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Industry News

Salmonella Outbreak Linked to Cantaloupe Products

Ryan Maus · December 1, 2023 ·

A new outbreak involving imported whole cantaloupe and downstream sliced/cubed cantaloupe containing products contaminated with Salmonella was posted by CDC and FDA officials on November 17, 2023. Currently, 99 individuals in the U.S. and 63 in Canada have reported illness. Initially, whole genome sequencing showed that Salmonella Sundsvall was closely related
genetically to the bacteria collected from those reporting illness. Salmonella Soahanina and Oranienburg are now also identified as outbreak strains detected in the imported product by Canadian officials. Numerous whole and sliced/cubed cantaloupe containing products have been recalled from major retailers across the U.S. and Canada.

Outbreaks involving cantaloupe are not uncommon. Contamination often begins in the field and is then spread to process/packaging facilities where it can become established in the environment. If proper controls are not in place, pathogens can spread to the edible fruit when cut and processed into ready-to eat products. This can spread to further products when cut cantaloupe is used as an ingredient. Investigation reports from three of the outbreaks highlighted in the table below are available from FDA.

Year Pathogen Product Illnesses Country
2022Salmonella Typhimuriumwhole cantaloupe87USA
2019Salmonella Javianacut fruit mix containing cantaloupe165USA
2019Salmonella Carraucut melon including cantaloupe137USA
2018Salmonella Adelaidecut melon including cantaloupe77USA
2012Salmonella Typhimurium
and Salmonella Newport
whole cantaloupe261USA
2012Listeria monocytogeneswhole cantaloupe147USA
2011Salmonella Panamawhole cantaloupe20USA
2008Salmonella Litchfieldwhole cantaloupe51USA

The following describes FDA’s investigational findings from their most recent report and provides their recommendations to growers of melons and similar produce. In August 2022, a CDC epidemiological investigation and traceback data identified a multistate cluster of Salmonella Typhimurium illnesses in the upper Midwest indicating melons as a potential source of exposures. The outbreak was traced to cantaloupe and resulted in eighty-seven illnesses and thirty-two hospitalizations across eleven states.

The FDA utilized traceback data to identify a common packinghouse of suspect cantaloupes associated with the outbreak. However, there was no convergence to a single shipment of products. Three farms in southern Indiana that supplied the common packinghouse were identified as potential sources of cantaloupe. Around the growing locations other commodities were grown such as grain, oilseed, and beans; interspersed with various vegetable crops, including melons; and several poultry feeding
operations. Heavy rains had also occurred in the growing region in late July resulting in floods.

Sampling of the packing house, the three farms, and the surrounding lands resulted in numerous findings of Salmonella, but only one of the farms produced an isolate genetically related to the outbreak strain (i.e., having an intermediate level of differences in genomes but not a genetic match). The results suggest that Salmonella presence is a reoccurring issue that may impact the safety of melons grown in this region.

FDA provides the following recommendations/requirements to producers of melons and similar produce.

  • Review current conditions and practices to determine whether they are adequate or if additional
    prevention measures are warranted.
  • Understand previous land use to identify and address potential sources of pathogens that may
    affect their farming operations.
  • Assess risks that may be posed by adjacent and nearby land uses, especially as it relates to the
    presence of livestock, poultry, and the interface between farmland, and other agricultural areas.
  • Consider additional tools such as pre-harvest and/or post-harvest sampling and testing of
    products to help inform the need for specific prevention measures.
  • Poultry manure, while valued for its fertilizer value, is a known reservoir for Salmonella
    spp. Proper application of a manure that has been treated with a validated and verified process
    to reduce pathogens (e.g., composting with time and temperature measurements) can
    significantly reduce the potential for the integration of Salmonella or other human pathogens into
    soils (as compared to the use of raw manures).
  • Inspect, maintain, and clean and, when necessary and appropriate, sanitize all food contact
    surfaces of equipment and tools used as frequently as necessary to protect against contamination.
  • When appropriate, use EPA-approved products according to the label for cleaning and sanitizing.
  • Inconsistent adherence to or deviation from existing SOPs for cleaning and sanitizing by farms can
    affect produce safety. Effective communication on farms about SOPs and any changes to those
    SOPs can help ensure that food safety practices are being followed.
  • Root cause analyses may be useful in identifying for growers how human pathogen sources in the
    broader agricultural environment may contribute to contamination.
  • Improve traceability through increased digitization, interoperability, and standardization of
    traceability records which would expedite traceback and help remove contaminated product from
    the marketplace more quickly, thereby preventing further illnesses. This is not only important for
    growers, but also critical for shippers, manufactures, and retailers as well, to improve overall
    traceability throughout the supply chain.

Salmonella Contaminated Dry Pet Food Causes Outbreak and Nationwide Recall

Ryan Maus · December 1, 2023 ·

An outbreak caused by Salmonella Kiambu has been linked to dry pet food products distributed nationally. Seven cases of illness affecting mainly children aged one year or less have been reported from multiple states since January 2023. Retail product collected for routine testing by the South Carolina State Department of Agriculture was found positive for Salmonella and determined to be closely related to the outbreak strain utilizing whole genome sequencing. This finding led to a nationwide recall of several brands of dry kibble produced at the manufacturing facility with a best by date before 10/31/2024. While outbreaks associated with dry kibble products are infrequent, this new outbreak highlights the challenges associated with dry pet food production and the persistence of Salmonella in low moisture products.

Salmonella is readily found in the ingredients (e.g. rendered animal byproducts and grains) used to make pet food kibble. However, thermal extrusion processes used to make kibble are generally lethal to this organism. Liquid water and/or steam is added to the dry ingredients that are pushed through the barrel of an extruder under intense heat and pressure before exiting through a shaping die. The extrusion process is often validated as a process preventive control to reduce vegetative pathogens by a minimum of 5 logs. Product is then dried resulting in a shelf stable product with a water activity (aw) <0.60.

The low aw prevents pathogen outgrowth but not pathogen persistence if reintroduced after the extrusion step. Product can be re-contaminated from the environment or from the addition of ingredients such as fat and flavorings that are sprayed on the dried kibble to enhance palatability. Post-extrusion contamination likely led to the last major Salmonella outbreak involving kibble that occurred between 2006-2007. During the investigation of this previous outbreak, the same Salmonella serotype was found in the pet food manufacturing environment as well as in two of the 25 brands of pet food produced at the facility. The only positive environmental sample was found in the enrobing/flavoring room where product was coated with a palatant after extrusion. Because the extrusion process utilized time/temperature parameters validated to kill Salmonella, it was thought that cross-contamination of the extruded kibble occurred from contaminated ingredients or environmental contamination during the enrobing/flavoring process.

Supply chain controls can mitigate hazards associated with ingredients added after the extrusion process. Hygiene and sanitation controls can mitigate hazards introduced post extrusion when verified with a robust environmental monitoring program. Pathogen testing should include line samples and environmental samples including air filters, equipment, vents, and drains. Guidance is available from FDA for the safe production of pet food. Deibel Laboratories can provide full service solutions from environmental assessments of facilities to finished product testing for pathogens and indicators as well as validation of nutritional labels for pet foods.

Know Your Suppliers to Protect Your Products

Laurie Post · December 1, 2023 ·

A Supply-Chain Control Program assures that the ingredients, raw materials, and non-food chemicals you receive are safe and suitable for use. Supplier control is an essential element of a preventive food safety system. The program is built on ingredient specifications that are defined following a hazard analysis, criteria for supplier selection, a process for approving suppliers, development of supplier agreements, and verification activities to assure that the program is in place and effective.

The hazard analysis identifies biological, chemical, physical, and Economically Motivated hazards associated with an ingredient that requires a control to significantly minimize or eliminate the hazard at your facility or at the supplier. It is critical to know what ingredients pose a food safety risk and who will control the identified hazard. If your supplier is controlling the hazard, then you should understand how they are accomplishing this. The food safety hazards presented by the supply chain are related to both the amount of control you have over the sourcing of the ingredient and the amount of transparency that you have with respect to the food safety practices of ingredient suppliers.

Approval of suppliers and ingredients should take place before the ingredient is received in your facility. Supplier Verification activities include audits of the supplier’s facility, reviews of their HACCP or Food Safety Plan, and verification testing of the ingredient at the supplier or upon receipt.

It is important to determine the ability and willingness of a supplier to meet your product specifications. A strong program is based on establishing a formal agreement with your supplier to ensure that they will share in the responsibility for food safety with respect to controlling hazards within their own facility. This may reduce the level of preventive controls needed by you upon receipt of the ingredient.

Your risk is lowest when every ingredient has a written specification detailing microbiological, chemical, and physical requirements as indicated by your hazard assessment and when each lot of ingredient is accompanied by a Certificate of Analysis (COA) reporting the results of appropriate verification testing from a trusted supplier. A robust in-bound receiving program with written procedures for reviewing COAs and documenting shipments with receiving records assures that each shipment meets your specification requirements. Even when other verification activities are in place, testing for hazards controlled by your supplier, at some designated frequency, provides additional evidence that supplier food safety systems are working. Your risk increases when you don’t require a COA for every lot purchased and do not require appropriate verification testing by the supplier or as part of your own receiving program.

Testing upon receipt may seem redundant when the supplier provides a COA. However, independent testing offers not only some assurance of the accuracy of the results reported on the COA, but also assurance that no adulteration of the ingredient has occurred between the time of analysis by the supplier and the time of receipt by the buyer. Verification of the supplier’s testing program as well as your own program should include corroboration that the laboratory performing the analyses is certified to conduct the tests and that methods are accredited and appropriate for testing the ingredients analyzed.

Good management of your suppliers will control microbiological, chemical, physical, Economically Motivated and food fraud hazards. For instance, as part of your Supply Chain Verification program, a review and approval of your supplier’s pathogen and allergen Preventive Control programs will minimize the risk that microbial contaminants and unlabeled allergens will enter your facility. This requires each supplier to have their own written programs. For ingredients you identify as having a particular pathogen concern, close the verification loop with an in-house program that screens statistically representative samples from each lot for the pathogen prior to use – either through a Preshipment Testing program or upon receipt.


The key to an effective Supply Chain Control Program is established policies and procedures and trusted suppliers with whom you are able to partner to prevent product safety issues.

Elevated Lead Levels Lead to Investigation of Cinnamon Used in Applesauce Pouches

Ryan Maus · December 1, 2023 ·

A recall and FDA public health alert has been issued for apple cinnamon fruit puree pouches after reports of acute lead exposure in children led to an investigation and finding of extremely high concentrations of lead in multiple product lots tested by health officials in North Carolina. An FDA investigation into how such high levels of lead contaminated the product is ongoing. However, since only products containing cinnamon had
elevated levels of lead, FDA’s leading hypothesis is that cinnamon used in these recalled pouches is the likely source of contamination. FDA is
currently trying to collect and test samples of the cinnamon sourced from Ecuador that was used in the recalled products as well as screen incoming shipments of cinnamon from multiple countries for lead contamination.


As of November 22, 2023, there are 52 reports of illness in children ages 1 to 4 years, with blood lead levels (BLLs) ranging from 4 to 29 micrograms per deciliter (µg/dL), potentially linked to recalled product. The FDA has found levels of lead in the recalled product as high as 2.18 ppm, 200 times higher than proposed action levels for similar products intended for babies and young children. Acute lead exposures are uncommon and have historically resulted from exposures to high concentrations of lead containing folk remedies, paint chips, or foreign bodies. Children exposed to large amounts of lead can develop gastrointestinal, hematological, and neurological effects. Symptoms include anemia, abdominal pain, weakness, and severe neurological sequelae (e.g., seizures, encephalopathy, and coma), which may result in brain damage. Elevated BLLs in children above 45 µg/dL may require hospital admission for monitoring and chelation therapy.


Lead is a naturally occurring heavy metal but also a man-made pollutant. According to the FDA and CDC, lead exposures related to food can involve:

  • water sourced from lead pipes, faucets, and plumbing fixtures;
  • fruits, vegetables, or grains grown in areas with lead containing soil, air, and water that resulted
    naturally or by contamination from human-activities such as pollution;
  • animals raised in high lead environments or that consumed lead contaminated feed;
  • leeching from lead contaminated food contact surfaces;
  • economically motivated adulteration – for example, lead-based dyes used to impact color have
    been found in spices such as chili powder, turmeric, and cumin.

While no level of lead exposure is safe for children, minimizing exposure from food is the focus of FDA’s Closer to Zero action plan. Draft guidance was issued in January 2023 proposing action levels for lead in food intended for babies and young children. It establishes the following action levels:

  • 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables),
    mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and singleingredient meats;
  • 20 ppb for root vegetables (single ingredient); and
  • 20 ppb for dry infant cereals.

Regulatory Update: FDA Releases FY 2021 Pesticide Residue Monitoring Report

Laurie Post · November 14, 2023 ·

The FDA published their annual Pesticide Residue Monitoring Program Report for Fiscal Year 2021 (FY 2021) on October 24, 2023.
The report summarizes findings from FDA testing of human and animal foods for approximately 750 different pesticides and selected industrial compounds from October 1, 2020, through September 30, 2021.


It is the legal responsibility of companies that produce and grow foods and manufacture products for food use sold in the U.S. to assure compliance with applicable Environmental Protection Agency (EPA) and FDA regulations.


The goal of the FDA’s pesticide residue monitoring program is to protect public health by assuring that pesticide tolerances, or maximum residue levels, set by the EPA are not exceeded in FDA-regulated foods shipped in interstate commerce and in foods imported into the U.S..

The FDA is responsible for enforcing pesticide tolerances. If the FDA finds that the amount of pesticide residue on a food is over the tolerance, or when a pesticide is found and there is no tolerance established, the FDA can take action. The findings of the 2021 monitoring program show that the levels of pesticide chemical residues measured by FDA in the U.S. food supply are generally in compliance with EPA pesticide tolerances.


Link: 2021 Report (PDF: 572 KB)


FDA selectively monitors a broad range of domestic and import commodities for residues of approximately 750 different pesticides and selected industrial compounds. FDA may also carry out focused sampling surveys for specific commodities or selected pesticides of special interest. In addition, FDA monitors the levels of pesticide chemical residues in foods prepared for consumption in its Total Diet Study (TDS), an ongoing program that monitors contaminants and nutrients in the average U.S. diet.

As with FY 2020, sample collection and analysis in FY 2021 was significantly impacted by the COVID-19 pandemic. Approximately 68% fewer human food samples and 78% fewer animal food samples were collected in FY 2021 compared with FY 2019, the most recent year not impacted by the global pandemic. Sample collection and analysis increased in FY 2022.

Overall Findings
Human Food Samples:
1,367 total samples (300 domestic food samples from 26 states and 1,067 imported food samples from 66 countries/economies).

  • 96.7% of domestic samples and 89.3% of imported samples were compliant with federal regulations (below EPA tolerances).
  • No pesticide chemical residues were detected in 35.0% of domestic samples and 44.5% of imported samples.


Animal Food Samples: 80 total samples (16 domestic food samples from 5 states and 64 imported samples
from 7 countries).

  • 100% of domestic samples and 98.4% of imported samples were compliant with federal
    regulations (below EPA tolerances).
  • No pesticide chemical residues were detected in 37.5% of domestic samples and 40.6% of
    imported samples.

Due to the low sample numbers, only limited conclusions can be drawn from the results. However, the violation rates for both human and animal food samples in FY 2021 were similar to recent years.

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