Risk management decisions based

The book concludes with a synthesis of the technical and regulatory factors that bear on the central questions of the book. Chapter 5 explores the themes of risk management and our ability to make thoughtful risk management decisions based on the state of the science. 

Regardless of the cause, the differences in interpretation of toxicological data illustrated here can obviously affect both the outcome of a risk assessment and the risk management decisions based on such an assessment. 

In order to make justified risk management decisions, the first step is to classify the risks. This is often not an easy task. There is a balance between acceptability of a risk (both socially and regulatory based) and the chance that it occurs. In the case of allergen cross-contamination, this latter aspect is a crucial factor as risk management often focuses on reduction of the chance rather than avoidance. 

Therefore, risk management decisions are currently based on common sense, a thorough analysis of the food production process, and the risk of the allergen as perceived by the company. Driven by fear for (legal) claims there may be a tendency to use a disclaimer (for instance may contain ) on the label when the chance of cross-contamination is realistic (Hefle et al. 2007). These disclaimers are not always based on sound risk analysis. 

Ultimately, the credibility—for scientists, stakeholders and society in general—of the data and assessments on which critical risk management decisions are based owes much to the underlying tenets of data quality discussed in this document. Credibility is a basic element of risk communication and social trust and, in turn, is a determining factor in risk acceptance and risk management. 

For instance, a risk management decision may be based on hazardous properties regardless of exposure levels [162]. 

Risk management was defined in the NAS report as the process of weighing policy alternatives and selecting the most appropriate regulatory actions. It is considered to be separate from the risk assessment process. Risk management decisions are based on the results of the risk assessment and other concerns that are relevant to the situation. 

These examples emphasize that risk management decisions are based in part on level of risk, but other factors are also considered to most effectively protect the public. In making risk management decisions, it is also necessary to understand the level of uncertainty in the technical data. For example, there is considerable uncertainty in predictions of potential impacts of global warming, but the consequences are potentially very large. It is often the case in risk... 

The National Center for Toxicological Research (NCTR), a component of the Jefferson Laboratories of the Food and Drug Administration (FDA), is located in Jefferson, Arkansas. Its mission is to conduct innovative peer-reviewed scientific research focused on FDA regulatory needs. Research findings provide the basis for FDA to make sound science-based risk management decisions that promote the health of the American people. 

The precautionary nature of risk management decisions made by public health authorities can approach a zero risk tolerance that is not based on the outcome of the risk assessment process or the certainty of the data that underlie the assessment process but rather on social and political influences. The original purpose of risk assessment was to separate important from less important risks and provide a basis for making decisions to protect the public health. With the adoption of risk assessment and risk management as a process for making public health decisions, the concept of achieving zero risk for suspect carcinogens was abandoned as a workable, achievable policy. 

Analysis of the Risk Assessment. In answering the question of whether the risk assessment is adequate for basing a risk management decision, a number of issues arise. Some are listed below. 

A risk management decision should be based on the clear understanding of the limitations of the risk assessment. This is difficult, if not impossible, if the risk assessment doesn t characterize the uncertainties comprehensively, e.g., identify the result of altering different assumptions which are bases of contention the major sources of uncertainty, etc. This could become a special section of the risk assessment document and would be invaluable to risk managers and the public in understanding the validity of the assessment. 

This is acceptance of risk management decisions of other countries and of the risk assessment on which such decisions arc based. If accepted universally by developing countries, this concept will have a significant effect on the world chemical industry and hasten the harmonization of regulations. 

For nongenotoxic chemicals, risk assessment is based on the concept of threshold doses, below which no adverse effect results from exposure. From human or experimental animal data, one tries to establish the no observable adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL). In order to establish safe levels of exposure to potentially toxic agents, the NOAEL is divided by a safety factor (often named uncertainty factor). When the risk assessment is based on data from experimental animals, a default safety factor of 100 is usually applied. The safety factor constitutes a factor of 10 for potential differences in susceptibility between animals and man, and another factor of 10 for interindividual differences among humans. The factors are combinations of differences in toxicokinetics and toxicodynamics, both in animals and man. If true factors are known, the size of the safety factor may be changed accordingly. When risk assessment is based on human data, a safety factor of 10 is applied in most cases, for instance, for food additives. However, for natural toxins in food, smaller factors are usually applied. This is a risk management decision, often based on information on the absence of adverse health effects at intake levels close to the estimated LOAELs. 

ABSTRACT The paper presents a decision support system (DSS) for evaluation of risk pipeline risk. The system is able to support risk assessment and risk ranking of sections of natural gas pipelines. The DSS uses an architecture based on a data base, a model base and user interface. The model base has been built based on Multi-Attribute Utility Theory. The multi-attribute approach analysis risks in three dimensions of impact. These dimensions are human, financial and environmental impact. The way in which the model translates decisionmakers preferences into risk management decisions is highlighted. The paper presents the DSS, including some dialogue modules of the system based on real appUcations. 

McDaniels, T Longstaff, H. Dowlatabadi, H. A value-based framework for risk management decisions involving multiple scales a salmon aquaculture example. Environmental V. 9, p. 423-438, 2006. 

---