2013 Annual Report
1a.Objectives (from AD-416):
1. Quality Assurance Services: To monitor all IR-4 Good Laboratory Practice (GLP) studies conducted at USDA-ARS research test sites. [IR-4 HQ will document the QA responsibilities and funds in sub-award agreements between Rutgers, the State University of New Jersey and each regional office: Michigan State University (North Central region), University of Florida (Southern region) and University of California, Davis (Western region).]
2. Ornamental Horticulture Research Activities: To develop appropriate efficacy and crop safety data to support the registration of safe and effective crop protection products on ornamental crops.
1b.Approach (from AD-416):
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 study procedures, facility equipment and personnel. Not all USDA-ARS sites which develop data cooperatively with IR-4 have Quality Assurance expertise and these 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”.
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 Ornamental 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.
This project is linked to Objective 1 "Quality Assurance Services to monitor all IR-4 Good Laboratory Practice (GLP) studies conducted at USDA-ARS research test sites and Objective 2 "To develop appropriate efficacy and crop safety data to support the registration of safe and effective crop protection products on ornamental crops" of the in-house project.
The IR-4 Quality Assurance has visited and inspected USDA-ARS field sites and analytical laboratory sites to ensure compliance with uniform experimental and standard operating procedures for residue analysis. Sites were visited in three regional areas including the North Central Region, the Southern Region and the Western Region.