Latest military lab concerns involve plague bacteria, deadly viruses

WASHINGTON — The Pentagon's most secure laboratories may have mislabeled, improperly stored and shipped samples of potentially infectious plague bacteria, which can cause several deadly forms of disease, USA TODAY has learned.

The Centers for Disease Control and Prevention flagged the practices after inspections last month at an Army lab in Maryland, one of the Pentagon's most secure labs. That helped prompt an emergency ban on research on all bioterror pathogens at nine laboratories run by the Pentagon, which was already reeling from revelations that another Army lab in Utah had mishandled anthrax samples for 10 years.

Army Secretary John McHugh ordered the research moratorium on Sept. 2, Pentagon officials say, out of an abundance of caution.

Moreover, officials point out that continuing testing has shown the suspect samples of plague contain a weakened version, and not the fully virulent form that was of concern to lab regulators at the CDC.

There is no danger to the public from the plague and encephalitis specimens found in the labs, said Army spokesman Dov Schwartz. After extensive testing, no danger has been found to scientists and researchers who have worked with the vials, he said. Final test results are expected by the end of the month.



However, for the first time since the scandal broke in May about an Army lab's botched handling of anthrax, the Pentagon is now acknowledging that worries now extend to other lethal agents that it studies. In addition to the plague samples and some additional anthrax specimens, the CDC has raised concerns about military labs' handling of specimens created from two potentially deadly viruses that are also classified as bioterror pathogens: Venezuelan equine encephalitis virus and Eastern equine encephalitis virus, which can cause rare but serious illnesses in people, including deadly inflammation of the brain.

The bacteria that cause plague, Yersinia pestis, can cause several types of serious and potentially fatal illnesses: bubonic plague, which has symptoms that include swollen lymph nodes; pneumonic plague, which involves the infection spreading to the lungs; and septicemic plague, which may involve skin and other tissues turning black and dying. It's the pathogen often blamed for the Black Death that killed millions of people in Europe during the 14th century. Today antibiotics can be used to treat the diseases, but plague still kills about 11% of those sickened, according to the CDC.

Untreated pneumonic plague has a fatality rate of about 93% and can be spread from person to person through aerosols generated during coughing.

The suspect specimens, which may be live despite being labeled as killed or weakened, indicate a wider range of dangerous bioterror pathogens being handled using sloppy safety practices at laboratories operated by the U.S. military. They also further illustrate the risks faced by other scientists who rely on pathogen "death certificates" to know whether or not a provided sample is still infectious and can be worked with safely without special protective equipment. An ongoing USA TODAY Media Network investigation has revealed numerous mishaps at government, university and private labs that operate in the secretive world of biodefense research prompting growing concern in Congress and among biosafety experts.

The revelations about plague and other specimens only add to bipartisan concerns in Congress about the effectiveness of safety practices and federal regulation at military and other labs working with dangerous pathogens.

The chairman of the House Energy and Commerce Committee Fred Upton, R-Mich., and ranking Democrat, Frank Pallone of New Jersey, in a joint statement on Thursday said: “Anthrax being mishandled is disconcerting enough, but now the mishandling also includes other potentially dangerous viruses including plague. The committee has zero tolerance for these widespread mishaps and will continue working to ensure that the Department corrects these failures so that the nation’s bioterrorism response efforts are not hampered further."

Last week's announcement on the moratorium failed to note the CDC's concerns about the plague and equine encephalitis. Instead the Pentagon traced the ban to the mishandling of anthrax at the Army's Dugway Proving Ground in Utah, called a "massive institutional failure" by Deputy Defense Secretary Robert Work. An ongoing international investigation has found that Dugway used an ineffective irradiation method and unwittingly shipped live anthrax — labeled as killed specimens — for more than a decade that ended up in research facilities in all 50 states and several foreign countries. Although no illnesses have been reported as a result of the mistakes, several researchers who handled the specimens were put on antibiotics as a precaution.



In a statement this week to USA TODAY, Schwartz said the CDC's concerns about the plague and encephalitis directly contributed to McHugh's ordering of the moratorium. An Aug. 17 CDC inspection at the Edgewood Chemical Biological Center in Maryland raised questions as to whether a strain of Yersinia pestis, the organism that causes plague, was infectious even though it was stored in an area designated for non-infectious material.

The new CDC investigation is focused on specimens created and stored by Dugway, Edgewood and two other military labs for further distribution by the Defense Department's Critical Reagents Program, a scientific materials supply group that offers a catalog of what are supposed to be "inactivated" and other pathogen specimens for researchers to use in developing and testing biodefense products, such as detection equipment and diagnostic tests.

Lab regulators at the CDC declined to be interviewed but acknowledged they are investigating issues at the four labs and the Critical Reagents Program. "CDC has identified a number of transfers of concern involving multiple organisms," the agency said in a statement in response to USA TODAY's questions.

Most of the shipments of the specimens went to other Defense Department facilities, the CDC said, and the agency's investigators are "working to track shipments and confirm the safety of those working with these materials." It is uncertain at this stage of the investigation, the CDC said, whether the material in the shipments contained live "select agent" pathogens, or a killed or weakened version that doesn't pose a severe risk to public health and is exempt from federal regulation.

Select agent is the government's term for certain viruses, bacteria and toxins that are regulated because of their potential to be used as biological weapons and the potential risks they pose to public health and agriculture.

"At this time, there is nothing to suggest risk to the health of workers or the general public," the CDC said.

Vials of plague specimens were the first to draw the CDC's concerns during an Aug. 17 inspection at the Edgewood Chemical Biological Center. How those samples were being handled prompted lab regulators to conduct a review of the labeling of specimens offered to other labs through the Critical Reagents Program's catalog, the Army's Schwartz said.

"The CDC raised questions about the labeling of some material listed within the catalog, including a strain of Bacillus anthracis and derivatives of equine encephalitis viruses, and consequently, whether this material was properly handled and shipped by the Department," Schwartz said. Bacillus anthracis is the bacterium that causes anthrax.

Gregory Koblentz, director of the biodefense program at George Mason University in Virginia, said the mounting issues at Pentagon labs show the need for a review by independent experts — not just the current peer review of safety that the military is undertaking during its moratorium.

“Since there are now concerns about the biosafety practices at multiple DoD labs there needs to be an independent review of the military's biosafety policies and practices,” Koblentz said Thursday. He said the Critical Reagents Program is an important biodefense resource. “It’s crucial that all problems with handling and shipping inactivated samples be resolved quickly so the program can resume its important role in strengthening U.S. biopreparedness.”

Richard Ebright, a Rutgers University microbiologist who has testified before Congress on federal lab safety problems, said that in the wake of the Defense Department’s bungling with anthrax samples “it is unsurprising that similar misfeasance occurred in the DoD programs for producing killed versions of other bioweapons agents.”

Ebright said mounting questions about biosafety practices at Pentagon labs should be a warning to researchers that they need to independently verify the specimens they receive from military labs because the “death certificates” sent with supposedly killed samples “are not worth the paper they’re printed on.”

Last week USA TODAY was the first to report that the Pentagon had ordered an immediate moratorium on work with a wide range of potential bioterror bacteria, viruses and toxins at nine biodefense laboratories while they perform safety reviews to ensure they are properly handling select agent pathogens.

McHugh issued his order for the sweeping safety review two days after lab regulators at the CDC on Aug. 31 ordered Dugway’s labs to suspend work will all types of select agent pathogens because of new revelations about sloppy biosafety practices at the Utah facility. Dugway officials, in testing surfaces in their laboratories, detected anthrax bacteria on the floors of two rooms where staff had worked with the deadly pathogen — an area where it shouldn't have been found.

The military labs covered by the safety review and moratorium include the four that produce specimens for the Critical Reagents Program: U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Dugway, the Edgewood Chemical and Biological Center and the Naval Medical Research Center's Biological Defense Research Directorate. McHugh's Sept. 2 order also called for "validating" current inventories, catalog items and record keeping for the military's Critical Reagents Program (CRP) and "ensuring that all materials associated with the CRP are properly accounted for." The labs were given 10 days to report back the findings of their safety reviews, according to McHugh's memo.

Read full coverage of USA TODAY's ongoing investigation of safety issues at labs nationwide: biolabs.usatoday.com.

Follow USA TODAY reporters Alison Young and Tom Vanden Brook on Twitter: @alisonannyoung and @tvandenbrook