Expanded Testing Methods for Elements and Metals in Animal Diagnostic Specimens

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