Reports from infectious disease lab in Montana show lax biosafety rules

by admin 25. November 2014 23:18

 

In a sleepy town in Montana’s Bitterroot Valley, federal police officers enforce security protocols designed to keep deadly viruses and toxins from escaping one of the government’s top laboratories.

Despite instruction and warnings, employees at Rocky Mountain Laboratories in Hamilton -- who are working on a vaccine for Ebola, studying Staphylococcus bacteria and other infectious diseases -- have broken the rules.

 

In one incident, a female animal handler reported an unauthorized man and child near a primate facility.

“She had observed an older man with grey hair and grey mustache wearing what appeared to be a maintenance uniform and an NIH badge in the hallway… near the animal unit with a child,” reads the report. “She related that she made contact with the man and asked him if he was aware that children were not allowed in that area. The man related ‘Shhhh’ and walked away with the child.”

A security officer later found the man next to a street sweeper vehicle with the 15-year-old boy in the driver’s seat as they were preparing to leave the facility.

The breach is one of six detailed in documents from the National Institute of Health Police. The Chronicle requested the documents under the Freedom of Information Act.

Of the six incidents reported in the documents, three involved personnel entering restricted areas without swiping their own key cards, a breach of protocol referred to as piggy-backing.

“I was dispatched to the Quad in reference to a ‘piggy-backing’ incident which had just occurred… a researcher and a ‘coffee shop lady’ had just gone through the visitor center and into the Quad. [The researcher] had badged in at each door. [The coffee shop lady] did not badge in at any door,” reads an Oct. 5, 2014, report written by NIH police officer R. Lessig.

“Neither subject seemed to feel this was an issue worth worrying about.”

The 86-year-old RML campus, known for its work on an Ebola vaccine and Rocky Mountain spotted fever, is operated by the National Institute of Health and houses a high security facility known as a biosafety level 4 lab.

Biosafety level 4 is required for work with dangerous and exotic agents that pose a high risk of infections and life-threatening diseases that are often fatal. They have no vaccines or treatments.

Missoula County Commissioner-elect Nicole Rowley was surprised by the reports. In 2011, she worked at RML as a post-doctoral fellow in the neuroimmunology unit.

“Sometimes those of us who were working would piggy-back through doors, but our supervisor warned us we could be fired for it so we always flashed our badge on the scanner even when entering together. In a pinch I did loan my badge to a co-worker to go to a different building and grab something,” Rowley said in an email to the Chronicle.

Rowley said she was not sure if researchers who broke the rules were punished or counseled. A spokesman for Rocky Mountain Laboratories refused to comment on disciplinary actions.

“I would definitely say the security at the lab housing high level biocontainment labs were well secured, and they also kept a very close eye on the animal facilities,” Rowley said. “I felt the whole campus was pretty secure while there. Things must have gone downhill.”

Nancy Kingsbury, an expert on biosafety labs who works for the Government Accountability Office in Washington, D.C., told the Chronicle that discipline surrounding safety and security at federal labs was generally good, but that the incidents in the police reports were alarming.

“The risk is not zero that someone would find a way into a high containment laboratory that would arise from some terrorist motive or something like that,” she said.

Earlier this year, Kingsbury learned that employees at the Center for Disease Control’s Bioterror and Advanced Technology Laboratory in Atlanta had also been “piggy-backing” through security doors, making it difficult to identify the 80 people who had been potentially exposed to live Anthrax spores during an incident in June.

“They were not reliably, individually badging into the labs,” Kingsbury said. “Now they all knew each other, so it was not a biosecurity issue, but it did prove to be an obstacle in their efforts to track down who might have been in that laboratory when the Anthrax was exposed.”

No one was hurt in the incident, but it and other incidents prompted a congressional hearing and a policy memo from the White House’s Office of Science and Technology Policy, urging government labs to review safety and security protocols.

“The administration takes seriously any issue that has the potential to place scientists, health care workers or the American public at risk of accidental exposure to infectious pathogens,” said the White House memo.

The Chronicle’s request to speak with the memo’s author, Dr. John Holdren, assistant to the president for science and technology, about implementation of the memo’s call for a “safety stand-down” was referred to the National Institute of Health.

Likewise, a request to speak with Rocky Mountain Laboratories’ associate director about unsecured “select agents” was pushed to the National Institute of Health in Washington, D.C.

“Select agents” are biological agents and toxins that federal agencies say pose a severe threat to human and animal health.

In response to the Chronicle’s interview request, the NIH said it had initiated a sweep of facilities, including Rocky Mountain Laboratories, which was completed in September.

A summary report of the findings will be posted soon, the agency said. So far, five select agents were found being improperly stored at NIH facilities – none at RML. The second phase of the search by the NIH’s Division of Occupational Health and Safety is expected to take several months.

Edward Hammond, a biosafety expert who tracks such incidents, said he was worried that the National Institute of Health was policing itself.

“The fact that they have redacted the room numbers in some of the reports suggests to me that they could have been in a select agent lab,” Hammond said.

Hammond said that it is too early to know if the administration’s memo on reviewing safety was going to improve biosafety and security.

“It’s not that anything I see seems to be especially alarming, but what it does is confirm the reality that these places just aren’t as secure as they’re sold to be,” Hammond said.

Earlier this year, Hammond obtained documents from RML that detailed how a small rodent who had been infected with the Lassa virus escaped from a cage and hid from researchers for hours before being trapped and dispatched.

Lassa virus, a select agent carried by rodents in West Africa, causes an estimated 5,000 deaths annually.

According to the documents, officials at Rocky Mountain Laboratory did not believe they needed to report the escaped rodent incident but later did when instructed to by CDC officials.

A spokesman for Rocky Mountain Laboratories downplayed the event in an emailed statement from NIH: “The rodent had been part of a study designed to understand the infectious process of Lassa fever virus. However, almost one month had passed since the animal had been infected as part of this study—ample time for the virus to have cleared the animal’s system,” the federal agency’s statement read.

NIH facilities are required to report any theft or loss of any toxins or pathogens relevant to human or animal health with the Center for Disease Control within one week.

“With these kinds of facilities on any given day the chance of someone getting infected or a deliberate act is really low, but you multiply that low probability over time and it gets bigger,” Hammond said. “When you’re dealing with agents that could cause community outbreak, the concern is real.”

Hammond said several congressional hearings have led nowhere.

“In Congress, people have been playing politics with this issue for a number years, and it would be nice to get past that phase and into a more serious phase,” he said. “It’s possible that’s starting now, but I’m not sure.”

Richard Ebright, a professor of chemical biology at Rutgers University, agreed with Hammond’s concerns that NIH had little oversight.

He criticized the insufficiency of the Center for Disease Control’s “select agent rule” as the only legally enforceable rule on securing the deadly materials. Ebright said that high-level officials had broken the rule this spring when a CDC employee in Atlanta accidentally sent a highly pathogenic strain of the H5N1 virus (avian flu) to another lab.

“The other federal lab fortunately recognized what they had and provided that information back to CDC,” Ebright said. “And then at every level up the CDC chain of command a decision was made not to file a report.”

There have been no significant consequences for violations of the rules, Ebright said.

“These security breaches are part and parcel of systematic pervasive violations in security and safety of biological weapons agents at federal labs supervised by the CDC,” Ebright told the Chronicle.

“They will be subject to oversight from the CDC, but the oversight, with respect to security, will be focused on their being a plan. CDC’s role in evaluating that is merely to establish that a written plan has been filed.”

Ebright said there were very powerful interests in Washington, D.C., including the White House and thousands of universities and private research groups, that opposed the creation of regulations that would improve security but might cost money.

“The select agent rule contains only one requirement and that is that there must be a lock either at the entrance of the facility or on the container holding the pathogens or toxins,” Ebright said.

Troy Carter, Bozeman Daily Chronicle

 

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