FDA Issues New Produce Handling Guidelines for Farmers and Food Processors

Two new draft guidance documents were released this week with the aim of helping US farmers and food producers comply with rules for the safe handling of produce. The guidance document for farmers, entitled ” Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry,” provides farmers with examples and approaches for complying with the Produce Safety Rule.  The Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for food. This rule is part of the FDA’s goal of implementing the Food Safety Modernization Act, which went into effect in January 2016.

The second draft guidance document is entitled “Guide to Minimize Food Safety Hazards of Fresh Cut Produce.”  This draft rule explains how fresh-cut produce processors can comply with good manufacturing practices and risk-based controls. According to the FDA, producers include those who manufacture, process, pack or hold fresh-cut produce. “Fresh-cut produce” means any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field without additional processing such as cooking.  The FDA is seeking public comments to ensure that the recommendations are effective and practical. Comments should be provided by April 22, 2019 to be included in the final versions of the guidance documents.

The guidance documents were issued because in recent years, the marker for fresh-cut produce has expanded exponentially due to consumer demand for fresh, healthy, and convenient foods. However, a variety of produce commodities, including fresh-cut varieties, have also been associated with foodborne illness outbreaks. Because many types of fresh-cut produce are ready-to-eat foods that consumers eat without cooking that could destroy pathogens, preventive controls to significantly minimize or prevent the contamination of fresh-cut produce with pathogens play a key role in food safety. The draft guidance states that: “Between 1996 and 2010, produce accounted for 23.3% of the total reported outbreaks and 42.3% of the total outbreak-related illnesses (78 FR 3504 at 3507, January 16, 2013). Both domestic produce and imported produce were identified as vehicles in these outbreaks.” Over the last few decades, illnesses linked to contamination of fresh-cut produce with pathogenic microorganisms have been reported in the United States (Ref. 5). Between 1996 and 2010, fresh-cut fruits and vegetables accounted for 16.8% of the total produce-related outbreaks (78 FR 3504 at 3507, January 16, 2013). From 2002 to 2017, there were 39 outbreaks of foodborne illness linked to the consumption of fresh-cut produce, resulting in approximately 3,432 illnesses, 643 hospitalizations and 15 deaths.

Some of the directions included in the guidance documents relate to proper hand washing, the allowable clothing to be worn by food processors, proper glove procedures, and maintenance of grounds and workspaces. The FDA’s goal in issuing these documents is to help US farmers and processors of produce comply with modernized food safety standards, to promote human health and safety. Together, the two documents provide practical, common-sense recommendations for how both farmers and processors can take steps to prevent foodborne illness arising out of USA-grown produce.

Of course, with new guidelines comes the risk of penalties for farmers and processors who fail to strictly adhere to the FDA’s requirements. If the guidance documents are implemented in 2019, farmers and food producers may be subject to lawsuits if their standards and practices do not conform to the guidance documents exactly. It would be in the interest of farmers and producers to closely review the proposed guidelines and submit comment regarding standards that would be difficult or impossible to follow. Once the rules are implemented, producers will be bound by the FDA’s regulations and subject to penalty or private legal action.


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