Schwab Bradley W, Hayes Eileen P, Fiori Janice M, Mastrocco Frank J, Roden Nicholas M, Cragin David, Meyerhoff Roger D, D'Aco Vincent J, Anderson Paul D
AMEC Earth and Environmental, Suite 1B, Westford, MA 01886, USA.
Regul Toxicol Pharmacol. 2005 Aug;42(3):296-312. doi: 10.1016/j.yrtph.2005.05.005.
The detection of low levels of pharmaceuticals in rivers and streams, drinking water, and groundwater has raised questions as to whether these levels may affect human health. This report presents human health risk assessments for 26 active pharmaceutical ingredients (APIs) and/or their metabolites, representing 14 different drug classes, for which environmental monitoring data are available for the United States. Acceptable daily intakes (ADIs) are derived using the considerable data that are available for APIs. The resulting ADIs are designed to protect potentially exposed populations, including sensitive sub-populations. The ADIs are then used to estimate predicted no effect concentrations (PNECs) for two sources of potential human exposure: drinking water and fish ingestion. The PNECs are compared to measured environmental concentrations (MECs) from the published literature and to maximum predicted environmental concentrations (PECs) generated using the PhATE model. The PhATE model predictions are made under conservative assumptions of low river flow and no depletion (i.e., no metabolism, no removal during wastewater or drinking water treatment, and no instream depletion). Ratios of MECs to PNECs are typically very low and consistent with PEC to PNEC ratios. For all 26 compounds, these low ratios indicate that no appreciable human health risk exists from the presence of trace concentrations of these APIs in surface water and drinking water.
在河流、小溪、饮用水和地下水中检测到低水平的药物，引发了关于这些水平是否会影响人类健康的问题。本报告针对26种活性药物成分（APIs）和/或其代谢物进行了人类健康风险评估，这些成分代表14种不同的药物类别，美国有其环境监测数据。利用可获得的大量关于APIs的数据得出每日可接受摄入量（ADIs）。得出的ADIs旨在保护潜在暴露人群，包括敏感亚人群。然后，ADIs被用于估计两种潜在人类暴露源的预测无效应浓度（PNECs）：饮用水和鱼类摄入。将PNECs与已发表文献中的实测环境浓度（MECs）以及使用PhATE模型生成的最大预测环境浓度（PECs）进行比较。PhATE模型预测是在河流低流量和无消耗（即无代谢、废水或饮用水处理过程中无去除以及河流中无消耗）的保守假设下进行的。MECs与PNECs的比值通常非常低，且与PEC与PNEC的比值一致。对于所有26种化合物，这些低比值表明地表水中和饮用水中痕量浓度的这些APIs不会对人类健康造成明显风险。
