Report | July 16, 2020

Followup Evaluation of Report DODIG-2016-078, Evaluation of the Department of Defense’s Biological Select Agents and Toxins Biosafety and Biosecurity Program Implementation (DODIG-2020-105)

Evaluation

Publicly Released: July 20, 2020

 

Objective

The objective of this followup evaluation was to validate implementation of recommendations from report DODIG‑2016‑078, “Evaluation of DoD Biological Safety and Security Implementation,” April 27, 2016, and determine whether the actions taken by the Office of the Under Secretary of Defense for Acquisition and Sustainment and the Secretary of the Army as the DoD Executive Agent for the DoD Biological Select Agents and Toxins Biosafety and Biosecurity Programs met the intent of the recommendations.

 

Background

Biological defense encompasses measures taken to protect and recover from the effects of biological select agents and toxins or emerging biological threats. Biological select agents and toxins (BSAT) are the microorganisms and poisonous substances that have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products. Common examples of BSAT are microorganisms that cause anthrax, bubonic plague, and smallpox, as well as the toxin ricin.

The Army and Navy maintain BSAT Biosafety and Biosecurity Programs to accomplish the biological defense vision to address biological threats and minimize their effects. The Army maintains three BSAT‑registered laboratories and the Navy has two BSAT‑registered laboratories.

  • U.S. Army Combat Capabilities Development Command Chemical Biological Center, Dugway Proving Ground, Utah
     
  • U.S. Army Combat Capabilities Development Command Chemical Biological Center, Aberdeen Proving Ground, Maryland
     
  • U.S. Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland
     
  • Naval Surface Warfare Center Dahlgren Division, Dahlgren, Virginia
     
  • Naval Medical Research Center Biological Defense Research Directorate, Fort Detrick, Maryland

In April 2016, the DoD Office of Inspector General published report DODIG‑2016‑078, “Evaluation of DoD Biological Safety and Security Implementation,” (our 2016 report) which included 13 recommendations concerning the execution of the DoD BSAT Biosafety and Biosecurity Programs. In January 2019, the Office of the Under Secretary of Defense for Acquisition and Sustainment issued a new directive, DoD Directive (DoDD) 5101.20E, to address the 13 recommendations.

The Secretary of Defense designated the roles and responsibilities for the DoD BSAT Biosafety and Biosecurity Programs to several DoD components, including the Office of the Under Secretary of Defense for Acquisition and Sustainment (OUSD[A&S]), the Secretary of the Army, the Department of the Army Inspector General (DAIG) Technical Inspections Division, and the BSAT Biorisk Program Office (BBPO).

 

Finding

The OUSD(A&S) and the Secretary of the Army as the DoD Executive Agent (EA) for the DoD BSAT Biosafety and Biosecurity Programs implemented actions that met the intent of 9 of the 13 recommendations from our 2016 report. For example, the Deputy Secretary of Defense designated the Secretary of the Army as the DoD EA for the DoD BSAT Biosafety and Biosecurity Programs, which addressed the recommendation regarding appointing a single EA responsible for biosafety and biosecurity. However, 4 of the 13 recommendations from our 2016 report had not fully been implemented.

  • The OUSD(A&S) did not issue policy requiring all DoD BSAT‑registered laboratories to implement an internal technical and scientific peer review function that addresses both biosafety and biosecurity. This occurred because an OUSD(A&S) Chemical and Biological Security Policy official stated that the language in DoDD 5101.20E requires both external and internal technical and scientific peer reviews. However, the directive only requires an external peer review.
     
  • The EA did not conduct standardized oversight of the BSAT‑registered laboratories or track all internal and external inspection results. This occurred because the BBPO officials, as directed by the former Executive Agent Responsible Official (EARO), focused more on support efforts to advise, assist, and advocate for the BSAT Biosafety and Biosecurity Programs and BSAT‑registered laboratories, without establishing themselves as an oversight body in accordance with DoDD 5101.20E.
     
  • The DAIG did not develop and implement training for BSAT laboratory inspectors and subject matter expert inspection team augmentees. This occurred because the DAIG Technical Inspections Division relied on training obtained from the Department of the Army Inspector General course, non‑DoD BSAT‑registered laboratory specific technical courses, and the inspectors’ experience. As a result, incomplete and inconsistent oversight of the DoD BSAT Biosafety and Biosecurity Programs remain, which increases the risk of exposing DoD BSAT entities, personnel, and the public to the hazards associated with BSAT.

 

Recommendations

In February 2019, the DoD Office of Inspector General closed the recommendations from our 2016 report. However, in this followup evaluation, we determined that 4 of the 13 recommendations from our 2016 report should not have been closed. Therefore, we are making 3 new recommendations (we combined two of the recommendations from our 2016 report into one new recommendation). Specifically, we recommend that the Office of the Under Secretary of Defense for Acquisition and Sustainment issue policy requiring all DoD biological select agents and toxins‑registered laboratories to implement an internal technical and scientific peer review function that addresses both biosafety and biosecurity.

We recommend that the DoD Executive Agent for the Biological Select Agents and Toxins Biosafety and Biosecurity Programs, in coordination with the Biological Select Agents and Toxins Biorisk Program Office, develop a plan to conduct standardized oversight of the DoD Biological Select Agents and Toxins Biosafety and Biosecurity Programs and biological select agents and toxins‑registered laboratories, including tracking all internal and external inspection results.

We recommend that the Department of the Army Inspector General Technical Inspections Division, in coordination with the Executive Agent for the DoD Biological Select Agents and Toxins Biosafety and Biosecurity Programs, develop and implement training requirements for biological select agents and toxins laboratory inspectors and inspection team subject matter expert augmentees.

 

Management Comments and Our Response

The Acting Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs, responding on behalf of the Under Secretary of Defense for Acquisition and Sustainment, agreed with the recommendation. Specifically, the Acting Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs will include a requirement for all DoD BSAT laboratories to establish internal technical and scientific peer review panels to review biosafety protocols and biosecurity policies in Change 1 to Department of Defense Directive 5101.20E, “DoD Biological Select Agents and Toxins (BSAT) Biosafety and Biosecurity Program.” Therefore, the recommendation is considered resolved, but will remain open.

The Department of the Army Surgeon General, as the Executive Agent Responsible Official, responding on behalf of the DoD Executive Agent for the BSAT Biosafety and Biosecurity Programs, agreed with the recommendation. The Surgeon General has developed a plan to conduct standardized oversight of the DoD BSAT Biosafety and Biosecurity Programs and DoD BSAT‑registered laboratories, including tracking all internal and external inspection results. Specifically, the EARO and a BBPO official have begun site visits to each BSAT‑registered laboratory and will provide formal communication to the BSAT biosafety and biosecurity community to clarify their oversight role with expected completion by August 31, 2020. Additionally, the BBPO developed and implemented a formal BSAT Executive Agent Responsible Official Program for Biosafety and Biosecurity Related Staff Assistance Visits Program, signed by the EARO on May 27, 2020. According to management comments and a review of program documentation, this Staff Assistance Visits Program will provide direct oversight of the DoD BSAT‑registered laboratories’ compliance status with Federal, DoD, Service‑specific, state, and local regulations to ensure the laboratories are inspection ready at all times. Additionally, the BBPO has moved from tracking the inspection results from the initial spreadsheet to the Quality Management System Inspections Database within the Joint Interagency Biorisk System. The BBPO has completed entry of inspection results from the Department of the Army Inspector General Technical Inspections Division and the Centers for Disease Control and Prevention Division of Select Agents and Toxins back to 2016, and has begun entering results from the Department of the Army Safety pre‑operational surveys with planned database entry completion by July 1, 2020. Therefore, we consider this recommendation closed.

The Department of the Army Inspector General, responding on behalf of the DAIG Technical Inspections Division, agreed with the recommendation. Specifically, the Department of the Army Inspector General agreed to require technical inspectors and external subject matter expert inspectors to participate in training specific to DoD and Service‑specific BSAT standards. Therefore, the recommendation is resolved, but will remain open.

 

 

This report is a result of Project No. D2019-DEV0PA-0188.000.