When a Maryland lab accidentally sent a batch of live anthrax to a children’s hospital in California in 2004, the U.S. Centers for Disease Control and Prevention sent a team of investigators to make sure such an error never happened again.
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.
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."
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.
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.”