Risk acceptance method

Step 7 Select risk assessment and risk acceptance methods and criteria... 

Two significant questions in the RAP are how should hazard risk be characterized for acceptance judgment and what acceptance criteria should be used. The risk acceptance method selected must address the concern of complexity versus utility. If the judgment criteria method is too complex it will not be used effectively. Figure 2.65 shows three different example approaches. The Hazard Risk Index (HRI) approach provided as an example in MIL-STD-882 (or some variation) is the most commonly used approach. 

Risk-Based Inspection. Inspection programs developed using risk analysis methods are becoming increasingly popular (15,16) (see Hazard ANALYSIS AND RISK ASSESSMENT). In this approach, the frequency and type of in-service inspection (IS I) is determined by the probabiUstic risk assessment (PRA) of the inspection results. Here, the results might be a false acceptance of a part that will fail as well as the false rejection of a part that will not fail. Whether a plant or a consumer product, false acceptance of a defective part could lead to catastrophic failure and considerable cost. Also, the false rejection of parts may lead to unjustified, and sometimes exorbitant, costs of operation (2). Risk is defined as follows ... 

It is the general consensus within the worldwide fire community that the only proper way to evaluate the fire safety of products is to conduct full-scale tests or complete fire-risk assessments. Most of these tests were extracted from procedures developed by the American Society for Testing and Materials (ASTM) and the International Electrotechnical Commission (IEC). Because they are time tested, they are generally accepted methods to evaluate a given property. Where there were no universally accepted methods the UL developed its own. 

Government risk assessment methods used to determine acceptable residues in foods (governed by tolerances) were not designed to detect or quantify the majority of these unique risks. 

In use of risk assessment methods, you will find that the methodology for calculating overall risk probabilities is quite well defined. But, assigning realistic values to individual probabilities can be quite difficult, and a matter of personal opinion of the analyst. So, the analyst must have intimate knowledge of the system being evaluated, as well as all effects being considered, before he can make an acceptable risk assessment. 

Risk insurance is the method chosen when the possible losses are financially too great to retain internally by risk acceptance and in some cases too expensive to prevent or avoid. However even the risk insurers will want to satisfy themselves that adequate precautions are being taken at facilities they are underwriting. Thus, they will look very carefully at risks they feel are above the industry norm or have high loss histories. 

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 liquid and solid effluents are well characterized. As the ACW I Committee noted in its original and supplemental reports, the gaseous process emissions will have to be characterized for health risk assessments and environmental risk assessments required by EPA guidelines (NRC, 1999, 2000a). These results, along with the results of analyses of metals emissions (including chromium VI), can be used to assess the environmental impact of a facility through accepted risk-assessment methods (EPA, 1998). 

Raska et al. (2010) introduced the concept of a risk based method transfer process (which is similar to USP transfer waiver approach). This involves assessing the risk that the sites involved in method transfer could generate non-comparable data either at transfer or subsequently thereafter and assessing the probability of that risk occurring. Thus with constrained resource it is more sensible to focus that resource on either avoidance or mitigation of high risk transfers, whilst accepting the limited risk inherent with a low probability risk scenario. 

The accepted risk is a risk inferior to a level defined in advance either by law, technical, economical, or ethical considerations. The risk analysis, as it will be described in the following sections, has essentially a technical orientation. The minimal requirement is that the process fulfils requirements by the local laws and that the risk analysis is carried out by an experienced team using recognized methods and risk-reducing measures that conform to the state of the art It is obvious that non-technical aspects may also be involved in the risk acceptation criteria. These aspects should also cover societal aspects, that is, a risk-benefit analysis should be performed... 

The project enables risk assessments (or components thereof) to be performed using internationally accepted methods, and these assessments can then be shared to avoid duplication and optimize use of valuable resources for risk management. It also promotes sound science as a basis for risk management decisions, promotes transparency in risk assessment and reduces unnecessary testing of chemicals. Advances in scientific knowledge can be translated into new harmonized methods. 

The safety of the subjects enrolled in the trial is always the primary concern of the researcher. Individuals at high or unknown risk to treatment with the drug are excluded from the study. For example, women of child bearing potential are usually excluded or required to use an acceptable method of birth control. Similarly, patients who are taking medications that might interact with the experimental drug, or who have medical conditions that place them at increased risk, are also excluded from participation. 

In toxic tort and product liability litigation, the admissibility of new risk assessment methods and data must be approved by the trial judge before being presented to the jury. The U.S. Supreme Court announced a new standard for the admission of scientific data in 1993 in its Daubert decision (Daubert 1993). Under this new standard, federal judges must serve as a gatekeeper to ensure that scientific evidence is reliable and relevant, which includes an assessment of whether the evidence (i) has been empirically tested, (ii) has a known rate of error, (iii) has been peer-reviewed and published, and (iv) is generally accepted within the relevant scientific field. Many state courts have adopted a similar standard, although some still apply the earlier standard on admissibility (Frye 1923), which is whether the evidence is... 

Contents indude qualitative and quantitative evaluation of human and animal studies, risk analysis, and acceptable concentrations. Helpful appendices Include a glossary, abbreviations, and acronyms, the USFDA risk analysis method for carcinogens, and equations. 

This is a defacto acceptance of certain risk management methods and decisions of other countries. The recommendation is likely to have a profound effect on multinational companies operating in India, and, if adopted by other developing Countries, then the effect will be felt internationally. As an initial step in this direction, the EC has introduced a regulation [19] on the export of banned or severely restricted chemicals which requires the Prior Informed Consent of the receiving country. 

The safety case regime of the United Kingdom and Australia is lypieal of the midpoint of the dimension whereby a process (risk assessment) is specified by which the goal of risk control is to be met, and acceptable methods of risk analysis are prescribed, but it is then left to the regulated company to convince the regulator of the way it is led to control risk by that risk assessment process. Further guidance is in the form of codes which have the status of acceptable translations of the goals, but leave the choice open to the company to comply in other ways. 

For workplace design, management and operations, and task performance aspects of safety, application of hazard analysis and risk assessment methods are vital to achieving an acceptable risk level. 

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