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.

Recalls and Alerts: December 10 – 12, 2020


Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations? Go to TAINTED to download the first couple of chapters of my new book.

United States

Food Safety Recall: Cozy Vale Creamery is advising consumers to discontinue consumption of their retail raw milk and cream products with the best by dates of 12-14 through 12-23 after the Washington State Department of Agriculture found shigatoxin-producing E. coli in a sample of retail raw cream dated 12-14. Consumers shouild dispose of or return the products to the place of purchase for a full refund.

Canada

Allergy Alert: L’Hippie-Curienne recalls four varieties of Assaisonnement à tartare / Tartar seasoning (125g; Best before NOV 2022) due to undeclared soy. Please refer to the recall notice for a list of affected varieties.

Food Safety Recall: Au Ciel Café bistro recalls three varieties of soup (1L glass jars; sold up to 11 December 2020) because the products were not held at refrigeration temperature from time of purchase and lacked required labelling instructions to “keep refrigerated.”

Food Safety Recall: Farine et basilic inc. recalls Sauce à la viande / Meat sauce (500 ml glass jars; sold up to 8 December 2020) because the product was not held at refrigeration temperature from time of purchase and lacked required labelling instructions to “keep refrigerated.”

Food Safety Recall: Boucherie L’Amiral inc. recalls two smoked salmon products due to lack of proper storage instructions on the product labels. Please refer to the recall notice for complete details.

Europe

Allergy Alert (Belgium): Aldi recalls Trader Joe’s brand Mendiants Classic (BIO) (250g; All Best before dates up to 23/05/2021) due to undeclared almonds.

Allergy Alert (Belgium): Aldi recalls Pirato brand TORTILLACHIPS – variante sweet chili / Sweet chili tortilla chips (200g; Lots 14 05 21 C 04:02 F11 46 jusqu’à et y compris 14 05 21 D 12:40 F11 46; Best before 14/05/2021) due to undeclared milk.

Allergy Alert (Finland): Snellmanin Kokkikartano Oy recalls Mr. Panini Gluteeniton kinkkupanini / Mr. Panini My Gluten Free Ham Panini (235g; Expiry dates 17.12.2020, 19.12.2020 & 24.12.2020) and Mr. Panini Gluteeniton kanapanini / Mr. Panini My gluten-free chicken panini (235g; Expiry dates 17.12.2020, 19.12.2020 & 24.12.2020) due to undeclared oats.

Allergy Alert (France): LESIEUR recalls Lesieur brand Sauce Algérienne (940g; Lot #20043G04; Expiry dates 28/02/2021 & 30/06/2021) due to undeclared mustard.

Allergy Alert (Italy): VALSOIA SPA recalls Valsoia brand Preparazione alimentare VEGETALE a base di SOIA FERMENTATA / Vegetable food preparation based on fermented soy (125g; Lot #L3210; Best before 01-03-2021) due to undeclared milk.

Allergy Alert (UK): Lakeland recalls Flower & White, Bake On Strong White Bread Flour (1.5 kg; Best before 01 May 2021 & 01 June 2021) due to undeclared gluten (wheat).

Allergy Alert (UK): Picard recalls multiple frozen products because they contain various allergens which are not listed in English on the label. Please refer to the recall notice for a complete list of affected products and undeclared allergens.

Food Safety Recall (Denmark): Nakskov Mill Foods A/S recalls X-tra Cornflakes (1 kg; 20.10.2021, 21.10.2021, 02.11.2021, 03.11.2021, 04.11.2021, 11.11.2021, 18.11.2021) and First Price Cornflakes (1 kg; Best before 16.11.2021) due to foreign matter (metal pieces) contamination.

Food Safety Recall (France): Auchan recalls Mère Lalie brand Terrine de lapin au serpolet / rabbit terrine with wild thyme (200g; Lot #J 09 10 2023) due to possible foreign matter (glass particles) contamination. 

Food Safety Recall (France): Auchan recalls Maxi Crousti de poulet / Maxi chicken crisps (400g; Lot #344060; Use by 31/12/2020) due to foreign matter contamination.

Food Safety Recall (France): La Société LOSFELD DISTRIBUTION recalls Fromagerie des 2 Caps brand Fromage des 2 Caps fromage fermier au lait cru / raw milk cheese (320g; Lot #272; Use by 17/11/2020 & 21/11/2020) due to E. coli contamination.

Food Safety Recall (France): Industry recalls Bonduelle brand Mesclun (145g; Lots #27631345 & 27631363; Best by 12/12/20) due to Salmonella contamination.

Food Safety Recall (France): Intermarché recalls Saint Eloi brand Mesclun (125g; Lot #27631329; Use by 10/12/20) due to Salmonella contamination.

Food Safety Recall (France): Industry recalls U brand Roquette salad (150g; Lot 27631323 – 27636358; Best by 10/12/20 – 11/12/20) and U brand Mesclun (175g; Lot #27631353; Best by 10/12/2020) due to Salmonella contamination.

Food Safety Recall (Luxembourg): Auchan recalls Mère Lalie brand Terrine de lapin au serpolet / rabbit terrine with wild thyme (200g; Lot #J 09 10 2023) due to possible foreign matter (glass particles) contamination. 

Asia, Africa and the Pacific Islands

Food Safety Recall (Israel): Meiri Beigel Ltd. recalls Classic Grissini Crumbs (200 grams; Batch codes 29420 and 29520; Best before 20.10.2021 and 21.10.2021) due to foreign matter (small plastic chips) contamination.