Deterministic exposure estimates

Uncertainties assessed at Tier 2 (deterministic) generate alternative point estimates for exposure and may be communicated in various ways, depending on the particular methods used for sensitivity analysis. As a minimum, this should identify which sources of uncertainty have been treated at Tier 2, state and justify the alternative quantitative estimates used for each one (e.g. minimum, maximum and most likely values), present exposure estimates for those combinations of alternative estimates that are considered plausible and state and justify any combinations of estimates that are considered implausible. In addition, it will be useful (especially if upper estimates exceed levels of concern) to show which of the quantified uncertainties have most influence on the outcome. 

TIERED APPROACHES TO EXPOSURE ASSESSMENT 144 Deterministic (Point-Estimate) Exposure Assessments 145 Probabilistic Exposure Assessments 145 REPORT WRITING 145 Protocol/User s Guide 146 General Description of Exposure Model 146 Detailed Description of Model Inputs and Outputs 146 Exposure Model Validation 146 Quality Assurance Practices 147 Archiving 147... 

First, individuals interpreting data must decide on whether to use a deterministic or a probabilistic approach to generate an exposure estimate for the analysis. The deterministic approach (point-estimate) is widespread and beginning with this approach is consistent with the tiered approach to exposure and risk assessment. 

When calculating chronic dietary exposure, the deterministic models use point values for both food consumption and residue concentration, thereby yielding a point estimate of dietary exposure. In the US, the initial chronic dietary exposure estimate is the Theoretical Maximum Residue Contribution (TMRC) and is analogous to the Theoretical Maximum Daily Intake (TMDI) used to estimate chronic dietary exposure in the EU. Both the TMRC and the TMDI are relatively conservative estimates of dietary expostire. The TMRC is calculated as the product of the mean consumption value and the US pesticide tolerance [6]. In the EU, the TMDI is calculated as the product of the mean consumption value and the Maximum Residue Limit (MRL) [7]. The objective of both calculations is essentially identical to calculate an estimate of the central tendency of the dietary exposure. Both calculated values use the central tendency dietary exposure estimate as the estimate of chronic (long-term) dietary exposure and calculate it using mean consumption data and the maximum residue permitted on the commodity. 

QRA is fundamentally different from many other chemical engineering activities (e.g., chemistry, heat transfer, reaction kinetics) whose basic property data are theoretically deterministic. For example, the physical properties of a substance for a specific application can often be established experimentally. But some of the basic property data used to calculate risk estimates are probabilistic variables with no fixed values. Some of the key elements of risk, such as the statistically expected frequency of an accident and the statistically expected consequences of exposure to a toxic gas, must be determined using these probabilistic variables. QRA is an approach for estimating the risk of chemical operations using the probabilistic information. And it is a fundamentally different approach from those used in many other engineering activities because interpreting the results of a QRA requires an increased sensitivity to uncertainties that arise primarily from the probabilistic character of the data. 

CASRAM predicts discharge fractions, flash-entrainment quantities, and liquid pool evaporation rates used as input to the model s dispersion algorithm to estimate chemical hazard population exposure zones. The output of CASRAM is a deterministic estimate of the hazard zone (to estimate an associated population health risk value) or the probability distributions of hazard-zones (which is used to estimate an associated distribution population health risk). 

The determination of the estimated levels of exposure is obviously a critical component of the risk assessment process. Both pesticide residue levels and food consumption estimates must be considered. Methods for determining exposure are frequently classified as deterministic and probabilistic methods (Winter, 2003). 

Measurement of dietary exposure to pesticides has historically relied upon deterministic methods that assign finite values to both the pesticide residue level and the food consumption estimates to yield a point estimate of exposure. The calculations are relatively simple, but consideration needs to be given to the accuracy of the assumptions concerning residue level and food consumption. 

The environmental concentration of a stressor, either measured or estimated, is compared with an effect concentration such as an LC50 (lethal concentration to kill 50% of individuals in a theoretical population in a set period of time) or no observed effect concentration (NOEC) [31, 32]. These are simple ratios of single exposure and effects values and may be used to express hazard or relative safety. This deterministic method uses point estimates to represent one or more factors in a risk assessment and treats them as if they were fixed and precisely known [33]. The calculation of HQs... 

The ability to use probabilistic approaches to assess dietary pesticide exposure has also changed much of the emphasis of pesticide risk assessment practices from assessing long-term (chronic) exposure to short-term (acute) exposure. Deterministic approaches worked well with chronic assessments since the day-to-day variability in food consumption patterns and the variability of pesticide residue levels tended to average out over the course of a 70-year exposure period. Deterministic approaches have also often been used in the assessment of acute dietary risk by assuming an upper percentile level of food consumption and the maximum detected or allowable level of residue. The point estimate determined in this manner is then compared with the RfD to determine the acceptability of exposure under the specified conditions. 

The risk index for any hazardous substance in Equation 1.1 or 1.2 (see Section 1.5.1) is calculated based on assumed exposure scenarios for hypothetical inadvertent intruders at near-surface waste disposal sites and a specified negligible risk or dose in the case of exempt waste or acceptable (barely tolerable) risk or dose in the case of low-hazard waste. Calculation of the risk index also requires consideration of the appropriate measure of risk (health-effect endpoint), especially for carcinogens, and the appropriate approaches to estimating the probability of a stochastic response per unit dose for carcinogens and the thresholds for deterministic responses for noncarcinogens. Given a calculated risk index for each hazardous substance in a particular waste, the waste then would be classified using Equation 1.3. 

EPA does not consider data on developmental toxicity, standing alone, as an adequate basis for estimating RfD. Investigators use acute or short-term exposures for these studies. Therefore, they are of limited use in estimating the threshold for deterministic responses. However, if developmental toxicity is the critical response for a chemical with a complete database, EPA will derive RfD from that study. 

Given the models for estimating external or internal radiation doses in specific organs or tissues, the following sections consider the responses resulting from a given dose by any route of exposure. As is the case with hazardous chemicals, both stochastic and deterministic radiation effects can occur. 

For purposes of health protection, the dose-response relationships for deterministic effects from exposure to radionuclides and hazardous chemicals are assumed to have a threshold. For either type of substance, the assumed thresholds are based on data for the most sensitive organ or tissue. However, there are potentially important differences in the way these thresholds are estimated and then applied in health protection of the public. 

For most chemicals that induce deterministic effects, the nominal threshold in humans or animals has been estimated based on NOAELs or LOAELs. However, the benchmark dose method should provide more reliable estimates of thresholds (see Section 3.2.1.2.7). Therefore, whenever the nominal threshold in humans for an important chemical in waste that induces deterministic effects has been estimated based on NOAELs or LOAELs, NCRP believes that the data should be re-evaluated using the benchmark dose method to promote greater consistency in classifying waste. As in the case of chemicals that induce stochastic effects discussed in the previous section, NCRP believes that uncertainties in the data beyond those incorporated in the benchmark dose method should be taken into account, if need be, in setting allowable exposures, rather than in an estimate of the nominal threshold. 

In many respects, the foundations and framework of the proposed risk-based hazardous waste classification system and the recommended approaches to implementation are intended to be neutral in regard to the degree of conservatism in protecting public health. With respect to calculations of risk or dose in the numerator of the risk index, important examples include (1) the recommendation that best estimates (MLEs) of probability coefficients for stochastic responses should be used for all substances that cause stochastic responses in classifying waste, rather than upper bounds (UCLs) as normally used in risk assessments for chemicals that induce stochastic effects, and (2) the recommended approach to estimating threshold doses of substances that induce deterministic effects in humans based on lower confidence limits of benchmark doses obtained from studies in humans or animals. Similarly, NCRP believes that the allowable (negligible or acceptable) risks or doses in the denominator of the risk index should be consistent with values used in health protection of the public in other routine exposure situations. NCRP does not believe that the allowable risks or doses assumed for purposes of waste classification should include margins of safety that are not applied in other situations. 

As an alternative to the assumption of a one-time exposure for 1,000 h at the time of facility closure, permanent occupancy of a disposal site following loss of institutional control could be assumed (see Section 7.1.3.4). The assumption of chronic lifetime exposure would affect the analysis for hazardous chemicals that induce deterministic effects only if estimated intakes due to additional pathways, such as consumption of contaminated vegetables or other foodstuffs produced on the site, were significant. Based on the results for lead in Table 7.8, an intake rate from additional pathways of about 50 percent of the assumed intake rate by soil ingestion, inhalation, and dermal absorption would be sufficient to increase the deterministic risk index above unity. The importance of additional pathways was not investigated in this analysis, but they clearly would warrant consideration. The increase in exposure time during permanent occupancy does not otherwise affect the analysis for chemicals that induce deterministic effects, provided RfDs are appropriate for chronic exposure, because chronic RfDs incorporate an assumption that the levels of contaminants in body organs relative to the intake rate (dose) are at steady state. 

Traditionally, risk characterization is based on a deterministic approach, meaning that the risk is based on a point estimate, usually the worst-case value for each input variable (worst-case NOAELs, assessment factors, and exposure levels). This worst-case approach is intended to ensure that even the most sensitive part of the population is protected under all conditions, and therefore generally overestimates the health risk. In the case of food allergens, the maximum consumption of a food may be multiplied by the maximum concentration of the allergen in this food. This results in the maximum estimate of the intake of the allergen. If this intake is higher than the lowest threshold observed, a possible reaction to the allergen cannot be ruled out. 

---