FDA gives Darwin’s pet food owners 15 days to clear up issues

Adulterated pet food, dead kitten, use of unapproved additive spur FDA warning letter

The FDA issued a formal warning letter to Arrow Reliance Inc. doing business as Darwin’s Natural Pet Products, citing pathogen problems at a production plant and saying scientific evidence shows the company’s cleaning solution is ineffective.

Darwin’s is a manufacturer of raw pet foods and is based in Tukwila, WA.

The April 2 warning letter from the Food and Drug Administration cites a history of consumer complaints and product recalls leading to the agency’s analysis of several Darwin’s products. Laboratory tests detected Salmonella, Listeria monocytogenes and E. coli O128 in one or more samples of the pet foods.

Foods under FDA jurisdiction, including pet foods, are deemed to be adulterated if they bear or contain a poisonous or deleterious substance that may render them injurious to health, according to the Federal Food, Drug, and Cosmetic Act (the Act). Introduction of an adulterated food into interstate commerce is a prosecutable violation of the Act.

Federal officials also found two Darwin’s products were also contaminated with Listeria innocua. Although it is not considered a pathogen in terms of human health, the warning letter underscored that the presence of Listeria innocua is an indicator that Listeria monocytogenes would be capable of surviving and growing in the product.

One of the consumer complaints that triggered the FDA investigation was lodged by the owner of a kitten that died as a result of a “severe systemic Salmonella infection” after being fed Darwin’s Natural Selections Duck Meals for Cats.

Salmonella was isolated from the dead kitten’s liver and from an unopened raw pet food package. Whole Genome Sequencing (WGS) analysis, often referred to as genetic fingerprinting, confirmed that the Salmonella recovered from the dead kitten and from the pet food sample were identical.

FDA also performed WGS analysis on Salmonella recovered from various other Darwin’s samples. The identical Salmonella strain was found in two different products manufactured two weeks apart and containing two different meat sources.

The presence of the identical Salmonella in these two products, according to the warning letter, suggests pathogen contamination in Darwin’s manufacturing facility.

In the letter, FDA also expressed its concern regarding Darwin’s use of a bacteriophage product to control pathogens in the raw pet foods, citing a lack of scientifically based validation of the controls and a change in the company’s protocol for applying the bacteriophage to the products.

The agency noted that the bacteriophage product is not “generally recognized as safe” (GRAS) nor is it the subject of a regulation describing additives permitted in animal foods.

The company was given 15 business days to reply to the warning letter, with a description of the steps taken to correct the violations and prevent these or similar violations from occurring in the future.

This story first appeared in Food Safety News and is reposted here with permission.

Darwin’s pet food owner knew of pathogens in production plant

The producer of Darwin’s brand raw pet foods knew about Salmonella in its plant, fielded more than 300 consumer complaints about sick or dead pets, and racked up a laundry list of food safety violations in 2017, according to government inspectors.

Investigators from the U.S. Food and Drug Administration and the Washington State Department of Agriculture (WSDA) identified numerous problems at Arrow Reliance Inc., doing business as Darwin’s Natural Pet Products. They undertook the December 2017 inspection in response to an ongoing pattern of product recalls and a consumer complaint received in October 2017.

Gary Tashjian, president and owner of Darwin’s, told the inspectors his company hadn’t received any specific complaints regarding Salmonella, E. coli or Listeria, according to a draft report from the inspectors. He said if consumers complained of pets’ illnesses, they would have to provide Darwin’s with test results from a veterinarian before the company would test its retained samples of implicated products. Only if the retained sample also tested positive would Darwin’s initiate a recall Tashjian told inspectors.

This week Darwin’s issued its fifth product recall since October 2016 after the Food and Drug Administration found Salmonella in four of its products. One of those products also was contaminated with E. coli O128.

According to the draft inspection report, obtained from WSDA by Food Safety News through a public records request, a review of the pet food company’s own records revealed much of the information that shows Darwin’s owners were aware of the pathogen problems.

Darwin did not have a written sanitation plan at the time of the inspection, according to the draft report.

The company was performing in-house pathogen testing that included screening for Salmonella. Darwin’s logs showed the company found Salmonella on the handle of a hand cart and the wheel of a garbage can that were on the processing floor in September. There was no documentation of a repeat test after the contaminated items were cleaned.

Similarly, an Aug. 24, 2017, log entry documented failure of the trench drain by the grinder. Again, there was no mention of corrective action.

Thermometer verification logs also showed several failures, with no corrective action documented.

Inspectors reported that Darwin’s maintains a record of customer complaints. During the period from Jan. 5, 2017, through Dec. 5, 2017, the company logged 332 complaint entries, including complaints of foreign material, spoiled and leaking packages, and pet illnesses and deaths.

More than one-third of the complaints — 36 percent — related to sickness. Ten percent were for foreign objects, including metal, plastic, rubber bands, produce bands and ties, hairnet material, and a pebble.

In addition to reporting on Darwin’s records, investigators recorded the following general “objectionable” conditions:

Failure to conduct operations under cGMPs (current Good Manufacturing Practices);
Raw materials were not thawed under conditions that would minimize the potential for growth of undesirable pathogens;
Animal food contact surfaces not made of appropriate materials or maintained to protect animal food from becoming contaminated; and
Equipment and utensils not used appropriately to avoid adulteration of animal food with contaminants.

Inspectors also cited the following specifics in their report:

A mallet with raw meat material on it was on a rack used to store sanitized equipment in the sanitizing room;
4-wheeled hand cart with two shelves covered with wet cardboard containing raw meat. Cart was touching a food preparation surface. Buckets used to carry and mix micro ingredients and phage preparation stored on the cart. Cart handle was broken and surface appeared to not be cleanable;
Dirty tool from processing floor placed on top of sanitized yellow pallet;
Food preparation table grooved and not cleanable;
Flashing between wall and floor and behind prep table was damaged and contained meat debris;
Employee observed breaking down dirty cardboard boxes with gloved hands and returning to processing floor without changing gloves or sanitizing;
Freezer box “B” had bloody and rusted metal racks; bloody floors and boxes storing frozen meat; organic material behind racks;
Cooler box “A” had bloody boxes of meat and vegetables stored on metal racks and pallets with organic material behind racks;
Cardboard boxes containing raw meat were observed leaking and dripping blood onto boxes stored below and onto adjacent boxes, pallets and metal racks;
Wooden pallets and metal racks not maintained or designed to be cleaned in a manner that protects ingredients against contamination;
Fork lift was observed moving from the receiving/loading dock, over the packing floor, through Box A and into the raw product prepping room;
Employees were wearing dirty boots in sanitation room and on process floor;
Damaged wall in preparation room;
Cement floor under hoses chipped and broken away. An approximately 12-inch x 12-inch hole was observed in first layer of cement;
Employee pocket knife observed on food contact service;
Door stops and upright pillar stops pitted and rusted;
Slider door between prep room and temping room rusted and dirty; and
Recycled wooden pallets noted in processing area at end of packing line.

FDA advice to consumers
People who think they might have become ill due to exposure to contaminated raw pet food or the feces of pets that have eaten contaminated raw pet food should talk to their health care providers.

Contact your health care provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.

People who think their pets have become ill after consuming contaminated raw pet food should contact their veterinarians. Veterinarians who wish to have dogs tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.

The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.

This story first appeared in Food Safety News and is reposted here with permission.

What has changed?

From time to time, I am asked why food safety hazards seem more prevalent now than they were two, three or more decades ago.

Why are more types of food at risk?

Where were Norovirus, Listeria monocytogenes, and other foodborne pathogens back then?

Why were we able to sample raw cake batter and raw cookie dough when we were kids without our parents worrying about Salmonella?

Much has changed in food production, processing and distribution in the last fifty years.

When I was growing up (in the 50s and 60s), most food to be found in grocery stores was still sourced locally. Produce was seasonal; we never saw fresh blueberries and strawberries in the our local grocery store in mid-winter.

The coming of large-scale food production and distribution was the harbinger of significant change to the way produce was harvested and the way food animals were raised.

Back then, large cattle feedlots for ‘finishing’ beef were the exception rather than the rule. My mother bought her meat and poultry from a neighborhood butcher shop and her bread from a local bakery. In short, if a food was contaminated, the extent of the potential outbreak was limited to the local market reach.

Amassing cattle in large feedlots under crowded conditions enhanced the potential spread of infections, resulting in the need to introduce antibiotics into the feed. At the low levels used, these antibiotics promoted ‘growth’ (ie., cattle fattened more quickly); however, they also promoted the development of antibiotic-resistant strains of bacteria.

The accumulated excrement from the cattle contaminated groundwater in the vicinity of the feedlots, increasing the spread of bacteria such as Salmonella and E. coli into the environment, including the wild animal populations.

Where fields were being farmed in the vicinity of feedlots, there was an increased potential for irrigation water (or run-off from rains) to spread the bacteria to the growing crops.

In the 50s and 60s, there was no effective method to detect Norovirus. Illnesses that today are attributed to Norovirus infections were written off as ‘stomach flu’ instead.

Some of the bacterial pathogens common today (notably, shiga-toxin producing E. coli, including E. coli O157:H7) are relatively recent mutations. The earliest report in the literature of an E. coli O157:H7 outbreak dates from 1983.

Large-scale production requires large-scale distribution networks, including transportation of liquid ingredients in tanker trucks. A Salmonella outbreak resulted from the transportation of pasteurized ice cream mix in a tanker that had previously carried liquid raw egg, and that hadn’t been sanitized between uses.

Climate change also has played a role. For example, shellfish are known to harbor Vibrio parahaemolyticus. However, this pathogen is cold-sensitive and was not a food safety hazard in the waters off the coast off Canada’s west coast in the past. With the rise in water temperatures, Vibrio parahaemolyticus has been found more frequently in shellfish harvested in those waters.

In 2007, ASM Press published my book, Food Safety: Old Habits, New Perspectives. Although now more than eleven years old, much of its content is still current.

As technology changes, so must the old habits we grew up with. By relying on yesterday’s food preparation methods, we lay ourselves open to tomorrow’s health threats.