Scientists wearing space-suitlike protective gear
searched for hours in May for a mouse —
infected with a virus similar to Ebola — that
had escaped inside Rocky Mountain
Laboratories in Montana, one of the federal
government's highest-security research
facilities, according to newly obtained incident
reports that provide a window into the
secretive world of bioterror lab accidents.
During the same month at St. Jude Children's
Research Hospital in Memphis, a lab worker
suffered a cut while trying to round up escaped
ferrets that had been infected with a deadly
strain of avian influenza, records show. Four
days later at Colorado State University's
bioterrorism lab, a worker failed to ensure
dangerous bacteria had been killed before
shipping specimens — some of them still able
to grow — to another lab where a worker
unwittingly handled them without key
protective gear.
Nobody was sickened in the incidents and the
mouse was caught the next day. Yet in the wake
of serious lab mishaps with anthrax and bird flu
at the Centers for Disease Control and
Prevention that prompted an uproar and a
Congressional hearing this summer, these
additional incidents are further fueling
bipartisan concern about lab safety.
"As long as we keep having an ad hoc system of
oversight in this country, we're going to keep
seeing more and more incidents," said U.S.
Rep. Diana DeGette of Colorado, the ranking
Democrat on the House oversight
subcommittee that held the hearing in July.
Added subcommittee Chairman Tim Murphy, R-
Pa.: "These incidents underscore why the
committee has been investigating the safety of
high-containment labs."
The CDC and the U.S. Department of
Agriculture jointly run the Federal Select Agent
Program that oversees government, university
and private laboratories working with
dangerous viruses, bacteria and toxins called
"select agents" because they're deemed to
pose serious threats to people and agriculture
and could potentially be used as bioweapons.
Most of these facilities are "high-containment"
laboratories operating at biosafety levels 3 and
4, the highest levels. Each level has increasingly
sophisticated safety equipment and protocols
to protect researchers from infection and keep
deadly pathogens from being released.
The Government Accountability Office, which is
the investigative arm of Congress, has warned
for years that no single federal entity is
responsible for oversight of high-containment
labs and there are no national standards for
their design or operation. It isn't even known
how many high-containment labs are in
operation nationwide because those working
with dangerous pathogens that aren't on the
federal "select agent" list — such as
tuberculosis, MERS-CoV coronavirus and some
potentially deadly bird flu strains — aren't
required to register with the CDC-USDA
program.
Citing bioterrorism laws, the Federal Select
Agent Program doesn't publicly release details
about accidents occurring in regulated labs.
More than 1,100 incidents involving select
agents were reported by labs from 2008
through 2012 and more than half were serious
enough workers received medical evaluation or
treatment, USA TODAY reported in August
after obtaining copies of the program's annual
reports to Congress. The reports, however,
don't name the labs and provide few details
beyond tallies of incidents by type.
The details of the May incidents were revealed
in minutes of those labs' institutional biosafety
committees and related reports obtained by
Edward Hammond, former director of the
Sunshine Project, an independent lab watchdog
group that operated from 1999-2008, until it
lost funding.
Hammond said it's difficult for policymakers
and the public to judge the safety of labs and
weigh the risks and benefits of proliferating
bioterror-related research projects without
data on how often incidents occur and details
about what happened.
"We need to require reporting and for
reporting to be public," said Hammond, now a
researcher based in Austin.
Since August, Hammond has been requesting
minutes of recent biosafety committee
meetings from about 100 labs across the
country and is in the process of reviewing the
records to identify incidents. Entities that
receive funding for recombinant DNA research
from the National Institutes of Health are
required to make certain records available to
the public, including biosafety committee
minutes.
Among the initial records Hammond has
received and reviewed so far, he identified
those at Colorado State, St. Jude and Rocky
Mountain National Laboratories as among the
most troubling and provided copies to USA
TODAY.
Colorado State University

Colorado State University
At Colorado State University in Fort Collins,
home to the Rocky Mountain Regional Center
of Excellence for Biodefense and Emerging
Infectious Diseases Research, records show
there were two significant lab accidents in May.
The university blacked-out key information in
the documents – such as the names of the
pathogens and researchers involved in the
accidents. Although the university cited select
agent rules as the reason for the redactions, it
routinely publishes on its website the names of
researchers and the bioterror agents they
study.
University officials answered questions about
the incidents in interviews with USA TODAY.
On May 16, a researcher, in a biosafety level 3
(BSL-3) lab boiled tubes containing specimens
of Burkholderia pseudomallei that had been
genetically modified to be resistant to the
antibiotic kanamycin, records show. The
bacteria, which can sicken people and animals
with a variety of symptoms including
pneumonia and life-threatening bloodstream
infections, are classified as a Tier 1 select agent
– a designation given by the federal
government to a handful of pathogens deemed
to present the "greatest risk of deliberate
misuse with significant potential for mass
casualties or devastating effect to the economy,
critical infrastructure, or public confidence, and
pose a severe threat to public health and
safety." The university blacked out the name of
the bacteria in the records it released, but
missed one reference to "B. pseudomallei."
The heat from boiling was supposed to
deactivate the bacteria so it could be safely
worked with in a lower-level lab where
scientists don't wear respirators and the rooms
lack negative air pressure and other special
equipment designed to contain dangerous
germs.
As a check to ensure the specimens had been
sterilized, the worker put a sample from each
tube into an incubator to see if the bacteria
would grow, the records show. But rather than
wait for the results of that safety check, which
can take a day or more, the tubes were sent
the same day to the lower-level lab at the
same facility where another lab staffer – whose
only safety gear noted in the report was a pair
of gloves – transferred them to new tubes.
"Based on past experience that all samples
prepared and tested this way over the last 6+
years had been sterile, DNA samples were
presumed to be sterile, and brought out of the
BSL-3 that afternoon," the incident report says.
But on May 19, two of the 20 the supposedly
sterile safety-check samples showed signs of
growth. The lower-level lab was
decontaminated. As a precaution, the
researcher who had worked with the bacteria
without proper protective gear received
antibiotics for three weeks and never showed
signs of infection, according to the records and
university officials.
Lauren Victoria Burke, AP
House Oversight and Investigations
Subcommittee Chairman Rep. Tim Murphy,
more
Earlier this summer the CDC in Atlanta also
failed to confirm that anthrax spores had been
deactivated before sending them to lower level
labs at the agency – resulting in the potential
exposure of dozens of workers to a particularly
deadly strain of the bacteria discovered when
growth was later seen on safety check plates.
None have showed signs of infection. In June
the CDC posted updated guidance to labs on its
website about ensuring select agents are
rendered inactive by using validated methods
and safety checks.
Colorado State's vice president for research,
Alan Rudolph, told USA TODAY that standard
procedure was to ship Burkholderia samples
out of the BSL-3 lab without confirmation of
inactivation because the process had been
100% successful in the past. The lab now
requires a 24- to 48-hour wait time to check
for any growth, he said, and some researchers
wait 48-72 hours "as an additional safety
measure, but this is not mandated," he said.
Rudolph said it's a mystery why all the bacteria
weren't deactivated in the May incident. "But
we know this particular agent, Burkholderia
pseudomallei, acts in unusual ways," he said,
and that's one reason why it's important to
study it so better tests and treatments can be
developed against drug-resistant strains.
One of the university's top Burkholderia
researchers, Herbert Schweizer, has said the
"strict regulations imposed on researchers in
the United States but not in other parts of the
world" impedes genetic research into these
select agent bacteria, according to a 2008
article he co-authored in an infectious disease
journal
. Schweizer, whose research is part of the NIH
grant number cited in the incident report, was
unavailable for comment, the university said.
"We have a great track record of safety,"
Rudolph said, noting that the university has
worked safely for years with select agents.
"This is an incident, as we reported, and we
should learn from it."
About a week after the Burkholderia mishap,
there was another serious incident at one of
the university's high-containment labs
experimenting with bacteria that cause
tuberculosis. The May 28 incident was
considered by the university's biosafety officer
to be "a severe incident because it potentially
put several others in jeopardy," according to
the university's biosafety committee minutes
for July.
Yet the researcher failed to mention the TB
incident to the biosafety officer for about three
weeks "because the individual was tired and
forgot," the minutes say. "Once they were
notified the BSO decontaminated the room"
and sent e-mails to everyone who may have
been exposed "during this time frame," the
minutes say, noting that risks of infection were
deemed minimal because of the use of
protective gear by lab workers.
The minutes don't say what the researcher did
wrong and the university blacked out
information that identifies the incident as
occurring in a TB lab.
Rudolph said the issue involved pus from a
dead guinea pig getting outside of a special
biosafety cabinet when a TB researcher was
removing a lymph node from the animal. He
said the interior and exterior of the cabinet
were immediately disinfected but because of
the nature of the incident "there was the
possibility that the bacterium had been
aerosolized."
"In research it's very difficult to envision a
zero-risk environment," Rudolph said. The key,
he said, is to balance working as safely as
possible while still pursuing work that is critical
to protecting public health.
St. Jude Children's Research Hospital
At St. Jude Children's Research Hospital in
Memphis, which has an internationally
recognized influenza research facility, a worker
in an enhanced BSL-3 lab on May 12 discovered
that five ferrets had escaped their cage. The
ferrets had been inoculated a week earlier with
the deadly H7N9 avian influenza virus but
didn't show any symptoms, according to the
hospital's incident report.
H7N9 is a strain of bird flu that in 2013 was
first identified as having seriously sickened
some people in China. Contact with infected
poultry or contaminated environments is
believed to be the source of most H7N9
infections in people, according to the CDC, but
there has been limited spread of the virus
from person-to-person in rare instances. Most
people sickened by the strain have suffered
severe respiratory illness and about one-third
have died.
CDC
Human infections with the H7N9 strain of avian
influenza virus were first identified in China in
early 2013.
As the worker at St. Jude corralled the ferrets
and put them back in their cage, she noticed
that she'd gotten a tear in the double gloves on
her right hand, and she later found she had
sustained a small cut to her index finger.
Although the occupational health physician
concluded her risk of exposure to the H7N9
virus was "very low," the tech was offered a
five-day course of an anti-viral drug and
underwent blood tests to look for signs of
infection and none were found. After reviewing
the report filed by the lab, NIH wrote a letter
saying the hospital responded appropriately to
the incident. H7N9 is not among the pathogens
on the federal government's select agent list.
According to the hospital's incident report, the
H7N9 virus being used in the experiment was
created through reverse genetics and "made to
be the same as the wild type viral sequence
with no introduced mutations." The research
was being overseen by Richard Webby,
according to the records, which did not redact
his name or the names of pathogens.
In June, when St. Jude's biosafety committee
reviewed the ferret escape incident, it also
approved a new project proposed by Webby to
do a controversial type of research that the
minutes say has the "high likelihood of
conferring enhancements" – in other words
making more dangerous – strains of avian
influenza virus that currently only have a low
ability to produce disease.
"After assessment of the biosafety risks, the
committee had no biosafety concerns" about
Webby's proposed research and approved the
project, the minutes say.
Hammond said the ferret escape incident
would be even more concerning if it occurred
with a lab-created strain that is engineered to
be more dangerous because of the potential
for an infected lab worker to spread it in the
community. Such "gain of function"
experiments, he notes, are highly
controversial.
In August 2013, Webby was among nearly two-
dozen co-signers of a letter in the journal
Nature arguing that controversial experiments
are urgently needed to see what changes in the
genome of the H7N9 virus could make it more
deadly so scientists can better understand its
potential to cause a future pandemic among
people if it were to mutate naturally.
Other scientists oppose the work as too
dangerous and of limited value when balanced
against what may be learned.
Officials from St. Jude declined to be
interviewed and did not answer many of USA
TODAY's questions. In an e-mailed statement,
St. Jude said: "We have a robust biological
safety program that meets and exceeds all
federal standards." The hospital did not answer
questions about Webby's new research project,
but said: "The project has not been started at
St. Jude."
Rocky Mountain Laboratories
Around 11 a.m. on May 16, scientists in one of
Rocky Mountain Laboratories' biosafety level 4
labs in Hamilton, Mont., thought they had fully
anesthetized several mouselike rodents called
Mastomys.
The animals had been infected with a strain of
Lassa virus 21 days earlier, according to the
lab's incident report.
Lassa virus causes a type of hemorrhagic fever
which has symptoms similar to Ebola, such as
bleeding from the gums, eyes or nose, and
repeated vomiting. According to the CDC, crude
estimates are that about 100,000 to 300,000
people are infected with Lassa fever each year
in West Africa and about 5,000 die from it.
Lassa virus is considered by regulators to be a
select agent.
Rocky Mountain Laboratories is operated by the
National Institute of Allergy and Infectious
Diseases, a division of NIH.
The space-suit clad scientist was reaching into
the cage to remove a sedated mouse to
undergo a procedure as part of research to
understand the infectious process of Lassa
fever virus. That's when another of the rodents
jumped out of the cage, ran down the
procedure table and dropped to the floor. It
was last seen running behind the table, before
it disappeared.
For "1-2 hours" the scientists in the bulky,
pressurized protective suits searched for the
mouse in and around the table and throughout
the procedure corridor – but couldn't find it,
records show.
Live traps containing food were placed around
the room, a "Do Not Enter" sign was posted and
the bottom of the door was barricaded to
prevent escape, the records say. Staff were also
instructed "to visually make eye contact with
the floor surrounding the door to ensure the
rodent did not attempt to leave the room as
the door was opened/closed." Yet when
scientists went back into the room at 3:30 p.m.,
they still couldn't find the rodent.
CDC
Lassa virus causes Lassa fever, a severe viral
illness common in West Africa. more
In the wild, Mastomys are considered a natural
host of Lassa virus and once infected are able
to shed the virus in their urine and droppings.
The next morning when staff entered the BSL-4
lab suite they captured the animal in the
necropsy room, where dead animals are
dissected. "The animal was disposed of," the
records say, and surfaces were decontaminated
in the animal procedure corridor, the necropsy
room and a support room.
Lab officials didn't initially believe they needed
to report the incident to the select agent
program as a possible release, the incident
report says. However CDC select agent officials
told the federal lab it needed to be reported.
In a statement to USA TODAY, the agency that
runs the lab said: "The animal could not exit
the BSL-4 laboratory and, as expected, was
found the following morning. At no time was
there a hazard to other parts of the facility or
to the surrounding community." It was the first
time a rodent had escaped inside the
maximum-containment lab, the agency said.
Because 21 days had passed since it was
infected with Lassa virus, researchers believe it
would have already cleared the animal's system
and it would not have been shedding virus at
the time of the escape. "Regardless, the risk of
virus exposure to laboratory workers is
extremely low because of the protective,
positive-pressure suits they wear, all of which
functioned properly during this incident," the
agency said.
Despite such assurances from all the labs,
some in Congress remain wary.
"It used to be we only had a few labs doing this
very high level and risky research. Now we
have them at places like St. Jude and academic
research institutions like CSU and other
places," said DeGette. "It appears none of
these breaches have lead to any kind of
infection. But it's only a matter of time."
Read USA TODAY's investigative coverage of
bioterror lab safety and security issues at
biolabs.usatoday.com.
Follow USA TODAY investigative reporter Alison
Young on Twitter: @alisonanny




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