GAO report reiterates biolab oversight gaps

Mar 26, 2013 (CIDRAP News) – The United States still lacks a way to assess the need for high-containment laboratories and national standards for building and maintaining them, despite 2009 recommendations, according to a report yesterday from the Government Accountability Office (GAO).

Members of Congress asked the GAO to explore the issues, which come at a time when lab safety has come under scrutiny in light of controversies about dual-use research, especially that involving lab-modified H5N1 avian influenza viruses.

The report focuses on biosafety level 3 (BSL-3) and BSL-4 labs, which expanded in number after the 2001 anthrax attacks and growing federal support of research on potential bioterror threats and the medical countermeasure needed to contain them. In September 2009 the GAO issued a report noting that the United States lacked an oversight strategy that would periodically weigh the need for more labs.

GAO investigators in the earlier report also identified a lack of national standards for building, operating, and maintaining the labs, which they said raised concerns about the risk of lab safety incidents.

At the time, the GAO advised the Obama administration's National Security Advisor to identify a single agency to determine the number of high-containment labs needed to meet US biosecurity goals, along with the risks involved and oversight needed, and develop national standards for the labs.

Yesterday's report describes an investigation from February 2010 to December 2012 of the progress that federal officials have made since the 2009 GAO recommendations.

The GAO's investigation found that the national security staff considered the recommendations, but determined that appointing a single oversight entity "was not in the best interests of national security to allocate resources that way," according to the report. Security advisors urged the GAO to direct additional questions about high-containment labs to the president's Office of Science and Technology Policy (OSTP).

Though OSTP officials opposed a single oversight entity as potentially too broad and cumbersome, they agreed that periodic assessments were needed to gauge national biodefense research needs, including high-containment labs. Also, OSTP officials told the GAO they had taken some steps to examine the need for national lab standards.

The GAO concluded that the need for high-containment labs is still unknown, but the knowledge gap is more critical than ever, given the need to make priority decisions against the backdrop of current budget constraints.

Regarding the need of national lab standards, the GAO said the guidance would be helpful for ensuring that upgrades and new construction meet minimum safety standards, but it wouldn't specify a "one-size-fits-all" approach.

In its recommendations, the GAO urged the OSTP to periodically assess biodefense research and development needs, including whether the nation has the high-containment lab capacity to meet the demands. It also advised the OSTP to explore the need to establish national standards for the labs.

The OSTP, in its written feedback on the latest GAO findings, agreed with the recommendations but disagreed on two technical issues. It disagreed with the GAO's assessment that the number of high-containment labs has expanded. The GAO said it based its estimate on the number of labs registered with the Federal Select Agent program, a list that is incomplete but reflects the most credible source.

Also, the OSTP disagreed that expansion of the labs has increased the overall risk. The GAO noted that even when the number of lab accidents is small, each lab's risk adds to the overall risk of an accident happening nationwide. "As laboratories operate independently, the risk is not increased for each laboratory. The risk at each laboratory leads to an overall increased risk with expansion," the investigators wrote.

UTMB lab reports missing vial
In a related development, a BSL-4 lab located at the University of Texas Medical Branch (UTMB) in Galveston announced on Mar 23 that it could not account for a vial containing a select agent. The statement from UTMB President David Callender said a vial containing about a quarter of a teaspoon of Guanarito virus had been stored in a locked freezer in a facility designed to handle the material safety.

He said the virus poses little public health threat, because it is not known to spread between humans and so far is known only to infect rodents and cause hemorrhagic fever in a limited area of Venezuela, where it is found.

The incident is the first time a select agent has gone missing at the UTMB lab, and officials notified the Centers for Disease Control and Prevention (CDC) immediately and launched activities to protect researchers, employees, and the community, Callender said.

An ongoing investigation so far suggests that the vial was probably destroyed during normal laboratory sterilization procedures, according to the statement.

See also:

Mar 25 GAO report on high-containment laboratory assessment

Mar 23 Galveston National Laboratory statement

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