November Regulatory Watch
FDA Introduces Final Guidance for Ready-to-Eat Fresh-Cut Produce
Fresh-cut produce can be particularly susceptible to contamination, which can be introduced in the environment where it’s grown, during transport, during manufacturing or at retail.
The U.S. Food and Drug Administration (FDA) has released final guidance to help manufacturers and processors of fresh-cut produce comply with the FSMA Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls (PCHF) rule.
Fresh-cut produce can be particularly susceptible to contamination, which can be introduced in the environment where it’s grown, during transport, during manufacturing, when it’s commingled with other products or at retail, and the opportunity for contamination can be amplified through each of these steps as it makes its way to consumers. Fresh-cut produce does not receive a kill step to eliminate pathogens that may be introduced during these processes and most are sold ready-to-eat. The guidance provides recommendations and examples of how the PCHF requirements can be implemented to protect fresh-cut ready-to-eat produce from contamination with biological hazards.
Fresh-cut produce includes any fruit or vegetable that has been physically altered from its whole state (e.g., by chopping, dicing, peeling, shredding) without additional processing (such as freezing or cooking) and distributed in fresh form. Examples of fresh-cut produce include chopped lettuce, cut cantaloupe, diced onions and shredded carrots.
The guidance extends to products that exhibit a water activity above 0.85. Almonds, walnuts, pistachios, pecans, macadamias and peanuts are examples of produce commodities with a water activity below 0.85 and would not be covered by this guidance.
The final guidance reflects public comments received on the October 2018 draft guidance and replaces the 2008 FDA fresh-cut produce guidance. This guidance represents the agency’s current thinking on the issues related to preventing contamination in fresh-cut produce. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities, unless specific regulatory or statutory requirements are cited.
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