The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) is expanding and renovating existing research facilities in Frederick, Maryland. These facilities are and will be designed to handle infectious agents that are considered Category A and Category B under the Centers for Disease Control and Prevention (CDC) schedules, and that require safety precautions to the extent of biosafety level (BSL)-3 and BSL-4 (see Chapter 2). The new USAMRIID will be part of the National Interagency Biodefense Campus, which includes the Department of Homeland Security’s National Biodefense Analysis and Countermeasures Center and the National Institute of Allergy and Infectious Diseases’ Integrated Research Facility. These two other facilities also will house BSL-3 and BSL-4 laboratories.
As part of the decision process for the USAMRIID expansion, the Army prepared an Environmental Impact Statement (EIS). The Record of Decision to construct and operate new USAMRIID facilities was issued in February 2007. However, residents of Frederick County have questioned whether the potential public health and safety risks and strategies to mitigate those risks were adequately considered in the decision to go forward with the expansion. To address these concerns, Congress directed the Secretary of Defense to commission an independent review by the National Research Council of certain aspects of the EIS relating to risks from work with infectious agents (P.L. 110-329). The specific scope of the study is delineated below:
The National Research Council will convene a committee of experts to evaluate the scientific adequacy and credibility of the analyses of health and safety risks associated with exposure to pathogen research in the proposed new USAMRIID high-containment labs as presented in the Final Environmental Impact Statement, Construction and Operation of New USAMRIID Facilities and Decommissioning and Demolition or Re-use of Existing USAMRIID Facilities at Fort Detrick, Maryland. The committee will also evaluate the proposed strategies to mitigate those risks as they are presented
in the EIS. In addition, the committee will examine the current procedures and regulations in use by USAMRIID to reduce exposure to pathogens and evaluate whether these procedures and regulations are comparable to those in place at other similar facilities and whether they meet accepted standards under the National Institutes of Health (NIH), CDC, and other rules and guidance. These procedures will include measures for handling/containing pathogens during use, storage and inventorying of pathogens, procedures laboratory workers follow for treating and disposing of laboratory solid waste within USAMRIID, and handling contaminated waste water. The focus of the study is on the safety of both the general public and the laboratory workers, and for this reason USAMRIID’s records on laboratory acquired infections will also be considered, as will the measures being taken for ensuring the prevention and mitigation of risks to the health and safety of workers and the public.
This committee was formed to develop findings with respect to the charge. The committee comprised individuals with expertise in biosafety, infectious diseases, industrial hygiene, environmental engineering, risk assessment, epidemiology, and stakeholder participation. This report presents the consensus findings of the committee.
It is clear that the impetus for this project was the Frederick County residents, who are concerned about risks to their health from the research that will be conducted at the new USAMRIID facility. The only readily available documentation regarding potential health risks has been the EIS. EISs are documents required under the National Environmental Policy Act (NEPA) of 1969 to identify probable environmental impacts from programs and actions of the Federal Government. They are required to provide full and fair discussion of significant environmental impacts and consider reasonable alternatives that would avoid or otherwise minimize adverse environmental impacts or enhance the quality of the human environment. The categories of impacts are mainly determined by federal statutes, such as those governing air quality and water quality, which require that a particular environmental impact be considered.
NEPA grew from public concern that federally funded projects were causing significant harm and destruction to the environment and human health without any regulation. The language of the Act (Section 101 [42 U.S. Code § 4331]) definitively states that its purpose includes the need:
“[to] assure for all Americans safe, healthful, productive, and aesthetically and culturally pleasing surroundings” (emphasis added)
“[to] attain the widest range of beneficial uses of the environment without degradation, risk to health or safety, or other undesirable and unintended consequences” (emphasis added).
NEPA (Section 1508.14) requires that EISs are developed to support major federal actions that significantly affect the quality of the human environment, with “human environment” to include “the natural and physical environment and the relationship of people with that environment.” However, NEPA has no specific provisions for how EISs should consider human health effects, especially how to consider impacts that are not governed by strong regulations. This is due largely to the breadth of projects that must undergo the EIS process before beginning. Thus, consideration of direct impacts on human health in EISs has been fairly sparse (Steinemann 2000; Cole et al. 2004; Bhatia and Wernham 2008). Federal agencies have their own sets of requirements and guidelines for preparing these statements, and the level of detail and topics in these guidelines varies greatly from agency to agency.
The U.S. Army NEPA Regulations handbook (32 Code of Federal Regulations [CFR] 651), describes NEPA’s background, details the actions requiring analysis, and provides guidelines for formatting the EIS and obtaining public involvement. The handbook contains little specific information regarding the actual content of the EIS reports. Appendix E of the handbook covers “Content of the Environmental Impact Statement,” but there is no explicit mention of human health impacts.
In contrast, the U.S. Department of Energy’s (DOE) recommendations for the preparation of EISs contain some of the most detailed explanations and guidelines for discussing human health impacts in an EIS. Although DOE’s recommendations for analyzing human health effects are limited to exposure to radiation and chemicals, they also are relevant to pathogen exposures. Excerpts of DOE’s recommendations are provided in Box 1-1. An important theme of the DOE guidance is that the EIS’s consideration of human health effects should involve “realistic scenarios,” “realistic exposure conditions,” and “reasonably foreseeable accidents.”
The committee held two public meetings to gather information to address its task. At the first meeting, held September 22, 2009, in Frederick, Maryland, the committee met with USAMRIID staff and contractors to obtain background on the EIS, learn about the plans for the new biocontainment facilities, get an overview of the procedures and regulations currently in place to reduce exposure to pathogens, and learn about the history of laboratory-acquired infections at USAMRIID. The committee also heard from representatives of the Frederick County Board of Commissioners and from interested members of the general
Excerpts from DOE (2004) Recommendations for Analyzing Human Health Impacts in EISs
public. At the second meeting, held November 5, 2009, in Washington, D.C., the committee met with the Commander of USAMRIID to learn about the institute’s biosurety plans for its facilities and personnel, and with the Fort Detrick Fire Chief and Emergency Manager to be briefed on emergency response coordination with Frederick County. The committee also was briefed on the agreements between the Barquist Army Health Clinic and Frederick Memorial Hospital. In addition, the committee met with the medical and security staff of Frederick Memorial Hospital, officials from Frederick County’s emergency management and health departments, and representatives from the community.
The committee reviewed numerous documents and testimony, which included the final EIS, supporting information provided by USAMRIID and its contractors, comments from members of the public (including a DVD of the proceedings of open hearings held by the Frederick County Commissioners), and the scientific literature. The committee focused its assessment on material relevant to assessing potential human health risks and available strategies for preventing or mitigating accidental exposures to pathogens. Such materials included Army regulations, USAMRIID operating procedures, operating guidelines from CDC and NIH, guidelines from the Department of Defense and other agencies regarding biological safety and security, and information on laboratory-acquired infections at USAMRIID and other biosafety laboratories. The information was evaluated in the context of whether appropriate and credible consideration was given to human health risks and whether strategies are in place to prevent and mitigate potential exposures from pathogen research and the spread of disease in the event that an exposure or illness occurs.
ORGANIZATION OF THE REPORT
The committee decided to organize its evaluation by first providing some context for its review of the EIS. Chapter 2 provides an overview of the guidelines, procedures, and regulations that govern the operations of USAMRIID to see if they meet acceptable standards under guidance from NIH, CDC, and other relevant agencies. Chapter 3 summarizes plans for medical and emergency management response to address any incidents that could occur at USAMRIID, possibly involving partnerships with Frederick County and Frederick Memorial Hospital. A review of the EIS is provided in Chapter 4, with a focus on the scientific adequacy and credibility of the analyses of health and safety risks associated with pathogen research. Finally, Chapter 5 considers the community concerns about the planned expansion of USAMRIID and measures that might be taken to address them.