Rational Risk Evaluation

From this point of view we consider it to be justified and necessary that technical and natural scientific assessments and social risk perceptions be brought together within rational risk evaluations (Fiorino, 1989). Now the question arises of how societies should decide on fundamental procedures concerning uncertain consequences of collective risks. Which strategy should a society choose if the consequences of risky actions concern many people with different preferences Philosophers and decision-making the- 

Therefore, we distinguish three categories of risks for a practicable and rational risk evaluation (see Fig. 1) the normal area, the intermediate area, and the intolerable area (area of permission) (cf. also Piechowski, 1994). The normal area is characterized by relatively low statistical uncertainty, rather low probability of occurrence, rather low extent of damage, high certainty of assessment, low persistency and ubiquity of risk consequences, and low irreversibility of risk consequences, and the risks iUso have low complexity or empirically proven adequacy. In this case the objective risk dimensions almost correspond to the scientific risk evaluation. For risks in the normal area we follow the recommendations of decision-making analysts who take a neutral risk attitude as a starting point for collective binding decisions. 

FIGURE 1 Ri.sk areas. Source WBGU, German Scientific Advisory 

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More recently, activist groups and disease-based organizations have presented patients as sophisticated rational actors who can review medical information and make informed decisions for themselves. Changes in FDA regulations consequently shifted certain aspects of risk evaluation and decisionmaking control to patients and physicians. Initiatives since the peak of political attention to the AIDS crisis in the early 1990s, notably the 1992 Prescription Drug User Fee Act (PDUFA) and the 1997 FDA Modernization Act (FDAMA),... 

To answer these questions and to be able to carry out such risk evaluations systematically, we propose a risk classification that summarizes specific risk types and determines particular strategies for rational management of risk types. 

Central to our concept of risk evaluation and management is the attempt to initiate a deliberative process, because rational criteria of evaluation ought to be applied in discur.sive. sellings and communicated to the political decision makers and the public at large. So the deliberation for an adequate ri.sk-policy should lake place within a multistage communication process that is characterized by forms of mutual consultation and a public network of communication. 

Whilst it may be tempting to re-evaluate previously discarded business propositions, a re-evaluation, or rationalization, of previous risk models can be a dangerous precept. Any initial risk evaluation, or risk re-evaluation, must be supported by the use of an accepted risk management process. In Australia, the AS/ NZS 4360 2004 for risk management is an example and a good starting point. 

Quantitative risk analysis (QRA) is a powerful analysis approach used to help manage risk and improve safety in many industries. When properly performed with appropriate respect for its theoretical and practical limitations, QRA provides a rational basis for evaluating process safety and comparing improvement alternatives. However, QRA is not a panacea that can solve all problems, make decisions for a manager, or substitute for existing safety assurance and loss prevention activities. Even when QRA is preferred, qualitative results, which always form the foundation for QRA, should be used to verify and support any conclusions drawn from QRA. 

When used to identify and evaluate significant risk contributors, as well as to assess the consequences of accident sequences, the PSA provides a comprehensive framework for making many types of decisions regarding reactor design, operation, and siting. These and other appi ications can be facilitated by the rational evaluation of the risks associated with a particular installation. 

In general, risk reduction is accomplished by implementing one or more protective layers, which reduce the frequency and/or consequence of the hazard scenario. LOPA provides specific criteria and restrictions for the evaluation of protection layers, eliminating the subjectivity of qualitative methods at substantially less cost than fully quantitative techniques. LOPA is a rational, defensible methodology that allows a rapid, cost-effective means for identifying the protection layers that lower the frequency and/or the consequence of specific hazard scenarios. 

The rational characterisation of risks requites iterative evaluation processes in different stages on the basis of easily available information (preliminary processes, screening). The step-by-step consolidation of information about substance properties and exposnre potential should be made depending on the risk involved in order to concentrate the required resources for information procurement and evalnation where the essential risks are located (proceduralisation 2). 

Given the eomplexity of eontaminated sediments, rationally ehosen and applied bioassays and bioindieators for hazard, risk and impaet assessment are needed that ean prediet and deteet the biologieal effeets of eontaminants in eombination with ehemieal analyses (Chapman and Mann, 1999). This thesis foeuses on the applieability of in vitro and and in vivo bioassays and bioindieators as tools for evaluating the effeets of eomplex ehemieal mixtures in the proeess of deeiding whether dredged harbour sediments ean be safely disposed of at sea. To this end three objeetives have been defined ... 

For food safety purposes the overriding aim is that food contamination should be reduced to the lowest practicable level, bearing in mind the potential costs and benefits involved. Since it is difficult to establish cause and effect relationships following long-term (chronic) exposure at low concentrations, it may be necessary to base action on prudence rather than on proven harm to health. However, if this approach is to maintain the confidence of both consumers and producers of food, a rational evaluation of all relevant information is required so that the balance between the risks and benefits of veterinary drugs can be assessed. Information on the incidence of potentially harmful drug residues is fundamental to this cost-benefit analysis so too is the consumption of the commodities involved (particularly for susceptible consumers or those consumers who eat more). Account must also be taken of the potential fall in food production if a drug is controlled or prohibited, and also the animal health and welfare implications that may result from the restriction of an animal medicine for which there may be no effective alternative. 

Computers are now used in the design and development of new chemicals, and their employment in toxicity prediction could lead to improved products that present a reduced hazard to humans. Although computers are useful for performing routine calculations, they do not usually possess insight or rationalization. Therefore, they should represent only one of a number of test procedures used to formulate a full safety evaluation in a given chemical. Where they are used, their results should be interpreted by a panel of expert toxicologists capable of providing an overall view of the likely toxic risk in the human environment. 

Finally, one must not accept the argument that too much money and effort already went into the project and that it needs only some further investment to rescue it. Decisions must be based on the future perspective of the project. The past, including all money spent, does not count. The project should be evaluated in exactly the same way as a new project proposal and using the same kind of information. If in the new scenario, chances and risks, cost and time to develop the product do not justify the continuation of the project, it should be stopped based upon objective and rational arguments, but not because someone failed. 

Each patient should be evaluated for the presence of indications (i.e., menopausal symptoms such as hot flushes or vaginal dryness) and possible contraindications. The risks and benefits of hormone therapy should be discussed with the patient so that she can weigh the risks and benefits versus alternatives and make a rational decision about whether to use hormone therapy. 

The use ofLt in early pregnancy may be associated with an increase in the incidence of cardiovascular anomalies of the newborn, especially Ebstein s malformation. The antimanic anticonvulsants valproic acid and probably carbamazepine have an associated risk of irreversible spina bifida that may exceed 1/100, and so do not represent a rational alternative for pregnant women. In balancing the risk versus benefit of using LG in pregnancy, it is important to evaluate the risk of untreated manic-depressive disorder and to consider conservative measures, such as deferring intervention until symptoms arise or using a safer treatment, such as a neuroleptic or ECT... 

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