Review of Risk Assessment Work Plan for the Medical Countermeasures Test and Evaluation Facility at Fort Detrick A Letter Report (2011) / Chapter Skim
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ATTACHMENT B Work Plan
ATTACHMENT B Work Plan
Pages 16-53
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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.
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Typical probabilistic risk assessment task flow................................................................... 35 List of Tables Table 1.
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for the Medical Countermeasures Testing and Evaluation Facility (MCMT&EF) at Fort Detrick, MD.
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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)
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A) Hazard Identification for Tularemia Tularemia is a zoonotic disease (an animal disease that can be transmitted to humans)
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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)
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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)
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Identify data gaps (vi) Other issues TBD b)
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Other issues TBD c) Conduct risk characterization 26
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Prepare risk communication materials (i) Risks will be presented in the context of existing background risks for accidental zoonotic disease transmission and other risks in daily life (community and occupational risks; auto accidents, heart disease…)
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The work plan, intermediate results, and final reports will be provided to USAMRMC as scheduled 4) Milestones and Deliverables The following work plan summary is proposed for assessing progress toward completion of final report to USAMRMC.
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Frame direct and mitigation-related hazard identification for workers and the community potentially exposed to the six agent classes currently included in portfolio for MCMT&E, including LAIs Develop strategy for agent-based tiered assessment Tier I: qualitative analysis for agents in current portfolio for o medical countermeasure testing and evaluation Tier II: quantitative analysis for selected o agent/route/pathway/endpoint combinations judged to represent reasonably foreseeable event scenarios (considering disease mechanisms) Draft figures, tables, and text communicating scope Commit to schedule and budget, and future reassessments Develop and implement conceptual model to frame qualitative and quantitative analysis QualRA Consider data and methods for stages of risk assessment (exposure Problem assessment; dose-response assessment; risk characterization)
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) ; run models and vet outputs to team Exposure Analysis Implement existing dose-response models for explicit list of scenarios; vet outputs to team Dose-Response Combine exposure assessment and dose-response assessment Analysis outputs to characterize risks for explicit scenarios; vet outputs to team Draft figures, tables, and text communicating results; organize results Risk into report sections or appendices Characterization Interim Report Risk Develop products for communicating what is known, and what is not Communication known, at this stage of the risk assessment process SSRA Final Report Combine interim QualRA and QuantRA reports with executive summary Submit and prepare responses to comments from USAMRMC and NAS peer review o NAS charge to assess the adequacy and validity of the proposed risk assessment methodology and the draft results of any assessments to be incorporated into the EIS Update final report for public release Brief with USAMRMC at public meeting Additional Consider needs and resources for updating or expanding analysis as Cycles of new products for T&E develop Analysis and Deliberation 30
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Agent list for current portfolio for medical countermeasure T&E Literature uploaded on FTP site Exposure Assessing exposure pathways and ambient exposures pathways and Conditions for laboratory infections by agent routes Primary and secondary engineering of facilities to prevent release o from a lab and the facility; rates of failure Primary containment (PPE) to protect workers o Biosurety to prevent intentional releases (insider)
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respiratory exposure and response, including what is known about susceptible populations End points Proposed sources of evidence on pathogenicity and virulence of (morbidity, agents and risk metrics mortality) Published relevant literature on nature and severity of diseases in humans, laboratory animals, and wildlife as appropriate from clinical and epidemiologic studies (e.g., CAMRA, CIDRAP, SERRA)
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FACILITY AT FORT DETRICK IN FREDERICK COUNTY MARYLAND Populations Laboratory workers Community members FINAL │ 15 JULY 2011 Routes Inhalation Ingestion Dermal/percutaneous Mucosal/ocular Secondary transmission 33 Pathways Air (indoor) Air (outdoor)
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Solid lines indicate scenarios for recent observations of LAIs and outbreaks, dashed lines indicate possible scenarios, and boxes without connecting lines indicate unlikely scenarios that are excluded from quantitative analysis. Rationale will be provided in QualRA section of the SSRA report for the scenarios considered and excluded.
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The work flow of a probabilistic risk assessment is a cyclic process. Once the objectives and perspectives of the PRA are defined, the first step is a period of familiarization with the system under study.
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2006. Paired-end sequence mapping detects extensive genomic rearrangement and translocation during divergence of Francisella tularensis subspecies tularensis and Francisella tularensis subspecies holarctica populations.
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1972. Pathogenesis of tularemia in monkeys aerogenically exposed to Francisella tularensis 425.
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Army Medical Research and Materiel Command VEE Venezuelan Equine Encephalitis WEE Western Equine Encephalitis WHO World Health Organization 39
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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 Appendix 1. Additional Planning by Agent based on Figure 3-2 of Science and Decisions (NRC 2008)
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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.
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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)
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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)
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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)
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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)
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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)
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