Project Summary Discipline A Microbiology, Track 5- Cyclospora Capability/Capacity Development The Texas Department of State Health Services (DSHS) Laboratory Services Section (LSS) works in conjunction with the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the state regulatory body, DSHS Consumer Protection Division (CPD), to ensure food and food products in Texas are safe. Cyclosporiasis, an intestinal illness caused by Cyclospora cayetanensis has increasingly been the source of outbreaks and significant sporadic illness in Texas. For this reason, DSHS LSS and CPD are interested in testing human food products for the presence of Cyclospora cayetanensis using real-time PCR for rapid and sensitive detection. The long-term goal is for this process to be a part of a routine surveillance test on food and environmental samples. An implementation plan has been developed to purchase equipment, train staff, modify the laboratory information management system, evaluate and validate testing methodology, and demonstrate competency through proficiency testing. DSHS LSS will then work with CPD to add Cyclospora cayetanensis to the Sample Collection and Analysis Project of the Microbiology Human Food Testing Track. LSS will also work with the DSHS Infectious Disease and Control Unit and the DSHS Texas Rapid Response Team during outbreak investigations of Cyclospora cayetanensis in human food. The LSS Consumer Microbiology Team (CMT) and Molecular Biology Team (MBT) will be performing procedures in methods following the FDA Bacteriological Analytical Manual 19b: Molecular Detection of Cyclospora cayetanensis in Fresh Produce Using Real-Time PCR. LSS will continue to follow FDA guidance for proper sampling and laboratory data documentation and participate in annual proficiency tests (PT) for work performed under this project. LSS will stay committed to its 20.88 agreement with the FDA and will attend the annual LFFM Face-to- Face meeting to ensure continued collaboration between LSS and FDA. This project will strengthen and improve the collaboration of surveillance testing activities already established between the FDA and our state and local partners improving the ability of DSHS to respond to a large-scale threat to the nation's food supply.