SAB Report: Development of the Acute Reference Exposure. Review of the Draft211 Document Methods for Exposure-Response Analysis for Acute Inhalation Exposure to 211 Chemicals: Development of the Acute Reference Exposure (EPA/600/R-68/051)

摘要

The Environmental Health Committee (EHC) reviewed the EPA's methodology document,211u001e'Methods for Exposure-Response Analysis for Acute Inhalation Exposure to 211u001eChemicals, Development of the Acute Reference Exposure'. the EHC commends the 211u001eAgency for developing methodology to derive Acute Reference Exposures (ARE), a 211u001echemical-specific acute exposure (with an uncertainty spanning an order of 211u001emagnitude) that is not likely to cause adverse effects in a human population. 211u001eOverall, approaches for the NOAEL and the benchmark concentration and for 211u001eduration extrapolation were found to be clear and appropriate. However, the EHC 211u001edoes not support the use of the categorical regression (CatReg) approach for 211u001edeveloping an ARE based on the lack of biological-plausibility for the 211u001emethodology, the lack of justification for the scaling factor to accommodate 211u001ewithin-group correlations and group size and the unrealiability of the types of 211u001econfidence limits used.