Risk assessment is an important tool in deciding how to allocate resources to controlling risks. In most cases it is based on hazard data derived from animal experiments and on exposure data from an assessment of the likely or actual exposure of the population of interest. Recent advances have improved the understanding of the use of the no adverse effect level (NOAEL) and safety factor for risk assessment by providing a scientific justification of the 100-fold safety factor. Concern about the risks of exposure by various routes simultaneously (aggregate exposure) and the risks of exposure to mixtures (cumulative risk assessment) have lead to new approaches to these issues. For many years, risk assessment of genotoxic carcinogens has relied on low-dose extrapolation using mathematical models. Recently, these methods are being reconsidered and, in some cases, replaced with the NOAEL/safety factor approach combined with all information on the mechanism of action and the magnitude of the response. It is vitally important to ensure that risk assessment provides accurate and unbiased estimates of risk of exposure so that appropriate measures can be taken to control the risks.
THE PURPOSE OF RISK ASSESSMENTThe number of different chemicals manufactured is estimated to be between 80 000 and 100 000 (medicines, food additives, cosmetics, pesticides, industrial chemicals, etc.). For the benefits of synthetic chemicals to be realized, they must be handled or used safely. In addition to synthetic chemicals, there are numerous natural chemicals with highly toxic properties-such as the mycotoxins (e.g., aflatoxin, ochratoxin, patulin, thricothecenes, etc.), plant toxins (e.g., alkaloids or cyanogenic glycosides), animal toxins (e.g., snake venoms), and chemicals that are produced naturally in the environment (such as heavy metals and ozone). We must know at what dose these chemicals are likely to cause harm. It is this task that requires risk assessment-establishing the safe dose of a chemical and the likely toxic effects that may be seen if that safe dose is exceeded.There are so many potential hazards from human activities, including from exposure to chemicals, that we have to prioritize the risks and use our limited resources for controlling the most serious risks. In order to do so, risk assessment is used as the method of providing information on the magnitude of the risks. This is vital if we are to direct our limited resources to creating the greatest reduction in risks, for it requires that those resources are focused on reducing the largest or most serious risks first.
DefinitionsThere are many different definitions of risk and the processes used in risk assessment. The majority makes the clear distinction between hazard and risk.