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 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 Program Information Management&Communications Creation andMaintenanceofInfrastructure Strengthened InternationalCooperation Research, Development andAcquisition 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

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] (SIGINT) • the information obtained from intercepted communications, radars or data transmission. [NSA] (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 “” 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 – requirements for appropriate use of BTAs and imposes criminal and civil penalties for inappropriate use • Public Health Security and 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) • (Clostridium ) •Plague (Yersinia pestis) • (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 Types of Threats / Means of Attack

Nuclear Weapon/Explosive Radiological Dispersal Device Biological Weapon/Material /Material Conventional Explosive Complex Interdependencies Physical Force Cyber Means e nc Insider m n a om h io in Emerging Threats c lt t F le a ta & e e or … y T H p ng rg & lic s er d ki e o b an at o n “Targets” n nf u r o a … E I P T W F B and Prevent Attacks Vulnerabilities Reduce Vulnerability

Minimize Damage & Recover Homeland Security Strategic Objectives Arrow Factors Influencing Biodefense R&D

ƒ 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. ƒ Promising products are accelerated in research & development. Presidential 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 of SMEs) - acquiring material: finished product or seed stock - production techniques: equipment, protocols, skills - material produced: amounts, quality (wet/dry), shelf life - dissemination: efficiency; viability etc. • Representative scenarios - urban aerosol release; food contamination; water - vulnerabilities; release points, mechanisms; “natural” attenuation - consequences: exposure, morbidity, mortality estimates; reload concerns BIOSECURITY Today and Tomorrow’s Fears…

CDC Select Agents The Unknown

“Category A” •Anthrax (Bacillus anthracis) •Botulism ( toxin) T •Plague (Yersinia pestis) H •Smallpox (Variola major) R Advanced Biological Agents •Tularemia (Francisella tularensis) •Viral hemorrhagic fevers (filoviruses [e.g. Ebola, Marburg] and E Modified Biological or Biochemical Agents A arenaviruses Traditional Threat Agents “Category B” T •Brucellosis (Brucella species) •Epsilon toxin of Clostridium perfringens Proteomics Biofilms •Food safety threats (e.g. Salmonella species, Escherichia coli 0157:H7) Bioinformatics Chimeric agents •Glanders (Burholderia mallei) Genomics siRNA •Melioidosis (Burkholderia pseudomallei) Neurosciences •Psittacosis (Chlamydia psittaci) Immunology Engineered viruses •Q fever (Coxiella burnetti) Physiology Nanotechnology •Ricin toxin from Ricinus communis (castor beans) •Staphylococcal entertoxin B rDNA technologies Modified Pathogens/Toxins •Typhus fever (Rickettsia prowazekii) •Viral encephalitis (alphaviruses [e.g Venezuelan equine, eastern equine) Pre-Genomic Era Post-Genomic Era •Water safety threats (e.g. Vibrio cholera, Cryptosporidium parvum) 1980 2000 2010

1949 1980 1985 20012004 Korean War WWII Space Race Soviet Threat 9/11 Viet Nam

Dual-Use Biological Research

“Biological research with legitimate scientific purpose that may be misused to pose a biological threat to public health and/or national security “

7 Areas of Concern

Would proceeding with the experiment…

1. Render a vaccine to a pathogen ineffective; 2. Confer antibiotic resistance to a pathogen so as to decrease the effectiveness of a countermeasure; 3. Increase the virulence of a pathogen; 4. Increase the transmissibility of a pathogen; 5. Increase the host range/tropism of a pathogen; 6. Enable evasion of diagnostic/detection capabilities; or 7. Demonstrate weaponization of a pathogen. National Science Advisory Board for Biosecurity

1. Develop guidelines for oversight of “Experiments of Concern” and provide ongoing evaluation and modification of these guidelines as needed.

2. Work with journal editors and other stakeholders to ensure the development of guidelines for the publication, public presentation, and public communication of potentially sensitive research, and encourage the adoption of these guidelines by international organizations.

3. Provide guidance on the development of a code of conduct for scientists and laboratory workers.

Opportunities arise from the “Complexity” of the R&D enterprise

Opportunities arise from the “Flexibility” of the R&D enterprise

Science is global LarryLarry Kerr,Kerr, Ph.D.Ph.D.

OfficeOffice ofof ScienceScience andand TechnologyTechnology PolicyPolicy AssistantAssistant DirectorDirector forfor HomelandHomeland SecuritySecurity Back-up slides National Science Advisory Board for Biosecurity

• On March 4, 2004 Secretary Tommy Thompson announced the creation of the NSABB – Provide advice to Federal Departments and agencies on ways to minimize misuse of knowledge and technologies emanating from essential biological research – Create a system of research review (through the Institutional Biosafety Committees) – Provide guidelines for the identification of research that may require special attention – Promote professional codes of conduct – Create educational materials for the research community about effective biosecurity

• 25 voting members with expertise in the following areas: molecular biology, microbiology, infectious diseases, biosafety, public health, veterinary medicine, plant health, national security, biodefense, law enforcement, scientific publishing

• Ex officio members from 15 Federal agencies and departments Protect public health, both the rare as well as the commonplace

A typical MTA/MTD takes several months

• Draft an initial MTA - extensive one-on-one interactions with SMEs • “Vet” in broad interagency/SME forum - typically day and a half meeting, 30-40 participants • Do additional homework and revise/refine MTA as needed • Draft MTD recommendations and presentation for Sec DHS • Obtain IAIP formal concurrence • Brief Sec DHS • Secretary signs out an MTD MTD Schedule

• Already done: - Smallpox - Botulinum toxin In progress: - Anthrax (MTA Dec 04) - Radionuclides (MTA Jan 04) - Nerve agent (MTA Feb 04) • By the end of FY05 -Plague - Tularemia - Major viral hemorrhagic fevers - Any major new concern from on-going HSPD-10 risk assessments