Calling the Defense Department’s inadvertent May delivery of live anthrax to a commercial lab “a massive institutional failure,” Deputy Defense Secretary Bob Work today outlined findings of the review and steps DoD will take to ensure it never happens again.

But given the failure, Work said at a Pentagon news conference, he, Defense Secretary Ash Carter and DoD senior leadership “take absolutely no comfort in this.”

The live-anthrax shipment to a commercial lab was narrowed down to one of four DoD labs, he said, and added that of the total batches in the lab’s inventory, more than half tested positive for live anthrax -- 17 of 33.

DoD ships inactivated samples of anthrax spores to outside labs for research and development of DoD countermeasures to protect U.S. troops, allies, partners and the American public from biological attack, the deputy defense secretary said.

“[In] the past, some nations have produced biological weapons, and we cannot be certain that rogue nations or terrorist groups won’t do the same in the future,” he said of DoD’s work with anthrax.

Four Labs Handle Anthrax

The four labs that handle anthrax are the Army’s labs at Dugway Proving Ground in Utah, and in Maryland, the Edgewood Chemical Biological Center, the Army Medical Research Institute of Infectious Diseases and the Naval Medical Research Center.

When the incident unfolded, the Centers for Disease Control began onsite investigations, and Work directed Frank Kendall, the undersecretary of defense for acquisition, technology and logistics, to conduct the 30-day review of the labs’ procedures, processes and protocols associated with inactivating anthrax spores.

The deputy secretary said he wanted to determine whether the accidental delivery was a one-time failure or a “more systemic problem” in DoD’s biohazard safety procedures, and he assembled a team of experts from the departments of Agriculture, Defense, Energy and Homeland Security, the FBI, academia and industry.

Review Committee

The review committee found the four labs had irradiated -- destroyed the bacterium with radiation -- 149 batches of live anthrax spores and reported them inactivated and safe for testing since 2003. All were accounted for and tested or destroyed, he said.

Other findings:

-- Fifty-three of the 149 batches are no longer in the DoD inventory or available for testing, and recipients were told to destroy remaining batches.

-- Of the 96 batches to test in DoD inventory at Dugway Proving Ground, 17 of 33 tested positive for re-growth/live anthrax.

“Obviously, when over half of anthrax batches presumed to be inactivated instead prove to contain live anthrax spores, we have a major problem, and the numbers confirm this judgment,” Work said.

“We know over the past 12 years, 86 laboratories in 20 states, the District of Columbia, and seven foreign countries ultimately received what were supposedly inactivated spores that originated at Dugway,” he added.

The deputy defense secretary said he expects the numbers to increase with secondary shipments, which CDC is responsible for tracking.

No Infections Resulted

Work said the live anthrax was delivered in small amounts of liquid in “extremely low concentrations,” and all were handled in labs. Not a single infection resulted in lab workers in 12 years, he added.

Three main causes led to the incident, Work said:

-- No national standards exist for anthrax inactivation procedures;

-- Several factors at Dugway led to a higher likelihood of misidentifying the live spores; and

-- Biohazard protocol is not standardized across DoD, because the labs report to multiple chains of command and two services.

“The American public expects much more from us, and we should expect much more from ourselves,” Work said. “Secretary Carter has made plain he expects these issues be dealt with swiftly and comprehensively to ensure that a failure of this sort never happens again.”

Work said he directed Kendall’s office to:

-- Work with DoD stakeholders, the CDC, and other relevant departments and agencies to develop standardized irradiation and viability testing protocols for all DOD labs that work with spore-producing organisms like anthrax;

-- Ensure sufficient funding is available through the Chemical and Biological Defense Program for research into the development of standardized irradiation and viability testing protocols;

-- Review and revise as necessary DoD biosafety and biosecurity policy and ensure consistent application across DoD laboratories; and

--Oversee military department and service implementation of the review committee’s recommendations.

Work said he also directed the secretaries of the Army and Navy to investigate and develop plans that cover quality assurance, peer review, and program management and to provide quarterly updates on progress. The Army secretary was designated as DoD’s executive agent for the Biological Select Agent and Toxin Biosafety Program, the deputy defense secretary added. The moratorium on production, handling, testing, and shipment will continue until the report’s recommendations are addressed, he said.

Notification Led to Immediate Action

Work commended the lab that notified the CDC of the live anthrax delivery.

“Because of their notification, the department was able to take immediate action, stop all shipping of inactivated anthrax, assess our procedures, processes, and protocols; and begin to institute needed changes,” he said. “In doing so, they helped ensure nobody was infected by anthrax.

“This review taught us lessons we needed to learn, and identified institutional and procedural failures we need urgently to address,” he continued. “We are shocked by these failures. … DoD takes full responsibility for these failures, and we are implementing changes and recommending the establishment of procedures, processes and protocols that will prevent such a biohazard safety failure does not happen again.”