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Vol. LXVI, No. 20
September 26, 2014
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‘Sweep’ Under Way for Select Agents, Toxins

On the front page...

Prompted by the Food and Drug Administration’s July 1 discovery of vials of smallpox virus in Bldg. 29A, NIH has embarked on Operation Clean Sweep, a two-part, top-to-bottom inventory of all NIH laboratories that starts first with all institutes and centers, followed by an audit conducted by specialists in occupational safety and health.

After discovery of 12 boxes containing 327 vials of infectious agents such as smallpox, dengue, influenza, Q fever and rickettsia, NIH director Dr. Francis Collins informed employees, “We have developed a plan of action for the conduct of this search. It requires investigators to examine all freezers, refrigerators, cold rooms, storage shelves and cabinets, as well as all other areas of storage such as offices associated with laboratories.”

The IC portion of the sweep has two parts, said Jeff Potts, NIH biorisk manager in the Division of Occupational Health and Safety (DOHS). “In phase 1, research staff at all NIH facilities are responsible for going through their areas to search for unregistered select agents [such as Ebola, anthrax and H5N1 bird flu]. They must also inventory all human pathogenic material that is handled at BSL [biosafety level] 2 or higher, human blood and body fluids and any toxins.” This is scheduled to be done by Sept. 30.

Continued...

Jeff Potts is NIH biorisk manager in the Division of Occupational Health and Safety. “I don’t feel unsafe, I don’t feel scared to do my job,” he said. “But it can be a stressful job. The last few months have been stressful. Additional discoveries will be stressful.”

Jeff Potts is NIH biorisk manager in the Division of Occupational Health and Safety. “I don’t feel unsafe, I don’t feel scared to do my job,” he said. “But it can be a stressful job. The last few months have been stressful. Additional discoveries will be stressful.”

Photo: Rich McManus

"This is unprecedented for NIH,” said Potts. He noted that biospecimens collected through clinical trials at NIH, mostly in Bldg. 10, are already subject to strict regulation. Inventory control for specimens in NIH’s basic research labs has not been as rigorous.

“Our goal is to ‘capture today.’ What do we have, and where?” he said.

For some laboratories, the number of specimens can be in the thousands. Said one technician with such a workload, “I have to know where in each freezer a sample is, what shelf it is on, what box it is in and what row it is in within the box. We almost need a new category of employee—a specimen reference librarian.”

Phase 2 of Clean Sweep starts Oct. 1, when a team of specialists from DOHS, augmented by contractors, visits 100 percent of all storage locations—freezers, cold rooms, refrigerators, etc.—to perform quality assurance (QA) checks.

“QA means we see if what the ICs reported is actually there, on campus and off, and in all leased facilities,” said Potts. Investigators will check a percentage of inventoried items to see if they square with what the ICs reported. “If they pass, our sticker will go next to their sticker,” indicating that surveillance is complete and accurate.

NIH management has established a deadline of 6 months to complete the survey. “We are trying to wrap our heads around the scope of this project,” Potts said. “There are 8 million square feet of space on campus. Anywhere NIH owns samples has to be searched and QA’d. We have to walk each building, top to bottom.”

Potts is one of 7 people in his 50-person division who manage NIH’s select agent program, which assures compliance with the regulations that govern the use, handling and storage of select agents and toxins.

A very small number of NIH investigators work with select agents, he said. “The regulatory compliance is so large and onerous that few are interested.”

Potts’ team of safety specialists conducts quarterly checks of 100 percent of the vials possessed by these investigators. In addition, they do year-round training and accident/injury investigation.

“There are tremendous security controls in place,” he explained. “Anyone working in a BSL-3 lab or higher has to have a background investigation.”

If a select agent or toxin is discovered in a place where it ought not be, research staff are not permitted to dispose of it themselves, Potts said. “We bring it back to the lab, secure it and notify the CDC [Centers for Disease Control and Prevention], which is the regulating agency. Then we can destroy the sample [usually by autoclave, a heating process] and provide proof to our regulators that this was done.”

Asked whether the hunt for unsecured pathogens worries him, Potts, who came to NIH a decade ago and is a certified biosafety professional, said, “It doesn’t scare me. Riding the Metro to work is more of a risk than working with these agents. We have very strict standard operating procedures.

“I don’t feel unsafe, I don’t feel scared to do my job,” he continued. “But it can be a stressful job. The last few months have been stressful. Additional discoveries will be stressful.”

He empathizes with the IC search that has been going on for the past 2 months. “They are doing this at the same time they are doing their normal research. Their heavy lifting is being done right now. Our heavy lifting begins Oct. 1.”

One advantage to the inventory process has been that the ICs “are getting rid of a lot of material they don’t need. I think it’s been a huge benefit to them,” said Potts. “We might be saving NIH a lot of money by getting rid of a couple hundred freezers. It’s kind of like spring cleaning. This process has been much needed, across the board.”

Suiting Up for Safety

A worker uses a positive pressure protective suit to work with dangerous pathogens.

A worker uses a positive pressure protective suit to work with dangerous pathogens.

Very little of the research that goes on at NIH requires what some call moon suits (positive pressure protective suits), says Jeff Potts of the Division of Occupational Health and Safety’s select agent program.

At biosafety level 1 (BSL-1), workers must wear a lab coat and gloves.

BSL-2 requires a lab coat, gloves and protective eyewear.

BSL-3 protection depends on the agent being studied, but typically requires double gloves, shoe covers and a full Tyvek suit. Researchers might also need to use a PAPR—powered air purifying respirator, which pulls room air through a HEPA filter and offers clean air to a worker’s breathing zone.

BSL-4, or what Potts calls “the big blue space suit with an air hose,” is not conducted on campus, he said. Only two NIH labs are at this level: NIAID’s Integrated Research Facility at Ft. Detrick in Frederick, Md., and NIAID’s Rocky Mountain Laboratories in Hamilton, Mont.

Potts has worn the positive pressure protective suit and says, “It’s different. If you’re claustrophobic, it’s not the job for you. They are deceivingly heavy. You’re lugging around 9-10 pounds of suit. It’s physically exhausting. You become very thirsty because you get dehydrated.

“We train staff to know their limits,” he said. Three hours of continuous work is a typical timeframe for working in this type of environment, although some are capable of more. “It’s like driving a car for too long,” Potts explains. “The longer you’re behind the wheel, the more the risks multiply.”

Besides knowing your BSLs, there are other terms indicating familiarity with lab safety. Many laboratories have freezers at two standard temperatures: 20 degrees below Celsius (“sub-20s”) and 80 degrees below Celsius (“sub-80s”). Toss words like that around and Potts might consider recruiting you to the 40-person team readying for Clean Sweep, phase 2.

One other thing: there are actually two Operation Clean Sweeps being conducted across NIH at the moment by the Office of Research Services and Office of Research Facilities. The first has to do with clearing hallways and corridors of accumulated junk and began well before the select agent campaign.


Collins Issues Interim Report

On Sept. 5, NIH director Dr. Francis Collins sent an all-hands email to NIH employees, updating the workforce on interim findings of NIH’s comprehensive search for improperly stored select agents, toxins or hazardous biological materials.

Three select agents were found at the Clinical Center’s department of laboratory medicine:

  • Burkholderia pseudomallei, a patient microbial isolate. B. pseudomallei causes melioidosis, which is an uncommon bacterial infection usually found in tropical or sub-tropical areas.

  • Francisella tularensis, the cause of tularemia, also known as rabbit fever. This was a College of American Pathologists (CAP) proficiency testing sample.

  • Two small lab vials of Yersinia pestis, the cause of plague. It is an acute bacterial infection transmitted to humans and some domestic animals by fleas that come from infected rodents. There have not been any human-to-human transmissions of plague in the United States since around 1925. This was also a CAP proficiency testing sample.

Two additional agents were found in other NIH laboratories:

  • One bottle of ricin of unknown quantity, but labeled 5 grams. Ricin is very poisonous if inhaled, injected or ingested; it acts as a toxin by inhibiting protein synthesis. This sample was found in a historical collection dating from 1914 and is thought to be 85-100 years old. Ricin has legitimate lab uses in very small quantities.

  • Botulinum neurotoxin in individual quantities below the regulatory limits, but in aggregate quantities above the allowable limit. This neurotoxin is the cause of botulism, which is a rare, but serious paralytic illness caused by a nerve toxin that is produced by the bacterium Clostridium botulinum.

All of the agents found were in sealed and intact containers and there were no personnel exposures associated with the storage or discovery of these vials or samples. All of the agents have been reported to the Centers for Disease Control and Prevention and destroyed in compliance with select agent regulations.

Collins said he would update the workforce again in early October, when a preliminary status report is expected.

 


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