FSMA Human Foods Preventive Controls Implementation Expansion in Georgia

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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.