R&D Magazine

GAO acknowledges lack of BSL oversight In an initial Oct. 4 Congressional hearing on biodefense lab construction and operation, the Government Accountability Office issued a preliminary report indicating a lack of central oversight of BSL-3 and -4 labs. In particular, BSL-3 labs have proliferated in the U.S., with estimates of such facilities ranging up to 1,400 nationwide. Nearly 500 of these are estimated to be academic labs registered to work with select agents, rather than government labs. There are 15 known BSL-4 labs in the U.S., counting some under construction. However, no single federal agency tracks biosafety lab construction or operation—a situation decried by watchdog groups such as the Sunshine Project.

The NIH/NIAID construction program of regional and national biosafety labs received particular scrutiny during the meeting. Sunshine Project director Edward Hammond contended that required biodefense work could be done with as little as 20% of the current BSL capacity, and said current oversight processes cannot keep up with all the planned construction.

Safety was cited as a driver of Congressional concern, especially in light of accidents at Texas A&M Univ. (where an accidental release of Brucella, not reported to the CDC, sickened an employee in 2006) and a 60-min power outage that affected Level-2 and -3 labs at the new CDC Building 18 facility in July. (Because the outage was localized rather than campuswide, the site’s backup power did not activate as planned; no injuries or infections have been reported, and the building’s BSL-4 lab is not yet operational and was thus unaffected.)

Accidental releases of foot-and-mouth pathogen from the Pirbright lab in Surrey, U.K., have also generated attention. In addition, hearing co-sponsor Jon Dingell (D-Mich.) expressed concern about the USDA’s proposed move of the Plum Island containment lab to a mainland facility (see July, page 1).

Legislators questioned why lab accident reports were reaching them through the Sunshine Project rather than the CDC; the agency responded that its inspectors depend on labs to be honest about reporting incidents. The CDC will undergo voluntary external review of the select agent program as well as an audit of select agent management practices by the Office of the Inspector General. The NIH also said it is setting up an intergovernmental task force to analyze biosafety lab operations and oversight.

The GAO’s report said the following goals should be top priorities in light of the recent incidents:
• Identify and overcome barriers to reporting accidents.
• Train lab staff for better safety protocols.
• Develop mechanisms for communicating with medical providers regarding select agents in use at labs in their areas.
• Address confusion regarding the definition of occupational exposure.
• Ensure that BSL-4 labs have safety and security measures commensurate with the level of risk.
• Maintain high-containment labs to ensure infrastructure integrity.

The GAO stopped short of recommending that a single federal body be assigned to oversee biodefense lab construction and operations. However, report author Keith Rhodes, chief technologist for the GAO’s Center for Technology and Engineering, acknowledged that “unwarranted expansion without oversight is proliferation, not expansion.” He concluded, “Since the full extent of the expansion is not known, it is unclear how the federal government can ensure that sufficient but not superfluous capacity—that brings with it additional, unnecessary risk—is being created.”

After additional hearings, the GAO intends to release a final report in February, followed by a comment period and final recommendations next spring.
For more: www.gao.gov/new.items/d08108t.pdf.