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Fort Detrick research leaders confident despite CDC safety breach

FREDERICK, Md. — The people in charge of Fort Detrick’s biocontainment labs are confident in their operations, even as safety breaches at other federal agencies lead Congress to question lab security.

In response to those breaches, the director of the Department of Homeland Security’s lab at Fort Detrick said he worked with staff to verify that their training was up-to-date and that the recent incidents would become a “teaching moment.”

“It starts with expectations, it starts with leadership,” the director, Pat Fitch, said Tuesday at the National Biodefense Analysis and Countermeasures Center. NBACC is the federal government’s leading organization for forensic analysis of bioterrorism attacks or bio-crime and often assists the FBI in its investigations.

Shawn M. Boesen, chief of the Safety, Radiation and Environmental Division at the U.S. Army Medical Research Institute of Infectious Diseases, said his staff continuously reviews their safety process, but no plans exist to make changes to policy as a direct result of the June and July safety breaches involving anthrax at the Centers for Disease Control and Prevention and smallpox at the Food and Drug Administration.

The National Institute of Allergy and Infectious Diseases’ Integrated Research Facility also has high-security labs at Fort Detrick. Peter Jahrling, the facility’s chief scientist, said his staff have been reminded of standard operating procedures and regulations “and the consequences of non-compliance.”

The director of the National Institutes of Health, which oversees NIAID-IRF, asked in a memo that all laboratory storage areas be carefully inventoried, Jahrling said.

Building a culture of safety

Bob Hawley, a consultant and former biosafety officer at USAMRIID and the U.S. Army Medical Research and Materiel Command, said he is confident that accidents similar to the one at CDC will not occur at Fort Detrick’s labs.

“Just because it happens in one laboratory — which may very well be the flagship of the United States — I don’t see any reason for any additional regulations to be placed upon the other facilities,” he said. “We have sufficient enough guidelines.”

Beth Willis, chairwoman of Frederick's Containment Lab Community Advisory Committee, said despite all the rules, there is still an unpredictable variable in lab safety.

“Human error is almost always the problem,” she said. “The community has always assumed that there is good equipment and good procedures.”

Jahrling and Boesen said even a bulletproof safety policy may not be enough to eliminate human error.

“Human error is a factor that we consider in our risk assessment process,” Boesen said. “It can be reduced considerably through measures to reduce the probability and severity of consequences, but it cannot be completely eliminated.”

USAMRIID’s safety protocols are vetted through its safety office and a panel of experts on the subject matter, he said.

NBACC’s high-security labs were first approved in 2011 for work with select agents. NIAID-IRF received its select agent certification in March.

NBACC published a paper in 2013 on a “personnel reliability program” that would guide staff to report incidents promptly without putting undue pressure on the reporter. The program was implemented at NBACC in 2010.

According to the paper, in a typical month at NBACC, about 12 incident reports lead to staff being restricted from lab access for purposes that are “either medical or personal in nature.” Another 12 incident reports do not require a restriction of lab access. An average of seven more reports each month result in no action under the personnel reliability program.

According to Fitch, it has taken a concerted effort to build safety expectations at NBACC. He is pleased with the current safety culture.

“We’re all in this together,” Fitch said. If a single staff member fails to report a potentially dangerous incident, “we’re all paying the price.”

A lack of common standards

A long list of inspectors, including those from the CDC, the Nuclear Regulatory Commission and the Occupational Safety and Health Administration, ensure compliance with regulations at NBACC. A similar list for USAMRIID includes the Army's inspector general.

At the recent congressional hearing, some committee members suggested that, in light of the safety breach, another agency should oversee the CDC’s research labs.

Hawley said a replacement inspector shouldn't be necessary for the CDC or Fort Detrick's labs.

“The competency is there,” Hawley said. “I think the thought is that the fox is watching the henhouse, but the CDC is inspected by outside agencies for a lot of the work that they’re doing.”

The CDC’s inspection and research arms are separate. Fitch and Edwin said CDC inspectors are thorough.

“To say they’re anal is an insult, because they’re far worse than that,” Fitch said.

The Government Accountability Office has long decried the lack of design and construction standards across high-security biocontainment labs and advocates the formation of an independent agency to oversee them.

According to Hawley, biocontainment labs are built based on risk. Some need to withstand hurricanes, and others are in more earthquake-prone areas.

“We cannot have a cookie cutter for building a laboratory,” he said.

Clem Gaines, spokesman for the Army Corps of Engineers, said the corps is building USAMRIID’s new labs in accordance with the CDC’s Biosafety in Microbiological and Biomedical Laboratories handbook, regarded as the industry standard.

The GAO said in a 2013 report that the lack of national standards “raised concerns and increased the risk of laboratory accidents.”

The CDC's handbook provides guidance, the report states. “However, that guidance does not equate to standards that should be adhered to or ways to determine if such standards have been achieved.”

“Such standards need not be a constraining ‘one-size-fits-all’ model,” the report states.

The diverse nature of the agencies that operate high-security biocontainment labs may pose a challenge for a single agency’s oversight, Jahrling said.

“It is important, however, that there is some type of oversight of whoever has this responsibility,” he said. “Like the labs, the oversight bodies should also be held accountable for their activities.”
 

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