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

NIH RePORTER · FDA · U19 · $570,000 · view on reporter.nih.gov ↗

Abstract

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 ai...

Key facts

NIH application ID
10176080
Project number
1U19FD007100-01
Recipient
UNIVERSITY OF IOWA
Principal Investigator
MICHAEL David SCHUELLER
Activity code
U19
Funding institute
FDA
Fiscal year
2020
Award amount
$570,000
Award type
1
Project period
2020-09-01 → 2025-06-30