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 This month, the CDC is investigating a nearly identical anthrax
mixup — within its own highly secure Atlanta laboratories. The
question of what to do is back.
In the intervening decade, leaders in the field have found a
possible answer, so far rejected by the CDC, in a new process called
biorisk management. The approach asks scientists systematically to
consider what could go wrong before performing new experiments on
the most dangerous microbes, and to prepare responses. It is
designed in part to compensate for an over reliance on technological
safeguards, proponents say.
The private lab that sent the live anthrax in 2004 has broadly
adopted biorisk management, and Emory University, located a mile
away from the CDC in Atlanta, has become the first academic lab to
adopt it. Researchers around the globe are on board.
But not the CDC. The government lab last week launched its own
investigation into how researchers at one of its most secure
facilities could send a sample of possibly live anthrax to a less
secure lab, potentially exposing 84 people in the process.
The CDC is widely respected, despite the anthrax incident. But the
CDC's own analysis of the 2004 incident included recommendations not
followed last month.
In June, the anthrax sample left the lab 24 hours after the attempt
to kill it, which is less than the standard 48 hour waiting period
required by CDC scientific protocol. But after the 2004 incident, in
Oakland, California, the CDC recommended a lag of "several days". It
also recommended at the time that a lab receiving anthrax treat the
sample as live until confirmed dead.
The CDC's biosafety officer, Dr Paul Meechan, who joined years after
the Oakland incident, could not say why the lessons about handling
anthrax were not learned. "Why that did not become integrated into
the DNA of handling bacillus anthracis is a great question. I don't
have a good answer," he said in an interview with Reuters.
Meechan and other CDC officials say their organization has its own
risk management system, and that the international biorisk
management standards proposed in Europe and elsewhere are a response
to a lack of global biosafety regulations. The United States, by
contrast, has numerous regulations governing how dangerous pathogens
are handled.
"Those guidelines are out there globally. They are not necessarily
the most appropriate, useful or protective for U.S. laboratories,"
CDC director Dr Thomas Frieden said in an interview.
The CDC has many laboratories that work with anthrax and other
extremely dangerous microbes, and the June incident relates to only
one lab, he said, adding, "To suggest there is somehow something
problematic about the CDC's lab culture is very mistaken."
MANAGING 'BIORISK'
CDC’s recent history shows problems are not new.
The Inspector General of the Department of Health and Human
Services, CDC's parent agency, in reports released in 2008 and 2010,
documented a long list of issues. CDC labs working with the most
dangerous agents did not always ensure the physical security of the
pathogens or restrict access to them, and did not always ensure that
personnel received required training.
Frieden noted that after those concerns were raised, a 2012 review
of a CDC animal biosafety facility by Canada's public health agency
described some CDC biosafety practices as models. To say there is a
problem with safety at CDC "is simply wrong", he said.
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But Debra Sharpe, who investigated the Oakland incident as director
of compliance at Southern Research Institute, the contract lab whose
Frederick, Maryland, facility shipped the live anthrax in 2004,
questioned the training at the CDC and other U.S. labs.
"We spend millions of dollars on these laboratories, but we're not
spending the appropriate amount of money on training and safety and
implementing management systems," she said.
"I see a lot of scientists that have come from CDC. Generally, they
have poorer practices," compared with the private sector, she said.
Sharpe, now a biosafety and biosecurity consultant at
WorkingBuildings LLC in Atlanta, said that after the 2004 incident,
her former lab had implemented biorisk management controls. Every
lab procedure had to be meticulously documented and pre-approved,
and every scientist and technician received comprehensive training,
she said.
Formal biorisk management standards have been embraced by 24
countries in Europe, received backing by the World Health
Organization, and are in the process of being adopted by the
International Organization for Standardization, the same group that
sets environmental safety standards backed by the U.S. Environmental
Protection Agency.
U.S. labs that deal with dangerous pathogens are ranked in terms of
equipment and rules, from levels one to four. A level four lab is
equipped to handle hazards like ebola for which there is no cure.
The system tends to focus on equipment, rather than risk assessment,
said Ren Salerno, a biosecurity expert at Sandia National
Laboratories, part of the U.S. Department of Energy, who advises the
World Health Organization on biosafety. The CDC researchers in the
biosafety level 3 (BSL-3) lab should have stopped and considered the
risks around using the new process to kill anthrax, for instance.
Instead, the scientists apparently "decided, 'As long as we do the
work in a BSL-3 laboratory . . . we're safe,'" Salerno said,
emphasizing that he did not know what drove the decisions by CDC
scientists. But he added that the attitude was rampant in such labs.
“I think this is huge problem.”
Emory University has just implemented a biorisk management approach
for all of its labs.
The key, said Patricia Olinger, director of Emory's environmental,
health and safety office, is to get everyone looking for what could
go wrong, and approaching potential problems the same way.
"It's a way to connect the dots instead of having all of these
little silos out there," she said. Olinger sees the anthrax mishap
at the CDC as a turning point for U.S. labs. “I think it will bring
light to the fact that there is a systematic approach to managing
research safety programs.”
(Reporting by Julie Steenhuysen and Sharon Begley, editing by David
Greising and Peter Henderson)
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