All research at a Fort Detrick laboratory that handles high-level disease-causing material, such as Ebola, is on hold indefinitely after the Centers for Disease Control and Prevention found the organization failed to meet biosafety standards.
No infectious pathogens, or disease-causing material, have been found outside authorized areas at the U.S. Army Medical Research Institute of Infectious Diseases.
The CDC inspected the military research institute in June and inspectors found several areas of concern in standard operating procedures, which are in place to protect workers in biosafety level 3 and 4 laboratories, spokeswoman Caree Vander Linden confirmed in an email Friday.
The CDC sent a cease and desist order in July.
After USAMRIID received the order from the CDC, its registration with the Federal Select Agent Program, which oversees disease-causing material use and possession, was suspended. That suspension effectively halted all biological select agents and toxin research at USAMRIID, Vander Linden said in her email.
The Federal Select Agent Program does not comment on whether a program such as USAMRIID is registered and cannot comment on action taken to enforce regulations, Kathryn Harben, a spokeswoman for the CDC, wrote in an email.
“As situations warrant, [Federal Select Agent Program] will take whatever appropriate action is necessary to resolve any departures from regulatory compliance in order to help ensure the safety and security of work with select agents and toxins,” Harben said in the email.
The suspension was due to multiple causes, including failure to follow local procedures and a lack of periodic recertification training for workers in the biocontainment laboratories, according to Vander Linden. The wastewater decontamination system also failed to meet standards set by the Federal Select Agent Program, Vander Linden said in a follow-up email.
“To maximize the safety of our employees, there are multiple layers of protective equipment and validated processes,” she said.
Vander Linden could not say when the laboratory would be able to continue research.
“USAMRIID will return to fully operational status upon meeting benchmark requirements for biosafety,” she said in an email. “We will resume operations when the Army and the CDC are satisfied that USAMRIID can safely and consistently meet all standards.”
USAMRIID has been working on modified biosafety level 3 procedures and a new decontamination system since flooding in May 2018. This “increased the operational complexity of bio-containment laboratory research activities within the Institute,” she said.
At the time of the cease and desist order, USAMRIID scientists were working with agents known to cause tularemia, also called deer fly or rabbit fever, the plague and Venezuelan equine encephalitis, all of which were worked on in a biosafety level 3 laboratory. Researchers were also working with the Ebola virus in a biosafety level 4 lab, Vander Linden said.
Of the pathogens, Ebola, bacteria Yersinia pestis (plague), and bacterium Francisella tularensis (tularemia) are on the list of the Health and Human Services select agents and toxins. The three are considered Tier 1 agents, which pose a severe public health and safety threat.
Venezuelan equine encephalitis also falls under the Federal Select Agent Program, according to the Code of Federal Regulations.
The military research institute is looking at each of its contracts to see what will be affected by the shutdown. USARMIID work outside the lab is not expected to be affected, including on Ebola, Vander Linden said.
“We are coordinating closely with the CDC to ensure that critical, ongoing studies within bio-containment laboratories are completed under appropriate oversight and that research animals will continue to be cared for in accordance with all regulations,” she said in an email. “Although much of USAMRIID’s research is currently on hold, the Institute will continue its critical clinical diagnostic mission and will still be able to provide medical and subject matter expertise as needed to support the response to an infectious disease threat or other contingency.”
According to the Code of Federal Regulations, which also lists required training, records and biosafety plans, Federal Select Agents Program registration can be suspended to protect public health and safety. It is not clear if this is why the USAMRIID registration was suspended.
The code also gives the Department of Health and Human Services, under which the CDC falls, the right to inspect any site and records, without prior notifications. Vander Linden said in the email that the CDC inspected USAMRIID several times over the past year, both unannounced and on a regularly scheduled basis.
USAMRIID will work to meet requirements set by the Army and the CDC and have its suspension lifted, Vander Linden said.
“While the Institute’s research mission is critical, the safety of the workforce and community is paramount,” she said. “USAMRIID is taking the opportunity to correct deficiencies, build upon strengths, and create a stronger and safer foundation for the future.”
Facility know as Vector is one of only two sites holding virus, and also houses Ebola samples
A gas explosion has sparked a fire at a Russian laboratory complex stockpiling viruses ranging from smallpox to Ebola, authorities have said.
The State Research Centre of Virology and Biotechnology denied that the fire had exposed the public to the pathogens stored inside, some of the deadliest on Earth.
The blast took place during repairs to a fifth-floor sanitary inspection room at the facility – known as Vector – in Koltsovo, in the Novosibirsk region of Siberia, the centre said on Monday. The site housed secret biological weapons research during the Soviet era and is now one of Russia’s main disease research centres.
One worker suffered third-degree burns after the blast, which blew out the glass in the building. The fire reportedly spread through the building’s ventilation system. A fire covering 30 square metres was later extinguished.
Russian authorities insisted that the room where the explosion occurred was not holding any biohazardous substances and that no structural damage was caused. The mayor of Koltsovo said that the laboratory did not contain any disease samples because of ongoing repair work.
The smallpox virus survives in two places on Earth: at Vector and at another high-security laboratory at the US Centers for Disease Control and Prevention in Atlanta.
Russian authorities last month were slow to release information about an explosion at a military testing site that caused a spike in radiation levels in Arkhangelsk region. The blast occurred when a liquid-fuelled rocket carrying nuclear materials exploded, killing at least five people.
Authorities initially denied the incident had occurred and reportedly did not tell local hospital staff that the victims had been exposed to deadly levels of radiation. Russia has not said what the military specialists were working on, although experts have speculated it may be a nuclear-powered cruise missile mentioned by Vladimir Putin last year.
Monday’s incident was not the first at the Vector lab. In 2004, a researcher died at the complex after accidentally pricking herself with a needle carrying the Ebola virus. Russian media then claimed it was the only death from the virus in Russia’s history. Outbreaks of anthrax and smallpox were caused by Soviet weapons development programmes in the 1970s and subsequently covered up by the government.
The Vector institute was threatened by a lack of funding in the 1990s, raising concerns that researchers could sell their expertise or actual biological samples to governments such as Iraq and North Korea. The laboratory also gave training on how to respond to a potential terrorist attack in the 2000s. A weapons cache including grenade launchers reportedly belonging to a mafia group was found near the facility in 2006.
The lab has also held highly contagious forms of bird flu and strains of hepatitis.