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, protects
consumers, and promotes preparedness. The State Hygienic Laboratory has been engaged in maintaining
quality systems in the laboratory in compliance with ISO/IEC 17025 since September 2013 and maintains
AIHA 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 accrediting
authority/agency standards. The aims of this overall application are to: 1) ensure laboratory capacity for the
analysis 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 and
technical staff supporting food safety have substantial experience in the public health laboratory. SHL chemists
and microbiologists have performed food analysis for surveillance, outbreak and inspection samples since the
early 2000s. SHL has all required and supplemental resources for full continuation of the food program in Iowa
beyond the end of the FDA ISO 17025 and FDA FERN programs. SHL performs food operations in two lab
locations. Within lab locations are BSL2 and BSL3 suites, biosafety cabinets, and fume hoods. Instrumentation
includes ICPMS, LCMSMS, GCMSMS, IC, proportional counters, liquid scintillation counters, alpha and
gamma 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 by
the National Environmental Laboratory Accreditation Program (NELAP) with oversight from the Oregon
accrediting authority. SHL is supported by a LIMS developed and maintained in-house. A quality management
system is in place and guided by the Quality Management Plan. Incorporated in the quality systems are a
document control system (iPassport), a non-conforming event (NCE) protocol and a schedule of internal
audits. Safety is addressed through substantial training and education requirements. There are improvements
and new applications proposed that include expanded capability in Radiochemistry for rapid alpha-emitter
screen, expanded capability in Chemistry for the analysis of juice and other sugary products and applying
SHL'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 discontinued
ELISA toxin kits and particularly the mouse assay. In addition, the implications of COVID-19 on food and food
surfaces is a critical emerging research area in virology testing that will need development for this aim
relatively soon. SHL has the expertise, resources and facilities to contribute to that science, as well as all other
projects that are proposed that will not only be a benefit SHL and Iowa, but also the FDA and FERN networks.