Health Assessment Document for Diesel Emissions - NSCEP | US ...

1 12.3.3.2.4. Assessing risk using a comparative potency method. A third approach, developed
2 before either animal bioassay or human epidemiologic data became available, is the comparative
3 potency method of Albert et al. (1983). In this method, exhaust particle extracts obtained from
4 three light-duty engines, manufactured by Nissan, General Motors, and Volkswagen, and a
5 Caterpillar heavy-duty engine were evaluated for potency in a variety of short-term tests. The
6 ratios of potencies of these extracts were then multiplied by the unit risk estimates of related
7 combustion or pyrolysis products, such as roofing tar, cigarette smoke condensate, and coke oven
8 emissions, for which unit risk estimates based on human data had already been derived. The
9 potency ratio of DE to each of these was multiplied by their unit risk estimate. Using this method
10 Albert et al. (1983) derived a unit risk estimate for DE averaging about J x 1 o- 5 per Jlglm 3 •
11 The comparative potency method was developed more than 15 years ago because bioassay
12 data were lacking at the time and because it was believed that cancer induction was a function of
13 the organic components. Conceptually, this approach can still be of use in rationalizing lower
14 limits on risk. However, one must accept the assumption that relative potency in short-term tests
15 will be similar to relative potency for lung cancer induction. Any reluctance may be balanced by
16 considerable reliance on dermal exposure in some of the short-term studies. Since both skin and
17 lungs are epithelial tissues, confidence that relative potencies are similar increases. Another
18 possible weakness in the comparative approach is a failure to account for potential differences in
19 the relative bioavailability of the organic fraction during exposure to whole exhaust versus
20 exposure to particle extracts, or the possibility that association of organics with particles may alter
21 their effectiveness. It is not known whether these issues raise significant concerns.
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23
Tabular summary of animal-based risk estimates
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19 X 1 o-
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5 per J.lg/m3 Upper limit from low-dose rat studies
3.4 x 10· 5 per J.lg;/m3 Upper bound from high-dose rat responses
3 X 1 Q- 5 per J.lg/m3 Upper bound from BaP comparative potency
analysis
1 X 1 Q-5 per J.lg/m3 Linear extrapolation using BBDR model
30 12.3.3.3. Bounds for Cancer Risk and Margin of Exposure
31 Each of the dose-response and risk derivation approaches, using human or animal data, has
32 known uncertainties that seemingly preclude selecting one as the "most scientifically va\id" or
33 best estimate. Taken collectively, the approaches provide a numerical basis for defining a range
34 of plausible upper-bound risks, upper-bound meaning that conservative assumptions (e.g., linear
35 low-dose extrapolation) have been used and this is not likely to result in an underestimate of risk.
2/1/98 12-25 DRAFT--DO NOT CITE OR QUOTE