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Fall From Grace Texas A&M University’s Biodefense & Infectious Disease Research Labs   Presented By Malcolm Smith November 1 st  2007
Presentation Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Characteristics of a Select Agent ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Why are they considered dangerous
Select Agent Rule ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Explanation
Security Risk Assessment (SRA) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],How is this obtained?
Components of a  Select Agent Program ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Key Elements
Bio-Safety Level The biosafety level assigned to an agent is based on the activities typically associated with  the growth and manipulation of the quantities and concentrations of infectious agents  required to accomplish identification or typing. If activities with clinical materials pose a lesser risk to personnel than those activities associated with manipulation of cultures, a lower biosafety level is recommended. On the other hand, if the activities  involve large volumes and/or concentrated preparations ("production quantities"), or manipulations which are likely to produce aerosols or which are otherwise intrinsically hazardous , additional personnel precautions and increased levels of primary and secondary containment may be indicated.   BMBL 4 th  Edition Explanation
High Containment Lab Locations Locations of Major BSL-3 and Known BSL-4 Labs
Bio-Safety Level 3 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Basic Laboratory Design
Bio-Safety Level 3 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Standard Microbiological Practices
Bio-Safety Level 3 ,[object Object],[object Object],[object Object],[object Object],Special Practices
Bio-Safety Level 3 ,[object Object],[object Object],[object Object],[object Object],[object Object],Special Practices
The Sunshine Project Biodefense Research Watchdog
The Sunshine Project The Sunshine Project is an international non-governmental organization   dedicated to  upholding prohibitions against biological warfare and, particularly, to preventing what it sees as military abuse of biotechnology . With offices in Austin, TX and Hamburg, Germany, the Sunshine Project works by  exposing research on biological and chemical weapons . Typically,  it accesses documents under the Freedom of Information Act and other open records laws, publishing reports and encouraging action to reduce the risk of biological warfare . It tracks the construction of high containment laboratory facilities and the dual-use activities of the U.S. biodefense program.  http://www.sunshine-project.org/ Background
Noteworthy Individuals Director of the US Office of the Sunshine Project. Holds two Master's degrees from the University of Texas at Austin and worked on biotechnology-related policy since 1993.  Hammond is a member of the Pugwash Study Group on the Chemical and Biological Weapons Conventions. Hammond directs the Sunshine Project in the US and manages its research program on biodefense, incapacitants, and other issues   Edward Hammond
Freedom of Information Act ,[object Object],[object Object],[object Object],Definition
Texas A & M University ,[object Object],Location
Texas A & M University ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Campus Information
Texas A & M University ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Biodefense and Infectious Disease Department
Texas A & M University ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Biodefense and Infectious Disease Department
The Incident
Brucellosis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Clinical Features
Brucellosis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Treatment
Brucella Exposure ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],What Happened
Brucella Exposure ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],What Happened
Brucella Exposure ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],What Happened
Madison Aerosol Chamber
Coxiella burnetii: Q-Fever ,[object Object],[object Object],[object Object]
Coxiella burnetii: Q-Fever ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Clinical Symptoms
Coxiella burnetii: Q-Fever ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Clinical Symptoms
Coxiella Exposure ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],What Happened
CDC Inspection Observations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Incident Timeline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
May 17 th  2007 – TAMU responds to CDC facility inspection report June  July 18 th  2007 – Office of Inspector General notifies TAMU that they may be liable for civil penalties up to $750,000 for violating federal Select Agent Rule June 26 th  2007 – Sunshine Project Releases a report that three laboratorians were infected with Coxiella burnetti and noted high blood titers for the agent on April 3 rd  2006 June 30 th  2007 – CDC issues a “Cease and Desist Order” to TAMU for all Select Agent Work July 23 rd  2007 – CDC has a follow-up inspection of TAMU’s Select Agent Program August 17 th  2007 – TAMU proposes a settlement of $10,000 to the Office of the Inspector General for violation of Select Agent Rule August 31 st  2007 – CDC issues a Facility Inspection Report to TAMU citing 32 “observations” and asks TAMU to respond.  Following TAMU response a follow-up inspection will be conducted to investigate facility Incident Timeline
Both the RO (August 2007) and the ARO/Biosafety Officer (September 2007) resign their post at TAMU Incident Timeline
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Tamu Fall From Grace

  • 1. Fall From Grace Texas A&M University’s Biodefense & Infectious Disease Research Labs Presented By Malcolm Smith November 1 st 2007
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  • 7. Bio-Safety Level The biosafety level assigned to an agent is based on the activities typically associated with the growth and manipulation of the quantities and concentrations of infectious agents required to accomplish identification or typing. If activities with clinical materials pose a lesser risk to personnel than those activities associated with manipulation of cultures, a lower biosafety level is recommended. On the other hand, if the activities involve large volumes and/or concentrated preparations ("production quantities"), or manipulations which are likely to produce aerosols or which are otherwise intrinsically hazardous , additional personnel precautions and increased levels of primary and secondary containment may be indicated. BMBL 4 th Edition Explanation
  • 8. High Containment Lab Locations Locations of Major BSL-3 and Known BSL-4 Labs
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  • 13. The Sunshine Project Biodefense Research Watchdog
  • 14. The Sunshine Project The Sunshine Project is an international non-governmental organization dedicated to upholding prohibitions against biological warfare and, particularly, to preventing what it sees as military abuse of biotechnology . With offices in Austin, TX and Hamburg, Germany, the Sunshine Project works by exposing research on biological and chemical weapons . Typically, it accesses documents under the Freedom of Information Act and other open records laws, publishing reports and encouraging action to reduce the risk of biological warfare . It tracks the construction of high containment laboratory facilities and the dual-use activities of the U.S. biodefense program. http://www.sunshine-project.org/ Background
  • 15. Noteworthy Individuals Director of the US Office of the Sunshine Project. Holds two Master's degrees from the University of Texas at Austin and worked on biotechnology-related policy since 1993. Hammond is a member of the Pugwash Study Group on the Chemical and Biological Weapons Conventions. Hammond directs the Sunshine Project in the US and manages its research program on biodefense, incapacitants, and other issues Edward Hammond
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  • 34. May 17 th 2007 – TAMU responds to CDC facility inspection report June July 18 th 2007 – Office of Inspector General notifies TAMU that they may be liable for civil penalties up to $750,000 for violating federal Select Agent Rule June 26 th 2007 – Sunshine Project Releases a report that three laboratorians were infected with Coxiella burnetti and noted high blood titers for the agent on April 3 rd 2006 June 30 th 2007 – CDC issues a “Cease and Desist Order” to TAMU for all Select Agent Work July 23 rd 2007 – CDC has a follow-up inspection of TAMU’s Select Agent Program August 17 th 2007 – TAMU proposes a settlement of $10,000 to the Office of the Inspector General for violation of Select Agent Rule August 31 st 2007 – CDC issues a Facility Inspection Report to TAMU citing 32 “observations” and asks TAMU to respond. Following TAMU response a follow-up inspection will be conducted to investigate facility Incident Timeline
  • 35. Both the RO (August 2007) and the ARO/Biosafety Officer (September 2007) resign their post at TAMU Incident Timeline