FDA Finalizes FSMA Preventive Controls Guidance for Fresh-Cut Produce
The U.S. Food and Drug Administration (FDA) has released final guidance to help manufacturers and processors of ready-to-eat (RTE), fresh-cut produce comply with the Current Good Manufacturing Practice, Hazards Analysis, and Risk-Based Preventive Controls for Human Food rule (PCHF rule) under the Food Safety Modernization Act (FSMA).
The guidance provides recommendations and examples for implementing PCHF requirements to control known or reasonably foreseeable biological hazards in fresh-cut produce. Such products can be particularly susceptible to contamination because they typically do not undergo a kill step to eliminate pathogens and are often consumed without further processing.
FDA defined fresh-cut produce as “fresh fruits or vegetables that have been physically altered from their whole state, such as through chopping, dicing, peeling, shredding, slicing, or tearing, without additional processing like cooking or freezing.” Examples include chopped lettuce, sliced cantaloupe, diced onions, shredded carrots, coleslaw mixes, and fruit salads.
The guidance applies to RTE fresh-cut produce with a water activity above 0.85 and is intended for manufacturers and processors subject to 21 CFR part 117, including applicable processing activities at farm mixed-type facilities. It is not intended for farms.
The final guidance reflects public comments received on FDA’s October 2018 draft and replaces the agency’s 2008 fresh-cut produce guidance. FDA also encourages industry to continue improving food safety practices, including by developing and implementing best-practice documents tailored to specific commodities and processes.
As with other FDA guidance documents, the recommendations do not establish legally enforceable responsibilities but represent the agency’s current thinking on compliance with applicable requirements.
Looking for quick answers on food safety topics?
Try Ask FSM, our new smart AI search tool.
Ask FSM →
