Location: Vegetable Research
Project Number: 0500-00007-117-001-S
Project Type: Non-Assistance Cooperative Agreement
Start Date: Aug 1, 2020
End Date: Jul 31, 2025
Objective:
Objective #1) To monitor all IR-4 Good Laboratory Practices (GLP) studies conducted at USDA-ARS research test sites. IR-4 Project Headquarters (HQ) 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. HQ will perform the Quality Assurance responsibilities and provide funds in sub-award agreements between North Carolina State University and the following regional offices: Michigan State University (North Central region), University of Florida (Southern region) and University of California, Davis (Western region).
Objective #2) To develop appropriate efficacy and crop safety data to support the registration of safe and effective crop protection products on ornamental crops. IR-4 Project Headquarters will establish a sub-award agreement with Rutgers University to support environmental horticulture research at the Fruit and Ornamental Research and Extension Center in Cream Ridge, New Jersey.
Approach:
Approach for Objective #1:
1. The members of the IR-4 Quality Assurance Unit located at the IR-4 Regional Offices and 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 Good Laboratory Practices (GLP). 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 GLP 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 GLP. The GLP 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."
Approach for Objective #2:
1. A sufficient number of test plants are obtained that either are healthy for crop safety trials or have the target disease or insect present in adequate numbers.
2. At the appropriate time, the test chemical or biological agent is applied on to the plants following good research methods which approximate grower practices.
3. Numerous observations on the control of target pests and any injury on the crop are taken after test application.
4. The raw data from the research are statistically analyzed and summarized.
5. The final report, containing the summarized data is submitted to the IR-4 Environmental Horticulture Manager for submission to the cooperating registrant. The data will be used by the crop protection companies to support EPA approved registrations of chemical and biological crop protection products to allow the public to purchase high quality ornamental horticulture plants at a reasonable price.
