needs assessments, and develop their
preparedness strategy for terrorism, including bioterrorism

EPA $0.1 $2.0 Providing technical assistance in identifying and
decontaminating biological agents

Conducting assessments of water supply vulnerability to terrorism, including
contamination with biological agents FEMA $25.1 $30. 3 Providing grant
assistance and guidance to states for planning and training

Maintaining databases of safety precautions for biological, chemical, and
nuclear agents

Note: Total reported funding refers to budget data we received from
agencies. Agencies reported appropriations, actual or estimated obligations,
or actual or estimated expenditures. An agency providing appropriations is
not necessarily indicating the level of its commitments (that is,
obligations) or expenditures for that year- only the amount of budget
authority made available to it by the Congress. Similarly, an agency which
provided expenditure information for fiscal year 2000 may have obligated the
funds in fiscal year 1999 based on an appropriation for fiscal year 1998.

Source: Information obtained from departments and agencies.

Several federal departments and agencies have programs to increase the
ability of state and local authorities to successfully respond to a
bioterrorist attack. Some of these programs have focused on developing plans
for dealing with a terrorist attack or emergency in general. Departments and
agencies also contribute to state and local jurisdictions by helping them
pay for equipment, providing technical assistance,

increasing communications capabilities, and conducting training courses. In
addition to increasing the preparedness of state and local entities, federal
departments and agencies have been increasing their own capacity

to identify and deal with a bioterrorist incident. They are improving
surveillance methods for detecting disease outbreaks in humans and animals.
They have also established laboratory response networks to maintain state-
of- the- art capabilities for biological agent identification and
characterization of human clinical samples, as well as attempted to increase
their communications capabilities in order to improve the gathering and
exchanging of information related to a bioterrorist incident as well as
other events.

Some federal departments and agencies have developed teams to directly
respond to terrorist events. HHS? Office of Emergency Preparedness (OEP) and
DOD have created response teams that would provide medical treatment and
assistance in the event of a bioterrorist attack against the

civilian population in the United States. Four teams led by OEP, known as
National Medical Response Teams, are specially trained and equipped to
respond to incidents involving WMDs- chemical, biological, radiological, or
nuclear agents or weapons. The DOD teams would assist a local incident
commander in case of a domestic bioterrorist incident. DOD coordinates with
OEP in planning medical support for a civilian bioterrorist incident.
Several agencies are involved in increasing the availability of medical

supplies that could be used in the event of a bioterrorist attack. CDC and
OEP maintain repositories of pharmaceutical and other supplies that can be
delivered to the site of a terrorist incident. CDC?s National Pharmaceutical
Stockpile Program consists of two components. The first component is the 12-
Hour Push Packages, which contain pharmaceuticals,

antidotes, and medical supplies and can be delivered to any site in the
United States within 12 hours of a federal decision to deploy assets. These
supplies are prepackaged and cannot be tailored to an individual incident.
15 The second component is the Vendor Managed Inventory. Through the
Department of Veterans Affairs (VA), CDC has contracted with vendors to
store pharmaceutical and medical supplies that could be used in a terrorist
incident. These products can be tailored to an individual incident (that is,

only pharmaceuticals and supplies needed for a particular incident would be
sent) and would be available 24 to 36 hours after the National

15 The first emergency use of the National Pharmaceutical Stockpile occurred
on September 11, 2001. In response to the terrorist attack on the World
Trade Center, CDC released one of the eight Push Packages.

Pharmaceutical Stockpile staff notifies the appropriate vendors. 16 OEP?s
National Medical Response Teams have stockpiles that can be deployed with
the teams. Each team has the capability of carrying enough pharmaceutical
and medical supplies to treat up to 5,000 people, with the focus on the
medical response to chemical incidents. The Food and Drug Administration
(FDA) also has initiatives to increase the availability of medical
countermeasures. For example, FDA is developing an approach that would allow
drugs still in the FDA approval system to be used in the

field during a bioterrorist attack. FDA is also working with CDC to
implement a shelf- life extension program for the maintenance of stockpiled
pharmaceuticals and medical supplies. Bioterrorism response exercises are
conducted across the country, both as on- site and as ?tabletop? exercises.
For example, in May 2000, many

departments and agencies took part in the Top Officials 2000 exercise
(TOPOFF 2000) in Denver, Colorado, which featured the simulated release of a
biological agent. 17 Participants included local fire departments, police,
area hospitals, the Colorado Department of Public Health and the
Environment, the Colorado Office of Emergency Management, the Colorado
National Guard, the American Red Cross, the Salvation Army, HHS, DOD, FEMA,
the Federal Bureau of Investigation (FBI), and EPA. DOJ reported funding
that facilitated 52 tabletop exercises on bioterrorism in fiscal year 2001.
These 1- day exercises involve public health, fire, law

enforcement, and emergency management agencies. Participants work through a
simulation of a bioterrorism incident, starting with the incubation period
(the time between initial exposure to a biological agent and onset of
symptoms), followed by the recognition and initial response, and finally the
challenges of integrating federal assets with local response and recovery
efforts. Medical surveillance, epidemiologic investigation,

quarantine management, remediation, and mass fatality management are
addressed.

16 For more information on management of the National Pharmaceutical
Stockpile Program, see Combating Terrorism: Accountability Over Medical
Supplies Needs Further Improvement (GAO- 01- 463, Mar. 30, 2001). 17 In
addition to simulating a bioterrorism attack in Denver, the exercise also
portrayed a chemical weapons incident in Portsmouth, New Hampshire. A
concurrent exercise, referred to as National Capital Region 2000, simulated
a radiological event in the greater Washington, D. C., area.

Under the Victims of Crime Act of 1984, DOJ?s Office of Justice Programs
(OJP) manages a program that provides assistance to victims of terrorism,
including a bioterrorist attack. Under this program, funds can be used to
provide mental health services. In addition, FEMA can provide supplemental
funds to state and local mental health agencies to provide crisis counseling
to eligible survivors of presidentially declared major disasters. 18

Federal departments and agencies also provide support at special events to
improve response in case of an emergency. 19 For example, OEP deployed teams
from the National Disaster Medical System to provide medical services if
required during the presidential inauguration of 2001. In

addition, CDC is developing a surveillance system to provide increased
surveillance and epidemiological capacity before, during, and after a
special event. Besides improving emergency response at the events,
department and agency participation provides them with valuable experience
working together to develop and practice plans to combat terrorism. OEP
reported funding of $2 million in fiscal year 2001 for special events. It
was the only agency that reported funding for these activities.

Despite Efforts to Federal departments and agencies are using a variety of
methods to Coordinate Federal coordinate their activities to combat
terrorism. Departments and agencies

are developing interagency response plans, participating in a variety of
Programs, interagency work groups, and entering into formal agreements with
other Fragmentation agencies to share resources and capabilities in order to
improve

Remains coordination. However, during this and our previous work we found

evidence that coordination of federal terrorism research, preparedness, and
response programs is fragmented. Several different agencies are responsible
for various coordination functions, which limits accountability and hinders
unity of effort. Different agencies have developed separate threat lists of
biological agents, several agencies have not been included in 18 HHS can
also address emotional and mental health consequences of terrorist attacks.
On September 13, 2001, in response to the attack on the World Trade Center,
HHS released $1 million in funding for New York to support mental health
services and strategic planning for

comprehensive and long- term support. 19 Presidential Decision Directive 62
created a category of special events called National Security Special
Events, which are events of such significance that they warrant greater

federal planning and protection than other special events. Such events
include presidential inaugurations and major political party conventions.

bioterrorism- related policy and response planning, and agencies have
developed programs to provide assistance to state and local governments that
are similar and potentially duplicative. For example, FEMA, DOJ, CDC, and
OEP all offer separate assistance to state and local governments in planning
for emergencies, including potential bioterrorist incidents. Congress and
the President have recently taken steps to improve oversight

and coordination. For example, in May 2001, the President asked the Vice
President to lead an interagency effort to improve coordination of federal
programs to deal with the consequences of a potential use of a WMD.

Departments and Agencies Departments and agencies use several approaches to
coordinate their Use a Variety of Methods to activities on terrorism.
Interagency plans for responding to a terrorist Coordinate Activities

incident help outline agency responsibilities and identify resources that
could be used during a response. For example, the Federal Response Plan,
which has been in effect for almost a decade, provides a broad framework for
coordinating the delivery of federal disaster assistance to state and local
governments when a major disaster or emergency, including a bioterrorist
attack, overwhelms their ability to respond effectively. 20 The

Federal Response Plan designates primary and supporting federal agencies for
a variety of emergency support operations. For example, HHS is the primary
agency for coordinating federal assistance to supplement state and local
resources in response to public health and medical care needs in an
emergency, including a bioterrorist attack. HHS could receive support from

USDA, DOD, DOE, DOJ, DOT, VA, EPA, FEMA, and other agencies and
organizations to assist state and local jurisdictions.

Interagency work groups are being used by federal departments and agencies
to attempt to minimize duplication of funding and effort in federal
activities on terrorism. For example, the Technical Support Working

Group, 21 which receives funds from DOD and other agencies, is chartered to
coordinate interagency and international research and development
requirements for combating terrorism- including efforts to reduce
vulnerability, collect and disseminate terrorism- related information, and

prevent, deter, and respond to terrorist acts of any kind- in order to 20
See app. III for more details on selected federal policy and planning
documents. 21 A description of the funding for the Technical Support Working
Group is not included in this report because it does not primarily focus on
the public health and medical consequences of a bioterrorist attack.

prevent duplication of effort between agencies. 22 The Technical Support
Working Group, among other projects, helped to identify research needs and
fund a project to develop a means to detect biological agents in the food
supply that can be used by both DOD and USDA. Another example of an
interagency work group was provided by OEP officials, who told us that

DOD, DOJ, DOE, OEP, FEMA, and VA meet as necessary to review equipment
requests of state and local jurisdictions to ensure that duplicative funding
is not being given for the same activities. Formal agreements between
departments and agencies are being used to share resources and knowledge.
For example, CDC contracts with VA to

purchase drugs and medical supplies for the National Pharmaceutical
Stockpile because of VA?s purchasing power and ability to negotiate large
discounts from manufacturers that sell pharmaceuticals, equipment, and
supplies to the VA hospital system. USDA?s Animal and Plant Health
Inspection Service is negotiating an agreement with DOD?s Armed Forces
Medical Intelligence Center to share information and expertise on tracking

diseases that can be transmitted from animals to people and could be used in
a bioterrorist attack. Coordination Remains

Overall coordination of federal programs to combat terrorism, including
Fragmented Within the

bioterrorism, is fragmented within the federal government. 23 For example,
Federal Government

several agencies have coordination functions, including DOJ, FBI, FEMA, and
the Office of Management and Budget. Officials from a number of the agencies
that combat terrorism told us that the coordination roles of these various
agencies are not always clear and sometimes overlap, leading to a fragmented
approach. The Advisory Panel to Assess Domestic Response

Capabilities for Terrorism Involving Weapons of Mass Destruction (also known
as the Gilmore Panel) also concluded that the current coordination structure
does not provide for the requisite authority or accountability to

22 See GAO- 01- 822, Sept. 20, 2001, p. 79. Coordination of federal research
and development efforts to combat terrorism is still limited by a number of
factors, raising the potential for duplicative efforts among federal
agencies.

23 See also Combating Terrorism: Comments on Counterterrorism Leadership and
National Strategy (GAO- 01- 556T, Mar. 27, 2001), p. 1.

make policy changes and to impose the discipline necessary among the
numerous federal agencies involved. 24 The multiplicity of federal
assistance programs requires focus and

attention to minimize redundancy of effort. 25 Table 3 describes some of the
federal programs providing assistance to state and local governments for
emergency planning that would be relevant to responding to a bioterrorist
attack. While the programs vary somewhat in their target audiences, the

potential redundancy of these federal efforts highlights the need for
scrutiny. In a recent report, we recommended that the President, working
closely with Congress, consolidate some of the activities of the DOJ?s OJP
under FEMA. 26

Table 3: Selected Federal Activities Providing Assistance to State and Local
Governments for Emergency Planning Relevant to a Bioterrorist Attack
Department or agency Activities Target audience

HHS- CDC Provides grants, technical support, and State and local health
performance standards to support agencies bioterrorism preparedness and
response planning. HHS- OEP Enters into contracts to enhance medical

Local jurisdictions, response capability. The program includes a including
fire, police, focus on response to bioterrorism, including emergency medical
early recognition, mass postexposure

services, hospitals, and treatment, mass casualty care, and mass public
health agencies fatality management.

DOJ- OJP Assists states in developing strategic plans. States, including
fire, law Includes funding for training, equipment

enforcement, emergency acquisition, technical assistance, and exercise
medical services, planning and execution to enhance state and hazardous
materials local capabilities to respond to terrorist response services,
incidents.

hospitals, and public health departments

24 See Advisory Panel to Assess Domestic Response Capabilities for Terrorism
Involving Weapons of Mass Destruction, p. 7. 25 See also Combating
Terrorism: Issues in Managing Counterterrorist Programs (GAO/ TNSIAD- 00-
145, Apr. 6, 2000), p. 8. 26 See GAO- 01- 822, Sept. 20, 2001, p. 104.

(Continued From Previous Page)

Department or agency Activities Target audience

FEMA Provides grant assistance to support state State emergency and local
consequence management management agencies planning, training, and exercises
for all types of terrorism, including bioterrorism.

Source: Information obtained from departments and agencies.

Fragmentation is also evident in the different threat lists of biological
agents developed by federal departments and agencies. Several different
agencies have or are in the process of developing biological agent threat
lists, which differ based on the agencies? focus. For example, CDC
collaborated with law enforcement, intelligence, and defense agencies to
develop a critical agent list that focuses on the biological agents that
would have the greatest impact on public health. The FBI, the National
Institute of Justice, and the Technical Support Working Group are completing
a report that lists biological agents that may be more likely to be used by
a terrorist group working in the United States that is not foreign
sponsored. In addition, an official at USDA?s Animal and Plant Health
Inspection Service

told us that it uses two lists of agents of concern for a potential
bioterrorist attack developed through an international process (although
only some of these agents are capable of making both animals and humans
sick). According to agency officials, separate threat lists are appropriate
because of the different focuses of these agencies. In prior reports, we
have recommended that the federal government conduct multidisciplinary and
analytically sound threat and risk assessments to define and prioritize
requirements and properly focus programs and investments in combating

terrorism. 27 Fragmentation has also hindered unity of effort. Officials at
USDA, FDA, and DOT told us that their departments and agencies have often
been overlooked in bioterrorism- related planning and policy. USDA officials
told us that as federal policy and coordination were developed in
Presidential Decision Directive 62, the department was not included even
though it 27 See Combating Terrorism: Threat and Risk Assessments Can Help
Prioritize and Target

Program Investments (GAO/ NSIAD- 98- 74, Apr. 9, 1998), Combating Terrorism:
Need for Comprehensive Threat and Risk Assessments of Chemical and
Biological Attacks

(GAO/ NSIAD- 99- 163, Sept. 14, 1999), and Combating Terrorism: Selected
Challenges and Related Recommendations (GAO- 01- 822, Sept. 20, 2001).

would have key responsibilities if terrorists targeted the food supply. FDA
officials told us that FDA was involved in some issues with the National
Pharmaceutical Stockpile, but was not involved in the selection of all items
procured for the stockpile. DOT officials noted that even though its
programs cross many areas and the nation?s transportation centers for a

significant percentage of potential terrorist targets, the department was
not part of the founding group of agencies that worked on bioterrorism
issues and has not been included in bioterrorism response plans. DOT
officials also told us that the department is supposed to deliver supplies
for FEMA under the Federal Response Plan, but it was not brought in early
enough to understand the extent of its responsibilities in the
transportation process. It did not learn these details until its
participation in TOPOFF 2000.

Recent Actions Seek to In 1997, we reported that the amount of funds being
spent to combat Improve Coordination terrorism was unknown and difficult to
determine and no priorities had

been set for funding terrorism- related programs. 28 As a result, there was
no Across Federal assurance that agencies? requests were funded through a
coordinated and Departments and Agencies

focused approach. Subsequently, Congress required the Office of Management
and Budget to establish a reporting system on the budgeting and expenditure
of funds to combat terrorism. 29 The Office of Management and Budget and the
National Security Council created a process to reduce overlap and improve
coordination as part of the annual budget cycle in 1999. As part of this
process, the Office of Management and Budget started issuing an Annual
Report to Congress on Combating Terrorism, which details agency activities
and funding. These reports potentially represent a significant step toward
improved coordination by providing strategic oversight of the magnitude and
direction of spending for activities on terrorism. However, as we have
testified, we have not yet seen evidence

that these reports have established priorities or identified duplication of
effort. 30 28 See Combating Terrorism: Spending on Governmentwide Programs
Requires Better

Management and Coordination (GAO/ NSIAD- 98- 39, Dec. 1, 1997), pp. 3- 5. 29
Section 1051 of the National Defense Authorization Act for Fiscal Year 1998
(P. L. 105- 85).

30 See Combating Terrorism: Observations on Options to Improve the Federal
Response (GAO- 01- 660T, Apr. 24, 2001), p. 8.

In May 2001, the President asked the Vice President to oversee the
development of a coordinated national effort dealing with WMDs. 31 At the
same time, the President asked the Director of FEMA to establish an Office
of National Preparedness to implement the results of this effort that deal
with programs within DOD, HHS, DOJ, DOE, EPA, and other federal

agencies that address consequence management resulting from the use of WMDs.
The purpose of this effort is to better focus policies and ensure that
programs and activities are fully coordinated and integrated in support of
building the needed preparedness and response capabilities. 32 We have

previously recommended that the President appoint a single focal point for
all critical leadership and coordination functions to combat terrorism. 33
On September 20, 2001, the President announced the creation of the Office

of Homeland Security. The head of the office will lead, oversee, and
coordinate a comprehensive national strategy to safeguard the country
against terrorism and respond to any attacks that may occur. Despite Federal

The reports that we reviewed identified concerns about the preparedness
Efforts, Concerns Exist

of states and local areas to respond to a bioterrorist attack. These
concerns include insufficient state and local planning for response to
terrorist Regarding events, inadequacies in the public health
infrastructure, a lack of hospital Preparedness at State participation in
training on terrorism and emergency response planning,

and Local Levels insufficient capacity for treating mass casualties from a
terrorist act, and

the timely availability of medical teams and resources in an emergency. Some
federal programs have begun to provide funding to state and local
governments to try to improve preparedness.

Questions exist regarding how much progress has been made in improving
terrorism preparedness at the state and local levels. Most of the states
surveyed by the National Governors? Association in 1996 reported that they
had neither the equipment and trained personnel to detect a biological
hazard nor the protective equipment that would be necessary during an
attack. In 1997, FEMA identified planning and equipment for response to 31
According to the Office of the Vice President, as of June 2001, details on
the Vice President?s efforts had not yet been determined. 32 See GAO- 01-
822, Sept. 20, 2001, p. 36. 33 See GAO- 01- 822, Sept. 20, 2001, p. 41.

nuclear, biological, and chemical incidents as an area in need of
significant improvement at the state level. The federal government has
several programs to train and equip state and local authorities to respond
to terrorist WMD incidents. 34 All 50 states and approximately 255 local
jurisdictions will receive at least some federal assistance, including
training

and equipment grants, to help them prepare for a terrorist WMD incident.
However, survey results presented in an October 2000 report indicated that
even those cities receiving federal aid are still not adequately prepared to
respond to a bioterrorist attack. 35 According to the October 2000 report,
components of the nation?s

infectious disease surveillance system are still not well prepared to detect
a covert bioterrorist attack. 36 This report concluded that reductions in
public health laboratory staffing and training have affected the ability of
state and

local authorities to identify biological agents. CDC began taking steps to
improve the nation?s public health infrastructure for responding to
bioterrorism in fiscal year 1999. In fiscal year 2000, CDC awarded grants
totaling approximately $11 million to 48 states and four major urban health
departments to improve and upgrade their surveillance and

epidemiological capabilities. As we previously reported, even the initial
West Nile virus outbreak in 1999, 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. 37 Both the New York
state and CDC laboratories were quickly inundated with requests for tests
during the West Nile 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. In order to improve laboratory capacity for
biological agents, CDC awarded grants during fiscal year 2000 totaling

approximately $6 million to 42 states and two major urban health
departments. At the same time, it began to upgrade its own laboratory

34 See GAO- 01- 822, Sept. 20, 2001, p. 90 35 Smithson and Levy, p. 245. 36
Smithson and Levy, p. 245. 37 See West Nile Virus Outbreak: Lessons for
Public Health Preparedness (GAO/ HEHS- 00180, Sept. 11, 2000), p. 21.

capacity. CDC officials told us that the grants are beginning to improve
state and local public health agencies? abilities to detect and identify
biological agents. We plan to examine the efforts in preparing state and

local authorities to address the public health and medical consequences of a
bioterrorist attack in a future report. Inadequate training and planning for
bioterrorism response by hospitals is a major problem, according to recent
reports and to federal officials. The Gilmore Panel concluded that the level
of expertise in recognizing and dealing with a terrorist attack involving a
chemical or biological agent is problematic in many hospitals. 38 Other
recent reports have concluded that hospitals need to improve their
preparedness for mass casualty incidents, such as a bioterrorist attack. 39
In addition, a recent study found that hospitals often lack the basic tools,
such as Internet access, to communicate effectively with field units, health
departments, and laboratories. 40 Local officials told us that it has been
difficult to get hospitals and medical personnel to participate in local
training, planning, and exercises to improve their preparedness. Several
federal and local officials reported that there is little or no excess
capacity in the health care system in most communities for accepting and
treating mass casualty patients. A recent study concluded that the patient
load of a regular influenza season in the late 1990s overtaxed primary care

facilities, 41 and other studies have reported that emergency rooms in major
metropolitan areas such as Boston are routinely filled and unable to accept
patients in need of urgent care. 42 According to a local official, the
health care system might not be able to handle the aftermath of a disaster,
attack,

38 Advisory Panel to Assess Domestic Response Capabilities for Terrorism
Involving Weapons of Mass Destruction, p. 32. 39 American Hospital
Association, Hospital Preparedness for Mass Casualties, Summary of an
Invitational Forum, Aug. 2000. D. C. Wetter, W. E. Daniell, and C. D.
Tresser, ?Hospital Preparedness for Victims of Chemical or Biological
Terrorism,? American Journal of Public

Health, Vol. 91 (2001), pp. 710- 16. 40 Smithson and Levy, p. 273.

41 Smithson and Levy, p. 262. 42 J. Richards, M. Navarro, and R. Derlet,
?Survey of Directors of Emergency Departments in California on
Overcrowding,? Western Journal of Medicine, Vol. 172 (2000), pp. 385- 388.
R. Derlet, J. Richards, and R. Kravitz, ?Frequent Overcrowding in U. S.
Emergency Departments,? Academic Emergency Medicine, Vol. 8, No. 2 (2001),
pp. 151- 55.

or epidemic because of the problems caused by overcrowding and the lack of
additional capacity. OEP officials told us that its Metropolitan Medical
Response System (a program to improve local medical response

capabilities) can assist communities in planning, including identifying
alternative care facilities for treating victims, identifying reserve
medical personnel that could be brought in during an emergency, and planning
to treat mass casualties within and outside of hospitals. 43 CDC, working
with the Association for Professionals in Infection Control and
Epidemiology,

has developed guidance for individual hospitals on how to plan for a sudden
and significant increase in infectious disease patients, relevant for the
handling of anthrax, botulism, plague, and smallpox cases.

According to one report, local officials are also concerned about whether
the federal government could quickly deliver enough medical teams and
resources to help after a biological attack. 44 Federal officials said that
assets, such as the Disaster Medical Assistance Teams, could be on site
within 12 to 24 hours. Local officials who have deployed with such teams

said that cities would probably be on their own for the first 24 to 72
hours, and that the number of medical workers that could arrive even in that
time frame might fall far short of what would be needed. 45 Local officials
also told us that they were concerned about the time and resources required
to prepare and distribute drugs from the National Pharmaceutical Stockpile
during an emergency. Partially in response to these concerns, CDC has

developed training for state and local officials on using the stockpile and
will deploy a small staff with the supplies to assist the local jurisdiction
with distribution.

Agency Comments We provided a draft of this report to the eleven departments
and agencies for their review in August 2001. The Department of Commerce,
DOD, HHS, and DOJ submitted written comments that are provided in appendixes
XV through XVIII. They also provided technical comments. The Department of
the Treasury, VA, and FEMA provided technical comments only. The audit

liaison from DOT provided oral technical comments on a draft of this 43 See
app. VIII for a description of the Metropolitan Medical Response System. 44
Smithson and Levy, p. 227. 45 Disaster Medical Assistance Teams were
dispatched to the New York City and Washington, D. C., areas on September
11, 2001. The initial units included more than 300 medical and mortuary
personnel.

report; the audit liaison from EPA responded that the agency had no comments
on the report. The technical liaison from DOE provided oral comments noting
the department?s concurrence with the draft report. USDA did not provide
comments on the report. Written and oral comments from all of these agencies
have been incorporated in the report, as appropriate.

The Department of Commerce stated that the report did not sufficiently
discuss its integrated efforts with DOD, DOJ, and FEMA to develop chemical
and biological protective equipment standards. We have provided additional
detail on this activity in appendix V. In its technical comments DOD
expressed a concern that the report did not reflect some of DOD?s

bioterrorism research and preparedness activities which are focused on
battlefield scenarios and crisis management. We have not included these
activities because they are outside the scope of our work, which focuses on

the public health and medical consequences of a bioterrorist attack on the
civilian population. HHS noted the importance of the systems and programs
described in the report that could provide assistance to state and local
governments in the event of a bioterrorist attack. HHS also stated that many
of the services needed in response to a bioterrorist attack would be needed
to respond to other emergencies, including natural disasters and other types
of terrorist attacks, and we added this information to the

report. In response to a DOJ technical comment, we also modified the report
to indicate that the department stated it is appropriate for different
agencies to maintain separate lists of biological threats, noting that such
lists may have different purposes.

We are sending copies of this report to the Secretaries of Agriculture,
Commerce, Defense, Energy, Health and Human Services, Transportation, the
Treasury, and Veterans Affairs; the Attorney General; the Administrator of
the Environmental Protection Agency; the Director of the Federal Emergency
Management Agency; and other interested officials.

If you or your staffs have any questions about this report, please call me
at (202) 512- 7118. Another contact and key contributors are listed in
appendix XIX. Janet Heinrich Director, Health Care- Public Health Issues

List of Committees The Honorable Edward M. Kennedy Chairman

The Honorable Judd Gregg Ranking Minority Member Committee on Health,
Education, Labor, and Pensions United States Senate

The Honorable Robert C. Byrd Chairman The Honorable Ted Stevens Ranking
Minority Member Committee on Appropriations United States Senate

The Honorable W. J. ?Billy? Tauzin Chairman The Honorable John D. Dingell
Ranking Minority Member Committee on Energy and Commerce House of
Representatives

The Honorable C. W. Bill Young Chairman The Honorable David Obey Ranking
Minority Member Committee on Appropriations House of Representatives

Appendi xes Biological Agents and Pathogens Mentioned in

Appendi x I

This Report Agent/ pathogen Description

Anthrax (Bacillus anthracis ) Transmission is possible through three
different routes: direct skin contact with contaminated animals, ingestion
of contaminated meat, or inhalation of airborne particles. Cutaneous anthrax
causes itching, followed by papular

lesions (red elevation on skin) and then vesicular lesions (blisterlike
elevation on skin containing fluid). Untreated infections may spread to
lymph nodes and to the

bloodstream, leading to septicemia (presence of pathogenic microorganisms in
the blood). Untreated cutaneous anthrax has a case fatality rate between 5
and 20 percent. Gastrointestinal anthrax has a mortality rate of 25 to 60
percent. Patients present with nausea, vomiting, severe diarrhea, fever,
abdominal pain, and gastrointestinal bleeding. Inhalatory anthrax causes
necrotizing hemorrhagic mediastinitis (destruction of the structures of the
middle chest caused by the toxin). Initial presentation resembles viral
syndrome- fever, malaise, fatigue, nonproductive cough. Treatment after
onset of

symptoms of inhalatory anthrax is not effective, with mortality of 90
percent.

Plague (Yersinia pestis) Transmission is through the bite of infected fleas
or handling of tissues of infected animals, such as rodents and rabbits.
After bite of infected flea, patient usually develops bubonic plague, in
which patients present with malaise, high fever, and tender lymph nodes.
This may

progress spontaneously to septicemic plague, with fever, chills, absolute
exhaustion, abdominal pain, shock, and bleeding into skin and other organs.
Neither bubonic nor septicemic plague spreads person- to- person. A small
percentage of patients go on to develop pneumonic plague, which can be
spread by respiratory droplet. For untreated pneumonic plague, mortality
approaches 100

percent. Salmonellosis (Salmonella) Transmission is by ingestion of infected
food, including food contaminated by feces of an infected animal or person.
Symptoms include headache, nausea, vomiting,

chills, diarrhea, fever, and abdominal cramping. Deaths are uncommon.

(Continued From Previous Page)

Agent/ pathogen Description

Smallpox (variola major) Transmission is person- to- person, and the disease
is highly contagious. The disease was eradicated, and routine immunizations
have ceased. Any immunity conferred by the vaccine has waned. Patients
present with high fever, malaise, absolute exhaustion, headache, and
backache. A maculopapular rash (discolored spots on skin; some raised, some
not raised) appears on mucosa of the mouth and pharynx, face, and forearms
and spreads to trunk and legs. Within 1 to 2 days, the rash becomes
vesicular, and later, pustular (small elevation on skin containing pus),
which leaves pitting scars after recovery. Mortality rate is 30 percent or
more.

Tul ar emi a ( Francisella Transmission is through the bite of infected
ticks, by tularensis) drinking contaminated water, or rarely through the
bite of coyote, squirrel, skunk, hog, cat, or dog whose mouth presumably was
contaminated by eating an infected animal. Most times, patients present with
painless ulcers at the site of introduction and swelling regional lymph
node. Ingestion of organisms in contaminated water or food may produce
painful pharyngitis (inflammation of the throat area), abdominal pain,
diarrhea, and vomiting. Inhalation of infectious material may be followed
with pneumonic involvement or a primary septicemic syndrome with a 30 to 60
percent mortality rate if

untreated. West Nile virus (flavivirus) Transmission is through the bite of
an infected mosquito.

Most infections are mild, and symptoms include fever, headache, and body
aches, often with skin rash and swollen lymph glands. More severe infections
may be marked with headache, high fever, neck stiffness, stupor,
disorientation, coma, tremors, convulsions, muscle weakness, and paralysis.
The virus is rarely fatal.

Appendi x II

Scope and Methodology We began our work by identifying the federal
departments and agencies that have a role in the public health and medical
consequences of a bioterrorist attack on the civilian population. We
reviewed the Office of Management and Budget?s Annual Report to Congress on
Combating Terrorism to determine which federal agencies receive funding for
activities on terrorism. 1 We then reviewed the Federal Response Plan to
understand the roles of each agency in the consequence management of a

possible bioterrorist attack. See appendix III for more information
regarding the Federal Response Plan. We also reviewed each agency?s
performance plan to determine its specific activities on bioterrorism.

We identified the following federal departments and agencies as having a
role in the public health and medical consequences of a bioterrorist attack
on the civilian population: the Departments of Agriculture (USDA),

Commerce, Defense (DOD), Energy (DOE), Health and Human Services (HHS),
Justice (DOJ), Transportation (DOT), the Treasury, and Veterans Affairs
(VA); the Environmental Protection Agency (EPA); and the Federal Emergency
Management Agency (FEMA). We interviewed program directors at each
department and agency about their activities related to the research on and
preparedness for the public health and medical consequences of a
bioterrorist attack against the civilian population in fiscal year 1998
through fiscal year 2001. We asked them to identify activities with dual-
use purposes, such as preparedness activities for biological and chemical
attacks, and surveillance activities for emerging

infectious diseases. We also asked program directors about the coordination
of interagency activities and requested copies of memorandums of
understanding and memorandums of agreement to identify working relationships
between departments and agencies.

We asked the program directors to provide the amount of authorized,
appropriated, and obligated federal funds for activities on bioterrorism in
fiscal year 1998 through fiscal year 2001. Some departments and agencies
could not provide the categories of funding we requested. For example,

some agencies could only provide appropriations estimates, while others
could only provide expenditure data. Because these different
characterizations of budget data are not necessarily additive across
agencies for specific fiscal years, we have provided budgetary information
summarized only by agency and refer to this generally as ?funding

1 The report does not differentiate between biological, chemical, nuclear,
and radiological terrorism.

information.? We relied on the departments and agencies to identify relevant
programs and to provide funding information. We have not audited or
otherwise verified the information provided. Information concerning the
effectiveness of federal efforts to prepare state and local authorities for
a bioterrorist event was obtained by reviewing our previous work, as well as
reports from training exercises, including the multiagency Top Officials
2000 exercise (TOPOFF 2000). We interviewed officials who participated in
TOPOFF 2000. We also reviewed reports by the Advisory Panel to Assess
Domestic Response Capabilities for Terrorism Involving Weapons of Mass
Destruction (also known as the Gilmore Panel), and the Henry L. Stimson
Center and articles from peer- reviewed journals.

We conducted our work from January through September 2001 in accordance with
generally accepted government auditing standards.

Summaries of Selected Federal Policy and

Appendi x II I Planning Documents 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 (P. L. 93- 288, as
amended). The Stafford Act authorizes the President to provide financial and
other forms of assistance to state and local governments, certain private
nonprofit organizations, and individuals to support response, recovery, and
mitigation efforts following

presidentially declared major disasters and emergencies. The Federal
Response Plan lays out the manner in which the federal government responds
to domestic situations in which the President has declared an emergency
requiring federal disaster assistance. Presidential Decision Directive 39
was issued after the Oklahoma City bombing in 1995, and it provides a
framework for how the federal government will respond to weapons of mass
destruction (WMD) terrorism within the United States,

reaffirming the Federal Response Plan. The Federal Response Plan is an all-
hazards approach document, with an annex specific to terrorism added by FEMA
in 1997. In 1998, Presidential Decision Directive 62 was issued, which
further describes the federal agency roles in preparing for and responding
to WMD terrorism. In 2001, the U. S. Government Interagency Domestic
Terrorism Concept of Operations Plan (CONPLAN) was issued, which explains
agencies? responsibilities under Presidential Decision Directives 39 and 62
in more detail. 1

Federal Response Plan The Federal Response Plan lays out the manner in which
the federal With Terrorism government responds to domestic situations in
which the President has declared an emergency requiring federal disaster
assistance. The plan Incident Annex

outlines the planning assumptions, policies, concept of operations,
organizational structures, and specific assignment of responsibilities to
lead departments and agencies in providing federal assistance. The plan is
intended to be the single source for an all- hazards response to terrorism,
categorizing the types of federal assistance into specific emergency

support functions. Primary and supporting agencies are listed for each
emergency support function. Emergency support function number 8 is the
Health and Medical Services Annex. HHS is the primary agency for this annex
and could receive support from USDA, DOD, DOE, DOJ, DOT, VA,

EPA, FEMA, and other agencies and organizations to assist state and local
jurisdictions. Through the Health and Medical Services Annex, coordinated 1
For a more complete discussion on these and other documents, see Combating
Terrorism: Selected Challenges and Related Recommendations (GAO- 01- 822,
Sept. 20, 2001), pp. 131- 136.

federal assistance is provided to supplement state and local resources in
response to public health and medical care needs following a major disaster
or emergency. The Terrorism Incident Annex establishes a general concept of
operations for the federal response to a terrorist incident, including the
concurrent operation under other federal plans.

Presidential Decision Under Presidential Decision Directive 39, which was
issued in 1995, DOJ, Directive 39, U. S. acting through the Federal Bureau
of Investigation (FBI), is the overall lead

federal agency for domestic terrorist incidents. The FBI is the lead agency
Policy on for crisis management and FEMA is the lead agency for consequence
Counterterrorism

management in cases of terrorism. 2 This directive states that the director
of FEMA shall ensure that the Federal Response Plan is adequate to respond
to the consequences of terrorism, including terrorism involving WMDs
directed against the U. S. population.

Presidential Decision Presidential Decision Directive 62, which was issued
in 1998, organizes and Directive 62,

clarifies the roles and activities of many agencies responsible for
combating a wide range of terrorism preparedness and response activities.
Combating Terrorism This directive calls for the provision of necessary
equipment and training to state and local responders and the development of
stockpiles of vaccines and specialized medicines. It also created a category
of special events called National Security Special Events, which are events
of such

significance that they warrant greater federal planning and protection than
other special events. Such events have included presidential inaugurations,
major political party conventions, and Olympic games. The U. S. Secret
Service is responsible for the design, planning, and implementation of
security at designated National Security Special Events.

2 Crisis management is predominantly a law enforcement function and includes
measures to identify, acquire, and plan the use of resources needed to
anticipate, prevent, and/ or resolve a threat or act of terrorism. Crisis
management also includes assurance of public health and safety. Consequence
management includes measures to protect public health, safety, and the
environment; to restore essential government services; and to provide
emergency relief to governments, businesses, and individuals affected by the
consequences of terrorism.

U. S. Government The U. S. Government Interagency Domestic Terrorism Concept
of

Interagency Domestic Operations Plan (CONPLAN) was primarily developed
through the efforts of DOD, DOE, HHS, DOJ, EPA, and FEMA. It was ratified in
January 2001

Terrorism Concept of and is designed to provide overall guidance to federal,
state, and local Operations Plan

agencies concerning how the federal government would respond to a potential
or actual terrorist threat or incident that occurs in the United States,
particularly one involving a WMD. As a follow- up to the Federal Response
Plan Terrorism Incident Annex, it facilitates interdepartmental

coordination of crisis and consequence management activities and states in
more detail the responsibilities of primary and supporting agencies during a
terrorist attack. HHS is currently developing a bioterrorism annex to this
plan, which will address issues concerning the appropriate response to acts

of bioterrorism.

Appendi x I V

Department of Agriculture USDA has become involved in activities on
bioterrorism because of the increasing realization that the food supply may
become a vehicle for a biological attack against the civilian population. 1
Biological attacks on the health of animals and plants are also important to
recognize because there are a number of diseases and toxins that can cause
illness or death in humans, such as West Nile virus, that can be carried or
spread by animals and plants. However, USDA receives little funding
specifically for activities on bioterrorism. Most of the agency?s activities
on terrorism are conducted using general program funds (see table 4).

Table 4: Reported Funding for Activities on Bioterrorism at USDA (Dollars in
millions) Fiscal year

Fiscal year Fiscal year

Fiscal year Program/ initiative 1998 1999 2000 2001

Agricultural Research Service Research activities

Detection of biological agents 0 0 0 $0. 5

Animal and Plant Health Inspection Service Preparedness activities

Education and training programs 0 0 0 $0. 2

Tot al 0 00$ 0. 7

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

Office of Crisis The Office of Crisis Planning and Management is a
department- level office

Planning and under the Assistant Secretary for Administration. The office is
responsible

for coordinating activities on terrorism across USDA. The Director of the
Management

Office of Crisis Planning and Management serves as the department?s
Emergency Coordinator and coordinates USDA?s response to all disasters,
crises, and emergencies. The office coordinates emergency management

activities with other federal agencies, including FEMA, and coordinates
USDA?s role under the Federal Response Plan. The office also operates the

1 For example, USDA and DOD jointly planned and conducted a multiagency
simulation of a terrorist deliberately contaminating food with a biological
agent. See Food Safety: Agencies Should Further Test Plans for Responding to
Deliberate Contamination (GAO/ RCED- 00- 3, Oct. 27, 1999).

department?s Emergency Operations Centers, where representatives of
organizational elements of USDA gather to manage and coordinate emergency
response functions.

Agricultural Research The Agricultural Research Service conducts research
for several federal Service agencies, including agencies within USDA, such
as the Animal and Plant Health Inspection Service and the Food Safety and
Inspection Service. Research Activities The Agricultural Research Service is
working on a system to improve onsite rapid detection of biological agents
in animals, plants, and food in

cooperation with DOD and HHS. The agency received $500,000 in fiscal year
2001 to sponsor this research (see table 4).

Preparedness Activities The Agricultural Research Service is also repairing
and modernizing the Plum Island Animal Disease Center in New York state to
improve detection capacity for diseases and toxins that could affect animals
and humans. The center provides definitive diagnoses of foreign animal
diseases in North America. Animal and Plant

The Animal and Plant Health Inspection Service is responsible for the Health
Inspection

health of animals and plants and has a role in responding to biological
agents that are zoonotic, that is, capable of infecting both animals and
Service

humans. Preparedness Activities If a disease outbreak occurred in humans,
this agency would work with other federal, state, and local departments and
agencies to determine the source of the exposure to the disease. If the
exposure was determined to be related to an animal, the agency?s veterinary
epidemiologists would be responsible for tracing back the source of the
animal exposure. They would then be responsible for controlling and
eradicating the outbreak to minimize further exposure to both animals and
humans. The Animal and

Plant Health Inspection Service reported funding of $150, 000 in fiscal year
2001 to develop educational materials and training programs specifically
dealing with activities on bioterrorism (see table 4).

Food Safety Inspection The Food Safety Inspection Service provides emergency
preparedness for Service

foodborne incidents, including a bioterrorist attack. Preparedness
Activities The Food Safety Inspection Service routinely responds to actual
and potential food- borne disease outbreaks. Its response to a bioterrorist

incident would be the same as its response to any food- borne disease
outbreak. The Food Safety Inspection Service has not received any funding
for activities on bioterrorism.

Appendi x V

Department of Commerce Activities on bioterrorism within the Department of
Commerce center on developing performance standards for emergency response
equipment and are carried out in conjunction with DOD, DOJ, and HHS. Office
of Law

The Office of Law Enforcement Standards at the Department of Enforcement

Commerce?s National Institute of Standards and Technology is the principal
agent for equipment standards development for the criminal justice and
Standards public safety communities, including biological response
equipment. The office develops standards, test procedures, and user guides
that helps ensure that the equipment the communities purchase and the
technologies they use are safe, dependable, and effective. The department
reported

receiving $0. 5 million in fiscal year 2000 and $4.6 million in fiscal year
2001 from DOJ for research. It reported funding, also from DOJ, of $0. 3
million annually in fiscal year 1999 and fiscal year 2000 for preparedness
activities.

Research Activities The Office of Law Enforcement Standards develops
performance standards and evaluates test methods and procedures for WMD and
explosive emergency response equipment. The office manages research projects
with the National Institute for Occupational Safety and Health and the U. S.
Army Soldier Biological and Chemical Command to develop standards for
respiratory and other personal protective equipment, and detectors and
decontamination equipment designed to protect against biological and

chemical agents Preparedness Activities The Office of Law Enforcement
Standards also issues technical reports and

publishes user guides for WMD and explosive response equipment. The office
is the executive agent of the Standards Coordination Committee of the
Interagency Board for Equipment Standardization and Interoperability.

The Interagency Board, which is co- chaired by DOD and DOJ, develops and
maintains a Standardized Equipment List, which lists essential items for
responding to terrorist WMD attacks. Other agencies participating in this
effort include HHS, DOE, DOT, EPA, and FEMA. The Standardized Equipment List
can be used by local public safety organizations when developing response
plans and acquiring response equipment.

Appendi x VI

Department of Defense Although DOD is primarily responsible for service
members in the battlefield, it would provide support to the primary federal
agency under the Federal Response Plan in the event of an emergency,
including a bioterrorist attack on the civilian population. Research at DOD
is targeted for the battlefield, but is often shared with other agencies to
benefit the civilian population. DOD has civil support responsibilities
through the Defense Advanced Research Projects Agency, the Joint Task Force
for Civil Support, the National Guard, and the U. S. Army. The Assistant
Secretary of Defense for Special Operations and Low- Intensity Conflict
provides

oversight by supervising policy, requirements, priorities, resources, and
programs to ensure adherence to approved policy and planning guidelines. See
table 5 for DOD?s reported funding for activities on domestic terrorism. In
addition, we provide information on other activities for which DOD could not
provide funding data

Table 5: Reported Funding for Activities on Domestic Terrorism at DOD
(Dollars in millions) Fiscal year

Fiscal year Fiscal year

Fiscal year Program/ initiative 1998 1999 2000 2001

Joint Task Force for Civil Support Preparedness activities

Training, exercises, travel, contingency operations, garrison 0 0 $3. 4 $6.
5

support, communications, support contracts Communication link system 0 0 0
$2. 2

National Guard Preparedness activities

Weapons of Mass Destruction- Civil Support Teams 0 $73.0 $70. 0 $93. 3

U. S. Army Preparedness activities a

Program management $3.0 $2.5 $3. 3 $0. 9 Expert assistance $6.3 $4.8 $4. 7
$1. 9 Training $21.6 $30. 8 $10. 9 0 Director of military support travel 0 0
$0. 3 $0. 1 Exercises and testing $10.2 $7.9 $8. 4 $6. 2 Chemical
Biological- Rapid Response Teams $1.9 $1.9 $1. 9 $2. 6

Tot al $43.0 $120.9 $102. 9 $113. 7

Note: We have not audited or otherwise verified the information provided. a
Funding for preparedness activities has decreased over time due to a
transfer of responsibility for

these activities under the Domestic Preparedness Program from DOD to DOJ
beginning October 1, 2000. Source: DOD.

Defense Advanced The Defense Advanced Research Projects Agency is the
central research

Research Projects and development organization for DOD. It manages and
directs basic and

applied research and development projects for the department. Success of
Agency

the projects may provide military advances as well as civilian applications.
Research Activities The Defense Advance Research Projects Agency?s current
work includes

genetic sequencing to enable the identification of molecular targets for the
design of detection, diagnostic, and therapeutic strategies that will aid
service members and may be used for the civilian population. The agency?s
objectives include developing the capacity to detect the presence of
infection by a biological agent, differentiate the agent from other

pathogens, and identify the pathogen in the absence of recognizable clinical
signs. The agency often shares research results with other agencies to
benefit the civilian population. DOD has initiated discussions on how best
to evaluate and transition select technology for bioterrorism defense. The
agency does not receive funding to conduct research on the public health and
medical consequences of a bioterrorist attack against civilian

populations. Joint Task Force for

The mandate of the Joint Task Force for Civil Support at the Joint Forces
Civil Support Command is to plan for and integrate DOD?s support to FEMA for
WMD events in the continental United States.

Preparedness Activities The Joint Task Force for Civil Support plans and,
when directed, commands and controls DOD?s WMD and high- yield explosive
consequence management capabilities in providing support during a domestic
bioterrorist incident. The Joint Task Force for Civil Support provides
support through FEMA and the Federal Response Plan during an incident and
works with other federal agencies on planning and exercises. The Joint Task
Force for Civil Support and the Joint Forces Command are working in support
of FEMA and HHS? Office of Emergency Preparedness (OEP) to plan Force
Packages, which are groupings of units that the military would

designate to respond to an incident. It also coordinates with OEP on the
planning for medical support for any WMD incident. Reported funding for
Joint Task Force activities on terrorism was $3. 4 million for fiscal year
2000 (see table 5). It rose to $8.7 million for fiscal year 2001, including
$6.5

million for individual unit training, exercises, travel, contingency
operations, garrison support, purchased communications, and general support
contracts, and $2. 2 million for the establishment of a communication link
system.

National Guard The National Guard Weapons of Mass Destruction- Civil Support
Teams are meant to deploy to assist local responders in determining the
precise

nature of an attack and provide medical and technical advice. The teams also
help pave the way for the identification and arrival of follow- on state and
federal military response assets.

Preparedness Activities The National Guard Weapons of Mass Destruction-
Civil Support Team program is intended to help prepare the United States
against terrorist use of WMDs. Originally, 10 civil support teams (formerly
called Rapid Assessment and Initial Detection teams) were located in
alignment with the 10 FEMA regional offices. 1 Congress authorized an
additional 17 civil support teams in fiscal year 2000, and another 5 in
fiscal year 2001. 2 DOD

reported funding of $70 million and $93.3 million for these teams in fiscal
year 2000 and fiscal year 2001, respectively (see table 5). Although the
teams are federally funded and trained, they are primarily under the command
and control of the governors of the states in which they are located, to
facilitate their rapid deployment. Their roles can include entering a
contaminated area to gather air, soil, and other samples for on- site
evaluation. They also are to assist a local incident commander in
determining the nature and extent of an attack or incident, provide expert
technical advice on WMD response operations, and help identify and

support the arrival of follow- on state and federal military response
assets. Teams are designed to be ready to deploy within 4 hours to anywhere
within their area of responsibility, with their own detection and
decontamination equipment, medical supplies, and protective gear. As of
August 15, 2001, six civil support teams have been certified as fully
mission

capable. U. S. Army The U. S. Army engages in research and preparedness
activities on bioterrorism that have benefits for both military and civilian
populations. Research Activities The U. S. Army Medical Research Institute
of Infectious Diseases is a

biological research facility that deals with militarily relevant infectious
diseases and biological agents. The institute conducts research to develop
vaccines, drugs, and diagnostics for laboratory and field use, as well as 1
The civil support teams are located in California, Colorado, Georgia,
Illinois, Massachusetts, Missouri, New York, Pennsylvania, Texas, and
Washington.

2 The 17 additional teams for fiscal year 2000 are located in Alaska,
Arizona, Arkansas, California (creating a second team), Florida, Hawaii,
Idaho, Iowa, Kentucky, Louisiana, Maine, Minnesota, New Mexico, Ohio,
Oklahoma, South Carolina, and Virginia. As of

January 2001, team locations had not been determined for the additional five
teams for fiscal year 2001.

formulates strategies, information, procedures, and training programs for
medical defense against biological agents. The institute has a Biosafety
Level 4 laboratory, which is used for dangerous, exotic agents that pose a
high risk of life- threatening diseases and have no vaccines or drugs

available for treatment. The institute also provides definitive
identification of biological agents and diagnosis of the diseases they
produce. It provides professional expertise on issues related to
technologies, therapeutics, prophylactics, and education that could be used
to support readiness for a bioterrorist incident.

The institute helps supply diagnostic reagent 3 sets to the Centers for
Disease Control and Prevention (CDC) and serves CDC?s Laboratory Response
Network as a confirmatory diagnostic laboratory and subject matter expert. 4
It provides support for the development of an anthrax vaccine by the
National Institutes of Health (NIH). Other ongoing work with CDC and NIH
includes the development of a database for genetically engineered threats.
It works with CDC and the FBI to assist with potential bioterrorism
incidents on a consultation or confirmatory basis. The

institute, along with the U. S. Army Soldier Biological and Chemical
Command, the Director of Military Support, and the Joint Task Force for
Civil Support, is currently working on plans to provide support in the event
of a domestic bioterrorist incident. The institute does not receive funding
to conduct research on the public health and medical consequences of a
bioterrorist attack against civilian populations.

Preparedness Activities The Domestic Preparedness Program 5 was formed in
response to the National Defense Authorization Act of Fiscal Year 1997 (P.
L. 104- 201) and required DOD to enhance the capability of federal, state,
and local emergency responders regarding terrorist incidents involving WMDs
and high- yield explosives. The program was developed through work groups
with expertise with WMD response skills. Work groups were composed of
experts from

3 A reagent is a substance used to detect the presence of another substance.
4 For more information on the Laboratory Response Network, see app. VIII. 5
For more information concerning the Domestic Preparedness Program, see
Combating Terrorism: Opportunities to Improve Domestic Preparedness Program
Focus and Efficiency (GAO/ NSIAD- 99- 3, Nov. 12, 1998).

municipalities, counties, and states and federal first responders having
responsibility for responding to WMD terrorism incidents. The work groups
developed courses and training in accordance with the

Occupational Safety and Health Administration, the National Fire Protection
Agency, and standards set by the Joint Commission for the Accreditation of
Healthcare Organizations.

DOD created the Domestic Preparedness Program with four major elements: the
City Training Program, the Exercises Program, the Expert Assistance Program,
and the Chemical Biological- Rapid Response Team. The City Training Program
provides training for senior local officials and emergency first responders
and trainers in 120 cities. It includes equipment loans to the local areas
by DOD. The Exercises Program includes the federal, state, and local
exercise and the Biological Warfare -Improved Response Program. The Improved
Response Program is a multiagency, intergovernmental, and

interdisciplinary effort designed to improve our nation?s ability to respond
to domestic acts of terrorism involving biological agents. Program
activities include testing and evaluating biological agent response
concepts, developing technical and operational requirements for first
responder equipment, and conducting exercises to test the major

components and integrated response plan. Lessons learned from biological
weapons tabletop exercises 6 on the medical consequence management of a
biological attack have been applied to the Improved Response Program. Expert
Assistance Program activities include the emergency responders? WMD help
line (which provides nonemergency planning and technical information), a hot
line (a component of the National Response Center, which is located at the
Coast Guard?s Headquarter Command Center and allows the caller to alert
federal agencies and speak with technical experts who can provide critical
incident management information), a Web page

(which provides information about the Domestic Preparedness Program),
equipment testing and reports, a chemical- biological database (a repository
of information about chemical and biological weapons and agents,

6 With tabletop exercises, participants work through a simulation of a
bioterrorism incident, starting with the incubation period (the time between
initial exposure to a biological agent and the onset of symptoms), followed
by the recognition and initial response, and finally the challenges of
integrating federal assets in the response and recovery efforts.

detectors, and protection and decontamination equipment), and subject matter
experts (who provide support for technical inquiries).

The Chemical Biological- Rapid Response Team coordinates and manages all DOD
technical capabilities tasked to support a crisis response or consequence
management operation. The Rapid Response Team delivers

skills, training, and equipment to the scene of a chemical or biological
incident. As of October 1, 2000, the City Training Program, portions of the
Improved Response Program, and the help line, hot line, and Web page
elements of the Expert Assistance Program were transferred from DOD to DOJ.
DOD

will retain responsibility for the chemical- biological database and
equipment testing and the Chemical Biological- Rapid Response Team. DOD also
will retain responsibility for the annual federal, state, and local exercise
through fiscal year 2001. DOD will share responsibility for the Improved
Response Program with DOJ.

Appendi x VII

Department of Energy DOE is developing new capabilities to counter chemical
and biological threats. DOE expects the results of its research to be public
and possibly lead to the development of commercial products in the domestic
market. Table 6 lists funding for DOE?s research activities on terrorism.

Table 6: Reported Funding for Activities on Terrorism at DOE (Dollars in
millions) Fiscal year

Fiscal year Fiscal year

Fiscal year Program/ initiative 1998 1999 2000 2001

Chemical and Biological National Security Program Research activities

Chemical and biological detection $7. 3 $7.5 $9. 5 $10. 9 Modeling and
prediction $2. 3 $3.0 $4. 7 $5. 5 Decontamination and restoration $1. 8 $1.7
$2. 2 $1. 5 Biological foundations $4. 5 $5.0 $10. 0 $10. 9 System analysis
(includes Domestic Demonstration and

$1. 7 $1.8 $5. 5 $9. 1 Application Programs) Other $0. 4 0 $3.6 $1.7

Tot al $18.0 $19. 0 $35. 5 $39.6

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

The Office of Defense Among other duties, the Office of Defense Nuclear
Nonproliferation is Nuclear responsible for reducing global danger from
WMDs. Within this office is the

Chemical and Biological National Security Program, which participates in
Nonproliferation research related to bioterrorism. Research Activities The
mission of the Chemical and Biological National Security Program is to
develop, demonstrate, and deliver technologies and systems that will lead

to major improvements in the United States? capability to prepare for and
respond to chemical or biological attacks. The program was begun in 1997 to
involve DOE and its laboratories in research and demonstrations of terrorism
preparedness, including, but not limited to, bioterrorism.

The Chemical and Biological National Security Program is divided into three
components: analytical studies, technology development, and Domestic
Demonstration and Application Programs. Analytical studies

help guide the overall program direction as well as individual technical
areas. In general, these studies use analytical and simulation models to
assess the value of technology in system applications. Technology

development is the core research and development program element, with the
purpose of enhancing response capabilities across the full spectrum of
chemical and biological terrorism. In general, development is focused on
technologies for which the basic science is already understood. Technology

development is categorized into four areas: (1) chemical and biological
detection, (2) modeling and prediction, (3) decontamination and restoration,
and (4) biological foundations (that is, molecular biologybased capabilities
to support efforts in advanced detection, attribution, and medical
countermeasures). Finally, Domestic Demonstration and Application Programs
seek to integrate current technology into capable, prototype operational
systems directed at specific applications in 2 to 3 years. One current
demonstration project is the Biological Aerosol Sentry and Information
System. This portable system is intended to provide early

warning of airborne biological incidents for special events such as large
assemblies and dignitary visits. This system is planned for use in civilian
settings to detect a biological incident within a few hours of an attack,
early enough to mount an effective medical response. This system is intended
to estimate where an attack occurred, exposure levels, and duration, all of

which would assist the public health system in identifying the population
requiring treatment.

Appendi x VI II

Department of Health and Human Services Within HHS, five agencies or offices
work on bioterrorism issues. The Agency for Healthcare Research and Quality
(AHRQ), the Food and Drug Administration (FDA), and NIH are primarily
involved in research activities, and CDC and OEP are primarily concerned
with preparedness activities. HHS is the primary federal agency for the
medical and public health response to emergencies, including major disasters
and terrorist events, under the Federal Response Plan. In addition, the
Secretary of HHS

has recently appointed a Special Assistant for Bioterrorism to coordinate
antibioterrorism efforts across the department. The Secretary of HHS was
authorized $221 million in fiscal year 2001 through the Public Health
Improvement Act of 2000 for the medical and public health consequences of a
bioterrorist attack. However, despite this authorization, there were no
specific appropriations for such activities.

Agency for Healthcare AHRQ?s mission is to support research designed to
improve the outcomes Research and Quality

and quality of health care, reduce its costs, address safety and medical
errors, and broaden access to effective services. Working through an
informal interagency workgroup, AHRQ included officials across HHS (such as
those in CDC, OEP, and the Office of the Assistant Secretary for Planning
and Evaluation) in its anti- bioterrorism research planning efforts.

Research Activities AHRQ received $5 million in fiscal year 2000 to develop
research initiatives to identify effective and specific strategies for
improving the clinical preparedness of health care providers and health care
systems for a

bioterrorist attack. For example, the agency funded research on the use of
information systems and decision support systems to enhance preparedness for
the delivery of medical care in the event of such an attack. AHRQ, along
with other HHS agency partners, also provided funding to support a
bioterrorism symposium sponsored by the Center for

Civilian Biodefense Studies at Johns Hopkins University. Centers for Disease

HHS was designated to lead an effort to work with governmental and Control
and Prevention

nongovernmental partners to upgrade the nation?s capacity to respond to
bioterrorism. Several centers, institutes, and offices within CDC work
together on bioterrorism preparedness and response efforts. The principal
priority of the Bioterrorism Preparedness and Response 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. It has focused on
helping states with planning for a bioterrorist event; enhancing
surveillance and laboratory capacity at the national, state, and local
levels; and improving communications and training for bioterrorism
preparedness. Examples of CDC?s internal research activities include work on
anthrax

and smallpox. The agency also oversees a number of studies being conducted
by universities and hospitals. Table 7 lists CDC?s reported bioterrorism
funding for fiscal years 1998 through 2001.

Table 7: Reported Funding for Activities on Bioterrorism at CDC (Dollars in
millions) Fiscal year

Fiscal year Fiscal year

Fiscal year Program/ initiative a 1998 1999 2000 2001

Research activities

Research and development 0 0 $40. 5 $42.9 Independent studies b 0 $1.8 $7.7
$2. 6 Worker safety 0 0 0 $1. 1

Preparedness activities Upgrading state and local capacity 0 $55. 0 $56. 9
$66.7

Preparedness planning 0 $2.0 $1.9 $5. 8 Surveillance and epidemiology 0
$12.0 $15. 8 $16. 1 Laboratory capacity 0 $13.0 $9.5 $12. 8 Communications 0
$28.0 $29. 7 $32. 0

Upgrading CDC capacity 0 $12. 0 $13. 9 $20. 4

Epidemiologic capacity 0 $2.0 $1.8 $4. 0 Laboratory capacity 0 $5.0 $7.6
$11. 4 Rapid toxic screen 0 $5.0 $4.5 $5. 0

Preparedness and response planning 0 $1.0 $2.3 $9. 2 Building the National
Pharmaceutical Stockpile 0 $51.0 $51. 8 $51. 0 Tot al 0 $120.8 $173.1 $193.
9

Note: We have not audited or otherwise verified the information provided. a
CDC 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. However, since deterrence is outside the scope of our study, 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.

The Bioterrorism Preparedness and Response Program was placed within the
National Center for Infectious Diseases because of the likely similarity
between a bioterrorist attack and a naturally occurring infectious disease

outbreak. The National Center for Infectious Diseases oversees research,
surveillance, laboratory, and epidemiological response efforts. The National
Center for Environmental Health manages the National Pharmaceutical
Stockpile Program and associated emergency

preparedness and planning activities. Several other offices and institutes
also contribute to the Bioterrorism Preparedness and Response Program,
including the Epidemiology Program Office; the Public Health Practice
Program Office, which focuses on communications and training; and the
National Institute of Occupational Safety and Health. Program staff are

responsible for coordination within CDC and with other federal agencies and
for policy development.

Research Activities 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 are specific lines in the budget that fund
specific universities

and hospitals to do research and other work on bioterrorism. For example,
the Carnegie Mellon Research Institute received $1 million in fiscal year
2000 to study health and bioterrorism threats. Finally, 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 multipurpose public
health infrastructure at the national, state, and local levels. For example,
CDC reported receiving funding of $66.7 million in fiscal year 2001 to
upgrade state and local capacity to

detect and respond to a bioterrorist attack. CDC received an additional
$20.4 million to upgrade its own capacity in these areas, $9.2 million for
planning and response, and another $51 million for developing the National
Pharmaceutical Stockpile. These activities may have a dual use, such as
identifying and containing a naturally occurring emerging infectious disease
in addition to responding to a bioterrorism attack.

Upgrading State and Local In fiscal year 2000, CDC received $56.9 million to
award to 50 states and 4 Capacity

major metropolitan health departments for preparedness and response
activities. CDC also provides technical assistance to these agencies to
assist preparedness efforts. 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 DOJ 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 biological and chemical agents, as well as other public health
emergencies. States have received funding from CDC to increase staff,
provide better access to data sources, 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
the state and local public health agencies? 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 that maintains state- of- the- art capabilities
for biological agent identification and characterization. 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 in fiscal year 2000 to enhance chemical
laboratory capabilities. These funds were used to purchase equipment and
provide training.

CDC is working with state and local health agencies to build a modern
electronic infrastructure for public health communications that will improve
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 foundation for distance training that could
potentially reach a large segment of the public health community.

Upgrading CDC Capacity CDC is upgrading its own epidemiologic and disease
surveillance capacity. It has deployed, and is continuing to develop, 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, Washington). The agency is also increasing its veterinary
surveillance. In addition, CDC monitors unusual clusters of illnesses, such
as influenza in June. While these clusters may not be a cause for concern,
they can indicate a potential problem.

CDC has strengthened its own laboratory capacity. For example, it is
developing and validating diagnostic tests as well as creating agent-
specific protocols. In collaboration with the Association of Public Health
Laboratories and DOD, CDC has operationalized a secure Internet- 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 needed in performing
laboratory analysis of samples.

The agency has also operationalized 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 In fiscal year 1999, at the start of CDC?s
bioterrorism program, the agency

Planning received funding to develop an overall preparedness plan. CDC
received

$2. 3 million in fiscal year 2000 for preparedness and response training and
$9. 2 million in fiscal year 2001. Among the activities to be undertaken is
the initial implementation of a national bioterrorism response training
plan. This plan will focus on preparing CDC officials to respond to
bioterrorism and will include the development of exercises to assess
progress in achieving bioterrorism preparedness at the federal, state, and
local levels. The agency will also develop 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
antibioterrorism

programs. CDC has developed a bioterrorism Web site. This site provides
emergency contact information for possible bioterrorism events, a list of
critical 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 The National
Pharmaceutical Stockpile Program maintains a repository of Pharmaceutical
Stockpile

life- saving pharmaceuticals, antidotes, and medical supplies, known as 12-
Program

Hour Push Packages, that can be delivered to the site of a biological (or
other) attack within 12 hours of deployment for the treatment of civilians.
These Push Packages are prepackaged and contain products that could be

used in a variety of scenarios. 1 Additional antibiotics, antidotes, other
drugs, medical equipment, and supplies known as Vendor Managed Inventory,
can be delivered within 24 to 36 hours after the appropriate 1 The first
emergency use of the National Pharmaceutical Stockpile occurred on September
11, 2001. In response to the terrorist attack on the World Trade Center, CDC
released one of the eight Push Packages.

vendors are notified. The Vendor Managed Inventory can be tailored to an
individual incident (that is, only products needed for a particular incident
would be sent). 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 OEP 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 program also provides technical advisers in response to an

event to ensure the appropriate and timely transfer of stockpile contents to
authorized state representatives. 2 Food and Drug FDA?s responsibilities and
activities on bioterrorism are spread throughout Administration

the agency. These activities include safeguarding the food supply, ensuring
that new vaccines and drugs are safe and effective, and conducting research
for diagnostic tools and treatment of disease outbreaks.

Under the Health and Medical Services Annex of the Federal Response Plan,
FDA is the lead HHS agency for ensuring the safety of regulated foods,
drugs, medical devices, and biological products. In an emergency, FDA would
arrange for the seizure, removal, and/ or destruction of any contaminated
and unsafe products. FDA is revising its Emergency Operations Response Plan
to include bioterrorism preparedness and response elements.

Congress has earmarked $5 million for FDA for activities on bioterrorism in
fiscal year 2001. These funds were for FDA to continue previously initiated
work on bioterrorism that had been supported by departmental and general
purpose funds. HHS has allocated other funds to FDA?s activities on
bioterrorism. For example, the Center for Biologics Evaluation and Research
received $7. 5 million in fiscal year 2000 from departmental funds
specifically for vaccine projects (see table 8).

2 For more information on the National Pharmaceutical Stockpile Program, see
Combating Terrorism: Accountability Over Medical Supplies Needs Further
Improvement (GAO- 01463, Mar. 30, 2001).

Table 8: Reported Funding for Activities on Bioterrorism at FDA (Dollars in
millions) Fiscal year

Fiscal year Fiscal year

Fiscal year Program/ initiative 1998 a 1999 2000 2001

Center for Biologics Evaluation and Research Research activities

Premarket evaluation of vaccines, a $1. 2 $7. 5 $7. 0

develop vaccines

Center for Devices and Radiological Health Research activities

Develop data requirements for approving devices intended to a $0. 1 $0. 8
$0. 9 detect exposure to or infection with biological agents

Center for Drug Evaluation and Research Research activities

Determine procedures for allowing use of not- yet- approved a $0. 2 $0. 4
$0. 7 drugs, specify data needed for approval and labeling, gather and
supply information

Center for Food Safety and Applied Nutrition Preparedness activities

Monitor food supply, communicate with state and local officials a 0 0$ 0. 3

Center for Veterinary Medicine Preparedness activities

Communicate with state officials, held meeting on bioterrorism a $0. 1 $0. 1
$0. 3 risk

National Center for Toxicological Research Research activities

Define biological mechanisms of action underlying toxicity of a $0. 2 $0. 1
$0. 5

products, identify indications of toxicity associated with biological agents

Preparedness activities

Participate in training meetings a b bb

Office of Regulatory Affairs Preparedness activities

Communicate with other agencies and the public, conduct c cc $1. 5

investigations

Total d a $1. 9 $9. 0 $11. 2

Note: We have not audited or otherwise verified the information provided. a
Agency officials told us that in fiscal year 1998 funds were expended on
bioterrorism- related activities, but they did not report these levels to
us.

b We were unable to allocate funding within this program for research and
preparedness based on the information provided by FDA. Instead, we list all
the funding under research because the preponderance of activities within
that program are best categorized there.

c FDA reported that activities on bioterrorism were conducted by the Office
of Regulatory Affairs, but it did not specify how much was spent on them. d
Individual entries may not sum to totals because of rounding. Source: FDA.

Center for Biologics The mission of the Center for Biologics Evaluation and
Research is to Evaluation and Research

ensure the safety, efficacy, potency, and purity of biological and related
products, including vaccines, that could be used in case of a bioterrorist
attack.

Research Activities Among its responsibilities, the Center for Biologics
Evaluation and Research regulates the development and licensure of new
vaccines for anthrax, smallpox, and the associated vaccinia immune globulin
used to treat serious vaccinia infections or other adverse events caused by
the

smallpox vaccine. In addition to premarketing evaluation, vaccine products
require review of lot release data, inspection of manufacturing facilities,
assessment of product availability, and surveillance and compliance
activities. The center works closely with other government agencies such as
CDC and DOD to assist in ensuring that sufficient quantities of medical
products are available for military and civilian use during a bioterrorism
attack, and that the use is controlled under an acceptable clinical protocol
when the biological product is not licensed by FDA or is being used ?off

label.? 3 It also coordinates with industry and government agencies to
prepare surveillance methods for adverse event monitoring associated with
the use of biological products in a bioterrorism attack. The center engages
in vaccine research activities related to the regulation of the development
of vaccines for plague, tularemia, and encephalitis- causing viruses. 4 (See

app. I for a discussion of specific biological agents mentioned in this
report.) Since high- risk bioterrorism pathogens either do not exist
naturally or do not cause significant disease in large populations, the
traditional human testing and ultimate approval of products for mitigating a
disease in humans caused by a bioterrorist pathogen is neither ethical nor
feasible.

The center is working with CDC, NIH, and DOD, as well as academia and 3 ?Off
label? refers to the treatment of conditions other than those listed on
FDA?s approved drug label. 4 Encephalitis is inflammation of the brain.

industry to develop regulations that will define the type of nonhuman
research data required to demonstrate the potential efficacy of new products
on humans affected by biological WMDs.

Officials have noted that while there is a clear need to develop vaccines
for biological agents, there are limited commercial interests or market
incentives for addressing the problem. Consequently, it falls upon the

federal government to develop such vaccines. The Center for Biologics
Evaluation and Research has research projects under way dealing with
vaccines for anthrax, plague, and smallpox. Center for Devices and

The mission of the Center for Devices and Radiological Health is to ensure
Radiological Health

the safety and effectiveness of medical devices, including those that could
be used in the event of a bioterrorist attack.

Research Activities The center provided comments on a research protocol to
evaluate a device intended to identify anthrax in human specimens. It has
also conducted an advisory panel meeting to discuss data requirements for
approval of devices intended to detect exposure to or infection with
biological agents. In addition, the center is working with CDC on a process
that would allow

the use of investigational diagnostic devices in the event of a bioterrorist
attack. Center for Drug Evaluation

The Center for Drug Evaluation and Research helps ensure the availability
and Research of safe and effective human drugs. The center reviews research
to take appropriate action on the marketing of drugs, including those that
would be used in the event of a bioterrorist attack.

Research Activities The center is working with CDC on a process that would
satisfy the requirements for allowing the use of investigational drugs (not
approved by FDA) in the event of a bioterrorist attack. Testing drugs that
might be used in case of a bioterrorist attack is difficult because the
diseases caused by the biological agents rarely occur naturally and it would
be unethical to

infect healthy volunteers with the disease when there is no known cure. The
center is working with other government agencies and the manufacturers of
these drugs to determine what studies are needed to

generate sufficient safety and efficacy data to permit labeling of these
drugs. For products that might still be in the investigational stage, but
potentially the only therapies available for a specific disease caused by a

bioterrorist event, the center is working with CDC to determine additional
methods of data collection and analysis to evaluate the products? safety and
efficacy if it were necessary for them to be used. Although some drugs that
would be used in the case of a bioterrorist attack have been approved to
treat diseases caused by a biological agent, use of a number of these drugs
would be ?off- label.? The center is determining what

data are needed to enable approval of a label indicating that a drug would
treat a disease that might be caused by a bioterrorist attack. It has a
program in this area, but there has been limited funding for these
activities. The center has worked to facilitate the labeling of
ciproflaxacin for the treatment of inhalational anthrax and is now working
to assess what is needed in the way of studies to produce sufficient data
for labeling gentamicin to treat pneumonic plague. It is also determining
what types of

nonclinical (nonhuman) data are acceptable for product marketing approval if
traditional clinical studies are not feasible or ethical.

At the request of the National Security Council, the center has compiled a
list of and information on drugs that might be effective in case of a
bioterrorist attack. The information includes manufacturers, inventories,
lead time for producing the drugs, and bulk suppliers. Center officials
noted that they do not regularly collect this information. It is also
working with CDC to implement a shelf- life extension program for the
maintenance

of stockpiled supplies. Center for Food Safety and

The Center for Food Safety and Applied Nutrition is responsible for Applied
Nutrition promoting and protecting the public?s health by ensuring that the
nation?s food supply is safe, sanitary, wholesome, and appropriately
labeled. The center has been involved in preparing for a bioterrorist attack
on the food supply.

Preparedness Activities The Center for Food Safety and Applied Nutrition has
undertaken activities regarding contaminated food that are important for
bioterrorism response readiness. For example, the agency has developed a
procedures manual for dealing with foodborne attacks. The center works with
other federal and state agencies to monitor the safety of the U. S. food
supply. The agency has been involved in the development and support of two
surveillance systems for identifying and characterizing contaminated food,
FoodNet and

PulseNet. FoodNet is a collaborative project of FDA, CDC, USDA, and nine
state health departments. It is an effort to capture a more accurate and
complete picture of trends in the occurrence of foodborne illness and

provides information about the number of persons who were diagnosed with
specific infections that are likely to be foodborne. PulseNet is a
collaborative project of FDA, CDC, USDA, and state health department food
safety laboratories to facilitate subtyping bacterial foodborne

pathogens for epidemiological purposes. The center (along with the Office of
Regulatory Affairs) is leading an effort to improve coordination and
communication among federal, state, and local public health and food
regulatory officials. The efforts are targeted at outbreaks of illness
caused by foodborne pathogens and are meant to contribute to more effective
implementation of existing food safety programs.

Center for Veterinary The Center for Veterinary Medicine regulates the
manufacture and

Medicine distribution of food additives and drugs that will be given to
animals. These

include animals from which human foods are derived as well as food additives
and drugs for pet (or companion) animals. Since animals raised for food are
a potential target for a bioterrorist attack, the center has initiated
activities to increase its preparedness.

Preparedness Activities The Center for Veterinary Medicine has established
and maintains lines of communication with state regulatory officials and
personnel in state veterinary diagnostic laboratories. The center co-
sponsored a meeting to review the risks to U. S. and world food and
agriculture from plant and animal disease and bioterrorism.

National Center for The National Center for Toxicological Research conducts
scientific Toxicological Research research that supports and anticipates
FDA?s current and future regulatory needs. This involves fundamental and
applied research on biological mechanisms of action underlying the toxicity
of products regulated by

FDA. Research Activities The National Center for Toxicological Research has
examined proteins in food to determine the existence of bacteria. It has
also worked on

approaches to identify indications of toxicity associated with biological
agents. Preparedness Activities In the event of an attack, the center has
the ability to respond with animal studies and microbiological surveillance
to identify the agent.

Representatives from the National Center for Toxicological Research
participate in meetings with FEMA and Arkansas public health officials to
plan training activities for responding to bioterrorism threats.

Office of Regulatory Affairs Among its responsibilities, the Office of
Regulatory Affairs responds to emergencies involving products regulated by
FDA. If a bioterrorist event were to take place, the office would be
involved in the investigation. Preparedness Activities FDA would be involved
in the management of a response to any attack that targets a FDA- regulated
product. The Office of Regulatory Affairs? Office of Criminal Investigations
would conduct the criminal investigation and serve

as the liaison to the FBI and other law enforcement agencies. The Office of
Regulatory Affairs maintains a 24- hour emergency hotline, in part for
receiving information about a bioterrorist attack. It has also established a
notification system with the FBI for bioterrorist events.

National Institutes of NIH conducts medical research in its own laboratories
and supports the

Health research of nonfederal scientists in universities, medical schools,
hospitals,

and research institutions throughout the United States and abroad. NIH is
composed of 27 separate institutes and centers. One of these is the National
Institute of Allergy and Infectious Diseases (NIAID), which has a program to
support research related to organisms likely to be used as biological
weapons. This program includes research devoted to the development of (1)
rapid, accurate diagnostics, (2) effective therapy for those infected, and
(3) vaccines for those at risk of exposure.

All of NIH?s research on bioterrorism has been funded out of general
appropriations. Table 9 gives the amounts of reported funding for NIH?s
activities on bioterrorism for fiscal year 1998 through fiscal year 2001.

Table 9: Reported Funding for Activities on Bioterrorism at NIH (Dollars in
millions) Fiscal year

Fiscal year Fiscal year

Fiscal year Program/ initiative 1998 1999 2000 2001 (estimate)

Research activities

Diagnostics $0. 3 $1.3 $0.9 $1. 1 Vaccines $3. 0 $6.6 $6.8 $7. 0
Antibiotics/ antivirals $0. 4 $3.3 $5.6 $6. 1 Basic research (genomics and
pathogenesis) $13. 2 $21.4 $29.7 $35. 4

Tot al a $17.0 $32.6 $43.0 $49. 7

Note: We have not audited or otherwise verified the information provided. a
Individual entries may not sum to totals because of rounding.

Source: NIH.

Research Activities The initial focus of NIAID?s research efforts on
bioterrorism was on smallpox and anthrax. The agency collaboratively funded
(along with DOD, DOE, and CDC) activities on smallpox, including research to
develop and test antiviral drugs against smallpox viruses, extend the
usefulness of the currently available, older vaccine, and to develop a
vaccine that can be used in all segments of the civilian population (for
instance, pregnant women and the immune- suppressed). For anthrax, NIAID has
formed the Working Group on Anthrax Vaccines to develop and test a new
vaccine that

could be used to replace the currently licensed vaccine. In addition to
these ongoing activities, NIAID provided support to sequence the genomes of
all bacterial pathogens considered by CDC to have the potential to be used
as bioterrorism agents. The results of such research,

along with other information, are expected to facilitate pursuit of a
variety of critical goals, including the development of rapid diagnostic
methods, antimicrobial therapies, and new vaccines for the most likely
bioterrorist agents.

NIAID also conducts and sponsors research in the areas of diagnostics,
therapeutics, and vaccines, as well as basic research on the origination and
development of diseases from biological agents. In diagnostics research, the
development of detection systems for smallpox antigens has been emphasized.
Therapeutics research has covered a number of areas including the
development of a replacement therapy for treating the serious complications
that would result from immunizing the civilian population

against smallpox. NIAID continues to work on vaccines for smallpox and
anthrax to prevent illness resulting from a terrorist attack. The agency has
collaborated with the U. S. Army Medical Research Institute of Infectious
Diseases on the development of a new anthrax vaccine to protect the American
public. NIAID is also conducting basic research in a number of areas,
including the genetic basis for the virulence of potential bioterrorist
agents.

Office of Emergency OEP coordinates the medical and public health response
to emergencies,

Preparedness including all kinds of terrorist attacks and natural disasters.
OEP has taken

an ?all- hazards? approach to emergency preparedness and response because it
is involved in the health response to many different types of situations,
including bioterrorism. See table 10 for OEP?s reported funding for
activities on terrorism.

Table 10: Reported Funding for Activities on Terrorism at OEP (Dollars in
millions) Fiscal year

Fiscal year Fiscal year

Fiscal year Program/ initiative 1998 1999 2000 2001

Research activities

Infrastructure- research and $0. 1 $0. 1 0 0 development Smallpox s tudy
$0.1 0 0 0

Special activities 0 0 0 $4. 6

Preparedness activities Combating terrorism $0.3 $19. 0 $20. 0 $27. 2

National Medical Response Teams 0 $1. 5 $1. 5 $1. 5 U. S. Public Health
Service Noble Training Center 0 $3.0 $1.0 $2.9 VA WMD training 0 0 0 $0. 8
Pharmaceutical Cache 0 0 $1. 0 $1. 2 Metropolitan Medical Response

0 $14. 5 $16. 5 $17. 4 System Special events 0 0 0 $2. 0

Surveillance and laboratory support $0.3 a 0 0 0 Special activities 0 0 0
$1. 4

(Continued From Previous Page)

Fiscal year Fiscal year

Fiscal year Fiscal year

Program/ initiative 1998 1999 2000 2001 Infrastructure $9.7 $12. 6 $15. 3
$18. 9

Office/ regions $5. 0 $7. 5 $8. 8 $12. 3 Planning and evaluation $1. 2 $1. 0
$1. 0 $1. 0 Training and exercises 0 $0. 8 $2. 5 $2. 5 Disaster Medical
Assistance Team development $2. 5 $2.5 $2.5 $2.6 Communications $1. 0 $0. 8
$0. 5 $0. 5

Tot al b $10.2 $31. 7 $35. 3 $50. 7

Note: We have not audited or otherwise verified the information provided. a
This money was transferred to CDC, FDA, and HHS? Agency for Toxic Substances
and Disease

Registry. This funding stopped once these agencies began receiving
bioterrorism funding. b Individual entries may not sum to totals because of
rounding.

Source: OEP.

Research Activities OEP has participated in research and evaluation
activities. It has worked with the Institute of Medicine to develop an
assessment methodology and performance measures for the Metropolitan Medical
Response System. OEP also oversees $4.6 million in fiscal year 2001 for
research special activities, which are earmarks in the budget for specific
universities,

hospitals, or response systems to conduct studies (see table 10).
Preparedness Activities HHS coordinates many of its medical response
activities with other agencies through the National Disaster Medical System.
OEP leads this system, a partnership among HHS, DOD, VA, FEMA, state and
local governments, and the private sector, which is intended to ensure that
resources are available to provide medical services following a disaster
that overwhelms the local health care resources. The overall purpose of the
system is to establish a single, integrated national medical response

capability to (1) assist state and local authorities in dealing with the
medical and health effects of major peacetime disasters and (2) provide
support to the military and VA medical systems in caring for casualties
evacuated to the United States from overseas armed conflicts. About 2, 000

civilian hospitals have pledged resources that could be marshaled in any
domestic emergency under the system.

In addition to providing additional capacity in the event of an emergency,
the National Disaster Medical System also has response teams that can

provide support at the site of a disaster. Disaster Medical Assistance Teams
can deploy to disaster sites with sufficient supplies and equipment to
sustain themselves for 72 hours while providing medical care at a fixed or
temporary site. 5 In mass casualty events, the teams would perform triage,
provide medical care, and prepare patients for evacuation. In other types of
situations, the teams may also provide primary health care and/ or serve to
augment overloaded local health care staffs. There are also specialized
Disaster Medical Assistance Teams. Some of the specialized teams deal with
specific medical conditions, such as burns or mental health. Disaster
Mortuary Operational Response Teams provide mortuary services and victim
identification. There are four National Medical Response Teams located
around the country that are specially equipped and trained to provide
medical care for victims of WMDs. Three of these are deployable anywhere in
the country, and all four teams have a

stockpile of pharmaceuticals and medical supplies to treat up to 5,000
people. However, these stockpiles are primarily for treating victims of a
chemical weapon.

OEP received $2 million in fiscal year 2001 that was transferred to VA to
provide funding for VA to manage caches of pharmaceuticals for the National
Medical Response Teams and for training of National Disaster Medical System
hospitals in response to WMD events. OEP also received

approximately $2. 9 million in fiscal year 2001 to provide management staff
and operating funds for the U. S. Public Health Service Noble Training
Center in Alabama. This center is developing curricula and providing
training activities for physicians, nurses, and emergency medical
technicians. This facility will primarily provide training in response to a
chemical incident, but will also have some bioterrorism response duties.

The office received $2. 6 million in fiscal year 2001 for Disaster Medical
Assistance Team development, which funds training programs for the teams and
other specialty teams (see table 10 for detailed budget information). OEP
received an additional $1. 5 million to expand the National Medical Response
Teams, primarily by providing additional team members and purchasing
equipment. Some funding from both of these

5 Disaster Medical Assistance Teams were dispatched to the New York City and
Washington, D. C., areas on September 11, 2001. The initial units included
more than 300 medical and mortuary personnel.

sources was also used to provide management and oversight of the annual
National Disaster Medical System conference. OEP was allocated received $2.5
million in fiscal year 2001 to provide additional training and exercise
activities for Disaster Medical Assistance Teams and local responders to
ensure that teams are operational in a field setting, and that the community
and response teams can work together to achieve an integrated approach to
medical care during a terrorist event.

These funds also provide for coordinated training and exercises with other
departments, such as DOD and DOE, during response to special events.

The office also deploys teams from the National Disaster Medical System to
high- security events, such as visits by heads of state. In fiscal year
2001, OEP received $2 million to support the costs of deploying teams to a
number of special events, including $1 million for the Olympic games and $1
million for other special events, such as the presidential inauguration.

OEP?s Metropolitan Medical Response System emphasizes enhancement of local
planning and response capability, tailored to each jurisdiction, to care for
victims of a terrorist incident involving WMDs. The program includes a focus
on response to bioterrorism, including disease surveillance, mass casualty
care, and mass fatality management. OEP, under the Metropolitan Medical
Response System, has entered into contracts with 97 local areas to develop
and coordinate local medical response capabilities. This program

works at the local level because of the rapid response time that would be
required to manage the consequences of a terrorist attack. OEP received
approximately $17 million in fiscal year 2001 to expand the program to 25
additional communities and continue development in 25 existing areas begun
in fiscal year 2000. In addition, 47 of the areas received additional
funding to plan for an appropriate health system response to a bioterrorist
attack. Planning and evaluation funds were used, in part, to provide

oversight and technical assistance for response system activities. In fiscal
year 2001, OEP is overseeing $1. 4 million that was earmarked in the budget
for the Charlotte, North Carolina, Metropolitan Medical Response System. The
funds will be used to coordinate and enhance preparedness of community
health care facilities, for provider training, and to integrate the public
health system into a mass casualty response system.

OEP received approximately $12 million in fiscal year 2001 for general
emergency preparedness infrastructure development and maintenance. This
includes headquarters and regional staff salaries, rent, and other

operating costs. It also received $500,000 to maintain and enhance systems
to communicate during disasters and special events.

Appendi x IX

Department of Justice DOJ has a variety of responsibilities for combating
terrorism. The Office of Justice Programs (OJP) administers programs to
provide equipment, training, exercises, and technical assistance to first
responders, including some components of the Domestic Preparedness Program
that were transferred from DOD, 1 and to provide assistance to victims of
terrorism. Under Presidential Decision Directive 39, DOJ, acting through the
FBI, is the overall lead federal agency for domestic terrorism incidents.
The FBI is the lead agency for crisis management of any terrorist incident
within the

domestic United States and houses the National Domestic Preparedness Office,
which was established to coordinate all federal efforts to assist state and
local first responders in preparing for a terrorist incident. See table 11
for DOJ?s reported funding for activities on bioterrorism.

Table 11: Reported Funding for Activities on Bioterrorism at DOJ (Dollars in
millions) Fiscal year

Fiscal year Fiscal year

Fiscal year Program/ initiative 1998 1999 2000 2001

OJP Research activities

Biological agent detection $0.2 $1. 1 $0.2 0 Development of equipment
performance standards and test protocols 0 0 $0.5 $4. 6 for emergency
response equipment Preparedness activities

Development of chemical/ biological agent list $0.3 0 0 0 Exercises 0 0 $6.1
a $3. 2 Development of an emergency response to domestic biological 0 0 $0.5
$1. 0 incidents Metropolitan Medical Response System outreach plan 0 0 $0.3
0

Veterinary Laboratory Network for rapid analysis of biological agents 0 0
$0.4 0 Hospital Provider Course Development And Delivery 0 0 0 $0. 9
Biological Planning Guide 0 0 0 $0. 2 Development of equipment guides 0 $0.3
$0. 3 0

1 See app. VI for more information on the Domestic Preparedness Program.

(Continued From Previous Page)

Fiscal year Fiscal year

Fiscal year Fiscal year

Program/ initiative 1998 1999 2000 2001 FBI Research activities

Detecting and characterizing biological agents 0 0 0 $1. 1

Tot al $0.5 $1. 4 $8.3 $11. 0

Note: We have not audited or otherwise verified the information provided. a
OJP could not report how much of $6.1 million for exercises was only for
activities on bioterrorism.

Source: DOJ.

Office of Justice OJP sponsors research on emergency response equipment,
provides grants Programs

and technical assistance, and can provide assistance to victims of
terrorism. Research Activities The National Institute of Justice within OJP
conducts research activities on terrorism. Among its programs, the institute
conducts operational testing and assessment of new technologies and supports
efforts to develop lower cost, more effective emergency response equipment.
It is also working with

the Office of State and Local Domestic Preparedness Support, the FBI, and
the Technical Support Working Group on a study to determine the chemical and
biological agents that terrorists are most likely to use.

Preparedness Activities The Anti- Terrorism and Effective Death Penalty Act
of 1996 (P. L. 104- 132, sec. 822) authorized OJP and FEMA to fund and
develop a terrorism emergency response training program for fire, emergency
medical service,

and public safety personnel. The 1998 Commerce, Justice, and State
Appropriations Act (P. L. 105- 119) provided funding used to create an
equipment acquisition grant program as well as two training centers for
emergency responders. The grant and training programs target the nation?s
120 largest metropolitan jurisdictions. The Office for State and Local
Domestic Preparedness Support administers the Domestic Preparedness Program
and the grant and training programs. This office assists state and

local jurisdictions in enhancing their domestic preparedness capabilities by
providing assistance to jurisdictions to acquire equipment, technical
assistance, exercises, and training. For example, this office has developed
an on- line data collection tool to assist states in conducting their
threat,

risk, and needs assessments 2 and to develop their WMD preparedness
strategy, which is designed to be used by the states to target grant funds
in order to improve preparedness. OJP reported $5.3 million in fiscal year
2001 as being related to the public health and medical consequences of a
bioterrorist attack against the civilian population, as shown in table 11.
However, the funding in table 11 represents only part of DOJ?s more general-
purpose spending on activities on terrorism, which could also benefit
preparedness for a bioterrorism event. DOJ reported $3.2 million was used to
facilitate biological tabletop

exercises in 52 cities in fiscal year 2001. These 1- day exercises involve
public health, fire, law enforcement, and emergency management agencies.
Participants work through a simulation of a bioterrorism incident, starting
with the incubation period (the time between initial exposure to a
biological agent and the first onset of symptoms), followed by the
recognition and initial response, and finally the challenges of integrating

federal assets in the response and recovery efforts. Medical surveillance,
epidemiology, quarantine, patient tracking, remediation, and mass fatality
management are addressed.

OJP also reported funding of $1.0 million in fiscal year 2001 to develop and
deliver a course on planning a response to a bioterrorist attack (see table
11). The office reported about $0. 3 million to develop a plan to enhance
awareness of the Metropolitan Medical Response System and approximately $0.
4 million to establish a Veterinary Laboratory Network for the rapid
analysis of biological and infectious disease agents in fiscal year 2000. 3
OJP may also provide assistance to victims of terrorism under the Victims

of Crime Act of 1984 (P. L. 98- 473, ch. 14, as amended). These funds could
be used, for example, to provide mental health treatment to victims of
terrorism.

2 During the threat and risk assessment process, states identify the threat
and risk posed to a community by the terrorist use of a WMD device and
integrate vulnerability, threat, and public health performance information
to yield a risk profile. The needs assessment outlines a state?s needs for
training, equipment, and other resources.

3 See app. VII for more information on the Metropolitan Medical Response
System.

Federal Bureau of The FBI conducts some bioterrorism- related research, is
the lead agency Investigation

for crisis management, and houses the National Domestic Preparedness Office.
Research Activities The Hazardous Materials Response Unit conducts research
on detecting

and characterizing biological materials for law enforcement reasons, such as
associating some person, group, or geographical region with the biological
material. This research could also have benefits in identifying biological
agents for public health and medical systems. In fiscal year 2001, the
Hazardous Materials Response Unit awarded $500,000 for research activities
related to detection and characterization of biological materials

($ 250,000 each to the Massachusetts Institute of Technology and the U. S.
Soldier Biological and Chemical Command). It has an additional $585,000 in
awards pending. This amount includes $150,000 for CDC?s Laboratory Response
Network for bioterrorism. 4 The FBI participated in the creation of
protocols used by the Laboratory Response Network to ensure uniformity in
testing and the establishment of the proper chain of custody

for biological, evidentiary samples. Preparedness Activities In the FBI?s
role as lead agency for crisis management, it conducts interagency threat
assessments of WMDs (a process established to determine the credibility of
WMD threats), and provides a situational assessment during a WMD incident.
The FBI has designated a WMD

coordinator in each of its 56 field offices. If necessary, the FBI
coordinates deployment of the Domestic Emergency Support Team in response to
an emergency under the U. S. Government Interagency Domestic Terrorism
Concept of Operations Plan (CONPLAN).

The FBI also houses the National Domestic Preparedness Office, which was
established to coordinate all federal efforts to assist state and local
emergency responders with planning, training, equipment, medical and

health, and exercise needs necessary to respond to a WMD incident. The
office serves as a single point of contact and clearinghouse for WMDrelated
information for state and local responders, including fire, hazardous
materials, law enforcement, public health, and medical

4 See app. VII for more information on the Laboratory Response Network.

personnel. It also provides emergency responders with access to subject
matter experts and links to federal resources. The FBI and CDC are engaged
in a series of four regional meetings to identify the core capacities
required to prepare for and respond to an act of bioterrorism. These
sessions will assist in prioritizing the capabilities of the public health
community and identify how law enforcement can promote and benefit from
these programs. The FBI and CDC are also developing guidelines that will
assist CDC in disseminating information to the public health departments
through the communications system, Epi- X. Epi- X is a

secure, moderated, Web- based communications network for public health
officials that is intended to simplify and expedite the exchange of routine
and emergency public health information between CDC and state health
departments. Following the guidelines should allow the public health
community to obtain necessary information without releasing case specific

or law enforcement sensitive information not relevant to the health related
concerns.

Appendi x X

Department of Transportation DOT is responsible for reducing vulnerabilities
to terrorism affecting the security of all airports in the United States,
all aircraft and passengers, and all maritime shipping under the U. S. flag
or registration, or operating within the territory of the United States. DOT
also coordinates security measures

for rail, highway, mass transit, and pipeline facilities. Through the
National Response Center, which is staffed by the Coast Guard and located in
the Coast Guard?s Headquarters Command Center, DOT also serves as the sole
national point of contact for reporting all biological, oil, chemical,
radiological, and disease- causing discharges into the environment anywhere
in the United States and its territories. DOT received $800,000 in fiscal
year 1999 and $800,000 in fiscal year 2000 for preparedness activities

on bioterrorism from DOD. Research Activities DOT is conducting research on
the ability of metropolitan areas to respond to attacks on local transit
systems. Most of the WMD research at DOT is focused on chemical, not
biological, agents. Preparedness

The National Response Center serves as the first- alert center for all
Activities

releases of biological agents, maintains incident databases, and provides
private and secure conferencing for the law enforcement, emergency response,
and public health sectors on an incident- specific basis. It is also the
communications and operations center for the National Response Team. Both
the National Response Center and the National Response Team are components
of the National Response System. The system is the

government?s mechanism for emergency response to discharges of oil and the
release of chemicals into the navigable waters or environment of the United
States and its territories. It provides a framework for coordination among
federal, state, and local responders and responsible parties. The National
Response Team provides a national planning, policy, and coordinating body to
provide guidance before and assistance during an incident. Its membership
consists of 16 federal agencies 1 with expertise in various aspects of
emergency response to pollution incidents. The National Response Center
participates in terrorism exercises as requested by other

1 The 16 federal agencies are the Departments of Agriculture, Commerce,
Defense, Energy, Health and Human Services, the Interior, Justice, Labor,
State, Transportation, and the Treasury; the Environmental Protection
Agency; the Federal Emergency Management Agency; the General Services
Administration; the Nuclear Regulatory Commission, and the U. S. Coast
Guard.

agencies. Some emergency response and management training courses at DOT
have a bioterrorism component, but there are no training courses dedicated
to bioterrorism.

Appendi x XI

Department of the Treasury Within the Department of the Treasury, the U. S.
Secret Service receives funding for activities on bioterrorism. U. S. Secret
Service The U. S. Secret Service is responsible for the protection of the
President, the Vice President, and their families; heads of state and other
designated

individuals; the investigation of threats against these protectees; and
protection of the White House, the Vice President?s Residence, foreign
missions, and other buildings within Washington, D. C. The U. S. Secret
Service is also responsible for design, planning, and implementation of
security at designated National Security Special Events.

Research Activities The U. S. Secret Service reported funding of $450,000
for fiscal year 2001 to support the development of a biological agent
detector. It reported funding of an additional $60,000 for laboratory
identification of biological and chemical agents.

Preparedness Activities The Hazardous Agent Mitigation and Medical Emergency
Response teams, which are part of the Secret Service?s Chemical, Biological,
Radiological, and Nuclear Countermeasures program, travel with the
presidential motorcade and respond to chemical and biological events. The
Secret Service has a role to protect the civilian population in special
events such as the Olympic games.

Appendi x XII

Department of Veterans Affairs VA manages one of the nation?s largest health
care systems and is the nation?s largest drug purchaser. The department
purchases pharmaceuticals and medical supplies for the National
Pharmaceutical Stockpile Program and the National Medical Response Team
stockpiles and it participates in other bioterrorism preparedness
activities. Preparedness

VA purchases pharmaceuticals and medical supplies for federal stockpiles
Activities

because of its purchasing power and ability to negotiate large discounts
from manufacturers that sell pharmaceuticals, equipment, and supplies to the
VA hospital system. 1 VA is under contract with CDC to purchase drugs

for the National Pharmaceutical Stockpile Program and manages a spectrum of
contracts for the storage, rotation, security, and transportation of the
stockpile. The CDC contracts included an estimated $14 million for fiscal
year 2000 and another $60 million for fiscal year 2001.

VA also works with OEP by agreement to purchase, store, and maintain drugs
for the four National Medical Response Teams, and to train the National
Disaster Medical System civilian hospital staff. VA received $0. 9 million
in fiscal year 2000 and $1. 2 million in fiscal year 2001 from OEP for the
purchase, storage, and maintenance of drugs. Also in fiscal year 2001, VA
received $0.8 million from OEP to begin developing training for staff in the
National Disaster Medical System hospitals.

In addition, VA hospitals throughout the United States participate in local
community emergency planning. VA personnel have been deployed to many
presidentially declared emergencies (for example, the Oklahoma City
bombing). 1 See app. VIII for more information on the stockpiles.

Appendi x XI II

Environmental Protection Agency EPA has responsibilities to prepare for and
respond to emergencies involving oil, hazardous substances, pollutants, or
contaminants (which include chemical, biological, and radiological
materials) that also could be components of a WMD attack. If necessary, EPA
can assist the FBI in determining what sort of hazardous substance may be,
or has been,

released in a terrorist incident. Following an incident, EPA can help with
environmental monitoring, sampling, decontamination efforts, and longterm
site cleanup activities. In addition, Presidential Decision Directive 63
gives EPA responsibility for the protection of the U. S. water supply from
terrorist attack, including the protection of water supplies from biological
contamination.

EPA?s participation in a potential bioterrorist event would vary on a
caseby- case basis. EPA might advise the national, state, or local
government on what the agent might be and could have a role in the potential
cleanup and decontamination if asked to assist by other agencies. For
example, this might include testing the water system for contaminants,
including

biological agents, if an outbreak of a disease occurred. EPA works with CDC
on a case- by- case basis to tailor its response to address the specific
agent. EPA received little funding specifically for activities on
bioterrorism during fiscal year 1998 through fiscal year 2001 (see table
12).

Table 12: Reported Funding for Activities on Bioterrorism at EPA (Dollars in
millions) Fiscal year

Fiscal year Fiscal year

Fiscal year Program/ initiative 1998 1999 2000 2001

Research activities

Detection of biological agents 0 0 0 $0. 5

Preparedness activities

Vulnerability assessments $0.01 0 $0.1 $2. 0

Tot al $0. 01 0 $0. 1 $2. 5

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

Research Activities EPA reported funding of $500,000 in fiscal year 2001 to
sponsor research to investigate methods to detect and identify biological
agents in water.

Preparedness EPA is training its staff to respond to a WMD incident. EPA has
Activities

approximately 220 On- Scene Coordinators across the country, who are the on-
location staff responsible for coordinating EPA?s response to a hazardous
material spill or release into the environment. The coordinators are
responsible for bringing in the necessary resources, including EPA
contractors, or tasking other agencies for support. The coordinators and EPA
contractors are receiving training on WMD agents, especially biological
agents, in order to get more specific, in- depth knowledge to enhance their
overall ability to handle a bioterrorist incident. EPA is coordinating with
CDC to add a bioterrorism module to EPA?s training on

terrorism. EPA is considering additional training for its coordinators to
provide them with the in- depth knowledge they need to lead an appropriate
response. However, because situations with biological agents are unique, it
is hard to make generalizations about how to respond. For example,

weather conditions can alter the need to decontaminate a site because
temperature, among other factors, can render biological agents harmless. EPA
has also been working with DOE and the American Water Works Association-
Research Foundation to develop a vulnerability assessment methodology for
the water supply sector. In fiscal year 1998, EPA received $10,000 to
partially fund the development of the National Infrastructure Assurance
Plan- Water Supply (see table 12). EPA received $66,000 in fiscal year 2000
to fund the development of the vulnerability assessment methodology and to
co- sponsor a workshop on water infrastructure

protection with DOE. EPA reported funding of $2.0 million to continue the
development of this methodology and related water issues in fiscal year
2001.

Appendi x XI V

Federal Emergency Management Agency FEMA is the lead federal agency for
consequence management preparedness and response to terrorist incidents
involving WMDs, and it is helping to build a bioterrorist response system
that is part of a broader terrorist response system. FEMA reported funding
for activities on terrorism of $25.1 million for fiscal year 2000 and $30.3
million for fiscal year 2001 (see table 13).

Table 13: Reported Funding for Activities on Terrorism at FEMA (Dollars in
millions) Fiscal year

Fiscal year Fiscal year

Fiscal year Program/ initiative 1998 1999 2000 2001

Preparedness activities

Response and recovery a $2. 0 $2.0 $6.3 Preparedness, training, and
exercises a $0. 5 $1.8 $2.3 Fire prevention and training a $4. 0 $4.9 $5.1
Emergency management planning grants a $8.3 $16. 4 $16. 6

Tot al $14.8 $25. 1 $30. 3

Note: We have not audited or otherwise verified the information provided. a
FEMA did not supply us with funding amounts for fiscal year 1998. Source:
FEMA.

Preparedness At the federal level, FEMA is involved with preparedness
activities in

Activities coordination with other departments and agencies, using the
structures of

the Federal Response Plan. At the state and local levels, preparedness
activities include the provision of grants to the states and the delivery of
first- responder and emergency management training programs to support

their terrorism- related planning, training, exercise, equipment, and
assessment requirements.

Planning FEMA works with other departments and agencies to support
consequence management planning at the national and regional levels. FEMA
coordinates the federal response planning through the Emergency Support
Functions Leaders Group, which is the principal body that addresses Federal
Response Plan planning and implementation at the working level,

and the Catastrophic Disaster Response Group, which provides guidance and
policy direction on response coordination and operational issues. Also, FEMA
plans and participates in activities to address consequence

management for special events such as the Olympic games. FEMA has been
actively engaged in the development and review of major organizational and
operational support documents, such as the CONPLAN (see app. III for details
regarding the CONPLAN). FEMA and DOJ?s OJP are working to incorporate a
bioterrorist response element into their terrorist response system.

At the state and local levels, FEMA provides assistance to support
terrorism- related emergency response planning. FEMA gives Emergency
Management Planning grants to support the development of terrorismspecific
annexes to existing state and local emergency operations plans. The grant
money can be used for activities such as planning, training, and

conducting exercises. FEMA negotiates a work plan for funding with each
state, and states have been given wide latitude in targeting this
assistance. FEMA can also provide supplemental funds to state and local
mental health agencies to provide crisis counseling to eligible survivors of
presidentially declared major disasters. FEMA also updates and maintains the
Rapid Response Information System,

which is authorized under the National Defense Authorization Act of Fiscal
Year 1997 (P. L. 104- 201, sec. 1417). This information system contains
databases of characteristics and safety precautions for nuclear, biological,
and chemical agents and materials and can be used as a resource guide for
response to such an incident.

Training FEMA has developed and delivered terrorism- related courses for
state and local emergency management personnel and first responders. It has

provided grant assistance to the states to support this training. Training
is provided through the Emergency Management Institute and the National Fire
Academy. The Institute also conducts a Senior Officials Course for local
government officials as part of the Domestic Preparedness Program. 1
Exercises FEMA participates in federal interagency terrorism response
exercises

sponsored by the FBI, DOD, and others. FEMA also provides funding to states
to support terrorism response exercises. FEMA participates in 1 See app. VI
for more information on the Domestic Preparedness Program.

special events such as the Olympic games, where it has the opportunity to
detect and correct weaknesses in its system. Equipment FEMA, in conjunction
with DOD and DOJ, assisted in the development and is currently helping to
refine the Standardized Equipment List to support

acquisition of equipment for fire, police, and emergency medical responders.
This equipment will conform to appropriate and applicable laws, regulations,
and to- be- developed national standards including those issued by the
National Institute of Justice, the National Institute for Occupational
Safety and Health, and the National Fire Protection Association.

Assessment FEMA and the National Emergency Management Association have
created a partnership to develop an emergency management readiness and
capability assessment system for state and local emergency managers. This
self- assessment is intended to help governments determine strengths and
weaknesses of their emergency management program. The baseline report was
released on March 2, 1998. In summary, it found that although states have
the basic capabilities in place to effectively respond to disasters that

normally confront them, there are areas that require attention and
improvement, such as planning and equipment for response to a terrorist
incident.

Comments From the Department of

Appendi x XV Commerce

Appendi x XVI Comments From the Department of Defense

Comments From the Department of Health Appendi x XVII and Human Services

Appendi x XVI II Comments From the Department of Justice

Appendi x XIX

GAO Contacts and Staff Acknowledgments GAO Contacts Janet Heinrich, (202)
512- 7118 Marcia Crosse, (202) 512- 3407 Acknowledgments In addition to
those named above, Barbara Chapman, Robert Copeland,

Greg Ferrante, LaKesha Jimmerson, Deborah Miller, and Roseanne Price made
key contributions to this report.

Related GAO Products

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- 600T, 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. 19, 2001).

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

(290018) Lett er

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Appendix I

Appendix I Biological Agents and Pathogens Mentioned in This Report

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Appendix II

Appendix II Scope and Methodology

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Appendix III

Appendix III Summaries of Selected Federal Policy and Planning Documents

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Appendix III Summaries of Selected Federal Policy and Planning Documents

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Appendix IV

Appendix IV Department of Agriculture

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Appendix IV Department of Agriculture

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Appendix V

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Appendix VI

Appendix VI Department of Defense

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Appendix VI Department of Defense

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Appendix VI Department of Defense

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Appendix VI Department of Defense

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Appendix VI Department of Defense

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Appendix VI Department of Defense

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Appendix VII

Appendix VII Department of Energy

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Appendix VIII

Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix VIII Department of Health and Human Services

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Appendix IX

Appendix IX Department of Justice

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Appendix IX Department of Justice

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Appendix IX Department of Justice

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Appendix IX Department of Justice

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Appendix X

Appendix X Department of Transportation

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Appendix XI

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Appendix XII

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Appendix XIII

Appendix XIII Environmental Protection Agency

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Appendix XIV

Appendix XIV Federal Emergency Management Agency

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Appendix XIV Federal Emergency Management Agency

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Appendix XV

Appendix XV Comments From the Department of Commerce

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Appendix XVI

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Appendix XVII

Appendix XVII Comments From the Department of Health and Human Services

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Appendix XVII Comments From the Department of Health and Human Services

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Appendix XVIII

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Appendix XIX

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