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Government inspectors have been warning for years that labs used to handle dangerous agents such as anthrax have been poorly regulated and that the lack of oversight has put the public at risk, yet little has been done to heed their warnings, an official said Wednesday.
And no one’s listened to repeated calls for research to be done so that a cohesive national policy can help agencies do a better job of keeping lab workers and the public safe, a Government Accountability Office expert testified at a hearing.
They document equipment failures so severe that in one incident, air from a biosafety cabinet that was supposed to be sucked away and filtered instead vented right back into the lab. And there was a freezer full of anthrax that was locked — but the key was left in the lock.
Yet Centers for Disease Control and Prevention director Dr. Tom Frieden said several startling incidents involving anthrax, smallpox and other dangerous pathogens came as a “wake-up call” to his agency.
He said CDC was working to correct the errors, and one expert cautioned Congress against punishing scientists who made unintentional errors. But some members said they were not in a forgiving mood.
"Our investigation has uncovered that this was not CDC’s first wake-up call," Pennsylvania Republican Tim Murphy, who chairs the House Energy and Commerce oversight subcommittee, said in opening the hearing. "I am not sure that 'wake-up call' is the right statement."
"I just don't understand why they didn't heed those warnings."
The subcommittee opened a hearing Wednesday into the lapses, in which CDC workers were exposed to potential live anthrax bacteria, a USDA lab was sent a batch of avian influenza virus contaminated with highly pathogenic H5N1 bird flu, and a box full of glass vials full of live smallpox virus was discovered squirreled away in a lab on the National Institutes of Health campus.
Hours after the hearing ended, the Food and Drug Administration confirmed that staffers found 327 vials in the same area as six glass vessels labeled as smallpox. "The investigation found 12 boxes containing a total of 327 carefully packaged vials labeled with names of various biological agents such as dengue, influenza, Q fever, and rickettsia," FDA said in a statement.
CDC says it's cracking down. "I am overseeing sweeping measures to improve that culture of safety," Frieden testified. "If had it to do over again, I wish I had recognized the pattern."
But the GAO says the agency should not have been surprised.
“GAO’s past work has found a continued lack of national standards for designing, constructing, commissioning, and operating high-containment laboratories,” the GAO’s Nancy Kingsbury told the hearing in written, prepared testimony. “This deficiency may be more critical today than five years ago when we first reported on this concern.”
Sooner or later its luck will run out ... and someone will die."
Kingsbury attached a list of previous GAO reports going back to 2002, all containing warnings about a lack of strategy and oversight. They show the anthrax scare was nothing unique — in 2004, lab workers at Children’s Hospital Oakland Research Institute in California were accidentally exposed to live anthrax after staff did not follow procedure. The CDC said then that all research workers should operate on the assumption that anthrax samples are infectious unless confirmed otherwise.
“These recommendations are relevant to the June 2014 incident in Atlanta but were not followed,” she said.
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) also issued cautionary reports, including one done jointly with CDC. “The APHIS reports show that in the 18 months prior to the June Anthrax release, inspectors identified numerous safety problems in CDC laboratories,” the Oversight Committee said in a statement.
“Equipment failures included broken or nonfunctioning machinery, the failure to use filters or replace filters on a regular basis, the use of equipment that was not sufficient to contain the select agent or toxin (e.g., equipment used on a laboratory bench top instead of in a biosafety cabinet), and biosafety cabinet grilles obstructed with pens or other items,” the memo reads.
“During one inspection, APHIS inspectors smoke-tested the exhaust flow on the biosafety cabinets in laboratory rooms and discovered the exhaust flowing into the laboratory instead of being safely sucked away.”
Just since 2013, APHIS inspectors say they saw 27 lab fails ranging from a failure to wash hands — something that should be biosafety 101 — to allowing unauthorized access to labs.
"Despite the number of red flags, these incidents keep happening," Murphy said. "This is not sound science and it will not be tolerated. It is inexcusable."
Later he added: "CDC should not assume that its luck with these near-miss events will continue. Sooner or later its luck will run out ... and someone will die."
"I just don't understand why they didn't heed those warnings," Colorado Democrat Diana DeGette agreed.
Frieden said he has cracked down on biosafety level 3 and 4 labs, those designed to contain the most dangerous pathogens.
"They cannot have the authority to regulate themselves."
"I have implemented a moratorium on transfer of any biological material out of any BSL-3 or BSL-4 laboratory at CDC until processes are reviewed and improved, and this moratorium will be lifted on a lab-by-lab basis once corrective actions have been taken and confirmed," he said.
The National Institutes of Health also scrambled to resuscitate a biosafety advisory panel that hasn't met in nearly two years.
Several experts said the federal governments needs independent oversight of lab safety. "CDC and USDA regulate their own biosafety and security," said Richard Ebright, who heads microbiology labs at Rutgers University. "They perform the work. They fund the work...They cannot have the authority to regulate themselves."
Frieden said he was working to change the culture at CDC to one where people feel free to report even the smallest lapses. "We need to encourage reporting. We need to encourage all staff to take responsibility," he said.
Safety expert Sean Kaufman agreed and cautioned Congress against punishing CDC.
"It’s well known that punishment does three things. It builds resentment. It teaches no new behavior. And it hides true behavior," he said.
Murphy countered with a dramatic end to the hearing. "Are you making excuses for these scientists?" he demanded. "It sounds like you are saying they need more training. Boo-hoo." He help up a plastic bag containing what everyone in the room hoped were mock-ups of growing anthrax cultures.
"You don't need training to know this is dangerous," he said.