Risk assessment historical perspective

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, 

Risk assessment has evolved somewhat since 1983. Let us consider the early risk assessment process, called here the classical era. Hazard was considered as a simple yes or no question. Exposiu-e was used instead of the dose normally used in classic dose-response models in pharmacology studies. The mechanisms between exposure and the observed effects were usually unknown or a virtual black box.  

Next comes neoclassical era or where we are today. Here there is a foray into a better understanding and accounting for mechanisms of action. Time and resomce requirements continue to be high and even increased in many cases. 

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Velasquez, S.E. Schoeny, R. Rice, G.E. Cogliano, V.J. Cancer risk assessment historical perspectives, current issues, and future directions. Drug Chem. Toxicol. 1996, 19 (3), 161-185. 

Previous sections have presented technical and historical information on radiation and chemical risk assessment and on classification of radioactive and hazardous chemical wastes. This information provides important perspectives for establishing the foundations of a new hazardous waste classification system. Before establishing these foundations, it is useful to specify the attributes that an ideal waste classification system should possess. The following sections identify the desirable attributes of a waste classification system including that the system should be risk-based, it should allow for exemption of waste, and it should be comprehensive, consistent, intrinsic, comprehensible, quantitative, compatible with existing systems, and flexible. These attributes should be recognized as goals that are not all likely to be fully realized in a practical waste classification system. 

Scheuplein, R.J., and W.G. Flamm. 1989. A historical perspective on FDA s use of risk assessment. In International food regulation handbook, ed. R.D. Middlekauff and P. Shubik. New York Marcel Dek-ker. 

This entry presents a discussion of the principles of respiratory toxicology including (1) an historical perspective, (2) approaches used to evaluate respiratory responses to inhaled chemicals, (3) classification of airborne chemicals, (4) concepts of dose-time relationships, (5) factors influencing toxicity of airborne substances, (6) the basic biology of the respiratory system with emphasis on those structures and functions that are involved in toxicological responses, (7) biomarkers of pulmonary effects, (8) toxicological response associated with inhaled chemicals, and (9) assessing the human risk of airborne chemicals. 

Management of Assessed Risks from Carcinogens (W.J. Nicholson, Editor, Annals of the New York Academy of Sciences, Vol. 363, April 30 1981) is a broad, multiauthor treatment. My own paper in this volume, Regulation of carcinogens in food provides some historical perspective on food safety and also deals with the problem of naturally-occurring carcinogens. 

TABLE 1.1. Historical Perspectives of the Development of the Risk Assessment Process... 

Center for Risk Analysis. A Historical Perspective on Risk Assessment in the Federal Government. Boston Harvard School of Public Health, March, 1994. 

HISTORICAL PERSPECTIVE ON THE USE OF LYMPHOCYTE IMMUNOPHENOTYPING IN IMMUNOTOXICITY RISK ASSESSMENT FOR PHARMACEUTICALS... 

Gombar VK, Mattioni BE, Zwickl C, Deahl JT (2006) Computational approaches for assessment of toxicity a historical perspective and current status. In Ekins S (ed) Computa-titmal toxicology risk assessment for pharmaceutical and environmental chemicals. Wiley, Hohoken, NJ... 

ABSTRACT Shipping accidents can have severe consequences, causing concerns to various stakeholders. This has led to research into risk assessment methods for the maritime transportation system. This paper presents an analysis of risk concepts and perspectives adopted in 44 methods for risk assessment in maritime transportation. As a methodological framework for analysis, a historical classification of risk concepts and a novel categorization of risk perspectives along the realist-constructivist continuum are apphed. Analyses reveal that in the maritime transportation, risk is strongly tied to probability and that a wide range of perspectives is found, from realism over scientific proceduralism to more constructivist views. 

The historic overview clearly shows that a wide range of perspectives has been applied in risk assessments for maritime transportation. Most of the work is rooted in the idea that a true, mind-independent risk exists in line with realist perspectives on the continuum of Table 1. Using different modeling approaches, the majority of the methods aim to estimate this true risk. While the use of expert judgment has gained steady support, many of the applications rely heavily on accident and traffic data. Even when judgment is applied, it is considered to be truth-oriented. From the overview, it is also found that constructivist views, where the assessment is seen rather as a reflection of an assessor s interpretation of the system risk, are rare. The uncertainty view, where an assessor expresses his uncertainty about the occurrence of events and consequences, is not found in the application area. 

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