Inspection results show Arrow Reliance (Darwin’s) is a repeat offender

Observations recorded by FDA investigators during an August 26—September 18, 2024, inspection of the Arrow Reliance Inc. (Darwin’s Natural Pet Products) pet food production facility in Tukwila, Washington reveal that the company has failed to correct siginificant food-safety violations, some of which date back to 2018.

This information was obtained by eFoodAlert in response to a Freedom of Information Act request.

The repeat offenses

Darwin’s has not identified and implemented adequate controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented (repeat observation from inspection conducted in 2023)

As evidence, FDA investigators cited:

Six finished product samples confirmed to contain Salmonella, one of which also contained Listeria monocytogenes
Lack of documentation to support use of peroxyacetic acid to control Listeria effectively
Employees not following the company’s written procedures for conducting swabbing to verify effectiveness of cleaning and sanitizing in production room

Operations not conducted in accordance with current good manufacturing practices; adequate precautions not taken to prevent contamination of food or to conduct manufacturing under conditions to protect against contamination (repeat observation from inspection conducted in 2018)

FDA investigators cited multiple examples, including:

The peroxyacetic acid additive used by Darwin’s to control pathogens in its raw, ready-to-eat pet foods is not been used in a manner consistent with the ingredient labeling and is not generally recognized as safe for use in animal food
During a sanitation shift, aerosolized waster was being blown throughout the room and onto exposed ready-to-eat product on the uncovered packaging line and in an open hopper
Aerosolized water from a sink hose was blowing throughout the room where exposed product was being prepared for rework
An employee was handling multiple items, including soiled paper towel, filler hose, and finished product without changing gloves or cleaning them in a hand dip
Water from a hose was spraying onto boxed ingredients staged for production

The company had not maintained food contact surfaces to protect food from being contaminated (repeat observation from inspection conducted in 2018)

FDA investigators observed the following:

White plastic cutting board portion of meat prep table contained deep cut marks that appeared to remain discolored even after cleaning and sanitation
A grinder used to grind raw meat and poultry ingredients appeared damage, with numerous gouges and scratches throughout
A blade housing with visible apparent rust
Several parts stored on shelving units appeared pitted, damaged or rusty even after cleaning and sanitizing. These parts were considered by the company to be clean and ready for use

Additional observations

Maintenance issues

The floor through the production room appeared damaged and pitted. There was an accumulation of water, blood, and raw ingredients across the floor during production.
There was damage around the entire base of a pillar near the meat prep table, with accumulation of water, blood, and raw ingredients in the crevaces. Thawed, boxed raw proteins for processing are staged against this pillar.

Design deficiencies

Plant was not constructed or designed to facilitate cleaning, maintenace and pest control
Visible condensation and apparent dust build-up on the production room ceiling, including over the uncovered packaging line
Drops of condensate observed falling from the ceiling into clean/sanitized vemag carts (wheeled bins used to move bulk product and ingredients from place to place in the plant)

HACCP plan deficiencies

Company did not identify drug residues associated with incoming raw meat and poultry as a known or reasonably foreseeable hazard
Company did not identify specific vitamin/mineral toxicities and deficiences of concern for dogs and cats as a known or reasonably foreseeable hazard for those pet foods manufactured and labeld as “complete diets”

Pathogens

Finished product testing

On August 27, 2024, the FDA sampled six finished products for pathogen testing. The samples were collected from Darwin’s third-party cold storage facility. Salmonella was recovered from all six products. In addition, Listeria monocytogenes was found in one of the products. A second species of Listeria (L. innocua) was found in one product.

Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR CATS, Lot No. 10832:- Salmonella detected
Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR CATS, Lot No. 10856:- Salmonella detected
Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR CATS, Lot No. 10890:- Salmonella detected
Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR DOGS, Lot No. 10828:- Salmonella and Listeria monocytogenes detected
Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR DOGS, Lot No. 10844:- Salmonella detected
Natural Selections Antibiotic & Grain-free CHICKEN RECIPE FOR DOGS, Lot No. 10887:- Salmonella and Listeria innocua detected

Environmental testing

FDA collected 63 environmental swab samples during the course of the inspection and submitted these for Listeria monocytogenes analysis. No Listera were found in any of the 63 environmental samples.

FDA collected 101 environmental swab samples during the course of the inspection and submitted these for Salmonella analysis. Salmonella Typhimurium was found in one of the swab samples.

What next for Arrow Reliance/Darwin’s?

The FDA has classified the results of this inspection as “Official Action Indicated.” This can mean anything from a Warning Letter up to and including legal action to halt the company’s operations until it complies with FDA regulations.

On two past occasions—in April 2018 and February 2023—the FDA has issued Warning Letters citing a long list of violations. These have been totally ineffective.

Pet families can only hope that the FDA will take a firmer hand this time around.

“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

Available from all major on-line retailers, including:

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.

What should consumers do?

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.

What’s the big deal?

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.

How to report a pet illness

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.

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

Available from all major on-line retailers, including:

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.

What FSIS found

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.

Boar’s Head’s response

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 bottom line

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?