NRC seeks detailed risk assessment for Army biodefense lab

May 2, 2011 (CIDRAP News) – The National Research Council (NRC), in a letter report, has advised the US Army to prepare a more comprehensive risk assessment than it initially proposed for a biodefense laboratory to be built at Ft. Detrick in Frederick, Md.

The lab, called the Medical Countermeasures Test and Evaluation (MCMT&E) Facility, will work on new vaccines and drugs against such diseases as anthrax, Ebola and Marburg fever, tularemia, and plague, according to the report.

The lab is to be built by the Army Medical Research and Materiel Command and will cover 492,000 square feet on the north side of the National Interagency Biodefense Campus. That installation also includes the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and other facilities.

The Army had asked the NRC to review its plan for preparing a site-specific risk assessment (SSRA), according to the report. That step came in response to the NRC's critique last year of the Army's health-hazard assessment for high-containment labs planned by USAMRIID. An NRC committee found that USAMRIID's assessment failed to provide an "adequate and credible" analysis of risks to the public.

In response to the Army's request for guidance, an NRC committee was assigned to review the Army's proposed approach for preparing a risk assessment for the countermeasures lab and any draft results of the assessment, but not to evaluate independently the safety of the facility itself.

The eight-member NRC committee, chaired by Charles N. Haas, PhD, includes five members who served on the committee that criticized USAMRIID's hazard assessment last year.

The Army and project contractors described the MCMT&E project and its risk-assessment plan at a meeting with the NRC panel Mar 21 and 22. But the panel subsequently decided that the information presented by the Army at the meeting was not comprehensive enough to constitute a formal work plan for the assessment.

"In the absence of a formal work plan and preliminary facility designs, it was difficult to assess whether the Army contractor's approach will result in a comprehensive and credible SSRA," the report says. "Therefore, the committee has approached its task by describing significant critical elements that are important for executing a successful SSRA."

According to the report, the Army said its assessment would address eight organisms and types of organisms—Bacillus anthracis, Ebola virus, Marburg virus, Francisella tularensis, Brucella, three types of arbovirus, and Yersinia pestis—but did not explain the rationale for choosing them. The NRC panel said that more than 20 other agents, plus other emerging pathogens, may be tested in the future, so the risk assessment will need to specify the strategy used to pick representative agents.

The report also says the MCMT&E lab is intended to serve outside organizations, "such as pharmaceutical companies, on a fee-for-service basis, so it is likely that it will be asked to undertake activities not envisioned during the scoping process. Because such activities might alter the risk associated with the facility, the Army should describe, up front, the threshold of change in operations that would trigger the need to conduct a supplemental EIS [environmental impact statement] and risk assessment."

In other comments, the NRC panel recommended that the Army contractor prepare probabilistic safety analyses for a wide variety of events, including natural disasters, sabotage, loss of key utilities, and aircraft crashes, that could cause facility failures.

"Recent natural events, such as the earthquake in Japan followed by a tsunami, highlight the importance of identifying potential catastrophic failures that can result in large-population, infrastructure, and economic impacts," the report states.

See also:

National Academies Press page offering access to NRC letter report

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