Food Defense and Surveillance in Support of the FDA by the State Hygienic Laboratory at the University of Iowa

Project Summary/Abstract - Overall:The culture of food safety that has been developed and sustained within the State Hygienic Laboratory (SHL)at the University of Iowa is a high-quality, performance-based effort that enhances public health, protectsconsumers, and promotes preparedness. The State Hygienic Laboratory has been engaged in maintainingquality systems in the laboratory in compliance with ISO/IEC 17025 since September 2013 and maintainsAIHA Laboratory Accreditation specifically for the food scope by providing the resources - including systems,equipment, and personnel - to ensure adherence to rigorous QA/QC protocols and appropriate accreditingauthority/agency standards. The aims of this overall application are to: 1) ensure laboratory capacity for theanalysis of foods, 2) strengthen and enhance food response in urgent and emergency situations/outbreaks,and 3) enhance currently validated and potentially develop new analytical methods. The SHL management andtechnical staff supporting food safety have substantial experience in the public health laboratory. SHL chemistsand microbiologists have performed food analysis for surveillance, outbreak and inspection samples since theearly 2000s. SHL has all required and supplemental resources for full continuation of the food program in Iowabeyond the end of the FDA ISO 17025 and FDA FERN programs. SHL performs food operations in two lablocations. Within lab locations are BSL2 and BSL3 suites, biosafety cabinets, and fume hoods. Instrumentationincludes ICPMS, LCMSMS, GCMSMS, IC, proportional counters, liquid scintillation counters, alpha andgamma spectrometers, thermocyclers, and substantial support equipment. AIHA program certificates for food,unique scopes, industrial hygiene and environmental lead are current for these locations. SHL is accredited bythe National Environmental Laboratory Accreditation Program (NELAP) with oversight from the Oregonaccrediting authority. SHL is supported by a LIMS developed and maintained in-house. A quality managementsystem is in place and guided by the Quality Management Plan. Incorporated in the quality systems are adocument control system (iPassport), a non-conforming event (NCE) protocol and a schedule of internalaudits. Safety is addressed through substantial training and education requirements. There are improvementsand new applications proposed that include expanded capability in Radiochemistry for rapid alpha-emitterscreen, expanded capability in Chemistry for the analysis of juice and other sugary products and applyingSHL's Microbiology validated in-house Cyclospora RT PCR assay to produce surveillance. In future years,SHL Microbiology plans to validate Endopep-MS procedure for C. botulinum toxin to replace discontinuedELISA toxin kits and particularly the mouse assay. In addition, the implications of COVID-19 on food and foodsurfaces is a critical emerging research area in virology testing that will need development for this aimrelatively soon. SHL has the expertise, resources and facilities to contribute to that science, as well as all otherprojects that are proposed that will not only be a benefit SHL and Iowa, but also the FDA and FERN networks.