Department of Homeland Security Science & Technology

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Emory Griffin
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1 Department of Homeland Security Science & Technology Presentation to the FAZD Annual Meeting Dr. Daniel Gerstein Deputy Under Secretary Science & Technology Directorate June 27,

2 One of 10 DHS Components Provides key technical & analytical capacity for DHS Operationally focused Supports DHS, Component and HSE requirements with innovation S&T statistics: ~1.2% of DHS Budget ~1,200 personnel S&T At A Glance 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 Biodefense, chemical, explosives, urban environment Adding new agricultural biodefense lab Responsible for usage of DOE Labs & FFRDCs DHS S&T Mission: Strengthen America s security and resiliency by providing knowledge products and innovative technology solutions for the Homeland Security Enterprise (HSE) 2

DHS Mission Guidance Complex & Dynamic Environment White House Guidance (Examples)

Globalization & Transportation Border Security & Immigration Violent Extremism

HSPD-5 National Incident Management System (2003) HSPD-7 Critical Infrastructure

Defense of United States Agriculture and Food U.

QHSR (Feb 2010) Energy Sector Plan (2010) Threats Smaller Scale Terrorism

Consequence WMD Core Missions 1. Preventing terrorism & enhancing security 2.

3 DHS Mission Guidance Complex & Dynamic Environment White House Guidance (Examples) Strategic Guidance (Examples) Quadrennial Homeland Security Review (QHSR) 2010 Globalization & Transportation Border Security & Immigration Violent Extremism Cyber Domain Nature of Innovation Natural Disasters More Threats, Less Resources HSPD-5 National Incident Management System (2003) HSPD-7 Critical Infrastructure Identification & Protection (2003) PPD-8 National Preparedness (2011) HSPD-9 Defense of United States Agriculture and Food U.S Law & Interagency Homeland Security Act 2002 National Response Framework (2008) QHSR (Feb 2010) Energy Sector Plan (2010) Threats Smaller Scale Terrorism Trafficking & Crime Pandemics, Accidents, Natural Hazards Violent Extremism High Consequence WMD Core Missions 1. Preventing terrorism & enhancing security 2. Securing and managing our borders 3. Enforcing & administering immigration laws 4. Safeguarding and securing cyberspace 5. Ensuring resilience to disasters 3

4 Department of Homeland Security Homeland Security Enterprise (HSE) First Responders across the Nation Critical Infrastructure Personnel: DHS is about 230K HSE is about 3.5M Culture of law enforcement Focus on borders, customs enforcement & maritime Requires threat, lexicon, plans, procedures, communications, etc. 4

5 Organization of DHS Science & Technology (S&T) Aligned with Mission Under Secretary Deputy Under Secretary TSA, CBP, CIS, ICE, USSS, FEMA, USCG, NPPD, DNDO, OHA, First Responders First Responders Group (FRG) Interoperability & Compatibility Technology Clearinghouse National Urban Security Technology Lab (NUSTL) Homeland Security Advanced Research Projects Agency (HSARPA) Borders & Maritime Chemical/Biological Cyber Security Explosives Resilient Systems Acquisition Support & Operations Analysis (ASOA) Research & Development Analysis & Assessment Transportation Security Lab (TSL) Federally Funded Research & Development Centers Program Management Office Standards Test & Evaluation S&T s Value Added Proposition Operationally focused focused technology options & operational process enhancements Innovative develop innovative, systems-based solutions to complex homeland security problems 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 Research & Development Partnerships (RDP) Interagency International National Labs Plum Island (PIADC) National Biodefense Analysis & Countermeasures Center (NBACC) Chemical Security Analysis Center (CSAC) National Bio & Agro-Defense Facility (NBAF) Public-Private Partnerships University Programs 5

Develop Objectives & Priorities Fill Requirements & Gaps What is a comprehensive biodefense strategy?

6 Maximizing Operational & Technology Returns in Challenging Fiscal Times From R&D to r&d Collaboration B A Including Technology Foraging Systems Analysis Biodefense Example Deliverables Identify Threats, Risks & Opportunities. Develop Objectives & Priorities Fill Requirements & Gaps 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? 6

7 DHS S&T Performers DOE National Labs Federally Funded Research & Development Centers (FFRDCs) International DHS S&T Labs CSAC TSL NUSTL PIADC Private Industry Large Integrators NBACC NBAF Medium & Small Business Industry Organizations Investment Community DHS Centers of Excellence (COE) & Academic Institutions Interagency 7

8 Nature of the Biological Threat State-Sponsored BW Programs Rajneeshee Attack Aum Shinrikyo Amerithrax Attack Inspire Magazine Proliferation of BSL-3+ labs Historical Perspective Zaire ebolavirus (ZEBOV) BWC EIF Sverdlovsk Anthrax Release E. Coli (Germany) West Nile Virus in USA H1N1 SARS Pandemic UK FMD Outbreak H7N9 MERS-CoV State like capabilities in hands of non-state actors Rapid naturally occurring disease spread Biotech & Dual Use Concern Recombinant DNA Gene Modification Human Genome Project Polymerase Chain Reaction (PCR) Poliovirus Synthesized Synthetic Pathogens First Synthetic Cell H5N1 Articles Open-Source Biosynthetics Role of Bioinformatics Advanced Manufacturing Selective DNA Isolation Insider Threat DIY Bio Likelihood of Event State BW Use Future 8

Examining the Potential for Bioterror P Viable Attack P Viable Attack = f {Capabilities, Intent, Knowledge} 1.

Eckert Wimmer Dr. Mark Butler Dr. Steven Kurtz Amerithrax 77 BW events in over 100 years Dr. Jerzy Mierzejewski Dr.

yr 6 months 1940 1950 1960 1970 1980 1990 2000 Solid State Peptide and Nucleic Acid Synthesis 1970 Vaccines Nucleic Acid Probes

Project 1989 Encapsulization & Stabilization Antibiotics Bioactive Peptides Cell Growth Chambers / Fermenters 1940 1950 1960

9 Examining the Potential for Bioterror P Viable Attack P Viable Attack = f {Capabilities, Intent, Knowledge} 1.0 Why did Aum Shinrikyo fail? Why did the Rajneeshes fail? What did we learn from the Anthrax attacks? (+) 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 (-) (Height of line indicates rate of development time to double) (Arrows show enabling technology) 5 yr 1 yr 6 months Solid State Peptide and Nucleic Acid Synthesis 1970 Vaccines Nucleic Acid Probes Chimeric Monoclonal Antibodies Monoclonal Antibodies 1972 Sensors 1984 DNA Engineering 1982 Pathogen Efficacy 1992 Human Genome Project 1989 Encapsulization & Stabilization Antibiotics Bioactive Peptides Cell Growth Chambers / Fermenters What does this tell us about the potential for a bioterror attack in the future? -20 Years -10 Years Today + 10 Years +20 Years +30 Years 9

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

10 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) 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 FMD is widely considered to be the number one agricultural threat to the US 10

11 Biological/Agricultural Threat: U.S. Government Biodefense Programs Natural Disease Outbreak Unintended Consequences Accidents Negligence Vandalism, Sabotage Biodefense issues are: International & Interagency Complex & Multidisciplinary Inherently Dual Use Deliberate Use of BW Biological Threat Spectrum Biorisk Management: Biosafety, Biosecurity, Bioethics Laboratory Response Network (LRN) Dual Use Research of Concern (DURC) BWC FAO & OIE Australia Group Nunn-Lugar Cooperative Engagement (State & Defense) WHO International Health Regulations (IHR) One Health Export Controls UNSCR 1540 BSAT Regulations Bilateral arrangements 11

S&T s Agricultural Defense Programs span the entire outbreak spectrum Tools to support planning and response, drive requirements for countermeasures development and inform

to verify disease free status so uninfected animals and products can continue to move maintaining business continuity Enhanced Passive Surveillance (EPS): includes

threaten the U.S. agricultural critical infrastructure.

12 S&T s Agricultural Defense Programs span the entire outbreak spectrum Tools to support planning and response, drive requirements for countermeasures development and inform postoutbreak response activities by creating scalable (local to national) simulation and modeling tools to analyze potential responses and control options to minimize FAD spread. Vaccines (VX) to rapidly prevent disease in healthy animals prevents disease spread among healthy herd, maintaining business continuity Agricultural Screening Tools (AST): to verify disease free status so uninfected animals and products can continue to move maintaining business continuity Enhanced Passive Surveillance (EPS): includes diagnostic tests, surveillance tools and data integration procedures to identify infected animals prior to overt symptoms and improve our ability to detect diseases that threaten the U.S. agricultural critical infrastructure. High throughput diagnostics (DX) allow more rapid confirmation of disease status and increased sample processing capabilities enhancing our ability to contain outbreaks Livestock Depopulation, Disposal and Decontamination (3D): New methodologies and decision support tools for depopulation, disposal and decontamination that facilitate rapid response and prevent disease spread in a manner that minimizes waste, environmental impact and negative public perception.

DHS S&T Contributions to Biodefense Chem-Bio Division Save lives & protect

point of care diagnostics Medical Countermeasures Development (MCM) support

Threat Reduction Agency (DTRA) Department of Agriculture Others Interagency

Assessment (BTRA) Bioforensics Areas of Concern (Examples) Crisis

l/domestic Response Training Supply Chain Security Decon of CI/KR (Ag &

13 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 DOE National Labs Defense Threat Reduction Agency (DTRA) Department of Agriculture Others Interagency International & Academic Threat characterization studies Bioterror Risk Assessment (BTRA) Bioforensics 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 Forecasting Future Threats Local Response Capability Integrated Consortium of Laboratory Networks (ICLN) 13

14 Accomplishment: Adenovectored FMD Vaccine License Public-private partnership between DHS, USDA and industry Can be produced within the U.S.- does not contain full FMDv genome Included field safety study with 500 dairy and beef cattle Planning ongoing for additional studies other species, duration of immunity, etc. as per needs of industry and USDA Companion DIVA diagnostic test in development by PIADC, FAZD, and VMRD, Inc. 14

University/DHS S&T Success Stories (Examples) 3 B ELISA Assay

vaccine to differentiate infected from vaccinated animals Improved

enterprise to reduce the cost from delays in decision making

product movement for the dairy industry in the event of an outbreak

Business Continuity USDA CEAH SAHOs Practitioners Producers State

15 University/DHS S&T Success Stories (Examples) 3 B ELISA Assay AgCONNECT Bulk Milk Tank Assay Companion diagnostic test for FMD vaccine to differentiate infected from vaccinated animals Improved data integration and coordination across emergency response enterprise to reduce the cost from delays in decision making Provides evidence needed for decisionmakers to permit animal product movement for the dairy industry in the event of an outbreak Biosurveillance Emergency Response PERSPECTIVES Laboratory Capacity Business Continuity USDA CEAH SAHOs Practitioners Producers State epi USDA NCAHEM AVICs SAHOs USERS USDA NAHLN Diagnostic labs USDA NCAHEM AVICs SAHOs Producers 15

Threat Awareness 1 Enhanced Bioterrorism Risk Assessment Process 2 3 Intelligence and Scientific Communities expert elicitation Validate Input Data Use Probabilistic Risk Assessment (PRA) methodology

16 Threat Awareness 1 Enhanced Bioterrorism Risk Assessment Process 2 3 Intelligence and Scientific Communities expert elicitation Validate Input Data Use Probabilistic Risk Assessment (PRA) methodology to explore risk space 6 Conduct sensitivity analysis also provide to key external audiences for use in conducting further analysis 5 Validate Results 4 Scenario of interest Range of outcomes by agent, scenario, etc. Identify and validate key scenarios within the risk space 7 Publication of risk assessment document and briefing of results Use of the Bioterrorism Risk Assessment for Interagency and DHS operational planning and resource prioritization 16

17 DHS S&T Agricultural Biodefense Laboratory Plum Island Animal Disease Center (PIADC) Protect U.S. livestock from the accidental or deliberate introduction of foreign animal diseases (FAD) Built in 1954, PIADC is Undergoing upgrades to maintain safety and provide added near-term capacity BSL-3 only Limited capacity Serves as a critical resource for FAD Development of countermeasures Vaccines, diagnostics, biotherapeutics Will replace PIADC with National Bio and Agro-Defense Facility (NBAF) NBAF is both an economic and security issue Agriculture and the food industry contributes more than $1 trillion to the economy per year and one-sixth of the our gross national product (GDP) One of every eight Americans work in the agricultural sector including farmlands, feedlots, processing plants, warehouses, research facilities, factories for food preparation and packaging and distribution Currently only conducting research on Foot and Mouth Disease (FMD), African Swine Fever, Classical Swine Fever Many of the most dangerous and likely bioterror weapons are zoonotic as determined by DHS Bioterror Threat Assessment (BTRA) The economic impact of an agricultural biological threat would include direct loss of crops, livestock and assets, secondary losses in upstream and downstream markets, lost export markets, significant price effects and a reduction in economic growth caused by allocation of resources 17

The S&T Ag Defense Pipeline S&T s research partnership model fills the pipeline for:

pipeline: From FY10-FY12, FAZD attracted $7.

and priorities from S&T, USDA, State partners, Industry Universities partners develop

18 The S&T Ag Defense Pipeline S&T s research partnership model fills the pipeline for: Testing Piloting Prototyping Concept of operations development COEs are filling the pipeline: From FY10-FY12, FAZD attracted $7.7 M in targeted research contracts from DHS Advancing the partnership model Requirements and priorities from S&T, USDA, State partners, Industry Universities partners develop candidates that fill the pipeline S&T targets early stage candidates for advanced development (15 fold increase) Presenter s Name June 17,

19 Principles of Agricultural Defense Research 1. Holistic systems solutions Define and address the entire problem scope Quality facilities and technologies fit for purpose Early detection and rapid cleanup Controlled movement of animals in uninfected areas 2. Cross-sector collaboration Livestock industry and producers Government including State animal health officials Biopharmaceutical industry and veterinarians First responders and diagnostic laboratories Trusted sharing of information between government and industry 3. Opportunities to field test technologies worldwide Countries endemic to emerging and zoonotic disease U.S. mainland testing of non-replicating vaccines 4. Next generation zoonotic disease professional training Education programs that target gaps in agriculture defense workforce Standardized training programs for the first responders/agriculture interface 5. Critical need for academic innovation High risk, high impact technologies Presenter s Name June 17,

DHS S&T Funded Efforts in Transboundary Animal Diseases and Opportunities for Industry Collaboration

DHS S&T Funded Efforts in Transboundary Animal Diseases and Opportunities for Industry Collaboration 24 October 2012 Michelle Colby, D.V.M., M.S. Branch Chief, Agricultural Defense Chemical and Biological