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Research Halted at USAMRIID Over Biosafety Issues

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the only Biosafety Level 4 laboratory in the Department of Defense, has ceased research operations on high-risk pathogens after failing to meet Federal biosafety requirements.

The move results from several actions recently taken by the Centers for Disease Control and Prevention in response to concerns about USAMRIID’s past management of its Biological Select Agents and Toxins (BSAT) research program.

During a site visit to USAMRIID in June 2019, CDC inspectors identified several deviations in Standard Operating Procedures designed to safeguard laboratory workers in Biosafety Level-3 and BSL-4 containment laboratories.

In July 2019, USAMRIID received a formal Cease and Desist Order from the CDC for failing to have sufficient systems in place to decontaminate wastewater generated by BSL-3 and BSL-4 laboratory operations. That notice was followed by a formal suspension of USAMRIID’s registration by the Federal Select Agent Program, effectively halting all BSAT work in registered laboratory areas.

The May 2018 failure of the Fort Detrick Steam Sterilization Plant and USAMRIID’s subsequent transition to modified BSL-3 procedures and a new chemical effluent decontamination system increased the operational complexity of biocontainment laboratory research activities within the Institute.

In an emailed statement to Global Biodefense, the Institute noted it had begun a major re-set of its biological safety program and is working with the CDC on a path forward.

“USAMRIID is engaged in ongoing discussions with the CDC to address the way forward, and is committed to doing the serious work required to effect a meaningful and permanent change in its safety culture. While the Institute’s research mission is critical, the safety of the workforce and community is paramount. USAMRIID is taking this opportunity to correct deficiencies, build upon strengths, and create a stronger and safer foundation for the future.”

Timeframe and Transparency

The flooding at Fort Detrick happened over a year ago. The CDC site visit was in June 2019. USAMRIID was given notification at an unspecified date in July 2019 that the organization’s registration with the Federal Select Agent Program was suspended.

The only publicly available reporting on this appears to be from the Fort Detrick community’s local paper, the Frederick News Post, on 2 Aug. There are no press releases or public notices available regarding this news at the Fort Detrick, USAMRIID, CDC, Select Agent Program or U.S. Army websites.

USAMRIID did respond on 5 Aug. to Global Biodefense with an email statement, the details of which are reported in this article.

Laboratory Response Network (LRN)

In addition to USAMRIID’s role in Department of Defense medical countermeasure development, it also serves as a National Laboratory (along with the CDC in Atlanta) as part of the Laboratory Response Network (LRN).

The LRN is composed of local, state and federal public health, food testing, veterinary diagnostic, and environmental testing laboratories. They provide the laboratory infrastructure and capacity to respond to biological and chemical terrorism, and other public health emergencies.

USAMRIID and the CDC sit at the top of the LRN national security pyramid to handle confirmatory testing for agents that other labs are not capable of testing, as well as performance of specialized tests to assist with bioterrorism countermeasure response and forensic investigations.

There has been no word from the U.S. Army or CDC as to how the suspension from the Federal Select Agent program will impact the LRN role.

Project BioShield: Building a Better Medical Countermeasure Pipeline

Biodefense Headlines – 11 August 2019