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DoD Inspector General to Reevaluate Select Agent Facilities, Biosafety Oversight

Image of Ebola virus, a biological Select Agent, color adjusted for 'camouflage'.

The Department of Defense Office of the Inspector General (DoD OIG) is conducting a Follow-Up Evaluation of DoD Biological Select Agents and Toxins (BSAT) Biorisk Program Office implementation of recommendations from the April 2016 “Evaluation of DoD Biological Safety and Security Implementation“.

The OIG assessment was announced in a 12 Aug 2019 memorandum distributed to the Secretary of the Army; Surgeon General of the Army; Office of the Secretary of the Army; U.S. Army Medical Research and Material Command; Director, DoD Biological Select Agents and Toxins Biorisk Program Office; Under Secretary of Defense for Acquisition and Sustainment; Assistant Secretary of Defense for Nuclear, Chemical and Biological Defense Programs; Deputy Assistant Secretary of Defense for Chemical and Biological Defense; and the Director, Defense Health Agency.

The memo noted the OIG objective is to validate implementation of recommendations from the April 2016 report (available below), and assess the development of the oversight capabilities of the Biological Select Agents and Toxins (BSAT) Biorisk Program Office.

News broke to the public on 2 Aug 2019 that the U.S. Army DoD’s highest-level containment laboratory, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), had failed to meet biosafety standards and lost accreditation with the Federal Select Agent Program, effectively halting critical research on countermeasures for some of the world’s deadliest pathogens.

It comes as little surprise that the Inspector General is reacting to the situation at USAMRIID. After all, it was the May 2015 discovery that a DoD lab in Utah had inadvertently shipped incompletely inactivated Bacillus anthracis to 194 laboratories and contractors worldwide over the course of 12 years that lead to the overhaul of the biosafety and biosecurity implementations the OIG evaluated and outlined in the original 2016 report.


Reverse Timeline of DoD BSAT Program and Biosafety Incidents

Jan 2019: DoD Issues Directive 5101.20E for BSAT Program

DoD Directive 5101.20E Establishes policy and assigns responsibilities for the DoD BSAT Security Program established in DoD Instruction 5210.88 and for meeting the safety standards for microbiological and biomedical laboratories prescribed in DoD 6055.18-M.

Outlines responsibilities of the Secretary of the Army as the DoD Executive Agent (EA) for the DoD BSAT Biosafety and Biosecurity Program, who exercises this authority through the Surgeon General of the Army, in accordance with DoD Directive (DoDD) 5101.1.

Sep 2018: GAO Outlines Progress and Shortcomings in DoD’s Biosafety and Biosecurity Program

The following are excerpts from the U.S. General Accountability Office (GAO) report released 20 Sep 2018.

The Department of Defense (DOD) has made progress by taking a number of actions to address the 35 recommendations from the Army’s 2015 investigation report on the inadvertent shipments of live Bacillus anthracis (anthrax). However, DOD has not yet developed an approach to measure the effectiveness of these actions. DOD reports 18 recommendations as having been implemented and 17 as having actions under way to implement them. These actions are part of a broader effort to improve biosafety, biosecurity, and overall program management.

The Secretary of the Army, as DOD’s Executive Agent, has implemented a BSAT Biosafety and Biosecurity Program to improve management, coordination, safety, and quality assurance for the DOD BSAT enterprise. However, DOD has not developed a strategy and implementation plan for managing the program. Without a strategy and implementation plan, Dugway Proving Ground, Utah, and DOD’s laboratory facilities that currently produce and handle BSAT may be unclear about DOD’s strategy to harmonize BSAT operations to ensure safety, security, and standardization of procedures throughout DOD’s BSAT enterprise.

The Army has not fully institutionalized measures to ensure that its biological test and evaluation (T&E) mission remains independent from its biological research and development (R&D) mission so that its T&E procedures are objective and reliable. In April 2016, the Army directed the transfer of the operational T&E mission from West Desert Test Center-Life Sciences Division at Dugway Proving Ground, Utah, to Edgewood Chemical Biological Center, Maryland. The Army issued a memorandum of agreement between the two entities to lay out roles and responsibilities for test processes and procedures. However, the memorandum does not distinguish T&E from R&D mission requirements, and does not contain guidelines to mitigate risks associated with potential conflicts of interest between the R&D and T&E missions. Without these measures, there is a potential risk to the independence of the T&E mission.

The National Defense Authorization Act (NDAA) for Fiscal Year 2017 required DOD to report by February 1, 2017, on the feasibility of consolidating BSAT facilities within a unified command, partnering with industry for the production of BSAT in lieu of maintaining such capabilities within the Army, and whether such operations should be transferred to another government or commercial laboratory. DOD has not completed this required study and evaluation of its BSAT infrastructure which, when complete, will affect the future infrastructure of the BSAT Biosafety and Biosecurity Program. Further, DOD officials have no estimated time frames for when DOD will complete the study and evaluation. Without time frames for completing the study and evaluation, DOD is unable to provide decision makers with key information on its infrastructure requirements.

We reported in June 2015 on the need for DOD to designate an entity to identify, align, and manage its chemical and biological defense infrastructure, which includes its BSAT-related infrastructure. We found that CBDP had not fully identified the infrastructure capabilities required to address threats, had not planned to identify potential duplication without considering information from existing federal studies, and had not updated its guidance and planning process to include specific responsibilities and time frames for risk assessments. As a result, we recommended, among other things, that DOD: identify and designate an entity within the CBDP Enterprise with the responsibility and authority to lead the effort to ensure achievement of infrastructure goals; and establish time lines and milestones for achieving the goals it has identified for chemical and biological infrastructure, including the Program Analysis and Integration Office’s 2008 recommendation that the CBDP Enterprise identify its required infrastructure capabilities. DOD concurred with all of our recommendations.

In response to our recommendations, DOD, among other things, designated an infrastructure manager for CBDP and is implementing a three-phase process to identify and define the roles and responsibilities of the position by the end of 2018. As part of its BSAT infrastructure, DOD currently has five covered facilities that contain various laboratories across the military services that possess and handle BSAT. Each of these facilities currently is registered with the Federal Select Agent Program to possess BSAT in the United States. A sixth DOD facility, the BioTesting Division at Dugway Proving Ground, Utah, is working to regain its certification as a covered facility.

Sep 2016: Congressional Hearing on Inactivation Procedures for Dangerous Pathogens

The Subcommittee on Oversight and Investigations held a hearing on 27 Sep 2016 entitled “Bioresearch Labs and Inactivation of Dangerous Pathogens.”

Key Documents

Witnesses

  • Dr. Timothy M. Persons, Chief Scientist, Government Accountability Office Testimony
  • Dr. Daniel Sosin, Deputy Director and Chief Medical Officer, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention Testimony
  • Dr. Steve Monroe, Associate Director for Laboratory Science and Safety, Centers for Disease Control and Prevention Testimony
  • Mr. Mark Davidson, Associate Deputy Administrator, Veterinary Services, U.S. Department of Agriculture, Testimony
  • Mr. Jeff Potts, BioRisk Manager, National Institutes of Health, Office of Research Services Testimony
  • Major General Barbara R. Holcomb, Commanding General, U.S. Army Medical Research and Materiel Command at Fort Detrick, Deputy for Medical Systems to the Assistant Secretary of the Army for Acquisition, Logistics, and Technology, Chief, U.S. Army Nurse Corps, Department of the Army Testimony

Jul 2016: Army Directive 2016-24 Issued for Biological Select Agent and Toxins (BSAT) Biosafety Program

This directive establishes policy and assigns responsibilities for the Department of Defense (DoD) Biological Select Agent and Toxins (BSAT) Biosafety Program.

The scope of the DoD BSAT Biosafety Program includes, but is not limited to, the following Army, Navy, and Air Force laboratories:

(1) U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD, which is subordinate to U.S. Army Medical Research and Materiel Command, U.S. Army Medical Command, Joint Base San Antonio-Fort Sam Houston, TX.

(2) Edgewood Chemical and Biological Center (ECBC), Aberdeen Proving Ground, MD, which is subordinate to U.S. Army Research, Development, and Engineering Command, Aberdeen Proving Ground, which is subordinate to Army Materiel Command (AMC), Redstone Arsenal, AL.

(3) Life Science Division, Dugway Proving Ground (DPG), UT, which is subordinate to ECBC, Aberdeen Proving Ground.

(4) Naval Medical Research Center, Fort Detrick, MD, and Naval Medical Research Units Cairo, Egypt, and Lima, Peru, which are subordinate to Navy Medicine West, San Diego, CA, which is subordinate to the Department of the Navy Bureau of Medicine and Surgery, Falls Church, VA.

(5) Chemical, Biological, and Radiological Defense Division, Naval Surface Warfare Center, Dahlgren Division, Dahlgren, VA, which is subordinate to the Naval Surface Warfare Center, Naval Sea Systems Command, Washington Navy Yard, DC.

(6) 711th Human Performance Wing, Wright-Patterson Air Force Base, OH,
which is subordinate to the Air Force Research Laboratory, Air Force Materiel
Command, Wright-Patterson Air Force Base.

April 2016: OIG Report Released: Evaluation of DoD Biological Safety and Security Implementation

KEY FINDINGS

  • DoD had not maintained biosafety and biosecurity program management, oversight, and inspections of its BSAT laboratories according to applicable Federal regulations.
  • BSAT laboratories in Military Services were inspected according to different guidance, standards, and procedures, risking dangerous lapses in biosafety practices.
  • Lack of coordinated oversight of DoD laboratories led to multiple, missing, and duplicative inspections, and, therefore, an excessive administrative burden that could interfere with scientific research performance.
  • Inspection quality varied as inspection team members sometimes lacked necessary training or sufficient experience and expertise, or a combination of each.
  • DoD did not require that deficiencies identified by inspections were tracked and remain corrected after they were initially closed.
  • DoD lacked a single coordinating entity to oversee and manage biosafety and biosecurity deficiencies in high risk BSAT laboratories.

RECOMMENDATIONS

OIG recommends that the Deputy Secretary of Defense appoint a single Executive Agent responsible for biosafety and biosecurity to perform the following tasks:

  • Track all internal and external inspection results and ensure appropriate corrective actions are taken
  • Ensure that all BSAT laboratories are inspected regularly according to a standardized set of criteria
  • Coordinate external technical and scientific peer reviews, and develop standardized training for inspectors, and ensure inspection teams consist of personnel with appropriate experience and expertise.

OIG recommends that the Under Secretary of Defense for Acquisition, Technology, and Logistics:

  • Issue guidance that all Department of Defense BSAT laboratories implement internal technical and scientific peer review functions that address both biosafety and biosecurity issues.
  • Develop implementing guidance that requires site-specific laboratory security vulnerability assessment findings be included during Biological Select Agent and Toxins laboratory inspections.

Jan 2016: DoD Press Briefing: Reorganization of Critical Reagents Program, New Biological Inspection Program

Select comments from a DoD 15 Jan 2016 press briefing outlining progress from the bio-safety task force investigating biological select agents and toxins from the anthrax incident.

We have disestablished the office known as the critical reagents program, or CRP, and in its place, formed an office called the Defense Biological Product Assurance Office.

We have and are in the process of developing new DOD procedures for the inactivation and testing of bacillus anthracis, which, when the underlying scientific research is completed, and we expect it’ll take at least a year, will serve as our single DOD and Centers for Disease Control validated procedure for this procedure.

We have transferred control of the biological laboratory at Dugway Proving Ground, from the Army Test and Evaluation Command to the Research, Development and Engineering Command, and eliminated their mission of producing biological agents for export across our customers. So that production mission will no longer be conducted at Dugway Proving Ground, it will be done at other laboratories within the DOD.

And finally, we’ve put in place a new DOD biological inspection program in favor of a central program. Previous to this, we had at least eight separate inspection teams. Now, we will have one DOD inspection team, which will partner with the Centers for Disease Control to provide a much more — less variability in our standards and increased integration.

Dec 2015: U.S. Army Issues Report on Investigation of Anthrax Bacteria Shipments

In December 2015, the Army issued an investigation report on its findings which, among other things, determined that although the inadvertent shipment of incompletely inactivated Bacillus anthracis was a serious breach of regulations and raised biosecurity concerns, it did not pose a public health risk. The investigation also determined that there was insufficient evidence to establish a single failure as the cause for the inadvertent shipments of incompletely inactivated Bacillus anthracis. However, the report cited scientific and institutional issues and said that senior management at Dugway Proving Ground had contributed to “a culture of complacency, resulting in laboratory personnel not always following rules, regulations, and procedures.” The Army’s 2015 investigation report resulted in recommendations to the Army to improve scientific knowledge gaps on irradiation and viability testing processes, address institutional concerns to reduce the risk of future mishaps involving biological material, and address individual accountability for the failures that contributed to the inadvertent shipment of incompletely inactivated Bacillus anthracis.

Sep 2015: Immediate Safety Review Ordered at All Labs After Finding Bacillus anthracis Outside Primary Containment Area at Dugway

The U.S. Army announced on 3 Sep 2015 an immediate safety review at all DoD labs and facilities involved in the production, shipment, and handling of live and inactivated select agents and toxins.

The action was prompted by the discovery of Bacillus anthracis contamination in secure areas located outside the primary containment area (but still contained within the special enclosed lab for holding these materials) at Dugway Proving Ground in Utah.  The contamination was discovered during the ongoing review of all policies, procedures and processes affecting the use and shipment of bacillus anthracis.

Jul 2015: CDC Federal Select Agent Program Leadership Testifies to Congress on DoD Anthrax Shipments

On 28 July 2015, testimony was given on the DoD live anthrax shipments before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, U.S. House of Representatives.

Dr. Daniel M. Sosin, Deputy Director and Chief Medical Officer with the Office of Public Health Preparedness and Response at the Centers for Disease Control and Prevention (CDC) testified on CDC’s role in the investigation as the Federal Select Agent program authority.

On May 22, 2015, after being advised by a laboratory that live anthrax was detected in a sample from Dugway that was supposed to have been inactivated, CDC initiated outreach to what has amounted to 183 domestic laboratories (164 of which are not DoD labs) to track 575 shipments of presumed inactivated anthrax material (that turned out to include live anthrax) coming from Dugway. (There were an additional nine labs in seven foreign countries that received lots from Dugway, making for a total of 192 labs that received hot lots, but CDC’s outreach was only to domestic labs).

In the last two months, CDC has reached out to each laboratory to identify potential exposure to this material within the past year – with most outreach coming within hours of learning that the laboratory might hold incompletely inactivated material. If a potential exposure was encountered, CDC doctors and scientists, in collaboration with state health departments, assessed workers and the laboratory environment for any possible aerosol spore exposure (inhalation anthrax is considered to be the most deadly form of anthrax). CDC laboratory scientists tested samples shipped from Dugway to confirm our understanding of low concentrations of spores in the positive results, and CDC environmental microbiologists and hygienists worked with EPA to develop recommendations for decontamination of the laboratories to allow them to be back up and running again and ensure the safety of the people that work there.

CDC assessed the risk to workers in all 164 domestic civilian laboratories that received the live DoD anthrax specimens, and only eight individuals, working in three different civilian laboratories, were identified as potentially exposed. (DoD managed assessment and follow-up of additional individuals who worked in DoD labs). Out of an abundance of caution, given that our assessment concluded low exposure and disease risk, post-exposure prophylaxis was recommended for these eight individuals. Of those eight, two began but later discontinued post-exposure prophylaxis. The other six individuals will have completed their 60-day postexposure prophylaxis regimen of antibiotics and vaccine by July 27. As of submitting this testimony, none have experienced complications. In fact, in over more than a decade (since 2004) of working in laboratories with these presumed inactivated samples from Dugway, no laboratory researcher has been diagnosed with anthrax infection.

Jul 2015: Deputy SecDef Implementation of the Recommendations in the Comprehensive Review Report

A 23 July 2015 memorandum orders the implementation of recommendations from the Comprehensive Review report and designates the Secretary of the Army as the DoD Executive Agent for the DoD Biological Select Agent and Toxin (BSA T) Biosafety Program, responsible for the technical review, inspection, and harmonization of biosafety protocols and procedures across DoD laboratories that handle BSAT.

Jul 2015: DoD Announces Findings of Live Anthrax Shipment Comprehensive Review

Deputy Secretary of Defense Bob Work in a press briefing on 23 July 2015 announced the findings of the investigative committee and calling the Defense Department’s inadvertent delivery of live anthrax to commercial labs “a massive institutional failure.”

Source: Defense.gov

Al Mauroni, Director of the U.S. Air Force Center for Unconventional Weapons Studies, commented on the investigation findings in depth in a piece for War On The Rocks. Highlighted excerpt:

While the recommendations are mostly useful, two significant misfires are included. First, the report calls for the Department of Defense’s Chemical and Biological Defense Program to fund the research required to develop standardized irradiation and viability testing protocols. The Chemical and Biological Defense Program is a management function run by the Office of the Secretary of Defense (OSD) to procure defense equipment for the military. Over the past five years, it has diverted funds from equipment development to paying for Army infrastructure bills associated with chemical and biological defense research and development. Maintaining laboratory buildings and equipping these buildings is appropriately an Army installation management responsibility, but budget pressures have caused the Army leadership to try to convince OSD to pay for its operations and maintenance bills. This problematic practice needs to be addressed.

Second, Frank Kendall’s memo calls for the Army to become a Department of Defense Executive Agent for the Biological Select Agent and Toxin Biosafety Program, adding to the list of 40 other DoD Executive Agent roles that the Army maintains. The Army has been the Executive Agent for Chemical and Biological Defense since 1976, and this new responsibility is really a subset of that existing one. The department does not have to do anything more than tell the Army to execute its existing responsibilities. Adding a repetitious and meaningless title won’t add value to the existing regulations on Army biosurety.

In addition, the Army’s track record as DoD Executive Agent for Chemical and Biological Defense is not promising. Over the past decade, senior Army leaders have repeatedly avoided confrontations as OSD senior leaders made very bad decisions affecting the development of military chemical and biological defense capabilities.

Read the full article here.

May 2015: Live Anthrax Shipments from Dugway Proving Ground Discovered, Investigation Initiated

In May 2015, the U.S. Department of Defense discovered that one of its laboratories at Dugway Proving Ground, Utah, had inadvertently shipped incompletely inactivated Bacillus anthracis to 194 laboratories and contractors worldwide over the course of 12 years. In response to this discovery, the Deputy Secretary of Defense ordered an immediate 30-day review in May 2015 that resulted in a moratorium on the production, handling, testing, and shipment of inactivated Bacillus anthracis. The Deputy Secretary of Defense subsequently directed a more detailed review by the Army.

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