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A live agent test chamber at the U.S. Army Dugway Proving Ground in Dugway, Utah. Federal officials are investigating how dozens of samples of live anthrax -- that were supposed to have been killed by irradiation -- were sent from Dugway to labs across the country and abroad.(Photo: Kristin Murphy, AP)
A Pentagon investigation blames inadequate killing<span style="color: Red;">*</span>and<span style="color: Red;">*</span>testing of anthrax specimens among the<span style="color: Red;">*</span>main<span style="color: Red;">*</span>causes of why an Army lab mistakenly<span style="color: Red;">*</span>shipped live spores to dozens of labs in the USA<span style="color: Red;">*</span>and abroad for a decade, according to a report released Thursday on the<span style="color: Red;">*</span>military's investigation of the blunders.
"By any measure, this was a massive institutional failure," Deputy Secretary of Defense Bob Work<span style="color: Red;">*</span>said Thursday.
Even though the Army's Dugway Proving Ground in Utah is the nation's "largest<span style="color: Red;">*</span>producer"<span style="color: Red;">*</span>of inactivated<span style="color: Red;">*</span>anthrax for use in biodefense research, the Pentagon's review found Dugway<span style="color: Red;">*</span>did less testing than other U.S. military facilities<span style="color: Red;">*</span>to ensure potentially deadly<span style="color: Red;">*</span>specimens were killed before shipment to defense contractors and<span style="color: Red;">*</span>university and government<span style="color: Red;">*</span>labs. When Dugway used radiation to kill a batch of anthrax, it tested only 5% of the material to ensure it couldn't still grow. This<span style="color: Red;">*</span>small<span style="color: Red;">*</span>sample size was "prone to error" and failed to detect that<span style="color: Red;">*</span>not all the anthrax spores had been killed, the report said.
"The development and implementation of ineffective irradiation and viability testing procedures took place over the last decade," the report said,<span style="color: Red;">*</span>"this represents an institutional problem at [Dugway] and does not necessarily reflect on any one individual."
Even so, Pentagon officials said their review raised questions about why Dugway's scientific staff and leadership didn't recognize they had a problem<span style="color: Red;">*</span>inactivating anthrax.<span style="color: Red;">*</span>Dugway's own records, based on its limited testing,<span style="color: Red;">*</span>showed a 20% failure rate for inactivating anthrax specimens, the Pentagon investigation team found.
"We believe there were indicators that people should have known there was a problem," Work said. He's directed Secretary of the Army John McHugh to conduct a full accountability assessment of those responsible for Dugway's<span style="color: Red;">*</span>anthrax program.
The Army said it is working to ensure all of its labs are safe. "Secretary McHugh was deeply troubled by the report's findings," said Col. David Doherty, an Army spokesman. He said a "15-6 investigation" will be conducted to determine whether there were any failures of leadership. A 15-6 is a formal investigation that could be a career killer.
The military's ongoing investigation has determined that Dugway sent live anthrax specimens to<span style="color: Red;">*</span>at least 86 labs<span style="color: Red;">*</span>operated by companies, academic institutions and government agencies for use in developing tests and equipment to protect against bioterror attacks. Those labs are in the USA<span style="color: Red;">*</span>and seven foreign countries: Japan, South Korea, the United Kingdom, Australia, Canada, Italy and Germany. Though no illnesses have been linked to the specimens, at least 21 people who had direct contact with the specimens have been given<span style="color: Red;">*</span>antibiotics as a precaution.
The Dugway Proving Ground is a major production and<span style="color: Red;">*</span>testing facility for the military's chemical and biological defense programs. It is located on 800,000 acres about 75 miles southwest of Salt Lake City. The inactivated anthrax produced by Dugway is used in the development of tests to detect the presence of the pathogen as well as<span style="color: Red;">*</span>equipment to protect against exposure to it. The kill process has to be sufficient to ensure the anthrax is incapable of growing, experts say, yet still allow the material to be recognizable as anthrax for use in testing equipment. It's a difficult balancing act, and the Pentagon report notes that anthrax is "an exceptionally resilient organism."
The Pentagon review found that no other military facilities involved in the production and inactivation of anthrax research specimens appear to have mistakenly shipped any live anthrax. Unlike at Dugway, the report said, staff at<span style="color: Red;">*</span>other military labs<span style="color: Red;">*</span>were able to routinely identify when they had live anthrax in their irradiated samples. Still, the report raises concerns about a lack of standardized biosafety procedures among defense department labs. It recommends improving the military's programs for killing pathogens and testing them to verify they're dead, enhancing quality assurance at labs and improving scientific oversight.
"We are shocked by these failures," Work said. "I want to stress to you that DoD takes full responsibility for these failures."
The report notes that the "significant differences" in the irradiation procedures and viability testing done for anthrax raises questions about how military labs handle other dangerous pathogens and called for a review of procedures at Defense Department facilities for all "select agent" pathogens. Select agent is the government's term for several dozen viruses, bacteria and toxins that pose significant health threats and have the potential to be used as bioweapons.
An investigations subcommittee of the House Energy and Commerce Committee has scheduled a hearing<span style="color: Red;">*</span> Tuesday to examine the effectiveness of <span style="color: Red;">*</span>federal oversight of labs working with potential bioterrorism pathogens that will focus on Dugway's<span style="color: Red;">*</span>anthrax mistakes.
Multiple federal investigations were launched in May after a private biotech company in Maryland discovered that a sample of what was supposed to be inactivated – or dead – anthrax sent recently from Dugway was actually still capable of growing and causing disease. The specimen was part of a project to develop a <span style="color: Red;">*</span>diagnostic test for potential bioterror pathogens.
A June 5 report by lab regulators at the Centers for Disease Control and Prevention, obtained last month by USA TODAY, concluded that Dugway had been mistakenly shipping live anthrax to labs in the USA<span style="color: Red;">*</span>and abroad for more than 10 years because the facility failed to have effective and standardized procedures for killing anthrax with radiation.
The CDC report cited the Dugway Proving Ground's Life Science Test Facility in Utah with three violations of federal regulations for working with potential bioterror agents and orders the facility to immediately cease all shipments of "inactivated" anthrax specimens.
Dugway scientists used<span style="color: Red;">*</span>Cobalt 60 gamma radiation to kill or deactivate anthrax specimens before shipping them to government or private labs for further research, the CDC report said. Dugway's standard procedures for irradiating anthrax "did not account for the variable amounts of spores treated in the gamma cell irradiator," the report said. The method used "was not validated using standardized control spore samples at varying concentrations, volumes, and levels of irradiation."
Anthrax spores.<span style="color: Red;">*</span>(Photo: Centers for Disease Control and Prevention)
As a result, the CDC concluded, Dugway mistakenly shipped live anthrax at least 74 times from January 2005 to May 2015. Anthrax spores can be potentially fatal if inhaled.
The labs at Dugway have a history of biosafety failures with anthrax: In 2007, they faced potential sanctions from the select agent program for failing to properly kill anthrax with an experimental chemical method – and ignoring test results that indicated the kill process wasn't effective, USA TODAY reported in June. It is unclear why CDC lab inspectors over the years apparently didn't identify Dugway's other ongoing failures in its use of radiation to kill anthrax specimens.
The Army's own anthrax scientists have apparently been aware for years that the military's methods for killing anthrax specimens<span style="color: Red;">*</span>— <span style="color: Red;">*</span>then doing tests to verify the kill step was fully<span style="color: Red;">*</span>effective<span style="color: Red;">*</span>— were not trustworthy. More than seven years ago, the nation's most infamous anthrax researcher warned military colleagues about the issue. The emails of<span style="color: Red;">*</span>Bruce Ivins, the Army microbiologist accused in the <span style="color: Red;">*</span>anthrax letter attacks in 2001, raised concerns that when a batch<span style="color: Red;">*</span>of anthrax was<span style="color: Red;">*</span>irradiated that too few samples were tested to ensure all the spores were dead, USA TODAY reported last month.<span style="color: Red;">*</span>In a 2008 email,<span style="color: Red;">*</span>Ivins discussed how some think only 10% of an irradiated batch needed to undergo sterility testing, but <span style="color: Red;">*</span>he'd found at least 50% should be tested because of past irradiation failures.
The Pentagon report released Thursday said that in addition to Dugway, the military has three other<span style="color: Red;">*</span>facilities involved in the production and inactivation of anthrax research specimens.<span style="color: Red;">*</span>All are in Maryland:<span style="color: Red;">*</span>the Edgewood Chemical Biological Center; the U.S. Army Medical Research Institute of Infectious Diseases, often referred to as USAMRIID; and the Naval Medical Research Center.<span style="color: Red;">*</span>The facilities have been<span style="color: Red;">*</span>under a shipment moratorium since the Dugway issues were discovered, the report says, noting that the Navy facility was not currently<span style="color: Red;">*</span>involved in inactivating anthrax.
At Edgewood, staffers test<span style="color: Red;">*</span>10% of an<span style="color: Red;">*</span>irradiated anthrax batch<span style="color: Red;">*</span>to check for any live bacteria, the report said, noting that this is "insufficient for verification of complete inactivation." At USAMRIID, the review <span style="color: Red;">*</span>found staff tested 10% of an irradiated anthrax batch<span style="color: Red;">*</span>but noted that a researcher at the facility doing other spore work "chose to conduct viability testing by taking 50% of the preparation<span style="color: Red;">*</span>as the sample."
The serious and widespread anthrax failures by Dugway emerged this spring as lab safety was already under scrutiny in the wake of several other high-profile lab incidents in 2014 involving mishaps with anthrax, Ebola and a deadly strain of avian influenza became public at the CDC's own labs in Atlanta.
In May, the USA TODAY Network's "Biolabs in Your Backyard" investigation revealed mishaps at research facilities nationwide and found that much of the oversight of labs working with anthrax and other "select agent" pathogens is cloaked in secrecy. More than 100 labs working with these kinds of potential bioterror pathogens have faced enforcement actions since 2003, the newspaper revealed. Five labs have had "multiple referrals" for sanctions, two labs have been kicked out of the program and five others have been suspended. The CDC and the U.S. Department of Agriculture – which jointly regulate labs under the Federal Select Agent Program – refuse to release the labs' names, citing a 2002 bioterrorism law that they say requires the secrecy.
In response to the USA TODAY investigation, key members of Congress are demanding better oversight and accountability of labs, and one investigative committee has told regulators it wants the names of labs that have faced sanctions.
Read USA TODAY's ongoing investigation of safety and security issues at laboratories nationwide: biolabs.usatoday.com
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