Path C The FDA's Cooperative Agreement Program for States and Territories to Implement a National Produce Safety Program (U2F) Clinical Trials Not Allowed

KDA Produce Safety Program Project Summary/Abstract In 2022, the KDA Produce Safety Program assumed fully state authority for Produce Safety in Kentucky via the passage of a State Produce Safety Statute/Regulation. Under the 2021-2026 Period of Performance, KDA intends to shift its efforts from building a state program to that of full implementation of FDA’s national Produce Safety Program. During the next 5-year Period of Performance, KDA aims to utilize this robust regulatory foundation, along with fully executed, foundational program SOPs to fully execute a robust Farm Inventory, Education/Outreach, Inspection/Compliance/Enforcement, and Produce-Related Event Response foundation towards the specific aim of assisting federal/state partners and Kentucky produce growers in achieving Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR Part 112). The overall health relatedness of this project is that of consumer and public health protection by implementing specific goals/objectives in the Project Plan aimed at minimizing the risk of serious adverse health consequences or death from consumption of contaminated produce through the application of science-based minimum standards for the safe growing, harvesting, packing, and holding of produce raw agricultural commodities grown for human consumption. This cooperative agreement is for full program execution directed towards grower education, technical assistance, development of a verified inventory of covered farms and conducting prioritized inspections of farms covered by the Produce Safety Rule. KDA and its sub-awardees will continue to conduct education, outreach, and identification of covered farms. KDA’s long-term objectives, specific aims, and key focus during 2021-2026 Produce Safety CAP Grant Period of Performance seek to ensure that robust Administrative, Farm Inventory, Regulatory Program Foundation, Education/Outreach, and Inspection/Compliance/Enforcement systems are in place and fully executed in order to advance Federal/State efforts for a nationally integrated food safety system (IFSS), enhance produce safety in the Commonwealth and abroad, and achieve high rates of compliance with FDA’s Produce Safety Rule and the state statute/regulation.