BiologicalBiologicalLarryLarry Kerr,Kerr, ThreatThreat Ph.D.Ph.D. Agents:Agents: DeterminationDetermination andand ImplicationImplication forfor LifeLife OfficeOfficeSciencesSciences ofof ScienceScience ResearchResearch andand TechnologyTechnologyLarry Kerr, Ph.D.PolicyPolicy AssistantAssistantAssistant DirectorDirectorDirector for Homeland forfor HomelandHomeland Security Office of ScienceSecuritySecurity and Technology Policy Executive Office of the President MIT Security Studies Program MIT Faculty Club Cambridge, MA March 7, 2005 Comprehensive WMD Preparedness Strategy W MD PRE-EVENT E POST-EVENT VE NT PREVENTION PROTECTION SURVEILLANCE RESPONSE AND RECOVERY AND DETECTION RESEARCH, DEVELOPMENT AND ACQUISITION Investment Review and Prioritization THREAT ASSESSMENT AND AWARENESS Domestic & International INFORMATION MANAGEMENT AND COMMUNICATIONS FUTURE THREAT INITIATIVE Pillars of our Biodefense Program Information Management&Communications Creation andMaintenanceofInfrastructure Strengthened InternationalCooperation Research, Development andAcquisition Research, Development Biothreat Biothreat Plum IslandAnimalDiseaseCenter Plum IslandAnimalDiseaseCenter Testing andEvaluationCenter Biodefense Biodefense Testing andEvaluationCenter Bioforensic BiodefenseTHREAT Bioforensic AWARENESS Bio Characterization Bio Public Preparedness Assessment SupportCenter Assessment SupportCenter - - Countermeasures Countermeasures PREVENTION Knowledge Center Knowledge Center Analysis Center BioforensicsPROTECTION Analysis Center SURVEILLANCEAgrobio- terrorismDETECTION AgrobioRESPONSE- terrorismRECOVERY Biological Threats ContagiousContagious non-treatablenon-treatable “e.g.“e.g. engineeredengineered viruses”viruses” High SmallpoxSmallpox Non-contagious,Non-contagious, non-treatablenon-treatable Antibiotic-resistantAntibiotic-resistant anthraxanthrax AnthraxAnthrax aerosolaerosol Medium AgroAgro TerrorTerror Cutaneous Threat Sophistication Anthrax Low Salmonella food poisoning Low Medium High Potential Consequence Is “X” a threat? High Medium Threat Sophistication Low Low Medium High Potential Consequence The Intelligence Community’s Cycle The IC’s Collection “Disciplines” Human source intelligence (HUMINT) • the operational use of individuals who know or have access to sensitive information. [CIA, Defense HUMINT Service, DIA] Signals intelligence (SIGINT) • the information obtained from intercepted communications, radars or data transmission. [NSA] Imagery intelligence (IMINT) • the use of space-based, aerial, and ground-based systems to take electro-optical, radar or infrared images. [CIO] Measurement and Signature intelligence (MASINT) • the collection of data that locates, identifies, or describes distinctive characteristics of targets . [DIA] Is “X” a threat? Subject Matter Experts: public health scientific biosafety veterinary law industry education etc. “Lists” of Biological Threat Agents CDC “Select Agent” List • Sec. 551 The Antiterrorism and Effective Death Penalty Act of 1996 • “biological agents and toxins that have the potential to pose a severe threat to public health and safety” • CDC formed an interagency group of SMEs to develop the list • 10-26-01 USA Patriot Act – requirements for appropriate use of BTAs and imposes criminal and civil penalties for inappropriate use • Public Health Security and Bioterrorism Preparedness and Response Act 02 • Requires the list to be reviewed at least biennially USDA “High Consequence Pathogens” • Agricultural Bioterrorism Protection Act of 2002 • “USDA Sec. to establish and maintain a list of biological agents and toxins that have the potential to pose a severe threat to animal or plant health…” CDC Select Agent List “Category A” •Anthrax (Bacillus anthracis) •Botulism (Clostridium botulinum toxin) •Plague (Yersinia pestis) •Smallpox (Variola major) •Tularemia (Francisella tularensis) •Viral hemorrhagic fevers (filoviruses [e.g. Ebola, Marburg] and arenaviruses [e.g. Lassa, Machupol]) “Category B” •Brucellosis (Brucella species) •Epsilon toxin of Clostridium perfringens •Food safety threats (e.g. Salmonella species, Escherichia coli 0157:H7, Shigella) •Glanders (Burholderia mallei) •Melioidosis (Burkholderia pseudomallei) •Psittacosis (Chlamydia psittaci) •Q fever (Coxiella burnetti) •Ricin toxin from Ricinus communis (castor beans) •Staphylococcal entertoxin B •Typhus fever (Rickettsia prowazekii) •Viral encephalitis (alphaviruses [e.g Venezuelan equine, eastern equine, western equine]) •Water safety threats (e.g. Vibrio cholera, Cryptosporidium parvum) “Category C” – emerging infectious diseases Biological Threat Agent X High Medium Threat Sophistication Low Low Medium High Potential Consequence RadiologicalNuclear DispersalWeapon/ExplosiveTypes Device of Threats / Means of Attack Biological Weapon/Material Chemical Weapon/Material Conventional Explosive Physical Force Cyber Means Emerging Threats Insider … Homeland Security Complex Interdependencies Strategic Objectives Energy Prevent Attacks Reduce Vulnerability Minimize Damage & Recover Info & Telecomm Public Health Transportation Water Food Banking & Finance … “Targets” Vulnerabilities and Arrow Factors Influencing Biodefense R&D Factors include: • (1) threat information; • (2) potential for major public health impact, such as large outbreaks of disease; • (3) anticipated morbidity and mortality; • (4) availability of safe and effective vaccine, drugs and other countermeasures; • (5) impact on health care infrastructure, economy and national security. Promising products are accelerated in research & development. Presidential Biosecurity Initiatives BioWatch Environmental Surveillance in Cities BioSurveillance Traditional and Non-traditional Clinical Symptom tracking BioShield Medical Countermeasures Defending communities from biological attacks requires timely detection and warning Epidemic BioSense 30000 Infections (Symptoms) Outcomes (Casualties/ Fatalities) 20000 Cities Preparedness Number Affected BioShield 10000 Incubation Mass Casualty Care 0 0 2 4 6 8 10 12 510152025 BioWatchHours Days Prevent Warn Protect Contain / Decon Treat Intel Facilities Wide area Restoration Early diagnostics Transport monitoring Portable detection Intel/Law Bldg. Mayor First responders Public Health Org. PHO owner Hazmat lead Forensics PROJECT BIOSHIELD Project BioShield was announced by President Bush in his State of the Union address on January 28, 2003. $5.6 Billion over 10 years was appropriated to DHS in FY04. $890 million for the FY04, $2.5 billion for FY05-07 under DHS appropriations for “Project BioShield.” Project BioShield Act of 2004 (P.L. 108-276) was signed by President Bush on July 21, 2004 to develop and accelerate acquisition of medical countermeasures to CBRN threats. BIOSHIELD 1. Establishes a new spending authority to spur development and procurement of “next generation” medical countermeasures (vaccines, therapeutics, and diagnostics) against biological, chemical, radiological, or nuclear agents . - This authority is granted to the Secretaries of DHHS and DHS to present to the President and OMB Director recommendations for procurement. 2. Authorizes the NIH/NIAID to speed research & development in promising areas of medical countermeasures to the agents. - Grants increased flexibility and authority to award contracts and grants under expedited peer review procedures; and - Allows more rapid hiring of technical experts deemed necessary for R&D. 3. Establishes new FDA “emergency-use” authorization for medical countermeasures - The authorization requires a finding by the Secretary of DHHS that the treatment in question is expected to have benefits in the emergency situation that outweight its expected risks. Authorization lasts one year. WMD Medical Countermeasures RADIOLOGICAL BIOLOGICAL CHEMICAL NUCLEAR “Operational” R&D Components Components R&D T&E Vaccines Therapeutics Standards Acquisition Procurement Manufacture Diagnostics Deployment CONOPS WMD Medical CM Committee • Prioritize federal initiatives • Address immediate and long-term needs • Recommend national requirements for vaccines, drugs, antitoxins, diagnostics • Represent needs of civilian and military • Coordinate research, development, and acquisition efforts of key federal agencies: HHS, DHS, and DoD • Accelerate development via public-private partnership How to spend $5.6 billion wisely? • Credibility and immediacy of threat • Target population – Who is targeted (civilian, military, high risk groups, other)? – In what settings would the countermeasure be used? • Availability of alternative countermeasures – Current and projected • Dosing schedule for prevention or treatment • Feasibility of deployment in a public health emergency • Product shelf-life and ongoing requirements Determination of Threat Under Project Bioshield, DHS is responsible for Material Threat Determinations (MTDs) • Material threat: any agent whose introduction into the U.S. population is sufficient to affect national security • Material Threat Determination (MTD): letter from the Sec DHS that an agent constitutes a material threat • Material Threat Assessment (MTA): a risk assessment (threat x vulnerability x consequence) that: * forms the basis of an MTD decision * provides a “plausible worse case” for sizing the amounts of required countermeasures Determination of Threat MTAs focus on “plausible worse cases” and address: • Intel information on capabilities and intent (DHS/IAIP + IC) – Intelligence information not necessary for analysis but included • Scientific feasibility (DHS/S&T + broad range