Integrated approach for environmental assessment of new and existing substances.

To ensure the environmental safety of new and existing substances, the environmental fate and potential effects resulting from their release into the environment must be assessed. This requires the development of reasonable, consistent, and effective methods to conduct environmental risk assessments and to prioritize testing for these substances. This assessment must integrate fate and effects at the point-of-entry; it should also extend to an assessment of the potential to persist, and the consequences of increases in exposure concentrations, and to bioaccumulate. The conventional environmental risk assessment approach is used to assess the fate and effects of a substance at its point-of-entry into the environment. In this paper, an approach is presented for conducting quantitative environmental risk assessments of new and existing substances that builds on this conventional approach by including quantitative assessment of the potential for, and consequences of, persistence and bioaccumulation. The approach is described for aquatic, sediment, and terrestrial environments. For each environmental compartment, the approach includes (i) classification of the substance, based on environmental partitioning processes, to ensure that the appropriate data are collected and models used; (ii) a fate assessment to understand the ultimate fate of the substance after entry into the environment or "an environmental compartment" and to predict the exposure concentration of the substance at point-of-entry; (iii) a persistence assessment which determines the potential for increase in the exposure concentration as a result of repeated additions of the substance; (iv) effects assessment; (v) environmental risk assessment to examine the potential for adverse impact on ecosystems; and (vi) a bioaccumulation assessment to evaluate the potential for direct and indirect effects on the species of interest due to bioaccumulation. The assessment approach is illustrated using data for a hypothetical consumer product substance that is disposed down-the-drain.