This letter report reviews a work plan for conducting a site-specific risk assessment (SSRA) for the Army’s Medical Countermeasures Test and Evaluation (MCMT&E) facility at Fort Detrick in Frederick, Maryland. The development of the work plan was informed by findings and recommendations made by this committee (see Attachment A for roster and biographies) in a letter report issued in May 2011, who commented on proposed approaches for conducting the SSRA (NRC 2011a). The following background on the request for these reviews is excerpted from the committee’s first letter report.
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 human health 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 USAMRIID laboratories, as well as procedures and regulations for their operation. The committee found that the 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.
CHARGE TO THE COMMITTEE AND ITS APPROACH
The committee was tasked with reviewing and providing technical input to a new environmental impact statement (EIS) to be prepared for the Medical Countermeasures Test and Evaluation (MCMT&E)
1 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.