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Manganese Testing under a Clean Air Act Test Rule and the Application of Resultant Data in Risk Assessments

机译：清洁空气法测试规则下的锰测试以及结果数据在风险评估中的应用

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In the 1990’s, the proposed use of methylcyclopentadienyl manganese tricarbonyl (MMT) as an octane-enhancing gasoline fuel additive led to concerns for potential public health consequences from exposure to manganese (Mn) combustion products in automotive exhaust. After a series of regulatory / legal actions and negotiations, the U.S. Environmental Protection Agency (EPA) issued under Clean Air Act (CAA) section 211(b) an Alternative Tier 2 Test Rule that required development of scientific information intended to help resolve uncertainties in exposure or health risk estimates associated with MMT use. Among the uncertainties identified were: the chemical forms of Mn emitted in automotive exhaust; the relative toxicity of different Mn species; the potential for exposure among sensitive subpopulations including females, the young and elderly; differences in sensitivity between test species and humans; differences between inhalation and oral exposures; and the influence of dose rate and exposure duration on tissue accumulation of Mn. It was anticipated that development of specific sets of pharmacokinetic (PK) information and models regarding Mn could help resolve many of the identified uncertainties and serve as the best foundation for available data integration. The results of the test program included development of several unique Mn datasets, and a series of increasingly sophisticated Mn physiologically-based pharmacokinetic (PBPK) models. These data and models have helped address each of the uncertainties originally identified in the Test Rule. The output from these PBPK models were used by the Agency for Toxic Substances and Disease Registry (ATSDR) in 2012 to inform the selection of uncertainty factors for deriving the manganese Minimum Risk Level (MRL) for chronic exposure durations. The EPA used the MRL in the Agency’s 2015 evaluation of potential residual risks of airborne manganese released from ferroalloys production plants. This resultant set of scientific data and models likely would not exist without the CAA section 211(b) test rule regulatory procedure.
机译：在1990年代，提议使用甲基环戊二烯基三羰基锰（MMT）作为增强辛烷值的汽油燃料添加剂，引起了人们对暴露于汽车尾气中的锰（Mn）燃烧产物的潜在公共健康后果的担忧。经过一系列监管/法律行动和谈判，美国环境保护局（EPA）根据《清洁空气法》（CAA）第211（b）条发布了替代方法2测试规则，该规则要求开发旨在帮助解决以下方面的不确定性的科学信息：与MMT使用相关的暴露或健康风险估计。确定的不确定性包括：汽车尾气中锰的化学形式；不同锰物种的相对毒性；包括女性，年轻人和老年人在内的敏感亚人群的接触潜力；测试物种与人类之间的敏感性差异；吸入和口服暴露之间的差异；剂量率和暴露时间对锰组织积累的影响。可以预期，开发特定的有关Mn的药代动力学（PK）信息和模型集将有助于解决许多已确定的不确定性，并为可获得的数据整合提供最佳基础。测试程序的结果包括开发了几个独特的Mn数据集，以及一系列越来越复杂的Mn基于生理学的药代动力学（PBPK）模型。这些数据和模型有助于解决测试规则中最初确定的每个不确定性。这些PBPK模型的输出在2012年被有毒物质和疾病登记局（ATSDR）用来通知不确定性因素的选择，以得出慢性暴露持续时间的锰最低风险水平（MRL）。 EPA在原子能机构2015年对铁合金生产厂释放的机载锰潜在残留风险的评估中使用了最大残留限量。没有CAA第211（b）条测试规则监管程序，可能就不会有这样一组科学数据和模型。

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