The New Army Biological Surety Program

1. The New Army Biological Surety Program

2. 2 IG Provisos For official use only Exempt from mandatory disclosure under the FOIA  Dissemination is prohibited Bio surety program in development

3. 3 Acronyms BDPR Biological Duty Position Roster BPRP Biological Personnel Reliability Program BSI Biological Surety Inspection CO Certifying Official PDI Potentially Disqualifying Information PPE Personal Protective Equipment PRP Personnel Reliability Program SIP Special Immunization Program

4. 4 History Bio Program ended 1972 Army was EA for Bio Defense RDA Program Two guiding Regulations - AR 70-65, Management of Controlled Substances, Ethyl Alcohol, and Hazardous Biological Substances in Army Research, Development, Test, and Evaluation Facilities, 1 Sep 79 - AR 385-69, Biological Defense Safety Program, 31 Dec 93 Accountability and Security programs lay fallow

5. 5 History 9/11/01 War on Terrorism Anthrax mailings Concern about security DAIG Special Inspection Nov 01 Anthrax / others Accountability Physical Security

6. 6 Recommendations - IG Special Inspection Develop regulation(s) that cover: Standards for the Bio Agent Defense Program BPRP Accountability, inventory Physical security Standards for contractor labs

7. 7 Recommendations - IG Special Inspection Develop regulation(s) that cover: Oversight by Army and MACOMs Inspections Drug testing for bio workers Occupational Health Programs [SIP, PPE] Medical input to PRP/CO Other biological agents

8. 8 Decision by DCSA 1 Feb 02 Action to Army G3 [others supporting] Immediate safety, security, & accountability measures Develop an Army Biological Surety Program AR 50-X, Biological Surety AR 190-X, Biological Security DA Pam 40-X (Medical Support)?

9. 9 Interim Messages Intent to establish Bio Surety Program [with PRP] Designated biological surety agents Directed accountability, security, safety procedures Addressed Contract labs Requested cost & facility data Identified grey areas, potential difficulties Requested input Four messages, Dec 01 – July 03 Intent to establish Bio Surety Program [with PRP] Designated biological surety agents Directed accountability, security, safety procedures Addressed Contract labs - accountability - responsibilities - rules Requested cost & facility data Identified grey areas, potential difficulties Requested input Four messages, Dec 01 – July 03 Intent to establish Bio Surety Program [with PRP] Designated biological surety agents Directed accountability, security, safety procedures Addressed Contract labs - accountability - responsibilities - rules Requested cost & facility data Identified grey areas, potential difficulties Requested input

10. 10 Designated Biological Surety Agents Bacillus anthracis Clostridium botulinum & toxins Yersinia pestis [plague] Francisella tularensis Variola virus [smallpox] Filoviruses [Ebola, Marburg]

11. 11 AR 50-X Developed by Army G3 PRP is centerpiece Integrates Safety, Security, Reliability Programs and Documents

12. 12 AR 50-X Chapter titles 1 Introduction 2 Personnel Reliability 3 Inventory Management 4 Transportation of Biological Select Agents 5 Bio Select Agent Safety and OH Program 6 Bio Select Agent Security Program 7 Biological Accident or Incident Response 8 Bio Surety Program Evaluation Requirements 9 Managing Bio Select Agent Contracts

13. 13 AR 50-X Two-Tiered Surety System Biological Select Agents High Priority Agents & Toxins [HPAT] One-Tiered BPRP Medical input during IE and CE Oriented to civilian & contractor medical support Two-Tiered Surety System 1 - Biological Select Agents - designated by CDC - 42 CFR 72, App A 2- High Priority Agents & Toxins [HPAT] - Designated by DOD - Previous list [“Designated Agents”] + Arenaviruses [Lassa, Machupo] Surety is the big umbrella – some differences by tier PRP is a smaller, included program - same for both tiers IE:-Interview, Personal Security Investigation, drug test -Risk Assessment by Att Gen & DHHS - medical input CE: - Drug test, Personal Security Investigation update - Periodic Re-approval by Att Gen & DHHS - medical inputTwo-Tiered Surety System 1 - Biological Select Agents - designated by CDC - 42 CFR 72, App A 2- High Priority Agents & Toxins [HPAT] - Designated by DOD - Previous list [“Designated Agents”] + Arenaviruses [Lassa, Machupo] Surety is the big umbrella – some differences by tier PRP is a smaller, included program - same for both tiers IE:-Interview, Personal Security Investigation, drug test -Risk Assessment by Att Gen & DHHS - medical input CE: - Drug test, Personal Security Investigation update - Periodic Re-approval by Att Gen & DHHS - medical input

14. 14 Biological Select Agents Bacteria - Bacillus anthracis, Brucella abortus, B. melitensis, B. suis, Burkholderia (Pseudomonas) mallei, Burkholderia (Pseudomonas) pseudomallei, Clostridium botulinum, Francisella tularensis, Yersinia pestis  Viruses - CCHF, EEE, Ebola, Equine Morbillivirus, Lassa, Marburg, Rift Valley, South American Haemorrhagic fevers (Junin, Machupo, Sabia, Flexal, Guanarito), Tick-borne encephalitis complex, Variola (Smallpox), VEE, Hanta pulmonary, YF  Rickettsiae - Coxiella burnetii, Rickettsia prowazekii, Rickettsia rickettsii  Fungi - Coccidioides immitis  Toxins - Abrin, Aflatoxins, Botulinum toxins, Clostridium perfringens epsilon toxin, Conotoxins, Diacetoxyscirpenol, Ricin, Saxitoxin, Shigatoxin, Staphylococcal enterotoxins¸Tetrodotoxin, T-2 -designated by CDC - 36 agents [currently] - genetically altered microorganisms that mimic above - high bioterrorism risk - mass casualties -designated by CDC - 36 agents [currently] - genetically altered microorganisms that mimic above - high bioterrorism risk - mass casualties

15. 15 High Priority Agents & Toxins [HPAT] Bacillus anthracis Clostridium botulinum & toxins Yersinia pestis [plague] Francisella tularensis Variola virus [smallpox] Filoviruses [Ebola, Marburg] Arenaviruses [Lassa, Machupo] Previous list [designated agents] + Arenaviruses [Lassa, Machupo] Designated by DOD Most dangerous agents Previous list [designated agents] + Arenaviruses [Lassa, Machupo] Designated by DOD Most dangerous agents

16. 16 AR 50-X Responsibilities of TSG Medical policies to support BPRP GME program for surety physicians Bio surety consultant Responsibilities of MEDCOM Commander OH & IH support Provide trained staff Review contract medical operations

17. 17 AR 50-X Other Medical Elements Reliability standards Designated BPRP positions, BDPR Identification of health records Medical restriction & disqualification Biological Accident or Incident Response [BAIR] BSI every 24 months SIP & PPE not mentioned Expect a medical DA PamExpect a medical DA Pam

18. 18 Biological Surety Units & Locations USAMRIID Ft Detrick, MD ECBC Edgewood, MD W Desert Test Center Dugway Prv Grnd, UT WRAIR WRAMC, DC AFIP WRAMC, DC MEDCEN Clin Labs Various Contractor Rsch Labs Various Bio Surety Program is agent-based Here are the units & locations that will have Bio surety programs Bio Surerty Program is agent-based, not facility-based Clinical labs are part of Lab Response Network [LRN] Maintain reference samples for Dx purposes Here are the units & locations that will have Bio surety programs Bio Surerty Program is agent-based, not facility-based Clinical labs are part of Lab Response Network [LRN] Maintain reference samples for Dx purposes

19. 19 Status of 50-X Final stages Expect publication Fall 03 One more staffing of AR 50-X [Aug 03] Expect publication Fall 03One more staffing of AR 50-X [Aug 03] Expect publication Fall 03