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of uncertainty within which even differences of several fold may not affect the decision.

 

It is important for both risk managers and critics of risk assessment to avoid pursuing the ideal risk assessment. These individuals must bear in mind the limits of the real world. These limits include time, money, and the state of scientific knowledge.

4.

Statutory mandates may place constraints on the development and use of risk characterization data that are not consistent with our understanding of the underlying science. The establishment of risk targets (or bright lines) such as 10-6, for example, have been criticized as not allowing the consideration of weight-of-evidence in decision making. Another example is the requirement that the Agency consider the risk to the ''person most exposed" to emissions from an air toxics source. Thus, the statutory framework constrains full consideration of the distribution of risk across the exposed population.

5.

Statutes or court action often mandate regulation at a specific time, effectively mandating decision-making based upon available data. This is exacerbated by the fact that the development of robust health and safety data (e.g., well-conducted animal bioassays, epidemiological, or exposure studies) are both resource- and time-intensive.

6.

The risk management process is often the focus of considerable outside attention and controversy. This is particularly true where the impacts of decisions are costly, or where they adversely affect well-organized groups. On these circumstances, there is a natural tendency to continue the process of data development and analysis, rather than to make decisions in an atmosphere of uncertainty. While such an environment can cause delay, it can also have the effect of encouraging more rigorous examination of data and careful consideration of options.

7.

Persistent requests for information and more studies lead to paralysis by analysis and the waste of limited resources. The risk of inaction is often forgotten. Additional information needs must be balanced against the need to take timely action where it is warranted. This is particularly true in the risk assessment process, where the limitations of the current state of the science often prevent definitive answers, and can encourage continual additional data development. Reviewers of Agency risk assessments must consider the reasonable resource constraints under which the Agency operates.



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