After-Action Findings and COVID-19 Response Revealed Opportunities to Strengthen Preparedness (GAO-21-513)
Summary
A GAO report to congressional committees, GAO-21-513, dated August 2021, on biodefense. It states that the COVID-19 pandemic shows how catastrophic biological incidents can cause substantial loss of life and economic damage and require a whole-of-nation response. GAO reports that key federal agencies, including the Departments of Homeland Security, Defense, Health and Human Services, and Agriculture, developed a range of strategic, operational and tactical interagency response plans for nationally significant biological incidents. Its title states that after-action findings and the COVID-19 response revealed opportunities to strengthen preparedness.
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United States Government Accountability Office
Report to Congressional Committees
BIODEFENSE
August 2021
After-Action Findings
and COVID-19
Response Revealed
Opportunities to
Strengthen
Preparedness
GAO-21-513
August 2021
BIODEFENSE
After-Action Findings and COVID-19 Response
Revealed Opportunities to Strengthen Preparedness
Highlights of GAO-21-513, a report to
congressional committees
Why GAO Did This Study What GAO Found
The COVID-19 pandemic shows how Key federal agencies, including the Departments of Homeland Security (DHS),
catastrophic biological incidents can Defense (DOD), Health and Human Services (HHS), and Agriculture (USDA),
cause substantial loss of life, economic developed a range of interagency response plans to prepare for nationally
damage, and require a whole-of-nation significant biological incidents. These strategic, operational, and tactical level
response involving multiple federal and plans address responding to a broad spectrum of biological threats, including
nonfederal entities. The 2018 National those that are intentional, accidental, or naturally occurring.
Biodefense Strategy outlines specific
goals and objectives to help prepare DHS, DOD, HHS, and USDA conducted numerous interagency exercises to help
for and respond to such incidents. prepare for and respond to a wide variety of biological incidents, such as anthrax
attacks, influenza pandemics, and diseases affecting plants and animals.
The CARES Act includes a provision
Specifically, GAO identified 74 interagency biological incident exercises
for GAO to conduct monitoring and
oversight of federal efforts to prepare
conducted from calendar years 2009 through 2019.
for, respond to, and recover from
COVID-19. This report addresses: (1) Number of Interagency Biological Incident Exercises Conducted, Calendar Years
interagency plans key federal agencies 2009 through 2019
developed, and exercises they
conducted, to help prepare for
biological incidents; and (2) the extent
to which exercises and real-world
incidents revealed opportunities to
better achieve National Biodefense
Strategy objectives.
GAO reviewed biological incident plans
and after-action reports from exercises
and real-world incidents from calendar
years 2009 through 2019, including a
non-generalizable sample of 19 reports
selected based on threat scenario and
other factors. GAO interviewed federal
and state officials to obtain their
perspectives on plans, exercises, and
the COVID-19 response.
What GAO Recommends
GAO is making four recommendations
each to DHS, DOD, HHS, and USDA,
including that the secretaries work GAO’s analysis of after-action reports for selected interagency biological incident
through the Biodefense Steering exercises and real-world incidents, as well as the COVID-19 response, identified
Committee to communicate exercise long-standing biodefense challenges. GAO found that the nation lacked elements
priorities and conduct monitoring. The necessary for preparing for nationally significant biological incidents, including a
departments generally concurred but in process at the interagency level to assess and communicate priorities for
response to comments GAO modified exercising capabilities. Further, it determined that agencies do not routinely work
the recommendations to reflect that the together in monitoring results from exercises and real-world incidents to identify
secretaries work through the patterns and root causes for systemic challenges. Assessing and communicating
Committee identified above. exercise priorities and routinely monitoring the results of the exercises and
incidents will help ensure the nation is better prepared to respond to the next
For more information, view GAO-21-513 or biological threat.
contact Chris Currie at (404) 679-1875 or
CurrieC@gao.gov.
United States Government Accountability Office
Contents
Letter 1
Background 7
Agencies Developed Interagency Response Plans and Conducted
Biological Incident Exercises 16
Interagency Exercises and Real-World Incidents Show
Opportunities to Better Implement the National Biodefense
Strategy 30
Conclusions 50
Recommendation for Executive Action 51
Agency Comments and Our Evaluation 54
Appendix I National Biodefense Strategy Preparedness and
Response Categories 59
Appendix II National Preparedness Goal and Public Health Capabilities 62
Appendix III Comments from the Department of Homeland Security 66
Appendix IV Comments from the Department of Defense 70
Appendix V Comments from the Department of Health and Human Services 73
Appendix VI GAO Contact and Staff Acknowledgments 77
Tables
Table 1: National Biodefense Strategy Preparedness and
Response Objectives 12
Table 2: Number of After-Action Report Areas for Improvement
with Interagency Implications, by Most Common National
Biodefense Strategy Objectives 32
Table 3: National Biodefense Strategy Preparedness and
Response Objectives 59
Page i GAO-21-513 Biodefense
Figures
Figure 1: Federal Interagency Biological Incident Planning
Framework and Selected Response Plans, As Identified
By Agencies 19
Figure 2: Number of Interagency Biological Incident Exercises
Conducted, Calendar Years 2009 through 2019 27
Figure 3: Number of Interagency Biological Incident Exercises
Conducted from Calendar Years 2009 through 2019, by
Threat Scenario Category 28
Figure 4: Participants in Interagency Biological Incident Exercises
Conducted from Calendar Years 2009 through 2019, by
Threat Scenario Category 30
Figure 5: Supply Shipment during the COVID-19 Pandemic 38
Figure 6: Participants in a Biological Incident Exercise 45
Figure 7: National Preparedness Goal’s 32 Emergency
Management Core Capabilities by Mission Area 63
Figure 8: Public Health Emergency Preparedness and Response
Capabilities 65
Page ii GAO-21-513 Biodefense
Abbreviations
CDC Centers for Disease Control and Prevention
COVID-19 Coronavirus Disease 2019
DHS Department of Homeland Security
DOD Department of Defense
FEMA Federal Emergency Management Agency
HHS Department of Health and Human Services
NDAA National Defense Authorization Act
NSPM-14 National Security Presidential Memorandum-14
PanCAP Pandemic Crisis Action Plan
SARS Severe Acute Respiratory Syndrome
USDA U.S. Department of Agriculture
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Page iii GAO-21-513 Biodefense
Letter
441 G St. N.W.
Washington, DC 20548
August 4, 2021
Congressional Committees
The outbreak of the Coronavirus Disease 2019 (COVID-19) pandemic
demonstrates how catastrophic biological incidents have the potential to
cause substantial loss of life and sustained damage to the economy,
societal stability, and global security. 1 The National Biodefense Strategy,
issued in 2018, outlines specific goals and objectives designed to help the
nation prepare for and respond to nationally significant biological
incidents like the COVID-19 pandemic, as well as future incidents that
could be even more consequential. Throughout this report we use the
term “nationally significant biological incident” to distinguish more routine
public or animal health responses—such as localized or regional disease
outbreaks or foodborne illness—from incidents that have an unusual
impact on the nation. 2 Examples of nationally significant biological
incidents contemplated in this report include attacks on the homeland
using biological agents, emerging infectious outbreaks with pandemic
potential, and declared pandemics.
The Strategy brings together, for the first time under one strategic
umbrella, all the critical functions needed to prevent, detect, prepare for,
1As defined by the National Biodefense Strategy, biological incidents are: (1) any act of
biological warfare or terrorism; (2) a crime involving a biohazard; or (3) any natural or
accidental occurrence in which a biohazard harms humans, animals, plants, or the
environment.
2Individual federal agencies or established structures designed specifically for routine
incidents generally can respond using existing authorities and responsibilities. Conversely,
nationally significant biological incidents require extensive and sometimes unique
applications of federal authorities and resources, across multiple federal departments and
agencies, because of their scale or potential consequences (both economic and health).
An overlapping concept in the context of disease outbreaks and biological attacks is the
public health emergency. A public health emergency is a formal legal authority that the
Secretary of Health and Human Services can invoke to direct response resources toward
health-related emergencies. Apart from COVID-19 and the opioid crisis, nearly all
declared public health emergencies in the past decade have been for secondary health
effects resulting from climate or seismic disasters. Our definition of a nationally significant
biological incident does not generally include such secondary health effects, because they
tend to be more localized and can usually be addressed using existing authorities and
responsibilities.
Page 1 GAO-21-513 Biodefense
respond to, and recover from such incidents regardless of their cause. 3
The nature of biological threats can be intentional, naturally occurring, or
accidental and can affect human, animal, and plant health. Several
federal agencies have responsibilities related to nationally significant
biological incidents and for implementing the Strategy. The National
Defense Authorization Act for Fiscal Year 2017 (NDAA) specifically
charged four federal departments with developing the Strategy: the
Departments of Homeland Security (DHS), Defense (DOD), Health and
Human Services (HHS), and Agriculture (USDA). 4
As we have previously reported, preparing for and responding to
nationally significant biological incidents requires a whole-of-nation,
multidisciplinary approach involving multiple federal agencies and
coordination with nonfederal entities. 5 The COVID-19 pandemic, for
example, has required an unprecedented use of multiple systems and
authorities established for both public health crises and natural disasters.
The nation’s biodefense capabilities consist of all efforts to counter
biological threats, reduce risks, and prepare for, respond to, and recover
from biological incidents that could have catastrophic consequences. 6
Activities undertaken to prepare for such incidents, regardless of size or
scale, include building and sustaining capabilities, developing interagency
plans, conducting exercises with multiple federal and nonfederal entities,
and developing after-action reports and lessons learned with
corresponding corrective actions. We have previously reported on a wide
range of biodefense-related efforts carried out by multiple federal
3See GAO, National Biodefense Strategy: Additional Efforts Would Enhance Likelihood of
Effective Implementation, GAO-20-273 (Washington, D.C.: Feb. 19, 2020).
4The National Defense Authorization Act for Fiscal Year 2017 (NDAA) called for the
development of a national biodefense strategy. See Pub. L. No. 114-328, § 1086, 130
Stat. 2000, 2423 (2016) (codified at 6 U.S.C. § 104).
5GAO-20-273. Nonfederal entities include state, local, tribal, and territorial entities, such
as state and local public health departments, as well as private sector and nonprofit
entities, such as hospitals and pharmaceutical companies.
6In the context of emergency management and related functions, a capability is the
combination of leadership and organization, planning, personnel, training, equipment and
systems, and assessment needed to successfully execute a particular mission.
Page 2 GAO-21-513 Biodefense
departments and agencies and on long-standing challenges to building
and maintaining the nation’s biological defense capabilities. 7
The CARES Act includes a provision for GAO to conduct monitoring and
oversight of federal agencies’ efforts to prepare for, respond to, and
recover from the COVID-19 pandemic. 8 GAO is to report on, among other
things, the pandemic’s effects on the health, economy, and public and
private institutions of the United States, including the federal
government’s public health and homeland security efforts. This report
addresses the following objectives:
1. What interagency plans have key federal agencies developed, and
what exercises have they conducted, to help prepare for nationally
significant biological incidents?
2. To what extent have past exercises and real-world incidents, including
the COVID-19 response, revealed opportunities to better achieve the
objectives of the National Biodefense Strategy?
To identify what interagency plans key agencies developed to help
prepare for nationally significant biological incidents, we asked officials
responsible for emergency preparedness planning from four key
agencies—DHS, DOD, HHS, and USDA—to identify any biological
incident plans their agencies contributed to from calendar years 2009
through March 2020. 9 We reviewed strategic, operational, and tactical
plans identified by the agencies to confirm whether they had both an
interagency and biological incident nexus. We analyzed the interagency
biological incident plans identified to obtain descriptive information on the
different layers of federal planning efforts and to determine the types of
biological threats covered. Specifically, we reviewed the 2018 National
Biodefense Strategy, the 2017 Biological Incident Annex to the Federal
7GAO, Biodefense: The Nation Faces Long-Standing Challenges Related to Defending
Against Biological Threats, GAO-19-635T (Washington, D.C.: June 26, 2019).
8Pub. L. No. 116-136, § 19010, 134 Stat. 281, 579-81 (2020). We regularly issue
government-wide reports on the federal response to COVID-19. For the latest report, see
GAO, COVID-19: Continued Attention Needed to Enhance Federal Preparedness,
Response, Service Delivery, and Program Integrity, GAO-21-551 (Washington, D.C.: July
19, 2021). Our next government-wide report will be issued in October 2021 and will be
available on GAO’s website at https://www.gao.gov/coronavirus.
9We selected these agencies because of their roles in biodefense, and the NDAA
requirement that they develop the National Biodefense Strategy. We selected this time
period to cover a range of federal planning efforts from the H1N1 outbreak in 2009
through the beginning of the COVID-19 pandemic.
Page 3 GAO-21-513 Biodefense
Interagency Operational Plans, the National Food and Agriculture Annex,
and the 2018 Pandemic Crisis Action Plan, among others referenced in
this report. We further interviewed DHS, DOD, HHS, and USDA officials
to determine the process by which key agencies review and update
interagency biological incident plans. 10
To identify what interagency exercises these key federal agencies
conducted to help prepare for nationally significant biological incidents,
we obtained and reviewed documentation, such as after-action reports,
on interagency biological incident exercises in which DHS, DOD, HHS,
and USDA participated from calendar years 2009 through 2019. 11 We
catalogued descriptive information, such as the exercise date, threat
scenario exercised, types of exercise participants, and core capabilities
exercised. We also interviewed or provided written questions to DHS,
DOD, HHS, and USDA officials responsible for exercise efforts to obtain
additional details on exercises within our scope. 12
To address the extent to which past exercises and real-world incidents
revealed opportunities to better achieve the objectives of the National
Biodefense Strategy, we analyzed a non-generalizable, judgmental
sample of 19 after-action reports developed from calendar years 2009
through 2019. 13 The sample included 11 after-action reports produced for
exercises and eight after-action reports produced for real-world incidents.
To select the exercise after-action reports, we first categorized the threat
scenario of each exercise based on four categories, then stratified the
sample based on the proportion of exercises from each category to the
total number of exercises we identified to ensure a range of different
10While biological incidents can have global implications and require outreach and
coordination beyond our borders, this report focuses on domestic preparedness and
response efforts.
11We asked DHS, DOD, HHS, and USDA officials to identify interagency biological
incident exercises in which they participated and compared the lists of exercises we
received with exercise information obtained from DHS, DOD, and HHS for current and
prior GAO work.
12Because of agencies’ heavy involvement in COVID-19 response activities, we accepted
written responses in lieu of meeting early in the review.
13We selected this time period to cover a range of exercises and events from the H1N1
outbreak in 2009 through the time period immediately before the start of the COVID-19
pandemic. Beginning in 2020, agency efforts across the whole-of-government were
focused on responding to the pandemic.
Page 4 GAO-21-513 Biodefense
scenarios. 14 We then selected after-action reports in each category based
on the number of federal agencies participating and the type of plan
exercised. 15 For real-world incidents, we selected and reviewed all of the
after-action reports agencies identified for the H1N1, Ebola, and Zika
incidents (a total of eight), because they were among the five incidents
declared a Public Health Emergency of International Concern from 2009
through 2019. 16 In addition, the H1N1 and Ebola incidents resulted the
highest numbers of fatalities. 17
In reviewing the 11 exercise and eight real-world incident after-action
reports, we identified over 500 findings with which to conduct further
analysis. We analyzed each finding from the 19 selected after-action
reports and determined whether the finding had interagency implications,
meaning that it involved activities undertaken by multiple federal
departments. We categorized findings with interagency implications into
one of the objectives from the preparedness or response goals of the
National Biodefense Strategy. 18 We then analyzed the results to identify
any patterns or common areas of findings across the exercises. The
results of our analysis are not generalizable to all biological incident after-
action reports; however they provide insight into common areas of
findings.
14The four categories included: (1) naturally occurring influenza incidents primarily
affecting human health (“Natural influenza”); (2) naturally occurring non-influenza incidents
primarily affecting human health (“Natural non-influenza”); (3) intentional incidents
primarily affecting human health (“Intentional”); and (4) incidents primarily affecting
animal/plant health (“Animal/plant”). We included four Natural influenza, two Natural non-
influenza, three Intentional, and two Animal/plant exercise after-action reports in our
sample.
15We selected exercises with the highest number of federal agencies participating as a
proxy for the exercises that are more likely to have findings with interagency implications.
We further considered whether the after-action reports provided sufficient detail for us to
capture and categorize findings.
16The two remaining incidents declared to be Public Health Emergencies of International
Concern from 2009 through 2019 were poliomyelitis (polio) (2014 to present) and the
Ebola outbreak in Democratic Republic of Congo (2018–2020). The COVID-19 pandemic
(2020 to present) was also declared a Public Health Emergency of International Concern.
17While fatalities from Zika infection were rare, the incident posed significant concerns for
birth defects (e.g., microcephaly) in children born to mothers infected with the virus.
18We summarized the objectives for readability and ease of reporting. For a list of these
objectives, see appendix I.
Page 5 GAO-21-513 Biodefense
Because the COVID-19 response is ongoing, agencies had not yet
produced after-action reports at the time of our review. We therefore
reviewed documentation on initial federal response challenges, such as
the Federal Emergency Management Agency’s (FEMA) initial
assessment report. We also asked selected agency officials and
nonfederal entities—including health care and emergency management
associations, health care experts, and state officials—about any
challenges that emerged during the COVID-19 response and gaps in
preparedness for biological incidents. Specifically, we interviewed officials
from DHS, DOD, HHS, and USDA who were responsible for aspects of
the COVID-19 response as well as officials from six FEMA regions, and
officials from the departments of health and emergency preparedness
from 10 states. 19 We selected eight of these states to include a range of
COVID-19 case counts per capita and number of recent disaster
declarations. 20 We further selected these states to ensure regional
diversity and include both participants and non-participants in Crimson
Contagion—a 2019 large-scale influenza exercise—as well as a range in
level of public health and state preparedness. 21 In addition, we conducted
an interview with the National Emergency Management Association,
which offered perspectives of the association plus the individual
perspectives of two additional states. 22 While the results of these
interviews are not generalizable to all states, they provide a range of
perspectives on the topics in our review.
Once we identified and categorized findings from exercises and real-
world incidents, including the COVID-19 response, we then assessed
DHS, DOD, HHS, and USDA activities and documents against the
National Biodefense Strategy’s preparedness and response goals and
objectives. Additionally, we reviewed after-action reports to determine
whether past exercises focused on capabilities identified as challenges in
the COVID-19 response. We also assessed agency efforts against
Homeland Security Exercises and Evaluation Program guidance related
to exercising capabilities and after-action reports. Several components of
19HHS regional officials participated in two of our FEMA region interviews.
20The eight states are California, Colorado, Idaho, Massachusetts, Nebraska, New Jersey,
New Mexico, and South Carolina.
21The FEMA regions we interviewed represent six of these eight states and were selected
based on similar factors.
22The two additional states were Kansas and Iowa.
Page 6 GAO-21-513 Biodefense
standards for internal control were also significant to this objective. 23
Specifically: (1) the control environment component and the related
principle that management should assign responsibility and delegate
authority; (2) the information and communication component and related
principle that management should communicate with external parties; and
(3) the monitoring component and related principle that management
should conduct ongoing monitoring and evaluations. We assessed DHS,
DOD, HHS, and USDA activities and documents related to National
Biodefense Strategy implementation against these components. We
further interviewed DHS, DOD, HHS, and USDA officials responsible for
implementing the National Biodefense Strategy to obtain their
perspectives on interagency efforts to achieve the Strategy’s objectives.
We conducted this performance audit from April 2020 to August 2021 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.
Background
Biological Threat Understanding the vast and evolving biological threat landscape is a
Landscape necessary step in effectively preparing for and responding to nationally
significant biological incidents. Our prior work assessing biodefense
activities has discussed a wide variety of biological threats facing the
nation, including infectious disease threats to humans and animals, crop
failure, threats of biological warfare and bioterrorism, and safety and
security lapses at facilities that house biological threat agents, among
others. 24
Biological threats can be unpredictable, as humans, animals, and plants
are vulnerable to a variety of naturally occurring infectious disease and
pest threats with potentially serious health, economic, and national
security implications. Urbanization, habitat encroachment, and increased
23GAO, Standards for Internal Control in the Federal Government, GAO-14-704G
(Washington, D.C.: Sep. 10, 2014).
24Recent reports from which these examples were drawn include GAO-20-273 and GAO,
Biodefense: Federal Efforts to Develop Biological Threat Awareness, GAO-18-155
(Washington, D.C.: Oct. 11, 2017).
Page 7 GAO-21-513 Biodefense
and faster travel, coupled with weaknesses in global health systems,
increase the risk of infectious diseases spreading rapidly across the
globe. This is evidenced by the rapid spread of COVID-19, which was first
reported in Wuhan, China on December 31, 2019, declared a public
health emergency in the United States by HHS on January 31, 2020, and
characterized as a pandemic by the World Health Organization on March
11, 2020.
Pandemic influenza also presents a constant threat to global public health
and exemplifies the susceptibility of humans to diseases with animal
origins. For example, a novel influenza A (H1N1) virus emerged in 2009
with a new combination of genes from swine, avian, and human influenza
viruses and led to a global pandemic. Other examples of zoonotic disease
threats—infectious diseases that are transmissible between animals and
humans—include the Ebola and Zika viruses, and coronaviruses such as
COVID-19.
Threats to agriculture can have serious economic consequences for the
nation. For example, from December 2014 through June 2015, an
outbreak of high pathogenicity avian influenza (known as HPAI) in the
United States led to the deaths of approximately 7.4 million turkeys and
43 million egg-laying chickens, either from the disease itself or from
depopulation efforts to contain the outbreak. HPAI was detected in
commercial premises, backyard flocks, wild captive birds, and/or wild
birds in 21 states. According to USDA, this outbreak was the most
significant animal health event in U.S. history, costing federal taxpayers
more $700 million and devastating affected agricultural businesses.
Additionally, extreme climate conditions, such as sustained drought and
heat waves can affect crops and livestock, and excess precipitation can
also increase flooding events and erosion, and decrease soil quality.
According to DHS, in addition to the direct impact of drought and heat
waves on the crops and livestock, these conditions may also render the
crops, the livestock, and even the population, more susceptible to disease
of either natural or intentional origin. Losses of livestock and crops from
the biological threats of disease, pests, or extreme climate conditions
could have significant effects on trade and the national economy.
The use of biological weapons or their proliferation by state or non-state
actors also presents a significant challenge to our national security, our
population, our agriculture, the economy, and the environment.
Additionally, in many countries around the world, pathogens are stored in
laboratories that lack appropriate biosecurity measures which increases
Page 8 GAO-21-513 Biodefense
the risk that pathogens could be diverted by actors with intent to do harm,
such as terrorist organizations or lone wolves, or be accidentally released
from the facility.
Key Federal Agencies’ Effectively preparing for and responding to nationally significant biological
Planning and Exercising incidents transcends what any one agency can achieve on its own and
requires a whole-of-community approach involving federal, state, local,
Responsibilities
tribal, territorial, and private sector involvement. As stated above, at the
federal level, DHS, DOD, HHS and USDA were the agencies tasked in
federal law with developing a national biodefense strategy. 25 Each has
key biodefense responsibilities from a homeland security and national
security perspective, including planning and exercising functions.
• DHS. Within DHS, FEMA is the lead federal agency responsible for
disaster preparedness, response, and recovery. As such, FEMA
facilitates planning efforts for all hazards, including biological
incidents. FEMA also supports efforts to exercise capabilities
nationwide through the National Exercise Program—a two-year cycle
of exercises that examines and validates core capabilities. The
Program includes selected exercises involving federal, state, local,
territorial, tribal, and private sector partners that are aligned to a set of
strategic priorities. 26 The Countering Weapons of Mass Destruction
Office leads DHS efforts and coordinates with domestic and
international partners to safeguard the United States against
chemical, biological, radiation, nuclear, and health security threats.
This includes serving as the DHS lead for developing biodefense
strategy and policy, and coordinating the Department’s efforts to
25See Pub. L. No. 114-328, § 1086, 130 Stat.at 2423 (codified at 6 U.S.C. § 104). While
our report focuses on the four departments originally tasked with developing the National
Biodefense Strategy, a number of departments and agencies have responsibility for
implementing the Strategy, which we describe in the next section.
26These priorities are referred to as the Principals’ Strategic Priorities and are determined
by the Principals’ Committee of the National Security Council. The priorities are
determined by stakeholder input, data from reports such as the National Preparedness
Report and the Threat and Hazard Identification and Risk Assessment, and exercise and
real-world after-action reports, among other things.
Page 9 GAO-21-513 Biodefense
defend U.S. food, agriculture, and veterinary systems against
terrorism and other high-consequence events. 27
• DOD. DOD protects U.S. armed forces from biological threats
worldwide. DOD is also responsible—subject to the availability of
resources and the direction of the President or by approval of the
Secretary of Defense—for providing support functions and
supplementing civil authorities’ resources in response to public health
and medical disasters. Within DOD, U.S. Northern Command
provides strategic planning guidance for the department’s efforts to
prepare for and respond to pandemic diseases, including influenza
and other infectious diseases.
• HHS. The Assistant Secretary for Preparedness and Response leads
the nation’s medical and public health preparedness effort for
responding to and recovering from disasters and public health
emergencies, such as biological incidents. 28 This office is responsible
for coordinating the federal public health and medical response to
emergent threats and all-hazards incidents, and develops and
conducts exercises focused on HHS preparedness issues, among
other things. It also leads the Biodefense Coordination Team, which
coordinates implementation of the National Biodefense Strategy. The
Centers for Disease Control and Prevention (CDC) supports public
health preparedness efforts to prevent, detect, and respond to new
and emerging health threats. 29 Within the National Institutes of Health,
the National Institute of Allergy and Infectious Diseases conducts and
supports research to control and prevent infectious disease. The Food
27Additional DHS components also play a role in biodefense. For example, DHS’s Science
and Technology Directorate leads key efforts related to enhancing threat awareness with
a focus on bioterrorism; U.S. Customs and Border Protection plays a role in detecting
biological threats at the border; and the U.S. Coast Guard conduct ports and waterways
coastal security, search and rescue, and marine safety missions during a biological
incident.
28The Assistant Secretary for Preparedness and Response leads preparedness efforts
through planning and response; building federal emergency medical operational
capabilities; countermeasures research, advance development, and procurement; and
grants to strengthen the capabilities of hospitals and health care systems in public health
emergencies and medical disasters. Among other things, the office also maintains the
Strategic National Stockpile, a federal stockpile of vaccines, pharmaceuticals, and medical
supplies and devices designed to be available for rapid deployment in a public health
emergency.
29CDC provides scientific expertise and collaborates with state, local, and international
departments of health through the advancement of core public health functions such as
surveillance, epidemiology and assessment sciences, and laboratory science.
Page 10 GAO-21-513 Biodefense
and Drug Administration is also responsible for emergency and crisis
response activities involving regulated products, such as intentional
acts of food supply adulteration. 30
• USDA. USDA is the lead agency with responsibility to protect and
improve the health, quality, and marketability of our nation’s
agricultural products. Within USDA, the Animal and Plant Health
Inspection Service is responsible for working to prevent, control, or
eliminate harmful pests, pathogens, and diseases of animals and
plants. The Service consists of multiple component units with key
roles in biodefense including Veterinary Services and the Plant
Protection and Quarantine program. The Office of Homeland Security
leads the department’s security, preparedness and response efforts.
The Food Safety and Inspection Service is USDA’s public health
agency and promotes food defense and preparedness to respond to
acts of intentional food contamination. 31
National Biodefense The National Biodefense Strategy, issued in September 2018, outlines a
Strategy’s Preparedness whole-of-government approach intended to help the United States
actively and effectively assess, prevent, prepare for, respond to, and
and Response Goals
recover from all types of biological threats, whether they are natural,
accidental, or deliberate. The Strategy consists of five high-level goals
with associated objectives and sub-objectives designed to strengthen the
biodefense enterprise. 32 Two goals specifically address preparedness
and response actions needed to reduce or limit the effects of biological
incidents. For example, they outline key objectives to strengthen public
and veterinary health infrastructure as well as objectives designed to
coordinate response actions, such as ensuring risk-informed, accurate,
timely, and actionable public messaging during a response. Table 1
below summarizes the objectives under the Strategy’s preparedness and
30The Food and Drug Administration is also responsible for ensuring that medical
countermeasures—such as drugs, vaccines, and diagnostic tests—are safe, effective, and
secure. Additional HHS offices with a role in biodefense preparedness and response
include the Office of Global Affairs and the Office of National Security, among others.
31Food defense is the protection of food products from intentional contamination or
adulteration where there is an intent to cause public harm or economic disruption.
32The five goals include: (1) Enable risk awareness to inform decision making across the
biodefense enterprise; (2) Ensure capabilities to prevent bioincidents; (3) Ensure
preparedness to reduce the impacts of bioincidents; (4) Rapidly respond to limit the
impacts of bioincidents; and (5) Facilitate recovery to restore the community, the
economy, and the environment after a bioincident.
Page 11 GAO-21-513 Biodefense
response goals. For additional information on each of the objectives, see
appendix I.
Table 1: National Biodefense Strategy Preparedness and Response Objectives
Preparedness
• Support U.S. biodefense research, development, and investment
• Ensure a strong public and veterinary health infrastructure
• Develop, exercise, and update plans and capabilities
• Develop, exercise, and update risk plans to support effective public messaging, enhance public trust, and promote consistent
messaging
• Improve diagnostic capabilities and enhance medical countermeasures
• Enhance community mitigation measures development and capabilities
• Enhance decontamination preparedness
• Improve the ability for the federal government to collaborate with states and territories
• Work with international governments to improve global preparedness
Response
• Manage information
• Coordinate response operations and resources
• Conduct operations and investigations for intentional incidents
• Provide effective public messaging
Source: GAO summary of National Biodefense Strategy information. | GAO-21-513
The Strategy is important because of the complexity and fragmentation
inherent in an enterprise mission like biodefense. For example, our prior
work identified the need for a strategy to help ensure efficiency and
effectiveness across the entire biodefense enterprise (including federal
agencies, nonfederal governments, and private/nonprofit entities) by
connecting strategic approaches and investment decisions across
disparate but interrelated functions within the biodefense enterprise. 33
These functions are (1) understanding and defining threats, (2) taking
action to prevent and protect against attacks and significant national and
international infectious disease outbreaks, (3) employing new and existing
techniques and technologies to more quickly detect biological events, and
(4) preparing to respond and recover.
National Security Presidential Memorandum-14 (NSPM-14)—issued at
the same time as the Strategy—provides a governance structure to guide
the Strategy’s implementation, coordinate federal biodefense activities,
33See GAO, Opportunities to Reduce Potential Duplication in Government Programs,
Save Tax Dollars, and Enhance Revenue, GAO-11-318SP (Washington, D.C.: Mar 1,
2011).
Page 12 GAO-21-513 Biodefense
and assess the effectiveness with which its goals and objectives are
being met. NSPM-14 created the Biodefense Steering Committee, which
is chaired by the Secretary of HHS and includes the heads of federal
agencies with biodefense responsibilities or capabilities as members. It
also required the formation of a Biodefense Coordination Team. The
Team consists of staff from multiple agencies, and its purpose is to assist
the Committee in monitoring and coordinating implementation of the
Strategy. 34
NSPM-14 lays out, in broad strokes, a process to identify budget priorities
across federal biodefense efforts and to assess (1) how current resources
support the Strategy, (2) how existing programs and resources could
better align with the Strategy, and (3) how additional resources, if
available, could be applied to support the goals of the Strategy. This
process begins through a data call with participating agencies
documenting all biodefense programs, projects, and activities within their
purview in a biodefense memorandum. This information is then assessed
by the Biodefense Coordination Team and helps inform Joint Policy
Guidance for the president’s annual budget.
According to the Strategy, the Biodefense Steering Committee is
expected to reach beyond the federal government and engage with
nonfederal and nongovernmental entities, and to communicate
recommendations and feedback stemming from this outreach to agencies
in coordination with the annual budget cycle. NSPM-14 further states that
agencies are to coordinate and manage biodefense activities in support of
the broader biodefense enterprise, which includes federal, nonfederal,
nongovernmental, and international partners. This is consistent with our
past reporting that state and local resources are integral to supporting
national biodefense capabilities, such as biosurveillance, and should be
considered in federal planning efforts. 35
34As identified in its charter, Biodefense Coordination Team members include
representatives from: HHS, DOD, DHS, the Environmental Protection Agency, USDA, the
Department of Justice (including the Federal Bureau of Investigation), the Department of
Veterans Affairs, the Office of the Director of National Intelligence, the U.S. Agency for
International Development, and the Departments of State, Commerce, Energy, Treasury,
Interior, Transportation, and Labor.
35GAO, Biosurveillance: Nonfederal Capabilities Should Be Considered in Creating a
National Biosurveillance Strategy, GAO-12-55 (Washington, D.C.: Oct. 31, 2011).
Page 13 GAO-21-513 Biodefense
The National Following Hurricane Katrina in 2005, the Post-Katrina Emergency
Preparedness Goal and Management Reform Act of 2006 required FEMA to develop a national
preparedness system and assess preparedness capabilities to determine
Public Health Capabilities the nation’s disaster preparedness. 36 The White House released
Presidential Policy Directive/PPD-8 on National Preparedness in March
2011. It directed the Secretary of Homeland Security to design a national
preparedness system to address the threats posing the greatest risk to
the security of the nation and issue various policy and planning
documents designed to strengthen national preparedness. Additionally, it
required the Secretary to develop a National Preparedness Goal that
identifies the core capabilities necessary to achieve preparedness. In
September 2011, DHS issued the National Preparedness Goal, which
identifies and defines 32 core capabilities for national preparedness
across five broad mission areas, which include but are not limited to
disaster and emergency response. 37 These capabilities apply to all
hazards and threats and are not incident specific. They form the
foundation for measuring overall national preparedness and assisting the
nation in allocating resources to fill identified preparedness gaps.
Examples of these capabilities include information sharing, community
resilience, logistics and supply chain management, mass care services,
and housing, among others. 38
Additionally, in 2011, CDC developed 15 public health-specific
capabilities as part of the Public Health Emergency Preparedness
program to advance the emergency preparedness and response capacity
of state and local public health systems. 39 CDC updated these capabilities
in 2018 to address emerging technologies and threats. 40 According to
CDC, these capabilities support the public health and medical
components of the 32 core capabilities specified in the National
Preparedness Goal. Examples of the public health capabilities include
366 U.S.C. §§ 744, 749.
37The five mission areas are: prevention, protection, mitigation, response, and recovery.
38The National Preparedness Goal identifies five functional areas or activities that
contribute to building each core capability: planning, organizing, equipping, training, and
exercising. This report focuses on two of these five areas: planning and exercising.
39The Public Health Emergency Preparedness program provides funding to build and
sustain public health preparedness and response capacity.
40U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, Public Health Emergency Preparedness and Response Capabilities: National
Standards for State, Local, Tribal, and Territorial Health (Atlanta, GA: October 2018).
Page 14 GAO-21-513 Biodefense
medical countermeasure dispensing and administration, responder safety
and health, and mass care, among others. 41 For a complete list of
National Preparedness Goal and public health capabilities, see appendix
II.
Prior GAO Work on Since 2009, we have identified broad, cross-cutting issues in leadership,
Biodefense and COVID-19 coordination, and collaboration that arise from fragmentation throughout
the complex interagency, intergovernmental, and intersectoral biodefense
enterprise. Our past work has identified a number of key challenges
related to the nation’s ability to detect and respond to biological incidents
that transcend what any one agency can address on its own. 42 Since
March 2011, we have reported that the biodefense enterprise would
benefit from institutionalized leadership with sufficient time, responsibility,
authority, and resources needed to promote efficiency and
accountability. 43 We further called for a national biodefense strategy and
focused leadership because addressing these issues is a difficult and
complex challenge that crosses mission areas, federal departments, and
sectors.
In February 2020, we reported that the National Biodefense Strategy and
its associated plans presented an opportunity to identify gaps and
consider enterprise-wide risk and resources for investment trade-off
decisions. We also reported on the early challenges agencies faced
implementing the National Biodefense Strategy. 44 Among other things, we
found that there was no documented methodology or guidance for how
data are to be analyzed to help the enterprise identify gaps and
opportunities to leverage resources, including no guidance on how
nonfederal capabilities are to be accounted for in the analysis.
Additionally, we found there were no clear, detailed processes, roles, and
responsibilities for joint decision-making, including how agencies will
identify opportunities to leverage resources or who will make and enforce
those decisions. We made recommendations on these and other
41Medical countermeasures include both pharmaceutical products, such as vaccines, and
non-pharmaceutical products, such as ventilators, diagnostic tests, and personal
protective equipment, that may be used to prevent, mitigate, or treat health effects from a
biological incident.
42GAO-19-635T.
43GAO, Opportunities to Reduce Potential Duplication in Government Programs, Save Tax
Dollars, and Enhance Revenue, GAO-11-318SP (Washington, D.C.: Mar 1, 2011).
44GAO-20-273.
Page 15 GAO-21-513 Biodefense
challenges to the Biodefense Coordination Team, which under NSPM-14
currently has responsibility for coordinating Strategy implementation. 45
Beginning in June 2020, we have issued a series of products in response
to CARES Act provisions requiring GAO to report on our ongoing
monitoring and oversight efforts related to the COVID-19 pandemic. 46 Our
reports examine key actions the federal government has taken to address
the COVID-19 pandemic and evolving lessons learned relevant to the
nation’s response to pandemics. Among other things, we reported on
medical supply chain shortages; the need for clarity on the federal
government’s plans for distributing and administering vaccines; and
inconsistencies on guidance for reopening schools. Overall, we identified
four evolving lessons learned: (1) establish clear goals and define roles
and responsibilities; (2) provide clear communication; (3) collect and
analyze adequate and reliable data to drive future decisions; and (4)
establish transparency and accountability mechanisms. We made 72
recommendations to federal agencies between June 2020 and March
2021 on these and other issues. We are monitoring ongoing efforts to
address these recommendations.
Key federal agencies developed a range of interagency response and
Agencies Developed crisis action plans for biological incidents to provide strategic vision,
Interagency describe operational coordination and incident command, and guide
tactical response decisions. Likewise, agencies conducted numerous
Response Plans and interagency exercises since 2009 to help prepare for and respond to a
Conducted Biological
Incident Exercises
45HHS, which chairs the Biodefense Steering Committee, concurred with each of our
recommendations, and in April 2021 reported steps underway to address them. We
continue to monitor their efforts.
46See GAO, Opportunities to Improve Federal Response and Recovery Efforts,
GAO-20-625 (Washington, D.C.: June 25, 2020); GAO, COVID-19: Federal Efforts Could
be Strengthened by Timely and Concerted Actions, GAO-20-701 (Washington, D.C.: Sept.
21, 2020); GAO, COVID-19: Federal Efforts Accelerate Vaccine and Therapeutics
Development, But More Transparency Needed on Emergency Use Authorizations,
GAO-21-207 (Washington, D.C.: Nov. 17, 2020); GAO, COVID-19: Urgent Actions
Needed to Better Ensure an Effective Federal Response, GAO-21-191 (Washington, D.C.:
Nov. 30, 2020); GAO, COVID-19: Critical Vaccine Distribution, Supply Chain, Program
Integrity, and Other Challenges Require Focused Federal Attention, GAO-21-265
(Washington, D.C.: Jan. 28, 2021); and GAO, COVID-19: Sustained Federal Action Is
Crucial as Pandemic Enters Its Second Year, GAO-21-387 (Washington, D.C.: Mar. 31,
2021).
Page 16 GAO-21-513 Biodefense
wide variety of biological incidents. 47 These planning and exercising
activities included participation from more than one federal agency and
leveraged frameworks used in all-hazards response, like the National
Response Framework. Interagency exercises also included nonfederal
participation.
Key federal agencies To prepare for nationally significant biological incidents, key federal
developed interagency agencies developed interagency response and crisis action plans
informed by national level strategies. These strategies and plans reflect a
response and crisis action
continuum along long-range strategic vision at the highest level, to
plans intermediate operational guidance (that describes how incident command
is to be coordinated and structured to ensure clear roles and
responsibilities for critical response functions), and finally, to tactical,
incident-specific guidance at the most immediate and concrete level.
DHS, DOD, HHS, and USDA officials identified national level strategy and
planning frameworks that create an architecture that informed the specific
biological incident response and crisis action plans the agencies
developed.
According to agency officials, high-level national security strategies—
specifically, the National Security Strategy and the Global Health Security
Strategy, provide some of the highest-level strategic visions that inform
their planning. Similarly, specific to nationally significant biological
incidents, the 2018 National Biodefense Strategy provides an overarching
strategic vision for how to achieve preparedness. Officials from two
agencies also noted that they relied on the National Strategy for
Pandemic Influenza to provide strategic and operational direction in the
initial COVID-19 response. 48
The National Security Strategy sets priorities to address a broad array of
threats to American interests, including biological threats. The Global
Health Security Strategy describes how the United States will enhance
the ability to prevent, detect, and respond to infectious disease threats
globally and domestically by working with other nations, international
47The scope of our work covers the ten year period from 2009 to March 2020 to reflect the
time between the last declared global pandemics.
48While the scope of our work covers 2009 to March 2020, two agencies identified the
2005 National Strategy for Pandemic Influenza as a key strategy document, maintaining
that despite its age, it has not been superseded and remains an important planning
document. Agencies also develop agency-specific response plans for biological incidents
that pertain to internal operations, such as ensuring the continuity of operations during a
biological incident. These plans are not reflected here, as our focus is interagency plans.
Page 17 GAO-21-513 Biodefense
organizations, and nongovernmental stakeholders. The National
Biodefense Strategy is specific to preparing for and responding to
nationally significant biological threats regardless of their source; whereas
the National Strategy for Pandemic Influenza addresses national
coordination to prepare, detect, and respond to a pandemic.
Agencies engage in deliberate and incident-specific planning activities to
advance national preparedness, that are guided by a long range vision
and goals articulated in national level strategies. DHS developed a
layered planning architecture with its National Planning System, which
supports the National Preparedness Goal. This planning architecture
creates the strategic, operational, and tactical levels of planning and
planning integration. As described in DHS planning guidance, use of the
National Planning System promotes a unified approach to planning
through vertical and horizontal integration of plans across the whole
community, including federal and nonfederal entities. Because the
response to catastrophic incidents requires the capabilities of a wide
range of stakeholders, DHS planning guidance supports planning that
engages the whole community to developing response plans that
appropriately anticipate the necessary resources and authorities, and
identify the roles and responsibilities among partners for specific
incidents.
The biological incident response plans DHS, DOD, HHS and USDA
identified developing are nested within this planning architecture, as
described below. However, while agencies work together to develop
these plans, they may also interpret or use response plans in various
ways, meaning that along the continuum of strategy and plans, some
documents, such as the 2018 Pandemic Crisis Action Plan (PanCAP)
may provide both operational and tactical guidance, depending on the
context and the issues at hand. 49 We present the plans agencies
identified along a continuum below, recognizing that plans may straddle
more than one category (see figure 1).
49The PanCAP focuses on incidents generated by viral pathogens that have pandemic
potential.
Page 18 GAO-21-513 Biodefense
Figure 1: Federal Interagency Biological Incident Planning Framework and Selected Response Plans, As Identified By
Agencies
a
Plans may straddle more than one category.
b
The suite of documents within the USDA Foreign Animal Disease Preparedness and Response Plan
includes disease-specific response plans, strategies, and concept of operations.
Strategic level. Strategic level planning allows stakeholders to identify a
long-term vision and serves as a mechanism for unifying the efforts of
multiple entities to support a comprehensive approach for addressing a
particular issue or mission through agreed-upon governance, priorities,
doctrine, and desired end-state. 50 At the strategic level, the National
Response Framework—coordinated by DHS—is the nation’s highest level
50DHS, National Planning System, February 2016.
Page 19 GAO-21-513 Biodefense
guidance for how to prepare for a response to any type of disaster,
regardless of the source of the hazard. The National Response
Framework provides foundational emergency management doctrine for
how the nation responds to all types of incidents. 51 This all-hazards
approach is designed to manage any type of disaster or emergency
response, regardless of scale, scope, and complexity, including biological
incidents. The National Response Framework sets the highest-level
planning framework and doctrine for how entities build, sustain, and
deliver response capabilities identified in the National Preparedness Goal.
The biological incident plans key agencies identified make specific
mention of their nexus to the National Response Framework.
Operational level. Planning efforts at the operational level may be
guided by the objectives or priorities in national-level strategies, like the
National Biodefense Strategy, and leverage guiding principles from
strategic level plans, but operational plans further articulate the roles,
responsibilities, and critical tasks among agencies that are needed for
response. 52 Biological incidents can affect the health of humans, animals,
plants, and the environment; occur internationally or domestically; and
may be intentional, accidental, or occur naturally, as in cases of infectious
disease spread. Given the variety of scenarios these events can prompt,
conducting deliberate planning at the operational level allows federal
agencies and their nonfederal stakeholders to familiarize themselves—for
example, through exercises for biological incidents—with which roles and
responsibilities and what authorities might be used in different scenarios.
Within the National Response Framework are the Federal Interagency
Operational Plans, which provide a federal concept of operations to
integrate and synchronize national-level capabilities, and cover
prevention, protection, mitigation, response, and recovery activities to
support all levels of government. 53 Specifically, the Response Federal
Interagency Operational Plan describes how the federal government
coordinates its efforts to save lives, protect property and the environment,
51National level strategies that inform further strategic planning also have goals and
objectives that cover international response efforts. However, we have focused attention
on the National Response Framework because this report focuses on domestic, whole-of-
nation response activities for biological incidents.
52DHS, National Planning System, February 2016.
53These plans also help federal departments and agencies develop and maintain
department-level operational plans.
Page 20 GAO-21-513 Biodefense
stabilize communities, and meet basic human needs following an
emergency or disaster.
The response to certain types of threats or hazards may require unique
roles, responsibilities, resources, and concepts of operations that are not
addressed by the Response Federal Interagency Operational Plan. 54
Although the all-hazards approach of the National Response Framework
offers a foundation for the response and recovery function for biodefense,
the context in which federal agencies support response or recovery
functions is different for nationally significant biological events, and some
needs are wholly unique. Two specific incident annexes under the
National Response Framework identified by key agencies are designed to
address a variety of biological threats. They are the Biological Incident
Annex and National Food and Agriculture Incident Annex to the
Response and Recovery Federal Interagency Operational Plans. 55 These
annexes identify, among other things, the lead federal agency for various
types of incidents as well as funding and authorities to be leveraged for a
response.
Officials from DOD and DHS identified the Biological Incident Annex as
the primary interagency plan they use in response to biological events. As
part of the National Response Framework, these plans are designed to
be scalable, flexible, and adaptable to biological incidents, but are
fundamentally federal level planning documents, which focus on the
federal government’s ability to support nonfederal response efforts during
a biological incident.
The Biological Incident Annex and National Food and Agriculture Incident
Annex identify the lead federal agency for the response, depending on
the type of incident. For example, USDA is the lead federal agency for
incidents involving animal and plant agriculture, while HHS is the lead
federal agency for naturally occurring or intentional domestic incidents
affecting human health. According to the incident annexes, during
54DHS, National Response Framework, Fourth Edition, October 28, 2019.
55Other individualized incident annexes address the threats of power outage, cyber
incidents, oil/chemical incidents, nuclear/radiological incidents, terrorism, mass
evacuation, and impending space weather incidents.
Page 21 GAO-21-513 Biodefense
complex incidents, FEMA may be called upon to provide supplemental
operational coordination support to the lead federal agency. 56
Finally, both incident annexes describe how the response to biological
incidents will remain dynamic throughout, as full information about the
incident may not be immediately available. For example, decisions during
a response will be based on incomplete information as the cause, origin,
transmission, and impact of the biological incident may take time to
uncover and may evolve as events progress. Both documents also
recognize that events could also have cascading effects, such as
economic consequences, or may generate public fear.
Tactical level. In a supporting role to the incident annexes and further
along the response planning continuum, DHS, DOD, HHS and USDA
identified an additional layer of interagency response planning that is
targeted to specific biological incidents. Tactical level planning may
include both pre-incident plans and real-time plans. Key agencies
identified the following as incident-specific response plans that represent
pre-incident tactical planning efforts: the 2018 PanCAP, the USDA
Foreign Animal Disease Preparedness and Response Plan, and the
USDA National Plant Health Emergency Management Framework. 57 The
2018 PanCAP operationalized the Biological Incident Annex to focus on
incidents generated by viral pathogens that have pandemic potential. The
USDA Foreign Animal Disease Preparedness and Response Plan further
operationalizes the National Food and Agriculture Incident Annex and
consists of a suite of response planning materials. 58 The USDA National
Plant Health Emergency Management Framework encompasses
56During the early COVID-19 response, FEMA provided more than supplemental support.
The FEMA Administrator was part of the Unified Coordination Group, the entity which
provided incident management of the entire response effort. FEMA, specifically, provided
logistics management support to address key supply chain shortages. FEMA, as of
January 21, 2021, has also been assisting vaccine distribution efforts in alignment with the
new administration’s response strategy.
57USDA also identified an interagency plan issued in 2019 on the proper handling and
disposal of potentially highly infectious waste. Agencies developed this plan in response to
challenges United States health care and waste management facilities experienced in
2014-2015 as a result of treating patients with Ebola virus disease. Ebola after-action
reports developed by both the CDC and the National Security Council identified problems
with unclear guidelines, processes, and communication plans with regard to hazardous
waste management.
58These materials include manuals on information management, standard operating
procedures, roles and coordination among federal and nonfederal agencies and private
industry, as well as disease-specific response plans and strategies that address activities
related to diagnosing, treating, controlling, and eradicating the specific disease.
Page 22 GAO-21-513 Biodefense
guidance on preventing, preparing, responding, and recovering from
invasive pest introductions.
Officials from DHS, DOD, and HHS familiar with the planning processes
of their agencies, as well as those with expertise in preparing for
biological incidents, said that this type of pre-incident tactical planning
that addresses specific types of biological incidents is beneficial, in part,
because those plans immediately identify the key response partners
needed to address the crisis. According to the National Planning System,
tactical plans often outline the detailed actions necessary to accomplish
goals identified in an operational plan, such as the types of personnel or
equipment needed. In the biological incident context, this could mean
identifying needs for alternative care facilities or knowing how and when
to engage subject matter experts. For example, USDA personnel may be
needed during a response to determine which animal products or live
animals have the potential to introduce or spread a pandemic virus.
DHS and DOD officials said it is still important to recognize that each
biological incident will have unique characteristics, so even these pre-
incident tactical level plans may need to be further adapted to real-time
tactical plans during an event. However, these officials also said that
having pre-incident plans at this level allows also for opportunities to
exercise these plans in order to bring together all the key parties on a
more regular basis to discuss plan implementation and identify gaps.
Plans Have Evolved to Federal agencies with responsibility for the range of plans in the National
Reflect Lessons Learned Planning System architecture have revised and adapted them over the
years to reflect lessons learned from exercises and real-world events. For
and New Threats
example, the 2017 revision of the Biological Incident Annex incorporated
lessons learned from the H1N1 2009 pandemic, Ebola Virus Disease of
2013-2014, and Zika Virus Disease in 2015-2017. DHS officials stated
that the revision also drew from lessons learned from exercises focused
on aerosolized Anthrax attacks on large cities and the Severe Acute
Respiratory Syndrome (SARS) outbreak. According to DHS officials, the
Biological Incident Annex is currently undergoing another review and
revision. Officials stated this revision will incorporate lessons learned from
the ongoing COVID-19 pandemic, as well as lessons learned from the
2019 Crimson Contagion exercise, which exercised the planning
Page 23 GAO-21-513 Biodefense
assumptions in both the Biological Incident Annex and the 2018
PanCAP. 59
According to FEMA officials and other federal agency officials we
interviewed, FEMA determines when to review and revise the plans that
fall under the National Response Framework, such as the Biological
Incident Annex. DHS officials noted that when planning any revision to
planning documents, they consider the following elements: (1) changes in
guidance from DHS leadership, (2) any new information that informs the
facts or assumptions underpinning planning efforts, and (3) past lessons
learned. Officials we spoke with from all four agencies described how
FEMA engages other federal agencies in its planning cycle, and officials
from the DHS Countering Weapons of Mass Destruction Office and HHS
said they are involved in the current revision of the Biological Incident
Annex. USDA officials also said that FEMA finalized updates to the
National Food and Agriculture Incident Annex—to which USDA
contributed—in 2020, and they provide input on other planning
documents when requested.
FEMA officials said they typically review the planning annexes on a two or
three year schedule, but not all are reviewed on that schedule. They said
that if an annex or plan has not been revised, that does not indicate a lack
of planning. For example, officials noted that in between the 2008 and
2017 versions of the Biological Incident Annex, agencies worked together
to develop other biological incident planning documents. Examples of
these plans include the 2013 PanCAP and interagency plans to address
the threat from Ebola, H7N9 avian influenza, and Middle-East Respiratory
Syndrome Coronavirus. 60
59The Crimson Contagion 2019 Functional Exercise, conducted August 13–16, 2019,
exercised the nation’s ability to respond to a large-scale outbreak of a novel avian
influenza virus (H7N9) strain, which quickly spreads via human to-human transmission
around the world and across the continental United States with high rates of morbidity and
mortality. The after-action report for the exercise identified a number of areas for
improvement related to planning and other response functions, including that the
organization of the federal government response when HHS is the lead federal agency
was not sufficiently outlined in the Biological Incident Annex or the 2018 PanCAP. As we
reported in June 2020, HHS officials told us they had not been able to address the
Crimson Contagion findings because they were busy responding to the COVID-19
pandemic. FEMA officials similarly told us that they were not able to implement solutions
before the pandemic response began. See GAO-20-625.
60According to FEMA officials, the 2013 PanCAP was revised in 2018.
Page 24 GAO-21-513 Biodefense
In the early stages of the COVID-19 pandemic, agencies adapted the
2018 PanCAP, thereby creating a real-time tactical plan to address the
needs of the whole-of-nation response. The PanCAP Adapted U.S.
Government COVID-19 Response Plan (PanCAP Adapted), issued
March 13, 2020, was created to outline in real time the key federal
decisions, federal actions, and interagency coordination structures that
may be used during the COVID-19 pandemic. It was designed to
coordinate activities to limit the spread of COVID-19; to mitigate the effect
of illness, suffering, and death; and to sustain critical infrastructure and
key resources in the United States. Modifications made to adapt the 2018
PanCAP to the PanCAP Adapted for the COVID-19 response included:
(1) creating a White House Coronavirus Task Force to coordinate the
whole-of-government approach, (2) updating facts, assumptions, and
critical considerations unique to severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2, the virus that causes COVID-19), as it was
understood at the time, (3) expanding coordination structures for each
phase of the response, including options for HHS lead and FEMA lead
with the Unified Coordination Group, and (4) creating an Operations
Annex with detailed implementation guidance using a task force
construct. 61 According to DOD officials, response actions during the
COVID-19 pandemic continue to evolve to adapt to changing needs, but
the PanCAP Adapted has not been modified to reflect every evolution of
this dynamic event. 62
Officials said that they plan to revise the 2018 PanCAP in 2021 to
highlight existing COVID-19 response structures that have been
61The FEMA Administrator, the Assistant Secretary for Preparedness and Response at
HHS, and a CDC representative jointly lead the Unified Coordination Group for COVID-19,
which coordinates federal response and recovery operations. As we reported in June
2020, to address the multiple dimensions of the early pandemic response, eight
operational task forces brought together federal departments and agencies with the
relevant expertise, authorities, and capabilities necessary to address unmet needs.
Through these task forces, the National Response Coordination Center which is operated
out of FEMA and is the hub for coordinating actions and resources across federal
agencies, can use existing authorities, processes, resources, and funding for each of the
agencies that comprise each Emergency Support Function under the National Response
Framework to meet the needs of the response as they arise. See GAO-20-625. The
Unified Coordination Group is a key coordination structure identified in the Incident
Annexes mentioned above.
62DOD officials further stated that even the 2020 PanCAP Adapted, when it was released
in March 2020, reflected a single moment and understanding of the conditions at the time
and that agencies have continued to learn and adapt to the pandemic conditions to
execute response actions.
Page 25 GAO-21-513 Biodefense
successful and shift the focus from short-term response to planning for
emerging infectious diseases with pandemic potential. Officials from all
four agencies described ongoing efforts to collect lessons learned from
the COVID-19 response which will be used when updating plans, such as
the PanCAP.
In addition to interagency planning efforts, as the pandemic continues to
unfold and changes in leadership have occurred, additional changes to
manage the COVID-19 response continue to be made. For example, in
January 2021, the new administration released a new National Strategy
for the COVID-19 Response and Pandemic Preparedness. This strategy
includes goals for addressing the pandemic and is intended to improve
the effectiveness of the response and improve public trust and
accountability. On January 20, 2021, the President issued an Executive
Order to reorganize the structure of the COVID-19 response. 63 DHS
officials said they take these types of policy changes into consideration
when updating response planning documents. However, because
updates to the BIA and PanCAP are not yet complete, it is not clear
whether or how these changes will be reflected.
Agencies Conducted Key federal agencies have conducted numerous interagency exercises to
Numerous Interagency prepare for biological incidents. Specifically, we identified 74 interagency
biological incident exercises conducted from calendar years 2009 through
Biological Incident 2019. 64 We defined “interagency” to mean participation from one of the
Exercises federal departments in our scope (DHS, DOD, HHS, or USDA) and at
least one other federal department or agency. The exercises we identified
ranged from smaller tabletop exercises with a limited number of
participants exercising a biological incident scenario in one geographic
area, to full-scale functional exercises involving multiple federal and
63The Executive Order “established within the Executive Office of the President the
position of Coordinator of the COVID-19 Response and Counselor to the President
(COVID-19 Response Coordinator) and the position of Deputy Coordinator of the COVID-
19 Response. The COVID-19 Response Coordinator shall report directly to the President;
advise and assist the President and executive departments and agencies (agencies) in
responding to the COVID-19 pandemic; coordinate all elements of the COVID-19
response; and perform such duties as the President may otherwise direct.” Exec. Order
No. 13,987, 86 Fed. Reg. 7019 (Jan. 25, 2021).
64We identified these exercises through interviews with DHS, DOD, HHS, and USDA
officials and documentation provided by each agency, as well as by reviewing
documentation from current and prior GAO work.
Page 26 GAO-21-513 Biodefense
nonfederal partners exercising widespread scenarios. 65 As shown in
figure 2, at least three exercises were conducted each calendar year
during this time period, and 2010 and 2014 saw the highest number, at 12
exercises each.
Figure 2: Number of Interagency Biological Incident Exercises Conducted, Calendar
Years 2009 through 2019
Note: We identified 74 biological incident exercises in which the Department of Homeland Security,
Defense, Health and Human Services, or Agriculture and at least one other federal department or
agency participated. The total includes 21 individual exercises that were conducted across five
separate exercise series. Exercises conducted as part of the same exercise series typically use the
same threat scenario. Specifically, the total includes three exercises conducted during the 2019
Crimson Contagion series, four conducted during the 2013–2014 Pandemic Accord series, 10
conducted during the 2009–2010 Anthrax Response Exercise Series, two conducted during Lightning
Rescue 2012, and two conducted during the 2015–2016 Palo Duro II series).
Of the 74 exercises our analysis identified, agencies provided information
on the specific threat scenario exercised for 71. From calendar years
2009 through 2019, agencies exercised a range of naturally occurring and
intentional threat scenarios, including threats primarily affecting human
65For example, a 2013 tabletop exercise we reviewed involved participants from two
federal agencies and one state; while a 2019 exercise included participants from 18
federal agencies and 12 states. We did not evaluate the design of the exercises we
identified.
Page 27 GAO-21-513 Biodefense
health, such as pandemic influenza and anthrax attacks, as well as
threats primarily affecting animal health, such as foot-and-mouth
disease. 66 As shown in figure 3, 22 of the 71 exercises included a
naturally occurring influenza threat scenario; 24 included an intentional
scenario; 13 included a naturally occurring non-influenza scenario; and 12
included threat scenarios affecting animal or plant health.
Figure 3: Number of Interagency Biological Incident Exercises Conducted from
Calendar Years 2009 through 2019, by Threat Scenario Category
Note: We identified 74 interagency biological incident exercises and agencies provided information on
the specific threat scenario exercised for 71 of the 74 exercises.
66Foot-and-mouth disease is a highly contagious viral disease that causes painful lesions
on the hooves and mouths of some livestock, making it difficult for them to stand or eat.
The disease generally does not infect humans and is not considered a public health or
food safety threat. However, it poses a significant economic threat to U.S. interests.
Page 28 GAO-21-513 Biodefense
For 42 of the 74 exercises, we were able to determine additional
descriptive information, such as participant information. 67 As shown in
figure 4, more than half of these 42 exercises included nonfederal
government participants, such as state, local, and tribal governments.
Nonfederal government participation in exercises is important because
the capabilities and resources needed to respond to a nationally
significant biological incident exist at all levels and should be taken into
account when assessing capability and preparedness gaps. 68 Similarly,
more than half of the 42 exercises also included nongovernmental
participants, such as hospitals, universities, and professional
associations. According to FEMA officials, the ongoing COVID-19
response has demonstrated the necessity of effectively integrating the
private sector into planning and response operations.
67We obtained detailed descriptive information on 42 of the 74 exercises our analysis
identified. Specifically, we obtained after-action reports or other documentation on 11 of
22 natural influenza, four of 13 natural non-influenza, 18 of 24 intentional human, and nine
of 12 animal/plant exercises. Agencies provided several reasons for the lack of an
exercise after-action report, including: (1) the agency did not develop a report; (2) no after-
action report records were found; and (3) the agency was not the release authority for the
after-action report and was unable to identify such authority.
68We have previously reported on the challenges in assessing state and local
preparedness for emergencies and natural disasters. See: GAO, Federal Emergency
Management Agency: Progress and Continuing Challenges in National Preparedness
Efforts, GAO-16-560T (Washington, D.C.: Apr. 12, 2016); GAO, National Preparedness:
FEMA Has Taken Steps to Strengthen Grant Management, But Challenges Remain in
Assessing Capabilities; GAO-18-512T (Washington, D.C.: Apr. 23, 2018); GAO, FEMA:
Strengthening Regional Coordination Could Enhance Preparedness Efforts, GAO-16-38
(Washington, D.C.: Feb. 4, 2016).
Page 29 GAO-21-513 Biodefense
Figure 4: Participants in Interagency Biological Incident Exercises Conducted from Calendar Years 2009 through 2019, by
Threat Scenario Category
Note: This graph represents participation across the interagency biological incident exercises we
identified from 2009 through 2019 for which we obtained information on both the specific threat
scenario and participants (42 of 74 total exercises identified). The dashed line and number above
each threat scenario category represents the total number of exercises in that category for which we
obtained detailed participant information. The bars represent the number of exercises each
stakeholder group participated in out of the total for that category.
Our analysis of after-action reports for selected interagency biological
Interagency incident exercises and real-world incidents, as well as findings from the
Exercises and Real- COVID-19 response, demonstrates that the biodefense enterprise has
gaps in its capabilities-based approach to response planning. We
World Incidents Show identified common long-standing biodefense challenges in coordinating
Opportunities to response capabilities, managing information, and in overall planning and
exercise efforts. Existing gaps in preparing for nationally significant
Better Implement the biological events limit the ability to implement the preparedness and
National Biodefense response goals of the National Biodefense Strategy. Specifically, we
found the biodefense enterprise lacked elements necessary for preparing
Strategy for nationally significant biological incidents, including:
Page 30 GAO-21-513 Biodefense
• a set of defined capabilities that account for the unique elements
specific to responding to nationally significant biological incidents;
• a process at the interagency level for agencies to assess and
communicate priorities for exercising capabilities and consistently
reporting on those capabilities in after-action reviews; and
• routine monitoring at the interagency level of exercises and real-world
incidents in order to evaluate lessons learned across the government,
identify patterns and possible root causes for systemic challenges,
and make recommendations to address these challenges.
Exercises and Real-World Federal after-action reports from exercises and real-world biological
Incidents, Including incidents, as well as challenges identified in the COVID-19 response,
highlight a number of common, long-standing challenges related to
COVID-19, Reveal
interagency biological incident preparedness and response efforts
Common, Long-standing needed to achieve National Biodefense Strategy goals and objectives. 69
Biodefense Challenges In analyzing our judgmental sample of 19 after-action reports developed
from calendar years 2009 through 2019, 70 we determined that the most
common interagency challenges, or areas for improvement, identified in
these reports correspond to three specific response and preparedness
objectives in the National Biodefense Strategy: (1) Coordinate response
operations and resources; (2) Manage information; and (3) Develop,
exercise, and update plans and capabilities (see table 2 below). These
areas for improvement spanned after-action reports across the 10-year
period we reviewed.
69We determined that a finding had interagency implications if the gap or challenge, or
strength, identified applied to activities undertaken by two or more federal agencies.
70Specifically, we selected a non-generalizable sample of exercise after-action reports and
stratified the sample by the common threat scenario categories shown in figure 3.
Page 31 GAO-21-513 Biodefense
Table 2: Number of After-Action Report Areas for Improvement with Interagency Implications, by Most Common National
Biodefense Strategy Objectives
National Biodefense Strategy objective Number of areas for improvement
Coordinate response operations and resources: Conduct federal response 54
operations in coordination with nonfederal actors to contain, control, and rapidly
mitigate the impacts of biothreats or bioincidents.
Manage information: Compile and share biothreat and bioincident information to 52
enable decision-making and response operations across all levels of government and
with nongovernmental, private sector, and international entities.
Develop, exercise, and update plans and capabilities: Develop, exercise, and 22
update prevention, response, and recovery plans and capabilities.
Othera 27
Total 155
Source: GAO analysis of documentation from the Departments of Homeland Security (DHS), Defense (DOD), Health and Human Services (HHS), and Agriculture (USDA). | GAO-21-513
Note: This table includes findings from a stratified, non-generalizable, judgmental sample of 19
exercise and real-world event after-action reports developed by DHS, DOD, HHS, and USDA from
calendar years 2009 through 2019. We determined that a finding had interagency implications if the
gap or challenge, or strength, identified applied to activities undertaken by two or more federal
agencies.
a
Other areas for improvement include providing effective public messaging and working with
international governments to improve global preparedness, among others.
After-action reports we reviewed often identified strengths as well as
areas for improvement. Specifically, we identified a total of 70 strengths
with interagency implications in our sample. According to FEMA’s
continuous improvement guidance, in addition to sharing areas for
improvement, observations of strengths should also be shared on a
regular basis to promote successes and innovations across the
community.
In addition to areas for improvement in the after-action reports we
reviewed, we also identified challenges in the initial COVID-19 response.
Specifically, agency officials, health care associations, health care
experts, and selected state officials we interviewed identified a number of
similar challenges in the initial COVID-19 response and general gaps in
preparedness for biological incidents. In our prior 2020 and 2021 CARES
Act reports, we noted that federal agencies have demonstrated
extraordinary dedication and commitment in responding to the
unprecedented COVID-19 pandemic. We reported on extensive and
evolving efforts to respond to the pandemic, including through managing
the medical supply chain, increasing testing capacity; developing,
manufacturing, and distributing COVID-19 vaccines and therapeutics; and
collecting data on racial and ethnic disparities as they relate to COVID-19.
However, we also identified response challenges in these and other
Page 32 GAO-21-513 Biodefense
areas. These COVID-19-specific challenges and gaps primarily
correspond to the same three response and preparedness objectives in
the National Biodefense Strategy that our after-action report analysis
identified as the most frequently cited areas for improvement. 71 The
following are examples of challenges identified in the after-action reports
we reviewed and in the COVID-19 response.
Coordinate response operations and resources. Areas for
improvement and challenges identified in this category included
providing overall coordination among response partners, defining
roles and responsibilities, and pursuing efforts to secure and distribute
supplies, specifically medical countermeasures such as personal
protective equipment and testing supplies. For example, CDC’s after-
action report on the 2014 Ebola response found that CDC and the
State Department experienced challenges coordinating responder
health and safety procedures. The 2019 HHS Crimson Contagion
after-action report found that federal partners lacked clarity on
interagency roles and responsibilities during a pandemic, which led to
confusion about who was leading various exercise response activities.
Health care associations as well as officials from five of six FEMA
regions and eight of 10 states we interviewed cited initial COVID-19
response challenges related to coordination between emergency
management and public health functions at both the federal and
nonfederal level, particularly with regard to supplies. 72 In June and
September 2020, we reported on challenges with the overall
distribution, acquisition, and adequacy of supplies during the initial
COVID-19 response, and we have continued to report on ongoing
71We did not review the status of any corrective actions associated with each of the
individual interagency findings or challenges identified. As such, agencies may have taken
action to address findings in the individual examples we provide below. Rather, we asked
agencies about overall actions taken to address the broad categories of challenges
identified.
72HHS regional officials also participated in two of the six interviews we conducted with
FEMA regions, including those that identified challenges with emergency management
and public health coordination. HHS and FEMA each operate 10 regional offices
nationwide.
Page 33 GAO-21-513 Biodefense
challenges as well as improvements in this area as the response
evolves. 73
Manage information. After-action reports identified both federal-to-
nonfederal and nonfederal-to-federal information flow as challenges in
this category. For example, a DHS report on a 2010 anthrax-attack
exercise noted that state and local jurisdictions needed to be better
aware of information requirements from each federal agency.
Similarly, the 2019 HHS Crimson Contagion after-action report found
that HHS’ regional staff lacked clear guidance on the distribution of
information to state and local partners, and that states lacked clarity
on which channels they should use to request information from and
report information to federal partners throughout the response.
Health care associations and experts and officials from five of six
FEMA regions and all 10 states in our sample also identified
information management challenges in the COVID-19 response.
These challenges included inconsistent guidance from the federal
government, lack of transparency regarding supplies available in the
Strategic National Stockpile, 74 and data collection challenges.
Additionally, in January 2021, we reported that the federal
government did not have a process to help systematically define and
ensure the collection of standardized data across the relevant federal
agencies and related stakeholders to help respond to COVID-19. As a
result, we reported that information collected and reported by states
73GAO-20-625 and GAO-20-701. Challenges related to supplies have been due in part to
a supply chain that was overwhelmed by the demands of the global pandemic. We
reported on numerous efforts by federal agencies to mitigate supply chain shortages and
also made recommendations related to remaining challenges, including that HHS and
FEMA clearly document roles and responsibilities for supply chain management functions
and develop and communicate plans to stakeholders for addressing remaining supply
chain shortages. HHS disagreed with these recommendations, noting, among other
things, the work that the department had done to manage the medical supply chain and
increase supply availability. We acknowledge those efforts, but continue to maintain that
our recommendations are warranted. In March 2021, we reported that, to address more
immediate supply needs, the President has called for action that is consistent with our
September 2020 recommendation that HHS—in coordination with FEMA—develop and
communicate plans to stakeholders outlining specific federal government actions that will
be taken to help mitigate supply gaps. See GAO-21-387.
74The Strategic National Stockpile is a federal stockpile of vaccines, pharmaceuticals, and
medical supplies and devices designed to be deployed to support the response to a public
health emergency.
Page 34 GAO-21-513 Biodefense
and other entities to the federal government is often incomplete and
inconsistent. 75
Develop, exercise, and update plans and capabilities.
Preparedness related findings from after-action reports and the
COVID-19 response include the need to improve capabilities, conduct
exercises with a range of relevant participants, and improve overall
planning. For example, a DOD report on a 2015 anthrax-attack
exercise found a lack of surge capacity government-wide to respond
to a biological attack. The report also identified the need for exercises
to be conducted with a full range of federal, state, local, and regional
partners to create a better understanding of response capabilities.
Health care associations and experts, and officials from one FEMA
region and three states we interviewed noted that there was a lack of
a national plan or strategy for key COVID-19 response elements, such
as a testing strategy or a plan for acquiring personal protective
equipment, which exacerbated response problems. Additionally, as
we reported in September 2020, representatives of state, local, and
territorial health officials and health care providers we interviewed
emphasized the need for the federal government to develop and
share plans for the distribution and administration of COVID-19
vaccines. 76 DHS officials stated that the pandemic exposed the need
for more active engagement with the private sector in the face of the
unique and complex challenges posed, particularly with regard to
medical supplies.
In addition, our analysis of the COVID-19 response identified challenges
in two other National Biodefense Strategy categories that appeared less
75GAO-21-265. We recommended that HHS immediately establish an expert committee or
use an existing one to systematically review and inform the alignment of ongoing data
collection and reporting standards for key health indicators. HHS partially agreed with our
recommendation, noting that it would not be able to take action immediately because of
resource constraints and the ongoing response to the pandemic.
76GAO-20-701. We recommended that HHS, with the support of DOD, establish a time
frame for documenting and sharing a national plan for distributing and administering
COVID-19 vaccine, and among other things, outline an approach for how efforts would be
coordinated across federal agencies and nonfederal entities. DOD partially concurred,
while HHS neither agreed nor disagreed with our recommendation. In November 2020, we
reported that HHS and DOD had released initial planning documents. We are continuing
to monitor federal efforts related to vaccine implementation. In January 2021, we also
recommended that HHS develop a comprehensive COVID-19 national testing strategy.
See GAO-21-265. HHS partially agreed with our recommendation, but expressed concern
that developing a strategy would be overly burdensome during the pandemic. We maintain
that a comprehensive and public national strategy is an important and worthwhile
investment and can be done efficiently and flexibly, without imposing unnecessary burden.
Page 35 GAO-21-513 Biodefense
frequently in the after-action report findings we reviewed: (1) Provide
effective public messaging, and (2) Ensure a strong public and veterinary
health infrastructure.
Provide effective public messaging. We identified providing clear,
consistent communication as an evolving lesson learned in our June
and September 2020 reports. 77 Specifically, we reported that clear
and consistent communication among all levels of government, with
health care providers, and to the public is key during a nationwide
emergency. Uncoordinated communication between the federal
government and state and local jurisdictions, and with providers and
the general public can contribute to confusion and frustration. We
further reported on examples of inconsistent and conflicting
information from the White House and federal public health officials;
and noted that two public health experts we interviewed for the
September 2020 report stated that confusing and conflicting
communication from the federal government hindered response and
recovery efforts. Officials from one state noted that public messaging
from the federal government on supplies sent to states did not match
what they actually received and caused confusion and frustration with
regard to expectations and planning. Additionally, in November 2020,
we reported that frequent changes in CDC COVID-19 testing
guidelines, without transparent scientific rationale, raised the risk of
creating confusion and eroding trust in federal partners. 78
Ensure a strong public and veterinary health infrastructure. 79
DHS officials and health care associations we interviewed noted that
the lack of investments in public health infrastructure exacerbated
challenges in the COVID-19 response. For example, DHS officials
stated that public health investments have atrophied and that declines
in resources and grants combined with hospitals and emergency
77GAO-20-625, GAO-20-701.
78GAO-21-191.
79The National Biodefense Strategy refers to both public and veterinary health in this
category. While interviews related to the COVID-19 response did not discuss veterinary
health, we have previously reported on challenges in this area. For example, in March
2019, we reported on challenges USDA might face in detecting and responding to an
outbreak of foot-and-mouth disease and made recommendations aimed at strengthening
preparedness activities, including prioritizing corrective actions from exercises. USDA
agreed with our recommendations. See GAO, Foot-and-Mouth Disease: USDA’s Efforts to
Prepare for a Potential Outbreak Could Be Strengthened, GAO-19-103 (Washington,
D.C.: Mar. 12, 2019).
Page 36 GAO-21-513 Biodefense
rooms closing in the years leading up to COVID-19 had negative
national impacts on preparedness and response. As a result, officials
noted that limited capabilities at the nonfederal level necessitated a
more prominent federal response. In May 2018, we reported that,
according to HHS officials, grant awards funded by annual
appropriations are intended to establish and strengthen emergency
preparedness and capacity building, but may not fully support the
need for surge capacity that states and other jurisdictions require in
order to respond to an infectious disease threat. 80 We further reported
that HHS officials and nonfederal stakeholders noted that a funding
mechanism to fund rapid response activities when additional support
is needed would be beneficial and could help address timing
challenges. 81
When asked what steps agencies had taken to address the long-standing
challenges identified in after-action reports, officials from DHS and USDA
pointed to the development of a number of strategic and operational
plans—such as the 2017 Biological Incident Annex, 2018 National
Biodefense Strategy, and 2018 PanCAP—that were designed to improve
interagency efforts. DHS officials cited FEMA and HHS co-locating staff at
the National Response Coordination Center during the COVID-19
response as an example of improved coordination. In that regard, officials
said there has been steady improvement in preparedness since the 2009
H1N1 outbreak because of the results of lessons learned from exercises
and real-world incidents.
Nevertheless, challenges identified in prior exercises and incidents
persisted during the COVID-19 response, and selected federal and
nonfederal partners we interviewed felt underprepared to respond to the
COVID-19 pandemic. As we discuss below, the challenges revealed
during the COVID-19 response and our analysis of after-action report
findings with interagency implications highlight opportunities to better
achieve the National Biodefense Strategy’s objectives across federal
agencies and with nonfederal entities they depend on for successful
response.
80GAO, Infectious Disease Threats: Funding and Performance of Key Preparedness and
Capacity-Building Programs, GAO-18-362 (Washington, D.C.: May 24, 2018).
81We did not make recommendations as part of this work, but for certain HHS grant
programs, this type of mechanism has been developed and was used to award funding for
the COVID-19 pandemic.
Page 37 GAO-21-513 Biodefense
Federal Agencies Have Agencies responsible for implementing the National Biodefense Strategy
Not Defined the Set of have not defined the set of capabilities that account for the unique
elements specific to responding to nationally significant biological
Capabilities Needed to
incidents. The COVID-19 response illustrated that nationally significant
Drive Preparedness biological incidents require unique capabilities and application of existing
Efforts under the Strategy capabilities in novel and complex contexts. For example, FEMA officials
said that the COVID-19 response presented unique challenges, because
the pandemic affected the entire country simultaneously and posed
challenges for acquiring life-saving supplies in the face of global supply
chain shortages. Officials from DHS’s Countering Weapons of Mass
Destruction Office further stated that the pandemic revealed limitations of
a traditional emergency management response when an event is not
limited by time and geography—such as a wildfire or hurricane. Figure 5
below shows a supply shipment coordinated by the federal response
during the COVID-19 pandemic.
Figure 5: Supply Shipment during the COVID-19 Pandemic
Federal agencies have defined capabilities intended to address a wide
range of hazards, but these capabilities are not defined in a way that
provides sufficient context for nationally significant biological incidents. As
discussed in the background of this report, the federal government has
Page 38 GAO-21-513 Biodefense
defined 32 all-hazards preparedness capabilities and 15 compatible
capabilities specific to public health preparedness. 82 However, the current
sets of capabilities, as defined and implemented, do not provide federal
and nonfederal entities with sufficient context and detail on how to apply
them for the unique circumstances associated with nationally significant
biological incidents. For example, standard capability components, such
as mutual aid agreements, that may help nonfederal entities address
supply shortages during a response to a routine event, are likely not
practical to employ during a catastrophic incident affecting the entire
nation. Throughout the COVID-19 pandemic, nonfederal entities
simultaneously faced the same resource shortages in terms of supplies
and, in many cases, care facility capacity.
FEMA’s initial review of the COVID-19 response demonstrated that
capabilities needed for nationally significant biological incidents were
underdeveloped. In its January 2021 assessment of its response activities
during the initial phase of the pandemic, FEMA recognized that its ability
to anticipate nonfederal requirements during the pandemic was affected
by an insufficient understanding of projected consequences and
capabilities of nonfederal partners. 83 The report further states that existing
federal preparedness efforts did not adequately anticipate the magnitude
of the national response to the COVID-19 pandemic. FEMA’s assessment
report provided an example of one of their efforts to assess nonfederal
preparedness efforts at a very high level—the Stakeholder Preparedness
Report, which relies on input from nonfederal stakeholders’ Threat and
82As discussed above, the 32 core capabilities apply across five broad mission areas:
prevention, protection, mitigation, response, and recovery. Some core capabilities fall
within a single mission area, while others apply to multiple or all mission areas. For
example, 11 of the 32 capabilities apply only to the response mission area, while an
additional four capabilities apply to both response and one or more other mission area.
See appendix II for a list of all 32 core capabilities and their corresponding mission
area(s). These capabilities are a critical and well-established framework to drive overall
national preparedness efforts that support the National Preparedness Goal and CDC’s
efforts to build public health capabilities at the nonfederal level. For example, FEMA and
CDC have used the sets of core capabilities as a key performance management tool in
measuring emergency preparedness and public health emergency preparedness and
response.
83U.S. Department of Homeland Security, Federal Emergency Management Agency,
Pandemic Response to Coronavirus Disease 2019 (COVID-19): Initial Assessment
Report, (Washington, D.C.: January 2021).
Page 39 GAO-21-513 Biodefense
Hazard Identification and Risk Assessment. 84 According to the report, in
2019, only 25 states’ risk assessments included a pandemic among the
threats to which their communities are the most vulnerable. Additionally,
states and urban areas indicated that in a worst-case scenario, medical
care and life-sustaining goods delivery were two of the capabilities that
were furthest from the desired goal. In its assessment, FEMA also
recognized the important role of CDC’s preparedness efforts to help build
and strengthen nonfederal public health capabilities, but they also
described the need to better integrate preparedness efforts going forward,
based on the whole-of-nation response to COVID-19.
Additionally, in April 2021, we reported on challenges related to
communication and coordination capabilities that HHS faced in the
context of repatriation activities during the COVID-19 response. 85
Specifically we reported that HHS was not prepared for a repatriation
event in response to a pandemic, because the department and
component agencies had not exercised that scenario, including during the
2019 Crimson Contagion exercise, which was a multi-state, whole-of-
government exercise based on the spread of a novel influenza virus
starting in China. 86 For example, among other things, we found a lack of
clarity as to which agency was in charge when the first repatriation flight
from Wuhan, China, arrived at the quarantine facility, which caused
confusion among the HHS component agencies. The challenges HHS
experienced repatriating U.S. citizens from abroad have the potential to
cut across multiple National Preparedness Goal and CDC capabilities,
such as operational coordination, communication, or provision of public
health services.
The purpose of the National Biodefense Strategy is to help guide the
United States in assessing, preventing, detecting, preparing for,
84According to the FEMA report, states, territories, major urban areas, and tribes conduct
a Threat and Hazard Identification and Risk Assessment to model the consequences of
their most likely threats and hazards to better understand their risks and set targets for
preparedness capabilities, which are then assessed through the Stakeholder
Preparedness Report.
85GAO, COVID-19: HHS Should Clarify Agency Roles for Emergency Return of U.S.
Citizens during a Pandemic, GAO-21-334 (Washington, D.C., Apr 19, 2021). HHS agreed
to the two recommendations we made, and we continue to monitor HHS’s progress in
implementing them.
86The National Preparedness Goal highlights the important role exercises play in
preparedness as a means to evaluate capabilities.
Page 40 GAO-21-513 Biodefense
responding to, and recovering from a biological incident. The Strategy
recognizes the importance of developing, implementing, and exercising
biodefense and health security capabilities and acknowledges that the
federal biodefense mission is contingent upon coordination with and the
success of the community response. Specifically, Goal 3 of the Strategy
urges responsible agencies to develop, exercise, and update prevention,
response, and recovery plans and capabilities. Further, the Strategy’s
implementation guidance says that officials responsible for implementing
the Strategy have a responsibility for helping to identify and address gaps
in capabilities and preparedness through an annual assessment of
biodefense activities against the Strategy’s goals. 87 This guidance, along
with the NDAA, also anticipated that the Strategy and its implementation
would need to be reassessed and revised on a regular basis, recognizing
that biological threats and the actions needed to best prepare and
respond to them are ever changing. 88
DHS, DOD, USDA, and HHS officials stated that initial efforts within the
Biodefense Coordination Team to implement the Strategy focused on
identifying overarching interagency priorities, and did not focus on
defining a set of key biodefense capabilities. Additionally, cases of
COVID-19 began to appear in the U.S. in late January 2020; therefore,
Biodefense Coordination Team member agencies lacked sufficient time to
fully implement the Strategy by the time COVID-19 was declared a
pandemic and necessitated an interagency response. The process
described by the agencies to identify biodefense priorities is meant to
identify critical needs across the federal biodefense enterprise and
87Over the past decade, our work has found that many of the resources that contribute to
the nation’s biodefense are largely owned by nonfederal entities and that effective
response to significant national biological incidents relies heavily on nonfederal resources
and capabilities. In February 2020, we recommended that the Secretary of HHS direct the
Biodefense Coordination Team to, among other things, document methods and guidance
that ensure nonfederal resources and capabilities are accounted for in the annual analysis
of the resources needed to support the nation’s biodefense. HHS concurred with the
recommendation, and we continue to monitor their efforts to address this. See,
GAO-20-273.
88See Presidential Memorandum on the Support for National Biodefense/National Security
Presidential Memorandum-14, White House (September 18, 2018). The NDAA requires
that the Strategy be reviewed and, as appropriate, revised biennially. Pub. L. No. 114-328,
§ 1086, 130 Stat. at 2423 (codified at 6 U.S.C. § 104).
Page 41 GAO-21-513 Biodefense
subsequently drive federal agencies’ budget submissions. 89 As such, it is
an important part of effective and efficient implementation of the Strategy.
However, this process does not provide the kind of foundation for
advancing preparedness across federal and nonfederal response
partners through planning, exercising, and investing over time that a clear
and consistent articulation of the set of capabilities needed to fully
implement the Strategy could provide.
Defining the set of capabilities needed to prepare for and respond to
nationally significant biological incidents could not only help entities at all
levels identify and help address gaps in capabilities and preparedness,
but also serve as a means to measure preparedness for such events
across the nation. A clearer understanding of how to build, maintain, and
apply capabilities in the context of nationally significant biological
incidents should be consistent with the preparedness and response goals
for the National Biodefense Strategy. Defining the set of capabilities
needed to implement the goals of the Strategy is a key step in creating
plans that are threat-agnostic, adaptable to changing pathogen
characteristics, and scalable to address a whole-of-nation response.
Without defining the set of capabilities needed for nationally significant
biological incidents (which could include capabilities already identified in
the National Preparedness Goal and by CDC), the federal and nonfederal
agencies who play vital roles in responding to these incidents are without
a key source of information to drive effective and efficient preparedness.
The Biodefense Enterprise There is no process at the interagency level for agencies to assess and
Lacks a Process and communicate priorities for exercising capabilities that are specific to
nationally significant biological incidents. Additionally, our analysis found
Guidance to Assess and
that agencies do not consistently identify the capabilities exercised across
Communicate Exercise after-action reports. Officials from DHS, DOD, and HHS acknowledge that
Priorities and Consistently there is no formal process for assessing and communicating exercise
Track Findings priorities at the interagency level. However, they said the Biodefense
Coordination Team has held initial preliminary discussions about priorities
and scenarios for exercising biological incidents. DHS, DOD, HHS, and
USDA officials also acknowledged that there was an opportunity for the
Biodefense Coordination Team, in its role as the working-level federal
interagency group implementing the National Biodefense Strategy, to help
89As part of this process, agency officials said the Biodefense Coordination Team
identified budget priorities for fiscal year 2021, including biosurveillance, medical
countermeasure development, and strengthening global health. These priority budget
areas were consistent with some of the areas identified in our analysis of after-action
reporting and COVID-19 challenges.
Page 42 GAO-21-513 Biodefense
assess and set priorities for exercising capabilities specific to the unique
needs of nationally significant biological incidents. For example, an HHS
official noted that as the Biodefense Coordination Team further develops
and evolves, HHS expects its members will begin to discuss capabilities
that should be exercised for biological incidents and will communicate
those to interagency partners.
The response to the COVID-19 pandemic highlighted a disconnect
between preparedness activities and exercises conducted prior to the
pandemic and what was needed for an effective response. For example,
officials we interviewed from five of 10 states and one of six FEMA
regions said they felt underprepared to respond to the current pandemic,
in part due to its unprecedented complexity and scale. Officials from
these five states further commented that exercises were infrequently
designed to exercise large-scale logistics capabilities and other
challenges that arose during the COVID-19 response. For example,
officials from two states noted that past biological incident exercises did
not include scenarios that emphasized the significant role FEMA would
come to play in response to the COVID-19 pandemic. 90 Officials from one
state noted that no one had practiced responding to a long-duration event
with high unemployment rates and long-term economic consequences.
Officials from another state noted that it would be helpful to conduct an
exercise scenario in which there were severe supply shortages and a
vaccine was not available. Officials from two states further commented
that the COVID-19 response did not play out how they had exercised
public health emergencies in the past, particularly with regard to
90In March 2020, leadership for the overall response shifted from HHS to FEMA. HHS
officials noted that past exercises, such as the 2019 Crimson Contagion exercise,
assumed that because an influenza pandemic is not explicitly defined as a major disaster
under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, FEMA would
not be the lead agency in a pandemic response. The 2019 Crimson Contagion after-action
report found that existing statutory authorities and policies tasking HHS to lead the federal
government’s response to an influenza pandemic were insufficient and policies were often
in conflict with one another, resulting in confusion among exercise participants. However,
as discussed above, agency officials did not have time to take corrective actions prior to
the COVID-19 outbreak.
Page 43 GAO-21-513 Biodefense
requesting and receiving supplies through the Strategic National
Stockpile. 91
Additionally, our analysis of selected after-action reports shows that past
interagency biological incident exercises have not always focused on
capabilities identified as challenges in the COVID-19 response. 92 In
particular, evidence from the ongoing COVID-19 response indicates that
capabilities such as Supply Chain Integrity and Security and Logistics and
Supply Chain Management are especially necessary for responding to
large-scale biological incidents. For example, in 2020, we reported on
widespread challenges with the distribution, acquisition, and adequacy of
supplies during the initial COVID-19 response—including personal
protective equipment and testing supplies. 93 However, of the 28
interagency biological exercises we reviewed that included capabilities
information in their after-action reports, none identified Supply Chain
Integrity and Security as capabilities that were being exercised.
Additionally, only four individual exercises, and the exercises from one
exercise series, listed Logistics and Supply Chain Management as a
focus of the exercise. 94
After-action reports from these exercises identified a number of areas for
improvement related to the Logistics and Supply Chain Management
capability. For example, HHS identified supply chain-related challenges in
91The March 2020 PanCAP Adapted anticipated that states, tribes, and territories would
request federal assistance when requirements exceeded their capabilities to respond to
COVID-19. For the distribution of supplies, it focused on use of the Strategic National
Stockpile, which, at the outset of the COVID-19 pandemic was a critical resource to states
for needed and scarce medical supplies. However, as we reported in June 2020,
nationwide need for critical supplies to respond to COVID-19 quickly exceeded the
quantity of supplies contained in the national stockpile. When this condition became clear,
the federal government and its nonfederal partners had to employ numerous additional
avenues to meet supply needs. For additional information about the national stockpile’s
role in the response and efforts to modernize it, see GAO-21-387.
92We used examples from the COVID-19 response as a proxy for capabilities for nationally
significant biological events, as they have not yet been defined. As discussed above,
exercising is one of five functional areas FEMA has identified as key to building core
capabilities. FEMA officials noted the importance of training, another of the five functional
areas, and stated that exercises are most successful if training is provided in advance and
a common baseline knowledge is developed.
93GAO-20-625 and GAO-20-701.
94From December 2009 through October 2010, FEMA and DHS’ Office of Health Affairs
sponsored a series of anthrax response exercises in the FEMA regions. This series
exercised the Logistics and Supply Management capability, among others. We analyzed
after-action information for a total 42 exercises.
Page 44 GAO-21-513 Biodefense
the after-action report for the 2019 Crimson Contagion exercise. The
report found that the supply chain for medical countermeasures (such as
personal protective equipment and ventilators) may not meet the demand
of a global pandemic. It also found that states participating in the exercise
experienced multiple challenges requesting resources from the federal
government due to a lack of standardized, well-understood, and properly
executed resource request processes. The after-action report contained a
number of recommendations to address these challenges; however, HHS
officials told us that they have not yet had time to address the
recommendations due to the COVID-19 pandemic response that began in
2020. Figure 6 below shows participants gathering for a biological
incident exercise—an important practice to enhance preparedness.
Figure 6: Participants in a Biological Incident Exercise
Our analysis further found that agencies did not consistently identify the
capabilities exercised across the after-action reports we reviewed.
Specifically, 28 of the 42 interagency biological incident exercises for
which we analyzed after-action reports clearly discussed assessing one
or more of the National Preparedness Goal core capabilities. 95 However,
the remaining 14 after-action reports did not identify the capabilities
exercised.
95The most frequently exercised core capabilities included the three that span all five
mission areas―”Operational Coordination” (27), “Public Information and Warning” (14),
and “Planning” (12)―as well as the “Public Health, Healthcare, and Emergency Medical
Services” (12) core capability from the Response mission area. Some exercise more than
one capability.
Page 45 GAO-21-513 Biodefense
Homeland Security Exercise and Evaluation Program guidance provides
a set of fundamental principles for exercise programs across the whole
community and all mission areas, including that exercises should be
“capability-based and objective-driven.” The guidance notes that exercise
design and objectives, including the capabilities to be exercised, should
consider senior leader intent and guidance, as well as past findings from
exercises and real-world events, among other things. Applying Homeland
Security Exercise and Evaluation Program guidance at the interagency
level would involve the Biodefense Coordination Team assessing and
communicating updated priority capabilities for federal and nonfederal
response partners to exercise. This guidance also states that the after-
action reporting process can validate current capabilities already in place
and describe areas for improvement. Additionally, Standards for Internal
Control in the Federal Government states that management should
communicate quality information externally through reporting lines so that
external parties can help the entity achieve its objectives and address
related risks. 96
DHS, HHS, and DOD officials told us that, prior to the COVID-19
pandemic, it was challenging to build interest in and support for large-
scale biological incident exercises. Federal, state, and health care
association officials we spoke with also noted that it is important for
exercises to include a broad range of participants across multiple levels of
government, but that at the same time, it can be difficult to get response
partners to recognize the need to exercise high consequence, low
probability biological events such as the COVID-19 pandemic. For
example, officials from one state commented that, prior to the COVID-19
pandemic, some localities were reluctant to participate in biodefense
exercises because they thought it was a waste of time to exercise a
scenario that would never happen.
Additionally, as noted earlier in this report, agencies that make up the
Biodefense Coordination Team have been focused on responding to the
COVID-19 pandemic and have not had the opportunity to conduct
activities that would fully advance the preparedness goal of the National
Biodefense Strategy. Specifically, they have not yet had time to take
additional actions to assess and communicate exercise priorities, which
will be predicated on them first defining those capabilities to prioritize in
96GAO-14-704G.
Page 46 GAO-21-513 Biodefense
exercises. Additionally, they have not had the opportunity to develop
exercise reporting guidance for interagency partners.
Without a process to assess and communicate exercise priorities and
guidance on reporting the key capabilities needed to respond to nationally
significant biological incidents, the Biodefense Coordination Team cannot
track progress over time and across the biodefense enterprise to help
ensure efficient and effective preparedness efforts. As a result, federal
and nonfederal response partners may remain underprepared in key
biodefense capability areas. Moreover, establishing a process for
assessing and communicating exercise priorities that are based on a
defined set of capabilities, would help stakeholders coalesce around the
biodefense mission that transcends, but is supported by, individual
agency missions. Additionally, guidance about how to report on the
unique aspects of capabilities needed for nationally significant biological
events could help partners across the enterprise—federal and
nonfederal—capture critical information in a consistent manner so that the
Biodefense Coordination Team can track findings across time and across
the enterprise.
Lack of Cross- Our interviews with agency officials and our analysis of real-world after-
Government Review of action reports revealed that agencies do not routinely work together to
monitor and review results from exercises and real-world events and
Exercises and Incidents
evaluate lessons learned across the government to identify patterns and
Limits Ability to Identify possible root causes for systemic challenges. 97 According to FEMA
and Address Systemic officials, through the National Exercise Program, FEMA facilitates
Challenges solicitation of interagency feedback and reviews after-action reports to
develop priorities for the next National Exercise Program 2-year cycle.
However, these officials further noted that analysis of after-action reports
submitted to the program do not reflect the comprehensive view of all
exercises conducted across the nation. The National Exercise Program is
only one line of effort to conduct exercises, meaning analysis done
through this effort does not encapsulate all exercise or real-world incident
findings in order to identify patterns of challenges related to the unique
aspects of nationally significant biological incidents. Officials at HHS,
97In February 2009, we recommended that the Secretaries of HHS, USDA, and the
Department of Interior coordinate with federal, state, and local agencies to periodically
review assessments following zoonotic disease outbreaks to identify common challenges
and strategies to address them. These recommendations were closed as not
implemented. See GAO, Veterinarian Workforce: Actions Are Needed to Ensure Sufficient
Capacity for Protecting Public and Animal Health, GAO-09-178 (Washington D.C.: Feb. 4,
2009).
Page 47 GAO-21-513 Biodefense
which also organizes interagency biological incident exercises, further
noted that they do not have a process that would collect and analyze
exercise outcomes at multiple levels to drive future interagency biological
incident efforts.
As discussed above, our analysis of after-action reports for interagency
biological exercises and real-world events identified patterns of
challenges that existed before the COVID-19 pandemic. 98 Additionally,
our analysis of these after-action reports showed that approximately 44
percent (225 of 507) of the findings had interagency implications,
meaning that the gap or strength applied to activities undertaken by two
or more federal agencies. The response to COVID-19 continues to
demonstrate that a whole-of-nation response relies on multiple agencies
at all levels of government, as well as nongovernment sectors, to
coordinate in order to reduce morbidity and mortality, and to ensure
economic stability and national security.
Officials at DHS, DOD, HHS, and USDA also stated that ensuring
accountability for addressing these findings is a challenge and that in
addition to not having a mechanism to conduct cross government
analysis of findings, there is also no interagency mechanism to ensure
agencies implement corrective actions. For example, much like agencies’
responsibility for implementing the National Biodefense Strategy, heads
of agencies are responsible for holding their agencies accountable for
implementation of corrective actions. Officials from two associations
representing public health interests expressed concern that lessons
learned following exercises are not addressed and are not transferred
from one administration to another. Officials from DHS’ Countering
Weapons of Mass Destruction Office also recognized the challenge in
losing continuity of effort from one administration to the next, as each
administration sets its own priorities and must address emerging
challenges. They said those with institutional history—who work on these
issues across administrations—and those familiar with exercising
nationally significant biological incidents can use their knowledge to help
ensure that the best preparedness results in the best response.
Internal control standards state that management should establish and
operate monitoring activities to monitor the internal control system and
98We found that these same categories of challenges—such as coordinating response
operations and managing information—manifested during the COVID-19 response.
Page 48 GAO-21-513 Biodefense
evaluate the results. 99 This can be achieved through ongoing monitoring,
separate evaluations, or a combination of the two to obtain reasonable
assurance of the operating effectiveness of the organization’s internal
controls over the assigned process. In the context of implementing the
National Biodefense Strategy, the Biodefense Steering Committee needs
information that allows it to identify gaps and areas for improvement to
ensure efficient and effective preparedness for nationally significant
biological incidents. Federal internal control standards also state that in
order to achieve the entity’s objectives, management should assign
responsibility and delegate authority to key roles. In this context, once
patterns and root causes are identified, the Biodefense Coordination
Team could also identify responsibility for addressing these causes
among interagency partners and ensure implementation actions are taken
or endorsed by the Biodefense Steering Committee. Federal internal
control standards further state that, in deciding what information is
required to achieve objectives, management should consider the needs of
both internal and external users and that management should externally
communicate necessary quality information in order to meet objectives.
Communicating the results of monitoring activities to key decision
makers—such as cabinet-level secretaries and administrators—allows
them to be informed of critical issues that may require their attention and
action.
While agency officials we interviewed described the development and
updating of biodefense-related response plans as an interagency activity,
as discussed above, this type of interagency engagement does not
extend to implementing corrective actions. Additionally, interagency
efforts to implement the National Biodefense Strategy have focused on
identifying budget priorities. Attention among Biodefense Coordination
Team agencies has been divided between these efforts as well as
responding to the daunting and specific challenges of the COVID-19
response. Further, officials from DHS’s Countering Weapons of Mass
Destruction Office described an organic process through exercise
development, rather than a consistent, formal process to look at the
results of exercises and identify gaps and lessons learned across the
government. These officials said that most health, medical, and biological
exercises cascade off each other, meaning when one exercise identifies a
problem, the next exercise will use that as a gap and try to address it. In
that regard, officials said there has been steady improvement in
preparedness because of the results of exercises. However, officials from
99GAO-14-704G.
Page 49 GAO-21-513 Biodefense
DHS, DOD, HHS, and USDA recognized the value cross-agency analysis
of after-action findings could provide and said the Biodefense
Coordination Team, as the working-level group with responsibility for the
National Biodefense Strategy, is well-positioned to be the entity that
conducts analysis to identify patterns and root causes of longstanding
problems.
Institutionalized mechanisms to identify root causes of pervasive and
recurrent issues and to provide structure and accountability to help
ensure actions to address those causes would promote more effective
and efficient preparedness over time and across organizational
boundaries. Our analysis of findings regarding lessons learned during
interagency biological incident exercises and real-world events identified
longstanding challenges that existed before COVID-19. Taking steps to
monitor and identify persistent issues at the interagency level—that would
not otherwise be captured during individual agency reviews—could help
further enhance the preparedness activities of the many different partners
responsible for responding to nationally significant biological incidents.
Further, assigning accountability for addressing root causes to these
challenges at the interagency level could help ensure a more effective
response to future incidents.
The unprecedented scope and scale of the COVID-19 pandemic placed
Conclusions into sharp focus the critical capabilities needed to execute a whole-of-
nation response to a nationally significant biological incident. Capabilities
such as global supply chain logistics, mass testing and vaccination, data
integration and analysis, and communication among various levels of
government and directly with the public reach beyond the mission space
of a single agency and require federal and nonfederal agencies to work
united during a response. Federal agencies have taken steps to identify
both all-hazard and public health capabilities that could be used to
support or execute a response to biological incidents, but do not fully
address the unique characteristics and response needs for nationally
significant biological incidents.
The nature of biological incidents presents inherent and unique
challenges, not only because of the fragmented nature of preparedness
and response activities, but also because nationally significant biological
incidents tend to be low-probability, yet high-consequence events. While
executing large scale or complex scenarios that reflect the conditions and
challenges the nation faced during the COVID-19 pandemic may come at
a cost, so too will the repercussions of not effectively preparing for such
events in the future. Preparation for nationally significant biological
Page 50 GAO-21-513 Biodefense
incidents like COVID-19 cannot afford to suffer from a lack of imagination.
We found that several key themes continued to emerge as areas for
improvement over the past ten years during exercises and real-world
events, and that those same issues manifested as challenges during the
COVID-19 response.
The ability to monitor and assess the outcomes of interagency biological
incident exercises and real-world events could be instrumental in
identifying persistent challenges and their root causes before they
become systemic, intractable problems. Identifying these issues could
also help agencies prioritize which capabilities need further development
or exercising. The Biodefense Steering Committee includes the heads of
federal agencies with biodefense responsibilities. The Biodefense
Coordination Team, which plays a key role in implementing the National
Biodefense Strategy in coordination with the Biodefense Steering
Committee, is uniquely positioned to carry out these types of analysis
activities, as it combines the expertise from federal agencies with
biodefense responsibilities. Once the Team defines the set of capabilities
required, establishing interagency exercise priorities around those
capabilities, ensuring consistent reporting of capabilities exercised, and
routinely monitoring and communicating the results of the exercises and
incidents will help ensure the nation is better positioned to respond to the
next biological threat.
We are making 16 recommendations to the Secretaries of Homeland
Recommendation for Security, Defense, Health and Human Services, and Agriculture.
Executive Action
The Secretary of Homeland Security, should, with input from key
nonfederal partners, work through the Biodefense Steering Committee to
ensure that the Biodefense Coordination Team defines the set of
capabilities needed to prepare for and respond to nationally significant
biological incidents. (Recommendation 1)
The Secretary of Defense, should, with input from key nonfederal
partners, work through the Biodefense Steering Committee to ensure that
the Biodefense Coordination Team defines the set of capabilities needed
to prepare for and respond to nationally significant biological incidents.
(Recommendation 2)
The Secretary of Health and Human Services, should, with input from key
nonfederal partners, work through the Biodefense Steering Committee to
ensure that the Biodefense Coordination Team defines the set of
Page 51 GAO-21-513 Biodefense
capabilities needed to prepare for and respond to nationally significant
biological incidents. (Recommendation 3)
The Secretary of Agriculture, should, with input from key nonfederal
partners, work through the Biodefense Steering Committee to ensure that
the Biodefense Coordination Team defines the set of capabilities needed
to prepare for and respond to nationally significant biological incidents.
(Recommendation 4)
The Secretary of Homeland Security should work through the Biodefense
Steering Committee to ensure that the Biodefense Coordination Team
establishes a process to periodically assess and communicate exercise
priorities among the capabilities they identify to support nationally
significant biological incidents. (Recommendation 5)
The Secretary of Defense should work through the Biodefense Steering
Committee to ensure that the Biodefense Coordination Team establishes
a process to periodically assess and communicate exercise priorities
among the capabilities they identify to support nationally significant
biological incidents. (Recommendation 6)
The Secretary of Health and Human Services should work through the
Biodefense Steering Committee to ensure that the Biodefense
Coordination Team establishes a process to periodically assess and
communicate exercise priorities among the capabilities they identify to
support nationally significant biological incidents. (Recommendation 7)
The Secretary of Agriculture should work through the Biodefense Steering
Committee to ensure that the Biodefense Coordination Team establishes
a process to periodically assess and communicate exercise priorities
among the capabilities they identify to support nationally significant
biological incidents. (Recommendation 8)
The Secretary of Homeland Security should work through the Biodefense
Steering Committee to ensure that the Biodefense Coordination Team
provides guidance for federal and nonfederal partners for how to report
on capabilities in after-action reports for exercises and real-world
incidents in a consistent manner. (Recommendation 9)
The Secretary of Defense should work through the Biodefense Steering
Committee to ensure that the Biodefense Coordination Team provides
guidance for federal and nonfederal partners for how to report on
Page 52 GAO-21-513 Biodefense
capabilities in after-action reports for exercises and real-world incidents in
a consistent manner. (Recommendation 10)
The Secretary of Health and Human Services should work through the
Biodefense Steering Committee to ensure that the Biodefense
Coordination Team provides guidance for federal and nonfederal partners
for how to report on capabilities in after-action reports for exercises and
real-world incidents in a consistent manner. (Recommendation 11)
The Secretary of Agriculture should work through the Biodefense Steering
Committee to ensure that the Biodefense Coordination Team provides
guidance for federal and nonfederal partners for how to report on
capabilities in after-action reports for exercises and real-world incidents in
a consistent manner. (Recommendation 12)
The Secretary of Homeland Security should work through the Biodefense
Steering Committee to ensure that the Biodefense Coordination Team
routinely monitors the results of interagency biological exercises and real-
world incidents to identify patterns of challenges and potential root causes
of identified challenges, and reports these to the Biodefense Steering
Committee along with recommendations for addressing the root causes
that also identify the responsible agencies. (Recommendation 13)
The Secretary of Defense should work through the Biodefense Steering
Committee to ensure that the Biodefense Coordination Team routinely
monitors the results of interagency biological exercises and real-world
incidents to identify patterns of challenges and potential root causes of
identified challenges, and reports these to the Biodefense Steering
Committee along with recommendations for addressing the root causes
that also identify the responsible agencies. (Recommendation 14)
The Secretary of Health and Human Services should work through the
Biodefense Steering Committee to ensure that the Biodefense
Coordination Team routinely monitors the results of interagency biological
exercises and real-world incidents to identify patterns of challenges and
potential root causes of identified challenges, and reports these to the
Biodefense Steering Committee along with recommendations for
addressing the root causes that also identify the responsible agencies.
(Recommendation 15)
The Secretary of Agriculture should work through the Biodefense Steering
Committee to ensure that the Biodefense Coordination Team routinely
monitors the results of interagency biological exercises and real-world
Page 53 GAO-21-513 Biodefense
incidents to identify patterns of challenges and potential root causes of
identified challenges, and reports these to the Biodefense Steering
Committee along with recommendations for addressing the root causes
that also identify the responsible agencies. (Recommendation 16)
We provided a draft of this report to DHS, DOD, HHS, and USDA for
Agency Comments review and comment. In the draft report, we made a set of
and Our Evaluation recommendations to the secretaries to work through the Biodefense
Coordination Team, which is the working level group established to help
with National Biodefense Strategy implementation. DHS, DOD, and
USDA suggested that the recommendations be directed instead through
the Biodefense Steering Committee. This Committee is the group of
secretary-level officials with responsibility for the Strategy and for
directing the work of the Biodefense Coordination Team. We agree with
the departments’ suggestion. Accordingly, we have made this change to
the recommendations.
In addition to the above comments, DHS, HHS, and USDA otherwise
stated they concurred with all four recommendations made to each
agency and provided technical comments, which we incorporated as
appropriate. DOD partially concurred with all four recommendations. The
written comments of DHS, DOD, and HHS are reproduced in appendices
III, IV, and V. USDA’s audit liaison provided comments via email.
In response to recommendations 1 through 4 to define a set of
capabilities needed to prepare for and respond to nationally significant
biological incidents, with key input from nonfederal partners, DHS, HHS,
and USDA concurred. In its partial concurrence, in addition to suggesting
that the recommendations be made through the Biodefense Steering
Committee, DOD expressed concerns about the appropriateness of the
Secretary of Defense’s role in gathering and assessing nonfederal input
and providing it to the Biodefense Coordination Team. In response, we
note that the intent of the sixteen recommendations we make in this
report—four each to the four agencies given responsibility for the National
Biodefense Strategy in statute—is to ensure that all four agencies work
as full partners leading this effort in the ways that are most appropriate to
their particular responsibilities, authorities, and resources.
The agencies also described actions they have taken or plan to take to
address recommendations 1 through 4. Specifically, DOD, HHS, and
USDA described Biodefense Coordination Team efforts to identify
capabilities necessary for advancing the goals and objectives of the
National Biodefense Strategy. Although none of these agencies specified
Page 54 GAO-21-513 Biodefense
that the set of capabilities they described was to be the final set of
capabilities intended to form the foundation to prepare the nation for
future biologically significant incidents, they did indicate that work is
already underway. To fully address this recommendation, the agencies,
working through the Biodefense Coordination Team, will need to provide
a finalized set of capability descriptions and evidence of input from key
nonfederal partners.
In response to recommendations 5 through 8 to establish a process to
periodically assess and communicate exercise priorities, DHS, HHS, and
USDA concurred. DOD partially concurred. As with the other
recommendations, DHS, DOD, and USDA suggested that the
recommendation be made through the Biodefense Steering Committee.
DHS, HHS, and USDA also described avenues that the Biodefense
Coordination Team could use to help identify and communicate exercise
priorities. To fully address this recommendation, the agencies, working
through the Biodefense Coordination Team, will need to finalize a process
that includes a means for periodic assessment to prioritize among the
capabilities for exercises.
In response to recommendations 9 through 12 to provide guidance for
federal and nonfederal partners for how to report on capabilities in after-
action reports for exercises and real-world incidents in a consistent
manner, DHS, HHS, and USDA concurred. DOD partially concurred. In its
partial concurrence, DOD noted concerns about the appropriateness of
the Secretary of Defense’s role in leading efforts to standardize after-
action reporting for federal and nonfederal partners. As noted above, the
intent of the recommendation was for DOD to work with its interagency
partners in this effort. DHS and HHS also described mechanisms that
could be used for reporting capabilities in after-action reports. To fully
respond to this recommendation, the agencies, working through the
Biodefense Coordination Team, will need to provide guidance for
reporting on capabilities in after-action reports.
In response to recommendations 13 through 16 to routinely monitor the
results of interagency biological exercises and real-world incidents to
identify patterns of challenges and potential root causes of identified
challenges, and report these to the Biodefense Steering Committee along
with recommendations for addressing the root causes that also identify
responsible agencies, DHS, HHS, and USDA concurred. DOD partially
concurred. DHS and HHS also described ways in which the interagency
partners could communicate about challenges and their root causes. To
fully respond to this recommendation, the agencies, working through the
Page 55 GAO-21-513 Biodefense
Biodefense Coordination Team, will need to put in place the means to
routinely monitor incidents, to identify patterns of challenges and their root
causes, and to make recommendations to the Biodefense Steering
Committee for addressing those root causes.
We are sending copies of this report to the appropriate congressional
committees, the Secretary of Homeland Security, the Secretary of
Defense, the Secretary of Health and Human Services, the Secretary of
Agriculture, and other interested parties. In addition, the report is
available at no charge on the GAO website at https://www.gao.gov.
If you or your staff members have any questions about this report, please
contact Chris Currie at (404) 679-1875 or CurrieC@gao.gov. Contact
points for our Office of Congressional Relations and Public Affairs may be
found on the last page of this report. GAO staff who made key
contributors to this report are listed in appendix VI.
Chris P. Currie
Director, Homeland Security and Justice
Page 56 GAO-21-513 Biodefense
List of Committees
The Honorable Patrick Leahy
Chairman
The Honorable Richard Shelby
Vice Chairman
Committee on Appropriations
United States Senate
The Honorable Ron Wyden
Chairman
The Honorable Mike Crapo
Ranking Member
Committee on Finance
United States Senate
The Honorable Patty Murray
Chair
The Honorable Richard Burr
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate
The Honorable Gary C. Peters
Chairman
The Honorable Rob Portman
Ranking Member
Committee on Homeland Security and Governmental Affairs
United States Senate
The Honorable Rosa L. DeLauro
Chairwoman
The Honorable Kay Granger
Ranking Member
Committee on Appropriations
House of Representatives
Page 57 GAO-21-513 Biodefense
List of Committees Continued
The Honorable Frank Pallone, Jr.
Chairman
The Honorable Cathy McMorris Rodgers
Republican Leader
Committee on Energy and Commerce
House of Representatives
The Honorable Bennie G. Thompson
Chairman
The Honorable John Katko
Ranking Member
Committee on Homeland Security
House of Representatives
The Honorable Carolyn B. Maloney
Chairwoman
The Honorable James Comer
Ranking Member
Committee on Oversight and Reform
House of Representatives
The Honorable Richard Neal
Chair
The Honorable Kevin Brady
Republican Leader
Committee on Ways and Means
House of Representatives
Page 58 GAO-21-513 Biodefense
Appendix I: National Biodefense Strategy
Appendix I: National Biodefense Strategy
Preparedness and Response Categories
Preparedness and Response Categories
The National Biodefense Strategy consists of five high-level goals
intended to help enable the efficient assessment, prevention, preparation,
response, and recovery from natural, accidental, or deliberate biological
threats. Each goal has associated objectives and sub-objectives designed
to strengthen the biodefense enterprise. Table 3 below describes the
objectives under the Strategy’s preparedness and response goals.
Table 3: National Biodefense Strategy Preparedness and Response Objectives
National Biodefense Strategy Description
objectives
Preparedness
Support U.S. biodefense research, Ensure an innovative national science and technology base to support biodefense by:
development, and investment • enabling U.S.-led innovation through scientific, technical, and industrial bases; and
• integrating research and development into federal planning.
Ensure a strong public and veterinary Ensure a strong public and veterinary health infrastructure by:
health infrastructure • ensuring critical capacities and establishing capabilities to provide surge staffing,
resources, and supplies; and
• modernizing public and veterinary laboratories so they have access to updated
diagnostic tests, methods, equipment, and technologies.
Develop, exercise, and update Develop, exercise, and update prevention, response, and recovery plans and capabilities.
plans and capabilities This includes:
• developing and exercising policies, plans, guidelines, and recommendations to
support prevention, response, and recovery activities;
• ensuring that emergency funding mechanisms exist to support urgent responses to
bioincidents;
• supporting the effective deployment of medical counter-measure stockpiles;
• supporting the provision of health care and the conduct of clinical research during
bioincidents;
• supporting the continuity of operations; and
• supporting the provision of essential services, critical infrastructure, and long-term
recovery.
Develop, exercise, and update risk plans Develop, exercise, and update risk communication plans and promote consistent
to support effective public messaging, messaging to inform key audiences, expedite response actions, and address public
enhance public trust, and promote uncertainty and fear. This includes:
consistent messaging • improving federal messaging coordination for biothreats and bioincidents;
• developing and exercising communications plans; and
• enhancing messaging partnerships with the private sector.
Improve diagnostic capabilities and Enhance preparedness to save lives through medical countermeasures by:
enhance medical countermeasures • improving diagnostic capabilities; and
• enhancing the development, sustainment, and availability of medical counter-
measures.
Page 59 GAO-21-513 Biodefense
Appendix I: National Biodefense Strategy
Preparedness and Response Categories
National Biodefense Strategy Description
objectives
Enhance community mitigation Enhance preparedness to limit the spread of disease through community mitigation
measures development and measures. This includes:
capabilities • developing and assessing the effectiveness of community mitigation measures to
mitigate the impact of bioincidents; and
• establishing and promoting best practices for implementing such measures.
Enhance decontamination Enhance preparedness to support decontamination by:
preparedness • conducting research and developing verified technologies; and
• developing and exercising decontamination plans.
Improve the ability for the federal Strengthen preparedness to operate and collaborate across the United States, including
government to collaborate with U.S. territories by:
states and territories • establishing collaborative and resource sharing policies and operational frameworks.
Work with international Strengthen international preparedness to support international response and recovery
governments to improve capabilities. This includes:
global preparedness • strengthening foreign governments and international organizations’ commitment to,
preparedness for, and capacity to respond to bioincidents;
• enhancing international preparedness through medical countermeasures;
• enhancing international preparedness through community mitigation measures; and
• further developing, exercising, and updating plans for responding to and recovering
from international bioincidents.
Response
Manage information Compile and share biothreat and bioincident information to enable decision-making and
response operations across all levels of government and with non-governmental, private
sector, and international entities. This includes:
• ensuring access to timely, accurate, and useful information;
• coordinating federal decision making to support response operations; and
• enhancing situational awareness through real-time information sharing.
Coordinate response operations Conduct federal response operations in coordination with non-federal actors to contain,
and resources control, and rapidly mitigate the impacts of biothreats or bioincidents. This includes:
• ensuring appropriate oversight and coordination;
• deploying medical countermeasures and implementing community mitigation
measures;
• conducting real-time research regarding threats and countermeasures;
• implementing and supporting response operations; and
• preserving the continuity of operations of the U.S. government and critical
infrastructure.
Conduct operations and Conduct operations and investigations, and use available tools to hold perpetrators
investigations for intentional accountable. This includes:
incidents • strengthening capacity and capabilities to conduct incident operations and
investigations;
• conducting forensic examinations to support attribution of a biothreat or a bioincident;
and
• providing technical and logistical support to international investigations.
Page 60 GAO-21-513 Biodefense
Appendix I: National Biodefense Strategy
Preparedness and Response Categories
National Biodefense Strategy Description
objectives
Provide effective public Execute risk-informed, accurate, timely, and actionable public messaging.
messaging • Deliver public messaging to facilitate public understanding and decision-making during
a bioincident, including by providing timely, regular, accessible, and coordinated
information and combating misinformation.
Source: GAO analysis of National Biodefense Strategy. | GAO-21-513
Page 61 GAO-21-513 Biodefense
Appendix II: National Preparedness Goal
Appendix II: National Preparedness Goal and
Public Health Capabilities
and Public Health Capabilities
National Preparedness Goal Capabilities
The National Preparedness Goal identifies and defines 32 core
capabilities across five broad mission areas. 1 These capabilities apply to
all hazards and threats and are not incident specific. Further, they are
intended to apply to the whole community, and are not specific to any one
federal or nonfederal agency or organization. The core capabilities form
the foundation for measuring overall national preparedness and assisting
the nation in allocating resources to fill identified preparedness gaps. 2 As
shown in figure 7 below, three of the 32 core capabilities affect all mission
areas and are considered to be “crosscutting.”
1The five mission areas are: prevention, protection, mitigation, response, and recovery.
2The White House released Presidential Policy Directive 8 on National Preparedness in
March 2011. It directed the Secretary of Homeland Security to design a national
preparedness system to address the threats posing the greatest risk to the security of the
nation and issue various policy and planning documents designed to strengthen national
preparedness. Additionally, it required the Secretary to develop a National Preparedness
Goal that identifies the core capabilities necessary to achieve preparedness.
Page 62 GAO-21-513 Biodefense
Appendix II: National Preparedness Goal and
Public Health Capabilities
Figure 7: National Preparedness Goal’s 32 Emergency Management Core Capabilities by Mission Area
a
Prevention: Preventing an imminent threat, or actual act of terrorism.
b
Protection: Protecting citizens, residents, visitors, and assets in a manner that allows interests,
aspirations, and way of life to thrive.
c
Mitigation: Mitigating the loss of life and property by lessening the impact of future disasters.
Page 63 GAO-21-513 Biodefense
Appendix II: National Preparedness Goal and
Public Health Capabilities
d
Response: Responding quickly to save lives, protect property and the environment, and meet basic
human needs in the immediate aftermath of an incident.
e
Recovery. Recovering through a focus on the timely restoration, strengthening, and revitalization of
infrastructure, housing, and a sustainable economy, as well as the health, social, cultural, historic,
and environment fabric of communities affected by an incident.
Public Health Capabilities
In 2011, the Centers for Disease Control and Prevention (CDC)
developed 15 public health-specific capabilities as part of the Public
Health Emergency Preparedness program. 3 CDC updated these
capabilities in 2018 to address emerging technologies and threats. 4 As
shown in figure 8 below, CDC’s capability standards are organized into
six domains and two tiers. According to CDC, Tier 1 capability standards
are intended to form the foundation for public health emergency
preparedness and response, while Tier 2 capability standards are cross-
cutting, and reliant on the establishment of Tier 1 capability standards in
collaboration with external partners and stakeholders.
3The Public Health Emergency Preparedness program provides funds to build and sustain
public health preparedness and response capacity.
4U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, Public Health Emergency Preparedness and Response Capabilities: National
Standards for State, Local, Tribal, and Territorial Health (Atlanta, GA: October 2018).
Page 64 GAO-21-513 Biodefense
Appendix II: National Preparedness Goal and
Public Health Capabilities
Figure 8: Public Health Emergency Preparedness and Response Capabilities
Note: According to the Centers for Disease Control and Prevention, Tier 1 capability standards are
intended to form the foundation for public health emergency preparedness and response, while Tier 2
capability standards are cross-cutting, and reliant on the establishment of Tier 1 capability standards
in collaboration with external partners and stakeholders.
Page 65 GAO-21-513 Biodefense
Appendix III: Comments from the
Appendix III: Comments from the Department
of Homeland Security
Department of Homeland Security
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Appendix III: Comments from the Department
of Homeland Security
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Appendix III: Comments from the Department
of Homeland Security
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Appendix III: Comments from the Department
of Homeland Security
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Appendix IV: Comments from the
Appendix IV: Comments from the Department
of Defense
Department of Defense
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Appendix IV: Comments from the Department
of Defense
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Appendix IV: Comments from the Department
of Defense
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Appendix V: Comments from the Department
Appendix V: Comments from the Department
of Health and Human Services
of Health and Human Services
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Appendix V: Comments from the Department
of Health and Human Services
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Appendix V: Comments from the Department
of Health and Human Services
Page 75 GAO-21-513 Biodefense
Appendix V: Comments from the Department
of Health and Human Services
Page 76 GAO-21-513 Biodefense
Appendix VI: GAO Contact and Staff
Appendix VI: GAO Contact and Staff
Acknowledgments
Acknowledgments
Chris P. Currie at (404) 679-1875 or CurrieC@gao.gov
GAO Contact
In additional to the contact named above, Kathryn Godfrey (Assistant
Staff Director), Sarah Turpin (Analyst-in-Charge), Nasreen Badat, Benjamin
Acknowledgments Crossley, Danielle Curet, David Dornisch, Tracey King, Susanna Kuebler,
and Andrew Stavisky made key contributions to this report.
(104292)
Page 77 GAO-21-513 Biodefense
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