By Army Sgt. 1st Class Tyrone C. Marshall Jr.
DoD News, Defense Media Activity
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.
Two-pronged Investigation
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.
Review Process
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.
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