ABA’s citizen petition in July 2012 urged FDA to exempt storage facilities from FDA’s preventive controls provisions under the Food Safety Modernization Act (FSMA). FDA’s new proposal, “Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” was released last week and it contains several exemptions, including one for ambient temperature warehouses; this is a big victory for ABA and the industry. Refrigerated warehouses are subject to modified preventive control requirements. FDA’s proposal adds new preventive controls provisions for facilities registered with FDA’s current food facility registration regulations. Covered facilities will need to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions. FDA’s proposal also updates the current good manufacturing practice (cGMP) regulations. ABA will be preparing comments on FDA’s proposal.
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