Risk assessment human, definition

The probability and route of exposure of humans to a chemical are crucial parameters in risk assessment. By definition, in an extreme case where the probability of exposure is null, the risk is null. Thus, there is a considerable difference in the regulatory requirements for safety assessment of industrial chemicals and environmental contaminants that result in accidental exposures compared to chemicals designed for intentional exposure of the population, like cosmetics and pharmaceuticals. Each one of these categories is subjected to specific European laws. 

There are many definitions of the word risk. It is a combination of uncertainty and damage a ratio of Itazards to safeguards a triplet combination of event, probability, and consequences or even a measure of economic loss or human injury in terms of both the incident likelihood and tlie magnitude of the loss or injuiy (AICliE, 1989). People face all kinds of risks eveiyday, some voluntarily and otliers involuntarily. Tlierefore, risk plays a very important role in today s world. Studies on cancer caused a turning point in tlie world of risk because it opened tlie eyes of risk scientists and healtli professionals to tlie world of risk assessments. 

Envlroiunental testing Is a critical element In this process since It enables the qualitative and quantitative determination of toxic chemicals In the environment and the definition of environmental pathways which may lead to human exposure This paper briefly reviews the overall process of health risk assessments and the particular role which environmental testing plays Recent efforts to assess environmental health risks In relation to Love Canal Illustrate both the usefulness and the limitations of environmental testing In risk assessment ... 

The definitions of method detection and quantification limits should be reliable and applicable to a variety of extraction procedures and analytical methods. The issue is of particular importance to the US Environmental Protection Agency (EPA) and also pesticide regulatory and health agencies around the world in risk assessment. The critical question central to risk assessment is assessing the risk posed to a human being from the consumption of foods treated with pesticides, when the amount of the residue present in the food product is reported nondetect (ND) or no detectable residues . 

Regulatory officials nevertheless act on the basis of such hypothetical risks ( hypothetical definitely does not mean imaginary it means that the risk estimates are based on certain scientific hypotheses and that they have not been empirically tested). Such actions are in part based on legal requirements (Chapter 11) and in part on the prudence that is a traditional feature of public health policies. The scientific information, assumptions, and extrapolation models upon which risk assessments are based are considered sufficiently revealing on the question of human risk to prompt risk-control measures. To put off such actions until it is seen whether the hypothesized risks are real - to wait for a human body count - is considered to be an unacceptable course. 

Fault tree analysis is based on a graphical, logical description of the failure mechanisms of a system. Before construction of a fault tree can begin, a specific definition of the top event is required for example the release of propylene from a refrigeration system. A detailed understanding of the operation of the system, its component parts, and the role of operators and possible human errors is required. Refer to Guidelines for Hazard Evaluation (CCPS, 1992) and Guidelines for Chemical Process Quantitative Risk Assessment (CCPS, 2000). 

In the absence of definitive human data, risk assessment may have to depend on the results of cancer bioassays in laboratory animals, short-term tests, or other experimental methods. Hence the following issues must be addressed under such circumstances the ability of the test system to predict risks for man (quantitatively as well as qualitatively) the reproducibility of test results the influence of species differences in pharmacokinetics, metabolism, homeostasis, repair rates, life span, organ sensitivity, and baseline cancer rates extrapolation across dose and dose rates, and routes of exposure the significance of benign tumors fitting models to the data in order to characterize dose-incidence relationships and the significance of negative results. 

Risk assessment of chemicals does not, in practice, estimate the incidence and severity of the adverse effects likely to occur in the human population or environmental compartment due to actual or predicted exposure to a substance — the definition of risk characterization in Article 2 of Directive 93/67/EEC. The assessment process hinges on being able to say that there is a threshold below which the chemical has no adverse effects, in other words on being able to derive a no-effect level. Recent debates, discussed later, challenge the idea that there normally is such a threshold. 

Risk assessment of carcinogens is a two-step process involving first, a qualitative assessment of the data from the hazard identification stage (see above) and second, a quantitation of the risk for definite or probable human carcinogens. 

The fundamental question of risk assessment for potential human carcinogens requires definition of substances that exceed an evidentiary threshold. Once the scientific evidence establishes a substantial basis for conclusion of known or potential human cancer, it is then in order to determine a procedure for risk quantification. Quantitative risk assessments must always be read with the qualitative evidence of the likelihood of carcinogenicity. 

Definitive data are obtained with rigorous analytical methods, such as EPA-approved methods or other standard analytical methods. For the data to be definitive, either analytical or total measurement error must be determined. Definitive data, which are analyte-specific and have a high degree of confidence in analyte identity and concentration, are used for decisions that have consequences for human health and the environment, such as site closure, risk assessment, and compliance monitoring of water effluents and air emissions. Definitive data may be generated at a field (mobile) laboratory or at an off-site (fixed-base) laboratory. 

The terms below have been adopted or adapted from existing definitions for use in the context of human exposure assessment. Definitions of additional terms used in this document may be found in the IPCS risk assessment terminology Harmonization Project Document (IPCS, 2004). 

It is evident that some techniques do not have conceptually similar equivalents with various levels of complexity. Hence, tiering is not (yet) possible for all problem definitions. Moreover, it is clear that human risk assessment can sometimes operate on a higher conceptual tier than ecological risk assessment, for example, when BRN modeling and PBPK models are used. On the other hand, ecological risk assessment approaches may be sometimes more diverse, and can be better tailored to a risk assessment problem and its context. 

The review presented in the previous sections shows an enormous diversity in risk assessment methods and procedures for chemical mixtures. This diversity is characteristic for the current state of the art. The awareness that mixtures may cause risks that are not fully covered by single compound evaluations is growing, but the knowledge required to accurately assess the risks of chemical mixtures is still limited. The scientific community is attempting to unravel the mechanisms involved in mixture exposure and toxicity, and over recent decades, a multitude of new techniques to assess mixture risks have been developed. However, a comprehensive and solid conceptual framework to evaluate the risks of chemical mixtures is still lacking. The framework outlined in Section 5.4 can be considered a first step toward such a conceptual framework. The framework recognizes that the problem definitions vary greatly (between protective and retrospective assessments, for humans and ecosystems), and that each question has resulted in a different type of approach. 

There are many concepts in use for the assessment of risks or impacts of chemical mixtures, both for human and ecological risk assessment. Many of these concepts are identical or similar in both disciplines, for example, whole mixture tests, (partial) mixture characterization, mixture fractionation, and the concepts of CA and RA (or I A). The regulatory application and implementation of bioassays for uncharacterized whole mixtures is typical for the field of ecological risk assessment. The human field is leading in the development and application of process-based mixture models such as PBTK and BRN models and qualitative binary weight-of-evidence (BINWOE) methods. Mixture assessment methods from human and ecological problem definition contexts should be further compared, and the comparison results should be used to improve methods. 

Based in this information difference between the NOEL and human exposure or the risk at a given exposure is determined. Humans may be exposed to chemicals in the air, water, food, or on the skin. From the concentrations of a chemical in these different compartments the external daily exposure is estimated. The response to the chemical depends upon duration and route of exposure, the toxicokinetics of the chemical, the dose-response relationship and the susceptibility of the individual. Thus, the precise definition of the terms hazard, exposure, and risk is essential to understand toxicological evaluations (details on data requirements and procedures for risk assessment are given subsequently). 

Identifying a hazard is only a small part of the risk assessment process. Hazard must be differentiated from risk. Assessing risk involves an analysis of the likelihood that adverse effects to human health or the environment after exposure to a chemical may occur. For risk management, exposure assessments therefore play equal (if not more) important parts as evaluations of hazard. The following sections discuss how toxicology, exposure assessments, and risk characterisations contribute to the central scientific definition of risk as probability versus consequence [93-95]. 

For decades, risk assessors have essentially considered the effects on humans from exposure to individual substances. Standardized approaches have been developed along with research to improve this methodology and its reliability. The increased complexity of risk assessments and the numerous organizations performing them have led to the use of varied risk assessment concepts. Two main concepts—risk and hazard—were used earlier in different ways, creating confusion to the regulators and the public. To facilitate consistency, the National Academy of Sciences (NAS) recommended key definitions in... 

Cancer risk assessment involves two steps. The first step is a qualitative evaluation of all epidemiology studies, animal bioassay data, and biological activity (e.g., mutagenicity). The substance is classified as to the carcinogenic risk to humans based on the weight of evidence. If the evidence is sufficient, the substance may be classified as a definite, probable, or possible human carcinogen. 

For all these reasons, PBPK models are and will continue to be increasingly used in toxicology. This is especially true in risk assessment studies since better definition of the internal tissue dose, may contribute to reduce the uncertainty associated with extrapolation to human beings of responses observed in animal toxicity studies in which animals usually receive high doses of xenobiotics by routes often different from the one(s) anticipated in human exposures. 

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