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 格鲁吉亚农业部（GDA）将继续合作和促进工作， 与美国食品和药物管理局建立基于相互依赖和共同责任的食品安全体系 美国食品药品监督管理局（FDA）和其他利益相关者。该项目的总体目标是充分 实施现行药品生产质量管理规范、危害分析和基于风险的预防措施 人类食品控制法规（PCHF规则）纳入制造食品计划和国家 食品安全综合体系（IFSS）。作为一个国家监管机构，我们的首要目标是减少 已知在生产、加工、持有、销售和销售食品的公司中引起或促成食源性疾病的风险因素， 或者打包食物 该项目的目标包括以下内容：a）将PCHF规则纳入制成品 监管计划标准（MFRPS）培训计划要求并进行评估， 确定并记录为促进证据收集而需要对培训计划作出的任何改进 并支持可能的监管行动; B）通过实施 第三阶段审计和收集关于全面的污染控制中心检查的审计数据，以及参加 审计标准的制定和试点; c）确定和弥补GDA基础设施中的差距 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 检查和合规计划，其中包含PCHF规则，包括与FDA合作， 参与工作规划、工作共享和数据交换工作; e）确定任何必要的活动 采纳、合并、参考或利用PCHF规则，包括根据 f）制定与PCHF法规相关的推广计划和相关材料， 合规性和其他FSMA相关规则，作为GDA整体外展计划的一部分;以及g）与FDA会面， 有必要为双重视察的设施制定/监测工作规划进展，包括更新指南 文件和参与试点项目，以推动联合工作规划、信息共享、 格鲁吉亚和林业发展局之间的和解和执法行动。 该项目的目标包括：a）将PCHF规则纳入培训计划; B）实施 审计计划的第三阶段; c）计划改进和基础设施发展; d）预防性控制 检查和合规实施战略; e）立法研究、规则制定和政策分析; f） 制定一项外联计划和与人道主义援助基金规则有关的相关材料;以及g）联合工作规划， 与FDA合作。