Population characterization, human

Population Characterization. An important part of any exposure assessment is the development of a detailed and up-to-date human demographic data base for the area being studied. These data can provide the basis for estimates of subpopulations associated with different exposure pathways. In national exposure assessments it is common to use an average population density for the total U.S. or to simply distinguish between rural and urban densitites. In a geographic exposure assessment in which site-specific data on pollutant releases, environmental fate and ambient levels are measured or estimated, it is important to have equally detailed population data. Population breakdowns by age, sex, housing and... 

The Profile s Emphasis on Fish Consumption. Several panelists thought the toxicological profile overly emphasized, or incorrectly characterized, human exposure to PCBs through consumption of contaminated fish. One panelist explained that this exposure pathway is an important issue for certain populations (e.g., people who consume sport-caught fish from PCB-contaminated waters), but he thought the profile should not overstate this pathway s relevance to the general population. 

Human perception creates difficulty ia the characterization of flavor people often, if not always, perceive flavors differently due to both psychological and physiological factors. For example, certain aryl thiocarbamates, eg, phenylthiocarbamide, taste exceedingly bitter to some people and are almost tasteless to others (5). This difference is genetically determined, and the frequency of its occurrence differs from one population to another 40% of U.S. Caucasians are nontasters, whereas only 3% of the Korean population caimot perceive the strong bitter taste of the aryl thiocarbamates (6). Similar differences were found ia the sense of smell for compounds such as menthol, carvone, and ethyl butyrate (7). 

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-... 

Dose-Response Evaluation The process of quantitatively evaluating toxicity information and characterizing the relationship between the dose a contaminant administered or received, and the incidence of adverse health effects in the exposed population. From a quantitative dose-respoiise relationship, toxicity values can be derived that are used in the risk characterization step to estimate the likelihood of adverse effects occurring in humans at different exposure levels. 

A risk estimate indicates the likelihood of occurrence of the different types of health or enviromiiental effects in exposed populations. Risk assessment should include both human healtli and environmental evaluations (i.e., impacts on ecosystems). Ecological impacts include actual and potential effects on plants and animal (otlier than domesticated species). The numbers produced from the risk characterization, representing tlie probability of adverse health effects being caused, must be evaluated. 

Human chronic inflammatory diseases are characterized by populations of cells with altered regulation and function. A large body of evidence suggests that many of these cellular abnormalities may be linked to an increase in the production of free radicals and/or deficiencies of antioxidant defence systems. Oxygen free radicals attack cell structures, altering their function, and are cytotoxic. They have therefore been implicated in the pathogenesis of rheumatoid arthritis as well as many other human diseases (HaUiwell, 1991). 

Risk assessment pertains to characterization of the probability of adverse health effects occurring as a result of human exposure. Recent trends in risk assessment have encouraged the use of realistic exposure scenarios, the totality of available data, and the uncertainty in the data, as well as their quality, in arriving at a best estimate of the risk to exposed populations. The use of "worst case" and even other single point values is an extremely conservative approach and does not offer realistic characterization of risk. Even the use of arithmetic mean values obtained under maximum use conditions may be considered to be conservative and not descriptive of the range of exposures experienced by workers. Use of the entirety of data is more scientific and statistically defensible and would provide a distribution of plausible values. 

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. 

Hadi, M., et al., "Functional Characterization of Apel Variants Identified in the Human Population," Nucl. Acids Res., 28, 3871-3879 (2000). 

Studies using the inhalation route might be useful to determine the potential human health risk in populations that may be occupationally exposed to hexachloroethane vapors for long periods. Additional chronic oral studies may be useful to help further clarify the dose-response relationships and better characterize thresholds. Studies by the dermal route would not be useful until the rate and extent of absorption have been better characterized. 

Classifications of data have two purposes (Hartigan, 1983 Gordon, 1981) data simplification (also called a descriptive function) and prediction. Simplification is necessary because there is a limit to both the volume and complexity of data that the human mind can comprehend and deal with conceptually. Classification allows us to attach a label (or name) to each group of data, to summarize the data (that is, assign individual elements of data to groups and to characterize the population of the group), and to define the relationships between groups (that is, develop a taxonomy). 

---