FDA Building the Examinations, Inspections and Investigations Capacity Cooperative Agreement (U18) RFA-FD-12-027 Proposal Abstract The Washington State Department of Agriculture (WSDA) seeks funding from the U.S. Food and Drug Administration (FDA) under RFA-12-027. The funding level requested is for $300,000 for 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 the agency'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 into the Food Safety Program's Field Operations will enable WSDA to better integrate and build capacity for the Laboratory and Food Safety Program's food, feed and dairy sampling operations. Currently Food Safety Officers (FSOs) either hand-write or use electronic versions of the forms to record information about the samples they collect. Once in the Laboratory, staff enters information about the samples from the paper forms into XLIMS. Our proposal is to develop, pilot and implement use of XLIMS in the field. FSOs will collect information about each sample electronically, either by direct entry into XLIMS or by an Excel spreadsheet import, so that an electronic chain of custody begins at the point of sample collection. This will save time for both programs, reduce transcription errors, and ensure a traceable sample lifecycle (collection-testing-destruction). In addition, label information, photos, etc. about a particular sample can be uploaded into XLIMS. Food Safety Program staff will be able to view sample status (e.g., receiving information, testing status, reports) by accessing XLIMS. The Sampling Coordinator position associated with this project would report to the Food Safety Program Manager throughout the three-year project. In addition, she/he will need to quickly become knowledgeable about XLIMS, sample collection and handling in the field, and sample receiving 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 by the Food Safety Program and Consumer Services Division. This effort is well-aligned with WSDA's implementation of the Manufactured Food Regulatory Program Standards (MFRPS). By reducing the time required to collect samples, reducing sample collection errors, and enhancing analytical result reporting, the largest improvements will be 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 Program Resources (Standard 8).
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