Kentucky's FSMA Human Foods Preventive Controls Implementation Expansion Submission

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Project Abstract The Commonwealth of Kentucky is applying for federal funds to conduct activities that will enable the Food Safety Program of the Kentucky Department for Public Health’s Division of Public Health Protection and Safety to adopt and implement the risk-based Preventive Controls for Human Food regulation (PCHF Rule), as described in the Code of Federal Regulations (21 CFR 117). Currently, the state has adopted by reference 21 CFR 117 by incorporation into The Kentucky Food Processing, Packaging, Storage, and Distribution Operations Regulation (902 KAR 45:160), which establishes procedures and requirements for food processing, packaging, storage, and distribution operations in Kentucky. This state regulation mirrors the specific FDA requirements for food firms, food plant requirements regarding plan review, construction and maintenance, water supply, plumbing, sewage disposal, toilet facilities, hand washing facilities, and food transportation. In 2017, 902 KAR 45:160 also incorporated the FDA’s Food Safety Modernization Act (FSMA) Final Rule on Preventive Controls for Human Food. However, full- scope implementation of the PCHF Rule by the Food Safety Program has been limited by the availability of qualified auditors in the state, as well as by insufficient technical resources for data processing and information sharing. The Food Safety Branch intends to use these funds to hire and train two state auditors (within two years) to conduct Phase III inspections of food manufacturing facilities to meet FDA standards. The auditors will be auditing the state inspectors. In addition, a computer application database called KY First will be enhanced to communicate with the FDA’s system (NSFDX) and result in reducing the amount of time staff use for data entry.