NATIONALBIODEFENSE 

STRATEGY

2018
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THE NATIONAL BIODEFENSE STRATEGY

O N A L S T R A T E G Y T O C O M B A T T E R R O R I S T T R A V E L

i

FOREWORD

It is a vital interest of the United States to manage the risk of biological incidents. 

In today’s interconnected world, biological incidents have the potential to cost 

thousands of American lives, cause significant anxiety, and greatly impact travel 

and trade.

Biological threats—whether naturally occurring, 

accidental, or deliberate in origin—are among the 

most serious threats facing the United States and 

the international community. Outbreaks of 

disease can cause catastrophic harm to the United 

States. They can cause death, sicken, and disable 

on a massive scale, and they can also inflict 

psychological trauma and economic and social 

disruption. Natural or accidental outbreaks, as 

well as deliberate attacks, can originate in one 

country and spread to many others, with 

potentially far-reaching international 

consequences. Advances in science promise 

better and faster cures, economic advances, a 

cleaner environment, and improved quality of life, 

but they also bring new security risks. In this 

rapidly changing landscape, the United States 

must be prepared to manage the risks posed by 

natural outbreaks of disease, accidents with high 

consequence pathogens, or adversaries who wish 

to do harm with biological agents. 

Health security means taking care of the 

American people in the face of biological threats 

to our homeland and to our interests abroad. The 

significant infectious disease outbreaks of recent 

decades, including Severe Acute Respiratory 

Syndrome (SARS), pandemic influenza, Ebola 

virus disease, and Zika virus disease, have 

revealed the extent to which individual countries 

and international communities need to improve 

their preparedness and biosurveillance systems to 

detect and respond to the next health crisis. The 

health of the American people depends on our 

ability to stem infectious disease outbreaks at 

their source, wherever and however they occur. 

America’s biodefense enterprise needs to be 

nimble enough to address emerging infectious 

disease threats, the risks associated with the 

accelerating pace of biotechnology, and threats 

posed by terrorist groups or adversaries seeking to 

use biological weapons. 

The National Biodefense Strategy is aligned with 

the 2018 National Security Strategy of the United 

States. Pillar One of the 2018 National Security 

Strategy explicitly calls for protecting “the 

American people, the homeland, and the 

American way of life.” One component of this 

goal is achieved by detecting and containing 

biothreats at their source, supporting and 

promoting the responsible conduct of biomedical 

innovation, and improving emergency response. 

Pillar Two calls for “promot[ing] American 

prosperity,” which increasingly will depend on a 

vibrant life sciences and biotechnology enterprise. 

This National Biodefense Strategy highlights the 

President’s commitment to protect the American 

people and our way of life, laying out a clear 

pathway and set of objectives to effectively 

counter threats from naturally occurring, 

accidental, and deliberate biological events. It is 

broader than a Federal Government strategy. It is 

a call to action for state, local, territorial, and 

tribal (SLTT) entities, other governments, 

practitioners, physicians, scientists, educators, 

and industry.
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TABLE OF CONTENTS

FOREWORD ....................................................................................................................................... i

VISION.............................................................................................................................................. 1

PURPOSE........................................................................................................................................... 1

THREATS AND CONSEQUENCES....................................................................................................... 2

BIOLOGICAL RISK MANAGEMENT.................................................................................................. 2

ASSUMPTIONS .................................................................................................................................. 3

GOVERNANCE .................................................................................................................................. 4

GOALS AND OBJECTIVES................................................................................................................. 6

CONCLUSION.................................................................................................................................... 8

ANNEX I: NATIONAL BIODEFENSE STRATEGY IMPLEMENTATION PLAN ..................................... 9

ANNEX II: DEFINITIONS................................................................................................................ 28

ANNEX III: SCOPE, STATUTORY REQUIREMENTS, AND AGENCIES............................................. 29
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THE NATIONAL BIODEFENSE STRATEGY

O N A L S T R A T E G Y T O C O M B A T T E R R O R I S T T R A V E L

1

VISION

The United States actively and effectively prevents, prepares for, responds to, 

recovers from, and mitigates risk from natural, accidental, or deliberate biological 

threats.

PURPOSE

This National Biodefense Strategy brings together and puts in place for the first 

time, a single coordinated effort to orchestrate the full range of activity that is carried 

out across the United States Government to protect the American people from 

biological threats. With National Security Presidential Memorandum (NSPM)-14,

this strategy explains how the United States Government will manage its activities 

more effectively to assess, prevent, detect, prepare for, respond to, and recover from 

biological threats, coordinating its biodefense efforts with those of international 

partners, industry, academia, non-governmental entities, and the private sector. 

The mission of the Federal Government during a 

biological incident is to save lives, reduce human 

suffering, protect property and the environment, 

control the spread of disease, and support 

community efforts to overcome the physical, 

emotional, environmental, and economic impacts. 

This federal mission is contingent upon the 

coordination with and the success of the 

community response. This strategy describes the 

goals and objectives that will guide the United 

States in assessing, preventing, detecting, 

preparing for, responding to, and recovering from 

a biological incident, consistent with its 

international obligations, including those 

identified in the World Health Organization’s 

International Health Regulations (2005).

Enhancing the national biodefense enterprise will 

help protect the United States and its partners 

abroad from biological incidents, whether 

deliberate, naturally occurring, or accidental in 

origin. It will simultaneously build the U.S. 

innovation base for cutting edge medical 

countermeasures (MCMs), biosensors and 

diagnostics, and biosurveillance information 

technologies, and advance the biomedical 

industry.
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THREATS AND CONSEQUENCES

Naturally Occurring Biological Threats. Infectious disease threats do not respect borders. 

Urbanization, habitat encroachment, and increased and faster travel, coupled with weak health systems, 

increase the ability of infectious diseases to spread rapidly across the globe. Antimicrobial resistance, novel 

infectious diseases, and the resurgence and spread of once geographically limited infectious diseases can 

overwhelm response capacities and make outbreaks harder to control. An infectious disease outbreak—even 

in the most remote places of the world—could spread rapidly across oceans and continents, directly impacting 

the U.S. population and its health, security, and prosperity. 

Deliberate and Accidental Biological Threats. The use of biological weapons or their 

proliferation by state or non-state actors presents a significant challenge to our national security, our 

population, our agriculture, and the environment. Multiple nations have pursued clandestine biological 

weapons programs and a number of terrorist groups have sought to acquire biological weapons. In many 

countries around the world, pathogens are stored in laboratories that lack appropriate biosecurity measures 

where they could be diverted by actors who wish to do harm. Similarly, some laboratories do not have 

appropriate biocontainment or biosafety protocols, which could lead to an outbreak through a laboratory 

acquired infection or if a pathogen is accidentally released into the environment. Biological material is 

ubiquitous and can self-propagate; pathogens are found all over the world—in the environment, animal 

reservoirs, humans, and laboratories. A natural outbreak can lead quickly to not only a public health crisis, 

but also a biosecurity vulnerability due to the thousands of clinical samples that are generated during an 

epidemic, which, if handled without appropriate biosecurity measures, could facilitate the development of a 

biological weapon.

BIOLOGICAL RISK MANAGEMENT

Biological risk management requires understanding and assessing biological risks, 

and taking steps to prepare for, prevent, and respond to them, regardless of whether 

they originate in the United States or abroad. It also requires shared international 

recognition that the risk is global to empower effective, collective mitigation. In 

our interconnected world, it is not if, but when, the next biological incident will 

occur. 

As the biological threat continues to evolve, so 

must our biodefense capabilities. If all countries 

could prevent, detect, and respond to infectious 

disease outbreaks at the local level, we can 

minimize the risk of global health emergencies, 

saving both lives and resources. Preventing 

acquisition of dangerous pathogens, equipment, 

and expertise for nefarious purposes, and 

maintaining the capability to rapidly control 

outbreaks in the event of a biological attack, are 

strategic interests of the United States. These 

must be strategic interests for partners around the 

world as well. The United States cannot carry the 

burden alone. Finally, as we reap the benefits 

from biotechnologies, we must also understand 

and consider the risks they may pose. The United 

States will pursue an efficient and coordinated 

biodefense enterprise to protect the American 

people. 

Domestic action alone is insufficient to protect 

America’s health and security. The rapid 

globalization of science and technology and the 

interconnectedness of travel and trade necessitate 
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a strong biodefense enterprise that has global 

reach to effectively prevent, detect, and respond 

to biological incidents. The United States 

Government works at home and abroad to ensure 

that the United States and its partners are 

protected from natural, accidental, or deliberate 

biological threats. While the desired outcomes at 

home and abroad are the same, the conditions and 

avenues available to achieve these outcomes can 

be very different. Internationally, our efforts to 

protect the United States and our partners include 

direct investment in sustainable, contextappropriate capacity building that leads to selfreliance. We will work with multilateral 

organizations, partner nations, private donors, and 

civil society to control disease outbreaks at their 

source by supporting the development and 

implementation of biodefense and health security 

capabilities, policies, and standards.

The United States has long been an innovation 

leader. Whether augmenting our ability to 

provide health care and protect the environment, 

or expanding our capacity for energy and 

agricultural production towards global 

sustainability, continued research and 

development in life sciences is essential for a 

brighter future for the American people. To 

ensure that the United States is poised to meet the 

evolving biological risk landscape, at a time when 

unparalleled advancement and innovation in the 

life sciences globally continue to transform our 

way of life, we are committed to promoting 

innovation throughout the national biodefense 

enterprise. We will promote innovative 

technologies and systems; encourage innovative 

technology communities and industry leaders to 

meet our targeted biodefense and health capacity 

needs; link stakeholders with new ideas, tools, 

and products; and pursue innovative approaches 

and partnerships to achieve, at home and abroad, 

the desired goals articulated in this National 

Biodefense Strategy. 

Through the National Biodefense Strategy, the 

United States will use all appropriate means to 

assess, understand, prevent, prepare for, respond 

to, and recover from biological incidents—

whatever their origin—that threaten national or 

economic security. The National Biodefense 

Strategy recognizes that a collaborative, multisectoral, and trans-disciplinary approach to the 

national biodefense enterprise is necessary to 

counter biological threats effectively and 

efficiently.

ASSUMPTIONS

The evolving biological threat landscape requires a comprehensive approach, and 

the United States recognizes the following principles: 

 

 Biological Threats are Persistent. Pathogens have emerged and spread throughout history, and 

as new naturally occurring threats develop, the risk from them grows more acute as the world becomes 

more urbanized, travel increases, and habitats change. Separately, nation-states and terrorist groups have 

found value in pursuing biological weapons, and there can be no confidence that will change in the 

future. Advances in the life sciences will both reduce the technological hurdles to such weapons and 

expand the number of individuals with relevant skills to effectuate threats. 

 Biological Threats Originate from Multiple Sources. The United States will include, 

within the scope of biodefense, not just countering deliberate biological threats, but also the threats that 

stem from naturally occurring and accidental outbreaks. This approach will allow the United States 

Government to fully utilize, integrate, and coordinate the biodefense enterprise and ensure the most 

efficient use of all biodefense assets. 
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 Infectious Diseases Do Not Respect Borders. An interconnected world increases the 

opportunity for pathogens to emerge and spread so that a disease threat anywhere is a disease threat 

everywhere. Infectious diseases travel without visas and cross borders indiscriminately; infected 

travelers may not manifest any symptoms. The United States Government will mitigate biological 

incidents both here in the United States and work with partners abroad because the United States cannot 

counter biological threats nationally without addressing them internationally. We will also seek to 

improve our ability to prevent the spread of infectious diseases to the United States through inbound 

travelers and goods. The Ebola outbreaks of 2014 and 2018 demonstrated that the United States 

Government must be prepared to act swiftly, and unilaterally if necessary, to respond to public health 

emergencies abroad if multilateral institutions and partners are not prepared to do so. 

 Multi-sectoral Cooperation is Critical for Prevention and Response. This strategy 

calls for engagement and cooperation across all levels of government, to include SLTT governments, as 

well as internationally. It involves partnership with multiple sectors, including the medical; public, 

animal, and plant health; emergency response; scientific and technical; law enforcement; industrial; 

academic; diplomatic; defense and security; intelligence; and nonproliferation and counterproliferation 

sectors, among others. Engagement with non-governmental organizations (NGOs) and the private sector 

is critical to prevent the spread of disease and respond to the next outbreak before it becomes an 

epidemic. 

 A Multidisciplinary Approach Will Help Prevent Disease Emergence. The health of 

people, animals, plants, and the environment are linked, and diseases affecting one component can soon 

affect others. At least 75 percent of infectious disease threats to human health are of animal origin. 

Threats to animals and plants can cause economic disruption and physical harm to health and wellbeing. A coordinated, multidisciplinary approach, representing the collaborative efforts across local, 

national, and global jurisdictions, is a best practice for understanding, communicating, and mitigating 

biological threats swiftly and efficiently. Such an approach is necessary to prevent and detect early interspecies cross-over of infectious diseases.

 Science and Technology Will Continue to Advance Globally. The ongoing revolution 

in the life sciences and biotechnology will continue at an ever-increasing rate, offering solutions to many 

of the challenges of ensuring the health, prosperity, and security of a growing global population. These 

technologies, no longer confined to sophisticated research laboratories, are being developed and utilized 

all over the world and the necessary expertise, materials, and equipment are available widely. Advances 

in science and technology bring revolutionary cures and progress, but they also have the potential to 

facilitate intentional misuse. The United States has a responsibility to ensure our technology, 

development, and assistance programs do not exacerbate this risk unintentionally.

GOVERNANCE

The NSPM that accompanies the issuance of this National Biodefense Strategy

creates a dedicated mechanism, housed within the U.S. Department of Health and 

Human Services, to coordinate federal biodefense activities and assess the 

effectiveness with which the National Biodefense Strategy’s goals and objectives 

are being met. Led by the President of the United States and coordinated by the 

National Security Council staff in the Executive Office of the President, with day-
5

to-day coordination and execution by the Secretary of Health and Human Services, 

this mechanism will continually assess how effectively the objectives of the 

National Biodefense Strategy are being met. 

The Assistant to the President for National 

Security Affairs will, in acting through the 

process described in NSPM-4, Organization of 

the National Security Council, the Homeland 

Security Council, and Subcommittees, serve as the 

lead for policy coordination and review, 

providing strategic input and policy oversight for 

federal biodefense efforts. 

The Biodefense Steering Committee, chaired by 

the Secretary of Health and Human Services, and 

comprising the Secretary of State, the Secretary of 

Defense, the Attorney General, the Secretary of 

Agriculture, the Secretary of Veterans Affairs, the 

Secretary of Homeland Security, and the 

Administrator of the Environmental Protection 

Agency, will be responsible for overseeing and 

coordinating the execution of the strategy and its 

implementation plan, and ensuring federal 

coordination with domestic and international 

government and non-governmental partners. The 

Chair of the Biodefense Steering Committee, the 

Secretary of Health and Human Services, will 

serve as the federal lead for implementation of the 

strategy. The heads of other agencies with 

responsibilities or capabilities pertaining to 

biodefense shall participate in the Biodefense 

Steering Committee, as appropriate. This 

coordination and oversight mechanism also has a 

mandate to reach beyond the Federal Government 

to engage with SLTT, non-federal, and nongovernmental stakeholders. Further, the 

recommendations and feedback stemming from 

this governance mechanism will be 

communicated back to departments and agencies 

in synchronization with the annual budget cycle. 

Recognizing that threats, actors, and biodefenserelated science and technology are constantly 

evolving, the governance mechanisms will be 

adaptive, reviewing and recommending changes, 

as appropriate, in the National Biodefense 

Strategy and its implementation plan.
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GOALS AND OBJECTIVES

The National Biodefense Strategy has five goals with associated objectives for 

strengthening the biodefense enterprise, establishing a layered risk management 

approach to countering biological threats and incidents.

GOAL 1: ENABLE RISK AWARENESS TO INFORM DECISION-MAKING ACROSS THE BIODEFENSE ENTERPRISE. 

The United States will build risk awareness at the strategic level, through analyses and research efforts 

to characterize deliberate, accidental, and natural biological risks; and at the operational level, through 

surveillance and detection activities to detect and identify biological threats and anticipate biological 

incidents.

OBJECTIVES:

1.1: Ensure decision-making is informed by 

intelligence, forecasting, and risk assessment.

1.2: Ensure that domestic and international 

biosurveillance and information-sharing systems are 

coordinated and are capable of timely bioincident 

prevention, detection, assessment, response, and 

recovery.

GOAL 2: ENSURE BIODEFENSE ENTERPRISE CAPABILITIES TO PREVENT BIOINCIDENTS. The United States will 

work to prevent the outbreak and spread of naturally occurring disease, and minimize the chances of 

laboratory accidents. The United States will also strengthen biosecurity to prevent hostile actors from 

obtaining or using biological material, equipment, and expertise for nefarious purposes, consistent with the 

United States Govermenent’s approach to countering weapons of mass destruction (WMD) terrorism. Goal 

2 will ensure we have the capabilities necessary to disrupt plots, degrade technical capabilities, and deter 

support for terrorists seeking to use WMD. This goal also recognizes the "dual use" natures of the life 

sciences and biotechnology, in which the same science and technology base that improves health, promotes 

innovation, and protects the environment, can also be misused to facilitate a biological attack. The United 

States seeks to prevent the misuse of science and technology while promoting and enhancing legitimate use 

and innovation.

OBJECTIVES: 

2.1: Promote measures to prevent or reduce the spread of 

naturally occurring infectious diseases.

2.3: Deter, detect, degrade, disrupt, deny, or otherwise 

prevent nation-state and non-state actors’ attempts to 

pursue, acquire, or use biological weapons, related 

materials, or their means of delivery.

2.2: Strengthen global health security capacities to 

prevent local bioincidents from becoming epidemics.

2.4: Strengthen biosafety and biosecurity practices and 

oversight to mitigate risks of bioincidents.
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GOAL 3: ENSURE BIODEFENSE ENTERPRISE PREPAREDNESS TO REDUCE THE IMPACTS OF BIOINCIDENTS. The 

United States will take measures to reduce the impacts of bioincidents, including maintaining a vibrant 

national science and technology base to support biodefense; ensuring a strong public health infrastructure; 

developing, updating, and exercising response capabilities; establishing risk communications; developing 

and effectively distributing and dispensing medical countermeasures; and preparing to collaborate across the 

country and internationally to support biodefense.

OBJECTIVES: 

3.1: Ensure a vibrant and innovative national science and 

technology base to support biodefense.

3.6: Enhance preparedness to limit the spread of disease 

through Community Mitigation Measures (CMMs).

3.2: Ensure a strong public and veterinary health 

infrastructure.

3.7: Enhance preparedness to support decontamination.

3.3: Develop, exercise, and update prevention, response, 

and recovery plans and capabilities.

3.8: Strengthen preparedness to operate and collaborate 

across the United States, including the U.S. territories.

3.4: Develop, exercise, and update risk communication 

plans and promote consistent messaging to inform key 

audiences, expedite desired response actions, and address 

public uncertainty and fear.

3.9: Strengthen international preparedness to support 

international response and recovery capabilities.

3.5: Enhance preparedness to save lives through MCMs.

GOAL 4: RAPIDLY RESPOND TO LIMIT THE IMPACTS OF BIOINCIDENTS. The United States will respond rapidly 

to limit the impacts of bioincidents through information-sharing and networking; coordinated response 

operations and investigations; and effective public messaging.

OBJECTIVES:

4.1: Compile and share biothreat and bioincident 

information to enable appropriate decision-making and 

response operations across all levels of government and 

with non-governmental, private sector, and international 

entities, as appropriate.

4.3: Conduct operations and investigations, and use all 

available tools to hold perpetrators accountable.

4.2: Conduct federal response operations and activities in 

coordination with relevant non-federal actors to contain, 

control, and rapidly mitigate impacts of biothreats or 

bioincidents.

4.4: Execute risk-informed, accurate, timely, and 

actionable public messaging.

GOAL 5: FACILITATE RECOVERY TO RESTORE THE COMMUNITY, THE ECONOMY, AND THE ENVIRONMENT AFTER A 

BIOINCIDENT. The United States will take actions to restore critical infrastructure services and capability; 

coordinate recovery activities; provide recovery support and long-term mitigation; and minimize cascading 

effects elsewhere in the world.

OBJECTIVES: 

5.1: Promote restoration of critical infrastructure 

capability and capacity to enable the resumption of vital 

U.S. activities.

5.3: Provide recovery support and conduct long-term 

mitigation actions to promote resilience.

5.2: Ensure coordination of recovery activities across 

federal and SLTT governments and, as appropriate, 

international, non-governmental, and private sector 

partners to enable effective and efficient recovery 

operations.

5.4: Reduce the cascading effects of international 

biological incidents on the global economy, health, and 

security.
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CONCLUSION

The risks from biological threats cannot be reduced to zero – but they can and must 

be managed. Wide-ranging threats require a comprehensive approach to 

minimizing the risks. Through this National Biodefense Strategy, the United States 

Government will optimize its own efforts, and harness the work of essential 

partners—inside government and outside, domestically and internationally—to 

understand, prevent, prepare for, respond to, and recover from the full range of 

biological threats that can harm the American people and our partners.
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ANNEX I

NATIONAL BIODEFENSE STRATEGY IMPLEMENTATION PLAN

GOAL 1:

ENABLE RISK AWARENESS TO INFORM DECISION-MAKING ACROSS THE 

BIODEFENSE ENTERPRISE.

1.1 Ensure decision-making is informed by intelligence, forecasting, and risk 

assessment.

1.1.1 Enhance Intelligence and Analysis Activities.

 Provide timely intelligence analysis and information that identifies and assesses current and 

future biological threats posed by nation-state and non-state actors.

 Provide strategic warning for, and assess the potential impacts of, diseases with the potential 

to affect U.S. national security or interests abroad, including assessments of the potential 

cascading effects (e.g., economic, societal, and governmental impacts).

 Incorporate forecasting and modeling into intelligence products and processes, as 

appropriate.

 Routinely evaluate developments and advances in the life sciences, biotechnology, and 

related fields to identify emerging hazards and mitigation options.

1.1.2 Conduct Research and Modeling Activities.

 Conduct research to characterize biological hazards, production methods, and dissemination 

methods that could be used in deliberate threats, when:

o The results of that research are critical to informing risk assessments and plans to prevent 

or respond to deliberate bioincidents; and

o The responsible department or agency utilizes a process to ensure that the research 

complies with treaties, laws, and policies and follows applicable nationally recognized 

guidance for best practices.

 Improve the ability to model and forecast the likelihood and impact of bioincidents, including 

accidental releases.

1.1.3 Assess Risks and Capabilities.

 Conduct periodic national bioincident risk assessments to evaluate the risks, including 

relative risks, of deliberate, accidental, and naturally occurring bioincidents.

 Assess the security risks posed by the deliberate misuse of biotechnologies and life sciences 

research and training with dual-use potential.

 Assess the risks posed by research, such as with potential pandemic pathogens, where

biosafety lapses could have very high consequences.

 Provide all levels of government with a common basis for understanding biological risks to 

support operational planning and preparedness actions.

 Develop risk-informed planning scenarios to facilitate capability and capacity assessments 

and identify gaps.
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 Assess the potential impacts of bioincidents on critical infrastructure and supply chains, and 

how disruption of these systems might affect the ability to respond to bioincidents.

1.2 Ensure that domestic and international biosurveillance and informationsharing systems are coordinated and are capable of timely bioincident 

prevention, detection, assessment, response, and recovery.

1.2.1 Enhance the Integration and Evaluation of Biosurveillance Systems.

 Improve development, interoperability, integration, and evaluation processes for domestic 

biosurveillance systems, including opportunities to better-leverage multi-sectoral 

information.

1.2.2 Improve Information-sharing and Reporting.

 Using a multi-sectoral approach, promote timely sharing of biosurveillance information 

among federal and SLTT biosurveillance programs and other federal programs designed to 

investigate biothreats and bioincidents.

 Coordinate and exchange relevant information between environmental biological detection 

systems and biosurveillance networks.

 Strengthen foreign governments’ and international bodies’ capability and commitment to 

identify, characterize, and report biothreats and bioincidents rapidly and transparently.

 Integrate international disease reporting data with domestic biosurveillance systems to enable 

early action that limits potential impact.

 Create biosurveillance and situational awareness reports tailored to inform decision-makers, 

the public, partner nations, and other audiences routinely and during a bioincident response.

 Ensure that the Federal Government, SLTT governments, partner nations, and the private 

sector have appropriate access to relevant information and analysis.

 As appropriate, ensure rapid downgrade of classified or otherwise sensitive intelligence 

information and write intelligence products for release, as appropriate, to enable sharing with 

those who need to act on it. 

1.2.3 Develop and Deploy Enhanced Biosurveillance and Bioincident Characterization Capabilities.

 Maintain and enhance public health, medical, animal, and plant surveillance systems for 

disease outbreaks that pose a risk to national security.

 Promote the sustainable development, maintenance, and improvement of SLTT, private 

sector, federal, regional, and international (United States Government and other national) 

surveillance systems and networks with reliable access to trained workforces and essential 

infrastructure for human, animal, and plant diseases.

 Identify and incorporate new technologies, data sources, analytic methods, and partnerships 

that include public, private sector, and non-traditional sources of data.

 Maintain and enhance biosurveillance capabilities for the identification of emerging 

biothreats, and monitor and assess short- and long-term post-bioincident health effects using 

traditional and non-traditional methods.

 Enhance capability to characterize bioincidents rapidly with respect to biohazards involved, 

populations and areas affected, and consequences (e.g., health, economic, societal, and 

environmental).

1.2.4 Develop and Deploy Enhanced Environmental Detection Systems, as Appropriate.

 Monitor and evaluate the capability and effectiveness of systems for the environmental 

identification and detection of human, animal, and plant biohazards, and disease vectors.
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 Develop improved environmental identification and detection systems, ensuring that they:

o Are aligned with assessments of evolving and emerging biothreats; and

o Can provide information that is timely, accurate, and relevant for response decisions.

 Assess options to ensure the effectiveness of environmental biodetection systems deployed 

by governmental or non-governmental entities.

1.2.5 Enhance Biosurveillance Laboratory Operations.

 Promote the sustainable development, maintenance, and improvement of SLTT, private 

sector, federal, regional, and international (United States Government and partner nation) 

laboratory networks, with reliable access to trained workforces and essential infrastructure, 

for human, animal, and plant diseases.

 Promote interoperability of laboratory reporting systems at all levels of government.

 Strengthen capabilities and address appropriate needs for sharing—under both routine and 

crisis conditions—timely information (e.g., data and results), samples, and reagents among 

sectors including research; human, animal, and plant health; emergency services; and law 

enforcement. 

 Address impediments to the timely sharing of information, samples, and reagents among 

countries and international organizations under both routine and crisis conditions.
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GOAL 2:

ENSURE BIODEFENSE ENTERPRISE CAPABILITIES TO PREVENT 

BIOINCIDENTS.

2.1 Promote measures to prevent or reduce the spread of naturally occurring 

infectious diseases.

2.1.1 Strengthen Infection Prevention Measures Domestically and Internationally.

 Using a multidisciplinary approach, strengthen medical, public health, animal health, and 

plant health capacities to improve infection prevention and control.

 Strengthen vaccination and other health intervention activities.

2.1.2 Reduce the Emergence and Spread of Antimicrobial-resistant Pathogens Domestically and 

Internationally.

 Strengthen awareness of drug-resistant pathogens and their associated diseases, and improve 

stewardship of medically important drugs.

 Strengthen understanding of the drivers of drug resistance and improve the development and 

adoption of effective mitigation measures.

 Promote the use of preventive and therapeutic options other than antimicrobial drugs.

 Accelerate basic and applied research and development of new antimicrobials, novel 

preventatives and therapeutics, vaccines, and diagnostic tests.

2.1.3 Strengthen Multidisciplinary Efforts to Control Vector-borne Disease Domestically and 

Internationally.

 Identify the risk of the vectors transmitting disease to humans, animals, and plants.

 Develop and disseminate, as appropriate, measures that will safely limit the exposure of 

humans, animals, and plants to disease vectors and the ability of vectors to transmit disease 

to humans and animals.

 Address resistance of vectors to vector control or mitigation measures.

2.1.4 Limit Trans-border Introductions and Domestic Spread of Biohazards, Including Those 

Responsible for Food-borne Illness.

 Identify, locate, and destroy or contain contaminated/infected plant, animal, and food prior 

to entry into the United States, and within the United States, that:

o Contain biohazards that could give rise to bioincidents, including food-borne illness; or 

o Harbor economically and environmentally significant pests.

 Improve capabilities and protocols for screening, isolation, and quarantine of humans, plants, 

and animals to reduce disease spread.

 Develop programs and policies to encourage plant and animal producers to report suspected 

or actual biohazards and encourage full compliance with response guidance to limit the 

spread of plant or animal diseases and reduce their impact on the overall industry.

2.1.5 Strengthen Animal Disease Detection and Prevention Capacity.

 Strengthen capacity to detect and prevent the spread of animal and zoonotic diseases.

 Support the development and deployment of diagnostics and countermeasures for use in 

animals as well as the development of disease-resistant animals.
13

 Strengthen international partnerships regarding awareness, detection and control, and 

eradication of animal diseases before they reach the United States.

2.1.6 Strengthen Plant Disease Prevention Capacity.

 Strengthen the capacity to prevent establishment and spread of plant pests.

 Support the development and deployment of new disease-resistant crops.

 Strengthen international partnerships regarding detection and management of plant diseases 

before they reach the United States.

2.1.7 Strengthen the Resilience of the Water Sector to Prevent or Contain Water-borne Disease 

Outbreaks.

 Identify water system vulnerabilities that increase the risk of drinking water contamination, 

and promote the development of engineering controls and best practices to reduce the risk.

 Develop plans and procedures to reduce the spread of contaminants in a compromised water 

system and reduce public exposure to contaminated water.

 Improve the ability to detect biohazardous agents in source and finished drinking water.

2.2 Strengthen global health security capacities to prevent local bioincidents 

from becoming epidemics.

2.2.1 Promote Global Health Security.

 Promote the development and implementation of national legal frameworks adequate to 

support and enable the implementation of the World Health Organization’s International 

Health Regulations (2005) and the World Organisation for Animal Health reporting 

requirements. 

 Promote transparent, independent, and objective assessments of country capacity to prevent, 

detect, and respond to bioincidents. 

 Strengthen timely surveillance and monitoring for core syndromes and confirmed reportable 

infections as outlined by international bodies to ensure quick identification and reporting of 

bioincidents. 

2.2.2 Strengthen Country Capacity to Prevent, Detect, and Respond to Bioincidents.

 Promote a prepared public health and animal health workforce appropriate for the population. 

 Strengthen capacity and promote policies and best practices to minimize transmission of 

disease between humans and animals.

 Promote incident management systems capable of activating an emergency operations system 

in response to public health emergencies. 

 Promote the development of a system for specimen referral and effective diagnostics to 

ensure timely testing of biological specimens, and work to remove barriers to the sharing of 

samples among countries and international organizations. 

 Promote national laboratory systems capable of timely receipt and testing of biological 

specimens from all jurisdictions in a country.

2.3 Deter, detect, degrade, disrupt, deny, or otherwise prevent nation-state 

and non-state actors’ attempts to pursue, acquire, or use biological 

weapons, related materials, or their means of delivery.
14

2.3.1 Deter Nation-state and Non-state Actors.

 Ensure accountability by increasing and communicating the political, economic, and other 

consequences for actors that develop, acquire, produce, or use biological weapons, or assist 

in such efforts.

 Ensure domestic and international capabilities to identify, investigate, and attribute 

development or use of biological weapons in order to hold accountable those who are 

responsible.

 Demonstrate reduced vulnerability through enhanced U.S. and partner-nation capacity to 

prevent, respond to, and recover from bioincidents.

 Reinforce the obligations in the Convention on the Prohibition of the Development, 

Production, and Stockpiling of Bacteriological and Toxin Weapons and on their Destruction 

(BWC) (1975) and United Nations (U.N.) Security Council Resolution 1540, as well as other 

standards and norms against nation-state or non-state development, acquisition, or use of 

biological weapons, related materials, or means of delivery.

2.3.2 Detect, Degrade, or Deny Acquisition, Development, or Transfer of Biological Weapons.

 Strengthen nations’ commitment and support their efforts to implement their obligations 

under the BWC and U.N. Security Council Resolution 1540 to establish and enforce 

appropriate and effective laws prohibiting and preventing the acquisition, development, or 

transfer of biological weapon-related materials, equipment, and means of delivery for 

purposes proscribed by these instruments.

 Strengthen domestic and international capabilities to identify, deny, and disrupt biological 

weapon-related transfers, and to identify and disrupt adversary proliferation networks.

 Deny the acquisition of pathogenic material, equipment, knowledge, or expertise for illicit 

purposes, and promote appropriate measures to impede misuse of life sciences and 

biotechnology, while facilitating legitimate use and innovation.

2.3.3 Prevent, Disrupt, Degrade, or Deny Use of Biological Weapons.

 Identify and locate threat actors and proliferation networks, and preempt or disrupt deliberate 

biothreats and bioincidents.

 Ensure robust capabilities to interdict, disable, destroy, render safe, and attribute 

responsibility for biological weapons and weapons-related equipment, material, means of 

delivery, and facilities.

 Strengthen the engagement of the law enforcement and security communities with other 

stakeholders to facilitate recognition and mitigation of situations involving deliberate 

biothreats and bioincidents.

2.3.4 Develop, Exercise, and Update Prevention and Disruption Plans and Capabilities.

 Ensure prevention and disruption capabilities and plans are developed, routinely exercised, 

evaluated, and updated, as appropriate.

2.4 Strengthen biosafety and biosecurity practices and oversight to mitigate 

risks of bioincidents.

2.4.1 Strengthen Biosafety and Biosecurity.

 Maintain and continuously improve biosafety, biosecurity, and oversight programs and 

practices for laboratories and other facilities, and for the end-to-end management of samples 

and specimens (e.g., collection, transport, inactivation, disposal, and waste management).
15

 Promote appropriate national and facility-specific biosafety, biosecurity (including 

cybersecurity), and oversight programs, policies, practices, and legislation in partner nations 

while facilitating legitimate research and innovation.

 Coordinate and conduct basic and applied biosafety and biosecurity research to provide an 

evidence base for improving safety and security practices.

 Encourage facilities working with biohazards to engage in pre-incident response planning, 

training, and exercises, including with local responders, to minimize impacts from accidental 

releases.

2.4.2 Support and Promote the Responsible Conduct of the Life Science and Biotechnology Enterprise.

 Support and promote a culture of global biosafety, biosecurity, ethical, and responsible 

conduct in the life sciences.

 Promote effective global oversight of:

o Dual-use research, to prevent misuse; and 

o Research for which biosafety lapses could have very high consequences, such as with 

potential pandemic pathogens.

 Encourage engagement among the health, scientific, biotechnology, enthusiast, and security 

communities in the United States, and with international partners, to reduce the risk of 

misuse.

 Promote the development and implementation of relevant national and international policies, 

guidance, training, and other resources across the health, scientific, biotechnology, 

enthusiast, and security communities to reduce the risk of misuse.
16

GOAL 3: 

ENSURE BIODEFENSE ENTERPRISE PREPAREDNESS TO REDUCE THE 

IMPACTS OF BIOINCIDENTS.

3.1 Ensure a vibrant and innovative national science and technology base to 

support biodefense.

3.1.1 Enable U.S.-led Innovation for Biodefense Through Robust Scientific, Technical, and Industrial 

Bases.

 Support investments and U.S. leadership in emerging technologies.

 Maintain laboratory capabilities required for biodefense preparedness and response, 

including:

o Assured United States Government access to laboratory infrastructure, including a 

trained workforce capable of supporting United States Government biodefense programs 

and decision-making; and

o A secure and dedicated United States Government laboratory capability for conducting 

forensic analysis of biological agents and traditional forensic examinations of 

contaminated evidence up to the highest biosafety levels. 

 Strengthen U.S. processes to prevent industrial espionage and other actions that would 

weaken the U.S. biodefense enterprise.

3.1.2 Integrate Research and Development (R&D) into Federal Planning.

 Identify and facilitate sharing of tools, practices, policies, and incentives across interagency 

response R&D efforts.

 Establish capabilities to conduct rapid-response, real-time R&D during bioincidents to 

inform ongoing response measures and to understand phenomena that only occur during 

bioincidents.

 Establish procedures for prioritizing, funding, and coordinating R&D efforts during 

bioincidents.

3.2 Ensure a strong public and veterinary health infrastructure.

3.2.1 Ensure Public and Veterinary Health Critical Capacities.

 Establish capability to provide surge staffing, resources, and supplies to SLTT public and 

veterinary health departments. 

 Advance and sustain a highly-skilled public and veterinary health workforce. 

3.2.2 Modernize Public and Veterinary Health Laboratories.

 Ensure core public and veterinary health laboratories have access to modern and updated

diagnostic tests, methods, equipment, and technologies.

3.3 Develop, exercise, and update prevention, response, and recovery plans 

and capabilities. 

3.3.1 Develop and Exercise Policies, Plans, Guidelines, and Recommendations to Support Prevention, 

Response, and Recovery Activities.

 Establish policies, plans, guidelines, and recommendations with multi-sectoral input (and 
17

international stakeholder input, as appropriate) to inform appropriate and timely federal and 

SLTT response actions to biothreats and bioincidents.

 Develop plans that implement or support surge capabilities across response sectors in 

coordination with SLTT entities, health care coalitions, foreign governments, international 

organizations, NGOs, and private sector partners, to include the following: 

o Medical surge response, including to augment specialized clinical care, behavioral and 

mental health care, transition to crisis standards of care, and provision of mass care and 

mass fatality management;

o Clinical guidance to assist with appropriate triage and medical management of illnesses; 

o Transport and reception system and capabilities for crossing borders and U.S. 

jurisdictions with highly infectious disease patients and materials related to incident 

response 

o Augmenting provision of human services, including shelters, housing, and commodity 

distribution;

o Implementing enhanced surveillance and public health measures for disease control;

o Clinical, environmental, food testing, and forensic surge laboratory operations; 

o Controlling, responding to, and recovering from animal and plant disease;

o Engineering response for managing water, land, waste, and air systems; and

o Routinely conducting and evaluating biothreat and bioincident response exercises for all 

incident management phases of the response at the federal and SLTT levels. 

3.3.2 Ensure that Emergency Funding Mechanisms Exist to Support Urgent Responses to Bioincidents.

 Establish, as appropriate, dedicated funding processes and mechanisms to respond to an 

actual or imminent bioincident. 

 Establish processes to access funds in a timely manner. 

3.3.3 Support the Effective Deployment of the MCM Stockpiles.

 Conduct pre-incident planning for distribution and dispensing of the MCM stockpiles to 

ensure such activities can be accomplished in a timely manner, are informed by appropriate 

guidance, and can be supported operationally by federal and SLTT agencies during a 

bioincident. 

 Ensure plans consider the provision of MCMs to personnel performing mission-essential 

functions to help ensure that mission-essential functions continue to be performed after a 

bioincident. 

 Ensure the safety, security (including cybersecurity), and reliability of supply chains to 

provide necessary MCMs and other materiel support during bioincidents.

 Ensure the capability to monitor the safety and effectiveness of deployed MCMs.

 Integrate the access and functional needs of at-risk individuals in planning for MCM 

distribution and dispensing. 

 Ensure that operational plans, clinical guidance, regulatory mechanisms, and operational 

capacity are in place to administer stockpiled MCMs effectively.

3.3.4 Support the Provision of Health Care and the Conduct of Clinical Research During Bioincidents.

 Establish procedures and guidelines for the use of MCMs, including personal protective 

equipment (PPE), and infection control strategies.

 Ensure plans address the needs of all populations, including at-risk individuals. 

 Establish and identify medical centers capable of providing specialized care, including at the 

initial stages of bioincidents. 

 Strengthen healthcare system preparedness to enhance hospital and health care facilities’ 

ability to maintain health care operations and provide necessary care during bioincidents.
18

 Identify existing mechanisms to protect health care workers from financial liability during 

federally-led responses. 

 Establish capabilities to conduct clinical research at the onset of a bioincident to inform 

optimal clinical care strategies for current and future bioincidents and to support MCM 

development. 

 Establish and pre-position protocols for the conduct of ethical, efficient, and interpretable 

clinical trials to test promising investigational MCMs during domestic or international 

bioincidents. 

 Establish mechanisms for the collection and sharing of clinical samples to support 

development of diagnostic tests.

 Establish a regional aid system that will improve national healthcare readiness and medical 

surge for bioincidents.

3.3.5 Support the Continuity of Operations.

 Further refine, exercise, and evaluate Continuity of Operations plans (including the 

mitigation of impacts on critical infrastructure located within and outside the United States) 

to ensure continuation of National Essential Functions during and after bioincidents. 

3.3.6 Support Provision of Essential Services and Long-term Recovery.

 Protect the continuity of critical infrastructure, and restore infrastructure and services 

disrupted by the bioincident.

 Restore critical infrastructure to minimize cascading effects.

 Provide an environment in which essential businesses can continue to operate.

 Support or restore transportation pathways and infrastructure to facilitate supply chains and 

movement of people.

 Facilitate movement/delivery of supplies critical to response and recovery.

3.4 Develop, exercise, and update risk communication plans and promote 

consistent messaging to inform key audiences, expedite desired response 

actions, and address public uncertainty and fear.

3.4.1 Improve Federal Messaging Coordination for Biothreats and Bioincidents.

 Develop a government-wide strategy that institutionalizes the use of risk communication 

principles to provide clear, consistent, and coordinated information. 

 Train spokespersons for federal departments and agencies on risk communications. 

 Clarify roles of lead agencies for risk communication messaging to key sectors (e.g., public 

health, medical, animal, plant, and the environment). 

3.4.2 Develop and Exercise Communications Plans.

 Develop and test messaging strategies, platforms, and materials for all sectors and 

stakeholders to synchronize messaging, address public fear and uncertainty, encourage 

appropriate response actions, and empower the public during biothreats and bioincidents.

 Develop messaging for non-English speaking populations and in formats that accommodate

the access and functional needs of all individuals.

 Establish a national “brand” where stakeholders may routinely seek information on 

biodefense activities and response actions. 

 Routinely exercise communication strategies during pre-incident planning to prepare for realtime biothreat and bioincident response communications. 
19

3.4.3 Enhance Messaging Partnerships.

 Identify a cadre of academic and private sector experts who would be encouraged to interact 

with traditional and social media and provide accurate information on biothreats and 

bioincidents.

 Strengthen pre-incident relationships between government communication specialists and the 

media who specialize in bioincidents and related topics.

 Strengthen pre-incident relationships with private sector social media and other nontraditional media partners capable of broadly disseminating information.

3.5 Enhance preparedness to save lives through MCMs. 

3.5.1 Improve Diagnostic Capabilities.

 Advance diagnostic capabilities, including for plants and animal diseases, to enable timely 

and accurate biohazard and disease detection. 

 Maintain a core capability to develop, produce, and refine diagnostic tests rapidly to meet 

outbreak response needs. 

 Develop instructions for public health and medical stakeholders regarding the use of Food 

and Drug Administration (FDA)-authorized or -cleared diagnostic tests, if available. 

 Enhance capability to rapidly characterize bioincidents to help inform ongoing or future 

response to biothreats and bioincidents. 

 Establish standardized Material Transfer Agreements for sample sharing.

3.5.2 Enhance MCM Development, Sustainment, and Availability.

 Use risk and intelligence assessments, epidemiologic analysis, and anticipated operational 

capacities to inform the life cycle of research, development, evaluation, manufacturing, 

acquisition, stockpiling, and sustainment of MCMs for humans and animals. 

 Support and strengthen mechanisms to comprehensively evaluate and make changes, as 

needed, across the portfolio of MCMs. 

 Prioritize the development and procurement of MCMs with the highest potential to reduce 

severe morbidity and mortality.

 Prioritize the development of modular platform and innovative technologies to support timely 

development, production, and availability of MCMs for bioincidents.

 Identify additional incentive mechanisms to engage MCM developers and stimulate private 

sector investment and innovation across the range of the MCM technology base. 

 Improve or develop affordable, flexible, and multi-functional PPE for responders, health 

professionals, and the general population.

 Establish manufacturing surge capacity for MCMs, including diagnostic tests and PPE.

3.6 Enhance preparedness to limit the spread of disease through CMMs.

3.6.1 Enhance Development of and Capabilities for Implementing CMMs.

 Develop and assess the effectiveness of CMMs to mitigate the impact of bioincidents.

 Establish and promote best practices for implementing CMMs during bioincidents.

3.7 Enhance preparedness to support decontamination.

3.7.1 Conduct Research and Develop Verified Technologies.

 Conduct research to understand the persistence and potential for secondary transmission of 

biological contaminants in a variety of environments and the ability of various disinfection 
20

technologies to inactivate or remove biological contaminants.

 Develop and verify technologies for all phases of environmental cleanup that address various 

types of infrastructure, equipment, and environments. 

 Develop readily available and scalable technologies and software tools to support water and 

wastewater infrastructure decontamination and the treatment of contaminated water. 

3.7.2 Develop and Exercise Decontamination Plans.

 Develop and verify plans for all phases of environmental cleanup for facilities, equipment, 

and the environment through drills and exercises that incorporate relevant partners and 

stakeholders. 

 Establish pre-incident decontamination and waste management recommendations for:

o Impacted community members, patients, and response personnel; 

o Contaminated drinking water; 

o Waste collection, handling, and packaging methods suitable for waste transport 

(including interstate transport), temporary storage, off-site treatment, and disposal;

o Handling and disposition of human remains; 

o Disposition of animal remains; and

o Environmental decontamination practices, as warranted.

3.8 Strengthen preparedness to operate and collaborate across the United 

States, including U.S. territories.

3.8.1 Establish Collaborative and Resource Sharing Policies and Operational Frameworks.

 Establish mechanisms to facilitate rapid deployment of federal and SLTT response personnel 

and response resources across jurisdictional boundaries. 

 Establish and augment mechanisms by which the Federal Government can use assistance 

from non-federal and foreign sources with medical products, qualified public health, medical, 

or other personnel, or other resources during a bioincident. 

 Establish protocols for timely sharing of samples, specimens, and related clinical information 

among federal departments and agencies and across public health, animal health, and 

environmental jurisdictions in the United States and U.S. territories. 

3.9 Strengthen international preparedness to support international response and 

recovery capabilities.

3.9.1 Strengthen Foreign Governments and International Organizations’ Commitment to, Preparedness 

for, and Capacity to Respond to Bioincidents.

 Promote global health security as a leadership priority and a national responsibility to 

accelerate bioincident detection, response, and recovery capacity-building. 

 Support health emergency response teams of qualified personnel to respond rapidly to 

international health emergencies. 

 Support workforce preparedness in emergency management principles, exercised on an 

Emergency Operation Center platform.

 Promote multi-sectoral and trans-disciplinary collaboration across diverse stakeholders to 

facilitate rapid and comprehensive response to bioincidents.

 Improve international access to and promote use of: best practices, model procedures, 

reporting templates, and training materials to facilitate rapid identification and notification 

of, and response to, potential biothreats or bioincidents. 

 Promote and enhance mechanisms for sharing specimens, samples, and information.
21

 Ensure that international mechanisms are prepared fully for the unique challenges of 

responding to deliberate biothreats and bioincidents.

 Support transparent, independent, and objective assessments of the international 

community’s capacity to respond to bioincidents. 

 Coordinate with partner countries to develop and implement multi-sectoral plans to address 

identified gaps in health security and ensure adherence to standards outlined in the 

International Health Regulations (2005) and by the World Organisation for Animal Health. 

 Support country and regional development and sustainment of public and veterinary core 

capacities and standards. 

3.9.2 Enhance International Preparedness through MCMs.

 Promote increased global capacities for research, development, evaluation, manufacturing, 

acquisition, stockpiling, deployment, and distribution of MCMs, including through 

collaborative arrangements.

 Address legal, regulatory, administrative, and financing barriers for international sharing of 

MCMs, other medical products, and qualified personnel.

 Ensure that international coordination and planning for bioincidents include consideration of 

the constraints to the ability of the United States to provide MCMs to other countries to 

address international bioincidents.

 Expand the international deployment and utilization of FDA-authorized or -cleared 

diagnostic tests. 

 Develop appropriate plans and agreements to facilitate the rapid international deployment 

and distribution of MCMs under the appropriate regulatory mechanisms, or for the rapid 

development, including clinical trials, of investigational MCMs during a crisis. 

 Strengthen international protocols for the conduct of clinical trials in a crisis.

3.9.3 Enhance International Preparedness Through CMMs.

 Promote the implementation of CMMs that can prevent transmission of communicable 

disease (e.g., voluntary isolation, hand washing with soap, covering mouth when coughing 

or sneezing, voluntary home quarantine).

 Support international partners in developing the authority to invoke and the capacity to 

implement threat-appropriate travel and border health measures, such as travel warnings and 

restrictions.

 Enhance engagement with community leaders to promote understanding of CMMs.

 Strengthen whole of society approaches through promoting multi-sectoral civil society, 

government, and private sector partnerships to improve incident reporting, and early action 

and response, and to mitigate the impact within communities by expanding coordination and 

response networks.

3.9.4 Further Develop, Exercise, and Update United States Government Plans for Responding to and 

Recovering from International Bioincidents. 

 Develop bioincident response plans for response and recovery at the international level with 

key international stakeholders as well as key SLTT, non-governmental, and private sector 

partners. 

 Ensure that international coordination and planning for bioincidents consider the constraints 

to the ability of the United States to provide response capabilities to address international 

bioincidents.

 Prepare and exercise plans for repatriation of personnel and materiel during a bioincident.
22

GOAL 4:

RAPIDLY RESPOND TO LIMIT THE IMPACTS OF BIOINCIDENTS.

4.1 Compile and share biothreat and bioincident information to enable 

appropriate decision-making and response operations across all levels of 

government and with non-governmental, private sector, and international 

entities, as appropriate.

4.1.1 Ensure Access to Timely, Accurate, and Useful Information.

 Coordinate and exchange biothreat and bioincident information and analysis across multisectoral stakeholders nationally and internationally.

4.1.2 Coordinate Federal Decision-making to Augment and Support Response Operations.

 Coordinate and communicate decision-making during biothreat and bioincident prevention, 

response, and recovery operations.

 Rapidly identify and resolve at the federal level any resource and policy issues related to ongoing response and recovery activities, both nationally and internationally.

 Utilize intelligence, biosurveillance, diplomacy, healthcare capacity and capability data, and 

modeling capabilities to maintain situational awareness and support decision-making across 

sectors and between local, national, and international organizations and partners throughout 

the response. 

 Notify, share information, and coordinate with international organizations and partners in 

accordance with the International Health Regulations (2005) and World Organization for 

Animal Health reporting requirements, and relevant frameworks throughout the bioincident 

response.

4.1.3 Enhance Situational Awareness Through Real-time, Incident Information Sharing.

 Rapidly share modeling, detection, healthcare capacity and capability data, and diagnostic 

information with appropriate stakeholders to monitor the bioincident continually and support 

multi-sectoral decision-making throughout the response.

 Utilize all sources of data, as appropriate, including social media and intelligence feeds, 

electronic medical records/health information exchanges, and new data analytic technologies, 

such as artificial intelligence, to further support incident awareness.

 Provide timely information to domestic and international stakeholders regarding utilization 

of border measures, prioritization of MCM dispensing, epidemiological control measures, 

and re-occupation of decontaminated areas.

4.2 Conduct federal response operations and activities in coordination with 

relevant non-federal actors to contain, control, and to rapidly mitigate 

impacts of biothreats or bioincidents.

4.2.1 Ensure Appropriate Oversight and Coordination.

 Identify a lead federal department or agency to provide overall coordination for the United 

States Government response to a national or international bioincident and to ensure 

coordination of response at the national/international interface level.
23

 Provide federal bioincident coordination to improve incident management across sectors and 

with all key stakeholders.

 Coordinate support to international bioincident response operations through the Department 

of State, including Chiefs of Mission, to prevent the spread of bioincidents.

 Identify mechanisms for access to budgetary resources to support the rapid response to a 

large-scale bioincident.

 When necessary, integrate coordinated federal activities into SLTT response efforts.

 Coordinate domestic assistance from international entities and from the private sector.

 Plan to use the Defense Production Act of 1950, as amended (2009) (50 U.S.C. 2061-2071) 

to obtain and facilitate distribution of resources that are urgently needed to respond to 

biological threats and incidents. 

4.2.2 Deploy MCMs and Implement CMMs.

 Rapidly identify potentially exposed populations to begin triage, preventive healthcare 

activities, and treatment.

 Ensure that access and functional needs of at-risk individuals are integrated into rapid 

deployment.

 Implement CMMs and other multidisciplinary bioincident control measures, to include

addressing service animal and wildlife concerns, animal vaccination, and agricultural 

depopulation.

 Deploy MCMs and support SLTT and medical supply distribution systems in the dispensing 

of MCMs, PPE, and medical equipment, under the appropriate regulatory mechanisms.

 Monitor the safety and effectiveness of deployed MCMs.

 Supplement, as necessary, the capabilities of affected jurisdictions to rapidly deploy MCMs 

following a bioincident, via a rapid response capability.

 Ensure provision of MCMs, as appropriate, to personnel performing or supporting missionessential functions following a bioincident.

 Ensure resources to maintain or develop clinical guidance and utilization policies to prepare 

for MCM deployment in crisis situations.

 Assess deficiencies in the health care system in the United States and U.S. territories to 

address these threats and coordinate in extremis. 

4.2.3 Conduct Real-time Research.

 Conduct real-time research during response to characterize emerging biothreat agents and 

develop response tools in order to improve response and recovery capacity, capability, and 

future preparedness. 

 Rapidly identify and disseminate guidelines and clinical approaches during a bioincident for 

the purpose of decreasing transmission, morbidity, and mortality; and rapidly identify and 

disseminate analogous approaches for animals and plants. 

 Conduct real-time clinical research to evaluate promising investigational MCMs, and identify 

potential novel diagnostics, treatments, and vaccines.

 Establish processes to accelerate protocol development, clinical sites identification, and 

institutional review board and regulatory review. 
24

4.2.4 Implement or Support Response Operations.

 Deliver and distribute response equipment and supplies, including healthcare resources and 

trained personnel, and provide for the availability of security capabilities to support response 

operations domestically and internationally.

 Facilitate implementation of crisis standards of care as needed and return to conventional 

care, as appropriate.

 Provide available federal medical, public health, and veterinary surge capacity and 

capabilities in a timely, coordinated manner to implement or support public and animal 

health, behavioral, and medical and veterinary services, including by augmenting SLTT 

capabilities.

 Provide mass fatality management including mortuary affairs, as appropriate.

 Augment transportation and reception systems and provide capabilities to support movement 

of highly infectious disease patients and response-generated materiels across borders and 

U.S. jurisdictions. 

 Provide oversight and assistance for carcass management services, as appropriate. 

 Conduct decontamination operations and the management of waste and contaminated 

materials in a manner that is protective of human, animal, and plant health, the environment, 

and the economy.

 Ensure the health and safety of federal, SLTT, private sector, and NGO responders involved 

in response operations.

4.2.5 Preserve the Continuity of Operations.

 Maintain comprehensive and effective continuity of operations, including appropriate 

devolution, to ensure the preservation of the United States Government’s structure under the 

U.S. Constitution and the continuing performance of National Essential Functions under all 

conditions.

 Secure, protect, and restore, as needed, critical infrastructure assets that have the potential to 

impact or be impacted by the spread of the bioincident.

 Secure and protect critical information and communications systems necessary for 

biodefense.

4.3 Conduct operations and investigations, and use all available tools to hold 

perpetrators accountable.

4.3.1 Conduct Incident Operations and Investigations.

 Utilize secure advanced communications capabilities between specialized response assets, 

technical experts, and senior decision-makers.

 Strengthen federal and SLTT law enforcement, medical, public health, animal, and plant 

health stakeholder capacity and capabilities to conduct joint criminal-epidemiologic 

investigations for suspect and confirmed intentional biothreats or bioincidents.

 Rapidly assess interdicted biological materials contained within a weapon or dispersal device, 

disable it, and contain the materials to prevent further dissemination.

 Transport biological weapons, materials, and means of delivery to an appropriate location for 

further characterization.

 Draw from national and international tools, including applicable laws and agreements, where 

appropriate and consistent with prosecutorial discretion, to hold perpetrators of intentional 

bioincidents accountable.
25

4.3.2 Forensics and Attribution.

 Utilize forensic tools and investigation capabilities to conduct forensic examinations to 

support attribution of a biothreat or a bioincident. 

 Use applicable protocols and memoranda of agreement to facilitate transport of potentially 

bio-contaminated evidence and classified materials to appropriate, predesignated facilities 

for analysis.

4.3.3 Support International Investigations.

 Provide appropriate technical and logistical support to investigations of alleged biological 

weapons, materials, and means of delivery under international auspices.

4.4 Execute risk-informed, accurate, timely, and actionable public messaging. 

4.4.1 Deliver Public Messaging to Facilitate Public Understanding and Decision-making During a 

Bioincident.

 Provide timely, regular, coordinated, and consistent risk communication, including 

information on response and recovery procedures and personal protective measures, across a 

range of media for the public.

 Provide mechanisms for stakeholders and members of the public to ask questions and provide 

comments and feedback.

 Use accessible communication strategies to maximize participation in appropriate response 

measures that address the needs for messaging in multiple formats and languages to 

accommodate the access and functional needs of the entire population.

 Identify and combat misinformation, including information regarding movement restrictions 

and re-entry of health workers and other incident responders. 
26

GOAL 5:

FACILITATE RECOVERY TO RESTORE THE COMMUNITY, THE ECONOMY,

AND THE ENVIRONMENT AFTER A BIOINCIDENT.

5.1 Promote restoration of critical infrastructure capability and capacity to 

enable the resumption of vital U.S. activities.

5.1.1 Restore Capability and Capacity.

 Ensure that safety measures are in place to enable and help restore health, social, and economic 

activity.

 Address the loss of critical infrastructure capability and capacity as quickly as possible to limit 

cascading effects by working with owners and operators, SLTT entities, and international 

partners, as appropriate.

 Support restoration of critical infrastructure in addition to continued performance of National 

Essential Functions through recovery of the federal, military, local first responders, and other 

critical workforces. 

 Facilitate health monitoring and surveillance for emergency responders, health care providers, 

federal personnel, and the public, including through the provision of post-exposure evaluations 

and medical monitoring. 

5.2 Ensure coordination of recovery activities across federal and SLTT 

governments and, as appropriate, international, non-governmental, and 

private sector partners to enable effective and efficient recovery 

operations.

5.2.1 Coordinate and Oversee.

 Coordinate recovery planning and information-sharing among federal, SLTT, nongovernment, and health care coalition partners.

 Support SLTT officials in decision-making and implementation of services such as 

relocation, alternative housing, and re-occupancy strategies, and access to health and social 

services.

 Support SLTT officials in decision-making regarding re-habitation and re-introduction of 

wildlife, livestock, service animals, and pets in the environment, homes, or commercial 

market.

 Conduct impact assessments, develop recovery strategies, and implement operational 

capabilities.

 Restore public confidence in community and environmental safety through frequent strategic 

communications via various media and other messaging partners.

5.3 Provide recovery support and conduct long-term mitigation actions to 

promote resilience.

5.3.1 Conduct Recovery and Mitigation Activities.

 Support SLTT officials in decision-making about long-term recovery operations, including 

remediation of remaining contaminated areas, long-term environmental monitoring, and 

assessing and communicating the appropriateness for re-occupancy of impacted areas.
27

 Support provision of long-term medical and behavioral health services to affected 

populations, including for emergency responders.

 Support effective and timely risk communication to promote public awareness of recovery 

operations. 

 Provide necessary support and augmentation of SLTT civilian capabilities to maintain and 

sustain public safety protection assurances.

 Assist recovery of private entities that cannot operate because of a bioincident, as funding 

and authorities permit.

 Support partner countries in decision-making about long-term recovery operations.

 Support SLTT officials and private-sector responders involved in determining how to 

integrate mitigation considerations into long-term recovery operations.

 Coordinate the activities of the Federal Government in support of SLTT officials to assess, 

restore, and initiate necessary interventions to re-establish critical capabilities in health and 

social services.

5.4 Reduce the cascading effects of international biological incidents on the 

global economy, health, and security.

5.4.1 Reduce International Economic, Health, and Security Impact.

 Promote the provision of recovery support and related activities to mitigate the second order 

impacts of a bioincident. 

 Assess impacts—such as severe disruptions of health services, economic and social activity 

and the decline of essential governmental services—caused by an international bioincident.

 Support activities to strengthen host governments’ ability to deliver critically needed services 

and to retain democracy and governance.

 Support households, communities, and agriculture markets to recover from the food safety 

impacts of the bioincident.
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ANNEX II

DEFINITIONS

The terminology used throughout the strategy is consistent with the following 

definitions:

Biodefense: Actions to counter biological 

threats, reduce risks, and prepare for, respond to, 

and recover from bioincidents.

Biodefense enterprise: Stakeholders with a role 

in the prevention, preparedness for, detection, 

response, and recovery from bioincidents (e.g., 

federal and SLTT governments, nongovernmental and private sector entities, and 

international partners).

Biological hazard (biohazard): A biological 

agent or biologically active substance—excluding 

toxic chemical substances that are considered 

solely as chemical weapons agents, regardless of 

origin (e.g., naturally occurring or 

bioengineered)—that represents an actual or 

potential danger to humans, animals, plants, or the 

environment. 

Biological incident (bioincident):

 Any act of biological warfare or terrorism;

 A crime involving a biohazard consistent 

with the scope of this strategy; or

 Any natural or accidental occurrence in 

which a biohazard harms humans, animals, 

plants, or the environment consistent with 

the scope of this strategy.

Biological threat (biothreat): An entity 

involved with, or a situation involving, a 

biohazard that can potentially cause a bioincident.

Biosurveillance: The process of gathering, 

integrating, interpreting, and communicating 

essential information and indications related to 

all-hazard threats or disease activity affecting 

human, animal, plant, and environmental health to 

achieve early detection and provide early 

warning, contribute to overall situational 

awareness of the health aspects of the incident, 

and to enable better decision-making at all levels.

Bioweapons-related: Materials, equipment, 

information, or technology covered by relevant 

multilateral treaties and arrangements, or included 

on national or international control lists, which 

could be misused for the design, development, 

production, or use of biological weapons and their 

means of delivery.

Clinical Guidance: Recommendations that 

define prevention, triage, and medical 

management of individuals who are at-risk or 

affected by biothreats.

Community Mitigation Measures (CMMs): 

Behaviors or actions that people and communities 

can take to help slow the spread of a biological 

hazard, to include threat-appropriate travel and 

border health measures. 

Delivery system: Any apparatus, equipment, 

device, or means of delivery used or intended to 

be used to deliver or disseminate biological 

material. 

Dual–use: Intended for legitimate purposes but 

having the potential for both benevolent and 

malevolent applications.

Healthcare coalition: A collaborative network 

of healthcare organizations and their respective 

public and private sector emergency response 

partners, including, but not limited to, hospitals, 

emergency medical services, and emergency 

management and public health agencies, that 

serves as a multiagency coordinating group to 

assist with preparedness, detection, response, 

recovery, and mitigation activities related to 

healthcare service delivery during bioincidents.

Medical Countermeasures (MCMs): 

Pharmaceutical products, such as vaccines, 

antimicrobials, and antitoxins, and nonpharmaceutical products, such as ventilators, 

diagnostic tests, PPE, and patient 

decontamination materials, that may be used to 

prevent, mitigate, or treat the adverse health 

effects from a bioincident.
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ANNEX III

SCOPE, STATUTORY REQUIREMENTS, AND AGENCIES

SCOPE

The National Biodefense Strategy addresses biothreats and bioincidents that have 

the potential to cause significant harm (as measured by injury or death, or damage 

to property, the environment, or the economy) to the United States or to U.S. 

interests; or that otherwise affect U.S. national security.

The National Biodefense Strategy is intended to 

inform the policy development process and is not 

a budget document. The commitment of federal 

resources to support activities associated with this 

document will be determined through the annual 

budget process, which will be informed by this 

strategy.

STATUTORY REQUIREMENTS

Section 1086 of the National Defense Authorization Act for Fiscal Year 2017 (Pub. 

L. No. 114-328; enacted December 23, 2016), codified at 6 U.S.C. 104, provides:

SEC. 1086. NATIONAL BIODEFENSE 

STRATEGY.

(a) STRATEGY AND IMPLEMENTATION 

PLAN REQUIRED.—The Secretary of 

Defense, the Secretary of Health and Human 

Services, the Secretary of Homeland Security, 

and the Secretary of Agriculture shall jointly 

develop a national biodefense strategy and 

associated implementation plan, which shall 

include a review and assessment of biodefense 

policies, practices, programs and initiatives. 

Such Secretaries shall review and, as 

appropriate, revise the strategy biennially.

(b) ELEMENTS. The strategy and associated 

implementation plan required under subsection 

(a) shall include each of the following:

(1) An inventory and assessment of all 

existing strategies, plans, policies, laws, and 

interagency agreements related to 

biodefense, including prevention, deterrence, 

preparedness, detection, response, 

attribution, recovery, and mitigation.

(2) A description of the biological threats, 

including biological warfare, bioterrorism, 

naturally occurring infectious diseases, and 

accidental exposures.

(3) A description of the current programs, 

efforts, or activities of the United States 

Government with respect to preventing the 

acquisition, proliferation, and use of a 

biological weapon, preventing an accidental 

or naturally occurring biological outbreak, 

and mitigating the effects of a biological 

epidemic.

(4) A description of the roles and 

responsibilities of the Executive Agencies, 

including internal and external coordination 

procedures, in identifying and sharing 

information related to, warning of, and 

protection against, acts of terrorism using 

biological agents and weapons and accidental 

or naturally occurring biological outbreaks.

(5) An articulation of related or required 

interagency capabilities and whole-ofGovernment activities required to support the 

national biodefense strategy.

(6) Recommendations for strengthening and 

improving the current biodefense 
30

capabilities, authorities, and command 

structures of the United States Government.

(7) Recommendations for improving and 

formalizing interagency coordination and 

support mechanisms with respect to 

providing a robust national biodefense.

(8) Any other matters the Secretary of 

Defense, the Secretary of Health and Human 

Services, the Secretary of Homeland 

Security, and the Secretary of Agriculture 

determine necessary.

(c) SUBMITTAL TO CONGRESS.—Not later 

than 275 days after the date of the enactment of 

this Act, the Secretary of Defense, the Secretary 

of Health and Human Services, the Secretary of 

Homeland Security, and the Secretary of 

Agriculture shall submit to the appropriate 

congressional committees the strategy and 

associated implementation plan required by 

subsection (a). The strategy and 

implementation plan shall be submitted in 

unclassified form, but may include a classified 

annex.

(d) BRIEFINGS. Not later than March 1, 2017, 

and annually thereof ter until March 1, 2019, 

the Secretary of Defense, the Secretary of 

Health and Human Services, the Secretary of 

Homeland Security, and the Secretary of 

Agriculture shall provide to the Committee on 

Armed Services of the House of 

Representatives, the Committee on Energy and 

Commerce of the House of Representatives, the 

Committee on Homeland Security of the House 

of Representatives, and the Committee on 

Agriculture of the House of Representatives a 

joint briefing on the strategy developed under 

subsection (a) and the status of the 

implementation of such strategy.

(e) GAO REVIEW.—Not later than 180 days 

after the date of the submittal of the strategy and 

implementation plan under subsection (c), the 

Comptroller General of the United States shall 

conduct a review of the strategy and 

implementation plan to analyze gaps and 

resources mapped against the requirements of 

the National Biodefense Strategy and existing 

United States biodefense policy documents.

(f) APPROPRIATE CONGRESSIONAL 

COMMITTEES DEFINED. In this section, the 

term “appropriate congressional committees” 

means the following:

(1) The congressional defense committees.

(2) The Committee on Energy and 

Commerce of the House of Representatives 

and the Committee on Health, Education, 

Labor, and Pensions of the Senate.

(3) The Committee on Homeland Security of 

the House of Representatives and the 

Committee on Homeland Security and 

Governmental Affairs of the Senate.

(4) The Committee on Agriculture of the 

House of Representatives and the Committee 

on Agriculture, Nutrition, and Forestry of the 

Senate.

AGENCIES 

Consistent with the requirements of the National Defense Authorization Act for Fiscal Year 

2017, the primary drafters for the National Biodefense Strategy are the Departments of 

Defense, Health and Human Services, Homeland Security, and Agriculture. In addition, 

the National Security Council Staff coordinated the review and finalization of the National 

Biodefense Strategy with the Departments of State, Treasury, Justice, Interior, Commerce, 

Labor, Transportation, Energy, and Veterans Affairs, the Environmental Protection 

Agency, the Office of Management and Budget, the Office of the Director of National 

Intelligence, the Office of Science and Technology Policy, the U.S. Agency for 

International Development, and the Federal Bureau of Investigation.