Why Recalls Happen: Sunshine Mills, Inc., Part 3

Recalls don’t just happen.

Whether bacterial, chemical, a natural toxin or an undeclared allergen, there is always a triggering event.

In the case of Sunshine Mills, Inc., the trigger was a pair of abnormal findings reported by two different states.

Georgia

On August 4, 2020, the Georgia Department of Agriculture (GDA) reported having recovered Salmonella in a sample of Nature’s Menu Super Premium Dog Food brand Natural Dog food with A Blend of Real Chicken & Quail (3-lb bags; Lot code TE2 22 APRIL 2020).

The GDA carries out routine retail-level sampling of pet foods for Salmonella and other pathogens. The Salmonella-positive sample was part of this routine testing program.

On August 12th, Georgia notified Sunshine Mills of the Salmonella-positive result.

Sunshine recalled the offending product on August 24, 2020.

Louisiana

The Louisiana Department of Agriculture and Forestry (LDAF) also performs routine retail surveillance sampling of commercial feeds, including pet foods.

According to a spokesperson for the LDAF, the state analyzes more than 2,000 such products annually, testing for protein, fat, fiber, moisture and minerals. In addition, depending on the products and the time of year, some samples may be tested for one or more of: mycotoxins (including but not limited to Aflatoxin, Fumonisin, and Vomitoxin), toxic heavy metals (i.e. Mercury, Cadmium, Chromium, Arsenic and Lead), Acid and Neutral Detergent Fiber, Total Digestible Fiber, Salmonella spp., Listeria monocytogenes, coliforms, antibiotics, pesticides and herbicides.

On August 17, 2020, the LDAF detected aflatoxin in a sample of Family Pet Meaty Cuts Beef Chicken & Cheese Flavors Premium Dog Food, manufactured by Sunshine Mills for Midwood Brands LLC. The product was sold in Family Dollar stores.

The level of aflatoxin in the dry dog food was four times the US Food and Drug Administration’s (FDA) action level for pet foods.

Upon finding the positive test results, the LDAF contacted the company to request a recall, and also placed a “stop sale” order on the product.

Sunshine Mills recalled the offending product on September 2nd, along with two other brands of dry dog food with similar formulations.

FDA steps in

Both the August recall due to Salmonella and the September recall due to elevated alfatoxin levels were announced on the FDA’s recall page.

On September 8, 2020, an FDA inspector presented a Notice of Inspection to Philip V. Bates, Chief Operating Officer of Sunshine’s Tupelo manufacturing plant. The inspection would continue, off and on, until October 27, 2020.

The FDA has declined to state (in response to a direct question from eFoodAlert) whether this inspection was triggered by the Salmonella contamination or by the alfatoxin finding. However, the timing of the inspection suggests that Louisiana’s detection of elevated aflatoxin in a dog food sample was the catalyst.

Once on the scene, the FDA inspector investigated both contamination issues, reporting on numerous deficiences, summarized in Part 1 and Part 2 of this series.

Questions left unanswered

Who notified the FDA?

Companies are required to notify the FDA within 24 hours “when there is a reasonable probability that an article of human food or animal food/feed (including pet food) will cause serious adverse health consequences or death to humans or animals.”

In 2018, when this same manufacturing plant learned that some of its pet foods contained elevated levels of Vitamin D, company management neglected to inform report this finding to the agency’s Reportable Food Registry within the mandatory 24 hour period. On that occasion, six days elapsed between the time Sunshine had confirmed the problem and the time the company’s management notified the FDA.

The FDA has declined to respond to eFoodAlert’s question as to whether the company or the state agencies notified FDA of the Salmonella and aflatoxin problems.

How much aflatoxin was in the contaminated corn ingredient?

Sunshine’s lab technician tested a sample of bulk yellow corn on April 3, 2020 and accepted that load of corn, even though the level of aflatoxin in the corn exceeded the company’s own rejection level.

We do not know how much aflatoxin was in the corn. That is considered by the FDA to be Confidential Commercial Information (CCI).

We do not know what Sunshine’s rejection level is for aflatoxin. This, too, is considered by the FDA to be CCI, and was redacted from the report that was supplied in response to eFoodAlert’s Freedom of Information Act request. It is likely, though, that Sunshine would have set a rejection level that matches the FDA’s 20 parts per billion (ppb) action level for aflatoxin in pet foods and pet food ingredients.

How much did Sunshine know and when did they know it?

At some point after the company had distributed pet foods containing the contaminated corn, the company found elevated aflatoxin levels in samples of three product formulas, specifically:

  • Savory Beef, Chicken, Cheese 18%
  • Complete Nutrition 21-10
  • TSC Bites & Bones

The Savory Beef, Chicken, Cheese formula was covered in the initial aflatoxin recall dated September 2, 2020.

The remaining two formulations were included in the expanded recall dated October 8, 2020.

According to the lot code information contained in the recall notices, all of the recalled products were manufactured during April 3–5, 2020.

The FDA has declined to reveal either the date (or dates) on which Sunshine performed aflatoxin tests on these products, or the level of aflatoxin found in the three product formulas, citing—you guessed it—Confidential Commercial Information.

What next for Sunshine Mills?

On June 25, 2019, the FDA issued a formal Warning Letter to Sunshine Mills, Inc., listing multiple violations that led to the presence of excessive vitamin D in its pet foods, and expressing dissatisfaction with the company’s corrective actions.

Despite the Warning Letter, the first item cited in this summer’s investigation was a repeat observation from the previous inspection. Specifically, the company “did not identify and implement preventive controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented.”

The FDA inspector’s report also makes clear that the company’s corrective actions in response to both the Salmonella and the aflatoxin contamination issues were inadequate.

What are the consequences for a repeat offender? Will there be another Warning Letter? Another slap on the wrist?

Or will the Food and Drug Administration take more drastic action?

Stay tuned for developments.

Why Recalls Happen: A Sunshine Mills, Inc. Case Study, Part 2 (Salmonella)

On August 4, 2020, the Georgia Department of Agriculture detected Salmonella in a sample of Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail, manufactured by Sunshine Mills, Inc. (Sunshine).

The state notified Sunshine of its finding on August 12th.

Twelve days later, the company announced a recall of multiple lot codes of the Nature’s Menu dog food.

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

What the FDA inspector found

  • Finished product storage bins that are not covered by the company’s environmental monitoring program or sanitation schedules
  • Inadequate sanitation prevention controls, including dry dog food build-up on the surface of certain equipment and pitted and porous surfaces on interior surface welds
  • Sanitation control monitoring records that are not reviewed by a responsible individual
  • Inadequate corrective action after receiving notification from Georgia of the Salmonella-positive result
  • Inadequate evaluation of the scope of Salmonella contamination across multiple batches of finished product
  • Pre-filling of the sanitation checklist before the sanitizing procedures were carried out

How Sunshine responded

The company responded to most of the FDA inspector’s observations by acknowledging their accuracy and promising corrections.

In response to the inspector’s complaint about the inadequacy of Sunshine’s corrective actions regarding the detection of Salmonella, Phil Bates, Chief Operating Officer of Sunshine Mills, Inc., placed a portion of the blame on the State of Georgia, saying,

“We were in the process of investigating the detection of Salmonella spp. in the finished dog food product. Upon notification from the State of Georgia, a request was made for a split sample of the product in question which is required to be provided under Georgia law. The investigation proceeded with testing for Salmonella spp. in the retain sample of the product in question which was negative. We were subsequently informed that Georgia would not be able to provide the split sample for testing. The inability of Georgia to provide the split sample for testing delayed the investigation and implementation of corrective actions.”

Obtained in response to Freedom of Information Act request

Bates also blamed the leader of the sanitation crew for pre-filling the checklist, adding that the proper procedure had since been reviewed with the Sanitation Lead and with each member of the crew.

Why Salmonella contamination of a pet food matters

The FDA has this to say about the risks of Salmonella infections to dogs and cats.

Salmonellosis is uncommon in dogs and cats, but they can be carriers of the bacteria. This means that even if the pets don’t show symptoms of salmonellosis, they can still shed Salmonella in their stool and saliva and then spread the bacteria to the home environment and to people and other pets in the household. For example, cats can spread Salmonella through shared litter boxes or when roaming throughout the house, such as on kitchen countertops. Some ways dogs can spread the bacteria is when they give people kisses or have stool accidents inside the home. Pet waste from both sick and healthy pets can be a source of infection for people.

When the disease is seen in an adult dog or cat, the animal typically has another infection or health problem at the same time. Puppies and kittens are more likely to show signs of disease. Signs of salmonellosis in dogs and cats include:

  • Vomiting;
  • Diarrhea (which may be bloody);
  • Fever;
  • Loss of appetite; and
  • Decreased activity level.

The Salmonella incident investigation overlapped with the FDA’s investigation of aflatoxin contamination in pet food manufactured in the same Sunshine facility (See Part 1). Stay tuned for Part 3 of this series, which will look at the interweaving of the two incidents and how they relate to conditions that were revealed at the manufacturing plant in 2018, when the company’s pet foods were found to contain excessive levels of vitamin D.

Note: Information contained in this story was obtained from the FDA website and from documents furnished by FDA in response to a Freedom of Information Act request.

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.