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.