WASHINGTON, June 4, 2015 – The Defense Department’s top acquisitions official will lead a comprehensive review of DoD’s laboratory procedures, processes and protocols associated with inactivating spore-forming anthrax, Deputy Defense Secretary Bob Work announced yesterday.
Speaking with Pentagon reporters following Work’s announcement, Frank Kendall, undersecretary of defense for acquisition, technology and logistics, discussed his plans for the review.
“As the deputy secretary stated,” Kendall said, “he has asked me to conduct a comprehensive review of DoD laboratory procedures, processes, and protocols associated with deactivating the anthrax samples used in countermeasure development by the department.”
Kendall said he is assembling a team of government and private-sector experts to examine the inactivation processes.
“They will report preliminary findings and recommendations by the end of June,” he said.
According to Kendall, the final report will depend upon the completion of the separate Center of Disease Control investigation, and will focus on two primary questions.
The CDC, he said, is leading the public health response and the investigation of what the department believes are the two key technical questions surrounding DoD’s review.
“Why was there an incomplete inactivation of the spore-forming anthrax samples?” Kendall said, “and why testing mechanisms to ensure the procedures to inactivate the anthrax failed?”
The focus, Kendall said, will be on the root cause for the incomplete inactivation of anthrax samples at DoD laboratories, and why post-inactivation sterility testing did not detect the presence of live anthrax, as well as reviewing existing biohazard safety protocols and procedures.
“I’ve also been in close consultation with the director of the Center for Disease Control and Prevention, Dr. Tom Frieden, regarding their investigation,” he said.
Context for Anthrax Use
Kendall provided some context to the department’s chemical and biological defense program and the processes for shipment of small anthrax samples which “are frequent in the government and commercial research space.”
This is done, he said, as part of the process used by the department’s chemical and biological defense program to develop capabilities to detect and protect the public and U.S. service members from chemical and biological threats.
“Across the country,” Kendall said, “there are hundreds of labs that work with anthrax. As part of this mission, DoD ships inactivated or dead anthrax samples to laboratories as well as to industry, academia and other federal laboratories to help develop countermeasures and for other purposes.”
The inactivation process requires the samples to be irradiated with gamma rays, he said, then checked to ensure they are dead, and the CDC investigation is carefully examining why those two steps failed.
As part of DoD’s review of these processes, Kendall said more than 400 batches are being tested to determine how many lots were not completely inactivated.
“So far, at least four batches, or lots, have been found to have live spores present,” he said. It takes 10 days to determine if there are no live spores present, therefore, other batches cannot quite yet be eliminated, Kendall said.
“We have to wait until that time to be sure that there are not additional live spores,” he added.
“The expectation is, given what we’ve found so far, that there probably will be more live spores,” Kendall said. “The department has for many years worked with over 100 labs around the country and internationally.”
As additional lots are identified that were not fully inactivated, he said, labs are also being identified that received the samples, and this takes time.
“So the numbers are likely to change and grow as we know more, as was indicated by the deputy [defense secretary],” Kendall said.
Kendall reiterated that department’s top priority is the safety of all workers and the public, and DoD is “committed to total transparency” as more information emerges.
Chemical-Bio Defense Program
Navy Cdr. Franca R. Jones, DoD director of medical programs and chemical biological defense, provided background on the department’s defense program.
“Our program develops medical and physical countermeasures,” Jones said, “to protect the warfighter and the nation from chemical and biological threats, as part of an integrated, layered defense.”
Specifically, she said, the program develops vaccines, drugs and diagnostics for medical use and personnel protective equipment such as masks, suits, gloves, and decontamination equipment and detectors.
In order for DoD and other federal agencies to achieve their goals to protect warfighters and civilians from biological threats, Jones said it is critical to work with the commercial and academic sector to get the best technologies for national security.
Countermeasure Development, Use
Jones said the department was instrumental in U.S. Ebola response efforts, making DoD-developed diagnostic tests available throughout the nation’s hospitals and in West Africa.
“Many of our vaccines and drugs for Ebola were transitioned into clinical trials in West Africa,” she said. “[Furthermore], the DoD developed the anthrax vaccine, which is currently part of the strategic national stockpile and available to civilians and military in the case of an anthrax bioterrorism attack.”
In order to achieve these goals, Jones said DoD and other government agencies regularly ship both live and dead biological materials for countermeasure development by industry, academia, and other federal laboratories.
“We have been shipping inactivated anthrax as part of our program for at least 10 years,” she said.
Inactivation, Shipping Demo
Jones provided a demonstration of the process of inactivating anthrax samples and testing to determine if the sample is dead before shipping, as well as packaging and shipping procedures.
“That’s what we do for live agent and dead agent,” she said. “There’s nothing different there.”
The only difference in the process, Jones said, is in the labeling -- the samples are labeled according to the Hazardous Materials Transportation Act because dry ice is used in the boxes.
“If it’s inactivated,” she said, “we will not have the label that says ‘infectious substance.’”
Zero Risk to General Public
Discussing risk to the public and to workers who may have handled sample boxes in the transportation process, Jones said, “we believe that the risk is zero for the general public as well as for the people who have handled this box.”
Not one milliliter of liquid is going to come out of the box, she said, noting DoD believes the potential risk -- while extremely low -- may be at the at the initiation of the packaging process or for the individual who has received it.
“We understand that there’s public concern around the incident,” Jones said. “I want to assure you that samples in question were tested using an approved protocol and shipped by the method that I had just described.”
No live anthrax should have been in those boxes at all, she said, and along with the CDC, DoD is reviewing what could have happened.