Risk Estimation Methods

The methods to be used in the process of risk assessment or estimation include  

There are other methods to be found in special books that deal with the subject. 

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In animal experiments exposures can be carefully controlled, and dose-response curves can be formally estimated. Extrapolating such information to the human situation is often done for regulatory purposes. There are several models for estimating a lifetime cancer risk in humans based on extrapolation from animal data. These models, however, are premised on empirically unverified assumptions that limit their usefulness for quantitative purposes. While quantitative cancer risk assessment is widely used, it is by no means universally accepted. Using different models, one can arrive at estimates of potential cancer incidence in humans that vary by several orders of magnitude for a given level of exposure. Such variations make it rather difficult to place confidence intervals around benefits estimations for regulatory purposes. Furthermore, low dose risk estimation methods have not been developed for chronic health effects other than cancer. The... 

The main difference between the two simplified risk estimation methods is that it is possible also to... 

The F-N curve, the risk profile, and the risk contour are the three most commonly used methods of graphically presenting risk results. Normally, you will elect to use more than one of these methods when evaluating risk estimates for decision making. 

The model contains a surface energy method for parameterizing winds and turbulence near the ground. Its chemical database library has physical properties (seven types, three temperature dependent) for 190 chemical compounds obtained from the DIPPR" database. Physical property data for any of the over 900 chemicals in DIPPR can be incorporated into the model, as needed. The model computes hazard zones and related health consequences. An option is provided to account for the accident frequency and chemical release probability from transportation of hazardous material containers. When coupled with preprocessed historical meteorology and population den.sitie.s, it provides quantitative risk estimates. The model is not capable of simulating dense-gas behavior. 

But it will also be seen that vapour pressure estimation methods provide critical analysis of all parameters involved in a fire hazard and thus allow refinement of the methods leading to a quantification of this risk. 

The program sets four criteria, leading to a three-level qualitative classification low risk, medium, high for each of them. Each criterion quantifies an aspect of the decomposition risk. So these four classifications need to be taken into account to arrive at a final estimation. Someworkers have tried to use a sole criterion, which mathematically combines the four criteria, but failed. Three out of these four criteria involve calculating the enthalpies of decomposition and combustion of the particular compound. In order to do so it is necessary to know the enthalpies of formation of the compound and of the decomposition and combustion products. A lot of these values are inevitably absent in Part Three, so it was thought necessary to include estimation methods for enthaipies of formation as weil as for enthalpies of vapourisation/condensation, since in many cases there is only available the value for the physical state of the compound that is not always appropriate. 

As probabilistic exposure and risk assessment methods are developed and become more frequently used for environmental fate and effects assessment, OPP increasingly needs distributions of environmental fate values rather than single point estimates, and quantitation of error and uncertainty in measurements. Probabilistic models currently being developed by the OPP require distributions of environmental fate and effects parameters either by measurement, extrapolation or a combination of the two. The models predictions will allow regulators to base decisions on the likelihood and magnitude of exposure and effects for a range of conditions which vary both spatially and temporally, rather than in a specific environment under static conditions. This increased need for basic data on environmental fate may increase data collection and drive development of less costly and more precise analytical methods. 

The third method used to interpret the level of risk associated with chlorpy-rifos use is Monte Carlo simulation. This method provides a range of exposure estimates for the evaluation of the uncertainty in a risk estimate based on ranges of input variables. The first step in performing a Monte Carlo simulation is determination of a model to describe the dose. This model describes the relationship between the input parameters and dose, and a specific model is presented here for one group of workers. 

This model tends to approach a zero probability rapidly at low doses (although it never reaches zero) and thus is compatible with the threshold hypothesis. Mantel and Bryan, in applying the model, recommend setting the slope parameter b equal to 1, since this appears to yield conservative results for most substances. Nevertheless, the slope of the fitted curve is extremely steep compared to other extrapolation methods, and it will generally yield lower risk estimates than any of the polynomial models as the dose approaches zero. 

A major objective in developing these risk estimation procedures was to provide a method capable of evaluating hundreds of properties in several communities within the DOE Uranium Mill Tailings Remedial Action Program in a timely manner. Therefore, we chose a calculation scheme that could be performed using commercially available database software (dBASE II, a trademark of Ashton-Tate, Culver City, CA), but that at the same time would be flexible enough that assessments for other contaminants could be readily incorporated. 

LOPA is a semi-quantitative tool for analyzing and assessing risk. This method includes simplified methods to characterize the consequences and estimate the frequencies. Various layers of protection are added to a process, for example, to lower the frequency of the undesired consequences. The protection layers may include inherently safer concepts the basic process control system safety instrumented functions passive devices, such as dikes or blast walls active devices, such as relief valves and human intervention. This concept of layers of protection is illustrated in Figure 11-16. The combined effects of the protection layers and the consequences are then compared against some risk tolerance criteria. 

Albert, R. E. et al., "The Carcinogen Assessment Group s Method for Determining the Unit Risk Estimate for Air Pollutants," U.S. Environmental Protection Agency, 1980. 

Most of the risks estimated to be associated with environmental chemical exposures are much less firmly established. So, although chemical risk information is often expressed in the same form as that based on directly measured risks, it is derived using quite different methods, and almost always includes extrapolations beyond measured risk data. 

Sanner et al. (2001) have evaluated the proposed T25 method by comparing risk estimates obtained with this method to those obtained by using the LMS method (Section 6.3.1) as well as the LEDio method proposed by the US-EPA in 1996 (Section 6.3.2). The comparisons included both genotoxic and non-genotoxic carcinogens, as the main purpose was to compare the methods when the same data set was used, as well as to evaluate the possible effects of different shapes of the dose-response curves. 

Communication between risk managers, risk assessors, and analysts is essential from the start of the assessment process, not just in communicating results. For example, the choice of uncertainty analysis methods will be dependent on 1) the questions posed by decision makers, 2) the closeness of the risk estimate and its bounds to thresholds of acceptability or unacceptability, 3) the type of decision that must be made, and 4) the consequences of the decision. 

Suter et al. 1993 Society of Environmental Toxicology and Chemistry [SETAC] 1994 European Union 1997 Ecological Committee on FIFRA Risk Assessment Methods [ECOFRAM] 1999 Campbell et al. 1999). The initial use of conservative assessment criteria (i.e., err on the side of caution) allows substances that do not present a risk to be eliminated from the risk assessment process early, thus allowing the focus of resources and expertise to be shifted to potentially more problematic substances or situations. As one ascends through the tiers, the estimates of exposure and effects become more realistic with the acquisition of more accurate and/or representative data, and uncertainty in the extrapolation of effects is thus reduced or at least better characterized. Likewise, the methods of extrapolation may become more sophisticated as one ascends through the tiers (Figure 1.2). 

De Zwart (2005) used a novel method to predict the effects of multiple stressors caused by pesticides based on a GIS map of agricultural land use, comprising 51 crops. Through the application of SSDs for aquatic organisms, in combination with rules for mixture-toxicity calculations, the modeled exposure results were transformed to risk estimates for aquatic species. The majority of the predicted risks were caused by pesticides applied to potato cropland, and approximately 95% of the predicted risk was caused by only 7 of the 261 pesticides currently used in The Netherlands. 

Extrapolation methods are used for various types of risk assessment. Methods may be used in the process of deriving environmental quality objectives, in the registration of new substances, and in the process of site-specific risk assessment. Suter (1993) called these approaches prospective (the former 2) and retrospective (the latter) risk assessments. The specific process in which extrapolation methods are used has implications for the concepts to be applied and the data to be used as input in extrapolation. Strictly described approaches are in place for the derivation of environmental quality criteria (EQCs) and the registration of pesticides and newly developed substances. The prescribed approaches for deriving EQCs can differ between jurisdictions. The approaches for retrospective investigations have more degrees of freedom. A characteristic of the latter approach is that the methods can make use of measured local exposure levels and can estimate local risk with known precision (or known uncertainty ). The latter is uncommon for EQCs. 

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