Source: The Altanta-Journal Constitution

CDC action at germ lab questioned

Duct tape used to seal door inside Atlanta facility after possible leak of bioterror bacteria last year.


The Atlanta Journal-Constitution
Published on: 06/22/08

At the Centers for Disease Control and Prevention’s new $214 million infectious disease laboratory in Atlanta scientists are conducting experiments on bioterror bacteria in a room with a containment door sealed with duct tape.

The tape was applied around the edges of the door a year ago after the building’s ventilation system malfunctioned and pulled potentially contaminated air out of the lab and into a “clean” hallway.

Nine CDC workers were tested in May 2007 for potential exposure to the Q fever bacteria being studied in the lab, CDC officials said this week in response to questions from The Atlanta Journal-Constitution.

The air-flow incident occurred very early in the morning, before the workday began. The blood tests were done out of an “abundance of caution,” CDC spokesman Tom Skinner said, and they showed that none of the workers who arrived after the incident were infected.

Q fever, which causes high fevers and sometimes fatal heart problems, is most commonly spread when humans inhale bacteria-laden dust from contaminated animal waste. Human-to-human transmission is rare. It is classified as a potential bioterror agent because it is moderately easy to disseminate.

The CDC Q fever lab’s air containment systems have since worked properly, agency officials said; the lab is safe and poses no risk to workers. The public was never at any risk because numerous security layers were in place between the lab and the outdoors, they said.

Yet the duct tape remains in place.

“It’s an enhancement,” said Patrick Stockton, CDC safety and occupational health manager, as he and four other agency officials took a reporter to see the door Wednesday. “We could take it off.”

Critics want answers

The CDC’s explanations drew skepticism from some biosafety watchdogs —- especially since this is the same lab building that came under scrutiny by Congress and the Government Accountability Office last summer after the AJC revealed the building experienced an hour-long power outage and backup generators failed to come on.

“I do not believe the CDC would approve this arrangement in a laboratory other than their own,” Richard Ebright, a microbiologist and biosafety expert at Rutgers University in New Jersey, said of the taped Q fever lab door.

The CDC is the federal agency responsible for inspecting U.S. labs —- including its own —- that work with certain dangerous germs that primarily infect humans. Because the Q fever bacteria, Coxiella burnetii, can cause disease both in humans and animals, the U.S. Department of Agriculture has secondary inspection authority.

Despite accompanying CDC inspectors on evaluations of the Atlanta lab building housing the duct-taped Q fever door, USDA spokeswoman Rachel Iadicicco said that agency’s inspectors were not aware of the use of duct tape. “We will discuss this with CDC,” she said.

Ebright said duct-taping a door adjacent to Q fever experiments with mice “raises very serious concerns about management. And those concerns are particularly important when one bears in mind this facility will ultimately be handling a full range of lethal pathogens —- up to and including smallpox.”

The GAO, the investigative arm of Congress, has warned of the importance of door seals in two recent reports on the safety of the nation’s high-containment laboratories.

“Because they are intended to contain dangerous microorganisms, usually in liquid or aerosol form, even minor structural defects —- such as cracks in the wall, leaky pipes, or improper sealing around doors —- can have severe consequences,” said Nancy Kingsbury, the GAO’s managing director of applied research and methods, in written testimony to Congress last month.

Ebright notes that the CDC’s biosafety standards manual states: “Seams, if present, must be sealed.” And duct tape wouldn’t appear to be adequate, he said.

CDC officials said the Q fever lab is in full compliance with all rules. They said the CDC’s lab inspectors are fully aware of the duct tape. “The lab is safe, and it’s passed its inspections. But we want to make the lab even more safe and are doing so,” said Skinner.

On Monday, designs were completed for a new self-sealing door to replace the one currently sealed with duct tape, said Ken Bowen, director of the CDC’s Facilities Maintenance and Engineering Office. Even though it’s not required, he said, the new door is being added “as a precaution.”

The construction to install the new door will begin sometime between November and next April, possibly sooner, depending on when there is a good stopping point in the experiments being conducted by the Q fever scientists.

Concern in Congress

The duct tape and the air-handling incident add to concerns about the CDC’s new lab building, said Rep. John Dingell (D-Mich.), chairman of the House Committee on Energy and Commerce. His committee and the GAO have been investigating whether the post-Sept. 11 proliferation of public and private bioterrorism labs poses public safety risks.

“This is yet another incident that calls into question the CDC’s self-inspection policy. I highly doubt that the CDC would accept duct-taped doors on the privately owned bio labs it inspects,” Dingell said Friday.

“If the going rate for a leaky door and roll of duct tape is $200 million, then I think I’m in the wrong line of business,” Dingell said.

Key labs not certified

The 368,000-square-foot lab building, known at the agency as Building 18, is formally called the Emerging Infectious Diseases Laboratory. It’s located on CDC’s main campus off Clifton Road.

Construction was completed in the fall of 2005 and about 500 workers and scientists moved into its many offices and labs.

But the building’s crown jewel —- a suite of four maximum containment Biosafety Level 4 labs —- still hasn’t been certified as safe to operate nearly three years after it were supposed to open. These BSL-4 labs are designed to contain smallpox, Ebola and other lethal germs while scientists work in spacesuit-like protective gear.

CDC officials have said the delay is not a result of any major construction or design problems with the BSL-4 labs or the building. Rather, they said the agency’s earlier opening dates were unrealistic given the complexity and uniqueness of the new labs.

A year ago, The Atlanta Journal-Constitution requested under the Freedom of Information Act that the CDC release records about safety issues at the lab building, including last June’s power outage. So far the agency has not released any records.

On Dec. 18, the building was evacuated after its new medical waste incinerator was started for a test, then vented smoke into the high-containment lab area, according to internal CDC memos recently obtained by the AJC. Excessive heat caused the failure of the incinerator’s bypass stack, which tore away from its anchor bolts and fire caulk, the records show.

The damaged stack was repaired in January —- under warranty and without additional taxpayer cost, CDC officials said last week. The incinerator problem has played no role in the delays, they said, and it has since been certified by state regulators and is now operational.

Air went the wrong way

The duct-taped Q fever lab, which is a Biosafety Level 3 (BSL-3) lab, is currently the only operating lab in the building’s “high-containment block,” which houses the four BSL-4 labs as well as three other BSL-3 labs.

One of the safety features of these high-containment labs is that they are designed to operate under negative air pressure, which keeps germs in by having air flow only in one direction. Air is constantly drawn from clean areas and halls into the lab, then vented outdoors through specially designed HEPA filters.

The incident that led to CDC lab workers having their blood tested began around 3 or 4 a.m. on May 25, 2007. That’s when CDC facilities staff shut down the building’s air handling system for maintenance, said Bowen. After the system was restarted, the Q fever lab lost its negative air pressure.

When workers arrived to begin their day, they discovered air coming out of the Q fever lab, rather than going into it, CDC officials said. “It pulled air out of that lab and into that corridor,” Bowen said.

A mix-up on doors?

The Q fever lab is somewhat unusual in its design, CDC officials acknowledge. To allow safe viewing of scientists’ work with Q fever bacteria and infected mice from a “clean” hallway, there typically would be a sealed glass window. But the lab has a door next to the window. Although it is locked and not used, it has no special seals along its edges, and allows the flow of air when not sealed with duct tape.

Seals are not required on BSL-3 lab doors, the CDC emphasized. The door was put there to increase the flexibility of the lab space, enabling it to someday be used for lower-level experiments that don’t require stringent BSL-3 precautions.

After the May 2007 incident when air was drawn out of the lab, the agency applied duct tape around all of the door’s edges as an added safeguard to control airflow.

Bowen and other CDC officials said there have been no other incidents where potentially contaminated air has blown out of the Q fever lab because air pressure changed from negative to positive.

But an inspection report written by a CDC animal lab consultant in March 2007, states: “Bldg. 18 —- positive airflow from the Q fever laboratory into the clean hallway … The door into the corridor was taped temporarily and did not adequately contain the airflow into this corridor. This issue must be corrected immediately to ensure the health and safety of personnel and research chimpanzees.”

The consultant, Bradford Goodwin Jr., declined to be interviewed. Goodwin, a veterinarian, is executive director of the Center for Laboratory Animal Medicine and Care at the University of Texas Health Science Center in Houston.

CDC officials said the duct-taped door that Goodwin cited in his report is a different door from the one that currently has tape on it. They said there was no positive air-flow problem —- where air moved out of the lab —- in March 2007.

“He misunderstood the fact that the door separated two clean corridors and therefore that resulted in misinformation being included in the report,” said Skinner, the CDC spokesman. Skinner noted the Q fever lab didn’t go “hot” and begin conducting experiments until two months after Goodwin’s visit.

But CDC officials agree that duct tape was on the door mentioned in Goodwin’s report. “This door was duct-taped as a means to stop entry and exit until an appropriate lock could be installed and to limit air transfers between the two clean corridors,” CDC officials said in a written statement.

Some experts said it’s difficult to gauge the significance of the duct tape on the lab doors without more information.

“It could be inconsequential or it could be consequential,” said Chris Newcomer, executive director of the Association for Assessment and Accreditation of Laboratory Animal Care International, commenting in general and not about CDC’s lab in particular.

“There’s nothing intrinsically dangerous about duct tape or repair with duct tape on the seal of a door,” Newcomer said.

WHAT IS Q FEVER?

Q fever is a disease caused by the bacteria Coxiella burnetii. It primarily affects cattle, sheep and goats. But humans are very susceptible to the disease, usually through inhaling airborne bacteria. Only a few organisms are needed to cause infection. Human-to-human transmission is rare.

MORE ON Q FEVER

Only about half the people infected with Q fever will show signs of illness, such as high fevers that last a week or two, severe headaches, confusion, nausea, pneumonia and chest pain. Only about 1 percent to 2 percent of people with acute Q fever die from it. In rare cases, people suffer chronic Q fever infections that damage their hearts, and as many as 65 percent of those will die from the disease.

In 2006, three researchers at Texas A&M University were infected with Q fever. The exposures at Texas A&M’s lab, along with other mishaps, led to CDC inspectors last summer suspending the university’s authorization to work with certain bioterror agents.

The CDC took the action after a now-defunct biodefense watchdog group, the Sunshine Project, obtained and published documents about incidents inside the university’s labs. The university has agreed to pay a $1 million fine for safety lapses.

Source: Centers for Disease Control and Prevention; AJC research

 

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