FSMA Human Foods Preventive Controls Implementation Expansion in Georgia

FSMA 人类食品预防控制措施在佐治亚州的实施扩展

• 批准号: 10168772
• 负责人: Natalie Adan
• 金额: $ 15万
• 依托单位: GEORGIA STATE DEPARTMENT OF AGRICULTURE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10168772
• 关键词: FSMA; Human; Foods; Preventive; Controls

Project Summary The Georgia Department of Agriculture (GDA) will continue collaborative and promotional efforts for the advancement of a food safety system based on mutual reliance and shared responsibility with the U.S. Food and Drug Administration (FDA) and other stakeholders. The overall objective of this project is full implementation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (PCHF Rule) into the Manufactured Food Program and a nationally Integrated Food Safety System (IFSS). Our overarching goal as a state regulatory authority is to reduce the risk-factors that are known to cause or contribute to foodborne illness in firms that manufacture, process, hold, or pack food. Objectives for this project include the following: a) incorporating the PCHF Rule into Manufactured Food Regulatory Program Standards (MFRPS) Training Program requirements and conducting an evaluation to identify and document any improvements to the training plan that are needed to promote evidence collection and support possible regulatory actions; b) expanding the Auditing Program by moving toward implementing Phase III audits and collecting audit data on full-scope PCHF inspections, as well as participating in the development and piloting of the audit criteria; c) identifying and remedying gaps in GDA's infrastructure necessary to implement the PCHF Rule as part of the manufactured food regulatory program; d) establishing an inspection and compliance program which incorporates the PCHF Rule that includes engaging with FDA to participate in workplanning, work-sharing, and data exchange efforts; e) determining any necessary activities to adopt, incorporate, reference, or utilize the PCHF Rule, including other rules promulgated under the authority of FSMA; f) developing an outreach plan and associated materials related to the PCHF regulation and compliance and other FSMA related rules as part of GDA's overall outreach plan; and g) meeting with FDA as necessary to develop/monitor workplanning progress for dual inspected facilities including updating guidance documents and participation in pilot projects to advance joint workplanning, information sharing, firm reconciliation and enforcement action between Georgia and FDA. The aims for this project include a) incorporating the PCHF Rule into the training program; b) implementing Phase III in the Audit Program; c) program improvement and infrastructure development; d) preventive controls inspection and compliance implementation strategies; e) legislative research, rulemaking and policy analysis; f) developing an outreach plan and associated materials related to the PCHF rule; and g) joint workplanning and enforcement with the FDA.

项目摘要 佐治亚州农业部（GDA）将继续为 基于相互依赖和与美国食品共同责任的食品安全系统的进步 和药物管理局（FDA）和其他利益相关者。该项目的总体目标已满 实施当前良好的制造实践，危害分析和基于风险的预防 对制造食品计划的人类食品法规（PCHF规则）的控制和全国范围 综合食品安全系统（IFSS）。我们作为国家监管机构的总体目标是减少 已知会导致或在生产，处理，持有， 或打包食物。 该项目的目标包括以下内容：a）将PCHF规则纳入制造食品 监管计划标准（MFRP）培训计划要求并进行评估 识别并记录培训计划的任何改进，以促进证据收集 并支持可能的监管行动； b）通过迈向实施来扩大审计计划 第三阶段审核并收集有关全范围PCHF检查的审计数据，并参与 审计标准的制定和试点； c）在GDA的基础架构中识别和补救差距 作为制造食品监管计划的一部分，实施PCHF规则所必需的； d）建立 一项检查和合规计划，其中包含PCHF规则，其中包括与FDA互动 参加工作计划，工作共享和数据交换工作； e）确定任何必要的活动 采用，合并，参考或利用PCHF规则，包括在 FSMA的权威； f）制定与PCHF法规有关的外展计划和相关材料 作为GDA总体外展计划的一部分，合规性和其他与FSMA相关的规则； g）与FDA会面 为双重检查设施开发/监视工作计划的必要条件，包括更新指南 文件和参与试点项目以推进联合工作计划，信息共享，公司 佐治亚州和FDA之间的和解与执法行动。 该项目的目的包括a）将PCHF规则纳入培训计划； b）实施 审计计划中的第三阶段； c）计划改进和基础设施发展； d）预防控制 检查和合规实施策略； e）立法研究，规则制定和政策分析； f） 制定与PCHF规则相关的外展计划和相关材料； g）联合工作计划和 使用FDA执行。