The U.S. Army Medical Research and Materiel Command (USAMRMC) plans to construct and operate a new Medical Countermeasures Test and Evaluation (MCMT&E) facility at Fort Detrick in Frederick, Maryland. The proposed site of the 492,000-square-foot facility is on the north side of the fort’s National Interagency Biodefense Campus.1 The facility will be designed to handle infectious agents that are considered Category A and Category B under the Centers for Disease Control and Prevention schedules and that require safety precautions to the extent of animal biosafety level-3 (ABSL-3) and ABSL-4 and biosafety level-3 (BSL-3) and BSL-4. Researchers at the facility will develop new vaccines and drugs against such pathogens as Ebola virus and Bacillus anthracis. The laboratories will be equipped to support nonhuman primate studies and have modern aerobiology and telemetry (remote monitoring) capabilities. Research with rodents will also be conducted.
An environmental impact statement (EIS) is currently being developed by an Army contractor for the MCMT&E facility. EISs are documents required under the National Environmental Policy Act (NEPA) of 1969 to identify and characterize the probable environmental impacts from programs and actions of the federal government. Human health effects are one of the many impacts considered in EISs. Agencies with biocontainment laboratories have struggled with approaches to conducting risk assessments, particularly because there is no generalizable framework that can be applied to assessing the specific risks from such laboratories. Recent reviews conducted by the National Research Council (NRC) of risk assessments performed to support the construction of biocontainment facilities have identified weaknesses in both the process and technical content of the assessments by other agencies and provide guidance for improvements (NRC 2007, 2008, 2010a,b,c,d).
In 2010, an NRC committee evaluated the health and safety risks of another Fort Detrick facility with high-containment laboratories—the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The evaluation included a review of a health hazard assessment for the new biocontainment laboratories, as well as procedures and regulations for their operation. The committee found that USAMRIID’s hazard assessment failed to provide adequate and credible technical analyses of the potential health risks to the general public. The Army was advised to improve its risk-assessment practices for infectious agents in future EIS processes and products (NRC 2010a). Thus, to support the EIS being developed for the new MCMT&E facility, the Army requested a review of its site-specific risk-assessment (SSRA) plans for the MCMT&E facility.
The committee was tasked with reviewing and providing technical input to the EIS being prepared for the MCMT&E facility. Technical input could include, but not be limited to, a review of the proposed work plan for preparing risk assessments, as well as information on the selection of pathogen agents, scenarios, and models to be used in the risk assessments. If the preliminary model results for the quantitative risk assessment and the qualitative assessments were available, they would be reviewed. The committee was not asked to perform an independent evaluation of the safety of the MCMT&E facility or the EIS as a whole but was asked to restrict its findings to assessing the adequacy and validity of the proposed risk-assessment methodology and the draft results of any assessment to be incorporated into the EIS. The committee’s full Statement of Task is provided in Attachment A.
The Army requested that the former NRC committee that performed the USAMRIID review be reconvened to the extent possible to review plans for the risk assessment of the MCMT&E facility. Five
Other facilities that comprise the National Interagency Biodefense Campus include the U.S. Army Medical Research Institute of Infectious Diseases, the Department of Homeland Security’s National Biodefense Analysis and Countermeasures Center, and the National Institute of Allergy and Infectious Diseases’ Integrated Research Facility.