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Salmonella Contaminated Dry Pet Food Causes Outbreak and Nationwide Recall

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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

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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.

Regulatory Update: FDA Releases FY 2021 Pesticide Residue Monitoring Report

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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.

Warning Letter Highlights Necessary Controls for C. botulinum

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A warning letter was recently issued to a manufacturer of refrigerated ready-to-eat baby food products packaged in a reduced oxygen environment. The investigation that led to the warning letter was initiated because of a consumer complaint that involved a case of infant botulism. Infant botulism is caused by the presence of C. botulinum spores that temporarily colonize an infant’s large intestine and produce botulinum neurotoxin. However, spores are not a hazard for the majority of the population with developed guts. Instead, controlling C. botulinum spore germination, outgrowth, and toxin production in products that can support growth should be the focus of food manufacturers as highlighted by FDA in this warning letter.

In the warning letter, FDA cites that the manufacturer’s hazard analysis did not identify the potential for C. botulinum growth and/or toxin formation due to reduced oxygen packaging. This hazard should have been identified because C. botulinum is associated with the various product ingredients that are grown in the ground. This organism is an anaerobe that can grow in the reduced oxygen packaged product and pose a food safety risk because the product did not undergo a sporicidal treatment and the formulation did not control outgrowth and toxin formation.

Although the product was stored refrigerated, FDA indicated that refrigeration temperatures exceeded the levels necessary to prevent non-proteolytic C. botulinum strain outgrowth, considered to be <3°C. Likewise, the manufacturer did not utilize calibrated temperature probes that often indicated misleading monitored results. When temperature is the only control for C. botulinum, strict monitoring of that control is necessary throughout product storage.

Because temperature control throughout product storage, during transportation, and by the consumer may be hard to maintain, manufacturers will turn to other controls for C. botulinum. This can include a sporicidal heat treatment as outlined in 21 CFR Part 113 (Thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers) or formulation and packaging controls that include:

• pH ≤4.6

• Water activity ≤0.935

• Aerobic packaging

• Preservatives such as nitrite, sorbic acid, phenolic antioxidants, polyphosphates, and ascorbates

A hurdle approach, or combination of controls, can also be used. In this case, no single control limits C. botulinum outgrowth. The combination of controls is commonly verified for effectiveness with a challenge study. Testing and handling of many bacterial toxins, like botulism toxin, requires sophisticated laboratory quality controls, including CDC / APHIS select agent accreditation. Deibel Laboratories has select agent approval and can conduct challenge studies to help verify that controls are effective to prevent C. botulinum outgrowth and toxin formation.

Failure to Develop a Foreign Supplier Verification Program -Top FDA Citation for Fiscal Year 2023

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According to FDA’s Data Dashboard, the most frequently cited violation by FDA investigators in fiscal year 2023 (ending September 30th) was the failure to develop an FSVP. This encompassed about 35% of all form 483 citations issued. Additionally, nine warning letters were published in the past month alone when food importers failed to correct FSVP violations cited during FDA investigations. According to FDA data, warning letters issued for FSVP violations in 2023 increased in number from the previous year. Forty-eight importers were placed on import alert and only two were removed. Normally, FDA investigators will determine if foreign food is imported during routine investigations. Manufacturers that import food and lack FSVP documentation will be cited for not following the FSVP rule if no exemptions apply.

Warning letters published this past month cited inaction on developing, maintaining, and following an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a) for any of the foods they import. Generally a written response to a warning letter is required within 15 working days of notification. If the matter is not adequately addressed, the FDA may take further action including an FDA product hold, detention, and Import Alerts (e.g. Import Alert # 99-41). Removal from an Import Alert is a lengthy process. The importer is required to submit information to the FDA that adequately demonstrates resolution of the conditions that gave rise to the FSVP violation and provide assurance that FSVP requirements will be met for future imports.

Final guidance is available from FDA to help importers comply with the FSVP rule. U.S. importers who have responsibility for fulfilling FSMA FSVP requirements for foreign suppliers that manufacture, process, pack, or hold food intended for human or animal consumption in the U.S. must use a qualified individual to develop and perform FSVP activities. These activities include determining known or reasonably
foreseeable hazards associated with each type of food, evaluating risks posed by the supplier’s performance, approving suppliers, conducting appropriate supplier verification activities, and verifying corrective actions that provide assurance the food’s hazards have been significantly minimized or prevented. Detailed records documenting these activities are also required.

A course specifically designed to train FSVP qualified individuals was developed by the Food Safety Preventive Controls Alliance (FSPCA) that provides a standardized curriculum recognized by the FDA. The course is offered by Deibel Laboratories.

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