Army lab lacked effective anthrax-killing procedures for 10 years

Alison Young | USA TODAY

The U.S. Army research facility that has mistakenly shipped live anthrax to unsuspecting labs in the U.S. and abroad for more than 10 years failed to have effective and standardized procedures for killing the deadly bacteria with radiation, according to a federal investigation report obtained by USA TODAY.

The report, dated June 5, cites 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.

According to the report by lab inspectors at the Centers for Disease Control and Prevention, Dugway scientists were using Cobalt 60 gamma radiation to kill or deactivate anthrax specimens before shipping them to government or private labs for further research.

But Dugway's standard procedures for irradiating anthrax "did not account for the variable amounts of spores treated in the gamma cell irradiator," the report noted. The method used "was not validated using standardized control spore samples at varying concentrations, volumes, and levels of irradiation."

As a result, anthrax bacteria were shipped out at least 74 times to dozens of labs in the U.S. and at least five foreign countries from January 2005 to May 2015. Anthrax spores can be potentially fatal if inhaled. So far, there have been no reports of infections from the Dugway mistakes, but 31 people who worked with the specimens have been put on antibiotics as a precaution.

The military declined to comment on the findings of the report. "We are conducting an investigation of this matter, and the CDC report is a component of that investigation," said Army Col. Steve Warren, a Pentagon spokesman.

A spokesperson for the CDC's Division of Select Agents and Toxins, which authored the report and regulates labs working with potential bioterror pathogens, said the agency had shared its report with the military but had no further comment.

USA TODAY reported last week that the Dugway Proving Ground faced potential sanctions in 2007 after federal lab regulators learned the facility had used a different kind of "experimental" chemical method of killing anthrax specimens that was ineffective and resulted in the unauthorized transfer of live anthrax bacteria to another facility. CDC investigators in that case found that Dugway staff apparently ignored the results of their own kill-confirmation tests that showed growth of bacteria after this chemical inactivation was done — yet shipped the specimen anyway. It's unclear why CDC investigators didn't identify problems with Dugway's irradiation procedures at that time.

The Department of Defense has refused for weeks to answer USA TODAY's repeated questions about the anthrax irradiation and kill-verification protocols used at Dugway and whether other military labs may also have failed to fully kill anthrax before shipping specimens.

The new CDC report about Dugway's anthrax mishaps, which is only three pages long, provides little detail about radiation dosages and durations, and exactly how Dugway's scientists were verifying that each batch was fully killed. The report addresses the problems in general terms.

But other military documents reviewed by USA TODAY indicate that some Army researchers had previously identified problems with the military's anthrax irradiation and kill-verification procedures.

More than seven years ago, the nation's most infamous anthrax researcher warned military colleagues that a common way of verifying that the deadly bacteria had been killed with radiation wasn't trustworthy enough to know specimens were safe for shipment.

The emails from accused anthrax letter terrorist Bruce Ivins — a microbiologist at the Army's elite infectious disease laboratory in Fort Detrick, Md. — offer possible clues about what may have happened at Dugway.

Emails sent by Ivins during the normal course of his work with anthrax at the U.S. Army Medical Research Institute of Infectious Diseases, often called USAMRIID, provide a window into the difficulties scientists face killing the bacterium and its hardy spores. They also indicate that scientists did not follow a universal, standardized protocol for what percentage of anthrax specimens in an irradiated batch needed to undergo verification tests before the batch was considered sterile and safe for shipment and use without significant safety precautions.

The emails are among a massive trove of Ivins' correspondence released in 2010 and posted online in a Freedom of Information Act reading room of the U.S. Army Medical Research and Materiel Command after federal officials formally closed their investigation into the 2001 anthrax attacks. Ivins, 62, died from an intentional overdose of acetaminophen in July 2008 as prosecutors prepared to charge him with sending the anthrax-filled letters that killed five and sickened 17 others.

In a March 2008 email about the planned shipment of some irradiated anthrax spores, Ivins references a recent division meeting and wrote: "As discussed at the meeting, 50% (5 ml) of the material was checked for sterility on SBA, and there was no growth at all. You may have seen [redacted] insistence that we need only check 10% of the material for sterility, but I think that a 50% check for B. anthracis samples is a good idea. We've had in the past some samples that failed sterility checks, so 50% leaves us 'better safe than sorry.' "

The email indicates that to verify that the irradiated spores were killed, samples were being put on a sheep blood agar plate to see if the bacteria would grow.

It is unclear whom Ivins was writing to in the email or where the specimens were going to be sent. The Army has redacted all other names, including that of the person or organization Ivins said was advocating only testing 10% of the irradiated samples. Over the years, Ivins' emails show he did work with anthrax researchers at Dugway Proving Ground and that USAMRIID had an anthrax spore production contract with Dugway.

In 2006 and early 2007, Ivins' emails indicate that he did verification tests only on 10% of irradiated anthrax specimens. "The spores were irradiated on October 30. On November 2, [redacted] plated out 10% of each of the preps onto SBA plates. All were negative for growth 24 hours later. They will be incubated over the weekend," Ivins wrote in a Nov. 3, 2006, email.

By the summer of 2007, however, Ivins and his colleagues ran into a concerning series of irradiation failures, the emails show.

"The 27 spore samples that were irradiated on 30 MAY 07 (see enclosed file) came back still 'hot,' " Ivins wrote in a June 7, 2007, email sent to eight other people whose names are redacted. The specimens, he wrote, would be sent back for another irradiation dose of 1 million rads "which should kill the remaining viable spores." Emails in the string show the May irradiation dose was 5 megarads.

But Ivins had bad news to report on June 13, 2007: "Irradiation sterilization failure … again," said the subject line of his email, which said that even with the additional radiation dose, the spores could still grow. His email said that verification tests were done on 18 of the 27 samples — and 12 of the 18 were still "hot." And so they were again going to be sent back to receive an additional 2 megarads of radiation. "Hopefully this will work. Stay tuned … - bruce," wrote Ivins

An unidentified recipient of the email replied: "What is going on with the irradiator? Is it not working properly? These things are going to be fried to a crisp!"

Ivins was puzzled, too. "In the past, 4 megarads would do the job. This is 2 million rads over that, and still no sterility," he replied.

The next morning, June 14, 2007, Ivins emailed with more bad news: "After recheck of the 6 samples that appeared to pass sterility check after a total of 6 million rads, only two samples remained negative." The other four, it turned out, weren't dead and needed more radiation, he wrote.

It's unclear what may have caused the repeated irradiation failures. Issues relating to irradiation are again mentioned in the publicly available emails in August 2007, when an unidentified person wrote to Ivins asking for the paperwork on the 27 spore samples. In his reply, Ivins wrote that "several rounds of irradiation had to be done to finally get all of the spores sterile. It seems as though the new irradiator isn't as reliable as the old one for some reason."

Military officials didn't answer USA TODAY's questions about the radiation doses used at the Dugway Proving Ground lab, which is the focus of the current international investigation of live anthrax shipments. They also didn't answer questions about what percentage of anthrax specimens in each irradiated batch were undergoing verification tests for sterility at Dugway. They did, however, email a statement on Wednesday about Ivins' emails detailing the 2007 irradiation failures:

"It is clear from these emails that the investigators did their due diligence to determine what was causing the failure and that no live material was used in the lab or sent to other labs," said the statement emailed by Maj. Eric Badger, a Defense Department spokesman. As part of the department's comprehensive review of Dugway's mishaps, investigators are "examining, among other things, the failure rates of gamma irradiation for killing anthrax."

For complete coverage of USA TODAY's ongoing investigation of safety and security issues at high-containment laboratories, go to: biolabs.usatoday.com

Follow USA TODAY investigative reporter Alison Young: @alisonannyoung