National Strategy for Countering Bio Threats

8/8/2019 National Strategy for Countering Bio Threats

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nat i o n a l s t r at e g yfor

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THE WHITE HOUSE

WASHINGTON

November 23,2009

My Fellow Americans,Since the dawn of civilization, infectious diseases have shaped the course of human history.During the 20th century, we made remarkable progress in advancing public health, but in manyways we are currently more vulnerable than ever. Today, a tremendous interconnectednessbrings the global community together and provides new opportunities for our mutualadvancement. At the same time, however, it increases the potential for the spread ofdiseasessuch as HINI influenza and SARS which ignore geographic and political boundaries.Advances within the life sciences hold extraordinary potential for beneficial progress, but theyalso can empower those who would use biological agents for il l purpose. Economic, political,and religious forces have given rise to a form of fanaticism that seeks to harm free societies.We know that some of these fanatics have expressed interest in developing and using biologicalweapons against us and our allies. Addressing these unique challenges requires a comprehensiveapproach that recognizes the importance of reducing threats from outbreaks of infectious diseasewhether natural, accidental, or deliberate in nature.This National Strategy for Countering Biological Threats articulates our vision for managingthese evolving and complex risks. It is a vision of shared commitment wherein the United StatesGovernment works with domestic and international partners to advance the health security of allpeople. It recognizes that the pace and progress of the life sciences require tailored approachesto mitigate the potential for misuse with minimal impacts upon beneficial use. Finally, itestablishes a series of mutually reinforcing activities to address specific threats as they arise.We will continue to face new and emerging biological threats that will require the coordinatedand concerted efforts of a broad range of domestic and international partners. As we take actionto counter these threats, we will work together to advance our own health security and providefor the improved condition of all humanity.


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Contents

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

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

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

Objectives o the Strategy . . . . . . . . . . . . . . . . . . . . . . . . 4Implementation 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 . . . . . . .13Objective 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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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

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:

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

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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 technical 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 U NTE RING BIO LO G IC AL THRE ATS

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 biological threat preparedness and response:

r 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).

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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:

r Advances in the lie sciences solely used in a peaceul and benecial manner should globallyavailable;

r A biological incident that results in mass casualties anywhere in the world increases the risk toall nations rom biological threats;

r Biological attacks against animals or crops threaten ood supplies and economic prosperity,potentially exacerbating broader security concerns and the global economy;

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

r It may not be possible to prevent all attacks; however, a coordinated series o actions can helpto reduce the risk;

r A comprehensive and integrated approach is needed to prevent the ull spectrum o biologicalthreats as actions will vary in their efectiveness against specic threats; and

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r The rapid detection and containment o, and response to, serious inectious disease outbreakswhether 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:

r 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.

r 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 thelie sciences to ensure that they are not diverted to harmul purposes.

r 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.

r 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.r 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.

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

r 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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implemeNtatioN of the Strategy

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 longterm 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 toassist, encourage, or induceany 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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Objective One: Promote global health security

Many nations struggle daily to address the impact o naturally occurring inectious disease within their

borders. In the ace o this challenge, it can be dicult to nd consensus on the need to address the risk

rom accidents or deliberate incidents.

In partnership with other nations, and consistent with international obligations, we will seek to advance

access to and efective use o technologies to mitigate the impact rom outbreaks o inectious disease,

regardless o their cause. As more nations are better able to mitigate this impact, we expect that they

may be better positioned to discussand take action to preventthe risks associated with misuse.

Building Global Capacity for Disease Surveillance, Detection, Diagnosis, and Reporting

Ensuring the global availability o lie science-enabled capabilitiessuch as disease surveillance and

detectionto mitigate the risks rom natural, accidental, and deliberate outbreaks directly enables

progress on all three. We will work with partner countries and regions to assist in their eforts to comply

with the World Health Organizations (WHO) International Health Regulations (IHR) as well as the WorldOrganization o Animal Healths (OIE) and the United Nations Food and Agricultural Organizations (FAO)

reporting guidelines in a manner that:

r Permits them to detect, identiy, and report promptly any public, animal, or plant health oragricultural emergencies o international concern;

Focuses on major population centers, known locations o endemic and epidemic disease and

their vectors, and any known associated local terrorist or criminal threats;

Is integrated and interoperable with their existing logistical inrastructure and sensitive to their

public and agricultural health priorities;

Is sustainable within the oten limited resources o the country/region, either unilaterally or

with other partners;

Improves coordination between human, plant, and veterinary disease reporting systems, espe

cially in relation to zoonotic diseases; and

Is transparent and enables the sharing o inormation with international human, plant, and

animal health agencies and the United States.

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Improving International Capacity against Infectious Diseases

Ensuring that communities can quickly and efectively respond to large outbreaks o inectious diseasein a manner that greatly reduces their impact is among the most efective ways to deter a deliberate

attack and to minimize the consequences should an attack occur. In todays interconnected world, an

outbreak o highly communicable disease anywhere on the globe increases the risk to everyone, par

ticularly i that outbreak is o deliberate origin. Accordingly, we will continue to build upon bilateral and

multilateral partnerships to improve international preparedness and global resilience against potentially

catastrophic outbreaks o inectious disease by:

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

r Supporting eforts o partner countries and regions to advance the capability o medical, publichealth, agricultural, and veterinary systems to respond to and recover rom disease outbreaks

o any origin;

r Facilitating eforts o partner countries and regions to develop and exercise plans or respondingto and recovering rom large outbreaks o inectious diseases;

r Exploring opportunities with partner countries and regions to conduct joint development andprocurement o medical countermeasures;

r Working with partner countries and regions to articulate and exercise plans in the event thatwe could contribute to their consequence management eforts;

r Sharing best practices and lessons learned rom our domestic resilience activities throughexchanges, joint exercises, and training; and

r Engaging international partners to optimize biological threat identication, assessment, andresponse 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:

r Encouraging the constituencies o the global lie sciences community to engage in a robust andsustained 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.

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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:

r Periodically reviewing, and as necessary, recommending updates to criminal statutes to ensurethat 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

r Ensuring members o stakeholder communities at unique risk o exploitation have access toguidance regarding actions that can reduce the risk o misuse;

r Supporting eforts o partner countries and regions to establish and build capacity to efectivelyimplement legislation criminalizing the development and/or use o biological weapons and/

or acts o bioterrorism; and

r Engaging international partners and nongovernmental entities under existing obligationssuch 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:

r Ensuring appropriate Federal investments in technology watch initiatives that provide cuttingedge 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.

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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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OBJECTIVE THREE: OBTAIN TIMELY AND ACCURATE INSIGHT ON CURRENT AND EMERGING RISKS

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

rom naturally occurring and deliberately introduced inectious diseases by:

r Supporting eforts in partner countries and regions to develop mechanisms and capabilitiesor 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.

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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:

r Dening, integrating, ocusing, and enhancing existing IC capabilities dedicated to current andstrategic biological threats, whether rom states, groups, or individuals;

r Ensuring the prioritization and sustained commitment o personnel and resources needed tooptimize the ICs targeting, collection, analytic, and technological capabilities directed against

biological threats;

r Advancing partnerships between the IC and non-IC departments and agencies in assessingpotential threats and the risks rom the intentional use o biological agents;

r Expanding the ICs support to non-IC departments and agencies and organizations at theFederal, State, local, and tribal level regarding actionable intelligence on biological threats; and

r 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:

r 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

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:

r Providing detailed guidelines that can aid in the identication o such inormation and enableactions 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.

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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:

r Optimizing our domestic laws, regulations, policies and practices or securing high-risk pathogens and toxins and providing detailed guidance or improved compliance;

r Improving use o mechanisms to report thet or loss or release rom laboratories holding dangerous pathogens and toxins to appropriate public health and law enorcement agencies;

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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

Objective Five: Expand our capability to prevent, attribute, andapprehend

No matter how efective our eforts to increase the barriers and reduce the perceived benets to devel

opment and/or use o biological weapons, we cannot eliminate the possibility that some may seek to

misuse the lie sciences to do harm. Also, because biological threats by their nature lend themselvesto permitting an aggressor to conduct multiple attacks in diferent areas, either simultaneously or in

sequence, our timely recognition and apprehension o the perpetrator is critical to reducing the risk

o ollow-on attacks. We must ensure that law enorcement, national security, and homeland security

communities have access to the ull range o tools and capabilities needed to identiy and disrupt the

eforts o those with ill intentpreerably beore they have the opportunity to conduct an attackand

apprehend and successully prosecute all ofenders.

Ensuring robust capabilities for law enforcement and security

Our law enorcement and homeland security communities are a critical ront line in recognizing, pre

venting, and responding to the entire spectrum o illicit activities involving the lie sciences or derivative

materials, techniques, or expertise. Whether the ofender is seeking to poison someone or is part o a

group that intends to contaminate a wide metropolitan area, Federal, State, local, and tribal law enorce

ment and security ocials must be well positioned to receive and respond to tips, saely and success

ully handle potentially contaminated material, conduct investigations, and prosecute perpetrators and

acilitators. We will seek to prepare those responsible or our security to address biological threats by:

r Establishing processes or sharing data and expertise on biological threats among Federal, State,local, and tribal law enorcement, health, and security communities;

Providing training or law enorcement, health, and security personnel on recognizing and

responding to situations involving potential biological threats, including perorming joint

criminal and epidemiological investigations;

Ensuring our law enorcement and security personnel have tailored tactics, techniques, and

procedures and access to the tools needed to respond to biological threats; and

Promoting bilateral and multilateral discussions with those rom international law enorcement

and security communities to improve inormation sharing on threats and best practices.

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Empowering an informed, involved, and observant citizenry

Individual members o our communities are best positioned to observe the initial indicators o illicitactivity. It is critical that these individuals are willing and able to inorm law enorcement and security

communities o suspicious or unusual activity. We must seek to encourage the development o social

networks that derive rom positive and productive relationships among our law enorcement and

security communities and members o those communities at unique risk o exploitation. We will seek

to oster these relationships by:

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NatioNal Strategy for CouNteriNg BiologiCal threatS

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

WMDrelated shipments o prolieration concern to and rom both States and nonState 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

r 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:

r Ensuring that all Federal partners develop, utilize, and update tools or communicating withthe 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 I NTER NATIO NAL DIALO G UE O N BIO LO G IC AL THR EATS

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:

r 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.

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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:

r Providing assistance to partner countries and regions along the spectrum o objectives in thisStrategyin 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.

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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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ro le S aNd re S p o NS iBilitie S

Roles and Responsibilities

Because o the broadbased 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 activitiesto 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 multilayered 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 highrisk

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

Providing guidance and, as appropriate, unding to the private sector to support awarenessraising, training, and appropriate publicprivate partnerships, in conjunction with states and

localities; and

Conducting the ull range o preparations to ensure an eective response in the event o abiological 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 highriskpathogens and toxins at acilities within their communities;

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

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

r Conducting organizational assessments regarding potential vulnerabilities that could give aidto those seeking to develop or use biological weapons and taking all reasonable measures to

reduce their risk o exploitation;

r Ensuring that all reasonable measures are taken to promote the saety and security o high-riskpathogens and toxins within their possession;

r Establishing and supporting robust participation in ora where sector colleagues and otherstakeholders can discuss risks, raise awareness, and explore community-based approaches and

best practices or risk management; and

r Maintaining productive working relationships with local, State, and Federal law enorcementagencies 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:

r Following general guidance or disaster preparedness, such as keeping supplies o ood andother materials at homeas recommended by authoritiesto support essential needs o the

household or several days i necessary;

r Being prepared to ollow public health guidance that may include limiting their mobilitythroughout the community or several days or weeks, or utilizing designated evacuation routes;

and

r Inorming appropriate authorities when they encounter or observe suspicious or unusualactivities.

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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RO LE S AND RE S P O NS IBILITIE S

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:

r Comply ully with their legal and politically-binding obligations under the BWC - or those thatare 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.

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National Strategy for Countering Bio Threats

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Transcript of National Strategy for Countering Bio Threats