Exposure assessments risk characterization

Baseline Risk Assessment. The risk assessment is the foundation upon which site remediation goals are determined and is developed following two fundamental assessments. A toxicity assessment is performed to collect the most recent and pertinent toxicity data for carcinogenic and noncarcinogenic effects of chemical contaminants detected in site media. An exposure assessment is performed to quantify human intake of contaminated media. Subsequently, by measuring the concentrations of chemicals detected in the site media, the dose of chemical intake can then be quantified to complete the exposure assessment. Risk characterization is the final step, performed by coupling the results of the toxicity assessment with those of the exposure assessment to obtain an overall cumulative site risk. 

Hazard characterization and delineation of dose-effect or dose-response relationships. 3. Assessment of exposure 4. Risk characterization... 

In the final phase of risk analysis—risk characterization—one integrates outputs of effects and exposure assessments. Risk is expressed in qualitative or quantitative estimates by comparison with reference values (e.g., hazard quotient). The severity of potential or actual damage should be characterized with the degree of uncertainty of risk estimates. Assumptions, data uncertainties and limitations of analyses are to be described clearly and reflected in the conclusions. The final product is a report that communicates to the affected and interested parties the analysis findings (Byrd and Cothern, 2000). 

The basic features of ecological risk assessment schemes are very similar throughout the world. Usually, one focuses on effects (concentration or dose response information), exposure, and risk characterization. The following paragraphs summarize how extrapolation practices can be developed in such a way that a consistent pattern emerges. 

Tillitt DE, Solomon KR, Mihaich EM, Cobb GP, Touart L, Kubiak TJ. 1998. Role of exposure assessment in characterizing risk of endocrine-disrupting substances in wildlife. In Suk W, editor. Principles and processes for evaluating endocrine disruption in wildlife. Pensacola (FL) SETAC Press, p 39-68. 

This chapter will address the implications of the data presented in previous chapters for assessing the risks from environmental chemical exposures. WHO/IPCS has defined risk assessment as an empirically based paradigm that estimates the risk of adverse effects from exposure of an individual or population to a chemical, physical, or biological agent. As shown in Figure 21, it includes the components of hazard identification (Is there an adverse effect ), dose-response assessment (How severe is it ), exposure assessment (What is the level of exposure ), and risk characterization (What is the risk ) (NRC, 1983 IPCS, 2000). 

Risk characterization provides for both qualitative and quantitative descriptions of risk. The step involves integrating the results of the hazard identification, dose-response assessment, and exposure assessment to characterize risk. Often, a direct comparison between exposure criteria developed in the first two steps and the results of the exposure assessment (concentration in the environmental media or the estimated dose, as appropriate) provide a basis for determining whether risks are acceptable. Typically, if criteria are exceeded, the risk is not acceptable. What is defined as acceptable, as well as the way risk is expressed, is often a... 

Data evaluation Exposure assessment Toxicity assessment Risk characterization... 

In risk characterization, step four, the human exposure situation is compared to the toxicity data from animal studies, and often a safety -margin approach is utilized. The safety margin is based on a knowledge of uncertainties and individual variation in sensitivity of animals and humans to the effects of chemical compounds. Usually one assumes that humans are more sensitive than experimental animals to the effects of chemicals. For this reason, a safety margin is often used. This margin contains two factors, differences in biotransformation within a species (human), usually 10, and differences in the sensitivity between species (e.g., rat vs. human), usually also 10. The safety factor which takes into consideration interindividual differences within the human population predominately indicates differences in biotransformation, but sensitivity to effects of chemicals is also taken into consideration (e.g., safety faaor of 4 for biotransformation and 2.5 for sensitivity 4 x 2.5 = 10). For example, if the lowest dose that does not cause any toxicity to rodents, rats, or mice, i.e., the no-ob-servable-adverse-effect level (NOAEL) is 100 mg/kg, this dose is divided by the safety factor of 100. The safe dose level for humans would be then 1 mg/kg. Occasionally, a NOAEL is not found, and one has to use the lowest-observable-adverse-effect level (LOAEL) in safety assessment. In this situation, often an additional un-... 

Most human or environmental healtli hazards can be evaluated by dissecting tlie analysis into four parts liazard identification, dose-response assessment or hazard assessment, exposure assessment, and risk characterization. For some perceived healtli liazards, tlie risk assessment might stop with tlie first step, liazard identification, if no adverse effect is identified or if an agency elects to take regulatory action witliout furtlier analysis. Regarding liazard identification, a hazard is defined as a toxic agent or a set of conditions that luis the potential to cause adverse effects to hmnan health or tlie environment. Healtli hazard identification involves an evaluation of various forms of information in order to identify the different liaz.ards. Dose-response or toxicity assessment is required in an overall assessment responses/cffects can vary widely since all chemicals and contaminants vary in their capacity to cause adverse effects. This step frequently requires that assumptions be made to relate... 

Risk characterization is lire process of estimating llie incidence of a health effect under the various conditions of human or animal exposure described in lire exposure assessment. It is performed by combining the exposure (see Cliapter 12) and dose response (see Cluipter 11) assessments. The summary effects of the uncertainties in lire preceding steps should also be described in lliis step. 

In tlie risk characterization, conclusions about hazard and dose response are integrated witli those from the exposure assessment. In addition, confidence about tliese conclusions, including information about tlie micertainties associated with each aspect of the assessment in the final risk sununary. should be higlilighted. In tlie previous assessment steps and in tlie risk characterization, tlie risk assessor should also distinguish between variability and uncertainty. 

Thus, tlie focus of tliis subsection is on qualitative/semiquantitative approaches tliat can yield useful information to decision-makers for a limited resource investment. There are several categories of uncertainties associated with site risk assessments. One is tlie initial selection of substances used to characterize exposures and risk on tlie basis of the sampling data and available toxicity information. Oilier sources of uncertainty are inlierent in tlie toxicity values for each substance used to characterize risk. Additional micertainties are inlierent in tlie exposure assessment for individual substances and individual exposures. These uncertainties are usually driven by uncertainty in tlie chemical monitoring data and tlie models used to estimate exposure concentrations in tlie absence of monitoring data, but can also be driven by population intake parameters. As described earlier, additional micertainties are incorporated in tlie risk assessment when exposures to several substances across multiple patliways are suimned. 

Risk characterization is tlie process of estimating tlie incidence of a healtli effect under tlie various conditions of human or animal exposure as described in the exposure assessment. It evolves from both dose exposure assessment and toxicity response assessment. The data are then combined to obtain qualitative and quantitative expression of risk. 

Based upon the various sources of adult consumer exposure to organotin compounds (section 6) and the TDI values derived above, it is possible to estimate the relative exposure from the various organotin compounds expressed as a percentage of the TDI values. The exposure calculations in section 6 were based on a realistic worst-case exposure assessment. Table 26 presents the results of this risk characterization. 

Risk characterization is the last step in the risk assessment procedure. It is the quantitative or semi-quantitative estimation, including uncertainties, of frequency and severity of known or potential adverse health effects in a given population based on the previous steps. Risk characterization is the step that integrates information on hazard and exposure to estimate the magnitude of a risk. Comparison of the numerical output of hazard characterization with the estimated intake will give an indication of whether the estimated intake is a health concern. ... 

The degree of confidence in the final estimation of risk depends on variability, uncertainty, and assumptions identified in all previous steps. The nature of the information available for risk characterization and the associated uncertainties can vary widely, and no single approach is suitable for all hazard and exposure scenarios. In cases in which risk characterization is concluded before human exposure occurs, for example, with food additives that require prior approval, both hazard identification and hazard characterization are largely dependent on animal experiments. And exposure is a theoretical estimate based on predicted uses or residue levels. In contrast, in cases of prior human exposure, hazard identification and hazard characterization may be based on studies in humans and exposure assessment can be based on real-life, actual intake measurements. The influence of estimates and assumptions can be evaluated by using sensitivity and uncertainty analyses. - Risk assessment procedures differ in a range of possible options from relatively unso-... 

There is a growing need to better characterize the health risk related to occupational and environmental exposure to pesticides. Risk characterization is a basic step in the assessment and management of the health risks related to chemicals (Tordoir and Maroni, 1994). Evaluation of exposure, which may be performed through environmental and biological monitoring, is a fundamental component of risk assessment. Biomarkers are useful tools that may be used in risk assessment to confirm exposure or to quantify it by estimating the internal dose. Besides their use in risk assessment, biomarkers also represent a fundamental tool to improve the effectiveness of medical and epidemiological surveillance. 

A total of 10,000 iterations or calculations of dose were performed as part of this simulation, and Figure 4 shows the resulting distribution of average daily doses of chlorpyrifos as determined by the Monte Carlo simulation. Common practice in exposure and risk assessment is to characterize the 50th percentile as a "typical" exposure and the 95th percentile as the "reasonable maximum" exposure.4 The distributional analysis for these calculated doses... 

The purpose of an exposure and risk assessment is to characterize the magnitude and extent of human or environmental exposure to selected pollutants and to quantify the potential adverse effects of those exposures. The assessment can be used both to provide a baseline estimate of existing health risks attributable to an environmental pollutant and to determine the potential reduction in exposure and risk for various control options. Exposure and risk assessments are playing an increasingly central role in... 

The scope of an exposure and risk assessment may be characterized by a number of key features ... 

The analysis of chemical risk is a process comprising the following elements hazard identification, exposure assessment, dose-response assessment, and risk characterization [6]. Figure 1 shows the main elements that constitute the risk characterization process together the methodologies used for their determination. The essence of risk characterization is to relate the exposure (the concentration of a... 

In this chapter the risk assessment is briefly introduced. Risk assessment is divided into four steps hazard identification, hazard characterization, exposure assessment, and risk characterization. This chapter also highlights five risk and life cycle impact assessment models (EUSES, USEtox, GLOBOX, SADA, and MAFRAM) that allows for assessment of risks to human health and the environment. In addition other 12 models were appointed. Finally, in the last section of this chapter, there is a compilation of useful data sources for risk assessment. The data source selection is essential to obtain high quality data. This source selection is divided into two parts. First, six frequently used databases for physicochemical... 

Due to this, it is necessary to assess the risk to human health and the environment due to the exposure to these chemical additives. In this chapter the impacts that a substance can cause to a certain receptor (humans and the environment) and the harms to the receptor at different exposure levels are identified in hazard identification and hazard characterization steps, respectively. Exposure assessment takes into account the amount, frequency, and duration of the exposure to the substance. Finally, risk characterization evaluates the increased risk caused by such exposure to the exposed population. 

The risk characterization procedure will result in a quantitative comparison per substance of the outcome of the exposure assessment and of the effects assessment. This comparison is made through the ratio PEC/PNEC. The generic name for PEC/ PNEC in EUSES is risk characterization ratio (RCR). Other ratios are used in EUSES for the risk characterization such as the margin of safety (MOS) or the ratio of the estimated no-effect or effect level parameter to the estimated exposure level for human subpopulations and the acceptable operator exposure level (AOEL). 

The exposure assessment in EUSES aims at reasonable worst-case, i.e., the exposure scenario was the worst scenario without being unrealistic and as much as possible using mean, median, or typical parameter values. If the outcome of the reasonable worst-case risk characterization indicates that the substance is not of concern, the risk assessment for that substance can be stopped with regard to the scenario considered. 

A number of EIA theorists believe in incorporating formal RA methods into EIA as a way to cope with uncertainties, especially in impact prediction where a formal framework for ecological risk assessment (EcoRA) is already developed. It includes three generic phases problem formulation, analysis, and risk characterization followed by risk management. The analysis phase includes an exposure assessment and an ecological effects assessment (see, e.g., US EPA (1998)). 

In formal EcoRA framework three phases of risk analysis are identified problem formulation, analysis, and risk characterization followed by risk management. The analysis phase includes an exposure assessment and an ecological effects assessment (see Figure 2). 

Quantitative nature of the CLL approach. Numerical tolerable exposure levels for pollutants of concern are defined to establish quantitative thresholds for risk characterization therefore the CLL approach provides a basis for quantitative ecosystem risk and damage assessment. 

In accordance with this zoning the environmental risk assessment procedure should be developed, especially those related to exposure pathway and risk characterization steps. 

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