Department of Homeland Security
Science & Technology
American Physical Society
Dr. Daniel Gerstein
Under Secretary (Acting)
Science & Technology Directorate
November 3, 2013
“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.”
-- National Strategy for Countering
Biological Threats, November 2009
1
Dimensions of Emergencies
State threatening
Existential
(ability of government to
function/survive in doubt)
* Chernobyl
PsychoSocial
Impact
2001 Anthrax
High
(Fear, Societal
Cohesion,
Survival)
*
Low
*
*
2003 SARS
*
2009 Flu Pandemic
1995 Aum
Shinrikyo
4
* Spanish Flu
*Haitian Earthquake
Japanese Earthquake
* & Tsunami
3
* 9/11
Catastrophes
Katrina
* (really big emergency)
Disasters
2
(big emergency)
UK Foot & Mouth
* 2001
Disease Outbreak
Minor 1
Emergencies
Low
Extreme
High
Extent of Damage (Life, Property, Economic)
SLTT Response
Federal Lead
2
Biological Weapons Present Diverse Risks
2001 Anthrax Attacks
1 gm
Number that received
antibiotic treatment
Aerosol Release
via letters
30,000
1-2 kg
via cropduster
Number that will need
antibiotic treatment
1.9-3.4 M
Number of illnesses
22
Number of illnesses
~450,000
Number of deaths
5
Number of deaths
~380,000
Decontamination
6 Buildings
Decontamination
City wide
Direct Economic Cost
>$1 B
Projected Economic Cost
>$1.8 T
3
Nature of the Biological Threat
State-Sponsored BW
Programs
Rajneeshee
Attack
Aum
Shinrikyo
Inspire
Magazine
Amerithrax
Attack
“Proliferation” of BSL-3+ labs
Zaire ebolavirus (ZEBOV)
Historical
Perspective
E. Coli (Germany)
West Nile Virus in USA
H1N1
Pandemic
SARS
Sverdlovsk Anthrax Release
Biotech &
Dual Use
Concern
H7N9
MERS-CoV
UK FMD Outbreak
BWC EIF
Recombinant DNA
Gene Modification
Human Genome Project
Poliovirus Synthesized
H5N1
Articles
Synthetic Pathogens
Polymerase Chain Reaction (PCR)
First Synthetic Cell
Insider
Threat
Selective DNA Isolation
State –like
capabilities in hands
of non-state actors
Rapid naturally
occurring disease
spread
Open-Source
Biosynthetics
Role of
Bioinformatics
Advanced
Manufacturing
DIY Bio
Likelihood
of Event
State BW Use
1975
1985
1995
2000
2005
2010
Future
4
Examining the Potential for Bioterror
P Viable Attack = f {Capabilities, Intent, Knowledge}
P Viable Attack
1.0
What did we learn
from the Anthrax
attacks?
(+)
Why did Aum
Shinrikyo fail?
Why did the
Rajneeshes fail?
(Height of line indicates rate of development – time to double)
(Arrows show enabling technology)
1940
1950
1960
1970
5 yr
1 yr 6 months
1980
1990
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
2000
Solid State Peptide and Nucleic Acid Synthesis 1970
Nucleic Acid Probes
Vaccines
Chimeric Monoclonal Antibodies
Monoclonal Antibodies
1972
What does this
tell us about the
potential for a
bioterror attack in
the future?
Sensors 1984
DNA Engineering 1982
Pathogen Efficacy 1992
Human Genome Project 1989
Encapsulization & Stabilization
Antibiotics
Bioactive Peptides
Cell Growth Chambers / Fermenters
1940
-20 Years
1950
-10 Years
1960
Today
1970
1980
+ 10 Years
1990
2000
+20 Years
+30 Years
5
Agriculture Threat Space
 Foreign Animal Diseases (FADs)
are endemic, spreading, and
emerging globally on six
continents
 FADs 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 US
 An “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 embargoes
Foot and Mouth Disease - 2010
6
Bioweapons are a Strategic Threat
 Massively lethal, proven to work – with 1960s technology
 Essential materials, know-how cheap, widely available, dual-use:
hard to track, easily hidden
 Attribution issue – Difficult for states to respond to attacks
 Reload potential: self-replicating organisms; risk multiple attacks
 Mitigation requires specific countermeasures quickly and in quantity
 Contagious disease introduces new dynamic
 Potency, diversity, and accessibility of biothreats will increase as
bioscience advances
State-like capabilities in the hands of small groups and individuals …
7
U.S. Government & DHS Biodefense Programs
Natural Disease Unintended
Consequences Accidents Negligence
Outbreak
Vandalism,
Sabotage
Deliberate
Use of BW
Biological
Threat
Spectrum
Biodefense issues are:
 International & Interagency
 Complex & Multidisciplinary
 Inherently dual use
Nunn-Lugar Cooperative Engagement (State & Defense)
Biorisk Management:
Biosafety, Biosecurity,
Bioethics
Australia
Group
WHO International Health
Regulations (IHR)
Laboratory Response Network (LRN)
Dual Use Research of
Concern (DURC)
BWC
FAO & OIE
One Health
UNSCR 1540
BSAT Regulations
Bilateral
arrangements
Export Controls
8
DHS Interest in Countering WMD
Laws &
Treaties
Other
International
Coalition of
the Willing
U.S.
Initiatives
DHS
Initiatives
Goals
UNSCR 1540
NPT
BWC & CWC
Australia Group
WHO International
Health Regulations
Wassenar
INTERPOL
Proliferation Security Initiative (PSI)
Global Initiative to Combat
Nuclear Terrorism (GICNT)
“Beyond the
Bilateral
Border”
arrangements
Export Control & Border
Security (EXBS)
Counter
Terrorism (CT)
GNDA
SAFE Port Act
HSPD-10
Biodefense
• Layered
defense
• Shared
Outcomes
• Build Partner
Capacity
• Catch
Cheaters
• Deterrence
PPD-8 National Preparedness System:
Prevention, Protection, Mitigation,
Response, Recovery
9
Department of Homeland Security
International
Federal
State
Local
Tribal
Territorial
Homeland
Security
Enterprise
(HSE)
 Department of Homeland Security
 First Responders across U.S.
 Critical Infrastructure
… the 16 critical
infrastructure
sectors
The Department
 Organizations: 22 to 1 …
 Personnel: DHS = ~230K;
HSE = ~3.5M
 Culture of law enforcement
 Coordination vs. direction
10
S&T At A Glance
DHS S&T Mission: Strengthen America’s security and resiliency by providing
knowledge products and innovative technology solutions for the Homeland
Security Enterprise (HSE)
 One of 10 DHS Components
 Provides key technical & analytical
capacity for DHS
 Supports DHS, Component and HSE
requirements with innovation
 Operationally focused
 S&T statistics:
 ~1.2% of DHS Budget
 ~1,100 personnel
 Federal, contractor, IPAs
 Highly technical staff
 Six primary commodity areas
 First responders, borders &
maritime, cyber, chem-bio defense,
explosives, resilience
 Highly collaborative
 Components & HSE
 State & Local
 Interagency & International
 Industry & Private sector
 Laboratories
 5 Internal Labs
 Explosives, biodefense, chemical,
urban environment
 Adding new agricultural
biodefense lab
 Responsible for usage of DOE Labs &
FFRDCs
11
Maximizing Operational & Technology
Returns in Challenging Fiscal Times
S&T’s Value Added Proposition
From R&D to r&D
 Operationally focused … focused technology
options & operational process enhancements
 Innovative … develop innovative, systemsbased solutions to complex homeland
security problems
 Building Partnerships … technical depth and
reach to leverage technology solutions from
federal, state, local and tribal governments, A
universities, and the private sector - across
the US and internationally
Systems Analysis – Biodefense Example
Identify Threats, Risks
& Opportunities.
Develop Objectives &
Priorities
Fill Requirements &
Gaps
B
Deliverables
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?
12
DHS Biodefense: Strategy to Capability
Biological
Threat
Spectrum
Strategic
Guidance
Operational
Directives
Homeland
Security
Presidential
Directive
(HSPD)-10
Requirements
DHS
Concerns
Natural Disease Unintended
Consequences Accidents Negligence
Outbreak
U.S. Federal
Law
HSPD-9
Defense of
U.S.
Agriculture &
Food
(2004)
Homeland
Security Act 2002
HSPD-10
Biodefense
for the 21st
Century
(2004)
Countering Biological
Threats (2009)
HSPD-18
Medical
CounterMeasures
Against
WMD (2007)
PPD-2
National
Strategy for
Countering
Biological
Threats (2009)
Vandalism,
Sabotage
Deliberate
Use of BW
Quadrennial Homeland
Security Review (2010)
Biological
Select Agent
& Toxin
Executive
Order (2010)
PPD-8
National
Preparedness
(2011)
Prevention, Protection, Mitigation, Response, Recovery
Knowledge
Management
Threat
Characterization
Detection &
Surveillance
Forensics &
Attribution
Response &
Recovery
Interagency &
International
Collaboration
Bioterrorism
Food
Contamination
Emerging
Infectious
Disease
Foreign
Animal
Disease
13
HSPD 10: Biodefense for the 21st
Century DHS Efforts
Threat Awareness
Prevention &
Protection
 Dual-Use Research of Concern
 Biological Threat Characterization
 Material threat assessments
 Lab studies
 Bio-Defense Knowledge Center
 Risk Assessments
Surveillance & Detection
 Foot-and-Mouth Disease (FMD) vaccine
 Protocols and Standards
 Compliance Assurance Program Office
 Promoting international standards for
BSAT and BWC compliance
 White Powder Sampling
Response & Recovery
Operational Tools for remediation &
decontamination
Bioforensic Research and Development
 BioAssays & biological materials repository
 Next Gen Bio Detection
 Detect-to-Protect for high value assets
 Rapid Biodetection
 Environmental sampling
 National Biosurveillance Integration Center (NBIC)
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
14
Risk Assessment Technical Approach
 Probabilistic Risk Assessment (PRA) Methodology
[Risk] = [Likelihood] X [Consequences]
Likelihood is the probability
that an adversary acquires,
produces, and disseminates a
weapon
Consequences are the
expected public health and
economic impacts of an
attack
Risk is a function of likelihood and consequences.
Terrorism risk assessments are ‘end-to-end,’ integrating
likelihood and consequences of terrorism events
 Consistent method for aggregating risk from a large set of scenarios
with consideration of uncertainty
 Useful for comparing risks against one another in a manner that
captures uncertainty
 Provides decision-makers with the opportunity to ask the ‘what-if’
questions. Can consider relative value of potential risk mitigation
strategies
15
Enhanced Bioterrorism Risk
Assessment Process
1
3
2
Validate
Input
Data
Use Probabilistic Risk
Assessment (PRA)
methodology to explore
risk space
Intelligence and Scientific
Communities expert elicitation
6
4
5
Conduct sensitivity analysis –
also provide to key external
audiences for use in conducting
further analysis
7
Validate
Results
Scenario of
interest
Range of
outcomes by
agent,
scenario, etc.
Identify and validate key
scenarios within the risk space
 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
Complicating Factor #1: Dealing with the
Number & Diversity of Key Actors
International
Private
Industry
Department
of Defense
First
Responders
Department
of Homeland
Security
Department
of Justice
Academia?
Others?
Non-state
Actors
Must develop common understanding of the
threat, lexicon, plans, procedures,
communications, etc.
17
17
Complicating Factor #2: Requires a
Systemic Approach to the Issue
Towards a layered defense …
Zone 1: Securing WMD
Material at the Source
Left of loss: “Is everything where it
should be?”
Zone 3: Finding
& Securing It in
the Homeland
 Federal, State,
Local assets
 Border Security
 Port Security
 US Coast Guard
 Others …
Zone 2: Finding &
Securing Materials In
Transit
 INTERPOL
 Proliferation Security
Initiative (PSI)
 International
Agreements
 Port & Maritime
Security






Personnel Reliability
Access Controls
Inventory Management
Detection, Alarms
Physical Protection
Emergency Response
18
Complicating Factor #3: Need to
Maximize Outcomes
19
19
DHS S&T Contributions to Biodefense
Chem-Bio Division
…Save lives &
protect Nation’s
infrastructure against
chemical, biological
& agricultural threats
& disasters.
S&T Labs
Successes (Examples)
 Foot & Mouth Disease (FMD) Vaccine
 Rapid point of care diagnostics
 Medical Countermeasures Development
(MCM) support
 “White Powder” standard
 Assay development standards
 Threat characterization studies
Interagency
 DOE National Labs
 Bioterror Risk Assessment (BTRA)
 Defense Threat Reduction
Agency (DTRA)
 Bioforensics
 Department of Agriculture
 Others …
International
&
Academic
Areas of Concern (Examples)
Crisis Management
International BSAT Standards
Agricultural Vaccines
Int’l/Domestic Response Training
Supply Chain Security
Decon of CI/KR (Ag & Bio)
Public Biothreat Education
Resilience Communication
Local Response Capability
Forecasting Future Threats
Integrated Consortium of Laboratory Networks (ICLN)
20
Reality Check
 All response is local! Feds will not arrive immediately and state and
locals will be overwhelmed
 US health care system and 90% of critical infrastructure is in private
hands
 What 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?
21