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Saturday, July 25, 2015

Review Committee Report: Inadvertent Shipment of Live Bacillus Anthrax Spores by DOD

The US Department of Defense issued a report concerning its shipment of live anthrax vaccine and concluded:

"On May 29, 2015, due to the inadvertent shipment of live anthrax from a Department of Defense (DoD) laboratory, the Deputy Secretary of Defense (DSD) directed the Under Secretary of Defense (USD) for Acquisition, Technology & Logistics (AT&L) to conduct a 30-day review of the Department’s safety practices for generating and handling inactivated Bacillus anthracis (BA).

This independent review was in addition to the concurrent investigation initiated by the Centers for Disease Control and Prevention (CDC). For more than a decade, DoD and CDC have been working closely on optimal oversight of and compliance with the select agent regulations.

These regulations impact all U.S. laboratories that work with biological select agents including those supported by the DoD's Critical Reagents Program (CRP), which primarily serves the interagency and the biodefense research community. USD (AT&L) established a review committee to conduct the comprehensive review mandated by DSD.

This document is the Review Committee’s report; membership of the committee is provided in Appendix C.

The committee was asked to address the following critical areas:

• The root cause for the incomplete inactivation of BA samples at DoD laboratories;

• Why post inactivation viability testing did not detect the presence of live BA;

• Existing DoD laboratory biohazard safety protocols and procedures;

• DoD laboratory adherence to established procedures and protocols; and

• Identification of systemic problems and what steps should be taken to fix those problems. The United States Department of Defense Chemical and Biological Defense Program (CBDP) develops medical and physical countermeasures to protect the warfighter from chemical and biological threats. BA is an exceptionally resilient organism.

This resilience combined with its infectious nature makes BA ideally suited for potential adversaries’ biological weapons programs.

Therefore it is critical for the Department to have a strong countermeasures program to protect our warfighters against this dangerous organism. As part of the above process, the DoD routinely inactivates many select agents such as Bacillus anthracis (the causative agent of anthrax), Francisella tularensis (the causative agent of tularemia), and Burkholderia mallei (the causative agent of Glanders disease in horses) through a number of chemical, thermal, or radiation procedures. There are many federal partners and private sector laboratories outside the DoD that depend on DoD’s ability to provide them with inactivated pathogens for national security and public safety missions.

The four DoD laboratories whose mission involves inactivation of BA are: Edgewood Chemical Biological Center (ECBC) in Maryland, the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in Maryland, the Naval Medical Research Center (NMRC) in Maryland, and Dugway Proving Ground (DPG) in Utah.

The DoD regularly ships inactivated biological materials for research, development, testing, and evaluation to industry, academia, and other Federal laboratories. On May 22, 2015, a private company notified the CDC that inactivated BA spores in its possession were live. Live BA has the potential to pose a threat to human health and it is only distributed to facilities regulated by the Federal Select Agent Program.

The CDC began an investigation and determined that a BA sample originating from DPG on April 20, 2015, was not fully inactivated and contained viable BA spores. We now know that, over the course of the last decade, 86 facilities in the United States and seven other countries have received low concentrations of live BA spore samples from DPG thought to be completely inactivated. The low numbers of live spores found in inactivated DoD samples did not pose a risk to the general public. Nonetheless, the shipment of live BA samples outside of the select agent program restrictions (at any concentration) is a serious breach of regulations. 

Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thompson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson-Reuters). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  have been representing injured workers and their families who have suffered occupational accidents and illnesses.