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Summary: FSMA Supplemental Notice of Proposed Rulemaking for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

Summary

Our proposed Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food regulation (Preventive Controls Rule) as analyzed in our original Proposed Regulatory Impact Analysis (PRIA) would include requirements for facilities subject to subpart C to maintain a food safety plan, perform a hazard analysis, and to institute preventive controls for the mitigation of those hazards. Our proposed revisions to the regulation include potential additional requirements for facilities subject to subpart C to institute risk-based environmental monitoring, product testing and a supplier program as appropriate to the food, the facility and the nature of the preventive controls, as well as a requirement to institute controls to help prevent hazards associated with economically motivated adulteration (EMA). If these provisions were adopted, facilities would be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records that document these actions. In this document we describe our estimate of the costs for each of our potential additional requirements.

Regulatory Impact Analysis
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

Federal Register: 79 FR 58523, September 29, 2014

Docket: FDA-2011-N-0920