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basis for EPA decisions, while numbers alone do not give a true picture of the assessment.
This problem is not EPA's alone. Agency contractors, industry, environmental groups, and other participants in the overall regulatory process use similar "short hand" approaches.
We must do everything we can to ensure that critical information from each stage of the risk assessment is communicated from risk assessors to their managers, from middle to upper management, from EPA to the public, and from others to EPA. The Risk Assessment Council considered this problem over many months and reached several conclusions: 1) We need to present a full and complete picture of risk, including a statement of confidence about data and methods used to develop the assessment; 2) we need to provide a basis for greater consistency and comparability in risk assessment across Agency programs; and 3) professional scientific judgment plays an important role in the overall statement of risk. The Council also concluded that Agency-wide guidance would be useful.
Principles emphasized during Risk Assessment Council discussions are summarized below and detailed in the attached Appendix.
Full Characterization of Risk
EPA decisions are based in part on risk assessment, a technical analysis of scientific information on existing and projected risks to human health and the environment. As practiced at EPA, the risk assessment process depends on many different kinds of scientific data (e.g., exposure, toxicity, epidemiology), all of which are used to "characterize" the expected risk to human health or the environment. Informed use of reliable scientific data from many different sources is a central feature of the risk assessment process.
Highly reliable data are available for many aspects of an assessment. However, scientific uncertainty is a fact of life for the risk assessment process as a whole. As a result, agency managers make decisions using scientific assessments that are less certain than the ideal. The issues, then, become when is scientific confidence sufficient to use the assessment for decision-making, and should the assessment be used? In order to make these decisions, mangers need to understand the strengths and limitations of the assessment.
On this point, the guidance emphasizes that informed EPA risk assessors