A rapid review team made up of various federal agency experts and academics concluded Thursday that the Defense Department has been inadvertently shipping live samples of the deadly Anthrax bacteria to public and private research facilities since 2002.
The vials, reviewers found, went to 86 separate research facilities, but all appear to have originated at the Army’s Dugway Proving Ground in Utah.
Updating an investigation which first began in May when a private research lab first noticed live Anthrax samples in a batch that was supposed to be dead, Pentagon officials said there still was no evidence that any military or private-sector personnel had been infected. But they also acknowledged that the episode represented a “massive institutional failure” on the part of DoD, whose laboratories cultivate Anthrax and other bioagents so they can be studied for potential cures or countermeasures.
At Dugway – one of three DoD facilities which produce Anthrax for research purposes – reviewers found during a June inspection that more than half of the samples that had been put through a gamma irradiation process designed to kill the bacteria and were awaiting shipment to research facilities still contained live Anthrax.
“Obviously when over half of the batches that were presumed to be inactivated still contain live spores, we have a major problem,” Deputy Defense Secretary Robert Work said Thursday during a press briefing. “The numbers confirm that judgement. Laboratories in 20 states and the District of Columbia and seven foreign countries received what were supposedly inactivated samples. All of them originated at Dugway.”
Work said he has ordered all DoD laboratories to halt their production and shipment of Anthrax samples indefinitely until a further round of investigations has run its course.
While Dugway is by far the government’s largest producer of Anthrax specimens, the new investigations will attempt to determine why that laboratory alone seems to have routinely failed to kill all of the spores in a given scientific sample and why it failed to detect live Anthrax after having subjected them to gamma radiation.
Officials emphasized Thursday that employees at the Utah research facility do not appear to have violated any protocols or engaged in any malfeasance in testing their samples for the presence of Anthrax.
Rather, the problem is the protocols themselves.
The review revealed that there are no nationwide standards, either for DoD or for the broader federal government to handle the inactivation of Anthrax and other biohazards. Work said he has ordered the Secretary of the Army to act as DoD’s executive agent to both create and enforce departmentwide protocols for bioagents.
“We are shocked by these failures,” Work said. “But this review taught us lessons we needed to learn. It identified institutional failures we urgently need to address, and we take full responsibility for these failures. We are implementing changes and recommending the implementation of processes, procedures and protocols that will prevent such a biohazard safety failure from ever happening again. We hope the lessons we’re learning will encourage the establishment of an inactivation and viability testing standard for every lab in the United States to follow.”
The report emphasized that creating inactivated samples of Anthrax and other infectious bacteria is an extremely difficult endeavor in the first place. Heat or chemicals offer full assurance that the bacteria is dead, but those methods also render the samples useless for research purposes.
And the authors noted scientific studies which appear to show that Anthrax can bounce back from what appears to be a dead sample if it’s left at room temperature long enough for “injured” spores to regenerate themselves.
But after a month of study, every live Anthrax sample the CDC and DoD have run across seems to have originated from the Utah facility. And Defense officials said Thursday that there are sufficient grounds to conduct a more extensive investigation into the scientific leadership at Dugway.
Frank Kendall, the undersecretary of Defense for acquisition, technology and logistics, said Dugway’s procedures were not “dramatically” different from the other three federal facilities that dealt with live Anthrax prior to the moratorium.
But he said a reexamination of that facility’s own test results strongly suggested that the procedures local scientists used to kill the bacteria were much less effective than the rest of DoD’s laboratories, and its leaders should have detected that fact long ago.
“The thing that stood out to us at Dugway was that a fairly large proportion of the samples they’d already irradiated turned out to be positive in their own testing. It was about 20 percent when the team audited their records. That should have been a clear indication that something was wrong, because it should have been much, much lower than that.” Kendall said. “There’s enough evidence there for me to conclude that individual accountability needs to assessed, but it should be assessed by a formal investigating body before you find somebody culpable and take corrective action. A 30-day review doesn’t do that, but the Army Inspector General has processes that can do that.”
Besides the new Dugway investigation, the secretaries of the Army and Navy are also being ordered to implement a series of reforms recommended by the independent review team and report back to the Pentagon.
The report noted that the shipment of live biohazards represented a severe breach of Defense Department policies. But the risk to individual employees and contractors working in DoD and private laboratories is and has been extremely small, because the Anthrax has moved from place to place in liquid vials instead of in its powdered form, the condition in which it its most likely to infect someone.
“But we take absolutely no comfort in this fact,” Work said. “This was a massive institutional failure with a potentially dangerous biotoxin.”