PPD2 National Strategy for Countering Bio Threats

8/7/2019 PPD2 National Strategy for Countering Bio Threats

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n o V e M b e r 2 0 0 9


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THE WHITE HOUSE

WASHINGTON


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Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Biological Threat Challenges . . . . . . . . . . . . . . . . . . . . . . . . 2

The National Strategy for Countering Biological Threats . . . . . . . . . . . . . . . 3

Objectives o the Strategy . . . . . . . . . . . . . . . . . . . . . . . . 4

Implementation o the Strategy. . . . . . . . . . . . . . . . . . . . . . . 4

Objective One: Promote global health security . . . . . . . . . . . . . . . . . . 6

Objective Two: Reinorce norms o sae and responsible conduct . . . . . . . . . . . . 8

Objective Three: Obtain timely and accurate insight on current and emerging risks . . . . . .10

Objective Four: Take reasonable steps to reduce the potential or exploitation . . . . . . .13

Objective Five: Expand our capability to prevent, attribute, and apprehend . . . . . . . .15

Objective Six: Communicate efectively with all stakeholders . . . . . . . . . . . . .18

Objective Seven: Transorm the international dialogue on biological threats . . . . . . . . 19

Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . .21


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1

National Strategy forCountering Biological Treats

Introduction

We are experiencing an unparalleled period o advancement and innovation in the lie sciences globally

that continues to transorm our way o lie. Whether augmenting our ability to provide health care and

protect the environment, or expanding our capacity or energy and agricultural production towards

global sustainability, continued research and development in the lie sciences is essential to a brighter

uture or all people.

The benecial nature o lie science research is reected in the widespread manner in which it occurs.

From cutting-edge academic institutes, to industrial research centers, to private laboratories in base-

ments and garages, progress is increasingly driven by innovation and open access to the insights andmaterials needed to advance individual initiatives.

We must support the ongoing revolution in the lie sciences by seeking to ensure that resulting discover-

ies and their applications, used solely or peaceul and benecial purposes, are globally available. At the

same time, we must be mindul o the risks throughout history posed by those who sought to misuse the

products o new technologies or harmul purposes. Specically, we must reduce the risk that misuse o

the lie sciences could result in the deliberate or inadvertent release o biological material in a manner

that sickens or kills people, animals, or plants, or renders unusable critical resources.

The efective dissemination o a lethal biological agent within an unprotected population could place

at risk the lives o hundreds o thousands o people. The unmitigated consequences o such an event

could overwhelm our public health capabilities, potentially causing an untold number o deaths. The

economic cost could exceed one trillion dollars or each such incident. In addition, there could be sig-

nicant societal and political consequences that would derive rom the incidents direct impact on our

way o lie and the publics trust in government.

Since 2001, the United States Government has signicantly expanded its eforts to improve the Nations

ability to recognize and respond to acts o bioterrorism or other signicant outbreaks o inectious

disease; however, eforts targeted to prevent such threats have received comparatively limited policy

ocus or substantive guidance at the National level. Although it is entirely easible to mitigate the impact

o even a large-scale biological attack upon a citys population, doing so incurs a signicant cost and

efort. We thereore need to place increased priority on actions to urther reduce the likelihood thatsuch an attack might occur.

This Strategywill guide our eforts to prevent such incidents by reducing the risk that misuse o the lie

sciences or derivative materials, techniques, or expertise will result in the use or intent to use biological

agents to cause harm. It also complements existing policies, plans, and preparations to advance our

ability to respond to public health crises o natural, accidental, or deliberate origin.


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NATIO NAL S TRATE G Y FO R C O UNTE RING BIO LO G IC AL THRE ATS

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Biological Threat Challenges

Biological weapons and their use or prolieration by States or non-State actors (biological threats) present

a signicant challenge to our national security. The development and use o biological weapons involves

the diversion o resources that are globally available. Distinguishing illicit intent within the expanse o

legitimate activity presents a unique challenge. It is quite possible that we would not obtain specicwarning o an imminent threat or impending attack in time to stop it.

Despite the challenge o identiying and characterizing current and active biological threats, there is

extensive documentation o a number o past activities that suggests the nature o the threat continues

to evolve:

From the end o World War II until the 1980s the principal threat has been rom state-run pro-

grams. Fortunately, arsenals built under these programs were never unleashed andthanks

to signicant investments and international cooperation over nearly two decadesthe threat

rom several such programs has been reduced.

In the last two decades, bioterrorism has emerged as another serious threat. In the 1980s, the

United States had its rst bioterrorist attack when the Rajneeshee cult contaminated salad

bars with Salmonella typhimurium in a politically motivated attack that sickened hundreds, but

ortunately, did not result in any loss o lie.

In the 1990s, the apocalyptic Aum Shinrikyo cult sprayed a liquid containing Bacillus anthracis

(anthrax) spores rom the roo o their headquarters near Tokyo, Japan. Once again, there was

no loss o lie as the strain o the bacteria used by the cult was not pathogenic.

In 2001, letters containing anthrax spores were distributed via the United States postal system,

inecting 22 people and resulting in 5 deaths, extensive social disruption, and enormous costs

or emergency response and remediation.

Also in 2001, while engaging the Taliban in Aghanistan, coalition orces came into possession

o a signicant body o evidence that al-Qaida was seeking to develop the capability to conduct

biological weapons attacks. Although al-Qaida has lost many o the resources it had compiled

prior to September 2001, it is prudent to assume that its intent to pursue biological weapons

still exists.

We are ortunate that biological threats have not yet resulted in a catastrophic attack or accidental

release in the United States. However, we recognize that: (1) the risk is evolving in unpredictable ways;

(2) advances in the enabling technologies will continue to be globally available; and (3) the ability to

exploit such advances will become increasingly accessible to those with ill intent as the barriers o tech-nical expertise and monetary costs decline. Accordingly, we cannot be complacent but instead must

take action to ensure that advances in the lie sciences positively afect people o all nations while we

reduce the risks posed by their misuse.


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THE NATIO NAL S TRATE G Y FO R C O UNTE RING BIO LO G IC AL THRE ATS

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TheNational Strategy for Countering Biological Threats

Reducing the risks presented by the deliberate or accidental release o a biological agent requires the

use o all instruments o national power, close coordination among all sectors o government, and

efective partnerships among public and private institutions both nationally and internationally. Under

the National Strategy for Countering Biological Threats (Strategy), we will encourage the alignment oglobal attitudes against the intentional misuse o the lie sciences or derivative materials, techniques,

or expertise to harm people, agriculture, or other critical resources.

Our Strategyis targeted to reduce biological threats by: (1) improving global access to the lie sciences

to combat inectious disease regardless o its cause; (2) establishing and reinorcing norms against the

misuse o the lie sciences; and (3) instituting a suite o coordinated activities that collectively will help

inuence, identiy, inhibit, and/or interdict those who seek to misuse the lie sciences.

The Strategyprovides a ramework or uture United States Government planning eforts that supports

the overall National Biodefense Strategy(Homeland Security Presidential Directive (HSPD)-10/National

Security Presidential Directive-33), and complements existing White House strategies related to biologi-cal threat preparedness and response:

Management of Domestic Incidents (HSPD-5) and the related National Response Framework;

National Preparedness (HSPD-8);

National Strategy for Defense of United States Agriculture and Food(HSPD-9);

Medical Countermeasures against Weapons of Mass Destruction (HSPD-18); and

Public Health and Medical Preparedness (HSPD-21).

This Strategyreects the act that the challenges presented by biological threats cannot be addressed

by the Federal Government alone, and that planning and participation must include the ull range o

domestic and international partners. It is guided by the ollowing assumptions:

Advances in the lie sciences solely used in a peaceul and benecial manner should globally

available;

A biological incident that results in mass casualties anywhere in the world increases the risk to

all nations rom biological threats;

Biological attacks against animals or crops threaten ood supplies and economic prosperity,

potentially exacerbating broader security concerns and the global economy;

Governmental, societal, organizational, and personal perceptions as to the legitimacy andecacy o biological weapons can have an important impact upon the risk;

It may not be possible to prevent all attacks; however, a coordinated series o actions can help

to reduce the risk;

A comprehensive and integrated approach is needed to prevent the ull spectrum o biological

threats as actions will vary in their efectiveness against specic threats; and


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The rapid detection and containment o, and response to, serious inectious disease outbreaks

whether o natural, accidental, or deliberate originadvances both the health o populations

and the security interests o States.

Objectives o the StrategyOurStrategyaddresses the ull spectrum o opportunities or risk management that link, or example, a

rural clinic overseas to a cutting-edge laboratory in America. Although the local circumstances in these

environments are unique, our objectives will remain relevant to achieving our goal: PROTECT against

the misuse o the lie sciences to develop or use biological agents to cause harm. The objectives o our

Strategyare:

Promote global health security: Activities that should be taken to increase the availabilityo and access to knowledge and products o the lie sciences that can help reduce impacts o

outbreaks o inectious disease whether o natural, accidental, or deliberate origin.

Reinorce norms o sae and responsible conduct: Activities that should be taken to reinorcea culture o responsibility, awareness, and vigilance among all who utilize and beneft rom the

lie sciences to ensure that they are not diverted to harmul purposes.

Obtain timely and accurate insight on current and emerging risks: Activities that serve toimprove threat identifcation, notifcation, and assessment capabilities as well as our understand-

ing as to the global progress and presence o the lie sciences to help identiy and understand

new and emerging challenges and inorm appropriate actions to manage the evolving risk.

Take reasonable steps to reduce the potential or exploitation: Activities that are targetedto identiy, sensitize, support, or otherwise saeguard knowledge and capabilities in the lie

sciences and related communities that could be vulnerable to accidents or misuse. Expand our capability to prevent, attribute, and apprehend: Activities that are intended

to urther hone the Nations ability to identiy and stop those with ill intent to reduce the risk o

single, multiple, or sequential attacks.

Communicate efectively with all stakeholders: Activities that should be conducted to ensurethe Federal Government is advancing cogent, coherent, and coordinated messages.

Transorm the international dialogue on biological threats: Activities targeted to promotea robust and sustained discussion among all nations as to the evolving biological threat and

identiy mutually agreed steps to counter it.

Implementation o the Strategy

This Strategyoutlines the Federal Governments approach to reducing the risks o biological weapons

prolieration and terrorism. While this Strategyprovides strategic guidance or the departments and

agencies o the United States Government, it does not articulate or assign specifc responsibilities to


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imp le me Ntatio N o f the S trate g y

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Federal Departments and Agencies. The implementation o this Strategy, specifc actions to be taken by

Federal entities, and their specifc measures o perormance and eectiveness will be directed separately.

We are in the midst o a global revolution in the lie sciences that will progress or at least the next ew

decades. As such, many o the objectives and courses o action outlined herein: (1) will take years to

implement ully; (2) will need to be revisited and potentially revised to complement the evolving risk;and (3) will require the long-term sustainment o eorts among the ull range o domestic and interna-

tional partners and stakeholders.

The ongoing revolution in the lie sciences already is a global endeavor. Broad access to lie science

fndings and products ultimately will provide the tools and capabilities needed to manage the risk o

accidents or misuse. Eorts to restrict or control the enabling materials and knowledge, while helpul

in specifc contexts, must be careully defned and targeted.

We will continue to uphold our obligation under the Convention on the Prohibition o the Development,

Production, and Stockpiling o Bacteriological (Biological) and Toxin Weapons and on Their Destruction

(BWC) not in any way to assist, encourage, or induce any State, group o States, or international orga-nizations to acquire biological weapons. Consistent with this and other obligations under domestic

law and international agreements, we will seek to pursue policies and actions that promote the global

availability o lie science discoveries and technologies or peaceul purposes.


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O BJEC TIVE O NE: P R O MO TE G LO BAL HEALTH SEC UR ITY

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Supporting eforts o partner countries and regions to advance the capability o medical, public

health, agricultural, and veterinary systems to respond to and recover rom disease outbreaks

o any origin;

Facilitating eforts o partner countries and regions to develop and exercise plans or responding

to and recovering rom large outbreaks o inectious diseases;

Exploring opportunities with partner countries and regions to conduct joint development and

procurement o medical countermeasures;

Working with partner countries and regions to articulate and exercise plans in the event that

we could contribute to their consequence management eforts;

Sharing best practices and lessons learned rom our domestic resilience activities through

exchanges, joint exercises, and training; and

Engaging international partners to optimize biological threat identication, assessment, and

response through eforts to develop capabilities to conduct joint criminal and epidemiologicalinvestigations.


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Objective Two: Reinforce norms of safe and responsible conduct

Through the course o its advancement, the ongoing lie sciences revolution will continue to place

signicant capabilities in the hands o an ever increasing number o individuals. The intent underlying

how these capabilities are used will determine the extent to which people benet rom them or experi-

ence the consequences o their misuse. Accordingly, we will advance and reinorce as a norm or thesae and benecial use o the lie sciences the exhortation o the BWC that their use as weapons would

be repugnant to the conscience o mankind.

Supporting the culture of responsibility in the life sciences

Lie scientists are best positioned to develop, document, and reinorce norms regarding the benecial

intent o their contribution to the global community as well as those activities that are undamentally

intolerable. Although other communities can make meaningul contributions, only the concerted and

deliberate efort o distinguished and respected lie scientists to develop, document, and ultimately

promulgate such norms will enable them to be ully endorsed by their peers and colleagues. We will

seek to acilitate these eforts by:

Encouraging the constituencies o the global lie sciences community to engage in a robust and

sustained dialogue as to the development o behavioral norms and options or their codication;

Encouraging proessional societies in the lie sciences to develop and communicate codes o

ethics and consider how their membership policies can best reect community norms;

Assisting proessional societies and other representatives o the lie sciences community in the

development o relevant educational and training materials;

Ensuring the availability o tools and resources needed to document, communicate, and rein-

orce norms during the education and throughout the career o lie scientists in academia,

industry, or government; and

Supporting eforts by lie scientists to explore community-based approaches or identiying

and addressing irresponsible conduct.

Advancing societal norms through legal mechanisms

Nations convey and reinorce behavioral norms within their civil society through a variety o means,

including civil and criminal statutes, regulations, guidance, proclamations, or edicts. These items com-

municate standards o behavior or citizens along with an awareness o penalties associated with their

violation and, when available, advice and recommendations or conducting positive and productive

activities. Although such tools do not eliminate the potential or illicit behavior, their routine and regular

enorcement help deter violation by the vast majority o people. We will seek to promote the use o such

tools at home and encourage their development abroad by:

Periodically reviewing, and as necessary, recommending updates to criminal statutes to ensure

that they are well suited to the evolving risks o misuse o the lie sciences;


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O BJEC TIVE TWO : R EINFO R C E NO R MS O F SAFE AND R ESP O NSIBLE C O NDUC T

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Ensuring members o stakeholder communities at unique risk o exploitation have access to

guidance regarding actions that can reduce the risk o misuse;

Supporting eforts o partner countries and regions to establish and build capacity to efectively

implement legislation criminalizing the development and/or use o biological weapons and/

or acts o bioterrorism; and

Engaging international partners and nongovernmental entities under existing obligations

such as the BWC and United Nations Security Council Resolution 1540and via existing mul-

tilateral orasuch as the Australia Group and the G-8 Global Partnershipto develop and

promulgate common standards, guidance, and best practices or actions relevant to preventing

illicit use.


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Objective Three: Obtain timely and accurate insight on current andemerging risks

Reducing the risks presented by those who seek to misuse the lie sciences requires our continuing

insight and thorough understanding o: advances in the lie sciences; their global availability and use;

naturally occurring inectious diseases in people, animals, and plants; global medical and public healthcapabilities and capacities; and specic eforts by those with ill intent to subvert resources available to

them. Much o the inormation needed to provide situational awareness is derived rom social networks

within distinct and disparate communities. We will emphasize the need or each o these groups to enrich

and expand their networks and ability to share data in a manner that appropriately protects individuals

privacy and other relevant sensitivities.

Staying abreast of the life sciences revolution

Advances in the lie sciences are progressing globally at an unprecedented rate. The vast majority o

this activity is wholly benecial and poses little to no risk o misuse. Select ndings and technologies

howeversuch as the ability o techniques used or synthetic genomics to enable the de novo synthesis

o certain high-risk pathogens and toxinsraise questions as to how we can best manage the risk while

minimizing the impact on legitimate science. Accordingly, we will ensure that our policies and activities

are ully inormed by a robust and current awareness o advances in the lie sciences and their potential

impact upon the risk by:

Ensuring appropriate Federal investments in technology watch initiatives that provide cutting

edge insight and analysis rom those currently engaged in the science;

Encouraging the broad distribution o technology watch ndings to those engaged in risk man-

agement activities across the Federal Government and appropriate nongovernmental partners;

Reviewing and, as appropriate, updating our regulatory requirements and guidance on export

controls to reect the current state o the lie sciences;

Promoting the continued expansion o opportunities or employment within the Federal

Government or those with lie science expertise; and

Ensuring lie scientists employed by the Federal Government have access to necessary edu-

cational resources to maintain technical currency in appropriate departments and agencies.

Building knowledge as to the global disease burden and technological capabilities

A robust understanding o the nature, prevalence, and severity o inectious diseases both at home and

abroad is critical or efective decisions or prevention, protection, preparedness, and response. In addi-

tion, a clear understanding o scientic capabilities and medical, veterinary, and public as well as agri-

cultural health capacity abroad is essential to inorm decisions on policies, programs, and investments

that can best manage current and emerging risks. We will encourage the constituencies that comprise

our scientic, agricultural, medical, and global public health communities to expand and strengthen


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OBJECTI VE THREE: OBTAIN TIMELY AND ACCURATE INSIGHT ON CURRENT AND EMERGING RISKS

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their individual networks and improve our knowledge o global capabilities and needs to manage risks

rom naturally occurring and deliberately introduced inectious diseases by:

Supporting eforts in partner countries and regions to develop mechanisms and capabilities

or reporting to the WHO, OIE, FAO, and other partners validated data on human, animal, and

plant outbreaks o inectious disease;

Engaging Federal, nongovernmental, and international partners to advance awareness and

understanding o global outbreaks o inectious disease;

Engaging Federal, nongovernmental, and international partners to promote greater awareness

and understanding o the global availability o and access to lie sciences technologies and

materials; and

Promoting the development and use o mechanisms or reporting, preserving, andas appro-

priate to improve transparency in governmentsharing data on Federal programs and invest-

ments in international scientic, agricultural, medical, and public health collaborations.

Improving intelligence on deliberate biological threats

Timely and accurate inormation as to the capabilities and intent o those who seek to subvert the lie

sciences is exceptionally dicult to obtain. The intelligence community (IC), in collaboration with the

broader United States Government and lie science communities, must seek to close the gaps in our

nations intelligence collection and analytic capabilities directed at countering biological threats. The

dynamic and evolving nature o the lie sciences and potential threats will demand a detailed approach

that yields actionable intelligence or all consumers. We will seek to meet this challenge by:

Dening, integrating, ocusing, and enhancing existing IC capabilities dedicated to current and

strategic biological threats, whether rom states, groups, or individuals;

Ensuring the prioritization and sustained commitment o personnel and resources needed to

optimize the ICs targeting, collection, analytic, and technological capabilities directed against

biological threats;

Advancing partnerships between the IC and non-IC departments and agencies in assessing

potential threats and the risks rom the intentional use o biological agents;

Expanding the ICs support to non-IC departments and agencies and organizations at the

Federal, State, local, and tribal level regarding actionable intelligence on biological threats; and

Evaluating on a regular basis the ICs eforts and progress on understanding and counteringbiological threats.


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Facilitating data sharing and knowledge discovery

Improving our access to the above sources o inormation will provide little beneft unless we can enable

the various communities to share inormation in a manner that yields meaningul discoveries while

protecting sensitive privacy, security, and proprietary data. We will seek to do this by:

Developing a strategy or advancing situational awareness and a plan that identifes key ele-

ments o inormation to be shared, critical sensitivities to be protected, and a ramework or

enabling inormation exchange;

Fostering inormation sharing between public health, law enorcement and security, intelli-

gence, and the lie sciences community to identiy potential threats, reduce vulnerabilities, and

improve response activities and investigations o suspected biological incidents; and

Evaluating the role or novel technologies in acilitating intradepartmental, interdepartmental,

and open sharing o inormation in a manner that protects those elements deemed critically

sensitive.


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OBJECTIVE FOUR: TAKE REASONABLE ST EPS TO REDUCE THE POTENTI AL FOR EXPLOI TATION

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Objective Four: Take reasonable steps to reduce the potential forexploitation

To present a credible biological threat, those with the intent to do harm must have access to relevant

expertise, inormation, and material. There is no easible or efective process that can restrict access to

the ull range o lie science resources that could contribute to misuse. Actions to identiy specic risksand protect relevant materials, items, and technologies can, however, increase both our chances o

detecting illicit activity and the costs and efort or such activity without having serious consequences

upon the pace and progress o legitimate lie science activities.

Managing risks posed by dual-use information of concern

Some o the inormation derived rom the lie sciences is reerred to as dual-use due to its potential or

misuse to cause harm. Certain pieces o this inormation o concern can be uniquely helpul in permit-

ting those with ill intent to present a biological threat. It is important or those who routinely access and

utilize such inormation to be aware o its potential or harm and ensure that it is responsibly used. We

will seek to address risks posed by dual-use inormation o concern by:

Providing detailed guidelines that can aid in the identication o such inormation and enable

actions that reduce the potential or its misuse while recognizing the importance o legitimate

use;

Encouraging activities by academia and the private sector to develop community-based mecha-

nisms or sharing experiences and best practices or risk management;

Promoting discussions among U.S. scientic experts and their international colleagues to raise

awareness o the risk and advance thoughts on how best to address it; and

Enabling eforts by the lie sciences community to incorporate guidance and best practices into

education and training materials.

Optimizing security of known virulent high-risk pathogens and toxins

Among the microbial organisms capable o causing disease, there are a relatively small number o high-

risk pathogens and toxins that have properties which enable them to be used in a deliberate attack.

Nearly all such pathogens and toxins are naturally occurring and can be ound in and isolated rom envi-

ronmental sources around the globe. As such, it is impossible to eliminate the risk posed by deliberate

use o these pathogens and toxins; however, it is reasonable to seek to reduce the risk by limiting ready

access to known virulent strains o high-risk pathogens and toxins. In addition, the use o proper saetycontrols and practices is a key contributor to risk management. Our eforts in this area will ocus on:

Optimizing our domestic laws, regulations, policies and practices or securing high-risk patho-

gens and toxins and providing detailed guidance or improved compliance;

Improving use o mechanisms to report thet or loss or release rom laboratories holding dan-

gerous pathogens and toxins to appropriate public health and law enorcement agencies;


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Natio Nal S trate g y fo r C o uNte riNg Bio lo g iC al thre atS

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Supporting the eorts o partner countries and regions to ensure the application o biologicalsecurity and saety practices in a risk-based and sustainable manner;

Maintaining and urther promulgating guidance on the use o best practices, saety equipment,and acility engineering controls or biological saety when working with high-risk pathogens

and toxins;

Promoting the development o international guidelines or saety and security o high-riskpathogens and toxins and their broadest possible adoption; and

Working with partner countries and regions to identiy collections o high-risk pathogens andtoxins, and where possible, consolidate collections at national regional centers o excellence,

keeping in mind the need to be able to comply with the WHOs IHR and OIE guidelines.

Addressing emerging technology-enabled risks

As our awareness o advances in the lie sciences expands, we may identiy novel or emerging capabili-

ties that impact the risk. We will engage experts in our eorts to evaluate the likely impact upon risk and

the benefts and costs o potential mitigative actions in a manner that seeks to appropriately balance

the potential or managing the risk with the potential or benefcial use. We will provide clear guidance

to acilitate compliance with any such mitigative actions.


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Natio Nal S trate g y fo r C o uNte riNg Bio lo g iC al thre atS

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Identiying and articulating our rationale or particular communities at heightened risk oexploitation;

Conducting outreach rom law enorcement and security community proessionals to willingrepresentatives o the identifed communities to discuss the risks;

Engaging members o the vulnerable community to raise awareness o the types o activitiesthat would reasonably be considered unusual or suspicious; and

Establishing mechanisms or willing members o the vulnerable community to notiy appropri-ate authorities o unusual or suspicious activities in a confdential manner.

Ensuring robust capabilities to disrupt or interdict illicit activity

Where we identiy States, groups, or individuals seeking to acquire or use biological weapons, we will

use all appropriate means to disrupt or deny their eorts, drawing on a wide range o counterterrorism,

counterprolieration, intelligence, law enorcement, and other tools.

Developing eective interdiction capabilities, both ourselves and in concert with partner nations,

can contribute to our eorts to counter or deter those who seek to transer, acquire, develop, or use a

biological weapon. Eective interdiction capabilities also can help deter those who otherwise would

consider providing materials, equipment, or assistance. For example, since 2003, more than 90 countries

have endorsed the Prolieration Security Initiative (PSI) and thus committed to cooperating to interdict

WMD-related shipments o prolieration concern to and rom both States and non-State actors. We will

continue to partner with other nations and advance our capabilities against biological threats by:

Ensuring that our armed orces, law enorcement, and security communities have access toappropriate plans, procedures, and tools or eective and sae operations;

Promoting the use o simulations among Federal partners to exercise our capabilities, refneoperational concepts, and strengthen relationships across government; and

Working with international partners through appropriate venues to promote appropriate com-munication, coordination, cooperation, and capacity building.

Enhancing microbial forensics and attribution

The primary objectives o any investigation into the alleged use, intended use, or development o a

biological weapon are to prevent casualties, protect the public health, and attribute the activity to its

perpetrator. Attribution o biological threats entails the analysis o data rom a variety o sources, includ-

ing technical inormation on samples containing biological material derived through microbial orensic

analyses. We will seek to continue to advance our capabilities or attribution and microbial orensics by:

Ensuring that law enorcement tactics, techniques, and procedures and public health and agri-cultural processes are coordinated and that the investigations are synergistic;


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O BJEC TIVE FIVE: EXP AND O UR C AP ABILITY TO P R EVENT, ATTR IBUTE, AND AP P R EHEND

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Ensuring the availability o a detailed concept o operations or inormation sharing and all-

source analysis to support timely attribution o biological incidents;

Establishing a National-level research and development strategy and investment plan or

advancing the feld o microbial orensics; and

Maintaining the National Biological Forensics Analysis Center as the Nations lead Federal acility

or orensic analysis o biological material in support o law enorcement investigations.


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Objective Six: Communicate efectively with all stakeholders

Successul implementation o this Strategyrequires the long term and concerted action o a broad range

o stakeholders, most o whom are not part o the United States Government. As such, there are a number

o activities that should be taken to ensure we advance cogent, coherent, and coordinated messages

regarding our understanding o the threat, steps we are taking to reduce the risks, and capabilities thatwe can make available to help our colleagues manage the risks. We will seek to advance efective com-

munications and increase transparency in our actions by:

Ensuring that all Federal partners develop, utilize, and update tools or communicating with

the ull range o domestic and international stakeholders;

Encouraging thatwhenever possibleFederal departments and agencies coordinate their

outreach eforts to include conducting joint or multi-partner activities;

Promoting greater outreach and participation o Federal representatives in scientic, technical,

academic, and other proessional and public ora; and

Establishing and maintaining an updated web-based portal that serves as the general point o

entry or the public or inormation on the ull range o our policies and activities related to risk

management in the lie sciences.


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O BJEC TIVE SEVEN: TR ANSFO R M THE INTER NATIO NAL DIALO G UE O N BIO LO G IC AL THR EATS

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Objective Seven: Transform the international dialogue on biologicalthreats

The lie sciences revolution is global in nature and people o all nations can benet rom eforts to

reduce the risk o misuse to enable biological threats. Optimal implementation o any efort to manage

the risk requires international cooperation and coordination. Currently, the plurality o perspectives inthe international community as to the severity o the risk and mitigative actions that nations should

take presents a challenge to risk management. We will seek to advance the international dialogue by

raming the risk in a broader context and seeking to identiy helpul activities that nations can agree to

undertake in a multilateral, bilateral, or unilateral manner even as varying perspectives on the imme-

diacy o the risk may persist.

Revitalizing the Biological and Toxin Weapons Convention (BWC)

The BWC is a uniquely important venue through which we can promote and globally advance our

objectives or non-prolieration and risk management o biological threats. The membership o the BWC,

however, is not universal and concerns remain that some treaty partners may be developing biological

weapons. As the central international orum dedicated to mitigating risks posed by the development

and use o biological weapons, the BWC can help ocus attention on the evolving nature o biological

threats, increase attention to and promote international eforts to prevent prolieration and terrorism,

and build tighter linkages between the health and security sectors. We will seek to utilize the BWC as our

premiere orum or global outreach and coordination on the ull scope o risk management activities by:

Promoting condence in efective BWC implementation and compliance by its States Parties,

inter alia, by promoting transparency about legitimate activities and pursuing compliance

diplomacy to address concerns;

Promoting universal membership in the Convention;

Ensuring that our participation in BWC meetings is broadly inclusive o relevant departments

and agencies and headed by an appropriately senior representative;

Advancing a substantive agenda that emphasizes topics and activities consistent with the

objectives o this Strategywith broad potential to enhance global risk management;

Seeking to renew existing relationships while building new, broader coalitions o like-minded

BWC States Parties; and

Encouraging stronger partnerships between security and public health communities by ocus-

ing on activities that improve global capabilities to counter inectious disease in a manner thatmitigates risks rom natural, accidental, and deliberate outbreaks.

Expanding our international partnerships and bioengagement

Over the past decade, our cooperative partnerships with a number o nations have demonstrably

reduced the risks posed by legacy biological weapons programs. By assisting with eforts to redirect


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ormer weapons scientists, repurpose or decommission acilities and equipment, develop and imple-

ment practices that permit sae and secure work with high-risk pathogens and toxins, build scientic

ties, and improve mutual understanding, our security engagement programs have developed a strong

track record o efective risk management. We will seek to build upon this record by orging new part-

nerships that reduce the risks rom biological threats by:

Providing assistance to partner countries and regions along the spectrum o objectives in this

Strategyin a manner that meets our partners needs and is sustainable within the oten limited

resources o the countries and regions, either unilaterally or in partnership with others;

Leveraging the best practices o our engagement programs while evolving and broadening the

scope and nature o eforts in which we engage our international partners;

Setting priorities and coordinating across United States Government assistance programs or

bioengagement, including public health, nonprolieration, and S&T programs to ensure that

eforts are appropriately targeted, mutually reinorcing, non-duplicative, and consistent with

program mission and U.S. policy priorities; and

Coordinating our biological security programs with our international partners in a manner that,

wherever possible, sets mutual priorities or engagement.

Integrating eforts to meet our international obligations

We, and many o our international colleagues, have a number o multilateral and bilateral obligations

that lie at the nexus o security, health, and science. We will continue to meet our obligations; however,

we will look or opportunities to leverage synergies in activities that are relevant to multiple ora.

For example, whether we are: (1) responding to assistance requests or guidance on handling high-

risk pathogens and toxins to enable partner countries to meet their obligations under United NationsSecurity Council Resolution 1540; (2) providing technical support to other countries to meet their dis-

ease surveillance and reporting obligations under the WHOs IHRs and OIE guidelines; (3) contributing

technical assistance or securing high-risk pathogens and toxins in a partner country in accordance with

Article X o the BWC; or (4) transerring material and equipment to permit, or example, a North Atlantic

Treaty Organization ally to respond more efectively to a local outbreak o a high-risk pathogen, our

eforts will reect improved coordination and communication among Federal departments and agen-

cies and with our international partners.


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Roles and Responsibilities

Because o the broad-based and unique challenges presented by biological threats, responsibility or

their prevention must involve all levels o government and include all segments o society, around the

globe. No single stakeholder can ully address the challenge o biological threats on its own.

The Federal Government

Although the Federal Government plays a crucial role in raming and coordinating eorts to reduce the

likelihood o biological threats, the success o this endeavor is largely dependent upon the activities

o partners at the local and State levels and internationally. Specic Federal responsibilities include the

ollowing:

Visibly complying with our obligations under the BWC, UNSCR 1540, WHOs IHR, OIE guidelines,

the Global Health Security Initiative, the Australia Group, and other relevant bilateral and mul-

tilateral agreements;

Advancing global situational awareness, disease surveillance, resilience, and other activities

to counter specic threats rom those who would seek to develop or use biological weapons;

Ensuring that Federal Departments and Agencies have developed and are employing comple-

mentary and multi-layered systems or infuencing, identiying, inhibiting, and interdicting those

who would seek to develop or use biological weapons;

Facilitating, through laws, regulations, guidance, and unding, State and local public health,

agricultural, medical, clinical, and law enorcement eorts to secure and protect high-risk

pathogens and toxins and recognize and respond to illicit biological activities;

Providing guidance and, as appropriate, unding to the private sector to support awareness-raising, training, and appropriate public-private partnerships, in conjunction with states and

localities; and

Conducting the ull range o preparations to ensure an eective response in the event o a

biological incident.

States and Localities

Our communities, and particularly our medical, scientic, veterinary, agricultural, and security practitio-

ners, are on the ront lines in reducing the domestic risks posed by biological threats. We will encourage

State and local governments to undertake the ollowing: Establishing comprehensive capabilitiesincluding coordination with appropriate Federal

partnersor law enorcement proessionals to recognize quickly and respond eectively to

suspected activities involving the planned illicit use o biological material;

Ensuring that all reasonable measures are taken to promote the saety and security o high-risk

pathogens and toxins at acilities within their communities;


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Promoting a productive dialogue between the health, agriculture, and security sectors o the

community; and

Preparing now to ensure an efective response in the event o a biological incident.

The Private Sector

The private sector represents a unique and multiaceted component o our society because o the

essential goods and services it provides and the capabilities it can bring to bear to mitigate the risks o

exploitation. We will encourage the United States private sector to undertake the ollowing:

Conducting organizational assessments regarding potential vulnerabilities that could give aid

to those seeking to develop or use biological weapons and taking all reasonable measures to

reduce their risk o exploitation;

Ensuring that all reasonable measures are taken to promote the saety and security o high-risk

pathogens and toxins within their possession;

Establishing and supporting robust participation in ora where sector colleagues and other

stakeholders can discuss risks, raise awareness, and explore community-based approaches and

best practices or risk management; and

Maintaining productive working relationships with local, State, and Federal law enorcement

agencies and reporting suspicious/illicit activities to appropriate authorities.

Individuals and Families

There is a critical role or amilies and individuals in reducing the risks rom biological threats. Individual

contributions to community resilience can undermine motivations or biological threats by reducingtheir efectiveness. We will encourage individuals and amilies to undertake the ollowing:

Following general guidance or disaster preparedness, such as keeping supplies o ood and

other materials at homeas recommended by authoritiesto support essential needs o the

household or several days i necessary;

Being prepared to ollow public health guidance that may include limiting their mobility

throughout the community or several days or weeks, or utilizing designated evacuation routes;

and

Inorming appropriate authorities when they encounter or observe suspicious or unusual

activities.

International Partners

Our relationships with the United Nations, international organizations, oreign governments, and the

private sector are critical to the success o our eforts and we will robustly engage them in multilateral

and bilateral ora. Our coordination with the international community to counter biological threats is a


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core and cross-cutting element o our overall strategy. The tone, tenor, and quality o the United States

Governments eforts and that o our international partners will be important to determine our mutual

success. We will look to encourage our international partners to:

Comply ully with their legal and politically-binding obligations under the BWC - or those that

are not party to the BWC, we will encourage them to sign and ratiy the Convention so that itsprinciples can be a truly global norm;

Advance policies and practices that establish and reinorce norms against the misuse o the

knowledge and capabilities that arise rom the lie sciences while encouraging their ree and

open availability or peaceul and benecial use;

Place special emphasis on meeting their obligations under the WHOs IHR and OIE and FAO

guidelines by establishing efective and sustainable systems or disease surveillance, detection,

diagnosis, and reporting;

Develop and employ complementary and multi-layered systems or inuencing, identiying,

inhibiting, and interdicting biological threats;

Place priority on establishing efective and sustainable capabilities to respond to potentially

catastrophic outbreaks o natural, accidental, or deliberate inectious disease within their bor-

ders and increase regional cooperation in consequence management;

Engage in broad dialogue as to the perception o the spectrum o riskscurrent and uture

enabled by the ongoing advances in the lie sciences and helpul steps that can be taken towards

risk management;

Pursue bilateral and multilateral partnerships targeted to acilitate the eforts o partner nations

to institute and implement laws, policies, and practices that collectively reduce the risks posed

by misuse o the lie sciences;

Ensure the development and application o biological security and saety practices in a risk

based and sustainable manner; and

Continue to partner on PSI, the Australia Group, and other multilateral and bilateral initiatives

to reduce the risk o biological weapons and other WMD threats.

Documents

PPD2 National Strategy for Countering Bio Threats