IR-4 PMC Meeting IR-4 HQ Princeton, NJ October 26, 2009 Tammy W. Barkalow RQAP-GLP IR-4 Assistant Director HQ QA The IR-4 QAU: An Overview

Overview  EPA Inspections Update – 2009  Fall QA meeting – Agenda  Audits and Inspections IR-4 QAU UPDATE

US EPA Inspections 2009, update –North Carolina State, R. Batts September 21-24, 2009 Failure to notify IR4 of all studies Follow up with F. Liem’s office No findings, great job by Mr. Batts, Ms. Knight, and Ms. Forder –Rutgers Ag. Exp. Station, Cream Ridge, Tom Freiberger Oct , 2009 –Under discussion, can it be postponed The IR-4 QAU: An Overview

Fall QA Meeting at IR-4 HQ Agenda Review of All Hands meeting Review of the final report submission spreadsheet for 2009 and 2010 Review of the new IR-4 database and its new components Training and update on the revised QA Sops and their distribution for satellite or contract QA Review of the 2009 field season, lessons learned and needs identified –Special projects – mosquito study potato post harvest fumigation SO2 Discussions on: –Routing of QA audit reports via systems (procedures to put into place to include expected printouts to be filed, wording of body, nomenclature for naming audit files, persons to send audit to (FRD and their regional QA coordinator, etc.), number of audits accepted per , etc) – Protocol wording covering calibration acceptance criteria –Changes made to the 2010 protocol and FDB Add study completion date (tie in to database dates) Experimental termination date to reflect GLP definition Other changed sections –Lessons learned from S. Benzen’s GLP statements and how the new statement is being used. Develop consensus on expectations for final reports. –Bracketing of scales used for field test substances and language in the FDB Facility inspection follow up, update on length of inspection to report, responses status Legibility of ASRs and final reports The IR-4 QAU: An Overview

Audits and Inspections FDBs remain, 4 with WSR QA, 2 with HQ QA 2008 – 41 in QA, 39 to come to QA, 472 complete 2009 – 55 in QA, 505 to come to QA Final Report and Field Data Book audit progress: The IR-4 QAU: An Overview

QA Resources Audits of 2008 FDBs 2008 FDBsDoneIn QAexpectedTotal HQ NCR NER SOR WSR Total The IR-4 QAU: An Overview

QA Resources Audits of 2009 FDBs 2009 FDBsDoneIn QAexpectedTotal HQ NCR NER0033 SOR WSR Total The IR-4 QAU: An Overview

QA Final report audits tracking, 10/13/09 In QA currentlyDone in 09 HQ413 NCR22 NER09 SOR38 WSR016 Total948 The IR-4 HQ QAU has 11final reports for 2 nd check and has completed 56 2 nd checks this year. HQ has audited and finalized 6 Amended Final Reports in The IR-4 QAU: An Overview

Thank You The IR-4 QAU: An Overview