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Dames & Moore, 1999 - USDA Forest Service

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are based on different mechanistic assumptions and expressed in different units. The two approaches are<br />

discussed below. Available toxicity criteria for humans are summarized in Table 7.1-38, and brief<br />

toxicological profiles for the IHSs are presented in Table 7.1-44.<br />

Non-Carcinogenic Effects<br />

Non-carcinogenic cleanup levels were calculated using reference doses (RfDs) developed by USEPA. An<br />

RtD is an estimate of the daily lifetime exposure level to humans (expressed in units of mg of chemicalkg<br />

of body weightjday), including sensitive subgroups, that is likely to be without appreciable risk of<br />

deleterious effects (USEPA, 1989). RfDs are usually derived from oral exposure studies with the most<br />

sensitive species, strain and sex of experimental animal known, the assumption being that humans are as<br />

sensitive as the most sensitive organism tested. They are based on the assumption that thresholds (exposure<br />

levels below which no adverse effect is expected) exist for non-carcinogenic effects, and incorporate<br />

uncertainty factors to account for the required extrapolations from animal studies and to ensure protection of<br />

sensitive human subpopulations. RfDs for constituents considered in the HHRA were obtained, whenever<br />

possible, from CLARC II. Table 7.1-38 summarizes both oral and inhalation RfDs and the toxic effects<br />

endpoint for IHSs.<br />

Carcinogenic Effects<br />

In contrast to non-carcinogenic effects, USEPA typically assumes that there is no threshold for carcinogenic<br />

responses; that is, any dose of a carcinogen is considered to pose some finite risk of cancer. The evidence<br />

for human carcinogenicity of a chemical is derived from two sources: chronic studies with laboratory<br />

animals, and human epidemiological studies where an increased incidence of cancer is associated with<br />

exposure to the chemical. As with the non-cancer toxicity studies, the most sensitive labratory species is<br />

generally used in cancer protocols.<br />

Since risks at the low levels of exposure usually encountered by humans are difficult to quantify directly by<br />

either animal or epidemiological studies, mathematical models are used to extrapolate from high<br />

experimental to low environmental doses. The slope of the extrapolated dose-response curve is used to<br />

calculate the cancer slope factor or potency factor (CPF), which defines the incremental lifetime cancer risk<br />

per unit of carcinogen (in units of risk per mg/kg/day). The linearized multi-stage model for low-dose<br />

extrapolation most often used by USEPA (USEPA, 1986a) is one of the most conservative available. and<br />

leads to a upper-bound estimate of risk (the upper 95 percent confidence limit on the modeled animal dose-<br />

response slope). The probability that the true risk is higher than that estimated is thus only 5 percent.<br />

Actual risk is likely to be lower, and could even be zero (USEPA, 1986a).<br />

Each tested chemical is assigned a weight-of-evidence classification that expresses its potential for human<br />

carcinogenicity. The USEPA's weight-of-evidence classification system is shown below:<br />

G:\~pd#uW)S\rrponrUloldco-2\n174~da 7-25<br />

17693-005-019Uuly 27.<strong>1999</strong>;5: 16 PMDRMT FINAL RI REPORT

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