Enhancing the Capacity and Capability of Human Food and Environmental Testing Laboratory at the Texas Department of State Health Services: Radiochemistry Food Defense

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Project Summary Discipline C Radiochemistry, Track 1 Food Defense Under this cooperative agreement, the primary goals for the Texas Department of State Health Services (DSHS), Laboratory Service Section (LSS) Radiochemistry Group are to ensure human food and human food products made and/or distributed in Texas are safe, determine the presence or absence of radioactive contamination, and determine the identities of radionuclides present in human samples. Data will be used to characterize the extent of food contamination, spotting trends, and calculating intakes. The DSHS LSS plans participation in the following specific aims and activities to achieve these goals. 1. Triage data to determine whether further analysis is needed; 2. Utilize results to determine if contamination is well above or well below regulatory limits; 3. Participate in FDA-requested triage exercises, and/or surveillance activities to support and maintain readiness. 4. Participate in national security event exercises, as available. 5. Participate in and pass annual proficiency test (PT) for work performed under this project. 6. Maintain FERN membership by participating in scheduled calls, meetings, and FERN activities. 7. Two Radiochemistry Group staff will attend the annual LFFM Face-to-Face meeting. 8. Maintain facilities and personnel necessary for testing related to this project. 9. Use FDA standardized validated methods, with the exception of emergency situations. 10. Provide a detailed quarterly summary of all samples collected and analyzed through the FERN website, as is normal procedure for FERN participants. 11. Follow best practices recommendations for proper sampling and laboratory data documentation and use FDA Form 431, or equivalent, for analytical for samples. 12. Notify the FDA project manager and the technical lead within one business day of any presumptive positive or “cannot rule out” (CRO) samples and submit the full laboratory package for any confirmed positive or violative sample within three business days of final. 13. Maintain a valid 20.88 agreement with FDA and participate in at least one FDA-requested annual assignment, if possible. 1