Risk assessment basis

The two main roles of the IPCS are to establish the scientific health and environmental risk assessment basis for safe use of chemicals (normative functions) and to strengthen national capabilities for chemical safety (technical cooperation). ... 

The first stage of the QA programme should be the design report. All gas protection designs should be accompanied by a design report that sets out the justification for the parameters used, demonstrates the conceptual model and includes the risk assessment basis on which the protection measures have been designed. The report should include a checklist such as the one in Appendix B to confirm that all the necessary aspects have been covered and the data provided. This will make it easier for regulators to quickly assess schemes. 

Prepare a design report that sets out the justification for the parameters used, demonstrates the conceptual model and includes the risk assessment basis on which the protection measures have been designed... 

An important part of hazard analysis and risk assessment is the identification of the scenario, or design basis by which hazards result in accidents. Hazards are constandy present in any chemical faciUty. It is the scenario, or sequence of initiating and propagating events, which makes the hazard result in an accident. Many accidents have been the result of an improper identification of the scenario. 

The remaining step in the hazard identification and risk assessment procedure shown in Figure 1 is to decide on risk acceptance. For this step, few resources are available and analysts are left basically by themselves. Some companies have formal risk acceptance criteria. Most companies, however, use the results on a relative basis. That is, the results are compared to another process or processes where hazards and risks are weU-characterized. 

Next, we review the eosts of quality that typieally exist in a manufaeturing business, and how these are related to the way produets fail in serviee. The remainder of the ehapter diseusses the important elements of risk assessment as a basis for design. This puts in eontext the work on designing for quality and reliability, whieh are the main topies of the book. 

The physical condition and characteristics of the material shipped should be considered in transportation risk assessments on a case-by-case basis. There may be options available to reduce transportation risk by reducing the potential for releases or the severity of the effects of releases. A few possible ways of improving safety by modifying conditions are ... 

The severe accident research program improved public risk assessment, reduced uncertainties, and the reliance on subjective expert opinion. To close two severe accident issues in NRC s Severe Accident Research Plan (NUREG-1365) Mark I Liner Attack and Direct Containment Heating (DCH) were addressed with a new approach using the Risk Oriented Accident Analysis Method (ROAAM) (Theofanous, 1994, 1989). The resolution of the Mark-I Liner Attack issue constitutes the first full demonstration of ROAAM. It emphasizes the determinism and provides a basis for synergistic collaboration among experts through a common communication frame. 

The Pickering A Risk Assessment (PARA) (Ontario Hydro, 1995) is also a level 3 PSA for 1 of the 4 units at Pickering. A difference between PARA and DPSE is that sequences beyond the design basis were modeled using the MAAP-CANDU codes with best estimate assumptions. Other parts of the analysis used licensing-type conservative assumptions. 

When the exposure is well below the limit values and it is possible to be confident that on a long-term basis the probability of exceeding the limit value is very low, the risk assessment may conclude that the nature and extent of the risks related to those chemical agents make a further detailed risk assessment unnecessary unless work conditions are modified in a significant way. In these cases, however, it must be regularly checked w hether the assessment leading to that conclusion is still applicable. 

To estimate tlie potential iiupaet on tlie publie or tlie environment of aeeidents of different types, the likely emergeney zone must be studied. For example, a liazardous gas leak, fire, or explosion may eause a toxie cloud to spread over a great distance. The minimum atmospheric dispersion model. Vtirious models can be used tlie more difficult models produce more realistic results, but tlie simpler and faster models may provide adequate data for planning purposes. A more tliorough discussion of atmospheric dispersion is presented in Part 111 - Healtli Risk Assessment. 

Uncertainty on tlie other hand, represents lack of knowledge about factors such as adverse effects or contaminant levels which may be reduced with additional study. Generally, risk assessments carry several categories of uncertainly, and each merits consideration. Measurement micertainty refers to tlie usual eiTor tliat accompanies scientific measurements—standard statistical teclmiques can often be used to express measurement micertainty. A substantial aniomit of uncertainty is often inlierent in enviromiiental sampling, and assessments should address tliese micertainties. There are likewise uncertainties associated with tlie use of scientific models, e.g., dose-response models, and models of environmental fate and transport. Evaluation of model uncertainty would consider tlie scientific basis for the model and available empirical validation. 

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. 

Tlie reader should also note that tlie risk to people can be defined in terms of injury or fatality. The use of injuries as a basis of risk evaluation may be less disturbing tlian tlie use of fatalities. However, tliis introduces problems associated with degree of injury and comparability between different types of injuries. Further complications am arise in a risk assessment when dealing witli multiple hazards. For example, how are second-degree bums, fragment injuries, and injuries due to toxic gas e.xposure combined Even where only one type of effect (e.g., tlueshold to.xic exposure) is being evaluated, different durations of e.xposure can markedly affect tlie severity of injury. 

The reader should note tliat since many risk assessments have been conducted on the basis of fatal effects, there are also uncertainties on precisely what constitutes a fatal dose of thennal radiation, blast effect, or a toxic chemical. Where it is desired to estimate injuries as well as fatalities, tlie consequence calculation can be repeated using lower intensities of exposure leading to injury rather titan dcatli. In addition, if the adverse healtli effect (e.g. associated with a chemical release) is delayed, the cause may not be obvious. Tliis applies to both chronic and acute emissions and exposures. 

Table 25 Estimates of TDI for use in the risk assessment on the basis of medium-term exposure.

A biomarker is here defined as a biological response to an environmental chemical at the individual level or below, which demonstrates a departure from normality. Responses at higher levels of biological organization are not, according to this definition, termed biomarkers. Where such biological responses can be readily measnred, they may provide the basis for biomarker assays, which can be nsed to stndy the effects of chemicals in the laboratory or, most importantly, in the field. There is also interest in their employment as tools for the environmental risk assessment of chemicals. 

At the practical level, an ideal mechanistic biomarker should be simple to use, sensitive, relatively specific, stable, and usable on material that can be obtained by nondestructive sampling (e.g., blood or skin). A tall order, no doubt, and no biomarker yet developed has all of these attributes. However, the judicious use of combinations of biomarkers can overcome the shortcomings of individual assays. The main point to emphasize is that the resources so far invested in the development of biomarker technology for environmental risk assessment has been very small (cf the investment in biomarkers for use in medicine). Knowledge of toxic mechanisms of organic pollutants is already substantial (especially of pesticides), and it grows apace. The scientific basis is already there for technological advance it all comes down to a question of investment. 

MAZUR w and adlercreutz h (1998) Natural and anthropogenic environmental oestrogens the scientific basis for risk assessment. Naturally occurring oestrogens in food. Pure Appl Chem. 70 (2) 1759-76. 

Although there are many biocide alternatives available on the market, for example enzyme technology or bio-dispersants, there appears to be a continued requirement for the use of biocides in order to reduce the levels of microbiological contamination entering the paper making process. The increased awareness of environmental and safety aspects will continue to play an important role on the selection of biocides for paper making processes. The use of legislation to select biocides must be done in parallel with each plants internal risk assessment. No one biocide active will meet all the criteria set out by different European countries and hence the use of these actives must be carefully assessed on a plant by plant basis. 

The purpose of this chapter is not to discuss the merits, or lack thereof, of using plasma cholinesterase inhibition as an adverse effect in quantitative risk assessments for chlorpyrifos or other organophosphate pesticides. A number of regulatory agencies consider the inhibition of plasma cholinesterase to be an indicator of exposure, not of toxicity. The U.S. Environmental Protection Agency, at this point, continues to use this effect as the basis for calculating the reference doses for chlorpyrifos, and it is thus used here for assessing risks. 

In general, plant-protection products are biocidal active substances and are therefore by nature toxic to target organisms. At least some of them are also toxic to humans therefore, the safe use of plant-protection products presupposes, among other things, an evaluation of worker exposure during re-entry, an adequate risk assessment on the basis of the various practical scenarios in agriculture and horticulture, and, if necessary, specific instructions for worker protection on the product label. 

The utilisation of RCP as secondary raw material has to find a quantitative risk assessment in the future to establish meaningful limit values as basis for the development of e.g. elimination processes or barrier coatings. 

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