Why Recalls Happen: A Sunshine Mills, Inc. Case Study, Part 1 (Aflatoxins)

Sunshine Mills, Inc. (Sunshine) is a manufacturer of pet foods and pet treats, with headquarters in Red Bay, Alabama, and production facilities in six states.

What happened?

On April 3, 2020, Sunshine’s Tupelo, Mississippi, facility sampled, tested AND ACCEPTED a bulk load of yellow corn that exceeded the company’s rejection level for aflatoxin.

The aflatoxin-contaminated batch of corn was used in the manufacture of multiple pet foods between April 3rd and April 5th.

On August 17, 2020, the Louisiana Department of Agriculture and Forestry detected aflatoxin in a sample of Family Pet brand dog food manufactured by Sunshine on April 5th. The aflatoxin level that Louisiana found was 82.4 parts per billion (ppb)—more than four times FDA’s action level of 20 ppb.

On September 2, 2020, Sunshine recalled three products due to the presence of aflatoxin “potentially above the acceptable limit.”

On September 8, 2020, the US Food and Drug Administration (FDA) initiated an inspection of Sunshine’s Tupelo facility.

One month later, on October 8, 2020, Sunshine announced an expansion of its previous recall to encompass an additional twenty-one products that were manufactured using the same batch of corn used in the manufacture of the aflatoxin-contaminated Family Pet dog food.

How did this happen?

According to the FDA inspector’s observations and the company’s formal response (both obtained in response to a Freedom of Information Act request), there were multiple failures, including:

  • The lab technician who carried out the aflatoxin test on the incoming corn did not follow Sunshine’s documented testing procedure and also incorrectly recorded the test result.
  • Sunshine never verified the performance and calibration of the mycotoxin-detection equipment used to test for aflatoxins.
  • Printouts from the mycotoxin-detection equipment were not legible, as the printer had cut off the top of the printed digits, resulting in numerous transcription errors when the data were recorded in the test result logs.
  • The company never validated its sampling method, including how large a sample should be drawn from each bulk grain shipment or how the sample should be collected to ensure that it represents the entire shipment.

What are aflatoxins?

Aflatoxins are a group of naturally occurring toxins produced during the growth of the mold, Aspergillus flavus, on certain agricultural commodities, including corn. They are carcinogens and mutagens, and also can cause liver failure in animals.

Aflatoxin contamination of pet foods resulted in pet illnesses and deaths and multiple recalls of pet foods in 1998, 2005, 2011 and 2013, according to FDA’s Compliance Policy Guide.

The FDA has established action levels for the presence of aflatoxins in human food, animal feeds and pet foods, including an action level of 20 ppb in pet foods.

Common symptoms of aflatoxin poisoning in pets are sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes, gums, or skin due to liver damage), and/or diarrhea. Some pets may suffer liver damage without displaying any symptoms.

Could this have been avoided?

  • IF the lab technician had been properly trained and supervised, the contaminated bulk grain shipment would have been rejected.
  • IF the equipment had been properly calibrated and certified, the aflatoxin result would have been accurate.
  • IF the Quality Assurance Supervisor had paid attention to equipment maintenance, the printouts would have been legible.
  • IF Sunshine’s preventive controls had included aflatoxin testing for the corn-based ingredient, the problem could have been caught before the ingredient was used in production.
  • IF the bulk grain sampling and testing methods had been properly validated, a contaminated shipment would be more likely to be caught and rejected.

Was this an isolated incident?

In 2018, this same Sunshine facility was responsible for the production of a number of dog foods that contained excessive levels of vitamin D.

An inspection of the manufacturing facility revealed that the company did not have adequate procedures in place to ensure that the vitamin D ingredient it purchased from its supplier met all ingredient specifications.

Sunshine used a vitamin D ingredient that was not accompanied by a Certificate of Analysis and did not perform any lab tests of its own to verify that the ingredient was of the correct concentration.

When Sunshine was notified by one of its private-label customers of a consumer complaint reporting an ill dog, the company determined that the complaint was valid, but did not immediately notify FDA as it was required by FDA regulations.

In its formal reply to the FDA inspection observations, Sunshine blamed its vitamin supplier for the incorrect shipment, and claimed that it believed the owner of the private-label brand would make a report to FDA.

Stay tuned for Part 2 of this case study, which will examine the story behind Sunshine’s 2020 recall of Salmonella-contaminated pet food.

Note: This story is based on information retrieved from the FDA website and on documents obtained as a result of Freedom of Information Act requests.

Salmonella case count soars in onion outbreak – UPDATED

As of August 7, 2020, the US Centers for Disease Control and Prevention (CDC) has received reports of 640 confirmed cases of Salmonella Newport infections across 43 states.

Eight-five outbreak victims have required hospitalization.

In addition to the US outbreak, 239 confirmed cases have been reported to the Public Health Agency of Canada (PHAC) across seven provinces as of August 7th. Twenty-nine Canadians have been hospitalized.

According to the US Food and Drug Administration (FDA) illnesses in both countries have been linked to red onions grown and supplied by Thomson International, Inc. (Thomson) of Bakersfield, CA.

On August 1st, Thomson recalled all varieties of onions that could have come in contact with potentially contaminated red onions, including red, yellow, white, and sweet yellow onions shipped from May 1, 2020 to present.

The recalled onions were supplied to customers in the USA and Canada under several brand names, including:

  • Thomson Premium
  • TLC Thomson International
  • Tender Loving Care
  • El Competitor
  • Hartley’s Best
  • Onions 52
  • Majestic
  • Imperial Fresh
  • Kroger
  • Utah Onions
  • Food Lion

In addition to the Thomson recall, companies in the United States and Canada have recalled Thomson-supplied onions or products that contain onions on the Thomson recall list. Please follow the links to the individual recall notices for a complete list of products.

US recalls

ALDI
Brookshire’s Food and Pharmacy (Southwest Turkey Cobb Salads)
Costco Wholesale (multiple recall notices)
Department of Defense Commissaries
Giant Eagle

Food Lion
Fred Meyer
Fry’s Food Stores
H-E-B
Kroger
Martin’s Groceries, Supermarket & Pharmacy
Publix Super Markets
Schnucks
Smith’s
Stop&Shop
Super 1 Foods
Taylor Farms (products without meat)
Taylor Farms (products containing meat)
Walmart (multiple recall notices)

Canadian recalls

List of recalled products in Canada
Costco Canada
Freshpoint Foodservice
Giant Tiger
Multiple companies
Sysco

This outbreak is not over. Both CDC and PHAC are anticipating additional cases. To keep yourself and your family and your customers safe, please take note of the following guidance:

Advice to consumers

Check your home for red, white, yellow, and sweet varieties, including whole, sliced, or chopped onions, and any prepared foods that contain onions as an ingredient, such as premade salads, sandwiches, wraps, salsas or dips. 

  • If you have onions at home:
    • Look for a label showing where the onion was grown. It may be printed on the package or on a sticker. 
    • If the packaging or sticker shows that it is from Thomson International Inc., don’t eat it. Throw it away and wash your hands.
    • If it isn’t labeled, don’t eat it. Throw it away and wash your hands.
    • If you don’t know whether the onion found in a premade salad, sandwich, wrap, salsa or dip contains onions from Thomson International Inc., don’t eat it. Throw it away and wash your hands.
    • Wash and sanitize any surfaces that may have come in contact with onions or their packaging, such as countertops, fridge drawers, pantry shelves, knives, and cutting boards.
  • If you buy onions at grocery or convenience stores:
    • Make sure they are not selling onions from Thomson International Inc., or serving fresh foods prepared with them. 
    • If you can’t confirm that the onion in stores is not from Thomson International Inc., don’t buy it.
  • If you order salad or any other food items containing onions at a restaurant or food establishment:
    • Ask the staff whether their onions come from Thomson International Inc. If they did, or they don’t know, don’t eat it.
  • Do not eat any recalled food products. Check to see if you have recalled food products at home. If you do, throw them out and wash your hands. 
  • If you believe you are experiencing symptoms of a Salmonella infection, consult a healthcare practitioner immediate.
  • If you have been diagnosed with a Salmonella infection or any other gastrointestinal illness, do not cook food for other people.
  • Contact your local public health authority to report any food safety concerns at restaurants or grocery stores, or if you suspect food poisoning from a restaurant or other food establishments.

Advice to restaurants, retailers, suppliers and distributors

  • Check the label on bags or boxes of onions, or ask their suppliers about the source of their onions.
  • Do not ship or sell onions from Thomson International Inc. of Bakersfield, California, USA, or any products made with these onions.
  • Clean and sanitize all surfaces and storage bins that onions may have come in contact with, including cutting boards, countertops, slicers, utensils, and containers used to store or transport them.

Pig ear pet treats blamed for human Salmonella outbreak

Pig ear pet treats have been linked to an outbreak of multidrug-resistant Salmonella infections in 13 states, according to an investigation report released today by CDC.

Forty-five individuals in California (1), Illinois (3), Indiana (3), Iowa (12), Kansas (3), Massachusetts (2), Michigan (7), Missouri (3), New York (6), North Dakota (1), Pennsylvania (2), South Carolina (1) and Wisconsin (1) have been infected with the outbreak strain, identified as Salmonella I 4,[5],12:i:-.

Twelve outbreak victims were hospitalized.

According to CDC, epidemiological evidence points to pig ear pet treats as a likely source of the illnesses.

Of the outbreak victims interviewed, 89% reported contact with a dog before getting sick and 71% reported contact with pig ear dog treats or with dogs who were fed pig ear dog treats.

In comparison, only 61% of healthy individuals reported contact with a dog, and only 16% reported having handled dog treats such as pig ears in the week before the interview.

Pig ear pet treats obtained from bulk bins at two Michigan retailers have tested positive for a number of different Salmonella strains, according to a report from the Michigan Department of Agriculture and Rural Development (MDARD).

According to FDA, MDARD found four different strains – Salmonella London, Salmonella Typhimurium, Salmonella Newport, and Salmonella Infantis – in the pig ear samples.

FDA is working with CDC and state health partners to determine whether any human or animal cases of Salmonella illness may be linked to the strains found in the treats tested by MDARD.

Other brands of individually wrapped or bagged pig ears sold at multiple retail locations in the state tested negative for Salmonella.

Pet Supplies Plus (Livonia, MI) issued a voluntary recall after learning that MDARD found Salmonella in “…aging bulk pig ear product…” in one of the company’s stores.

The contaminated bulk pig ears were stocked in open bins in Pet Supplies Plus stores in AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, VA, WI and WV. Prepackaged pig ears are unaffected by the recall.

The company has removed bulk pig ear treats from all of its stores and has stopped shipping these treats from its distribution center.

FDA is working to identify the source of the pig ear treats, how they became contaminated, and where they were distributed.

What consumers need to know

Salmonella can cause illness in both humans and animals. People infected with Salmonella can develop diarrhea, fever and abdominal cramps. Most individuals recover without treatment. However, in some cases, the diarrhea may be so severe that hospitalization is needed.

In severe cases, without antibiotic treatment the infection may spread from the intestines into the blood stream and from there to other parts of the body.

Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. Infected pets can shed the bacteria in their feces and saliva without showing signs of being sick.

If you or a household member is suffering from symptoms of Salmonella, consult a healthcare provider.

If you believe your pet may be infected with Salmonella, consult your veterinarian.

How to alert FDA to a problem

Veterinarians who wish to have pets tested for Salmonella 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.

FDA encourages consumers to report complaints about pet food products electronically through the Safety Reporting Portal. This information helps FDA further protect human and animal health.