House committee airs safety concerns about biodefense labs

Oct 4, 2007 (CIDRAP News) – A US House of Representatives committee today explored problems at the nation's biodefense labs, including a lack of coordinated federal oversight and even a lack of knowledge of how many high-containment labs exist.

These concerns have been highlighted recently by aggressive efforts from the Sunshine Project, a watchdog group that monitors biodefense research safety, and by other media reports.

During the hearing, witnesses from the Government Accountability Office (GAO) released a preliminary report on oversight of new biosafety level (BSL) 3 and BSL 4 laboratories in the United States that includes several steps officials should take to address the problem. The hearing was available on a live Webcast.

Rep Bart Stupak, D-Mich., who led the hearing, said today's session was the first of a series of committee hearings on the subject, which will include biosafety at labs outside of the United States and the proposed closure of the BSL 4 facility at Plum Island, N.Y. He said that he hoped for input from the Department of Homeland Security, but that it had declined a request to appear at today's hearing.

In his opening statement, Stupak said it has become clear that no single federal agency is responsible for ensuring the security of the nation's high-containment labs. "No one in federal government knows how many there are, what research is going on in them, or how safe and secure they are," he said.

The rising number of BSL 3 and BSL 4 labs in the United States is unprecedented, he said, pointing out that the National Institutes of Health (NIH) has allocated $1 billion toward the construction of new BSL 3 and BSL 4 labs in the past few years.

"We need to assess the need before writing the checks to build them," Stupak said.

Rep Joe Barton, R-Tex., reminded the committee that, despite apparent gaps in federal oversight, it should keep in mind that the biodefense work is critical to the nation's health and security.

GAO releases preliminary findings
Testifying on behalf of the GAO, Keith Rhodes, PhD, chief technologist for the office's Center for Technology and Engineering, said because a baseline of human error will always be present in laboratory settings, the level of safety risks will rise as the number of labs increases. Since the 9/11 terrorist attacks, the number of BSL 4 labs has risen from 5 to 15, he said. The GAO estimated in its report that there are nearly 1,400 BSL 3 labs in the United States.

Of 12 agencies the GAO surveyed, none is responsible for tracking the number of BSL 3 and BSL 4 labs in the United States. "Consequently, no agency is responsible for determining the risks associated with the proliferation of these labs," the GAO report states.

Rep Michael Burgess, R-Tex., countered that it might be necessary to undertake some greater risks to gain greater national security in the form of better vaccines and countermeasures against bioterrorist attacks. "But are we doing a good job of managing that risk?" he asked.

Rhodes said even some federal entities, particularly the Federal Bureau of Investigation (FBI) and intelligence agencies, have voiced concerns about the rapid expansion of biosafety labs. He pointed out that the FBI, for example, has said its workload has ballooned because it must do security checks on employees working at the high-containment labs, which takes time away from their other investigative duties.

Though the GAO's report was preliminary, Rhodes said GAO investigators have already identified six lessons, based on recent lab incidents in the United States, as well as at the Pirbright facility in the United Kingdom, which is thought to have triggered recent foot-and-mouth disease outbreaks. Health officials need to:

  • identify and overcome barriers to reporting lab accidents
  • improve the training of lab staff to ensure safety measures are followed
  • inform medical providers about the agents that lab staff work with to ensure quick diagnosis and treatment
  • clarify what constitutes an occupational exposure
  • ensure that BSL 4 labs have safety and security measures that reflect the level of risk they present
  • maintain the long-term physical integrity of high-containment labs

Some legislators asked why reports of laboratory accidents, such as the employee at Texas A&M University who was sickened by Brucella, came about through the efforts of the Sunshine Project, a nonprofit group based in Austin, Tex., rather than through Centers for Disease Control and Prevention (CDC) inspectors.

Sushil Sharma, PhD, the GAO's assistant director of applied research and methods, said the CDC inspectors depend on documentation and on people honestly reporting lab incidents.

Rhodes said the GAO would release a report detailing its recommendations in February, solicit comments from the public in March, and issue final recommendations in May.

CDC and NIH respond
Legislators had several questions about CDC's laboratory inspection protocols. Richard Besser, MD, who directs the CDC's office for terrorism preparedness and emergency response, said the labs are inspected every 3 years and more frequently if the facility changes the select agents it works with.

Besser said public concerns and questions about the labs were understandable and legitimate. "Just because there hasn't been a threat to the public, doesn't mean that an incident couldn't happen in the future," he said, adding that the CDC realizes it needs to improve inspections by interviewing more people at the labs, reviewing a broader range of documents, and releasing more outreach and training documents for labs.

The CDC has ordered an external review of its select agent program, and an audit of the CDC's select agent management practices by the Office of the Inspector General should be completed in 2008, Besser told the group.

Representing the National Institutes of Health (NIH) on the witness stand, Hugh Auchincloss, MD, deputy director of National Institute of Allergy and Infectious Diseases (NIAID), said the labs it funds are expected to follow good laboratory practices described in the Biosafety in Microbiological and Biomedical Laboratories manual , and that the agency monitors the work of local institutional biosafety committees (IBCs) that oversee recombinant DNA work in the labs, though he said there is no federal body that sets standards for IBCs.

He said the NIH is looking at several ways to strengthen its oversight of the labs and has set up an intergovernmental task force to analyze he current situation and develop recommendations for improving oversight.

A need for clarity and no-fault reporting
Texas A&M interim president Ed Davis, PhD, appeared on the stand to field questions about the lab accidents involving Brucella and Coxiella burnetti that were revealed in April by the Sunshine Project.

Davis said the university failed to report the Brucella incident in a timely manner and is taking the lab safety issues very seriously. However, he said episodes have exposed complex lab management issues. "There's a gap between understanding at the research compliance office and labs," he said, adding that clearer federal guidance is needed on what constitutes an occupational pathogen exposure.

Rep Burgess, along with Davis and other witnesses, said a no-fault reporting system, whereby laboratory employees and managers aren't penalized for reporting lab incidents, could improve lab safety.

"This would create a culture of not tolerating safety lapses and would allow employees, in a collaborative fashion, to learn from mistakes," Burgess said, pointing out that no-fault safety incident reporting has been successful in the federal aviation and aeronautics work environments.

Sunshine Project makes its case
Edward Hammond, director of the Sunshine Project, said the CDC has denied several of the group's freedom-of-information requests relating to lab safety issues. The Sunshine Project's goal, he said, is more government transparency, which he says would provide important benefits.

"There's a positive correlation between transparency and compliance and reporting," Hammond said, adding that the group's revelations about the lab incidents at Texas A&M have prompted a spike in reports from other labs to the CDC.

Legislators asked several of the witnesses if the federal government had ever assessed how many biosecurity labs were needed to conduct work toward its bioterror countermeasure development goals, but it was unclear if numbers were ever projected.

Hammond contended that the necessary government projects could be done—and the nation would be safer—with one fifth of the current biosafety lab capacity.

"Our system can't absorb all of the labs coming online," he said.

See also:

Oct 4 GAO preliminary report on high containment biosafety laboratories
http://www.gao.gov/new.items/d08108t.pdf

Sep 19 CIDRAP News story "Biosafety lapses reported at 3 more Texas labs"

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