FDA Building the Examinations, Inspections and Investigations Capacity Cooperative Agreement (U18) RFA-FD-12-027Proposal AbstractThe Washington State Department of Agriculture (WSDA) seeks funding from the U.S. Foodand Drug Administration (FDA) under RFA-12-027. The funding level requested is for $300,000for a three year period. The title of our proposal is:'The Development of a Comprehensive Food Sampling System.'If awarded, WSDA will hire a full-time project Sampling Coordinator to enhance and expand theagency's efforts in protecting public health.We propose to use the Microbiology Laboratory's Laboratory Information Management System(LIMS), as a means to meet the goals of this Cooperative Agreement. Expansion of XLIMS intothe Food Safety Program's Field Operations will enable WSDA to better integrate and buildcapacity for the Laboratory and Food Safety Program's food, feed and dairy samplingoperations. Currently Food Safety Officers (FSOs) either hand-write or use electronic versionsof the forms to record information about the samples they collect. Once in the Laboratory, staffenters information about the samples from the paper forms into XLIMS. Our proposal is todevelop, pilot and implement use of XLIMS in the field. FSOs will collect information about eachsample electronically, either by direct entry into XLIMS or by an Excel spreadsheet import, sothat an electronic chain of custody begins at the point of sample collection. This will save timefor both programs, reduce transcription errors, and ensure a traceable sample lifecycle(collection-testing-destruction). In addition, label information, photos, etc. about a particularsample can be uploaded into XLIMS. Food Safety Program staff will be able to view samplestatus (e.g., receiving information, testing status, reports) by accessing XLIMS.The Sampling Coordinator position associated with this project would report to the Food SafetyProgram Manager throughout the three-year project. In addition, she/he will need to quicklybecome knowledgeable about XLIMS, sample collection and handling in the field, and samplereceiving and testing in the laboratory.Budget for this project would pay for costs associated with the Sampling Coordinator position,including travel. Any additional hardware and software for FSOs would need to be provided bythe Food Safety Program and Consumer Services Division.This effort is well-aligned with WSDA's implementation of the Manufactured Food RegulatoryProgram Standards (MFRPS). By reducing the time required to collect samples, reducingsample collection errors, and enhancing analytical result reporting, the largest improvements willbe seen in the Inspection Program (Standard 3), Inspection Audit Program (Standard 4), Food-related Illness and Outbreaks Response (Standard 5), and Laboratory Support (Standard 10).Cross-over improvements will be felt in Compliance and Enforcement (Standard 6) and ProgramResources (Standard 8).

Public Health Relevance

FDA Building the Examinations, Inspections and Investigations Capacity Cooperative Agreement (U18) RFA-FD-12-027 Public Health Relevance The goal of the FDA/Office of Regulatory Affairs (ORA) Cooperative Agreement Program is to facilitate long-term improvements to the national food safety systems by building the capacity of state, local, tribal and territorial food safety agencies to undertake examinations, inspections and investigations and related food safety activities under section 702 of the FD&C Act. The WSDA Food Safety and Consumer Services Division protects public health by conducting surveillance sampling and testing of food, dairy and feed products, responding to food borne illness outbreaks and food related emergency situations, inspecting food and feed operations to ensure compliance with state and federal regulatory requirements, taking compliance actions as necessary and providing educational outreach to related producer, processor and consumer stakeholder groups. Our current food surveillance sampling efforts support public health in Washington State by actively assessing the microbiological safety of higher-risk foods. Existing surveillance efforts have successfully discovered incidents of food contamination and led to public health messaging and product recalls. The current proposal seeks to enhance existing efforts by streamlining sample collection and the reporting of analytical results. We hope to: ? reduce the time required to collect each sample ? reduce the number of errors made in sample collection reports ? improve the speed and clarity of analytical reporting ? increase the number of surveillance samples collected

National Institute of Health (NIH)
Food and Drug Administration (FDA)
Research Demonstration--Cooperative Agreements (U18)
Project #
Application #
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
WA State Department of Agriculture
United States
Zip Code