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
Expansion of validated test methods throughout the Vet-LIRN for macro and micro elements, rare earth elements and metals in animal diagnostic specimens will increase laboratory testing capacity and capability in order for the FDA Center of Veterinary Medicine to respond to animal food/drug contamination events. Rapid detection of chemical contamination in animal foods/feeds, either as unintentional contaminants or intentionally introduced adulterants, augments nationwide public health by ensuring the health of food producing animals and improving human food safety and security. Furthermore, chemical contamination of animal feeds is often a forewarning for contamination of the human food chain as illustrated in the late 2000s by multiple melamine contamination events in both animal and human foods.
