Risk Management Frameworks

The initial framework for risk assessment and risk management proposed by the NRC in 1983, as mentioned above, was the first U.S. publication that systematically related foodborne human health, risk assessment, and risk management. The work of the NRC marked the first major U.S. effort to define nomenclature for, and the key steps of, public health risk assessment (NRC, 1983). The Committee met to consider chemical hazards and carcinogenic consequences or end points. However, the work, referred to as the "Red Book," has been applied beyond its initial scope of risk assessment for carcinogens.

Risk Analysis Managerial Strategies

The NRC (1983) outlined a managerial structure of risk analysis in Figure 1.1 of their report. Certain features of this figure are depicted in Eq. 3.1.

Risk Risk

Research Assessment {Decisions} Management (3.1)

These relationships are consistent with the concept that risk assessment is a structured process that links science and policy. The first unidirectional arrow on the left indicates that research data and information are inputs to risk assessment. However, an implication of Eq. 3.1 is that the research goals and objectives are not influenced by the needs of risk assessors. In other words, research projects are not specifically designed to meet the needs of risk assessments. The President's Commission on Risk Management (1996) recognized this problem and stated that risk assessments should motivate research. Uncertainty and sensitivity analyses of risk assessment models can identify crucial research needed for improving estimations of risk.

The second and third unidirectional arrows emphasize the objectivity of the science and the independence of risk assessment from other influences that have bearing on the risk manager's decision making process. Developing preliminary analyses for the scope of the risk assessment requires some initial dialogue between risk assessors and risk managers. As the assessment is conducted, a risk manager should clearly refrain from exerting any influence on the process that might bias the results. Therefore, the phases of risk assessment dealing with scientific data generally exclude risk managers. However, as a risk assessment nears completion, risk assessors and risk managers might jointly develop policy options for mitigation or risk reduction and economic analyses such as cost-benefit analysis for potential mitigation, regulations, or guidance. This view of risk analysis demands some dialogue between risk assessors and risk managers, but as implied by Eq. 3.1, only at the end of the process, at the decision point.

The results of the risk assessment become an input to the risk manager's decision making process. One consequence, perhaps unintended, of these unidirectional relationships is the hindrance of open and transparent communication with risk managers and other stakeholders about the scientific data, assumptions, and methodologies used in the risk assessment. The possibility exists in this framework that risk assessment will become a "black box" for the risk manager as well as for the stakeholders.

As a consequence of these concerns, a more general framework is needed. Equation 3.2 represents a simple extension of the NRC model utilizing bidirectional arrows.

Research Risk Assessment Risk Management

The left bidirectional arrow implies that research should be motivated and directed by the needs of risk assessors in conducting risk assessments. This reflects a new emphasis on the opportunity for risk assessors to identify key data gaps and to take an active part in influencing the direction of research to improve risk assessment models. The right bidirectional arrow implies that not only is decision making a joint enterprise between risk assessors and risk managers, but also the assumptions and inferences used by the risk assessors must be communicated clearly to the risk managers. The bidirectional arrow on the right is not meant to imply that the influence of risk managers diminishes the independence of the risk assessment, but as a consequence independence could be diminished. Equation 3.1 still does not explicitly include risk communication structure.

The NRC 1983 framework appears to omit risk communication with the stakeholders. One motivation for change, or expansion of the framework, involves including stakeholders who want to understand risk and to choose how they respond to risk as individuals and societies (NRC, 1996). Many risk analysts and stakeholders recognize that the usefulness of unidirectional processes for risk analysis merits further scrutiny (President's Commission on Risk Management, 1996; Marks, 1998; FDA, 1999).

Many levels of communication are needed among researchers, risk assessors, and managers. For example, dialogue is necessary between the risk assessors and managers for defining the scope of the risk assessment, preparing and testing models for various risk management options, engaging in discussions about the results and interpretations of the results of the risk assessment, and influencing the direction of the research. However, communication between the risk analysis professionals and the stakeholders is more complicated. For example, one of the many sources of difficulty is the depth of technical knowledge required to understand the risk assessment. Many technical assumptions are made that can raise questions about the validity of the results. Another problem is that risk assessments often do not address the problem in its entirety, but rather address a portion of it, omitting other associated hazards that could become concerns to the community (NRC, 1996). For stakeholders to develop a better understanding of the nature of the problem and to evaluate possible solutions to the problem, it is necessary for them to understand in detail the risk assessment process. The next section provides a discussion of the nature and limitations of the risk assessment process.

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