ABSTRACT
Health risk assessment is the process wherein toxicology data from animal and human epidemiologic studies are evaluated, a mathematical formula is applied to predict the response at low doses, and information about the degree of exposure is used to predict quantitatively the likelihood that a particular adverse response will be seen in a specific human population [1-3]. More simply, risk assessment is a process by which scientists evaluate the potential for adverse health effects from exposure to naturally occurring or synthetic agents [4]. Regulatory agencies have used the risk assessment process for nearly 50 years, most notably the U.S. Food and Drug Administration (USFDA) [5]; however, the difference between assessments performed in the 1950s and 1960s and those performed in the 1980s and 1990s is that dose-extrapolation models, quantitative exposure assessments, and quantitative descriptions of uncertainty have been added to the process [6]. Because of increased ability to measure and predict exposures, the availability of quantitative computer software programs, and better quantitative methods for estimating the low-dose response (such as physiologically based pharmacokinetic [PBPK] models), risk assessments conducted today provide more accurate risk estimates than in the past [3,7,8].
