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.

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It is time to rebuild the US food safety system

Several weeks ago, food safety advocate Bill Marler launched his campaign to “Get the ‘F’ out of the FDA.”

Marler proposed that Congress split the Food and Drug Administration into two separate agencies—one with responsibility for food safety and human nutrition, and the other for drugs, cosmetics and medical devices.

While I agree with the need for a separate agency to oversee food safety and human nutrition, I believe Marler’s proposal does not go far enough.

It is time to consolidate all food safety activities at the federal level under a single umbrella.

Here’s why.

Split jurisdiction

At present, responsibility for overseeing food safety is split between two main federal agencies: the FDA and the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA).

The USDA is responsible for the safety of meat and poultry, catfish, and egg products.

The FDA is responsible for the safety of all food products that do not contain meat or poultry, for intact eggs, and for all fish other than catfish.

This division of responsibility by commodity has led to some strange and confusing situations.

canned foods containing meat or poultry come under FSIS jurisdiction, while all other canned foods are FDA-regulated.
pizzas containing more than 2% meat are the responsibility of FSIS; less than 2% meat, and the FDA takes over.
open-faced sandwiches containing meat are overseed by FSIS; closed sandwiches are the responsibility of the FDA, whether or not meat is present.

These arbitrary distinctions mean that many food processing plants must answer to two separate federal agencies.

Conflict of interest

The USDA operates under a double mandate.

On the one hand, it is responsible for certifying that the food products under its jurisdiction are safe for human consumption.

On the other hand, the USDA also is charged with promoting US agricultural products both domestically and to overseas markets.

This is akin to having the quality assurance department of a food company report to the head of the marketing department.

We have seen the consequences of this conflict most recently in the FSIS draft proposal to allow as much as one Salmonella per gram of chicken in raw, breaded stuffed chicken products.

An immodest proposal

It is time to demolish the current ineffective, wasteful, and conflicted system and build a new one, centered on a new Food Safety and Nutrition Agency (FSNA) with a seat at the Cabinet table.

The FSNA would take over all of the food safety and nutrition program activities currently performed by the FDA. In addition, all responsibility for meat, poultry, egg products and catfish would fall under the FSNA umbrella.

The USDA would retain responsiblity for certifying the fitness of livestock for slaughter and certifying the fitness of their meat for human consumption.

At the moment meat or poultry leaves the slaughterhouse, jurisdiction would shift to the FSNA.

This approach would have the benefit of eliminating the conflict of interest inherent in the USDA’s double mandate. It would also unscramble the arbitrary and confusing overlap of jurisdictions between the FDA and the FSIS.

The consolidation of all food safety responsibilities within a single, independent agency is not a new idea.

The Canadian Food Inspection Agency (CFIA) was created in 1997 by consolidating into a single agency the food safety components of the Health Protection Branch (then the Canadian equivalent to the FDA), the Department of Agriculture, and the Department of Fisheries and Oceans.

Other countries, including the United Kingdom, Australia, and New Zealand have followed a similar path.

The bottom line

Congress created the current dysfunctional structure over a span of many decades.

Therefore, it is up to Congress to deconstruct this broken system and build a new one that will work to the benefit of the public it has been elected to represent.

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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.

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Sunday Supplement: Proposed new FDA food structure leaves pet food out to dry

IN MY OPINION

The proposed new US Food and Drug Administration (FDA) organization structure leaves the Center for Veterinary Medicine (CVM) sucking on a hind teat.

Never a major player in the FDA heirarchy, the CVM has been formally excluded from the Human Foods Program, with only a dotted line connecting it to the Office of the Deputy Commissioner.

Although the CVM will report directly to the Office of the Commissioner of Food and Drugs, its relatively small budget and political profile will leave this essential element of food safety and nutrition with little voice or influence at the table.

Why does this matter?

The CVM is responsible for oversight of animal feed, pet foods and veterinary medicines.

If animal feeds are not properly regulated and supervised, animal nutrition–and ultimately human nutrition–suffers.

If veterinary medicines are not properly regulated and supervised, the health of livestock and the safety of the human diet suffers.

If pet foods are not properly regulated and supervised, the health of companion animals suffers.

Pet health matters

Pets play an important role in the mental and physical health of their human companions.

Those of us who have lost a dog, cat, or other pet to illness, accidents, or simply old age, understand the grief that this loss entails.

In addition, if an animal develops a gastrointestinal illness such as salmonellosis as a result of contaminated pet food, this illness can be passed along to people in the same household.

This is not speculation.

Kibble, raw pet foods, and pet treats contaminated with Salmonella have caused several outbreaks of human illness large enough to attract the attention of the US Centers for Disease Control and Prevention (CDC).

Without a strong voice at the budget table, the CVM will not have the resources to oversee the pet food industry.

We have seen what has happened in the past when a pet food manufacturer has been allowed to operate on a “voluntary compliance” basis. More often than is healthy, the emphasis is on voluntary, and compliance falls by the wayside.

Can this be fixed?

I realize that the CVM has elements both of food and of pharmaceuticals in its regulatory portfolio.

Nevertheless, every component of the CVM’s mandate–animal feed, animal medications, pet food–indirectly supports the safety and nutriton of human or animal food.

I would propose that the scope of the proposed new directorate be expanded to include the CVM, and that the word “Human” be dropped from the title of the new Deputy Commissioner.