USA TODAY International Edition
Labs cited for lax security in bioterror germ research
Federal officials are concerned a lab insider could unleash a pathogen on the public
Amid concerns about the potential of a laboratory insider unleashing a deadly bioterror pathogen on the public, President Obama ordered greater scrutiny of workers with access to the riskiest microbes five years ago. The goal was to prevent something like the 2001 anthrax letter attacks — or worse — from happening again.
But not all labs are taking required actions.
In the past two years, federal regulators have secretly threatened to revoke permits to study bioterror pathogens from at least six labs — including those operated by Brigham Young University in Utah, the University of HawaiiManoa and the California Department of Public Health — because they failed to take required actions to assess the be- havior and trustworthiness of their workers, plus other kinds of safety violations, records obtained by USA TODAY show.
In a letter to Brigham Young University, regulators said last year that they had “significant concerns” whether its lab staff could work with potential bioterror pathogens “in a manner which does not endanger public health and safety.” California’s Health Department lab in Richmond allowed unapproved staff to have key cards that let them into restricted areas and “failed to address safety issues over the course of the last four years,” regulators told the lab.
The University of Hawaii- Manoa was called out by regulators, in another letter the government and the university tried to keep secret, for “widespread regulatory non- compliance” and “a serious disregard” for regulations for security, biosafety, incident response and training. Issues
“It is clear that this system is not working.” Leaders of the House Energy and Commerce Committee
included failures to implement suitability assessments of key lab staff, installing a security system but not making it operational, and having lab staff that didn’t understand how to use respiratory protection needed to prevent exposure to infectious agents.
Officials at the three sanctioned labs that USA TODAY was able to identify refused to be interviewed but said in emails that the cited violations have been corrected. Brigham Young officials said their lab’s security violations involved administrative and paperwork issues. USA TODAY is working to identify the other three labs, whose names were removed from letters federal lab regulators released under the Freedom of Information Act.
How significant the security violations are is unclear because so much of the oversight of labs working with “select agents” — the government’s term for potential bioterror pathogens such as those that cause anthrax, plague and botulism — is cloaked in secrecy. Lab regulators at the Centers for Disease Control and Prevention refused to answer questions.
The Federal Select Agent Program, jointly run by the CDC and the U. S. Department of Agriculture, refused to release the names of more than 100 labs that have faced enforcement actions for a wide range of safety violations since 2003.
The lack of public information makes it difficult to gauge the risks posed by the violations and whether federal inspectors are focusing on issues that have a real impact on improving safety and security, said biosecurity experts and policymakers.
The bipartisan leaders of the House Energy and Commerce Committee, which has held two hearings on lab safety and oversight in the past year, said they are continuing their investigation to find root causes and solutions to serious safety incidents at U. S. research facilities. Among the high- profile blunders was the discovery this spring that an Army biodefense lab had been mistakenly shipping hundreds of live anthrax specimens — that it told recipients had been killed — for more than a decade, despite inspections by federal regulators.
The problems continued undetected despite regulators previously citing the lab in 2007 for failing to properly kill anthrax.
“After repeated, inexcusable blunders with anthrax, smallpox and other dangerous pathogens, it is clear that this system is not working,” said committee chairman Rep. Fred Upton, R- Mich., and Rep. Frank Pallone of New Jersey, the committee’s ranking Democrat, in a statement to USA TODAY.
A CDC inspection report released to USA TODAY by the California Department of Public Health — the only one of the three sanctioned labs willing to release any inspection records — provides a rare glimpse into what lab regulators examine and cite during their visits. Though some violations involved potential safety issues, many of the violations cited at the Richmond, Calif., lab appear to involve missing language in policy manuals found during paperwork reviews.
Less emphasis should be placed on the paperwork and more on actions that assess and improve safety cultures, some lab experts said.
“Sure, we need regulations and oversight,” said David Franz, a former commander of the U. S. Army Medical Research Institute of Infectious Diseases in Maryland. “But safety and security are not enhanced by nit- picking bureaucratic policy manual reviews, arbitrary interpretation of regs and agonizingly slow communication with the labs.”
Lab regulators at the CDC are in the midst of a 90- day review of how the agency regulates safety and security at hundreds of public, private and government labs working with select agent pathogens.
The review was launched in July in the wake of the USA TODAY Media Network’s ongoing investigation that has revealed government inspectors allowing labs to keep experimenting despite failing to meet key requirements on inspection after inspection.
Lab regulators at the USDA are doing a similar review of their part of oversight program. It was launched in June, a spokeswoman said Thursday.
CDC officials declined to be interviewed or to answer questions about their enforcement of the enhanced security regulations, many of which took effect in April 2013 and require initial and ongoing “suitability” assessments of lab workers with access to Tier 1 select agents. This group of pathogens is deemed by the government to pose the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating economic effects.
It includes the bacteria that cause anthrax, botulism and plague, the Ebola virus and several other agents.
The regulations require a variety of security enhancements, including evaluating unusual behaviors, incidents or life changes among lab workers in ways that go beyond FBI background checks. They stem from an executive order signed by President Obama in 2010.
The Federal Select Agent Program cites the anthrax letter attacks in October 2001 — which the FBI says were the result of an Army microbiologist — as an example of how deadly and costly the misuse of a pathogen by a lab “insider” can be.
Five people were killed and 17 others sickened. The contamination caused by the anthrax letters disrupted businesses and closed parts of government, costing more than $ 23 million to decontaminate one Senate building, according to a guidance document on the suitability regulations.
The Postal Service lost about $ 2 billion in revenue, and there was up to $ 3 billion in added costs to the Postal Service for decontamination and getting mailsanitizing equipment.
“Safety and security are not enhanced by nit- picking bureaucratic policy manual reviews.” David Franz, a former commander of the U. S. Army Medical Research Institute of Infectious Diseases