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

路径 C FDA 为各州和地区实施国家农产品安全计划 (U2F) 的合作协议计划 不允许进行临床试验

• 批准号: 10390179
• 负责人: Mark Reed
• 金额: $ 72.85万
• 依托单位: KENTUCKY STATE DEPARTMENT OF AGRICULTURE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10390179
• 关键词: Path; FDA; Cooperative; Agreement; Program

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.

KDA 生产安全计划 项目概要/摘要 2022 年，KDA 农产品安全计划完全获得国家对农产品的权威 通过州农产品安全法规/条例，确保肯塔基州的安全。 在2021-2026年业绩期间，KDA打算将其工作重点从 制定全面实施 FDA 国家农产品安全的国家计划 程序。在接下来的 5 年业绩期内，KDA 的目标是利用这一强大的 监管基础，以及完全执行的基础计划 SOP，以充分 执行强大的农场库存、教育/推广、 检查/合规/执法以及生产相关事件响应基金会 实现协助联邦/州合作伙伴和肯塔基州农产品的具体目标 种植者实现种植、收获、包装和保存标准 供人类消费的产品（21 CFR 第 112 部分）。 该项目的总体健康相关性是消费者和公共卫生的相关性 通过实施项目计划中的具体目标/目的来保护 最大限度地减少因消费而造成严重不良健康后果或死亡的风险 通过应用基于科学的最低标准来控制受污染的产品 用于农产品原料的安全种植、收获、包装和保存 为人类消费而种植的商品。本合作协议为全面合作协议 计划执行针对种植者教育、技术援助、 制定经核实的覆盖农场清单并进行优先排序 对《农产品安全规则》所涵盖的农场进行检查。 KDA 及其子获奖者 将继续对覆盖农场进行教育、宣传和识别。 KDA的 2021-2026年生产安全长期目标、具体目标和重点 CAP 授予绩效期旨在确保强有力的行政、农场 库存、监管计划基金会、教育/推广以及 检查/合规/执行系统已到位并得到充分执行，以便 推进联邦/州为全国综合食品安全系统（IFSS）所做的努力， 加强英联邦和国外的生产安全，并实现高比率 遵守 FDA 的农产品安全规则和州法规/法规。