ATTACHMENT B

WORK PLAN


SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY, MARYLAND











Final |  15 July 2011


Prepared by: BSA Environmental Services, Inc.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 16
ATTACHMENT B WORK PLAN SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY, MARYLAND Final│15 July 2011 Prepared by: BSA Environmental Services, Inc. 16

OCR for page 16
THIS PAGE INTENTIONALLY LEFT BLANK 17

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 Table of Contents Project Description (Planning and Scoping Stage) .....................................................................20 Approach for Qualitative Risk Assessment.................................................................................21 Approach for Quantitative Risk Assessment...............................................................................25 Quality Assurance.......................................................................................................................28 Milestones and Deliverables .......................................................................................................28 Selected References...................................................................................................................37 Acronyms and Abbreviations ......................................................................................................39 Appendix 1. Additional Planning by Agent based on Figure 3-2 of Science and Decisions (NRC 2008)...........................................................................................................................................41 List of Figures Figure 1. Illustration of the scope of the MCMT&EF SSRA ............................................................... 33 Figure 2. Typical probabilistic risk assessment task flow................................................................... 35 List of Tables Table 1. Work Plan Summary .....................................................................................................29 Table 2. Major Elements of Analysis Plan (Box 3-4, NRC 2008) ................................................31 18

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 THIS PAGE INTENTIONALLY LEFT BLANK 19

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 Project Description (Planning and Scoping Stage) The project goal for the U.S. Army Medical Research and Materiel Command (USAMRMC) is to develop a site-specific risk assessment (SSRA) for the Medical Countermeasures Testing and Evaluation Facility (MCMT&EF) at Fort Detrick, MD. The risk assessment aims to document the likelihood, adverse consequences, and uncertainty of reasonably foreseeable events that can affect the health of people working in and around the laboratory as well as members of the community. Environmental impacts will be identified and characterized in the Environmental Impact Statement (EIS) that will include the SSRA as an appendix that addresses human health risks. USAMRMC will be conducting vaccine and drug research for agents in the medical countermeasures portfolio. The SSRA will provide decision support for USAMRMC to address the adequacy of current controls and interventions protecting workers and preventing accidental releases that could cause human illness in the surrounding community. The SSRA will only address risk associated with acute health issues particular to the laboratory work conducted at MCMT&EF. Examples of possible intentional release scenarios will be consider within the constraints of the current Biosurety Program, regulations, and barriers for containment. The risk assessment approach described below represents a tiered assessment consistent with current knowledge of disease for portfolio agents and key risk references (National Research Council [NRC], 2008 Science and Decisions; the International Life Sciences Institute framework for microbial risk assessment (International Life Sciences Institute [ILSI], 2000); and National Academy of Sciences [NAS] letter reports (2011 and others). The major objectives of the tiered assessment are: Compile and structure available scientific evidence on conditions necessary to cause  disease (sources, stressors, populations, routes, pathways, endpoints; Figure 1) and provide transparency regarding knowledge and gaps for portfolio agents listed below: Bacillus anthracis (anthrax) o Brucella spp. (brucellosis) o Ebola/Marburg viruses (viral hemorrhagic fevers) o Francisella tularensis (tularemia) o Venezuelan Equine Encephalitis (VEE)/ Eastern Equine Encephalitis (EEE)/ o Western Equine Encephalitis (WEE) viruses (febrile disease, encephalitis) Yersinia pestis (plague) o Conduct a comprehensive review of contemporary scientific literature and publically  available information from national surveys to identify risks, hazards and mitigation processes associated with laboratory acquired illnesses for above listed pathogens, transmission to the community, intentional and accidental release, transportation release, work with animal species anticipated at MCMT&E, and the development and testing of vaccines and countermeasures Construct reasonably foreseeable scenarios (possible scenarios hereafter)  consistent with mechanisms of disease and knowledge of dose-response 20

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 relationships for likelihood and severity of disease given exposure, considering source, stressors (agents), populations, route, pathway, and endpoint (see Figure 1, including illustrative examples for tularemia) Develop conceptual model for analysis (see Figure 2)  Characterize human health risk qualitatively (unlikely or possible)  Identify possible scenarios amenable to quantitative analysis  Develop and run exposure assessment and dose-response assessment models to  characterize human health risks, with attendant uncertainty (qualitative narrative) Prepare risk communication materials from qualitative and quantitative results  Document future expansions for consideration as new data become available  As previously stated (March 21st presentation to the NAS panel), agent-specific evidence for disease mechanisms will be considered for defining plausible agent and route combinations. If the qualitative risk assessment (QualRA) results in 'unlikely' determination for either the exposure assessment or the dose-response assessment, the pathway or hypothetical scenario may be implausible. In light of the high level of community interest for the MCMT&EF, our strategy is to meticulously communicate what is known (and what is unknown) to preclude misleading the public, particularly when feared scenarios are implausible. For example, available evidence supports quantitative modeling of the exposure pathways for Ebola by the dermal/percutaneous route for laboratory workers, not ingestion and mucosal/ocular routes (see Appendix Figure A-3). Pathways determined unlikely in the QualRA for each agent would not be modeled due to inconsistency with current knowledge of mechanisms of disease, as scientific rigor may be insufficient to support modeling for the possible inhalation route for this agent. Scientific evidence will be structured to support both tiers (qualitative and quantitative) risk assessment. Structural evidence will be used to estimate unlikely and possible scenarios for QualRA and frequency and consequences of possible scenarios. Both approaches will address confidence measures representing uncertainties. Quantitative risk assessment (QuantRA) will be employed as a second tier of analysis when first-tier qualitative assessments cannot confidently bound scenario risks as ‘unlikely’ and sufficient data are available to support a quantitative assessment that significantly improves risk characterization. Gaps in scientific knowledge and research in progress will be noted as appropriate in uncertainty analyses. 1) Approach for Qualitative Risk Assessment The approach was developed based on knowledge of microbial risk assessment frameworks (e.g., ILSI, 2000), as well as published and ongoing research informing biothreat risk assessment, supplemented by targeted searches of the literature to identify additional relevant published studies for the pathogens in the current agent portfolio. Sections 2 and 3 of the work plan present our approach with specific examples for tularemia due to the concern of the local community and the recent laboratory 21

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 associated tularemia infection. For completeness and transparency, approaches planned for other agents in portfolio are outlined briefly in Appendix 1. A) Hazard Identification for Tularemia Tularemia is a zoonotic disease (an animal disease that can be transmitted to humans) caused by the Gram negative coccobacillus Francisella tularensis. This agent is thought to infect up to 250 animal hosts, more than any other known zoonotic pathogen (Dempsey et al., 2006). Contact with the following animals is associated with cases of human tularemia: beavers; cats; crayfish; dogs; dormice; hamsters; hogs and wild boars; mule deer; muskrats; non-human primates (NHPs); pheasants; prairie dogs; wild rabbits and hares; sheep; and squirrels. Tularemia is endemic in the U.S. (including Maryland) and around the world and is thought to persist in nature in enzootic cycles involving wild mammals (largely rodents, rabbits, and hares) and arthropod vectors (ticks, mosquitoes, flies) or amoeba. Evidence for the disease triangle or triad (pathogen, host, and environment, with interactions) influencing disease likelihood and severity) was compiled for tularemia as outlined below. Human tularemia is characterized by abrupt onset of febrile illness (fever and flu-like symptoms) that is often self-limiting and rarely fatal. Human cases from laboratory acquired infections (LAIs), clusters of sporadic cases, and outbreak cases were considered, as well as clinical studies in humans and NHPs, the most relevant animal models to humans anatomically and physiologically. Key studies include the following: Saslaw et al. 1961; Eigelsbach et al. 1962; Eigelsbach et al. 1968; Dahlstrand et al. 1971; Schricker et al., 1972; Martone and Marshall et al. 1979; Deverill et al. 1996; Feldman et al. 2003; Siret et al. 2006; Twenhafel et al. 2009; and Hauri et al. 2010. Also considered in development of this work plan are a consensus statement published in the medical literature (Dennis et al. 2001) and reviews by Adamovicz et al. (2006), the World Health Organization (WHO) (2007), Lyons and Wu (2007), and Sinclair et al. (2008). a) Pathogen (i) Major F. tularensis subspecies or biotypes causing human illness include:  Subspecies tularensis (Schu S4)  Subspecies holarctica (425; attenuated live vaccine strain) (ii) Fastidious and slow-growing bacteria requiring cysteine and sulfhydryl compounds; unlikely to grow in the environment outside of hosts and vectors b) Host (i) Describe  Typically occurring in previously healthy adults ◦ Workers in laboratory, landscaping, hunting and trapping, agriculture (farmers, hay handlers, herders, ranchers) ◦ Butchers, campers, cooks (game meats), sugar factory workers, veterinarians, walkers  Little knowledge for more susceptible populations ◦ Outbreak data include middle aged adults and some children and elderly adults 22

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 ◦ Occasional isolations from hospitalized febrile patients with underlying conditions (neutrophil deficiency; immunosuppression due to organ transplant, cancer, HIV; or the presence of a prosthetic medical device) from endemic areas  Human vs. NHP data c) Environment (i) Consider factors and pathways influencing viability, infectivity, and persistence of strains in various environments  Factors include humidity, temperature, ultraviolet radiation exposure (ii) Consider representativeness of experimental conditions to hypothetical releases  Pathways by route d) Interactions (conditions necessary to cause cases or disease outbreaks) (i) Tularemia is endemic worldwide, and human outbreaks are often associated with outbreaks in wild animal populations from direct contact with infected or dead animals or contaminated fecal material in air or water. Tularemia is perpetuated in complex enzootic cycles between wild mammals (predominantly rodents, rabbits, and hares) and invertebrates (~50 species of arthropods including ticks, mosquitoes, flies) and amoeba (ii) Present state of knowledge for mechanisms of host-pathogen interactions as illustrated in Figure 1. Temporal and spatial patterns of disease and disease progression for human and zoonotic disease will be addressed.  Incubation period before onset of disease; time to detection in lymph nodes, blood, lungs and pleura, spleen, liver, and kidneys; influence of innate and adaptive immunity, with and without vaccination; time to death; global distribution and severity  Human clinical disease forms ◦ Outbreaks or clustered exposures commonly ulceroglandular (frequently by tick or mosquito vectors or contact with infected animals or die-offs (e.g., voles, mice, rabbits, muskrats) ◦ Less commonly oropharyngeal following ingestion of food or water contaminated by infected or dead animals or feces ◦ Rare ocular associated with direct contact with infected pets or other animals or by transmittal on fingertips after handling an infected or dead animal ◦ Rare pneumonic disease outbreaks from contaminated agricultural dusts (landscapers in Martha’s vineyard, Swedish agricultural workers), contaminated aerosols from infected hares among participants in a hunt in Germany, and uncertain aerosol source infecting vacationers at a renovated mill in France (iii) Routes of human exposure  Primary (inhalation; ingestion; dermal/percutaneous; ocular/mucosal)  Secondary (no evidence for person-to-person or monkey-to-monkey transmission) 23

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 (iv) Describe estimated occupational exposures (for laboratory workers, hunters, landscapers, agricultural workers) and estimated exposures to community members  Describe bounds for exposures, e.g., U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) maximum production volume of culture slurries (20 mL per batch culture, USAMRIID 2008. Agent Information Sheet for ciprofloxacin-resistant F. tularensis) (v) Summarize sources of dose-response data and tabulate results by stressor (pathogen strain), population (and host), route, pathway, and endpoint causing mortality, illness, and no illness (Figure 1 for illustrative examples regarding tularemia; Appendix 1 for other agents in portfolio) (vi) Identify unlikely and possible scenarios B) Problem Formulation a) Develop conceptual models by agent, as illustrated in Figure 2, incorporating data collection and analysis from hazard identification and other information as needed b) Define objectives and key variables for inclusion (i) LAIs  Rate declining. For unspecified facilities, USAMRIID reported 225 cases prior to 1976, 2 deaths; for unspecified laboratories, WHO reported declining rates of LAIs from 5.7 cases per 1,000 workers in the 1950s to 0.3 cases per 1,000 workers in the 1960s  Risk mitigations for workers and community (e.g., training materials identify high risk activities; personal protective equipment; laboratory containment equipment and design specifications (e.g., negative pressure); autoclaving)  Recent LAIs generated by uncertain errors or deviations from protocols without transmission in community (ii) Define stability limits in air and water  Short-distance aerosol pathways (plumes/puffs) may be possible (pneumonic tularemia is rare, despite endemic presence and high experimental infectivity in humans and NHPs)  Short-distance water-borne pathways may be possible  Long-term exposures unlikely (iii) Define boundaries for selected accidental and intentional releases as possible scenarios that are reasonably foreseeable events during operation of MCMT&EF c) Describe key variables (populations, routes, pathways) for exclusion and rationale (i) Indoor air for community (ii) Outdoor air for workers (iii) Ingestion for workers (iv) Dermal/percutaneous for community (v) Mucosal/ocular transmission for workers (in personal protective equipment [PPE]) and community (vi) Secondary transmission 24

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 (vii)Vector transmission d) Describe inputs, outputs, data sources, data quality and quantity, methods of analysis, data gaps, and inferences, assumptions or judgments (i) Describe relationships in common language and in mathematical terms C) Technical Analysis (qualitative) a) Conduct exposure analysis (i) Describe evidence on exposure routes and pathways and discuss unlikely and possible scenarios for human tularemia cases in workers and the community (populations) (ii) Survival and decline by pathway (iii) Derive boundaries for magnitude, frequency, and duration of human exposures for possible scenarios (iv) Provide rationale for possible and unlikely scenarios (v) Identify data gaps (vi) Other issues TBD b) Conduct dose-response analysis (i) Describe evidence for dose-dependencies, for populations, routes, pathways, and endpoints (what we know and what we don’t know about human tularemia dose-response relationships)  Address resistance to illness (asymptomatic illness)  Address susceptibility to illness (mild/moderate/severe/fatal illness); reported quantitative measures include infective doses (IDs) for exposed volunteers and IDs and or lethal doses (LDs) for animals exposed in clinical studies ◦ ID50s (inhalation) in humans ~100 and in NHPs ~50 ◦ ID50s (ingestion) in humans and NHPs >106 and <108 (no illness in NHPs at 104) ◦ LD50s (inhalation) in humans unknown and in NHPs ~50 and >106  Report incubation periods, duration and severity of illness (ii) Identify data gaps (iii) Other issues TBD c) Conduct risk characterization (i) Compare outputs of exposure assessment and dose-response assessment to estimate the likelihood and severity for human morbidity and mortality for possible scenarios (ii) Prepare narrative summaries of results (iii) Describe sources of uncertainty and impacts on risk estimates d) Prepare risk communication materials 2) Approach for Quantitative Risk Assessment A) Problem Formulation 25

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 a) As mentioned above, QuantRA will be employed as a second tier of analysis for scenarios first-tier qualitative assessments cannot confidently bound scenario risks as "unlikely", and there is data to support a quantitative assessment that significantly improves the characterization of risk. (i) Approaches to QuantRA for complex systems can be subdivided between fine- grained and course-grained methods.  Fine-grained methods typically attempt to characterize risk and consequences of a scenario through detailed representations of system state changes. They are computationally intensive, require large amounts of data for parameterization and validation, and are often non-transparent because of their complexity and the platform specific aspects of their implementations.  Course-grained methods, sometimes referred to as semi-quantitative methods, typically use simple quantitative models that are more transparent but less exhaustive. We have determined that the course-grained approach is the preferred methodology for most of the current risk assessment for several reasons. b) Because of the limitations on the data available for the agents in the scope of this risk assessment and many open scientific questions regarding both the biology and the computational methodologies, we do not expect fine-grained methods to adequately reduce uncertainties in risk characterizations relative to course-grained methods. c) Since the primary goal of the scenario analyses will be to document scenarios and pathways with risk and consequences that will need mitigation and management, we feel the more-transparent course-grained methodologies will do the most appropriate for this assessment B) Technical Analysis and Modeling a) Structure and simulate possible exposure scenarios (i) Estimate magnitude, frequency, and duration of human exposures based on available evidence (ii) Identify the patterns and distribution of health consequences for exposure scenarios (iii) Address uncertainties for data and impacts of assumptions (iv) Identify data gaps (v) Other issues TBD b) Model dose-response relationships for likelihood and severity of human and NHP illness based on key studies (i) Address uncertainties for extrapolations (pathogen strain, host, endpoint) (ii) Identify data gaps (iii) Other issues TBD c) Conduct risk characterization 26

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION Accidental exposures in Accidental or intentional Sources laboratory releases from laborator y Stressors VEE/EEE/WEE Yersinia Francisella Ebola/Marburg B rucella spp. Bacillus (Current viruses (febrile pestis tularensis viruses (viral (brucellosis) anthracis agent disease, encephalitis) (plague) (tularem ia) hemorrhagic fevers) (anthrax) portfolio) FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND Populations L aboratory workers Community members FINAL │ 15 JULY 2011 Route Inhalation I ngestion Dermal/percutaneous M ucosal/ocular Secondary transmission 43 Pathway Air (indoor) Air (outdoor) F ood S oil W ater Infected worker or animal Endpoint No adverse effect Illness M ortality Figure A-1. Scope of microbial risk assessment for current portfolio of agents planned for MCMT&EF. For anthrax from accidental exposures in the laboratory, pathways are identified by solid blue lines for observed exposures in recent laboratory associated infections (LAIs) and by dashed blue lines for possible exposures. Unlikely scenarios are excluded (gray text box borders). Supporting evidence and rationale will be provided for all pathways in the qualitative risk assessment section.

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 THIS PAGE INTENTIONALLY LEFT BLANK 44

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION Accidental exposures in Accidental or intentional Sources laboratory releases from laboratory Stressors VEE/EEE/WEE Yersinia Francisella Ebola/Marburg Brucella spp. Bacillus (Current viruses (febrile pestis tularensis viruses (viral (brucellosis) anthracis agent disease, encephalitis) (plague) (tularemia) hemorrhagic fevers) (anthrax) portfolio) FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND Laboratory workers Community members Populations FINAL │ 15 JULY 2011 Route Inhalation Ingestion Dermal/percutaneous Mucosal/ocular Secondary transmission 45 Pathway Water Infected worker or animal Air (indoor) Air (outdoor) Food Soil Endpoint No adverse effect Illness Mortality Figure A-2. Scope of microbial risk assessment for current portfolio of agents planned for MCMT&EF. For brucellosis from accidental exposures in the laboratory, pathways are identified by solid red lines for observed exposures in recent laboratory associated infections (LAIs) and by dashed red lines for possible exposures. Unlikely scenarios are excluded (gray text box borders). Supporting evidence and rationale will be provided for all pathways in the qualitative risk assessment section.

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 THIS PAGE INTENTIONALLY LEFT BLANK 46

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION Accidental exposures in Accidental or intentional Sources laboratory releases from laboratory Stressors VEE/EEE/WEE Yersinia Francisella Ebola/Marburg Brucella spp. Bacillus (Current viruses (febrile pestis tularensis viruses (viral (brucellosis) anthracis agent disease, encephalitis) (plague) (tularemia) hemorrhagic fevers) (anthrax) portfolio) FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND Laboratory workers Community members Populations FINAL │ 15 JULY 2011 Route Inhalation Ingestion Dermal/percutaneous Mucosal/ocular Secondary transmission 47 Pathway Water Infected worker or animal Air (indoor) Air (outdoor) Food Soil Endpoint No adverse effect Illness Mortality Figure A-3. Scope of microbial risk assessment for current portfolio of agents planned for MCMT&EF. For Ebola infections from accidental exposures in the laboratory, pathways are identified by solid orange lines for observed exposures in recent laboratory associated infections (LAIs) and by dashed orange lines for possible exposures. Unlikely scenarios are excluded (gray text box borders). Supporting evidence and rationale will be provided for all pathways in the qualitative risk assessment section.

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 THIS PAGE INTENTIONALLY LEFT BLANK 48

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION Accidental exposures in Accidental or intentional Sources laboratory releases from laboratory Stressors VEE/EEE/WEE Yersinia Francisella Ebola/Marburg Brucella spp. Bacillus (Current viruses (febrile pestis tularensis viruses (viral (brucellosis) anthracis agent disease, encephalitis) (plague) (tularemia) hemorrhagic fevers) (anthrax) portfolio) FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND Laboratory workers Community members Populations FINAL │ 15 JULY 2011 Route Inhalation Ingestion Dermal/percutaneous Mucosal/ocular Secondary transmission 49 Pathway Water Infected worker or animal Air (indoor) Air (outdoor) Food Soil Endpoint No adverse effect Illness Mortality Figure A-4. Scope of microbial risk assessment for current portfolio of agents planned for MCMT&EF. For Marburg infections from accidental exposures in the laboratory, pathways are identified by solid brown lines for observed exposures in recent laboratory associated infections (LAIs) and by dashed brown lines for possible exposures. Unlikely scenarios are excluded (gray text box borders). Supporting evidence and rationale will be provided for all pathways in the qualitative risk assessment section.

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │15 JULY 2011 THIS PAGE INTENTIONALLY LEFT BLANK 50

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION Accidental exposures in Accidental or intentional Sources laboratory releases from laboratory Stressors VEE/EEE/WEE Yersinia Francisella Ebola/Marburg Brucella spp. Bacillus (Current viruses (febrile pestis tularensis viruses (viral (brucellosis) anthracis agent disease, encephalitis) (plague) (tularemia) hemorrhagic fevers) (anthrax) portfolio) FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND Laboratory workers Community members Populations FINAL │ 15 JULY 2011 Route Inhalation Ingestion Dermal/percutaneous Mucosal/ocular Secondary transmission 51 Pathway Water Infected worker or animal Air (indoor) Air (outdoor) Food Soil Endpoint No adverse effect Illness Mortality Figure A-5. Scope of microbial risk assessment for current portfolio of agents planned for MCMT&EF. For encephalytic infections from accidental exposures in the laboratory, pathways are identified by solid dark blue lines for observed exposures in recent laboratory associated infections (LAIs) and by dashed dark blue lines for possible exposures. Unlikely scenarios are excluded (gray text box borders). Supporting evidence and rationale will be provided for all pathways in the qualitative risk assessment section.

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND FINAL │ 15 JULY 2011 THIS PAGE INTENTIONALLY LEFT BLANK 52

OCR for page 16
WORK PLAN – SITE-SPECIFIC RISK ASSESSMENT FOR THE MEDICAL COUNTERMEASURES TESTING AND EVALUATION Accidental exposures in Accidental or intentional Sources laboratory releases from laboratory Stressors VEE/EEE/WEE Yersinia Francisella Ebola/Marburg Brucella spp. Bacillus (Current viruses (febrile pestis tularensis viruses (viral (brucellosis) anthracis agent disease, encephalitis) (plague) (tularemia) hemorrhagic fevers) (anthrax) portfolio) FACILITY AT FORT DETRCK IN FREDERICK COUNTY MARYLAND Laboratory workers Community members Populations FINAL │ 15 JULY 2011 Route Inhalation Ingestion Dermal/percutaneous Mucosal/ocular Secondary transmission 53 Pathway Water Infected worker or animal Air (indoor) Air (outdoor) Food Soil Endpoint No adverse effect Illness Mortality Figure A-6. Scope of microbial risk assessment for current portfolio of agents planned for MCMT&EF. For plague infections from accidental exposures in the laboratory, pathways are identified by solid purple lines for observed exposures in recent laboratory associated infections (LAIs) and by dashed purple lines for possible exposures. Unlikely scenarios are excluded (gray text box borders). Supporting evidence and rationale will be provided for all pathways in the qualitative risk assessment section.