Protocol for the Derivation of Environmental and Human ... - CCME
Protocol for the Derivation of Environmental and Human ... - CCME
Protocol for the Derivation of Environmental and Human ... - CCME
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Section 6<br />
Uncertainty in Guidelines <strong>Derivation</strong><br />
6.1 Sources<br />
Developing environmental soil quality guidelines requires a model that estimates (predicts) a level in soil<br />
considered to be acceptable <strong>for</strong> given l<strong>and</strong> use exposure scenarios. The models employed in <strong>the</strong><br />
ecological portion <strong>of</strong> this protocol are predictive in nature. Predictions based on model input<br />
parameters or mechanisms create aggregate uncertainties when <strong>the</strong> model is applied. In most regulatory<br />
settings, it is desirable to assess qualitatively, if not quantitatively, <strong>the</strong> level <strong>of</strong> uncertainty attached to<br />
<strong>the</strong>se predictive models. This is done so that decision-makers underst<strong>and</strong> <strong>the</strong> uncertainties associated<br />
with <strong>the</strong> scientific data on which <strong>the</strong> decision was based (Suter, 1993).<br />
A wide spectrum <strong>of</strong> methods can assess <strong>the</strong> uncertainty associated with model predictions. In general,<br />
<strong>the</strong> major distinction between various approaches depends on whe<strong>the</strong>r <strong>the</strong> cause <strong>of</strong> concern is <strong>the</strong><br />
propagation <strong>of</strong> error by models (sensitivity analysis methods), or <strong>the</strong> causes <strong>of</strong> prediction uncertainty<br />
(uncertainty or error analysis methods) (Summers et al., 1993). Suter (1993) describes three basic<br />
sources <strong>of</strong> uncertainty in ecological risk assessment:<br />
• <strong>the</strong> inherent r<strong>and</strong>omness in <strong>the</strong> world (stochasticity),<br />
• imperfect or incomplete knowledge <strong>of</strong> things that could be known (ignorance), <strong>and</strong><br />
• mistakes in execution <strong>of</strong> assessment activities (error).<br />
Finally, <strong>the</strong>re is uncertainty in model error concerning <strong>the</strong> relationship between measurement endpoints<br />
used in guidelines derivation <strong>and</strong> <strong>the</strong> actual field population response or assessment endpoint. This<br />
uncertainty can be expressed as variance in <strong>the</strong> proportion <strong>of</strong> species to be protected at <strong>the</strong> level <strong>of</strong> <strong>the</strong><br />
guideline <strong>and</strong> <strong>the</strong> confidence in that degree <strong>of</strong> protection (Suter, 1993).<br />
6.2 Use Of Uncertainty Factors in Guidelines <strong>Derivation</strong><br />
Traditionally, <strong>the</strong> development <strong>of</strong> environmental quality st<strong>and</strong>ards or guidelines, has relied on <strong>the</strong><br />
application <strong>of</strong> uncertainty factors (UFs) (also referred to as safety factors) to a reference toxicological<br />
value (e.g., LOEC, LC(D) 50 , EC 50 ) to arrive at a "safe" concentration that is extrapolated to field<br />
conditions. Uncertainty factors account <strong>for</strong> various sources <strong>of</strong> uncertainty associated with <strong>the</strong> model<br />
input parameters, model design, <strong>and</strong> to extrapolate to field conditions. It is important to note that, in <strong>the</strong><br />
beginning, <strong>the</strong> use <strong>of</strong> uncertainty factors to account <strong>for</strong> model error was intuitive ra<strong>the</strong>r than scientific<br />
<strong>and</strong> it was stated emphatically that:<br />
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