Army lab that shipped live Anthrax to nearly 200 sites is repeat violator of federal safety rules

Federal overseers charged with monitoring the government’s biotoxin safety programs made clear Tuesday that the Army research laboratory which mistakenly sent dozens of batches of live Anthrax to research facilities should have known years ago that something was amiss with their protocols for handling biotoxins.

Indeed, the Department of Health and Human Services had already identified at least four instances in which Dugway Proving Ground had run afoul of federal regulations over the last decade. And at least twice since 2007, HHS regulators have sent violation notices to Dugway officials that seem to have had little effect.

At a Tuesday Congressional hearing, officials disclosed that the number of research laboratories which had received supposedly inactivated Anthrax samples from Dugway over the past 12 years had risen to 192. Although there is no sign that anyone was infected, the receiving labs were in all 50 states and the District of Columbia.

The Pentagon <a href=”http://federalnewsradio.com/defense/2015/07/pentagon-report-finds-institutional-failures-led-shipping-live-anthrax/”>said last week</a> that its investigation had identified 86 labs as original recipients, but the Centers for Disease Control and Prevention now say some of those facilities transferred the improperly-irradiated material to another 106 labs, many of which are privately-operated.

DoD and CDC officials say they believe all of those samples have since been secured or destroyed.

The DoD investigation which began to expose the full scope of the problem started when a private lab noticed that a Dugway-originated Anthrax sample that was supposed to be dead was regrowing new spores.

But according to the Health and Human Services Department’s inspector general – the organization in charge of enforcing violations of the Federal Select Agent Program – Dugway had been repeatedly cited for past safety violations.

“In April 2007, Dugway shipped anthrax to a research facility with a certification that the anthrax was nonviable. The research facility tested the material and found the presence of a low concentration of viable anthrax. We found that Dugway ignored the results of its own post-inactivation viability test, which showed viable anthrax was present,” Gregory Demske, the chief counsel to the HHS IG told the House Energy and Commerce Committee. “In November 2010, a government laboratory received a shipment from Dugway that included a vial of botulinum neurotoxin. Small amounts of this select agent are exempt from the regulations, but in fact the shipment included a regulated amount. Dugway then self-reported two other unauthorized shipments of this select agent.”

But Demske says laboratories like Dugway present an “enforcement challenge” for his office since, like his organization, they are federal government entities.

Legally, the IG has the power to fine any lab which violates safety rules under the Select Agent Program. But it can also opt to issue a notice of violation – essentially, a written warning.

Since 2002, the office has investigated 16 separate cases involving federal labs, some of which are repeat offenders. But Demske said his office has never levied any actual penalty against a federal agency.

“Any (civil monetary penalty) on a federal entity would simply shift money within the government at a net cost to taxpayers, and may not promote better compliance,” he said. “Consistent with our approach to date with other entities, the OIG issued notice of violation letters to Dugway. The letters stated that OIG had determined Dugway violates the Select Agent regulations and it should examine its current policies and practices, take corrective action and monitor safeguards on an ongoing basis. Yesterday, OIG received another referral from CDC on Dugway. We are reviewing that matter now.”

Defense officials have also indicated they believe Dugway officials should have known their procedures were inadequate to kill the research-grade Anthrax they were producing. DoD has just begun a second investigation designed to assign culpability for any lapses in safety over the past decade, including the lab’s failure to fully kill the bacteria and its failure to verify the samples it was shipping were indeed inactivated.

But Dr. Marcia Crosse, the director for healthcare issues at the Government Accountability Office said the newly-uncovered issues at DoD are merely the latest in a series of systematic safety lapses at government-operated laboratories which handle biotoxins.

“We’ve been lucky so far,” she said. “Researchers in these labs work with high-risk biological agents that may result in serious or lethal infections, and in some instances they have the potential to be used in biological weapons. These labs do important work with pathogens to develop vaccines and countermeasures and to understand emerging infectious diseases. But the pathogens handled by these laboratories also have the potential for high-consequence accidents. If the types of mistakes we’ve seen were to occur with other pathogens, like certain strains of influenza, not only would the laboratory workers or their close contacts be at risk, but an epidemic could be triggered with consequences far beyond what we’ve seen to date.”

One reason the government has been “lucky” is that the Anthrax shipments from Dugway were in liquid vials – not the powdered form that’s easily transmissible through the air and which killed five people and sickened more than a dozen others in 2001.

As a precaution, dozens of workers who were unknowingly exposed to the live bacteria have been given prophylactic antibiotics to guard against infection. On Monday, all of the employees were given the all-clear from federal officials who said they had determined with a high degree of certainty that they were not infected.

The DoD investigation which concluded last week highlighted the fact that there are no common protocols in place amongst the military services’ laboratories for killing dangerous bacteria like Anthrax in a laboratory setting and that each of the four Defense labs that handle deadly agents are allowed to create their own protocols, each reporting through a different chain of command and with very little information sharing amongst them.

The Pentagon has promised to fix that, but Crosse said the government as a whole faces a similar problem. There is no single entity in charge of creating guidelines for any biotoxin, let alone Anthrax, and most laboratories are overseen by CDC, not the Defense Department.

GAO has been imploring the government to create a single agency for the oversight and management of biotoxins for several years, to no avail so far.

“We think that’s important, in part, because you need a more comprehensive set of plans for how many labs the country actually needs,” Crosse said. “There’s been a great increase in the number of labs since the attacks in 2001: a number of different federal agencies have expanded the number of labs that they have, academic institutions have built labs, some states have built labs, and a lot of private entities have built labs, and they’re all very expensive. But they are all developing their own validation procedures. There’s not an assurance of consistency. So while you can inspect them, when problems are found, they have only typically been going to the next level in the chain of command above the laboratory itself. These issues are not getting to the top of departments.”

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