Probabilistic methods for non-cancer health effects

Abstract

Noncancer risk assessment methods and harmonization with cancer assessment methods have advanced from the simple divide a No Observed Adverse Effect Level (NOAEL) by a default safety factor or a linear extrapolation to background of the early 1980's. This advance is due in part due to groups such as the American Industrial Health Council, the National Institute of Environmental Health Sciences, the Society for Risk Analysis, the Society of Toxicology, and the U.S. Environmental Protection Agency, the National Academy of Sciences (NAS), the International Programme on Chemical Safety, and to many independent researchers outside of and within a workshop series sponsored by the Alliance for Risk Assessment prompted by the NAS \\. Several of the case studies from this workshop series, and earlier work such as Bogdanffy et al., demonstrate that the dose response assessment of non-cancer toxicity and the harmonization of cancer and non-cancer methods are more than just a simple reflection of treating all non-cancer toxicity as if it has a threshold, or all cancer toxicity as if it did not. Moreover, one recommendation of NAS \\ was to develop a problem formulation with risk managers prior to conducting any risk assessment. If the development of this problem formulation only necessitates the determination of a safe, or virtually safe dose, then the estimation of a Reference Dose (RfD) or virtually safe dose (VSD) or similar constructs should be encouraged. Not all of our environmental problems need a precise quantitative solution.