Location: Vegetable Research
Project Number: 6080-22000-030-052-S
Project Type: Non-Assistance Cooperative Agreement
Start Date: Sep 17, 2025
End Date: Sep 16, 2027
Objective:
Objective #1) To monitor all IR-4 Good Laboratory Practices (GLP) studies conducted at USDA-ARS field research test sites. The Cooperator (IR-4 Project Headquarters at North Carolina State University) will provide a service to USDA-ARS by performing the US
Environmental Protection Agency (EPA) required GLP required inspections and audits. The Cooperator will perform the Quality Assurance responsibilities and provide funds in sub-award agreements between North Carolina State University and the following two
regional IR-4 offices: University of Florida (Southern region) and University of California, Davis (Western region) to perform this objective.
Approach:
1. The members of the IR-4 Quality Assurance Unit located at the IR-4 Regional Offices and/or IR-4 Headquarters periodically travel to USDA-ARS field test sites and analytical testing laboratories to conduct inspections of studies, including inspecting facilities, and observing critical phases of research as required by the EPA GLPs. This is necessary because the USDA-ARS sites which develop data cooperatively with IR-4 do not have Quality Assurance expertise and these inspections are needed to ensure the data developed by USDA-ARS will meet the Federal Good Laboratory Practice Standards regulations (40 CFR Part 160).
2. The data generated at USDA-ARS field test sites and the final reports generated from that data are also audited to assure compliance with the IR-4 protocol and conducted in accordance with 40 CFR Part 160, the Good Laboratory Practice Standards (GLPs). The GLPs require all studies be monitored by QA personnel to: "…assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part."