FDA advises pet owners against feeding certain Darwin’s Natural Selections pet foods

The US Food and Drug Administration (FDA) is advising pet owners not to feed certain Darwin’s Natural Selections chicken-based raw pet foods to their dogs and cats.

The warning came after the FDA found Salmonella in three lots of the company’s dog food and three lots of cat food.

One of the lots also was contaminated with Listeria monocytogenes.

The FDA’s advisory specifies the following products, all of which are sold in frozen 2-pound packages:

  • Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats
    • Lot No: 10832 MFG. Date: Jul 25, 2024
  • Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats
    • Lot No: 10856 MFG. Date: Aug 04, 2024
  • Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats
    • Lot No: 10890 MFG. Date: Aug 13, 2024
  • Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs
    • Lot No: 10828 MFG. Date: Jul 24, 2024
  • Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs
    • Lot No: 10844 MFG. Date: Jul 30, 2024
  • Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs
    • Lot No: 10887 MFG. Date: Aug 12, 2024

The FDA has recommended that the manufacturer, Arrow Reliance, Inc. (Tukwila, WA) recall the six contaminated production lots. The company has not yet done so.

Arrow Reliance, Inc., has a long history of disagreements with the FDA regarding the significance of Salmonella and Listeria monocytogenes in raw pet food. In February 2023, the company received a formal Warning Letter from the FDA, citing several unresolved issues following an inspection of the manufacturing facility.

If you have any of the Darwin’s Natural Selections pet food product listed above, stop feeding the product to your pets and throw it away in a secure container where other animals, including wildlife, cannot access it. Do not donate the food.

The product lot codes are printed on the front of the lower left unit of the package of food. If you no longer have the package or can’t read the lot code, throw the food away. 

Consumers who have had the products listed above in their homes should clean and disinfect all pet supplies, including all storage containers, bowls, utensils, food prep surfaces, pet bedding, litter boxes, toys, floors, and any other surfaces that the food or pet may have had contact with, including your refrigerator or freezer. Clean up the pet’s feces in places where people or other animals may become exposed. Consumers should thoroughly wash their hands after handling the product or cleaning up potentially contaminated items and surfaces.

Pet foods contaminated with Salmonella and L. monocytogenes are of particular public health importance because they can affect both human and animal health. Pets can get sick from Salmonella and may also be carriers of the bacteria and pass it on to their human companions without appearing to be ill.

The FDA is aware of cases in which humans and/or animals have gotten sick from exposure to Salmonella-contaminated pet foods.  Although FDA is not aware of a documented case of a person acquiring L. monocytogenes infection from a pet food, once Salmonella or L. monocytogenes get established in the pet’s gastrointestinal tract, the animal can shed the bacteria in the feces when it has a bowel movement, and the contamination may continue to spread. It is important to clean up the animal’s feces in yards or parks where people or other animals may become exposed, in addition to cleaning items in the home.

The Federal Food, Drug, and Cosmetic Act requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. Refrigeration or freezing does not kill Salmonella or L. monocytogenes

People who think their pets have become ill after consuming contaminated pet food should first contact their veterinarians. Veterinarians who wish to have pets tested for Salmonella and L. monocytogenes may do so through the Veterinary Laboratory Investigation and Response Network (Vet-LIRN Network) if the pet is from a household with a person infected with Salmonella or L. mono

The FDA encourages consumers to report complaints about pet food products electronically through the Safety Reporting Portal. Additionally, consumers can visit the SmartHub – Safety Intake Portal – Report a Product Problem (fda.gov) to obtain electronic assistance with submitting a report.   



“A complete and compelling account of the hidden and not-so-hidden ways the food we give our beloved pets can be contaminated.” JoNel Aleccia, Health Reporter, Food & Nutrition, The Associated Press.

“An invaluable resource for busy pet owners” – Food Safety News

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Boar’s Head shutters Jarratt plant ‘indefinitely’

Boar’s Head Provisions Co., Inc. has announced its intention to ‘indefinitely close’ its Jarratt production location. The announcement was posted yesterday (September 13, 2024) on the company’s website.

The company initially suspended production after receiving a Notice of Suspension from the USDA on July 26, 2024.

Liverwurst manufactured at the Jarratt location was identified as the probable source of a deadly outbreak of Listeria monocytogenes, which has sent 57 people to hospital, killing nine of them, according to the most recent update from the CDC, posted on August 28, 2024.

The Jarratt plant is one of five Boar’s Head production facilities registered with the USDA’s Food Safety and Inspection Service (FSIS). The other four facilities have not been implicated in this outbreak.

According to the company’s announcement, an investigation “identified the root cause of the contamination as a specific production process that only existed at the Jarratt facility and was used only for liverwurst.”

As a result, Boar’s Head also has decided to permanently discontinue production of liverwurst.

The FSIS Notice of Suspension highlighted multiple findings of product adulteration and unsanitary conditions, including:

  • Listeria monocytogenes outbreak strain was recovered from an unopened package of Boar’s Head liverwurst by the Maryland Department of Health
  • Listeria monocytogenes outbreak strain was recovered from the surface of a pallet jack during production of Beechwood Ham. The environmental swab sample was collected as part of the FSIS Intensified Verification Testing as part of the outbreak investigtion.
  • Beaded condensation on door opening and inside blast cell dripping over nine trees (ie., support racks) of Beechwood Hams
  • Clear liquid falling from a patch in the ceiling within ten feet of a fan that was blowing the liquid into an area where nine trees of Assorted Hams were stored.

The Jarratt location relied solely upon its Sanitation Standard Operating Procedures and sanitation program to control the risk of Listeria monocytogenes contamination. The FSIS determined that the recovery of Listeria monocytogenes from both a finished product and an environmental sample demonstrated the inadequacy of the company’s control methods.

The Notice of Suspension summarized the FSIS’s conclusions as follows:

The wholesomeness of your product is directly dependent on the design and implementation of your sanitation program, adequate Listeria monocytogenes control measures and overall maintenance of your facility, including the sanitary procedures conducted in your food production. Evidence demonstrates failure to comply with regulatory requirements identified in 9 CFR 416, including SPS and SSOP requirements, as outlined above. Findings result in FSIS being unable to conclude that sanitary conditions are being maintained, resulting in your establishment’s producing and shipping adulterated product. As such, product may have been prepared, packed, or held under insanitary conditions, whereby product may have become contaminated with filth or whereby product may have been rendered injurious to health, rendering the product adulterated.

In it’s September 13th announcement, the company revealed the measures it is taking to implement “enhanced food safety and quality measures.” Specifically,

  • Appointing a new Chief Food Safety & Quality Assurance Officer, to report directly to the president of the company.
  • Establishing a “Boar’s Head Food Safety Council” comprised of independent industry-leading food safety experts. Founding members of the Council will include Dr. David Acheson, Dr. Mindy Brashears, Dr. Martin Wiedmann, and Frank Yiannas, MPH. Some of these individuals have been assisting with the investigation of the problems in the Jarratt facility.
  • Creation of an enhanced companywide food safety and QA program, to be led by the Chief Food Safety Officer.

The evidence of unsanitary conditions at the Jarratt location was well documented during the course of a Food Safety Assessment conducted by the FSIS in October 2022.

Yet, the company was allowed to continue production.

The FSIS owes an explanation and an apology to the general public over its failure to act in the face of egregious sanitation and food-safety lapses on the part of the company.

Boar’s Head has apologized to consumers. When will the FSIS do likewise?


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USDA drops ball on Boar’s Head food safety oversight

Major deficiencies associated with the establishment’s physical conditions were observed that could pose imminent threat to product.”

– Conclusion from USDA Food Safety Assessment of Boar’s Head (Jarratt, VA), October 2022

In September/October of 2022, the USDA’s Food Safety and Inspection Service (FSIS) conducted a Food Safety Assessment (FSA) of the Boar’s Head production plant in Jarratt, Virginia.

The FSA, which was conducted by an Enforcement Investigation and Analysis Officer (EIAO), followed on the heels of numerous instances of non-compliance with sanitation, cleaning, and maintenance norms documented by Inspection Program Personnel.

The FSA began on September 27, 2022, with a “walk-through” to evaluate the production facility’s compliance with Sanitation Performance Standards.

During that walk-through, the EIAO observed nearly 100 individual instances of non-compliance, including:

  • condensation beading on pipes and ceilings; in some cases directly above ready-to-eat product
  • rusting brackets, clamps, and conduits
  • peeling paint
  • loose caulking
  • trash on floor
  • smoke and soot collected on ceiling and overhead pipes
  • holes in walls and floors
  • exposed insulation around piping
  • green mold in the vicinity of a crack in a wall
  • live insects

The second phase of the FSA focussed on compliance with Sanitation Standard Operating Procedures (SSOP). This part of the assessment was performed only after plant quality assurance personnel had completed their own pre-operation inspection and declared the areas to be ready to begin production.

During the SSOP inspection, performed on September 28th, September 29th, and October 4th, the EIAO documented 46 individual instances of inadequate cleaning and six maintenance issues, including:

  • multiple instances of product residue on and around production equipment, including on surfaces that would come into contact with fresh product
  • beads of condensation
  • numerous missing links in a conveyor belt line

Upon checking the facilities SSOP records for the dates in question, the EIAO discovered that neither the deficiencies nor any corrective action had been documented, as required.

Finally, in the course of reviewing the company’s HACCP plan and records, the EIAO found that multiple sites had been omitted from the list of Food Contact Surfaces in the Environmental Monitoring Program.

NOTHING!

No warning letter. No suspension of operations (except for a 1-hour pause in a single part of the facility).

And, as far as can be determined from subsequent routine inspections, no real change in the company’s attitude or behavior.

The on-site inspector continued to log instances of product residue and “meat over-splash” in areas that had been cleared by plant QA personnel for production.

Mentions of rust continued to appear on the inspection logs.

Insects still crawled onto the pages of the reports.

And condensation periodically beaded on the ceiling, sometimes above a product-contact area.

In all of the inspection reports, covering a two-and-a-half year period from January 2022 through July 2024, there is not a single mention of Listeria.

We don’t know whether, and to what extent, the company conducted environmental and finished product testing for Listeria, and there is no indication that the 2022 Food Safety Assessment included any such sampling.

The only testing that has been made public consisted of twelve finished product samples collected by the Virginia Department of Agriculture at the request of the FSIS and analyzed by a USDA laboratory. Listeria monocytogenes was not recovered from those samples.

In mid-September 2002, the CDC alerted the public to an outbreak of Listeria monocytogenes that was responsible for 26 illnesses and 4 deaths. By October 4th, the number of confirmed illnesses had increased to 40. Seven people died and three pregnant women miscarried.

Epidemiological analysis linked the outbreak to sliced turkey deli meat. Eventually, the outbreak strain was found in environmental samples collected at Pigrim’s Pride in Franconia, PA and from ready-to-eat poultry products manufactured by JL Foods (a company unaffiliated with Pilgrim’s Pride).

Both companies had a long history of Listeria monocytogenes contamination in their production facilities, dating back at least to 1990 in the case of JL Foods. In both cases, FSIS closed its collective eyes to multiple instances of non-compliance at both facilties.

Food safety regulation and enforcement is suffocating within the FDA. The relatively recent reorganization may help, but feels too much like a rearrangement of deck chairs on the Titanic.

For decades, enforcement of food safety regulations for meat and poultry products within the USDA has taken a back seat to the agency’s mandate as a promoter of US agricultural products and industries. There is an inherent conflict of interest in these dual mandates that cannot be solved by nibbling around the edges.

The current system in the United States is fraught with overlapping jurisdictions and completing interests. Arbitrary definitions can place a single plant be under FSIS jurisdiction for some products and FDA jurisdiction for others.

The only sensible solution is to do what many of the USA’s trading partners have already done.

Combine the food safety mandates of the FDA and FSIS into a single, independent Food Safety Agency.


TAINTED formats 3
“Reads like a true crime novel” – Food Safety News

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Chapter 6. Birth of a Pathogen

TAINTED is available in digital format from all major on-line retailers. Press the button to go directly to your preferred digital bookstore.