Risk characterization process science

The Handbook emphasized that other aspects than science influence risk characterization, and that science policy choices must be made to deal with uncertainties. Many choices are usually made during the course of the risk assessment process, resulting in a particular outcome. Therefore, it is possible to perform parallel risk assessments of the same data, but reach different results. 

In 1983, the National Research Council of the (US) National Academy of Sciences published a report titled Risk Assessment in the Federal Government Managing the Process this work has had a marked influence on the risk assessment process used by regulatory agencies worldwide. The risk assessment process, in this report, consists of four components hazard identification, dose-response assessment, exposure assessment, and risk characterization. 

Risk assessment is a process where the magnitude of a specific risk is characterized so that decision-makers can conclude whether the potential hazard is sufficiently great that it needs to be managed or regulated, reduced or removed. The National Research Council (NRC, 1983) of the National Academy of Sciences (NAS) first described the process of human health risk assessment, with an update in 1994 and 1996, as a four-component paradigm (i.e., hazard identification, dose-response assessment, exposure assessment, and risk characterization), with risk communication as a fifth area of study. The first four components are described briefly below. 

While risk assessment in the context of protecting public health has been performed for many years, it is the 1983 U.S. National Academy of Sciences Report (Committee on the Institutional Means for Assessment of Risks to Public Health Commission on Life Sciences National Research Council 1983) that has served as the tenet for practicing risk assessors (see Chapter 1). Risk assessment was defined as the characterization of the potential adverse health effects of human exposures to environmental hazards. The predictive aspect of risk assessment was set by the use of the word potential. A fundamental expectation of the risk assessment process was that it should attempt to accm-ately predict adverse effects before there is evidence of disease in the population. Thus, risk assessment goes beyond the mere description of epidemiological and clinical case-control studies. In that report, the committee defined logical components of a risk assessment which still serve as guiding principles today. They were and are (a) hazard assessment or the qualitative determination that a stressor poses a hazard as evidence by causal evidence of an ill effect,... 

Each of these steps combines numerous assumptions that allow the risk assessor to extrapolate from the available data to potential real-world scenarios. A detailed description of the art and science of risk characterization is beyond the scope of this book the reader should simply be aware that the process can reflect both scientific thinking and subjective judgment [78], and that in consequence risk assessments can produce a variety of estimates of risk from the same data. 

Process analytical technology is consistent with the quality systems approach in that it is based on science and engineering principles for assessing and mitigating risks related to poor product and process quality. In the PAT guidance, the FDA indicates that the desired state for pharmaceutical manufacturing may be characterized as follows ... 

Risk management is the part of the process where characterized risks are evaluated against options to reduce or avoid them. In general, aspects other than science (for instance cost, social responsibility, and (consumer) risk perception) are taken into account here. 

Precaution and Environmental Science. When the precautionary principle is discussed in its relationship to science, it is often portrayed as an antiscience or a risk-management principle that is only used after undergoing conventional scientific processes. As discussed earlier, in practice the limitations of science to characterize complex risks show that precaution is not at odds (Kriebel et al., 2001). Further, precaution is not just about additional safety factors or changing risk assessment default assumptions. Research by U.S. EPA scientists has demonstrated that many of the EPA s Reference Doses - or conservative safe exposures - may correspond to risks of greater than 1 in 1000, meaning that safety factors alone may not protect health (Castorina and Woodruff, 2003). 

Insurance models in actuarial sciences and financial engineering have a long history of development and wide applications in assessing underwriting risks. Popular approaches for characterizing catastrophic risk processes include a compound Poisson process (e.g., Rolski... 

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