Methods for risk management

Decisions about the risk management of additives must take into account both risks and benefits. The hypothetical risk associated with occasional exceedance of the ADI may be more acceptable for one additive, if it has tangible benefits associated with it, than for another. 

In making risk management decisions it is important to take into account nontechnical factors in addition to scientific and economic information. Recent crises in the food industry have indicated that consumers perceptions about risks are driven by factors that would not be considered in conventional risk assessments. Research has shown that factors such as whether sub-groups (particularly children) might be affected, whether the hazard is familiar, if there are effects on the environment or if risks and benefits are equitably shared can determine consumers reactions to an issue. 

Risk managers must be aware that in the event of a crisis consumers perceptions about risks can have as great or greater impact on the outcome than the real food safety issues. 

Recent trends have seen more open acknowledgement of the need to balance scientific and social factors. For example, in the UK the Food Advisory Committee that advises the Food Standards Agency on food safety issues is comprised of a wide range of expertise including toxicologists, chemists, food technologists, economists, and representatives of consumer organisations and the food industry. The Committee is thus able to provide a balanced view that takes all interests into account. 

The outputs from risk assessment will normally include information about the relationship between dose and risk and estimates of levels of doses and thus risks in the population. For contaminants that have a toxicological threshold the Provisional Tolerable Weekly Intake (PTWI) might be defined and the number of consumers who have the potential to exceed this level of intake quantified. If a PTWI cannot be established (such as for genotoxic carcinogens) then it may be possible to quantify the proportion of a population exposed to a given level of risk by using QRA methods. If QRA methods cannot be applied then a qualitative assessment can be made such as to reduce intake levels to as low as is reasonably practicable. In either case it is the function of risk management to identify an optimal course of action to minimise the risk to consumers. 

In many cases the risk assessment might indicate that the proportion of consumers with the potential to exceed the PTWI is zero and that there is no need for any action to be taken to control risks. However, even in these circumstances other risk management activities, such as risk communication, might be appropriate. 

If there is the potential for consumers to exceed the PTWI then it will be necessary to consider measures to control risks. The simplest approach would be to identify the level of contamination in a foodstuff that would cause a high-level consumer to exceed the PTWI and to introduce legislation or some other form of control to establish that as the maximum permitted concentration. In practice there may be multiple routes of potential exposure and so all potentially affected foods should be taken into account. Setting maximum permitted concentrations for all affected foods would then require that the PTWI be apportioned between foods according to the potential intake from each food. This method assumes that a high-level consumer always consumes foods that contain the contaminant at the maximum permitted level. In reality this is an 

Alternative methods for setting standards where several possible food routes are involved include probabilistic modelling which can take into account the proportion of a particular foodstuff that might be contaminated at a particular level. 

For non-thresholded contaminants some mechanism is required that will allow the benefits in terms of reduced risks and costs associated with control to be taken into account. The costs of control will include enforcement costs as well as costs to producers in reaching ever stricter standards. Ultimately these costs will be borne by consumers in taxes, increased prices or reduced choice. Economic theory dictates that there must be a point where the extra increase in the cost of control is not justified by the corresponding increase in benefit (reduction in risk). This optimal point will differ for each contaminant according to the technology needed to control it, the nature of the hazard, and the relationship between dose and risk. It is in this latter context that quantitative risk assessment (QRA) becomes critical (see section 2.3.4 of this chapter). 

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The Bayesian network technology embedded in the ARBITER tool is also well suited for learning both probability relationships (e.g., method reliability estimates) and the essential structure of cause and effect, from data sets where predictions and outcomes can be compared. Colleagues have already applied this capability on a large scale for risk management (selection of potentially suspect claims for further inspection and examination) in the insurance industry. 

Risk analysis, like most scientific disciplines is subject to continual evolution. This means that methods and concepts that are in common use today may well become discredited and obsolete in the future. This presents a problem for risk managers because it creates the impression that everything done before was somehow wrong . In fact, most changes are gradual and tend to take effect at... 

Monte Carlo analysis does not in itself provide a solution for risk managers. All the method can do is to provide the best possible representation of the real situation. The acceptability of a given proportion of consumers being exposed to a given residue level will depend on such factors as the nature of the hazard and the size of any safety margins, if present. For example, occasional minor stomach upsets would be far more acceptable than seizure or sudden death. 

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. 

Probabilistic risk assessment methods are described herein for determining a popnlation s distribution of the dose from exposure and the combination of that exposnre characterization with appropriate toxicological information to form aggregate and cumulative risk assessments. An individual s dose from exposure is characterized as a set of chemical- and route-specific dose profiles over time. Toxic equivalence factors (TEFs) that reflect the toxic endpoint and exposure duration of concern are used to scale chemical- and route-specific doses to toxic equivalent doses (TEDs). The latter are combined in a temporally consistent manner to form a profile over time of the Total TED. For each individual, a Total MOE is calculated by dividing a toxicologically relevant benchmark dose (e.g. an EDio) by the individual s Total TED. The distribution of the Total MOE in a popnlation provides important information for risk management decisions. 

Application of bioassays for ecological assessments The evaluation of threats posed to ecological receptors or functions is probably the most significant reason for the application of biological test methods. There exist different approaches for using bioassays to perform risk assessments and to draw conclusions for risk management decisions. 

In recent years, demand for better methods for phycotoxin management has emerged as a resnlt of increasing pnblic concerns on health risks, action levels, method specificity, and performance. These technical issnes have become matters of discussion in international bodies such as the EU Commission and the Codex Alimentarius. As a result, new analytical and functional approaches for phycotoxins have been developed. In particular, efforts have been undertaken to design in vitro methods alternative to the current MBA for paralytic shellfish poison. ... 

Sessions 19 and 20 were held in a series, the former representing the second part and focusing on issues of risk assessment methods, use of the results for risk management decisions and to communicate with the public. E. D. Caldas (Univ. of Brasilia, Brazil) presented the new JMPR methods for estimating consumer exposures and examples of the impact of better data. Y.-B. He (Ministry of Agriculture, China) presented methods used by China to estimate exposure and to... 

It always depends on the top-management of an entity which method for risk assessment will be selected. The use of the other method is based on the fact that if action values were derived without NIEMF athermal effects, first of all it should have been proved that these effects don t exist more importantly than to he satisfied only with the statement that the abovemen-tioned effects were not proved on a sufficient level of statistical significance. 

With regard to economic and military entities themselves it depends solely on the decisions of their top-management which method for risk assessment will be chosen. 

None of the above mentioned approaches, methodical instructions or suggestions for risk management of waste disposal at rim landfills is apphed in the Czech Republic. The mentioned resume has become the reason for the risk management execution and evaluation at the selected landfills, as well for the evaluation of their safety and elaboration of general principals of risk management for landfills operations. 

Consequently, we need to be systematically concerned with general methodology, which would define basic attributes and taxonomy of risk management and risk assessment with a unifying method. Its fundament is definition of a general model for risk management and derivation of specific models for individual areas of usage. 

Firstly the chapter approaches risk management in a general sense, including the phases of risk assessment (risk identification, risk analysis and risk evaluation), risk control (risk reduction or mitigation, and risk acceptance), risk documentation and communication, and risk review. Then some methods for risk assessment are explored further, such as matrix type and Failure Mode Effect Analysis (FMEA) using risk priority numbers (RPN). 

More can be said about methods for risk identification, risk analysis and risk evaluation. In Sect. 21.3 these phases were defined, and, as the capsule preparation example, executed in an informal, rather simple way. That section was meant as an introduction to the phases of risk management and the terminology. It also meant to convey the idea that defining and delimiting the process steps and thinking about risks with all staff concerned will already lead, halfway, to a proper result. 

TTie purposes of this paper are to raise awareness of the need and to propose a method for including management risks in risk analyses and safety cases. Section 2 briefly examines what might be done about management risks. Section 3 considers management and its risks from different perspectives. Section 4 makes proposals for a method of analysing the risks posed by management, and Section 5 offers a discussion of the proposals. 

A thorough risk analysis should identify assumptions, dteck their validity, test Q e confidence that they can reasonably at act, and determine their risks. In the intended method for conducting management-risk analysis, rules will ensure that assumptions are searched for, made explicit, and analysed. 

The method will require the essential prerequisite work of scope definition to be carried out. It will necessarily address the next three stages of risk analysis. Then, it will provide guidance on how the output of the risk assessment stage may be used to suggest options for risk management, for example by informing the placement of safety barriers. Further, the method will be appropriate to re-analysis of the improved system and may include guidance on this. 

The oldest form of risk management was insurance. The earliest known record of risk management is found in Hammurabi s Code, an ancient Babylonian set of laws written around 1752 b.c.e. This form of insurance, known as bottomry, was a type of marine insurance in which the owner of a vessel could borrow money to buy cargo. If the ship was lost at sea, the vessel owner did not have to repay the debt. For centuries, insurance remained the primary method of risk management for individuals and businesses. 

Some plants have used PSA or deterministic methods for configuration management to minimize risks during outages. 

Many hazards may be identified and controlled or eliminated through use of qualitative hazard analysis as defined in Guidelines for Hazard Evaluation Procedures, Second Edition (AICHE/CCPS, 1992). Qualitative studies typically identify potentially hazardous events and their causes. In some cases, where the risks are clearly excessive and the existing safeguards arc inadequate, corrective actions can be adequately identified with qualitative methods. CPQRA is used to help evaluate potential risks when qualitative methods cannot provide adequate understanding of the risks and more information is needed for risk management. It can also be used to evaluate alternative risk reduction strategies. 

Firstly, the use of a BBN as an advanced method for risk calculations yields new possibilities for risk analysis. Platypus generates risk analyses that yield risk distributions rather than point estimations. These risk distributions automatically address aleatory uncertainties in risk analysis (whose origin lies in randomness) and identifies instances of high risk that are overlooked in setting risk standards. The distribution will also yield new leading risk indicators and new methods and instruments for risk management. When estimates of epistemic uncertainty ranges are available, these can be incorporated in the overall distributions as well. 

The theory and application of systematic risk assessment is a part of effective risk control processes. Methods for risk assessment or estimation allow the quantification of the risks and, thus, provide top managers with relevant information for risk reduction within the Man-Machine-Environment system. The following theses form the basis for the risk assessment methods selection (see also Chapter 1) ... 

Labour markets have become more multinational. International corporations nse the same methods of risk management. MultUingnaUsm has gained more importance (see Chapters 1-6) and that has become a challenge for Ungnists. 

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