A GLP Audit in Salinas


Notebooks with PencilA Good Laboratory Practice (GLP) Standards inspection and data quality audit was conducted on December 11, 2018 at the USDA-ARS, Crop Improvement and Protection Research facility in Salinas, CA. The audit concerned research in support of the IR-4 Project through the ARS in-house project on Minor Use Pesticide Testing on Vegetables and Sugar Crops. The audit was led by EPA Chemist Mark Lehr from the EPA’s GLP Program. Also present were Sharon Benzen (Field Research Director), Martin Beran (IR-4 Western Region Quality Assurance), Alvin Simmons (Interim Coordinator for USDA-ARS Minor Use Pesticide Registration Program), and James McCreight (Location Coordinator and Research Leader). Mark Lehr presented his official credentials, and presented the FIFRA Notice of Inspection which was then signed by James McCreight. James McCreight gave an overview of the location six in-house research projects on agriculture. Sharon Benzen had prepared in advance by arranging associated documents for the inspection and audit on tables in the conference room.

The GLP standards compliance inspection included an interview of Sharon, tours of the laboratory, archives, test substance and storage areas, and field site. Personnel CV and training records, SOPs, and equipment and calibration/maintenance logs were inspected. In addition, the ongoing trial PR# 12251 / NMG787: Magnitude of the Residue on Strawberry was inspected. Audits were conducted on three studies (PR# 02660 / Nitrapyrin: Magnitude of the Residue on Mustard Greens; PR# 11503 / Cyromazine: Magnitude of the Residue on Pea Edible Podded and Succulent; and PR# 11029 / Fenpyroximate: Magnitude of the Residue on Bean – Succulent Shelled). The exit discussion was quite positive.

This inspection case closed on March 1, 2019 with a conclusion that compliance problems were not identified by EPA. Sharon had gone through previous audits at this site. In addition to a positive reflection of the quality of Sharon’s work, the support by Tammy Barkalow at IR-4 HQ and Martin Beran in the Western Region facilitated the smooth process of this inspection and audit.