Introduction

Public, academic and private laboratories that work with deadly diseases have mistakenly transferred highly contagious viruses and bacteria to unsecure locations at least twenty-one times in the past 13 years, a frequency more than double what the officials overseeing such work previously said their data showed, according to a new Government Accountability Office report.

The map depicts sites that received anthrax samples from the Defense Department’s Dugway Proving Ground in Utah that officials there incorrectly thought had been inactivated. Government Accountability Office

In each case, the scientists and officials involved wrongly concluded that the deadly pathogens had been inactivated and thus were safe to transport elsewhere. One of the incidents, involving mistaken shipments by a Defense Department laboratory of live anthrax bacteria, attracted wide notice in 2015. But the GAO report said key government agencies have been slow to fix managerial and policy lapses that contributed to that event and might provoke additional errors.

No government-wide standards exist for ensuring that pathogens have been inactivated – either by chemicals, radiation, heat or filtration — prior to their shipment via public channels, the GAO report said. No firm requirements exist for reporting mistakes, a circumstance that means the real number of improper shipments could be even greater than 21. And no clear policies have been set on how lapses are to be punished.

The Departments of Health and Human Services and the U.S. Department of Agriculture, two of the principal oversight agencies, “do not know the extent to which incomplete inactivation occurs and whether incidents are being properly identified, analyzed, and addressed,” the GAO said.

The auditors’ report focused on the government’s Select Agents Program, which regulates the use of bacteria, toxins, and viruses – including anthrax, Ebola, Marburg, and others — that have the capacity to pose a severe threat to humans, livestock, and crops, because the pathogens are deadly and no treatments may be available. As of May, 286 research facilities around the country were enrolled in the program, which allows them to conduct scientific experiments with such pathogens in laboratories outfitted with special gear to ensure the materials cannot leak.

They are all obliged to inactivate the pathogens before removing them from these laboratories, and in fact useful scientific work frequently occurs with inactivated as well as live pathogens. But government oversight of these labs is notoriously weak; in 2013, the GAO called it fragmented and too reliant on self-policing.

In the new report, the auditors lamented that the government is still “without a national strategy” for ensuring that the associated risks are minimized, and also complained that no single person or governmental organization is responsible for fixing problems.

The principal message of the report, which was requested by the House Committee on Energy and Commerce and produced in consultation with the National Academy of Science and top biology experts, was that the government as a result lacks accurate knowledge of how often live pathogens have been wrongly circulated and why; it also is generally unaware of how inconsistently the rules have been enforced.

Top officials of the Select Agents Program, for example, told GAO 10 improper shipments had occurred since the beginning of 2004, mostly involving anthrax but also including equine encephalitis virus – an agent once used in the U.S. biowarfare program – as well as Ebola and botulinum toxin.

After the GAO dug more carefully through the program’s own records, as well as a separate database at the National Institutes of Health, however, it found evidence of another 11 improper shipments of live “select” pathogens as well as at least four improper shipments of pathogens formed through artificial (or “recombinant”) engineering of such pathogens, typically to produce vaccines. In two instances involving the “select” agent shipments – from a university and from a private laboratory – those involved refused to talk to the GAO’s auditors.

The auditors noted that additional mistaken shipments of dangerous – but less deadly – pathogens such as West Nile virus and a bacterium that causes tuberculosis might also have occurred, but that no requirement exists to report these to oversight authorities. Experts have said such reporting should be required, the GAO said.

“High-containment laboratories we visited did not consistently apply safeguards when conducting inactivation, and there is limited guidance on doing so,” the GAO report said. Even the Centers for Disease Control, which is supposed to help oversee such work, failed to properly inactivate a sample of the Ebola virus before moving it from a high-security lab to another one in December 2014, the report noted.

The potential for public harm is substantial. In the incidents involving the Defense Department, a military laboratory in Utah was discovered to have wrongly shipped live anthrax to dozens of labs and nine foreign countries. Those labs, in turn, sent the samples – which they believed were safe — to other locations, according to the GAO report. An Army investigation into the Dugway shipments revealed senior management “allowed a culture of complacency to flourish at the facility, resulting in laboratory personnel who did not always follow rules, regulations, and procedures.”

Even though pertinent rules call for fines of up to $500,000 and even criminal charges for safety breaches in the Select Agents Program, just one fine has been imposed for any of these shipments – a $150,000 penalty against a private lab in 2004, causing GAO investigators to raise a concern that federal labs are receiving more lenient treatment. “This…raises questions about the appearance of a lack of independence in the regulation of these laboratories,” the report said. It said some of the enforcement agencies could not supply documents justifying their decisions to forego penalties.

The auditors recommended establishing a formal tracking system for shipments of active pathogens, and a more reliable, uniform system for assuring diseases are inactivated before they’re shipped.

Officials involved in the Select Agent Program at the Department of Health and Human Services and the Agriculture Department said in written responses to the report that they concurred with these recommendations, and promised to issue new rules this year meant to ensure that pathogens are inactivated before they are shipped. The Defense Department said it had no comment but added that the report would “inform” efforts to improve oversight.