Deibel Laboratories

Science you can trust from concept to consumer.

Uncategorized

Salmonella Outbreak Linked to Cantaloupe Products

· ·

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.

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

· ·

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.

Food Allergens – Understanding The Hazards

· ·

Violations due to food allergen hazards are a major food safety concern globally. In a recent article in the Journal of Food Protection, FDA reviewed recalls associated with major food allergens (MFA) and gluten in FDA regulated foods from fiscal years 2013 to 2019. The review distilled information about the foods most frequently implicated in allergen recalls and the specific food allergens associated with recalled products. The root causes of the recalls that occurred over the time period studied were also examined.


During fiscal year 2013-2019, 1417 allergen related recalls were reported. Most of the recalls (97%) were classified as Class I (51%), posing a reasonable probability of serious adverse health consequences or death or Class II (46%), posing a remote probability of serious adverse health consequences or temporary/reversible adverse health consequences. Of the 1471 recalls, 1415 recalls were due to MFAs, 34 recalls were due to a gluten-free labeling violation, and 23 recalls involved other allergens. Milk was the most common allergen involved in MFA recalls (37.5%), followed by soy (22.5%) and tree nuts (21.6%). Almond, anchovy, and shrimp were the most common allergens recalled within the MFA groups of tree nuts, fish, and Crustacean shellfish, respectively. About 97% of MFA recalls involved one product category and among them, the category of ‘bakery products, dough, bakery mixes and icings’ ranked first (367 recalls), followed by the category of ‘chocolate and cocoa products’ (120 recalls).

The top five recalled food product categories – major food allergens implicated and number of recalls.

Product CategoriesMultiple MFACrustacean
Shellfish		EggFishMilkPeanutSoyTree NutWheatTotal
Bakery
Products,
dough, bakery
mixes, and
icings		8303318922337531387
Chocolate and
cocoa
products		2201042257203120
Multiple food
dinners,
gravies,
sauces, and
specialties		312158201101112110
Snack foods
(flour, meal, or
vegetable
base)		9031456116586
Ice cream and
related
products		12050820223272
Adapted from G. M. Sharma et.al. 2023.

The “mode of discovery” for allergen issues leading to a recall was also examined. These issues were most often detected by consumer and downstream customer complaints.

DiscoveredDescriptionNumbers of recalls % of total recalls
ComplaintIncludes complaint from consumer, downstream customer,
distributor, or others; did not involve allergic or other adverse
reactions		39227.7
FDAIncludes inspection or other means of discovery by FDA19313.6
FirmIncludes recalling firm, manufacturing firm, or responsible firm27919.7
Other governmentIncludes inspection, notification or other means of discovery by
State agencies, other federal agencies, or foreign government		21515.2
ReactionIncludes consumer adverse reaction associated with the
consumption of the product		1258.8
Unknownmode of discovery not identified based on available information to
FDA		21114.9
Adapted from G. M. Sharma et.al. 2023.

Nineteen different root cause categories were identified for the MFA recalls that occurred during the period studied. Overall, allergen labeling and packaging errors were the major sources of issues resulting in 64.6% (N = 914) of total MFA recalls.

Allergen cross-contact, defined as the unintentional incorporation of a food allergen into a food, resulted in 21.3% (N = 301) of total MFA recalls. Sources of unintended allergen presence in food products were related to processing or production such as a mix-up in rework, the use of a wrong ingredient that was not communicated on the product label (5.6% of total MFA recalls), or inadequate sanitation practices (7.1% of total MFA recalls).
1163 recalls out of 1415 MFA recalls were traced to a specific root cause. Considering all sources of
allergen issues, these were identified as the most common root causes:
◼ 662 recalls were traced to errors in labeling and packaging.
◼ 307 recalls were traced to raw or incoming ingredients.
◼ 194 recalls were traced to processing or production errors within the facility.

Root CauseExamples
No carry-through • MFA in sub-ingredient not declared on the final product
• MFA in an incidental additive not declared on final product
Wrong Package • Use of wrong primary or secondary package
• Mix-up of wrong package at supplier or manufacturer level
Wrong Label• Use of wrong label or one labels on the product is wrong
• Label mix-up at supplier or manufacturer level
Terminology• Ingredient is declared but its MFA source is not
Cross-contact• Sanitation issues
• Change-over or sequencing issues
Wrong ingredient• Use of wrong formulation or recipe
• Use of wrong sub-product in a composite product kit
Adapted from G. M. Sharma et.al. 2023.

Identification of allergen controls that could mitigate the source of allergen errors are listed below. Label controls (includes label content controls and label management controls) could have prevented 893 out of 1163 MFA recalls (76.8%), whereas allergen cross-contact controls and supply chain controls could have prevented 16.7% and 6.5% MFA recalls, respectively.

Allergen controlsSource of problemRoot causeNumber of recalls% of total recalls
Cross-contact controlsProcessing or productionIn process171.5
Other cross-contact796.8
Positive allergen test171.5
Rework161.4
Wrong ingredient655.6
Total cross-contact controls19416.7
Label content controls Labeling and packagingComputer error534.6
Foreign language121.0
Knowledge 342.9
No declaration 252.2
Not updated564.8
Partial declaration353.0
Terminology12110.4
Raw or incoming ingredientsNo carry-through23119.9
Total label content controls56748.8
Label management controlsLabeling and packagingWrong label16113.8
Wrong package16514.2
Total label management controls32628.0
Supply Chain ControlsRaw or incoming ingredientsIngredient mislabeled211.8
Other cross-contact221.9
Positive allergen test191.6
Wrong ingredient141.2
Total supply chain controls766.5
Total allergen controls1163100.0
Adapted from G. M. Sharma et.al., 2023.

Recent guidance documents listed below provide useful information for food allergen hazard assessments and associated controls.

CPG Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact | FDA

-Major Food Allergen Labeling and Cross-contact Draft Compliance Policy Guide (CPG)

Update to Draft Guidance for Industry: Hazard Analysis

-Chapter 11: Food Allergen Program

Source of information: FDA.gov