Army lab cited eight years ago for failing to properly kill anthrax samples

The Army bioterror defense research facility that has mistakenly sent live anthrax to dozens of labs in the U.S. and abroad faced potential sanctions in 2007 for failing to properly kill specimens of the deadly bacteria – and ignoring test results that indicated their kill process wasn't effective, USA TODAY has learned.

The lab safety violations identified eight years ago at the Army's Dugway Proving Ground in Utah were so serious that federal regulators referred the facility for further investigation and possible enforcement action, federal lab regulators said in response to questions from USA TODAY. But no fine was ever issued and records show the incident was never disclosed in the annual reports sent to Congress by the program that oversees labs working with potential bioterror pathogens.

Officials with the Department of Defense and Dugway Proving Ground were not immediately available for comment. USA TODAY has been asking both entities questions about Dugway's inspection history since Wednesday. Lab regulators at the Centers for Disease Control and Prevention said it is important to note that the 2007 violations involved a different, chemical method of inactivating anthrax and not the gamma irradiation method that is the focus of the current federal investigation.

A massive international investigation was launched last month after a private biotechnology company in Maryland discovered that what was supposed to be a dead sample of anthrax it received from Dugway as part of a project to develop a new diagnostic test – was actually alive and capable of growing. The sample had a "death certificate" from Dugway saying it had been killed with radiation, and the Department of Defense now says at least 69 labs in the USA and five foreign countries received live anthrax samples. If inhaled, anthrax spores can be lethal even with treatment, sparking a high fever and other flu-like symptoms. So far no illnesses have been reported in association with the Dugway specimens.

The Dugway Proving Ground is a major test facility for the U.S. Army's chemical and biological defense programs. It is located on 800,000 acres about 75 miles southwest of Salt Lake City.

The new information obtained Friday reveals that in 2007 lab inspectors from the CDC cited Dugway for using an "experimental" chemical method of killing anthrax specimens that was ineffective and resulted in an unauthorized transfer of anthrax bacteria to another facility. The inspectors found that Dugway staff apparently ignored the results of their own kill-confirmation tests that showed growth of bacteria even after the chemical inactivation was done – yet shipped the sample anyway, according to the agency's written response to questions from USA TODAY.

Because of the serious nature of the violations, the CDC referred Dugway to the U.S. Department of Health and Human Services Office of Inspector General for potential enforcement action. In December 2009, the OIG closed the case, and while it agreed that an unauthorized transfer of anthrax had occurred, the office did not issue any fines, the CDC said. Officials at the inspector general's office were not immediately available for comment.

The CDC on Friday said: "It should be noted that this incident is not similar to the current investigation where Dugway was using an established irradiation protocol and no growth was observed following the gamma irradiation."

Yet there are similarities. The current anthrax situation involving Dugway shipping dozens of live anthrax samples that were supposed to be dead and, as in 2007, involves failures of the current inactivation process, as well as failures to recognize that it wasn't fully killing the bacteria and its hard-to-kill spores. The military has not answered USA TODAY's repeated questions about Dugway's protocols for killing anthrax and its procedures for conducting verification tests to ensure the process was consistently effective.

A May 29 CDC email obtained by USA TODAY indicates that the radiation process wasn't 100% effective. "We have concern that the inactivation procedures, when followed properly, are inadequate to kill all spores," wrote Daniel Sosin, deputy director of CDC's Office of Public Health Preparedness and Response in the email to state officials.

The CDC on Friday said the Dugway lab was currently using "a scientifically validated procedure" to inactivate anthrax bacteria, and provided a copy of a document that references a 1991 scientific paper that was the basis for Dugway's irradiation method. The select agent regulations require labs to develop biosafety plans that are adequate to address the risks posed by the specific pathogens they are authorized to possess – but leave it up to labs to pick their own methods of achieving safety. "There is no specific regulatory requirement for inactivation verification in the select agent regulations," the CDC said, but added it has issued guidance that notes the need to verify pathogens are killed.Inspectors verified that Dugway was doing sterility testing before issuing death certificates on samples, the CDC said.

Labs like Dugway that do research with anthrax and other potential bioterror pathogens are regulated by the Federal Select Agent Program, which is jointly run by the CDC and the U.S. Department of Agriculture. In the past year a series of high-profile incidents have occurred at labs overseen by the program, including mishaps at the CDC's own labs that have involved accidents with anthrax, Ebola and a deadly strain of bird flu. Last summer, an oversight subcommittee of the House Energy and Commerce Committee held a hearing on the CDC incidents. The recent anthrax mistakes involving Dugway Proving Ground have drawn questions from members of multiple Senate and House committees.

Much of the oversight of select agent labs is cloaked in secrecy, making it difficult to determine whether the current inspection and enforcement program is effective at ensuring safety, a USA TODAY Network investigation found last month. More than 100 labs working with "select agent" 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 from doing any work with these kinds of pathogens. But the CDC and USDA refuse to release the labs' names, citing a 2002 bioterrorism law they say requires the secrecy.

As a way of providing some oversight, Congress requires the Federal Select Agent Program to report each year on incidents with bioterror pathogens in regulated labs. Yet USA TODAY found the reports provide few details and only occasional vague information on a few serious incidents at unnamed labs. The reports, obtained under the federal Freedom of Information Act, do not include any incident description that matches Dugway's 2007 failure to kill anthrax specimens.

The Federal Select Agent Program refuses to release lab inspection reports, citing "national security" interests. The CDC said its lab inspectors identified no biosafety concerns when they visited Dugway in January 2015 for an announced renewal inspection. Dugway's institutional biosafety committee minutes, obtained under the federal Freedom of Information Act, show CDC inspectors cited the facility's labs for eight "observations" in 2013, but the minutes don't say what they were. CDC said Friday none of the 2013 infractions involved biosafety concerns. "The eight observations noted in the minutes you referenced had to do with missing references in the lab's standard operating procedures to work with specific select agents and toxins and inventory discrepancies," the CDC statement said.

Late Friday afternoon four bipartisan leaders of the full House Energy and Commerce Committee and its investigations subcommittee sent letters to the CDC and the HHS inspector general's office seeking copies of Dugway's inspection reports and enforcement referrals, as well as answers to questions about the facility's oversight history.

The letters are signed by U.S. Rep. Fred Upton, R-Mich., who chairs the full committee, and its ranking Democrat Frank Pallone, Jr., of New Jersey. It's also signed by subcommittee chair Tim Murphy, R-Pa., and ranking Democrat Diana DeGette of Colorado. In a joint statement, the members said they are "deeply concerned" about recurring problems with inactivation protocols in federal labs. "We hope that the documents will help shed light on how these unacceptable safety lapses have occurred, and how to prevent them from happening again in the future," the group said.

The current massive effort underway to identify and secure all the potentially live anthrax samples sent out from Dugway began May 22, when the private biotech firm in Maryland alerted the CDC Emergency Operations Center in Atlanta that it had a live sample of anthrax that was supposed to be dead. The Maryland company apparently did its own verification test on the specimen to ensure it was dead before working with it. In that test it was able to culture and grow live Bacillus anthracis, the anthrax bacterium. While nobody has been sickened from the specimens, 31 people who had potentially risky contact with them have been put on antibiotics as a precaution, the DOD has said.

Read USA TODAY's investigative coverage of safety and security issues at bioterror labs at biolabs.usatoday.com.

Follow USA TODAY investigative reporter Alison Young on Twitter: @alisonannyoung