By Stevie Kiesel
On April 29, 2016, the Department of Defense Office of Inspector General (OIG) published “Evaluation of DoD Biological Safety and Security Implementation” (Report No. DODIG-2016-078). This report had two objectives: (1) examine the application of biosafety and biosecurity policy and guidance across DoD laboratories that work with biological select agents and toxins (BSAT) and (2) evaluate biological safety and security oversight, compliance with applicable policy, and actions on recommendations from previous assessments. Although this review was initiated six months before the highly publicized Dugway Proving Ground anthrax inactivation incident, such biosafety and biosecurity lapses have made this report all the more relevant today. The OIG ultimately found four areas of deficiency in federal BSAT labs, with potentially grave consequences for public health and safety.
First, DoD did not maintain biosafety and biosecurity program management, oversight, and inspections of BSAT labs in accordance with the applicable governing documents. Because of this lack of standardization (which had been noted in previous reviews), the military Services conducted laboratory inspections based on Service-level guidance and procedures that was not standardized, and went beyond being tailored to suit individual Services’ needs. In some cases, inspection procedures even varied within a Service. Specifically, the inspection procedures varied because of (1) a lack of standardized training, (2) a lack of the requisite professional experience and/or expertise among inspection team members, and (3) failure to track inspection findings and ensure long-term implementation of recommendations. These deficiencies occurred because there is no single DoD entity that can track and correct deficiencies and implement standardization procedures. Therefore, the OIG recommended that the Deputy Secretary of Defense appoints an Executive Agent for Biosafety and Biosecurity, who would conduct standardized oversight and inspections, track and follow up on inspection results, improve training, and ensure that members of the inspection teams are adequately qualified.
Second, the BSAT labs did not consistently undergo internal or external technical or scientific peer reviews, which are essential for proper oversight. Although DoD guidance required the formation of institutional-level Biological Safety Committees (which must meet at least quarterly), implementation of this requirement varies widely among the many BSAT labs. Current guidance does not contain a requirement for a similar committee on biosecurity, nor does the guidance require reporting or tracking of incidents related to physical security or personnel reliability. There is also no mechanism currently in place for incorporating lessons learned. The OIG recommended two courses of action to mitigate these shortcomings: (1) the Executive Agent should implement an external technical and scientific peer review process that addresses both biosafety and biosecurity issues, and (2) the Under Secretary of Defense for Acquisitions, Technology, and Logistics (USD [AT&L]) should issue guidance that requires all DoD BSAT labs to implement such a peer review process.
Third, inconsistent inspection standards led to multiple, missing, and duplicative inspections, which ultimately put an undue administrative burden on the labs being inspected. According to Executive Order 13546, the DoD must coordinate inspections with the Centers for Disease Control (CDC) and the Animal and Plant Health Inspection Service (APHIS), who oversee the Select Agents program. Many inspections were not coordinated, resulting in a duplication of efforts that wasted time and resources. In other cases, inspections were not completed as fully or regularly as instructed. The OIG therefore recommended that the Executive Agent serve as the DoD point of contact for coordination with the CDC and APHIS, scheduling joint inspections and defining the combined inspection criteria and guidance. The Executive Agent would also serve as the point of contact within the Federal Select Agent Program regarding findings from these joint inspections.
Finally, some inspectors failed to review specific vulnerability assessments for their assigned labs to ensure that shortcomings identified during previous inspections had been mitigated. In some cases, these vulnerability assessments were not reviewed because they had never been conducted, or had not been conducted annually as required. Although Department of Defense Instruction 5210.89 (“Minimum Security Standards for Safeguarding Biological Select Agents and Toxins”) does not require that site-specific findings be considered during inspections, the OIG found that such a practice could rectify recurring issues. Thus, the OIG recommended that the Executive Agent should implement the inclusion of site-specific vulnerability assessments into all inspections, and the USD (AT&L) should implement guidance that requires the consistent consideration such assessments.
The Deputy Secretary of Defense and the USD (AT&L) both submitted comments to this report before publication, wherein they agreed with the OIG’s analysis and recommendations. The USD (AT&L) is currently drafting a DoD Directive for the DoD BSAT Biosafety and Biosecurity Program that will implement all four of the OIG’s recommendations. The OIG has accepted this action as meeting the intent of their recommendations. Before the draft DoD Directive is published, the OIG will review it to ensure that the recommendations have been fully met. Recent lapses at BSAT labs have brought biosafety and biosecurity into the public consciousness. Fear of a biological attack have loomed large in the wake of 9/11 and the 2001 anthrax attacks (Amerithrax), but labs working with such pathogens to protect the citizens from their effects must conduct their work in such a way that they do not put citizens’ lives at risk.