CDC permits partial operations at DOD’s lead lab for medical biological defense research

The Centers for Disease Control and Prevention (CDC) recently approved the reopening and partial operations of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the U.S. Department of Defense’s (DOD’s) lead laboratory for medical biological defense research.

This summer, research was put on hold at the USAMRIID’s Fort Detrick, Md., location following a federal government-ordered shutdown that prompted a major re-set of the institute’s biological safety program, which provides leading-edge medical capabilities to deter and defend against current and emerging biological threats.

The overall plan is to restore USAMRIID to full operational capability, according to U.S. Army Col. E. Darrin Cox, Commander of the institute.

“Our concept is to start with a small group of people, secure approval for a limited number of studies, and then gradually expand to include more research projects across additional laboratory suites,” Col. Cox said on Friday in a statement. “Resuming operations in this stepwise fashion also allows for continuous communication with the CDC and our Army leadership.”
USAMRIID has been the lead DOD laboratory for medical biological defense research since 1969.

Among several duties, the institute investigates disease outbreaks and public health threats, conducting myriad research that has led to medical solutions — including therapeutics, vaccines, diagnostics, and information — that benefit both military personnel and civilians, according to the institute.

The facility’s Biosafety Level-3 and BSL-4 containment laboratories, which are its highest-security labs, have worked on numerous pathogens, including Ebola and the plague, which are among those considered “select agents and toxins” by the U.S. Department of Health and Human Services (HHS).

In fact, HHS only allows authorized labs to work on such pathogens.

During a June site visit to USAMRIID, CDC inspectors identified several deviations in the institute’s Standard Operating Procedures that are designed to safeguard laboratory workers in its BSL-3 and BSL-4 labs.

In July, the CDC served USAMRIID with a cease and desist order after finding that the institute did not have “sufficient systems in place to decontaminate wastewater,” according to the CDC’s statement.

During the next four months, USAMRIID worked closely with the CDC on a comprehensive approach to improve infrastructure, training, compliance, and biosafety standards, and in early November, the CDC’s Division of Select Agents and Toxins (DSAT) conducted a site inspection.

Subsequently, the CDC provided additional conditions for research to gradually resume, including a limited number of studies to be performed. Work on these studies will be conducted in specified laboratories only, by select personnel who have undergone extensive training, according to a Nov. 22 statement released by USAMRIID.

Such limited activities will allow USAMRIID and DSAT the chance to evaluate the newly implemented processes and procedures, according to the statement, and the CDC will continue to conduct on-site evaluations to observe laboratory personnel.

Leaders from the U.S. Army Futures Command and the U.S. Army Medical Research and Development Command (USAMRDC), which oversees the USAMRIID, also are involved in the effort to bring USAMRIID back online, according to Brig. Gen. Michael Talley, Commanding General of USAMRDC and Fort Detrick.

“We are committed, first and foremost, to the safety of our workforce and the surrounding community,” said Talley. “We are also committed to restoring USAMRIID to full mission capability so we can continue doing the critical research that protects our warfighters and citizens, in this country and around the world.”

The CDC also will conduct real-time observations at all supervisory levels to ensure that practices comply with the revised biosafety plan and that any deviation is immediately corrected, according to USAMRIID.