Animal Feed Regulatory Program Standards (AFRPS) Maintenance and the Enhancement of Current Good Manufacturing Practices (cGMP) and Preventive Controls for Animal Food Regulatory (PCAF) Activities

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Project Summary/Abstract Animal Feed Regulatory Program Standards (AFRPS) Maintenance and the Enhancement of Current Good Manufacturing Practices (cGMP) and Preventive Controls for Animal Food (PCAF) Regulatory Activities FOA: PAR-20-13 Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed The Louisiana Department of Agriculture & Forestry’s (LDAF), Office of Animal Health & Food Safety (AHFS), Feed Program Division is currently finalizing year 5 of the Animal Feed Regulatory Program Standards (AFRPS) Development and Implementation Grant (RFA-FD-15-021) and expects to be found in full conformance during the program’s final FDA audit scheduled for August 2020. The LDAF AHFS Feed Program plans to move forward with the maintenance phase of the FDA AFRPS Program and enroll in the Preventive Controls (PC) Funding Opportunity to support the FDA Preventive Controls Initiative. The Feed Program plans to maintain FDA Contract work for feed related activities while annually increasing the capability and capacity to conduct all comprehensive inspections covered under 21 CFR Part 507. The LDAF AHFS Feed Program will support the LDAF Agricultural Chemistry Laboratory by providing trained personnel for sample collection allowing the Laboratory to enhance its scope and capacity. The Feed Program plans to identify and train a qualified field inspection trainer for comprehensive inspections which include Current Good Manufacturing Practices (cGMP) and Preventive Controls for Animal Food (PCAF). The program will enhance its outreach program by identifying outreach venues and developing outreach materials that pertain to PCAF regulation. The Feed Program plans to move forward with the State Auditor Program by moving towards Phase 2 and 3. The program plans to participate in and help develop capabilities to share regulatory data with the FDA through IT interface platforms such as the National Food Safety Data Exchange (NFSDX). The program will continue to work with the FDA to evaluate an enhance data collection and enforcement strategies, especially as it pertains to cGMP and PCAF compliance. The Feed Program will continue to support the FDA by providing current firm inventories categorized by risk. Finally, The LDAF AHFS Feed Program with develop a sound Exit Strategy by year 5 that will outline how the program will sustain required resources for program enhancement and implementation, advancements in cGMP/PC regulatory work activities and maintain full conformance with the AFRPS. Maintaining full conformance with the AFRPS will assist both Louisiana and the Food and Drug Administration (FDA) to better direct their regulatory activities toward preventing feed manufacturing compliance issues and increasing food safety and Public Health within the United States.