Discussion of Texas A&M Select Agent Program compliance issues

1. Fall From Grace Texas A&M University’s Biodefense & Infectious Disease Research Labs Presented By Malcolm Smith November 1 st 2007

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

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

21. The Incident

27. Madison Aerosol Chamber

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

36. Questions/Comments