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Protocol for the Derivation of Environmental and Human ... - CCME

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Part C, Section 2<br />

• inadequacies <strong>of</strong> <strong>the</strong> critical study.<br />

An additional uncertainty factor between one <strong>and</strong> five may be incorporated where <strong>the</strong>re is sufficient<br />

in<strong>for</strong>mation to indicate a potential <strong>for</strong> interaction with o<strong>the</strong>r chemical substances commonly present in<br />

<strong>the</strong> environment. If <strong>the</strong> chemical substance is essential or beneficial <strong>for</strong> human health, <strong>the</strong> dietary<br />

requirement is also taken into consideration in deriving <strong>the</strong> TDI. Numerical values <strong>of</strong> <strong>the</strong> uncertainty<br />

factor range from 10 to 10,000. Uncertainty factors greater than 10,000 are not applied since <strong>the</strong><br />

limitations <strong>of</strong> such a database preclude <strong>the</strong> development <strong>of</strong> a reliable TDI. Where <strong>the</strong>re are limitations in<br />

<strong>the</strong> protocol <strong>of</strong> <strong>the</strong> critical study a "tentative TDI" may be established.<br />

The TDI can be defined as:<br />

TDI = NO(A)EL OR LO(A)EL<br />

Uncertainty Factors<br />

Uncertainty factors are assigned by Health Canada based on pr<strong>of</strong>essional judgement. Health Canada<br />

has accepted <strong>the</strong> responsibility <strong>for</strong> determining <strong>the</strong> Tolerable Daily Intake (TDI) <strong>for</strong> each contaminant<br />

addressed by <strong>the</strong> NCSRP.<br />

78

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