Tuesday, April 22, 2025 4/22/2025

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

Award Number: U19FD007100
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	THE UNIVERSITY OF IOWA	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	000	5	4/3/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $435,000 )
2024	2024	THE UNIVERSITY OF IOWA	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	000	5	7/12/2024	NON-COMPETING CONTINUATION	$435,000
														Subtotal = $435,000

Issue Date FY: 2023 ( Subtotal = $488,588 )
2023	2023	THE UNIVERSITY OF IOWA	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	000	4	6/30/2023	NON-COMPETING CONTINUATION	$488,588
														Subtotal = $488,588

Issue Date FY: 2022 ( Subtotal = $392,780 )
2022	2022	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	002	3	8/3/2022	NON-COMPETING CONTINUATION	$392,780
2022	2022	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	003	3	8/12/2022	NON-COMPETING CONTINUATION	$0
2022	2021	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	000	2	10/19/2021	NON-COMPETING CONTINUATION	$0
2022	2021	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	001	2	3/21/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $392,780

Issue Date FY: 2021 ( Subtotal = $449,991 )
2021	2021	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	002	2	7/21/2021	NON-COMPETING CONTINUATION	$0
2021	2021	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	001	2	7/8/2021	NON-COMPETING CONTINUATION	$449,991
2021	2020	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	000	1	10/30/2020	NEW	$0
														Subtotal = $449,991

Issue Date FY: 2020 ( Subtotal = $570,000 )
2020	2020	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Food and Drug Administration Research	000	1	9/8/2020	NEW	$570,000
														Subtotal = $570,000

Grand Total All Awards = $2,336,359

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

Award Number: U19FD007100

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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