Safety compromised at biohazard labs
Report says oversight lacking at bioterrorism research laboratories
On Friday the 13th of June 2014, a scientist in a bioterrorism research laboratory at the Centers for Disease Control and Prevention in Atlanta noticed something unsettling. An unexpected growth appeared on a plate that supposedly held an inactivated form of the deadly anthrax bacteria.
More worrisome still, the plate was part of a larger sample — but the rest of that sample had been removed and taken to another CDC lab that wasn’t equipped for experiments on pathogens as easily spread as live anthrax. Unaware that the sample might be live, a scientist there had begun working with it, first using a nitrogen air stream to clean flakes off the plate holding it — a process that could transform the anthrax sample into an airborne threat.
By the time the CDC realized a live anthrax sample had been moved around its campus, sent to a low-security lab, handled by unknowing scientists and maybe even aerosolized, a week had passed. At first, just two CDC employees were sent for testing. Officials then discovered workers had come and gone from restricted areas without being accurately recorded, and in the end, 81 people had to be medically monitored.
No one was infected. But a recent audit by the investigative arm of Congress makes clear that porous government oversight played a part in the incident and concludes that the problems that enabled the breach to take place haven’t been fixed.
Safety, the agency found, was compromised by an inherent conflict of interest: Federal agencies such as the CDC that work with deadly pathogens and toxins, including Ebola, bird flu, smallpox, bubonic plague and ricin, determine for themselves whether that work is being done safely, without any independent oversight.
Instead, oversight is conducted through the so-called Federal Select Agent Program, in which the CDC and the Agriculture Department conduct inspections based on the rules they decide for themselves and set standards they must meet at their own financial expense. The inspectors are not “structurally distinct and separate from all the labs they oversee,” according to a report in October by the Government Accountability Office.
Moreover, the lead federal inspection agency — the CDC — has accumulated the largest number of rules violations, according to a lawmaker’s account of information provided to Congress in 2015.
Along with other flaws, these shortcomings render oversight “duplicative, fragmented, and dependent on self-policing,” the GAO report said. The United States’ approach, the report said, isn’t as hardy as some of its international allies, which also conduct sensitive work on deadly pathogens but assigned independent regulators to oversee it.
On Nov. 2 at a hearing of the House Energy and Commerce Committee subcommittee on oversight and investigation, Rep. Diana DeGette, D-Colo., said, “We can’t just keep stumbling along like this from year to year.” Unless the Select Agent Program is reformed, she said, “at some point, something very bad is going to happen.”
Asked for comment, CDC spokesman Jason McDonald said, “We believe that we are fulfilling the mandate given to us by Congress,” but “there is always room for process improvement.”
An internal review by the CDC in July 2014 called the previous month’s anthrax scare “a serious event that should not have happened.” The CDC promised concrete actions “to change processes that allowed this to happen” and said the agency “will do everything possible to prevent a future occurrence such as this in any CDC laboratory, and to apply the lessons learned to other laboratories across the United States.”
The next year, an Army lab in Utah sent live anthrax to laboratories in all 50 states, nine countries, three U.S. territories and Washington, D.C. A year after that, the Department of Homeland Security discovered that instead of an inert form of ricin — another deadly biological agent — one of its own labs had been sending active, lethal poison to a Federal Emergency Management Agency training center since 2011. As a result, as many as 10,000 trainees worked with a toxin that could have killed them in tiny doses. Near-catastrophic mistakes persisted in other labs monitored by the Select Agent program.
Under the Select Agent program, labs affiliated with the government, universities and private industry that intend to work with more than 60 dangerous biological agents and toxins must secure a license and submit to federal inspections. As of December 2016, 336 such institutions employing at least 4,000 workers — including some with multiple labs — were registered.
Lisa Cohen, chief of staff for DeGette, the ranking Democrat on the subcommittee, said one of the core issues is that “with the dual agencies reviewing this, nobody has full responsibility or ownership.”
According to lawmakers and federal auditors, there’s never been a public accounting of how many laboratories are necessary to meet U.S. defense and public health needs, nor has an entity been identified to perform such an audit. That means that in facilitating research ostensibly necessary to keep Americans safe, the spread of biocontainment laboratories across the country — still subject to error and lacking in effective oversight — may be doing the opposite.
The Center for Public Integrity is a non-profit investigative newsroom in Washington.
“We can’t just keep stumbling along like this from year to year. ... At some point, something very bad is going to happen.” Rep. Diana DeGette, D-Colo.