Expanded Testing Methods for Elements and Metals in Animal Diagnostic Specimens

1项目摘要：FDA目前缺乏标准化的方法， 2只动物）和动物诊断标本的尸检分析， 3起动物食品/饲料污染事件。为了弥补这一差距，现有的FDA方法必须 4可以扩展到新基质的测试，如牛奶，尿液，血液和组织。的目的 5本项目旨在验证痕量（宏观和微观）测定的分析方法 动物诊断样品中6种元素、重金属和稀土元素污染。一 2011-2012年进行的7项调查显示，全国有50多起污染事件归因于 铜、硫、铅、砷、锌、硒等8种微量元素和重金属， 9磷。此外，2009-2012年FDA召回的动物饲料包括 10起锌、钾、铜和钼污染事件。最后，稀土 事实证明，11项要素有助于追踪可疑的食品/饲料运输， 12个制造商、供应商和地理区域。兽医诊断协会 本提案中包括来自华盛顿、爱达荷州、怀俄明州和犹他州的13个实验室， 14起与历史悠久的矿物相关的动物污染事件 美国西部的15个采矿业。所有实验室将使用现有的微波 16消化和电感耦合等离子体质谱仪（ICP-MS）方法。以下 17 FDA指南，牵头实验室（华盛顿动物疾病诊断实验室- 18分析科学实验室）将在动物体内生成均匀和稳定的试验材料 19在研究过程中的饲料、动物组织（肝、肾、脑）、血液、乳汁和尿液（4 20年）的常量元素，微量元素，重金属和稀土元素。为每个 21分析物方法，将记录准确度、精密度、选择性的性能标准， 22检测限、定量限、线性、范围、测量不确定度和 23、坚强怀俄明州和犹他州的联合实验室将使用标准化方法 在项目期间开发了24个样本，用于分析盲态未知样本，以确定 25再现性和重复性。最终数据将根据AOAC 2002指南进行分析， 26化学方法验证和最终结果在整个Vet-LIRN中传达。的 合作协议的27项结果将增加所需的验证方法套件， 28份动物诊断样本，以提高FDA的应对能力 29起动物食品/饲料污染事件。 30

1 Project Summary: The FDA is currently lacking in standardized methods for ante mortem (live 2 animal) and post mortem analysis of animal diagnostic specimens potentially associated with 3 animal food/feed contamination events. To address this gap, existing FDA methodologies must 4 be extended to testing of new matrices such as milk, urine, blood, and tissues. The purpose of 5 this project is to validate analytical methods for determination of trace (macro and micro) 6 element, heavy metal, and rare earth element contamination in animal diagnostic samples. A 7 survey conducted in 2011-2012 revealed over 50 contamination events nationwide attributed to 8 trace elements and heavy metals such as copper, sulfur, lead, arsenic, zinc, selenium and 9 phosphorus. Furthermore, animal feed recalls by FDA from 2009-2012 have included 10 contamination events from zinc, potassium, copper, and molybdenum. Lastly, rare earth 11 elements have proved useful for tracing suspicious shipments of food/feed back to specific 12 manufacturers, suppliers, and geographical regions. The consortium of veterinary diagnostic 13 laboratories from Washington, Idaho, Wyoming, and Utah included in this proposal have 14 extensive experience animal contamination events associated with the long established mineral 15 mining industry in the western United States. All laboratories will use established microwave 16 digestion and Inductively Coupled Plasma Mass Spectrometer (ICP-MS) methods. Following 17 FDA guidelines, the lead laboratory (Washington Animal Disease Diagnostic Laboratory- 18 Analytical Sciences Laboratory) will generate homogeneous and stable test materials in animal 19 feed, animal tissues (liver, kidney, brain), blood, milk and urine over the course of the study (4 20 years) for macroelements, microelements, heavy metals, and rare earth elements. For each 21 analyte method, performance criteria will be documented for accuracy, precision, selectivity, 22 limit of detection, limit of quantification, linearity, range, measurement uncertainty and 23 ruggedness. Consortium laboratories in Wyoming and Utah will use standardize methods 24 developed during the project to analyze samples as blinded unknowns to determine 25 reproducibility and repeatability. Final data will be analyzed using AOAC 2002 guidelines for 26 validation of chemical methods and final results communicated throughout the Vet-LIRN. The 27 results of the cooperative agreement will increase the suite of validated methods needed for 28 animal diagnostic specimens in order to increase the capacity and capability of FDA to respond 29 to animal food/feed contamination events. 30