and the reality that, because of the inherent complexity of the systems being managed and the long-term implications of many decisions (such as cancer latency, changes in the structure of ecosystems, or multiple simultaneous sources of exposure), there will be little or no short-term feedback as to whether the desired outcome has been achieved by the decisions.
The combination of uncertainty in the scientific data and assumptions (the “inputs”) and inability to validate assessment results directly or to isolate and evaluate the impact of a resulting decision (the “outputs”) creates a situation in which decision-makers, the scientific community, the public, industry and other stakeholders have little choice but to rely on the overall quality of the many processes used in the conduct of risk assessment to provide some assurance that the assessment is aligned with societal goals.
Those challenging properties of the decision-making environment may be considered particularly acute for many health and environmental decisions, but they are by no means new to decision-makers generally. The academic discipline of decision analysis under uncertainty, among others, has a rich literature on which to draw for methods and findings (Morgan et al. 1990; Clemen 1996; Raiffa 1997). The importance of attention to process is entirely compatible with the theory of the management sciences that defines a good decision under uncertainty as one that uses the most appropriate processes and methods to assemble and interpret evidence, to apply the decision-maker’s values properly, and to make timely choices with available resources rather than defining a good decision only according to its (apparent) outcomes. This attention to process is also compatible with arguments for the inclusion of more deliberative approaches to assessment and decision-making. As such, the most appropriate processes and methods in a given situation may be an appropriate balance of deliberative and analytic methods, as advocated in NRC (1996).
The process of risk assessment involves generation of a number of individual products that are combined to form a final product (which is often referred to as “the risk assessment”). The final product of a risk assessment process is most often understood to be a report. The present committee suggests that the product of a risk assessment should be considered to include not only the report but various subproducts, such as computational models and other information that is assembled during the process. The subproducts have different uses and serve a variety of audiences. For example, a computational model with a user-friendly interface may be at least as valuable in informing decision-making as the technical report most often associated with the term risk assessment. In addition, such subproducts as dose-response assessments typically have value that transcends a particular decision-support application and may be used in thousands of future decision-support situations. It is also useful to consider that risk assessments and individual subproducts experience a life cycle (consisting, for example, of conception, design, development, testing, use, maintenance, obsolescence, and replacement) that should be explicitly recognized.
The products of risk assessment may be thought of as, among other things, communication products. Their value lies in their contribution to the objectives of the decision-making function, including their effects on the primary decision-maker and other interested parties who participate in the decision or otherwise use the information that the products convey. Although the effort expended in the process is largely scientific, the critical final process in risk assessment is ultimately communication.