Department of Homeland Security Science & Technology

1. Department of Homeland Security Science & Technology American Physical Society Dr. Daniel Gerstein Under Secretary (Acting) Science & Technology Directorate November 3, 2013 -- 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.”

2. Dimensions of Emergencies State threatening(ability of government to function/survive in doubt) Existential 4 * Spanish Flu * Chernobyl * Haitian Earthquake * 3 Psycho-Social Impact (Fear, Societal Cohesion, Survival) 9/11 * * Japanese Earthquake & Tsunami Catastrophes(really big emergency) 2001 Anthrax High * Katrina * 2003 SARS * 2009 Flu Pandemic 2 Disasters(big emergency) * 1995 AumShinrikyo * 2001 UK Foot & Mouth Disease Outbreak MinorEmergencies 1 Low Cyber Dimensions of Possible Future Emergencies Extreme High Low Extent of Damage (Life, Property, Economic) Federal Lead SLTT Response

3. Biological Weapons Present Diverse Risks 2001 Anthrax Attacks Aerosol Release 1 gm via letters 1-2 kg via cropduster

4. Nature of the Biological Threat Inspire Magazine Aum Shinrikyo Amerithrax Attack Rajneeshee Attack State-Sponsored BW Programs “Proliferation” of BSL-3+ labs State –like capabilities in hands of non-state actors Zaire ebolavirus (ZEBOV) Historical Perspective Biotech & Dual Use Concern Likelihood of Event E. Coli (Germany) West Nile Virus in USA H1N1 Pandemic Rapid naturally occurring disease spread Sverdlovsk Anthrax Release SARS H7N9 UK FMD Outbreak BWC EIF MERS-CoV Open-Source Biosynthetics Recombinant DNA Human Genome Project Poliovirus Synthesized H5N1 Articles Role of Bioinformatics Gene Modification Synthetic Pathogens Advanced Manufacturing First Synthetic Cell Polymerase Chain Reaction (PCR) Insider Threat Selective DNA Isolation DIY Bio Naturally Occurring (perhaps Black Swan) Biological Event Accident, Misuse or Bioterror State BW Use 4 1975 1985 1995 2000 2005 2010 Future

5. P Viable Attack = f {Capabilities, Intent, Knowledge} What did we learn from the Anthrax attacks? Why did Aum Shinrikyo fail? Why did the Rajneeshes fail? Examining the Potential for Bioterror P Viable Attack 1.0 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 (-) 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

6. 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

7. 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 …

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

9. DHS Interest in Countering WMD Goals UNSCR 1540 Laws & Treaties NPT BWC & CWC • Layered defense • Shared Outcomes • Build Partner Capacity • Catch Cheaters • Deterrence Australia Group Other International INTERPOL WHO International Health Regulations Wassenar Proliferation Security Initiative (PSI) Coalition of the Willing “Beyond the Border” Global Initiative to Combat Nuclear Terrorism (GICNT) Bilateral arrangements Export Control & Border Security (EXBS) Counter Terrorism (CT) U.S. Initiatives HSPD-10 Biodefense SAFE Port Act GNDA PPD-8 National Preparedness System: Prevention, Protection, Mitigation, Response, Recovery DHS Initiatives

10. Department of Homeland Security International Federal State Local Tribal Territorial • Department of Homeland Security • First Responders across U.S. • Critical Infrastructure • The Department • Organizations: 22 to 1 … • Personnel: DHS = ~230K; HSE = ~3.5M • Culture of law enforcement • Coordination vs. direction Homeland Security Enterprise (HSE) … the 16 critical infrastructure sectors

11. 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

12. 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, 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 B A Systems Analysis – Biodefense Example 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? Identify Threats, Risks & Opportunities. Develop Objectives & Priorities Fill Requirements & Gaps

13. DHS Biodefense: Strategy to Capability • Biological Threat Spectrum Unintended Consequences Natural Disease Outbreak Deliberate Use of BW Vandalism, Sabotage Negligence Accidents Strategic Guidance U.S. Federal Law Homeland Security Act 2002 Countering Biological Threats (2009) Quadrennial Homeland Security Review (2010) HSPD-10 Biodefense for the 21st Century (2004) PPD-8 National Preparedness (2011) HSPD-9 Defense of U.S. Agriculture & Food (2004) HSPD-18 Medical Counter-Measures Against WMD (2007) PPD-2 National Strategy for Countering Biological Threats (2009) Biological Select Agent & Toxin Executive Order (2010) Operational Directives Prevention, Protection, Mitigation, Response, Recovery Homeland Security Presidential Directive (HSPD)-10 Requirements Knowledge Management Threat Characterization Detection & Surveillance Forensics & Attribution Response & Recovery Interagency & International Collaboration Foreign Animal Disease Bioterrorism Food Contamination Emerging Infectious Disease • DHS Concerns

14. HSPD 10: Biodefense for the 21st Century DHS Efforts Threat Awareness Prevention & Protection • Dual-Use Research of Concern • Foot-and-Mouth Disease (FMD) vaccine • Protocols and Standards • Compliance Assurance Program Office • Promoting international standards for BSAT and BWC compliance • White Powder Sampling • Biological Threat Characterization • Material threat assessments • Lab studies • Bio-Defense Knowledge Center • Risk Assessments 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 • BioAssays & biological materials repository • Next Gen Bio Detection • Detect-to-Protect for high value assets • Rapid Biodetection • Environmental sampling • National Biosurveillance Integration Center (NBIC)

15. Probabilistic Risk Assessment (PRA) Methodology 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 Risk Assessment Technical Approach [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

16. 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 Scenario of interest 5 Range of outcomes by agent, scenario, etc. Validate Results • Conduct sensitivity analysis – also provide to key external audiences for use in conducting further analysis • Identify and validate key scenarios within the risk space 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

17. 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 Non-state Actors Academia? Others? Must develop common understanding of the threat, lexicon, plans, procedures, communications, etc. 17

18. Complicating Factor #2: Requires a Systemic Approach to the Issue Towards a layered defense … Zone 1: Securing WMD Material at the SourceLeft of loss: “Is everything where it should be?” Zone 2: Finding & Securing Materials In Transit Zone 3: Finding & Securing It in the Homeland • Federal, State, Local assets • Border Security • Port Security • US Coast Guard • Others … • INTERPOL • Proliferation Security Initiative (PSI) • International Agreements • Port & Maritime Security • Personnel Reliability • Access Controls • Inventory Management • Detection, Alarms • Physical Protection • Emergency Response

19. Complicating Factor #3: Need to Maximize Outcomes 19

20. DHS S&T Contributions to Biodefense Successes (Examples) • Chem-Bio Division …Save lives & protect Nation’s infrastructure against chemical, biological & agricultural threats & disasters.  • Foot & Mouth Disease (FMD) Vaccine • Rapid point of care diagnostics • Medical Countermeasures Development (MCM) support • “White Powder” standard • Assay development standards • Threat characterization studies • Bioterror Risk Assessment (BTRA) • Bioforensics S&T Labs Interagency • DOE National Labs • Defense Threat Reduction Agency (DTRA) • Department of Agriculture • Others … Areas of Concern (Examples) Crisis Management International BSAT Standards Agricultural Vaccines Int’l/Domestic Response Training International & Academic 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)

21. 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?