Objective: By publishing the scientific opinion entitled "Use of the benchmark dose (BMD) approach in risk assessment: Guidance of the Scientific Committee," the European Food Safety Authority (EFSA) recommended that the BMD approach, as an alternative to the traditionally used no-observed-adverse-effect level approach, be used as the method of choice for the determination of the reference point for deriving health-based guidance values and margins of exposure, and described the BMD approach as being extensively applicable to all chemicals, even to dose-effect assessment of epidemiological data. When the BMD approach was first proposed, the approach was expected to estimate the dose causing a low but measurable target organ effect. We examined whether the BMD approach can be applied to epidemiological endpoints with clinical standards.
Methods: Comparisons between the BMD approach recommended by the EFSA and classical BMD approach (hybrid method) were conducted using epidemiological data with clinical standards.
Results: The 95% lower confidence limit of the EFSA-based BMD tended to be considerably lower than that of the hybrid method. The former approach is easily applicable to dose-response data in published papers, though it is difficult to adjust for possible confounders. The cutoff values, calculated by the hybrid method, of epidemiological endpoints are nearly concordant with the clinical standards.
Conclusions: By using the BMD approach recommended by the EFSA, human health safety may be better guaranteed because of the lower reference points for hazardous substances. However, its application to epidemiological data does not always reflect toxicological implications in light of the clinical standard.