The United States Department of Defense Biological Threat Reduction Program. Threat Agent Detection and Response and Cooperative Biological Research

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1 The United States Department of Defense Biological Threat Reduction Program Threat Agent Detection and Response and Cooperative Biological Research Shawn Cali, Sara Mayer and Roger Breeze February 23, 2007 UNCLASSIFIED

Response and Cooperative Biological Research Shawn

2 Biological Threat Reduction Program (BTRP) Program Purpose: Combat bioterrorism and prevent proliferation of biological weapons (BW) related technology, pathogens and expertise. Program Objectives: Prevent the sale, theft, diversion or accidental release of BW related materials, technology and expertise Consolidate especially dangerous pathogens (EDPs) into safe, secure central reference laboratories Improve Former Soviet Union states capabilities to detect and respond to human and animal EDP disease outbreaks Integrate Former Soviet Union scientists into the international scientific community Eliminate BW infrastructure and technologies UNCLASSIFIED 2

Program Objectives: Prevent the sale, theft, diversion or accidental release of BW related materials, technology and expertise Consolidate especially dangerous

3 Countries Currently Engaged by the BTRP Russia Kazakhstan Georgia Uzbekistan Azerbaijan Ukraine UNCLASSIFIED 3

4 BTRP Priority Pathogens All human and livestock pathogens identified as US Select Agents Immediate Priorities - Human diseases/pathogens Anthrax* Botulism Brucellosis* Plague* Tularemia* Smallpox virus Crimean-Congo Hemorrhagic fever (CCHF)* Tick-borne encephalitis Rickettsia prowazekii Rickettsia rickettsii Coxiella burneti Fevers of Unknown Origin requiring hospitalization Flu-like Symptoms requiring hospitalization Immediate Priorities Livestock diseases/pathogens Foot and mouth disease Classical swine fever Rinderpest Sheep, Goat and Camel pox Highly Pathogenic Newcastle disease* Highly Pathogenic Avian Influenza* Anthrax* Brucella abortus*, suis*, melitensis* Plague* Glanders* * Denotes zoonotic pathogen (transferable between humans and animals) UNCLASSIFIED 4

Flu-like Symptoms requiring hospitalization Immediate Priorities Livestock diseases/pathogens Foot and mouth disease Classical swine fever Rinderpest Sheep, Goat and Camel pox Highly Pathogenic

5 Current BTRP Partners U.S. Government Collaborators Centers for Disease Control and Prevention, Walter Reed Army Institute of Research, Naval Medical Research Center, US Army Medical Research Institute of Infectious Diseases, Armed Forces Research Institute of Medical Sciences, United States Department of Agriculture, Armed Forces Institute of Pathology, and Naval Medical Research Unit-3 U.S. Scientific Collaborators Louisiana State University, New Mexico State University, Arizona State University, University of Maryland, Pennsylvania State University, University of Florida, and Texas A&M University UNCLASSIFIED 5

Research Institute of Infectious Diseases, Armed Forces Research Institute of Medical Sciences, United States Department of Agriculture, Armed Forces

6 Threat Agent Detection and Response (TADR) A nationwide system, an international network Nationwide Surveillance System Close to real time reporting and response Integrated reporting of human health and veterinary health, including vectors Tracks diagnostic tests, results and stored specimens Electronic Integrated Disease Surveillance System (EIDSS) Diagnostic Laboratory System Close to real time detection Standard and molecular methods minimizing culture volumes U.S. Biosafety level 2 except for Central Reference Laboratory UNCLASSIFIED 6

results and stored specimens Electronic Integrated Disease Surveillance System (EIDSS) Diagnostic Laboratory System Close to real time

7 Threat Agent Detection and Response (TADR) Ministries National Facilities Regions or Oblasts Districts or Raions Telephone Primary Healthcare or Livestock Services Telephone IT components required for the TADR Surveillance, Reporting and Response System Lab components required for the TADR Diagnostic System (MOH,MOA,MOD) UNCLASSIFIED

Telephone IT components required for the TADR Surveillance, Reporting and Response

8 Human Health Enhanced Reporting Regional Epidemiologists are being trained and equipped to: Receive reports of suspect EDP cases Investigate cases using dedicated transport Collect and deliver samples to the laboratory Report case investigations by EIDSS Perform computer based epidemiological analysis UNCLASSIFIED 8

dedicated transport Collect and deliver samples to the laboratory Report case

9 Georgia: Human Urgent Notification EIDSS

10 Georgia: Human Urgent Notification Card 58/1

11 Regional EDP Diagnostic Laboratories Separate MOH and MOA (and MOD) facilities Use conventional and molecular techniques to identify EDPs in human and animal samples at BSL2 on behalf of Regional Officials Send suspect/probable EDP samples to the CRL for confirmation (no EDP storage) Report lab results to Regional officials by EIDSS UNCLASSIFIED 11

BSL2 on behalf of Regional Officials Send suspect/probable EDP samples to the CRL for

12 Other Regional Laboratories As needed, Regional laboratories that are not Regional EDP laboratories will be equipped for safe pathogen processing and packaging to send samples to the Regional EDP lab or CRL May also do serological tests, microscopy and dipstick test screening Result will be reported by EIDSS UNCLASSIFIED 12

packaging to send samples to the Regional EDP lab or CRL May also do serological

13 Human Health EDP Surveillance and Diagnostic Locations MOH EDP Diagnostic Laboratory MOH Regional Public Health Center (EPI) MOH Central Reference Laboratory UNCLASSIFIED 13

14 Veterinary EDP Surveillance and Diagnostic Locations MOA Food Safety, Veterinary and Plant Protection National Service MOA Regional Vet Office (EPI) MOA Central Reference Laboratory MOA EDP Diagnostic Lab (EMS) MOA Regional Diagnostic Lab UNCLASSIFIED 14

Regional Vet Office (EPI) MOA Central Reference Laboratory MOA

15 Central Reference Laboratory (CRL) Work place for PCR reaction A shared human and veterinary health facility Confirms pathogen identifications made at the Regional EDP labs Stores EDPs in secure Repository for further characterization and research Provides a secure site for the EIDSS server and database Meets U.S. biosafety, biosecurity and environmental standards with biosafety level 2 and 3 laboratories for diagnosis and research National laboratory for EDP research at BSL 3 May conduct epidemiological analysis UNCLASSIFIED 15

16 CRL Schematic Service Service Service Service BSL-2 & -3 Vivarium Lab Office BSL-2 & BSL-3 Labs Animal Support Human Support BSL-2 & BSL-3 Labs Lab Office Entry Pathogen Repository Pathogen Repository Entry Animal Health Facility Human Health Facility UNCLASSIFIED 16

BSL-3 Labs Lab Office Entry Pathogen Repository Pathogen

17 New CRL being built in Georgia A shared MOH, MOD and MOA facility for EDP diagnosis and research at BSL 2 and 3 UNCLASSIFIED 17

18 Mobile Outbreak Response Units Cross-trained MOH & MOA teams of epidemiologists, laboratorians physicians and/or veterinarians Deployed from the national level to provide additional surveillance, diagnostic or response capacity when regional/oblast resources are not sufficient to control an outbreak UNCLASSIFIED 18

the national level to provide additional surveillance, diagnostic or response

19 Select Agent Security Repository meets U.S. DOD security standards Select Agent inventory and access controlled by BTRP developed Pathogen Asset Control System (PACS) Stand alone electronic database with associated infrastructure and equipment Select Agents will be characterized for defensive and peaceful purposes through cooperative research projects in the US and Recipient State UNCLASSIFIED 19

database with associated infrastructure and equipment Select Agents will be characterized for

20 Cooperative Biological Research Project Goals Increase transparency and encourage high standards of conduct Enhance the EDP diagnostic, epidemiological and response capacity of partner state scientists and technicians Engage former Soviet Union scientists in mutually beneficial research UNCLASSIFIED 20

epidemiological and response capacity of partner state scientists and

21 Challenges faced by the BTRP Introduction of new technology, methods and practices creates adoption and sustainment challenges Cannot reach all levels of health systems Important diseases remain to be addressed BTRP mission focused on EDPs - we recognize important and common human and animal health issues persist BTRP is providing enhanced health infrastructure, equipment and training that can be built on for other continuing health needs by recipient state governments with assistance of international agencies UNCLASSIFIED 21

22 Questions? UNCLASSIFIED Contact: Shawn Cali, Program Manager Biological Threat Reduction Program UNCLASSIFIED 22

SEOUL DECLARATION GLOBAL HEALTH SECURITY AGENDA 2015 HIGH-LEVEL MEETING IN SEOUL

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