American Physical Society Dr Daniel Gerstein Under Secretary Acting Science amp Technology Directorate November 3 2013 1 National Strategy for Countering Biological Threats November 2009 ID: 780016
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Slide1
Department of Homeland Security Science & Technology
American Physical SocietyDr. Daniel GersteinUnder Secretary (Acting)Science & Technology DirectorateNovember 3, 2013
1
-- National Strategy for Countering Biological Threats, November 2009
“The effective dissemination of a lethal biological agent within an unprotected population could place at risk the lives of hundreds of thousands of people. The unmitigated consequences of such an event could overwhelm our public health capabilities, potentially causing an untold number of deaths. The economic cost could exceed one trillion dollars for each such incident.”
Slide2Dimensions of Emergencies
2LowHigh
Existential
LowPsycho-Social Impact(Fear, Societal Cohesion, Survival)HighExtremeExtent of Damage (Life, Property, Economic)SLTT ResponseFederal Lead
Disasters
(big emergency)
Catastrophes
(really big emergency)
1
State threatening
(ability of government to function/survive in doubt)
2001 Anthrax
9/11
Katrina
*
*
Spanish Flu
*
*
2009 Flu Pandemic
Chernobyl
*
Haitian Earthquake
*
2003 SARS
*
Japanese Earthquake & Tsunami
*
2
3
4
Cyber Dimensions of Possible Future Emergencies
Minor
Emergencies
*
*
2001 UK Foot & Mouth Disease Outbreak
*
1995
Aum
Shinrikyo
Slide3Aerosol Release
2001 Anthrax Attacks
Number that received antibiotic treatment
30,000Number of illnesses22Number of deaths5Decontamination6 Buildings
Direct Economic Cost
>$1 B
Number that will need antibiotic treatment
1.9-3.4 M
Number of illnesses
~450,000
Number of deaths
~380,000
Decontamination
City wide
Projected Economic Cost
>$1.8 T
1 gm
via letters
1-2 kg
via cropduster
Biological Weapons Present Diverse Risks
3
Slide4Nature of the Biological Threat
4
4
Historical Perspective
Biotech & Dual Use Concern
Likelihood of Event
BWC EIF
Rajneeshee
Attack
Aum
Shinrikyo
Inspire
Magazine
Advanced Manufacturing
Polymerase Chain Reaction (PCR)
Human Genome Project
Amerithrax
Attack
First Synthetic Cell
Recombinant DNA
Gene Modification
Open-Source
Biosynthetics
Poliovirus Synthesized
Synthetic Pathogens
Selective DNA Isolation
H5N1 Articles
UK FMD Outbreak
SARS
H1N1 Pandemic
Zaire
ebolavirus
(ZEBOV)
West Nile Virus in USA
Insider Threat
E. Coli (Germany)
State –like capabilities in hands of non-state actors
Sverdlovsk Anthrax Release
“Proliferation” of BSL-3+ labs
DIY Bio
State-Sponsored BW Programs
State BW Use
Accident, Misuse or Bioterror
Naturally Occurring (perhaps Black Swan) Biological Event
1975
1985
1995
2000
2005
2010 Future
Rapid naturally occurring disease spread
Role of Bioinformatics
H7N9
MERS-
CoV
Slide5Examining the Potential for Bioterror
5
-20 Years -10 Years Today + 10 Years +20 Years +30 Years
Why did the Rajneeshes fail?Why did Aum Shinrikyo fail?
What did we learn from the Anthrax attacks?
P
Viable Attack
1.0
P
Viable Attack
=
f
{Capabilities, Intent, Knowledge}
What does this tell us about the potential for a bioterror attack in the future?
Project
Bacchus
Dr. Eckert Wimmer
Dr. Mark Butler
Dr. Steven Kurtz
Amerithrax
77 BW events in over 100 years
Dr. Jerzy Mierzejewski
Dr. William Patrick
task
(-)
(+)
Slide6Agriculture Threat Space
Foreign Animal Diseases (FADs) are endemic, spreading, and emerging globally on six continentsFADs could be easily introduced intentionally (agroterrorism) or accidentally (food imports, foreign travelers)FMD is widely considered to be the number one agricultural threat to the USAn “across the nation” outbreak of a FAD like foot-and-mouth disease could result in losses of up to $60 billion (USDA, 2005) resulting from control measures and protective embargoes6
Foot and Mouth Disease - 2010
Slide7Massively lethal, proven to work – with 1960s technology
Essential materials, know-how cheap, widely available, dual-use: hard to track, easily hiddenAttribution issue – Difficult for states to respond to attacksReload potential: self-replicating organisms; risk multiple attacksMitigation requires specific countermeasures quickly and in quantityContagious disease introduces new dynamicPotency, diversity, and accessibility of biothreats
will increase as bioscience advancesBioweapons are a Strategic Threat
7State-like capabilities in the hands of small groups and individuals …
Slide8U.S. Government & DHS Biodefense Programs
8
One Health
BSAT RegulationsDual Use Research of Concern (DURC)Export ControlsNunn-Lugar Cooperative Engagement (State & Defense)Biorisk Management: Biosafety, Biosecurity, BioethicsBWCWHO International Health Regulations (IHR)UNSCR 1540Australia GroupBilateral arrangements
Laboratory Response Network (LRN)
Biological
Threat
Spectrum
Natural Disease Outbreak
Unintended Consequences
Accidents
Negligence
Vandalism, Sabotage
Deliberate Use of BW
Biodefense issues are:
International & Interagency
Complex & Multidisciplinary
Inherently dual use
FAO & OIE
Slide9PPD-8 National Preparedness System: Prevention, Protection, Mitigation, Response, Recovery
DHS Interest in Countering WMD 9Laws & Treaties
UNSCR 1540
NPTOther International INTERPOLAustralia GroupCoalition of the WillingProliferation Security Initiative (PSI)U.S. InitiativesExport Control & Border Security (EXBS)Counter Terrorism (CT)
Layered defense
Shared Outcomes
Build Partner Capacity
Catch Cheaters
Deterrence
Goals
WHO International Health Regulations
Wassenar
Global Initiative to Combat Nuclear Terrorism (GICNT)
BWC & CWC
HSPD-10 Biodefense
GNDA
“Beyond the Border”
DHS Initiatives
Bilateral arrangements
SAFE Port Act
Slide10Department of Homeland Security
10
The DepartmentOrganizations: 22 to 1 …
Personnel: DHS = ~230K; HSE = ~3.5MCulture of law enforcementCoordination vs. directionDepartment of Homeland SecurityFirst Responders across U.S.Critical InfrastructureHomeland Security Enterprise (HSE)Federal
State
Local
Tribal
Territorial
International
… the 16 critical infrastructure sectors
Slide11One of 10 DHS Components
Provides key technical & analytical capacity for DHSSupports DHS, Component and HSE requirements with innovation Operationally focused S&T statistics:~1.2% of DHS Budget~1,100 personnelFederal, contractor, IPAsHighly technical staffSix primary
commodity areasFirst responders, borders & maritime, cyber, chem-bio defense
, explosives, resilienceHighly collaborativeComponents & HSEState & LocalInteragency & InternationalIndustry & Private sectorLaboratories5 Internal LabsExplosives, biodefense, chemical, urban environmentAdding new agricultural biodefense labResponsible for usage of DOE Labs & FFRDCsS&T At A GlanceDHS S&T Mission: Strengthen America’s security and resiliency by providing knowledge products and innovative technology solutions for the Homeland Security Enterprise (HSE)11
Slide12Systems Analysis – Biodefense Example
DeliverablesMaximizing Operational & Technology Returns in Challenging Fiscal Times12
What is a comprehensive biodefense strategy?
How does the Department of Homeland Security fit into the national biodefense architecture?What are the seams and gaps in the architecture?Identify Threats, Risks & Opportunities.Develop Objectives & PrioritiesFill Requirements & Gaps
S&T’s Value Added Proposition
From R&D to
r&D
A
B
Operationally focused
… focused technology options & operational process enhancements
Innovative
… develop innovative, systems-based solutions to complex homeland security problems
Building Partnerships
… technical depth and reach to leverage technology solutions from federal, state, local and tribal governments, universities, and the private sector - across the US and internationally
Slide13DHS Biodefense: Strategy to Capability
13Strategic
Guidance
OperationalDirectivesHomeland Security Presidential Directive (HSPD)-10RequirementsHSPD-18Medical Counter-Measures Against WMD (2007)PPD-8National Preparedness(2011)PPD-2National Strategy for Countering Biological Threats (2009)HSPD-9Defense of U.S. Agriculture & Food
(2004)
HSPD-10
Biodefense for the 21st Century
(2004)
Prevention
, Protection, Mitigation, Response, Recovery
Biological Select Agent & Toxin Executive Order (2010)
DHS Concerns
Knowledge Management
Threat Characterization
Detection & Surveillance
Forensics & Attribution
Response & Recovery
Bioterrorism
Foreign Animal
Disease
Food Contamination
Emerging Infectious Disease
Interagency & International
Collaboration
Homeland Security Act 2002
Quadrennial Homeland Security Review (2010
)
Countering Biological Threats (2009)
U.S. Federal Law
Natural Disease Outbreak
Unintended Consequences
Accidents
Negligence
Vandalism, Sabotage
Deliberate Use of BW
Biological
Threat
Spectrum
Slide14HSPD 10: Biodefense for the 21st
Century DHS Efforts14
Biological Threat Characterization
Material threat assessmentsLab studiesBio-Defense Knowledge CenterRisk Assessments Threat Awareness Prevention & ProtectionDual-Use Research of ConcernFoot-and-Mouth Disease (FMD) vaccineProtocols and Standards Compliance Assurance Program OfficePromoting international standards for BSAT and BWC complianceWhite Powder Sampling
BioAssays
& biological materials repository
Next Gen Bio Detection
Detect-to-Protect for high value assets
Rapid
Biodetection
Environmental sampling
National Biosurveillance Integration Center (NBIC)
Surveillance & Detection Response & Recovery
Operational Tools for remediation & decontamination
Bioforensic Research and Development
Systems Approaches for developing guidance
Underground Transport Restoration
Anthrax
reaerosolization
to examine the properties of dry powder anthrax to determine guidance, countermeasures and decontamination strategies
Slide15Risk Assessment Technical Approach
Probabilistic Risk Assessment (PRA) MethodologyConsistent method for aggregating risk from a large set of scenarios with consideration of uncertaintyUseful for comparing risks against one another in a manner that captures uncertaintyProvides decision-makers with the opportunity to ask the ‘what-if’ questions. Can consider relative value of potential risk mitigation strategies
Consequences
are the expected public health and economic impacts of an attackRisk is a function of likelihood and consequences. Terrorism risk assessments are ‘end-to-end,’ integrating likelihood and consequences of terrorism eventsLikelihood is the probability that an adversary acquires, produces, and disseminates a weapon[Risk] = [Likelihood] X [Consequences]15
Slide16Enhanced
Bioterrorism Risk Assessment Process
Intelligence
and Scientific Communities expert elicitation Validate Input DataUse Probabilistic Risk Assessment (PRA) methodology to explore risk space 1
2
3
Identify and validate key scenarios within the risk
space
Range of outcomes by agent, scenario, etc.
Scenario of interest
4
Validate Results
5
Conduct sensitivity analysis – also provide to key external audiences for use in conducting further analysis
6
7
Publication of risk assessment document and briefing of results
Use of the Bioterror Risk Assessment for Interagency and DHS operational
planning and resource prioritization
16
Slide17Complicating Factor #1: Dealing with the Number & Diversity of Key Actors
17
Must develop common understanding of the threat, lexicon, plans, procedures, communications, etc.
17Non-state ActorsDepartment of Justice
Department of Homeland Security
Private Industry
Department of Defense
First Responders
Academia?
Others?
International
Slide18Complicating Factor #2: Requires a Systemic Approach to the Issue
18Zone 2: Finding & Securing
Materials In Transit
INTERPOLProliferation Security Initiative (PSI)International AgreementsPort & Maritime SecurityZone 3: Finding & Securing It in the HomelandFederal, State, Local assetsBorder SecurityPort SecurityUS Coast GuardOthers …
Zone 1: Securing
WMD Material
at the Source
Left of loss: “Is everything where it should be?”
Personnel Reliability
Access Controls
Inventory Management
Detection, Alarms
Physical Protection
Emergency Response
Towards a layered defense …
Slide19Complicating Factor #3: Need to Maximize Outcomes
19
19
Slide20DHS S&T Contributions to Biodefense
International & Academic
S&T Labs
Successes (Examples)Chem-Bio Division …Save lives & protect Nation’s infrastructure against chemical, biological & agricultural threats & disasters. DOE National LabsDefense Threat Reduction Agency (DTRA)Department of AgricultureOthers …InteragencyFoot & Mouth Disease (FMD) Vaccine
Rapid point of care diagnosticsMedical Countermeasures Development (MCM) support
“White Powder” standard
Assay development standards
Threat characterization studies
Bioterror Risk Assessment (BTRA)
Bioforensics
20
Areas of Concern (Examples)
Agricultural Vaccines
International BSAT Standards
Resilience Communication
Crisis Management
Local Response Capability
Forecasting Future Threats
Public Biothreat Education
Supply Chain Security
Int’l/Domestic Response Training
Integrated Consortium of Laboratory Networks (ICLN)
Decon of CI/KR (Ag & Bio)
Slide21All response is local! Feds will not arrive immediately and
state and locals will be overwhelmedUS health care system and 90% of critical infrastructure is in private handsWhat is appropriate investment in preparation for routine hazards vs. high consequence events of indeterminate probability?How can we educate and train responders and the public for rare events?How can we collaborate internationally more effectively?
Reality Check
21