The Centers for Disease Control and Prevention (CDC) conducted an internal review of the incident that involved the unintentional release of B. anthracis on its campus in June 2014. In the review’s report, four other incidents occurring over the past decade, concerning B. anthracis, C. botulinum, Brucella, and H5N1 influenza, were acknowledged. In response to the report, a moratorium on the transport of any biological material leaving any CDC biosafety level (BSL) 3 or 4 laboratory was levied on July 11, 2014, by the CDC.
Major media outlets have reported on the incidents. Already, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on July 16, 2014, with the CDC Director, Thomas Frieden, MD, MPH; Jere Dick, DVM, Associate Deputy Administrator of the Animal and Plant Health Inspection Services; Nancy Kingsbury, PhD, Managing Director of Applied Research and Methods at the Government Accountability Office; and others.
The CDC internal review found several actions that contributed to the anthrax incident, including:
- Use of unapproved sterilization techniques
- Transfer of material not confirmed to be inactive
- Use of pathogenic B. anthracis when non-pathogenic strains would have sufficed
- Inadequate knowledge of peer-reviewed literature
- Lack of a standard operating procedure to document inactivation in writing
- Lack of a reviewed and approved written research plan
While assessments and follow-up actions are on-going, the report issued recommendations that are intended to address the immediate situation as well as agency-wide safety measures. The laboratory at the center of the incident, the Bioterrorism Rapid Response and Advanced Technology laboratory, has been closed to select agent services since mid-June. It will remain closed until the level of skills, knowledge and training are assessed for all laboratory staff; clear, proven producers are established and communicated on inactivation and non-viability testing of all materials produced by the laboratories; and all findings in the investigation are resolved.
Other recommendations include requiring all CDC laboratories that handle select agents and other hazardous pathogens to have written, validated and verified transfer procedures. The procedures will include requirements that all transferring laboratories confirm non-stability by proven, effective methods before material leaves the containment laboratory. Documentation must accompany the transfer and the receiving laboratory must confirm that the materials are not viable.
It is also suggested that CDC establish a lead laboratory scientist position to serve as the single point of accountability for laboratory safety. This individual will be responsible for adherence to laboratory quality and safety protocols and to review and monitor the implementation of training policies for staff.
The agency may consider allowing fewer laboratories and scientists to work with select agents and/or reduce the number of pathogenic strains being studied. It may promote the use of non-pathogenic organisms in research and training activities. It will accelerate the implementation of laboratory quality management systems throughout all CDC laboratories.
This incident may also impact broader regulatory actions for all U.S. laboratories.