Ce. Cowan et al., INTEGRATED APPROACH FOR ENVIRONMENTAL ASSESSMENT OF NEW AND EXISTING SUBSTANCES, Regulatory toxicology and pharmacology, 21(1), 1995, pp. 3-31
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 environmen
tal risk assessments and to prioritize testing for these substances. T
his assessment must integrate fate and effects at the point-of-entry;
it should also extend to an assessment of the potential to persist, an
d the consequences of increases in exposure concentrations, and to bio
accumulate. The conventional environmental risk assessment approach is
used to assess the fate and effects of a substance at its point-of-en
try into the environment. In this paper, an approach is presented for
conducting quantitative environmental risk assessments of new and exis
ting substances that builds on this conventional, approach by includin
g quantitative assessment of the potential for, and consequences of, p
ersistence and bioaccumulation. The approach is described for aquatic,
sediment, and terrestrial environments. For each environmental compar
tment, the approach includes (i) classification of the substance, base
d on environmental partitioning processes, to ensure that the appropri
ate data are collected and models used; (ii) a fate assessment to unde
rstand the ultimate fate of the substance after entry into the environ
ment or ''an environmental compartment'' and to predict the exposure c
oncentration of the substance at point-of-entry; (iii) a persistence a
ssessment 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 appr
oach is illustrated using data for a hypothetical consumer product sub
stance that is disposed down-the-drain. (C) 1995 Academic Press, Inc.