The heartbreaking fact of these recalls – it all could have (should have) been prevented.
On September 3, 2020 Sunshine Mills announced a recall “of certain dog food products due to levels of Aflatoxin that are potentially above the acceptable limit.” The company expanded the recall a month later (October 9, 2020) – “This is an expansion of the recall initiated September 2, 2020, after an investigation conducted along with the U.S. Food and Drug Administration determined that additional corn-based pet food products produced between April 3, 2020 and April 5, 2020 may contain corn from a single load of corn with elevated levels of aflatoxin.”
The expanded recall press release tells pet owners that Sunshine Mills failed to do several things:
- Sunshine Mills failed to test incoming corn ingredients.
- Sunshine Mills failed to test batches of pet foods produced between April 3, 2020 and April 5, 2020.
- And the pet food manufacturer failed to properly trace the contaminated corn ingredients to include all pet foods lots manufactured with the aflatoxin contaminated corn.
Federal law – Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals – requires pet food manufacturers to have written procedures to identify all potential hazards and written procedures of how the company will prevent those hazards from entering the pet foods produced. These laws state (in part):
“You must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control.”
“You must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the animal food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act.”
Law requires pet food manufacturers to have these hazard analysis and preventive control procedures in writing – specifically to hold manufacturers accountable for the products they produce. Aflatoxin is a well established hazard of corn, with certainty corn ingredients in a pet food would require the manufacturer to note the aflatoxin hazard and establish preventive measures to prevent pet food contamination.
Thus…
Sunshine Mills was required by law to establish and implement measures to prevent aflatoxin contaminated corn to be used in their pet foods. Examples of preventive measures are: each load of corn delivered to Sunshine Mills should be tested for aflatoxin and each batch of pet food that includes corn should be tested for aflatoxin. Per the FDA Enforcement Reports database, Sunshine Mills recalled 1,374,405 pounds of dog food over 5 weeks. More than 1 million pounds of recalled pet food indicates this pet food manufacturer did not abide by the required hazard analysis and preventive controls.
As well, pet food manufacturers are required to keep detailed records of each ingredient – from supplier name to pounds received to every lot number of pet food each ingredient was used in. Sunshine Mills records should have immediately told them the lot numbers of pet foods that included the reported “single load of corn with elevated levels of aflatoxin.”
But that didn’t happen as evidenced by the expanded recall. The expanded recall notice told us that FDA properly traced all the lots of pet foods that included the single load of corn; “This is an expansion of the recall initiated September 2, 2020, after an investigation conducted along with the U.S. Food and Drug Administration determined that additional corn-based pet food products produced between April 3, 2020 and April 5, 2020 may contain corn from a single load of corn with elevated levels of aflatoxin.”
With Sunshine Mills failing to properly trace that single load of aflatoxin contaminated corn (which never should have been allowed in the pet food plant to begin with had proper testing been performed), dangerous pet foods remained on store shelves for five weeks (from September 3, 2020 to October 9, 2020).
And then…history repeated itself.
On December 30, 2020 Midwestern Pet Food issued a recall for nine different lots of dog and cat food for “levels of Aflatoxin that exceed acceptable limits.” A little less than two weeks later Midwestern Pet Food expanded the aflatoxin recall to include more than 1,000 lots of dog and cat food; “we have expanded this recall to cover all corn products containing pet foods with expiration dates prior to 07/09/22.”
Just like the Sunshine Mills recall a couple of months earlier, Midwestern Pet Food failed to:
- test incoming corn ingredients.
- test batches of pet foods produced with a known hazardous ingredient.
- properly trace the contaminated corn ingredients to include all pet foods lots manufactured with the aflatoxin contaminated corn.
History repeated itself in an ugly way. Per the FDA Enforcement Reports database, Midwestern Pet Food recalled 58,301,600 pounds of aflatoxin contaminated pet food. (The Enforcement Reports did not include pounds recalled for 21 lots of Nunn Better Hunter’s Select dog food and 46 lots of Sportmix Premium Stamina dog food. These products are not included in the 58 million pounds total.)
The same laws that required Sunshine Mills to acknowledge in writing potential pet food hazards and required Sunshine Mills to take steps to prevent known hazards from entering the pet food – were also required of Midwestern Pet Food. The same laws that required Sunshine Mills to properly trace all ingredients – documenting each lot of pet food that contains every incoming ingredient – were also required of Midwestern Pet Food. The recall of more than 58 million pounds of pet food evidences Midwestern Pet Food did not follow pet food safety laws.
Where does ‘history’ leave pet owners?
The Hazard Analysis and Preventive Control laws quoted above are part of the Food Safety Modernization Act (FSMA) which FDA brags is “the most sweeping reform of our food safety laws in more than 70 years“. FDA explains “FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination of the food supply to preventing it.”
Prevention certainly failed in these recalls.
FSMA laws also include required FDA inspections of pet food plants to assure pet food manufacturers have established written hazard analysis and have implemented preventive measures. These FDA inspections began in 2016.
Did Midwestern Pet Food and Sunshine Mills have proper hazard analysis and preventive measures in place? Did they pass FDA inspection?
These recalls prove the existing system of regulating pet food is not working. The FDA states “As of January 21, FDA has been made aware of more than 110 dogs that have died and more than 210 that are sick after eating certain pet food manufactured by Midwestern Pet Foods.” Our question to FDA will be – how many pets have to die for the agency to acknowledge and fix the failures?
The system has to be fixed. We (consumer advocates) are putting together an action plan to submit to FDA and an action plan for pet owners – this will be provided very soon (final details are being worked on now). It is our hope that with action by FDA and pet owners, this type of deadly pet food failure will never happen again.
Wishing you and your pet(s) the best,
Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
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Sherri
January 27, 2021 at 7:49 pm
There are many regulations in commercial pet food, many are simply ignored and few are enforced. I cannot foresee a day when they will ever clean up their act. I encourage everyone I meet to dump kibble. I don’t think there is anything any commercial kibble company could do to convince me to feed their garbage. A balanced homemade diet or a commercial raw or gently cooked diet are all options. No it’s not as cheap or convenient as a bag of kibble but my dogs are healthy, happy and never at the vet so I feel it pays for itself.
Peter
January 28, 2021 at 8:35 am
The change that is necessary, is that animals need to be recognized legally as sentient beings, not as “property.” Families have been destroyed by this company’s willful negligence, borne of its operational process defined solely by profit. Were these victims human, there would be financial consequences that would lead to change.