Peer Resources and Issue Briefs
FY21 FDA Fresh-Cut Cantaloupe Sampling Assignment
In August 2021, United Fresh because aware of an FDA sampling assignment related to fresh-cut cantaloupe produced from domestic whole cantaloupe. The attached information reflects our current understanding of this sampling assignment, which is subject to change. This sampling assignment is not listed on the FDA microbiological sampling page, so this information is being provided as a service to the industry.
Supplier Risk Assessment Tool
In February 2021, a United Fresh Food Safety Council working group formed to address the challenges that many buyers face when dealing with limited time and resources while simultaneously needing to assess and vet potentially hundreds of suppliers for their organizations. The following excel document was developed as a tool for buyers to support the supplier verification and risk assessment process for an entity that is purchasing a product for their sale or further processing. The customizable tool includes identification of product characteristics and drop-down menus to evaluate suppliers and document the assessment process.
Known or Reasonably Foreseeable Hazards
In recent communications to the produce industry, FDA stated that the organisms of concern may be “known or reasonably foreseeable hazards.” This is a term that does appear in the Produce Safety Rule, but is likely more familiar to those with a background in HACCP and who’ve conducted hazard analyses in accordance with the Preventive Controls Rule. So what is a “reasonably foreseeable hazard” in the context of a growing environment? And what is the implication to others in the supply chain? A subgroup of the United Fresh food safety council was able to have a conversation with FDA on this topic in July 2021, and the synopsis below reflects our interpretation of the discussion.
Food Safety Vendor Assessment Tool
In January 2020, the United Fresh Food Safety Council formed a working group of twelve food safety professionals from across the industry to identify key areas that companies could address to assess the potential of new and novel technologies, services, and products. This group organized and augmented ideas developed during a council exercise. The purpose of this document is to facilitate reviews of the products, services and technologies offered to the produce industry. Providers of such products and services may benefit from understanding the issues that may be raised when initiating conversations with potential users. The vendor assessment tool can be found here.
Root Cause Analysis
When an issue, food safety or otherwise, occurs, it’s not uncommon that several things “went wrong” resulting in the issue. A “root cause analysis” is a systematic, detailed process that is conducted in to reveal the underlying reasons that a problem arose, so that a recurrence can be prevented. Pew convened groups of experts to discuss the process and drafted the findings into the Root Cause Analysis Case Study.
In 2021, a group of produce industry associations, including United Fresh, developed and published two guidance documents for the industry on Root Cause Analysis (RCA). The first guidance document, “When to do Root Cause Analysis? A Decision-Making Guide for the Produce Industry,” discusses when to conduct an RCA during growing, harvest and post-harvest operations, considering company-specific resources and risks. To view the document, click here. The second guidance document, “Conducting Root Cause Analysis: A “How-To” Guide for the Produce Industry,” provides a step-by-step guide on how to conduct an RCA. Both documents are available for download below. Click here to access the document.
International Association for Food Protection
The 2019 annual meeting of the International Association for Food Protection brought together roughly 3800 food safety professionals from academia (including students who presented hundreds of posters and technical sessions), government, and the breadth of the food industry. PMA and United Fresh have collaborated to offer a brief 2019 IAFP synopsis, highlighting the produce safety topics that were discussed in this diverse forum.
To address questions about the handling of iced produce in distribution centers, United Fresh and PMA have developed a document to identify items to consider in a hazard analysis and also recommend possible control measures.
Regulatory Investigations and Sampling
Read the draft guide to Handling a Regulatory Inspection. This document was prepared based on the dialogue within round table discussions of the United Fresh Food Safety Council held January 10, 2017.
Read the draft on Handling a Regulatory Sampling Request, prepared by a subgroup of the Food Safety Council Steering Committee in December 2018.
Offer feedback on the pros and cons of Holding Produce, prepared by the Food Safety Council Steering Committee in December 2019.
Whole Genome Sequencing
Background Information on WGS:
Is it really a big deal? YES
Why? Because FDA (and other regulators) are using it to link pathogen isolates from your food or your facility to human illness.
Didn’t they have systems to do this before? How is this new? It is a newer technology that is far superior to the previous approach (pulsed field gel electrophoresis; PFGE). In a 2015 article in Scientific American David Acheson, a former official at both the USDA and the FDA, likened the difference to a witness in a hit and run accident. “While PFGE might identify the vehicle as a brown Toyota Corolla, whole genome sequencing provides the license number and even the vehicle identification number.”
Is this related to the “swabathons” I’ve heard about, where FDA or states take hundreds of environmental samples? Yes. Any time they find L. monocytogenes, they are sequencing the isolate and entering it into the database to see if there is a match to illness—even if that illness occurred years ago.
Additional information: Whole genome sequencing (WGS) technology has rapidly evolved in recent years. It is now possible to rapidly and inexpensively sequence bacteria, such as foodborne pathogens, to obtain a “fingerprint”. WGS has been adopted by FDA, USDA and CDC and has been used in microbial foodborne illness investigations for the last several years. Government agencies use a database called GenomeTrakr, which now has over 60,000 bacterial isolates from food and clinical sources. It is vital that the food industry understand the emerging technology and its application.
Food Safety News reported that by using WGS, FDA was able to show that a specific strain of L. monocytogenes in an ice cream production facility was resident (not transient). The company received a warning letter which stated, “The evidence demonstrates that L. monocytogenes has maintained its presence within your production facility since 2015. The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility…These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility.”
Just because FDA (or USDA FSIS) finds a match between your product or facility and human illness, does it prove that you are at fault? While the single piece of evidence may not be conclusive, you can certainly expect the regulators to come asking questions. A poster presented at the United Fresh Produce Convention in June 2016 described a 2-year study of L. monocytogenes found in multiple packing houses. The researchers, out of Dr. Suslow’s lab at UC Davis, used different molecular techniques including Whole Genome Sequencing and Pulse Field Gel Electrophoresis (PFGE) to sort and characterize the isolates. They found that “Indistinguishable and closely related pulsotypes were observed in the same packing facility on multiple sample collection dates suggesting persistence or residency of a given strain. Furthermore, some L. monocytogenes isolates recovered from different facilities (geographically far apart), in different years were found to have indistinguishable or highly related PFGE pulsotypes.”
More science is needed to understand how quickly different organisms evolve, and the geographic distribution and persistence of “indistinguishable” pathogens. Although there is still a lot to learn about what WGS can and can’t tell us, regulators are nevertheless using this technology and the impact on the fresh produce industry will continue to increase.
For more information please contact Dr. Jennifer McEntire, Senior VP of Food Safety and Technology or 202.303.3419.
For any questions on these resources or to report broken links, contact Katie McGowan, Manager, Food Safety Programs, via email at email@example.com or by phone at (202) 303-3402.