FDA FERN Cooperative Agreement Program 2015

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FDA FERN Cooperative Agreement Continuation Program (U18) RFA-FDA-OR-15-019 State of Wisconsin Department of Agriculture, Trade and Consumer Protection 2811 Agriculture Drive PO Box 8911 Madison, WI 53708-8911 Project Facility - Bureau of Laboratory Services Project Summary Project Goals: Maintain the testing program that addresses the threat to food safety and security from large-scale contamination events affecting foods or food products. Provide support for an integrated food safety system. Provide for sample surge capacity at the state level for an event which exceeds the testing capacity of FDA field laboratories. Provide for dedicated capacity to perform special food surveillance assignments. Assure the state laboratory has capability and capacity to provide testing when the testing capacity of FDA field laboratories is exceeded, and assure the state capacity is continuing and reliable. The project will meet the goals through activities which:  Maintains an overarching, comprehensive laboratory program in place that supports food security and food safety programs as a regular course of business, and is charged with operating in a regulatory environment. Assuring stability of the resources available and assure any emergency response in a regulated food environment is consistent with FDA practices.  Defines a Quality Management system that assures high quality and accurate results are reported during an incident.  Supports the availability of dedicated, professionally capable staff trained on the use of FDA test methods. Assuring that highly trained state lab resources will be brought on line immediately in any event where surge capacity is needed.  Makes available highly knowledgeable state staff to direct and manage the activities supporting the objectives and goals. Assuring that direction of programmatic tasks is effective and program goals are met through operational management from highly skilled staff.  Maintains state laboratory facility infrastructure, and appropriate scientific instrumentation necessary to provide equivalent testing when surge capacity is required. Assuring that capacity and capability, in addition to being available, is scientifically relevant and effective. In addition, these goals will be met within the context of four key project areas: 1. The use of Gas Chromatography\Mass Spectrometry (GC\MS) analysis. 2. The use of Liquid Chromatography\Mass Spectrometry (LC\MS) analysis. 3. The use of Inductively Coupled Plasma\Mass Spectrometry (ICP\MS) analysis. 4. The use of Enzyme Linked Immunosorbent Assay (ELISA) analysis.