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Long-Term Health Risk Quantification

Astronauts face hazards during spaceflight, including space radiation exposure, isolation and confinement, traveling far distances from Earth, reduced gravity levels, and closed and hostile environments. These hazards drive the definition of human health and performance risks associated with spaceflight. NASA’s Human System Risk Board maintains the human spaceflight risk posture for in-mission risks, as well as post-flight, Long-Term Health (LTH)risks potentially occurring later in the astronaut’s life. LTH risk encompasses the timeframe from immediately post-flight, through the rest of an astronaut’s career, through retirement, and until death. Possible LTH risk outcomes include the time and interventions needed for the astronaut to return to preflight physiological states after experiencing spaceflight hazards and recovery from any in-mission medical events that persist into the post-flight timeframe. It includes chronic complications that may arise due to experiencing in-flight medical conditions or injuries and medical conditions that occur later in life with a higher probability of occurrence or with more severity because of their spaceflight exposure. Finally, LTH risk outcomes can also include a reduction in life expectancy due to spaceflight exposures. There have been 144 medical conditions identified by NASA’s Lifetime Surveillance of Astronaut Health team to be associated with LTH risk. Epidemiological studies have been performed for some of these conditions to determine if astronauts suffer from an increased prevalence or severity of the condition due to their spaceflight experience compared to a comparable cohort .Differences in astronaut mortality or morbidity due to spaceflight experience were not detected in several of these studies. There were two cases where a modest increase in the incidence rate of astronaut LTH outcomes was detected. The first suggested an increase in the incidence of melanoma cases in astronauts, where the number of cases in astronauts were similar to the elevated number of cases observed in airplane pilots. The second provided some evidence of elevated numbers of cardiovascular disease events in astronauts compared to an appropriate healthy comparator cohort, which may warrant additional investigation. The lack of detection of LTH risk outcomes should not ease concerns about astronaut LTH. The studies highlighted here constitute only a small portion of the potential LTH conditions that could occur. Once epidemiological studies are performed on all conditions, significant findings may be detected. The analysis of astronaut LTH also suffers from limited numbers of data points because of the limited numbers of astronauts overall and the even fewer who have reached an age where LTH outcomes may begin to manifest. As shuttle and ISS astronauts begin to age and increase the feasibility of analysis, LTH outcomes may be detected. An application of risk quantification is the use of risk metrics within trade studies for resource prioritization and decision making. Trade studies regarding countermeasures to LTH risk outcomes would benefit from a quantification of LTH risk. NASA has ground-based processes in place such as astronaut screening and access to continuous medical monitoring and care during and after their astronaut career which are the main methods for mitigating LTH risk. In-mission countermeasures, such as acceptable levels of medical care and available countermeasures to counter spaceflight related physiological decrements, can mitigate a poor health and performance status immediately post-flight. Identifying appropriate risk metrics, obtaining valid quantities for them, and tying them to LTH countermeasures are necessary steps for realizing their use in trade studies. This presentation will highlight the challenges associated with the identification, quantification, and utilization of LTH risk metrics

Beth Lewandowski↗

Risk Evaluation for CO2 Geosequestration in the Knox Supergroup, Illinois Basin Final Report

This report describes a process and provides seed information for identifying and evaluating risks pertinent to a hypothetical carbon dioxide (CO2) capture and sequestration (CCS) project. In the envisioned project, the target sequestration reservoir rock is the Potosi Formation of the Knox Supergroup. The Potosi is identified as a potential target formation because (1) at least locally, it contains vuggy to cavernous layers that have very high porosity, and (2) it is present in areas where the deeper Mt. Simon Sandstone (a known potential reservoir unit) is absent or nonporous. The key report content is discussed in Section 3.3, which describes two lists of Features, Events, and Processes (FEPs) that should be considered during the design stage of such a project. These lists primarily highlight risk elements particular to the establishment of the Potosi as the target formation in general. The lists are consciously incomplete with respect to risk elements that would be relevant for essentially all CCS projects regardless of location or geology. In addition, other risk elements specific to a particular future project site would have to be identified. Sources for the FEPs and scenarios listed here include the iconic Quintessa FEPs list developed for the International Energy Agency Greenhouse Gas (IEAGHG) Programme; previous risk evaluation projects executed by Schlumberger Carbon Services; and new input solicited from experts currently working on aspects of CCS in the Knox geology. The projects used as sources of risk information are primarily those that have targeted carbonate reservoir rocks similar in age, stratigraphy, and mineralogy to the Knox-Potosi. Risks of using the Potosi Formation as the target sequestration reservoir for a CCS project include uncertainties about the levels of porosity and permeability of that rock unit; the lateral consistency and continuity of those properties; and the ability of the project team to identify suitable (i.e., persistently porous and permeable) injection depths within the overall formation. Less direct implications include the vertical position of the Potosi within the rock column and the absence of a laterally extensive shale caprock immediately overlying the Potosi. Based on modeling work done partly in association with this risk report, risks that should also be evaluated include the ability of available methods to predict and track the development of a CO2 plume as it migrates away from the injection point(s). The geologic and hydrodynamic uncertainties present risks that are compounded at the stage of acquiring necessary drilling and injection permits. It is anticipated that, in the future, a regional geologic study or CO2-emitter request may identify a small specific area as a prospective CCS project site. At that point, the FEPs lists provided in this report should be evaluated by experts for their relative levels of risk. A procedure for this evaluation is provided. The higher-risk FEPs should then be used to write project-specific scenarios that may themselves be evaluated for risk. Then, actions to reduce and to manage risk can be described and undertaken. The FEPs lists provided as Appendix 2 should not be considered complete, as potentially the most important risks are ones that have not yet been thought of. But these lists are intended to include the most important risk elements pertinent to a Potosi-target CCS project, and they provide a good starting point for diligent risk identification, evaluation, and management.

Hnottavange-Telleen, Ken↗

Describing patterns of familial cancer risk in subfertile men using population pedigree data

STUDY QUESTION Can we simultaneously assess risk for multiple cancers to identify familial multicancer patterns in families of azoospermic and severely oligozoospermic men? SUMMARY ANSWER Here, distinct familial cancer patterns were observed in the azoospermia and severe oligozoospermia cohorts, suggesting heterogeneity in familial cancer risk by both type of subfertility and within subfertility type. WHAT IS KNOWN ALREADY Subfertile men and their relatives show increased risk for certain cancers including testicular, thyroid, and pediatric. STUDY DESIGN, SIZE, DURATION A retrospective cohort of subfertile men (N = 786) was identified and matched to fertile population controls (N = 5674). Family members out to third-degree relatives were identified for both subfertile men and fertile population controls (N = 337 754). The study period was 1966–2017. Individuals were censored at death or loss to follow-up, loss to follow-up occurred if they left Utah during the study period. PARTICIPANTS/MATERIALS, SETTING, METHODS Azoospermic (0 × 10 6 /mL) and severely oligozoospermic (<1.5 × 10 6 /mL) men were identified in the Subfertility Health and Assisted Reproduction and the Environment cohort (SHARE). Subfertile men were age- and sex-matched 5:1 to fertile population controls and family members out to third-degree relatives were identified using the Utah Population Database (UPDB). Cancer diagnoses were identified through the Utah Cancer Registry. Families containing ≥10 members with ≥1 year of follow-up 1966–2017 were included (azoospermic: N = 426 families, 21 361 individuals; oligozoospermic: N = 360 families, 18 818 individuals). Unsupervised clustering based on standardized incidence ratios for 34 cancer phenotypes in the families was used to identify familial multicancer patterns; azoospermia and severe oligospermia families were assessed separately. MAIN RESULTS AND THE ROLE OF CHANCE Compared to control families, significant increases in cancer risks were observed in the azoospermia cohort for five cancer types: bone and joint cancers hazard ratio (HR) = 2.56 (95% CI = 1.48–4.42), soft tissue cancers HR = 1.56 (95% CI = 1.01–2.39), uterine cancers HR = 1.27 (95% CI = 1.03–1.56), Hodgkin lymphomas HR = 1.60 (95% CI = 1.07–2.39), and thyroid cancer HR = 1.54 (95% CI = 1.21–1.97). Among severe oligozoospermia families, increased risk was seen for three cancer types: colon cancer HR = 1.16 (95% CI = 1.01–1.32), bone and joint cancers HR = 2.43 (95% CI = 1.30–4.54), and testis cancer HR = 2.34 (95% CI = 1.60–3.42) along with a significant decrease in esophageal cancer risk HR = 0.39 (95% CI = 0.16–0.97). Thirteen clusters of familial multicancer patterns were identified in families of azoospermic men, 66% of families in the azoospermia cohort showed population-level cancer risks, however, the remaining 12 clusters showed elevated risk for 2-7 cancer types. Several of the clusters with elevated cancer risks also showed increased odds of cancer diagnoses at young ages with six clusters showing increased odds of adolescent and young adult (AYA) diagnosis [odds ratio (OR) = 1.96–2.88] and two clusters showing increased odds of pediatric cancer diagnosis (OR = 3.64–12.63). Within the severe oligozoospermia cohort, 12 distinct familial multicancer clusters were identified. All 12 clusters showed elevated risk for 1–3 cancer types. An increase in odds of cancer diagnoses at young ages was also seen in five of the severe oligozoospermia familial multicancer clusters, three clusters showed increased odds of AYA diagnosis (OR = 2.19–2.78) with an additional two clusters showing increased odds of a pediatric diagnosis (OR = 3.84–9.32). LIMITATIONS, REASONS FOR CAUTION Although this study has many strengths, including population data for family structure, cancer diagnoses and subfertility, there are limitations. First, semen measures are not available for the sample of fertile men. Second, there is no information on medical comorbidities or lifestyle risk factors such as smoking status, BMI, or environmental exposures. Third, all of the subfertile men included in this study were seen at a fertility clinic for evaluation. These men were therefore a subset of the overall population experiencing fertility problems and likely represent those with the socioeconomic means for evaluation by a physician. WIDER IMPLICATIONS OF THE FINDINGS This analysis leveraged unique population-level data resources, SHARE and the UPDB, to describe novel multicancer clusters among the families of azoospermic and severely oligozoospermic men. Distinct overall multicancer risk and familial multicancer patterns were observed in the azoospermia and severe oligozoospermia cohorts, suggesting heterogeneity in cancer risk by type of subfertility and within subfertility type. Describing families with similar cancer risk patterns provides a new avenue to increase homogeneity for focused gene discovery and environmental risk factor studies. Such discoveries will lead to more accurate risk predictions and improved counseling for patients and their families. STUDY FUNDING/COMPETING INTEREST(S) This work was funded by GEMS: Genomic approach to connecting Elevated germline Mutation rates with male infertility and Somatic health (Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): R01 HD106112). The authors have no conflicts of interest relevant to this work.

60 APPLIED LIFE SCIENCES↗

RISK-INFORMED BALANCING OF SAFETY, NONPROLIFERATION, AND ECONOMICS FOR THE SFR

A substantial barrier to the implementation of Sodium-cooled Fast Reactor (SFR) technology in the short term is the perception that they would not be economically competitive with advanced light water reactors. With increased acceptance of risk-informed regulation, the opportunity exists to reduce the costs of a nuclear power plant at the design stage without applying excessive conservatism that is not needed in treating low risk events. In the report, NUREG-1860, the U.S. Nuclear Regulatory Commission describes developmental activities associated with a risk-informed, scenario-based technology neutral framework (TNF) for regulation. It provides quantitative yardsticks against which the adequacy of safety risks can be judged. We extend these concepts to treatment of proliferation risks. The objective of our project is to develop a risk-informed design process for minimizing the cost of electricity generation within constraints of adequate safety and proliferation risks. This report describes the design and use of this design optimization process within the context of reducing the capital cost and levelized cost of electricity production for a small (possibly modular) SFR. Our project provides not only an evaluation of the feasibility of a risk-informed design process but also a practical test of the applicability of the TNF to an actual advanced, non-LWR design. The report provides results of five safety related and one proliferation related case studies of innovative design alternatives. Applied to previously proposed SFR nuclear energy system concepts We find that the TNF provides a feasible initial basis for licensing new reactors. However, it is incomplete. We recommend improvements in terms of requiring acceptance standards for total safety risks, and we propose a framework for regulation of proliferation risks. We also demonstrate methods for evaluation of proliferation risks. We also suggest revisions to scenario-specific safety risk acceptance standards, particularly concerning seismic and aircraft impactrelated risks. Most importantly, within the context of the TNF historical SFR safety concerns about energetic core disruptive accidents are seen to be unimportant, but those of rare scenarios mentioned above are seen to be of dominant concern. In terms of proliferation risks the SFR energy system is seen not to be of considerably greater concern than with other nuclear power technologies, providing that highly effective safeguards are employed. We find the economic performance of proposed SFRs likely, due to the problems of using sodium as a coolant, to be inferior to those of LWRs unless they can be credited for services to improve nuclear waste disposal, nuclear fuel utilization and proliferation risk reductions. None of the design innovations investigated offers the promise to reverse this conclusion. The most promising innovation investigated is that of improving the plant's thermodynamic efficiency via use of the supercritical CO{sub 2} (rather than steam Rankine) power conversion system. We were unable to reach conclusions about the economic and proliferation risk implications of competing nuclear fuel processing methods, as available designs are too little developed to justify any such results. Overall, we find the SFR to be a promising alternative to LWRs should the conditions governing the valuation change substantially from current ones.

11 NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗

Risk Management Issues - An Aerospace Perspective

Phased-approach for implementation of risk management is necessary. Risk management system will be simple, accessible and promote communication of information to all relevant stakeholders for optimal resource allocation and risk mitigation. Risk management should be used by all team members to manage risks--risk office personnel. Each group is assigned Risk Integrators who are facilitators for effective risk management. Risks will be managed at the lowest-level feasible, elevate only those risks that require coordination or management from above. Risk reporting and communication is an essential element of risk management and will combine both qualitative and quantitative elements.. Risk informed decision making should be introduced to all levels of management. Provide necessary checks and balances to insure that risks are caught/identified and dealt with in a timely manner, Many supporting tools, processes & training must be deployed for effective risk management implementation. Process improvement must be included in the risk processes.

Perera, Jeevan S.↗

NASA's Risk Management System

Leadership is key to success. Phased-approach for implementation of risk management is necessary. Risk management system will be simple, accessible and promote communication of information to all relevant stakeholders for optimal resource allocation and risk mitigation. Risk management should be used by all team members to manage risks -- risk office personnel. Each group is assigned Risk Integrators who are facilitators for effective risk management. Risks will be managed at the lowest-level feasible, elevate only those risks that require coordination or management from above. Risk reporting and communication is an essential element of risk management and will combine both qualitative and quantitative elements. Risk informed decision making should be introduced to all levels of management. Provide necessary checks and balances to insure that risks are caught/identified and dealt with in a timely manner. Many supporting tools, processes & training must be deployed for effective risk management implementation. Process improvement must be included in the risk processes.

Perera, Jeevan S.↗

Framework for Modeling High-Impact, Low-Frequency Power Grid Events to Support Risk-Informed Decisions

Natural and man-made hazardous events resulting in loss of grid infrastructure assets challenge the electric power grid’s security and resilience. However, the planning and allocation of appropriate contingency resources for such events requires an understanding of their likelihood and the extent of their potential impact. Where these events are of low likelihood, a risk-informed perspective on planning can be problematic as there exists an insufficient statistical basis to directly estimate the probabilities and consequences of their occurrence. Since risk-informed decisions rely on such knowledge, a basis for modeling the risk associated with high-impact low frequency events (HILFs) is essential. Insights from such a model can inform where resources are most rationally and effectively expended. The present effort is focused on development of a HILF risk assessment framework. Such a framework is intended to provide the conceptual and overarching technical basis for the development of HILF risk models that can inform decision makers across numerous stakeholder sectors. The North American Electric Reliability Corporation (NERC) 2014 Standard TPL-001-4 considers severe events for transmission reliability planning, but does not address events of such severity that they have the potential to fail a substantial fraction of grid assets over a region, such as geomagnetic disturbances (GMD), extreme seismic events, and coordinated cyber-physical attacks. These are beyond current planning guidelines. As noted, the risks associated with such events cannot be statistically estimated based on historic experience; however, there does exist a stable of risk modeling techniques for rare events that have proven of value across a wide range of engineering application domains. There is an active and growing interest in evaluating the value of risk management techniques in the State transmission planning and emergency response communities, some of this interest in the context of grid modernization activities. The availability of a grid HILF risk model, integrated across multi-hazard domains which, when interrogated, can support transparent, defensible and effective decisions, is an attractive prospect among these communities. In this report, we document an integrated HILF risk framework intended to inform the development of risk models. These models would be based on the systematic and comprehensive (to within scope) characterization of hazards to the level of detail required for modeling risk, identification of the stressors associated with the hazards (i.e., the means of impacting grid and supporting infrastructure), characterization of the vulnerability of assets to these stressors and the probabilities of asset compromise, the grid’s dynamic response to the asset failures, and assessment of subsequent severities of consequence with respect to selected impact metrics, such as power outage duration and geographic reach. Specifically, the current framework is being developed to;1. Provide the conceptual and overarching technical paradigms for the development of risk models; 2. Identify the classes of models required to implement the framework - providing examples of existing models, and also identifying where modeling gaps exist; 3. Identify the types of data required, addressing circumstances under which data are sparse and the formal elicitation of informed judgment might be required; and 4. Identify means by which the resultant risk models might be interrogated to form the necessary basis for risk management.

97 MATHEMATICS AND COMPUTING↗

Application of quantitative risk assessment to address stakeholder questions in geologic carbon storage

Ambitious international greenhouse gas emissions reduction targets demand a rapid transformation to a low-carbon economy. This transformation includes the accelerated adoption of carbon dioxide (CO2) capture and storage (CCS) technology. However, as with any large-scale engineering enterprise, the widespread commercial-scale deployment of geologic carbon storage (GCS) raises important questions about technology and cost-effectiveness, safety, environmental risk, and long-term liability. Effectively assessing and managing risks and liability associated with GCS projects is a key technical need throughout the project life cycle-from site selection and permitting to monitoring design, operational risk management, and post-operational site closure. This presentation highlights recent advancements in tools for quantitative risk assessment, being developed by the National Risk Assessment Partnership (NRAP). NRAP is a multi-year, multinational laboratory research collaboration sponsored by the U.S. Department of Energy's Office of Fossil Energy and Carbon Management. Our focus will be on these tools' applications in addressing critical stakeholder questions related to supporting permitting to ensure secure and environmentally protective storage; designing effective and efficient monitoring plans; evaluating the effectiveness of remedial actions and risk management alternatives; and informing liability assessment and investment decisions. This paper will detail the key functionality of NRAP’s Open-Source Integrated Assessment Model (NRAP-Open-IAM), a computational framework for assessing leakage risk and containment assurance. This model features streamlined workflows for calculating leakage risk profiles, delineating risk-based area of review, and assessing contingency plans and post-injection site care requirements. ORION is an open-source, observation-based ensemble forecasting toolkit to help operators assess the seismic hazard at a carbon storage site. The State of Stress Analysis Tool (SOSAT), designed to assess subsurface stress conditions and evaluate geomechanical risk resulting from CO2 injection in an area of interest will also be presented. We will also introduce a prototype model to evaluate storage project costs and liability associated with risk management. The Technoeconomic and Liability Evaluation for Storage (TALES) model uses results from forecasts of leakage and induced seismicity risk to estimate the lifecycle cost of managing risk. Finally, a preliminary example of how the NRAP Risk-based Adaptive Monitoring Plan (RAMP) tool can be used to design efficient and effective site monitoring plans and estimate the detectability of fluid leakage will be provided. The relevance of these tools for addressing key stakeholder questions amidst uncertainty will be emphasized.

decision support↗

An Introduction to Risk with a Focus on Design Diversity in the Stockpile

The maintenance and security of nuclear weapons in the stockpile involves decisions based on risk analysis and quantitative measures of risk. Risk is a factor in all decisions, a particularly important factor in decisions of a large scale. One example of high-risk decisions we will discuss is the risk involved in design diversity within the stockpile of nuclear weapons arsenal. Risk is defined as 'possibility of loss or injury' and the 'degree of probability of such loss' (Kaplan and Garrick 12). To introduce the risk involved with maintaining the weapons stockpile we will draw a parallel to the design and maintenance of Southwest Airlines fleet of Boeing 737 planes. The clear benefits for cost savings in maintenance of having a uniform fleet are what historically drove Southwest to have only Boeing 737s in their fleet. Less money and resources are need for maintenance, training, and materials. Naturally, risk accompanies those benefits. A defect in a part of the plane indicates a potential defect in that same part in all the planes of the fleet. As a result, safety, business, and credibility are at risk. How much variety or diversity does the fleet need to mitigate that risk? With that question in mind, a balance is needed to accommodate the different risks and benefits of the situation. In a similar way, risk is analyzed for the design and maintenance of nuclear weapons in the stockpile. In conclusion, risk must be as low as possible when it comes to the nuclear weapons stockpile. Design and care to keep the stockpile healthy involves all aspects of risk management. Design diversity is a method that helps to mitigate risk, and to help balance options in stockpile stewardship.

45 MILITARY TECHNOLOGY, WEAPONRY, AND NATIONAL DEF↗

Lessons Learned With Risk Management: A Systems Engineer's Perspective

Risk management is a communications device that, when executed as an essential task, enables systems engineering to effectively balance risk across the project. Developing and baselining risks is an essential continuous task to ensure top project concerns both from bottom up and top down are being mitigated. Risk management provides the opportunity to avoid the consequence of the risk when mitigation steps start early enough. Just discussing risk with all the project flight elements during development, even if no risks are open, provides an excellent communication opportunity between systems engineering and those elements, ensuring concerns and worries have a platform for discussion. A well-managed risk identification process will identify concerns that are serious but not being clearly communicated, and it will enable mitigation of those potential problems before they cause a failure. Effective risk management requires considerable time and effort, but that effort will save time and money across the development. Risk management must be frequent enough to be useful and in depth enough to bring out emerging issues. It also requires a trusting relationship between the lead systems engineer and element and/or subsystem leads. The discussions need to be with the right number of individuals (typically a handful) and the right duration in time (typically an hour a month). Outside of these risk working groups, there is a formal management process to input, status, and disposition risks, and a monthly Risk Management Board meeting where key project stakeholders are informed. This paper provides good guidance on effective risk management from a systems engineering perspective and provides project lessons learned from the NASA spaceflight missions NICER, Landsat 9, LRO, and OSIRIS-REx to demonstrate the effectiveness of risk management.

Lessons Learned↗

Lessons Learned With Risk Management: A Systems Engineer’s Perspective

Risk management is a communications device that, when executed as an essential task, enables systems engineering to effectively balance risk across the project. Developing and baselining risks is an essential continuous task to ensure top project concerns both from bottom up and top down are being mitigated. Risk management provides the opportunity to avoid the consequence of the risk when mitigation steps start early enough. Just discussing risk with all the project flight elements during development, even if no risks are open, provides an excellent communication opportunity between systems engineering and those elements, ensuring concerns and worries have a platform for discussion. A well-managed risk identification process will identify concerns that are serious but not being clearly communicated, and it will enable mitigation of those potential problems before they cause a failure. Effective risk management requires considerable time and effort, but that effort will save time and money across the development. Risk management must be frequent enough to be useful and in depth enough to bring out emerging issues. It also requires a trusting relationship between the lead systems engineer and element and/or subsystem leads. The discussions need to be with the right number of individuals (typically a handful) and the right duration in time (typically an hour a month). Outside of these risk working groups, there is a formal management process to input, status, and disposition risks, and a monthly Risk Management Board meeting where key project stakeholders are informed. This paper provides good guidance on effective risk management from a systems engineering perspective and provides project lessons learned from the NASA spaceflight missions NICER, Landsat 9, LRO, and OSIRIS-REx to demonstrate the effectiveness of risk management.

Lessons Learned↗

NASA Risk Management Handbook: Version 2.0, Part 1

The purpose of this handbook is to provide an in-depth reference for the practice of risk management in NASA, updating the guidance offered in its original version, NASA/SP-2011-3422 (November 2011), and closely aligning the updated guidance with the current NASA Procedural Requirements for Agency Risk Management, NPR 8000.4, and the parent NASA Policy Directive for NASA Governance and Strategic Management, NPD 1000.0. NPD 1000.0 introduces with emphasis the concept of “Risk Leadership,” making it a fundamental tenet and pillar of the risk management culture that it advocates for the Agency. NPR 8000.4 applies this concept and establishes Risk Management (RM) requirements for the Agency as an integrated enterprise, as well as the RM requirements for portfolio elements within the enterprise. Such elements include the various programs and projects that contribute to the Agency’s objectives and the various institutional activities carried out by entities that contribute to mission support. The present version of the handbook also emphasizes the integration of risk management processes across activity and project life cycles and their coordination and interaction with day-to-day programmatic and organizational functions. Areas of application of risk assessment and management that were not covered with specific guidance in the preceding version are addressed in this version with in-depth examples. The handbook is structured into two parts, whose chapters are in turn organized in a sequential order intended to facilitate a gradual and progressive introduction of the reader to risk management principles and practices. Part 1 of the handbook is dedicated to the introduction of the basic foundations of the NASA integrated risk management framework, the related fundamental risk concepts, the description of the risk management and decision processes that are to be implemented within the framework, the discussion of the risk assessment techniques that should be utilized in support of such processes, and the management and organizational interactions and interfaces that should be enabled to implement an effective integration of risk management activities within the Agency. Part 2 provides self-contained, end-to-end examples of application of the processes and techniques introduced in Part 1, in the context of both programmatic (i.e., project and/or mission related) and institutional activities.

Uncertainty↗

NASA Risk Management Handbook: Version 2.0, Part 2

The purpose of this handbook is to provide an in-depth reference for the practice of risk management in NASA, updating the guidance offered in its original version, NASA/SP-2011-3422 (November 2011), and closely aligning the updated guidance with the current NASA Procedural Requirements for Agency Risk Management, NPR 8000.4, and the parent NASA Policy Directive for NASA Governance and Strategic Management, NPD 1000.0 (January 2020). NPD 1000.0 introduces with emphasis the concept of “Risk Leadership,” making it a fundamental tenet and pillar of the risk management culture that it advocates for the Agency. NPR 8000.4 applies this concept and establishes Risk Management (RM) requirements for the Agency as an integrated enterprise, as well as the RM requirements for portfolio elements within the enterprise. Such elements include the various programs and projects that contribute to the Agency’s objectives and the various institutional activities carried out by entities that contribute to mission support. The present version of the handbook also emphasizes the integration of risk management processes across activity and project life cycles and their coordination and interaction with day-to-day programmatic and organizational functions. Areas of application of risk assessment and management that were not covered with specific guidance in the preceding version are addressed in this version with in-depth examples. The handbook is structured into two parts, whose chapters are in turn organized in a sequential order intended to facilitate a gradual and progressive introduction of the reader to risk management principles and practices. Part 1 of the handbook is dedicated to the introduction of the basic foundations of the NASA integrated risk management framework, the related fundamental risk concepts, the description of the risk management and decision processes that are to be implemented within the framework, the discussion of the risk assessment techniques that should be utilized in support of such processes, and the management and organizational interactions and interfaces that should be enabled to implement an effective integration of risk management activities within the Agency. Part 2 provides self-contained, end-to-end examples of application of the processes and techniques introduced in Part 1, in the context of both programmatic (i.e., project and/or mission related) and institutional activities.

Risk Leadership↗

Recommended Practices for Managing Induced Seismicity Risk Associated with Geologic Carbon Storage

The geologic storage of carbon dioxide (CO 2 ) is one method to help reduce or eliminate atmospheric CO 2 emissions. The sequestered CO 2 is originally captured from the atmosphere or from a stationary industrial source and subsequently injected into a deep subsurface porous rock formation. To facilitate the successful deployment of field scale carbon storage projects, the U.S. Department of Energy (DOE) is developing tools and protocols for defensible, science-based frameworks to quantify and mitigate risks associated with the long-term storage of CO 2 . This protocol specifically addresses the risk of induced seismicity due to injection in a geologic carbon storage (GCS) site. This integrated and risk-based protocol is a product of the U.S. DOE Fossil Energy’s National Risk Assessment Partnership (NRAP), a multi-year collaborative research effort of Los Alamos National Laboratory (LANL), Lawrence Berkeley National Laboratory (LBNL), Lawrence Livermore National Laboratory (LLNL), National Energy Technology Laboratory (NETL), and Pacific Northwest National Laboratory (PNNL). These recommended practices describe a set of 7 steps to evaluate, manage, communicate, and mitigate the risk of induced seismicity at GCS sites. The base methodology of the recommended practices follows a framework similar to the Protocol for Addressing Induced Seismicity Associated with Enhanced Geothermal Systems (Majer et al., 2012), developed for the Geothermal Technology Office of the U.S. DOE. These recommended practices present a framework to systematically assess the induced seismicity risk and quantify the associated uncertainties. These recommendations are based on current research and are sufficiently general to allow for modification and application to a variety of different types of sites. The substance of the recommended practices contained herein includes both technical and non-technical issues, and covers all operational stages of the GCS project lifecycle. They start at the preliminary risk assessment phase, continue through site assessment and characterization, include best practice communication and seismic monitoring plan methodologies, discuss the evaluation and mitigation of seismic hazard and risk, and closes with an exploration of operational management plans, which conclude when the induced seismicity risk abates back to background level. The focus of these recommendations is on actively managing the risks associated with induced seismicity by developing an actionable risk management plan that starts at the project proposal stage and continues through site closure through an iterative assessment and improvement process. The audience of this document is expected to include all interested stakeholders (e.g., operators, project developers, regulators, and the general public) and is expressly written to be accessible to this broad range of partners. This document is intended to disseminate knowledge gained through recent advances in the science of induced seismicity hazard and risk assessments, to provide updates based on recent experience gained by similar corollary injection-induced seismicity cases, and most importantly to establish a uniform framework to carry out a successful induced seismicity risk management plan for carbon storage projects in the future. These recommendations do not directly address any domestic or international regulations or standards. A complementary NRAP report makes recommendations for the assessment and management of environmental subsurface risks associated with unwanted fluid migration at GCS sites (Thomas et al., 2021) and should be referred to in order to address those additional GCS site risks.

54 ENVIRONMENTAL SCIENCES↗

Recommended Practices for Managing Induced Seismicity Risk Associated with Geologic Carbon Storage

The geologic storage of carbon dioxide (CO 2 ) is one method to help reduce or eliminate atmospheric CO 2 emissions. The sequestered CO 2 is originally captured from the atmosphere or from a stationary industrial source and subsequently injected into a deep subsurface porous rock formation. To facilitate the successful deployment of field scale carbon storage projects, the U.S. Department of Energy (DOE) is developing tools and protocols for defensible, science-based frameworks to quantify and mitigate risks associated with the long-term storage of CO 2 . This protocol specifically addresses the risk of induced seismicity due to injection in a geologic carbon storage (GCS) site. This integrated and risk-based protocol is a product of the U.S. DOE Fossil Energy’s National Risk Assessment Partnership (NRAP), a multi-year collaborative research effort of Los Alamos National Laboratory (LANL), Lawrence Berkeley National Laboratory (LBNL), Lawrence Livermore National Laboratory (LLNL), National Energy Technology Laboratory (NETL), and Pacific Northwest National Laboratory (PNNL). These recommended practices describe a set of 7 steps to evaluate, manage, communicate, and mitigate the risk of induced seismicity at GCS sites. The base methodology of the recommended practices follows a framework similar to the $\textit{Protocol for Addressing Induced Seismicity Associated with Enhanced Geothermal Systems}$ (Majer et al., 2012), developed for the Geothermal Technology Office of the U.S. DOE. These recommended practices present a framework to systematically assess the induced seismicity risk and quantify the associated uncertainties. These recommendations are based on current research and are sufficiently general to allow for modification and application to a variety of different types of sites. The substance of the recommended practices contained herein includes both technical and non-technical issues, and covers all operational stages of the GCS project lifecycle. They start at the preliminary risk assessment phase, continue through site assessment and characterization, include best practice communication and seismic monitoring plan methodologies, discuss the evaluation and mitigation of seismic hazard and risk, and closes with an exploration of operational management plans, which conclude when the induced seismicity risk abates back to background level. The focus of these recommendations is on actively managing the risks associated with induced seismicity by developing an actionable risk management plan that starts at the project proposal stage and continues through site closure through an iterative assessment and improvement process. The audience of this document is expected to include all interested stakeholders (e.g., operators, project developers, regulators, and the general public) and is expressly written to be accessible to this broad range of partners. This document is intended to disseminate knowledge gained through recent advances in the science of induced seismicity hazard and risk assessments, to provide updates based on recent experience gained by similar corollary injection-induced seismicity cases, and most importantly to establish a uniform framework to carry out a successful induced seismicity risk management plan for carbon storage projects in the future. These recommendations do not directly address any domestic or international regulations or standards. A complementary NRAP report makes recommendations for the assessment and management of environmental subsurface risks associated with unwanted fluid migration at GCS sites (Thomas et al., 2021) and should be referred to in order to address those additional GCS site risks

58 GEOSCIENCES↗

Continuous Risk Management: An Overview

Software risk management is important because it helps avoid disasters, rework, and overkill, but more importantly because it stimulates win-win situations. The objectives of software risk management are to identify, address, and eliminate software risk items before they become threats to success or major sources of rework. In general, good project managers are also good managers of risk. It makes good business sense for all software development projects to incorporate risk management as part of project management. The Software Assurance Technology Center (SATC) at NASA GSFC has been tasked with the responsibility for developing and teaching a systems level course for risk management that provides information on how to implement risk management. The course was developed in conjunction with the Software Engineering Institute at Carnegie Mellon University, then tailored to the NASA systems community. This is an introductory tutorial to continuous risk management based on this course. The rational for continuous risk management and how it is incorporated into project management are discussed. The risk management structure of six functions is discussed in sufficient depth for managers to understand what is involved in risk management and how it is implemented. These functions include: (1) Identify the risks in a specific format; (2) Analyze the risk probability, impact/severity, and timeframe; (3) Plan the approach; (4) Track the risk through data compilation and analysis; (5) Control and monitor the risk; (6) Communicate and document the process and decisions.

Rosenberg, Linda↗

Risk Management Implementation Tool

Continuous Risk Management (CM) is a software engineering practice with processes, methods, and tools for managing risk in a project. It provides a controlled environment for practical decision making, in order to assess continually what could go wrong, determine which risk are important to deal with, implement strategies to deal with those risk and assure the measure effectiveness of the implemented strategies. Continuous Risk Management provides many training workshops and courses to teach the staff how to implement risk management to their various experiments and projects. The steps of the CRM process are identification, analysis, planning, tracking, and control. These steps and the various methods and tools that go along with them, identification, and dealing with risk is clear-cut. The office that I worked in was the Risk Management Office (RMO). The RMO at NASA works hard to uphold NASA s mission of exploration and advancement of scientific knowledge and technology by defining and reducing program risk. The RMO is one of the divisions that fall under the Safety and Assurance Directorate (SAAD). I worked under Cynthia Calhoun, Flight Software Systems Engineer. My task was to develop a help screen for the Continuous Risk Management Implementation Tool (RMIT). The Risk Management Implementation Tool will be used by many NASA managers to identify, analyze, track, control, and communicate risks in their programs and projects. The RMIT will provide a means for NASA to continuously assess risks. The goals and purposes for this tool is to provide a simple means to manage risks, be used by program and project managers throughout NASA for managing risk, and to take an aggressive approach to advertise and advocate the use of RMIT at each NASA center.

Wright, Shayla L.↗

Communicating Risk to Program Managers

Program Managers (PM) can protect program resources and improve chances of success by anticipating, understanding and managing risks. Understanding the range of potential risks helps one to avoid or manage the risks. A PM must choose which risks to accept to reduce fire fighting, must meet the expectations of stakeholders consistently, and avoid falling into costly "black holes" that may open. A good risk management process provides the PM more confidence to seize opportunities save money, meet schedule, even improve relationships with people important to the program. Evidence of managing risk and sound internal controls can mean better support from superiors for the program by building a trust and reputation from being on top of issues. Risk managers have an obligation to provide the PM with the best information possible to allow the benefits to be realized (Small Business Consortium, 2004). The Institute for Chartered Accountants in England and Wales sees very important benefits for companies in providing better information about what they do to assess and manage key business risks. Such information will: a) provide practical forward-looking information; b) reduce the cost of capital; c) encourage better risk management; and d) improve accountability for stewardship, investor protection and the usefulness of financial reporting. We are particularly convinced that enhanced risk reporting will help listed companies obtain capital at the lowest possible cost (The Institute of Chartered Accountants in England &Wales, June 2002). Risk managers can take a significant role in quantifying the success of their department and communicating those figures to executive (program) management levels while pushing for a broader risk management role. Overall, risk managers must show that risk management work matters in the most crucial place-the bottom line- as they prove risk management can be a profit center (Sullivan, 2004).

Shivers, C. Herbert↗