Biological/Agricultural Threat: U.S

Department of Homeland Security Science & Technology

Presentation to the FAZD Annual Meeting

Dr. Daniel Gerstein Deputy Under Secretary Science & Technology Directorate

June 27, 2013

1 S&T At A Glance

One of 10 DHS Components  Highly collaborative . Provides key technical & analytical . Components & HSE capacity for DHS . State & Local . Operationally focused . Interagency & International . Supports DHS, Component and HSE requirements with innovation . Industry & Private sector S&T statistics:  Laboratories . ~1.2% of DHS Budget . 5 Internal Labs . ~1,200 personnel  Biodefense, chemical, explosives,  Federal, contractor, IPAs urban environment  Highly technical staff  Adding new agricultural Six primary commodity areas biodefense lab . First responders, borders & . Responsible for usage of DOE Labs & maritime, cyber, chem-bio defense, FFRDCs explosives, resilience 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 & White House Strategic Guidance Quadrennial Homeland Dynamic Guidance (Examples) Security Review (QHSR) 2010 Environment (Examples)

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

Homeland Security  First Responders across the Nation Enterprise (HSE)  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 Organization of DHS Science & Technology (S&T) Aligned with Mission

Under Secretary TSA, CBP, CIS, ICE, USSS, FEMA, USCG, NPPD, DNDO, Deputy Under Secretary OHA, First Responders

Homeland Security Acquisition Support Research & First Responders Advanced Research & Operations Development Group (FRG) Projects Agency Analysis (ASOA) Partnerships (RDP) (HSARPA)  Interoperability &  Borders & Maritime  Research & Development  Interagency Compatibility Analysis & Assessment  Chemical/Biological  International  Transportation Security  Technology  National Labs  Cyber Security Lab (TSL) Clearinghouse  Plum Island (PIADC)  Federally Funded Research &  Explosives  National Biodefense Analysis  National Urban Security Development Centers & Countermeasures Center Technology Lab (NUSTL)  Resilient Systems Program Management Office (NBACC)  Standards  Chemical Security Analysis  Test & Evaluation Center (CSAC)  National Bio & Agro-Defense S&T’s Value Added Proposition … Facility (NBAF)  Public-Private Partnerships  Operationally focused … focused technology options & operational  University Programs 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 5 Maximizing Operational & Technology Returns in Challenging Fiscal Times

From R&D to r&D Collaboration

A Including Technology Foraging

Systems Analysis – Biodefense Example Deliverables

Identify Threats, Risks What is a comprehensive biodefense strategy? & Opportunities. How does the Department of Homeland Develop Objectives & Security fit into the national biodefense Priorities architecture?

Fill Requirements & What are the seams and gaps in the Gaps architecture? 6 DHS S&T Performers

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

Investment Community

7 Nature of the Biological Threat

Aum Inspire Rajneeshee Amerithrax State-Sponsored BW Shinrikyo Magazine Programs Attack Attack “Proliferation” of BSL-3+ labs

Zaire ebolavirus (ZEBOV) State –like Historical E. Coli (Germany) capabilities in hands Perspective West Nile Virus in USA H1N1 of non-state actors Sverdlovsk Anthrax Release SARS Pandemic Rapid naturally occurring disease H7N9 BWC EIF UK FMD Outbreak spread MERS-CoV

Open-Source Biosynthetics Recombinant DNA Human Genome Project Poliovirus Synthesized H5N1 Biotech & Gene Modification Role of Dual Use Synthetic Pathogens Articles Bioinformatics Concern Advanced Polymerase Chain Reaction (PCR) First Synthetic Cell Manufacturing

Selective DNA Isolation Insider DIY Bio Threat

Likelihood of Event

State BW Use

1975 1985 1995 2000 2005 2010 Future 8 Examining the Potential for Bioterror

P = f {Capabilities, Intent, Knowledge} P Viable Attack Viable Attack

1.0 What did we learn from the Anthrax attacks? Project Bacchus Dr. Eckert Wimmer (+) Dr. Mark Butler Dr. Steven Kurtz Why did Aum Amerithrax Shinrikyo fail? 77 BW events in over 100 years Dr. Jerzy Mierzejewski Why did the (-) Dr. William Patrick task Rajneeshes fail?

1 yr 6 months (Height of line indicates rate of development – time to double) 5 yr (Arrows show enabling technology)

1940 1950 1960 1970 1980 1990 2000

Solid State Peptide and Nucleic Acid Synthesis 1970 Vaccines Nucleic Acid Probes Chimeric Monoclonal Antibodies Monoclonal Antibodies 1972 Sensors 1984 What does this tell us DNA Engineering 1982 Pathogen Efficacy 1992 about the potential for Human Genome Project 1989

Encapsulization & Stabilization Antibiotics a bioterror attack in

Bioactive Peptides Cell Growth Chambers / Fermenters the future? 1940 1950 1960 1970 1980 1990 2000

-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 (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 Foot and Mouth Disease - 2010 and protective embargoes

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

10 Biological/Agricultural Threat: U.S. Government Biodefense Programs

Natural Disease Unintended Vandalism, Deliberate Biological Accidents Negligence Outbreak Consequences Sabotage Use of BW Threat Spectrum Biodefense issues are:  International & Interagency  Complex & Multidisciplinary  Inherently Dual Use

Nunn-Lugar Cooperative Engagement (State & Defense) Biorisk Management: Biosafety, Biosecurity, Bioethics Australia WHO International Health UNSCR 1540 Group Regulations (IHR) Laboratory Response Network (LRN) BSAT Regulations Dual Use Research of One Health Concern (DURC) Bilateral arrangements

BWC FAO & OIE Export Controls

11 S&T’s Agricultural Defense Programs span the entire outbreak spectrum

Tools to support planning and Vaccines (VX) to rapidly response, drive requirements prevent disease in for countermeasures healthy animals prevents development and inform post- disease spread among outbreak response activities healthy herd, maintaining Agricultural Screening Tools by creating scalable (local to business continuity (AST): to verify disease free national) simulation and status so uninfected animals modeling tools to analyze and products can continue to potential responses and move maintaining business control options to minimize continuity FAD spread.

Enhanced Passive Surveillance (EPS): includes diagnostic tests, surveillance tools and data integration procedures to identify infected animals prior to Livestock Depopulation, Disposal and Decontamination overt symptoms and improve our (3D): New methodologies and decision support tools for ability to detect diseases that threaten High throughput diagnostics (DX) allow more depopulation, disposal and decontamination that facilitate the U.S. agricultural critical rapid confirmation of disease status and rapid response and prevent disease spread in a manner that infrastructure. increased sample processing capabilities minimizes waste, environmental impact and negative public enhancing our ability to contain outbreaks perception.

12 DHS S&T Contributions to Biodefense

Chem-Bio Division Successes (Examples) …Save lives & protect Nation’s  Foot & Mouth Disease (FMD) Vaccine infrastructure against chemical, biological  Rapid point of care diagnostics & agricultural threats & disasters.  Medical Countermeasures Development S&T Labs (MCM) support  “White Powder” standard  Assay development standards  Threat characterization studies Interagency  DOE National Labs  Bioterror Risk Assessment (BTRA)  Defense Threat Reduction  Bioforensics Agency (DTRA)  Department of Agriculture Areas of Concern (Examples)  Others … Crisis Management International BSAT Standards International Agricultural Vaccines Int’l/Domestic Response Training & Supply Chain Security Decon of CI/KR (Ag & Bio) Academic Public Biothreat Education Resilience Communication Forecasting Future Threats Local Response Capability Integrated Consortium of Laboratory Networks (ICLN) 13 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 AgCONNECT Bulk Milk Tank Assay

Companion diagnostic Improved data integration Provides evidence test for FMD vaccine to and coordination across needed for decision- differentiate infected emergency response makers to permit from vaccinated enterprise to reduce the animal product animals cost from delays in movement for the decision making dairy industry in the event of an outbreak

PERSPECTIVES Biosurveillance Emergency Laboratory Business Response Capacity Continuity

• USDA CEAH • USDA NCAHEM • USDA NAHLN • AVICs • SAHOs • AVICs • Diagnostic labs • SAHOs • Practitioners • SAHOs • USDA NCAHEM • Producers • Producers • State epi USERS

15 Threat Awareness 1 audiences for use in conductingin use for audiences 6

Communities 7 Conduct sensitivity analysissensitivity Conduct

also provide to key external keyto providealso Intelligence   further analysisfurther operational and DHS InteragencyforAssessment Risk Bioterrorism the Use of results of briefingand documentassessment risk of Publication expert elicitation expert and Scientific and Enhanced planning and resource prioritization resource and planning

Assessment Assessment –

Validate Validate Validate Results Bioterrorism Risk Risk Bioterrorism Input Input Data 2 5

Process 4 3

scenarios within the risk the within scenarios Scenario of interest methodology to explore to methodology Identify and validate keyvalidate and Identify Use Probabilistic Assessment (PRA)Assessment

risk space risk

scenario, etc. outcomes by

Risk Range of

agent, space

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 Advancing the partnership model model fills the pipeline for: Requirements and priorities from S&T, USDA, State partners, Industry  Testing Universities  Piloting partners develop candidates that fill the pipeline  Prototyping

 Concept of operations S&T targets early stage candidates development for advanced development COEs are filling the pipeline: From FY10-FY12, FAZD attracted $7.7 M in targeted research contracts from DHS

(15 fold increase)

Presenter’s Name June 17, 2003 18 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, 2003 19