Food-Safety Marathon: Keeping Up With the Produce Safety Rule

Tacy CalliesFood Safety


By Travis Chapin, Matt Krug and Michelle Danyluk

It’s been four years since the final Produce Safety Rule (PSR) was published in the Federal Register. The further we get into implementation of the PSR, the more it really seems like a marathon and not a sprint.

By January 2020, all operations covered under the PSR should be complying with applicable provisions, excluding the requirements on agricultural water. This is the area where we’ve seen movement around the published regulatory standards. While the Florida citrus industry was in the off-season when regulatory inspections began this summer, the Food and Drug Administration (FDA), the Florida Department of Agriculture and Consumer Services (FDACS) and other state departments of agriculture have been busy inspecting produce farms and packinghouses across the United States. There are a few things we’ve learned along the way.

On March 15, 2019, prior to the start of regulatory inspections, FDA announced that compliance dates for the provisions related to agricultural water would be formally extended until at least 2022 due to widespread concerns about the complexity and practicality of the requirements. Shortly thereafter, on April 10, the FDA and Centers for Disease Control and Prevention (CDC) announced an outbreak involving romaine lettuce and E. coli O157:H7 from Yuma, Arizona.

After a month’s long investigation and environmental assessment in the implicated growing region, evidence pointed toward contamination of surface water used for irrigation combined with close proximity to cattle feeding operations and unusual weather events (frost and wind) as the most likely culprits. The investigation also revealed that the surface water implicated in the outbreak was tested by growers and met the water quality criteria in the PSR. This has added another layer of complexity to the process of identifying suitable strategies for ensuring the safety of water used during crop production.

The revelations that the agricultural water provisions of the PSR were being delayed and that there was a produce outbreak related to preharvest water that met the current PSR requirements resulted in various efforts to identify appropriate risk-reduction strategies. The United Fresh Produce Association and the Produce Marketing Association developed a diverse Romaine Task Force that consisted of over 100 industry, academic and regulatory stakeholders.

Some recommendations were developed specific to romaine, and others were broader recommendations. The task force recommended adoption of the new California/Arizona Leafy Greens Marketing Agreement (LGMA), which requires surface water applied to leafy greens within 21 days of harvest be treated.

On an international level, the Food and Agriculture Organization (FAO) of the United Nations met in Rome earlier this year and issued a report on the “Safety and Quality of Water Used in Food Production and Processing,” including in the preharvest produce environment. This report recognizes the lack of data available to support specific microbial standards for preharvest water. The FAO reports that use of site- and source-specific decision trees or more of a hazard analysis and critical control point process could be used. United Fresh Produce Association assembled a different working group to look at strategies for managing preharvest water quality across the produce industry. This group also concluded that “the risk of agricultural water must be assessed and managed based on the circumstances of use.”

New food-safety standards adopted by, or developed for, certain commodities or segments of the produce industry often shape broader market-driven and regulatory standards that apply across the board. We still aren’t sure how the events around the romaine outbreak, new LGMA standards, the Romaine Task Force’s recommendations or the FAO document will shape FDA’s thinking on revisions to its agricultural water standards. The citrus industry should remain engaged in the process to identify and adopt strategies that satisfy general concerns around use of agricultural water.

Another development we have been anticipating from the Food Safety Modernization Act is regulatory requirements for ensuring product traceability throughout the supply chain. One of the broader recommendations coming out of the Romaine Task Force was for the produce industry to pursue modern (i.e., electronic and searchable) supply-chain traceability of produce items back to their source (field). The FDA and CDC attributed poor recordkeeping practices related to product traceability as one of the reasons the romaine outbreak investigation extended over several months.

FDA has also announced a new regulatory approach called the “New Era of Smarter Food Safety” that is expected to include product traceability as a major initiative. In parallel with the “New Era of Smarter Food Safety,” FDA is also taking a closer look at its own performance measures and has added a “Food Safety Dashboard” in its FDA-TRACK tool. This will ensure transparency regarding internal metrics for food-safety outcomes, show how those metrics are measured and share data regarding regulatory implementation.

The first wave of PSR inspections in Florida has followed the patterns of produce production across the state. This winter, those patterns are expected to bring inspections to the Citrus Belt. In Florida, FDACS continues to perform the PSR inspections and will make reasonable attempts to schedule an inspection rather than showing up unannounced. The initial round of inspections is intended to be educational in nature, but inspectors are obligated to take measures to protect public health if serious issues are observed.

To prepare for inspections, growers, harvesters and packers should, at a minimum, follow good agricultural practices and have completed the Produce Safety Alliance (PSA) grower training. The PSA grower trainings continue to be offered at the highly subsidized price of $25 through collaborations with the University of Florida Institute of Food and Agricultural Sciences (UF/IFAS), FDACS and the Florida Fruit & Vegetable Association.

The On-Farm Readiness Review (OFRR) program is another way to help growers prepare for a PSR inspection through a personalized site visit where UF/IFAS and FDACS representatives can address questions about specific practices or conditions at a specific farm or packinghouse. There is no cost associated with an OFRR.

See for the list of upcoming Produce Safety Alliance grower trainings. Sign up at for an OFRR.

Travis Chapin is a statewide food-safety Extension agent and Michelle Danyluk is a professor, both at the UF/IFAS Citrus Research and Education Center in Lake Alfred. Matt Krug is a statewide food science Extension agent at the UF/IFAS Southwest Florida Research and Education Center in Immokalee.