There are three main components of the safety lifecycle: analysis, realization, and operation. To start, the first thing to do in both safety and security is do a detailed process, hazard and risk analysis of the system. Parallel to activities of management of functional safety and assessments, you need to look at the root safety requirements of the system and make sure that they are current.
Similar to the safety lifecycle, the cybersecurity lifecycle has an assess phase, analysis phase, implementation phase, and operational phase. First start with the cyber security risk assessment itself, which involves being clear about exactly what equipment is involved and what analysis you'll be doing. Detailed cyber security risk assessment inputs include policies and procedures, which are the basis for the Recognized and Generally Accepted Good Engineering Practices (RAGAGEP). One of the other key components of risk assessment is basically a snapshot or a clear understanding of the interconnections within your system. Now we want to start leveraging the process hazard analysis and start asking some questions. As you are doing this analysis, there is a methodology to follow, starting with high-level cyber risk assessment. For those of you who are just starting operations, otherwise known as greenfield operations, you have a clean slate and can do these analyses from the start and build your implementations from the beginning. There is a need to make judgments early when planning risk assessments regarding the purpose, scope, and technical approaches that will be used.
The objective of the problem formulation phase is to define an assessment endpoint to determine what ecological entity is important to protect. Once the entity has been identified, the next step is to determine what specific attribute(s) of the entity is potentially at risk and important to protect. The challenge is to find ecological values that are scientifically rigorous and are also recognized as valuable by risk managers and the public.
Once assessment endpoints are chosen, a conceptual model is developed to provide a visual representation (a map, flow chart, or schematic) of hypothesized relationships between ecological entities and the stressors to which they may be exposed, accompanied by a written description of this process and of the risk questions. The objective of the analysis phase is to provide the ingredients necessary for determining or predicting ecological responses to stressors under exposure conditions of interest. Analysis is the determination of what plants and animals are exposed and to what degree they are exposed and if that level of exposure is likely or not to cause harmful ecological effects. The objective of the risk characterization phase is to use the results of analysis to estimate the risk posed to ecological entities.


A good risk characterization will restate the scope of the assessment, express results clearly, articulate major assumptions and uncertainties, identify reasonable alternative interpretations, and separate scientific conclusions from policy judgments.
Transparency - The characterization should fully and explicitly disclose the risk assessment methods, default assumptions, logic, rationale, extrapolations, uncertainties, and overall strength of each step in the assessment. Clarity - The products from the risk assessment should be readily understood by readers inside and outside of the risk assessment process. Consistency - The risk assessment should be conducted and presented in a manner which is consistent with EPA policy, and consistent with other risk characterizations of similar scope prepared across programs within the EPA.
Reasonableness - The risk assessment should be based on sound judgment, with methods and assumptions consistent with the current state-of-the-science and conveyed in a manner that is complete, balanced, and informative.
In order to achieve this in a risk characterization, these same principles need to have been applied in all of the previous steps in the ecological risk assessment which lead up to the risk characterization.
Finally, EPA scientists integrate the effects and exposure characterizations into a risk characterization that describes the ecological risk from the use of the pesticide or the likelihood of effects on aquatic and terrestrial animals and plants based on varying pesticide use scenarios. An ecological risk assessment tells what happens to a bird, fish, plant or other non-human organism when it is exposed to a stressor, such as a pesticide. In scientific terms, an ecological risk assessment "evaluates the likelihood that adverse ecological effects may occur or are occurring as a result of exposure to one or more stressors" (U.S. This assessment process combines all the information from the toxicity tests (ecological effects), the exposure information, assumptions, and uncertainties in a way that helps the risk assessor understand the relationships between the ecological effects and the stressors (pesticides) and helps support decision-making. In determining whether a pesticide will harm the environment and wildlife, EPA conducts an ecological risk assessment for each pesticide active ingredient and major degradation products. These three phases are described in the following section under Framework for Ecological Risk Assessment. In developing its ecological risk assessments, the Office of Pesticide Programs follows the framework that was developed by EPA's Risk Assessment Forum.
In this second phase of the risk assessment process, the risk assessors evaluate exposure to stressors (exposure characterization) and the relationship between stressor levels and ecological effects (ecological effects characterization).
During these analyses, the scientists evaluate the uncertainties in the exposure and effects characterizations. The risk characterization is the final phase in which exposure and ecological effects characterizations are integrated into an overall conclusion (risk estimation).
The integrated risk characterization includes the assumptions, uncertainties, and strengths and limitations of the analyses. When developing risk characterizations, EPA scientists follow the guidance presented in EPA's Risk Characterization Handbook (PDF) (189 pp, 2.08 MB, About PDF).


We will be taking a look at the analysis phase, particularly related to the cyber industry. In the case of safety, you should allocate safety functions that will protect against those risks that you have identified and create a safety specification or set of requirements for each of those safety functions that you are going to apply. Your zone and conduit drawings need to be correct, you need to have a clear understanding of corporate goals, any standards or regulations that your industry needs to listen to and you need to have a technical team that is familiar with these requirements, understand your existing system, and has good, clear knowledge of cyber risk assessment methodologies.
Unfortunately, my guess is that many of you are involved in existing operations and systems and are trying to put together an assessment or cyber strategy and put it onto existing systems.
To simplify our discussion of planning the following structure focuses on ecological risk assessment.
The assessor then describes the risk, indicating the overall degree of confidence in the risk estimates, summarizing uncertainties, citing evidence supporting the risk estimates, and interpreting the adversity of ecological effects. This framework can be found in EPA's February 1992 report Framework for Ecological Risk Assessment, which was later updated as the Agency's Guidelines for Ecological Risk Assessment (April 1998). In this phase, the risk assessor compares the levels of exposure (estimated environmental concentrations) expected in the field to those levels that produce toxic effects in laboratory tests. After this phase is completed, risk assessors formally communicate and discuss their results with risk managers.
Once those requirements are in place, the realization phase is similar to other realization efforts, including design and engineering, acceptance testing and installation, and various validation stages. This table identifies means to address those high-level risks and gain insight as to what needs the initial detailed risk assessment. The problem formulation articulates the purpose and objectives of the risk assessment and defines the problem and regulatory action. In addition to the risk assessment report, risk managers consider other information, such as social, economic, political, and legal issues, in their decisions. For every 20 years of operation, the company should have at least 20 months of realization, and 20 weeks of analysis for building that system. The analysis in this particular rule of thumb is not only for cyber analysis, but also for safety hazard analysis.



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