Botulism and baby food. The Oceanitan affair

On January 24, 2023, the Missouri Department of Health and Human Services alerted the US Food and Drug Administration (FDA) to a possible case of Clostridium botulinum in an infant.

Although primarily breastfed, the infant had also been fed some packaged refrigerated baby food on or around January 7th (pumpkin) and January 11th (broccoli). On January 18th, the infant began to show symptoms of botulism.

By January 22nd, the infant had been hospitalized, and treatment with an anti-toxin was initiated.

The treatment was successful and the infant survived.

The baby food was manufactured by Oceanitan, LLC, a contract manufacturer of baby food products located in Los Angeles, California.

The investigation

On February 3rd, a Missouri health inspector collected samples of the product from the infant’s home and submitted them to the FDA for analysis.

On February 16th, with the lab analysis underway, the FDA began an in-depth inspection of Oceanitan’s manufacturing facility—an inspection that would continue into early April.

The inspection revealed multiple, serious violations of various federal standards (“rules”) for safe manufacture of food products. These violations included:

Lack of preventive controls for bacterial growth and/or toxin formation by Clostridium botulinum in the finished, packaged ready-to-eat products
Use of uncalibrated and inaccurate thermometers to measure storage temperatures
Exposure of cooked ingredients and products to potential environmental contamination during cooling, production, and packaging
Lack of an environmental monitoring program
Inadequate sanitation controls procedures
Lack of a validation study to support cooking parameters specified in the written Process Control document
Dripping water, exposed rust, and peeling paint in various areas of the manufacturing facility

While the inspection was still in progress, the FDA laboratory completed its analysis. The products collected by the Missouri inspector from the home of the sick infant were contaminated with both a non-toxin strain of Clostridium botulinum and a strain of Clostridium beijerinckii.

Although both of these strains were non-pathogenic, they represented clear evidence that a toxin-producing strain of Clostridium botulinum would have been fully capable of growing in the baby food. The lab also reported that the pH and water activity of these products were well within the range to promote growth of the pathogen.

The follow-up

In keeping with the agency’s standard operating practice, the FDA investigator met with company management on April 6th at the completion of the inspection to make a formal presentation of FDA Form 483 (Inspectional Observations) and review the documented violations.

On April 27th, Oceanitan’s Chief Executive Officer, Nelson Lee, responded in writing to the list of observations. He informed the FDA that the company had purchased calibrated temperature data monitors for its coolers, contracted a third-party lab to initiate an environmental monitoring program, updated its sanitation program, cleaned and repaired ceilings and walls, and initiated steps to have other repairs performed by an outside contractor.

After reviewing the company’s response, the FDA issued a Warning Letter on September 7, 2023. In its letter, the agency noted that Oceanitan had not taken steps to update its hazard analysis or implement written procedures for monitoring a preventive control. Nor did the company provide a validation study for its process control parameters.

The FDA gave Oceanitan fifteen working days from receipt of the letter to notify the agency in writing of the steps it was taking to correct the remaining violatiosn and prevent a recurrence, and also advised the company that the agency would be conducting a follow-up inspection to determine Oceanitan’s compliance with the requirements of the Federal Food, Drug, and Cosmetic Act and its asssociated regulations.

Botulism—Infant and otherwise

Botulism is not a common occurrence.

In 2019, the most recent year for which data are posted on its website, the US Centers for Disease Control and Prevention (CDC) reported 152 cases of infant botulism and just 21 cases of foodborne botulism.

That same year, the CDC logged 58,371 non-typhoidal Salmonella reports and 16,939 reports of shiga toxin-producing E. coli.

Infant botulism can be associated with consumption of honey that is contaminated with spores of Clostridium botulinum. In fact, in Canada, raw honey is the only food that has been specifically linked to infant botulism.

In foodborne botulism, individuals become ill from eating a food that contains pre-formed toxin. But in the case of infants, it’s not necessary for the toxin to be present in the food. Clostridium botulinum spores can multiply and produce their deadly toxin in the baby’s intestine.

The take-aways

The baby food products manufactured under contract by Oceanitan were neither commercially sterile nor shelf-stable.

The products were sold as refrigerated, “ready-to-eat” baby foods.

Information on the brand(s) of baby food products manufactured by Oceanitan was redacted from the documents obtained by eFoodAlert under the Freedom of Information Act, as this information is considered to be proprietary.

The manufacturing process consisted of cooking the individual ingredients before they were mixed and puréed. There was no second “kill” step either before or after the products were filled into their 4-ounce plastic jars. And there were serious flaws in the company’s hazard analysis, environmental monitoring, and facility maintenance.

By neglecting fundamental principles of safe food manufacture, the company and its commercial customers put a vulnerable population at risk.

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Primal Pet Foods—A Cautionary Tale

Management missteps led to 2023 Warning Letter

Primal Pet Foods, Inc. (Primal) is a manufacturer of frozen and freeze-dried raw food and treats for dogs and cats.

Incorporated in California in 2001, the company distributes its products through retailers in the United States and Canada from its base in Fairfield, California.

In 2011, the Washington State Department of Agriculture, following up on a consumer complaint, found Salmonella in a sample of the company’s frozen turkey cat food.

Following a visit by the FDA in response to the Salmonella finding, the company recalled the contaminated batch.

The FDA next visited Primal in March 2015, once again as a result of a consumer complaint about one of the company’s cat foods.

This time, the consumer reported that their cat, which had been eating Primal Pronto Formula Wholesome Raw Foods for Cats (Turkey), was diagnosed with a thiamine deficiency.

The FDA’s laboratory analyzed two samples of the cat food and found that both samples contained significantly less thiamine than was disclosed on the package labeling. The quantity of thiamine in the samples also was below the minimum nutritional requirement for a “complete and balanced” diet for cats.

In response to the FDA’s report, the company recalled the implicated batch of cat food.

Although the FDA classified the results of the 2015 inspection as “Voluntary Action Indicated,” the investigation team did not issue a formal “Inspectional Observations” (Form 483) at the end of the inspection. Instead, they discussed several issues with the company’s president in a face-to-face meeting.

And there matters rested for four years.

The 2019 inspection

In April 2019, the FDA began a “…comprehensive, full scope Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls in Animal Foods inspection” of Primal’s Fairfield, California, manufacturing facility.

During the course of the inspection, FDA investigators reviewed the company’s food safety plan, shipping and receiving, processing, sanitation, environmental monitoring, product specifications, analytical results, and consumer complaints records.

The inspection uncovered several deficiencies, resulting in a four-point Inspectional Observations report (Form 483), issued at the close of the inspection on May 14, 2019.

The details

The FDA investigators supported their Inspectional Observations with multiple examples, including:

Between October 1, 2017 and April 18, 2019, Primal received 1073 consumer complaints identified as “pet got sick” and 159 complaints of foreign objects in the pet food.
The company’s Food Safety Plan did not identify thiamine deficiency in cat food as a hazard (even though Primal had recalled a batch of product for this precise problem four years before).
The company’s Food Safety Plan did not identify vitamin D excess in dog food as a hazard.
The company did not have a written plan for conducting food recalls.
Primal employed high pressure pasteurization (HPP) to treat raw poultry meat (but not raw, red meats) prior to incorporation into pet food formulas, but was not able to provide any documentation as to how the time and pressure conditions for the HPP process were arrived at. Nor did the company have any records to show that the process being used was effective.
Between October 1, 2017, and April 18, 2019, company records showed 75 lots of ready-to-eat beef bones had tested positive for Listeria monocytogenes, and two lots had tested positive for Salmonella.
The company’s Quality Assurance Manager, who served as the sole Preventive Controls Quality Individual (PCQI), was trained in human food safety issues, but had received no formal training in the specific issues associated with animal food.

The company’s response

In a June 2019 written reply to the FDA’s Form 483, the company undertook to correct all of the issues raised during the inspection, including:

Adding a sampling protocol for thiamine and vitamin D;
Instituting an approval process for the company’s ingredient and primary packaging suppliers;
Undertaking a validation study of its HPP process; and
Adding a “Corrective and/or Preventive Action” procedure to its food safety plan.

Fast forward to 2022

The 2022 inspection

In July 2022, Primal announced a product recall after the FDA found Listeria monocytogenes in a sample of Raw Frozen Primal Patties for Dogs Beef Formula during the course of routine surveillance sampling.

The FDA followed up on the finding with a comprehensive inspection of the manufacturing operations. By the completion of the inspection, it was clear that conditions at the facility had deteriorated significantly since 2019.

At the end of the inspection, the FDA investigation team issued a list of fourteen (14) Inspectional Observations, documenting each one with specific examples. The Form 483 handed to company management at the close of the inspection was twenty-three (23) pages long.

The details

Among the violations and inadequate practices documented during the inspection were:

51 positive results for Listeria, Listeria monocytogenes, or Salmonella in various ready-to-eat cat and dog foods and treats between August 2021 and August 2022, indicating that the company’s pathogen control program was not effective at controlling pathogens.
Inadequate controls to ensure correct levels of thiamine and vitamin D in cat foods and dog foods, respectively.
Absence of validation records for the company’s pathogen control program.
Inadequate identification of biological or chemical hazards associated with multiple ingredients used to produce finished pet foods and treats.
Absence of supply chain preventive controls.
Inadequate documentation (missing Certificates of Analysis) for some batches of raw ingredients.
No root cause analysis performed to determine the potential cause or source of contamination in a finished product.
Inaccurate weighing of some ingredients due to improperly calibrated or verified scales.
Inadequate documentation of preventive measures for controling pathogens in finished products.
Inadequate or improper cleaning and sanitation procedures.
Lack of timely review of environmental or finished product monitoring records by qualified Preventive Controls Qualified Individual.
Requested documentation of raw ingredient testing records not provided to FDA investigator.

The company’s response

On November 1, 2022, Primal responded in detail to the 14-point Inspectional Observations report, prefacing many of its responses with a “Root Cause” analysis that blamed many of the flaws on a third-party food safety group that “…lacked a full understanding of animal food operations and the full scope of PPF production and documentation and did not perform a thorough review or implement an approval process for programs and documentation created or updated during the food safety program review.”

According to the company’s response, the situation was further complicated by an inept Quality Assurance Manager, who actually resigned while the 2022 inspection was still in progress. The lack of a strong QA manager, the company explained, “…prevented a cohesive team approach when conducting the third party food safety program review and update, and the creation of the food safety plan.”

In its response, the company elaborated on a number of corrective measures it planned to undertake, including the drafting and implementation of an entire new Hazard Analysis and Food Safety Plan under the guidance of a new third-party consultant team with specific expertise in pet food safety.

FDA issues Warning Letter

Although Primal Pet addressed many of the FDA’s concerns in its November 2022 letter, the agency was not entirely satisfied with the company’s response.

Accordingly, the FDA issued a formal Warning Letter on February 21, 2023, acknowledging the steps Primal had taken to correct the issues listed in the Form 483 report, and explaining where those actions had fallen short.

Specifically, the FDA noted the lack of supporting documentation to demonstrate that the described corrections were completed and were being consistently implemented.

In response to a validation study report submitted to support the company’s use of probiotics as a preventive control for Salmonella, the FDA took issue both with the lab methods used in the study and with its conclusion.

Primal responded to the Warning Letter with additional documentation, including a copy of its new Food Safety Plan, samples of test results, and additional details on validation of probiotics as a preventive control for pathogens in Primal’s products.

As of the latest information available, the FDA is continuing to evaluate the effectiveness of these corrective actions, and is working with Primal to ensure that the company comes fully into compliance with all regulatory requirements, including those covered by Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulations.

The take-away

Just like an Aesop’s fable, this story comes with a moral. Multiple morals, actually.

#1: Never hire a plumber to do carpentry

Primal Pet hired a third-party food safety consultant to design and oversee a hazard analysis and food safety plan for the company. But the consulting team—although experienced in human food safety—were novices when it came to the particular requirements for producing safe pet foods. As a result, the programs and procedures they designed were not fully appropriate to the task.

#2: Know the capabilities and characters of your key employees

Primal’s Quality Assurance manager at the time of the 2019 inspection was trained as a Preventive Controls Qualified Individual for human food safety, but had not received corresponding training for pet food safey.

The Quality Assurance manager at the time of the 2022 inspection (who may or may not have been the same individual) was described by the company as “…not strong or fully committed.” The QA manager resigned while the 2022 inspection was in progress.

#3: Don’t walk into a tree while you focus on the forest

A company’s CEO is supposed to focus on “the big picture” and leave the details to his or her subordinates. However, a good CEO must keep an eye on the performance and interactions of those subordinates. Had the CEO of Primal paid closer attention to the performance of his QA Manager, many of the failures of process and protocols might have been prevented.

#4: The FDA is not the boogeyman

The pattern of actions and enforcement activities displayed in this decade-long series of inspections, recalls, and reinspections are fairly typical of the FDA’s approach to dealing with a company that is trying to understand and cooperate with the agency’s requirements.

The agency’s investigators refrained from issuing a formal Form 483 report at the end of the 2011 and 2015 inspections, even though both of those inspections revealed safety issues (Salmonella-positive sample in 2011; low thiamine content in 2015). Instead, the agency discussed verbally with management what needed to be done.

The 2019 inspection was the first occasion on which a Form 483 was issued. Even so, the agency classified the inspection results as Voluntary Action Indicated and relied on management’s good faith to effect improvements.

It was only in 2022, when it was clear that the situation at the company’s Fairfield manufacturing facility had deteriorated rather than improved, that the FDA stepped up its enforcement classification level to Official Action Indicated, and issued a formal Warning Letter when the company’s initial response did not meet all of the agency’s requirements.

Note: This story is based on information found on the FDA website and obtained in response to a series of Freedom of Information Act requests.

“A complete and compelling account of the hidden and not-so-hidden ways the food we give our beloved pets can be contaminated.” – JoNel Aleccia, Health Reporter, Food & Nutrition, The Associated Press.

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FDA identifies source of decade-long Listeria outbreak

The US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention ( CDC) have identified queso fresco and cotija cheese manufactured by Rizo Lopez Foods (Modesto, CA) as the source of a deadly outbreak of Listeria monocytogenes illnesses that has gone unsolved for almost ten years.

Since June 2014, the outbreak has caused twenty-six illnesses, including two deaths. Twenty-three of the outbreak victims required hospitalization. Confirmed cases have been reported in eleven states.

The CDC investigated this outbreak twice before (in 2017 and 2021). Although epidemiological evidence pointed to queso fresco and other similar cheeses as the likely source at that time, health authorities were unable to trace the illnesses to a specific manufacturer.

The breakthrough came in January 2024, when the Hawaii State Department of Health found Listeria monocytogenes in a sample of Rizo Bros Aged Cotija cheese.

In response to the finding, the company recalled the contaminated production batch, and the FDA initiated an inspection of the Modesto, California, manufacturing facility.

While the inspection has not yet been completed, the FDA revealed yesterday (February 6, 2024) that it had recovered Listeria monocytogenes from an environmental sample collected at the plant. Whole genome sequencing carried out on the strain recovered from both the cotija sample and the environmental sample revealed that these were a match for the outbreak strain that has been circulating since 2014.

Rizo Lopez has now expanded its initial recall to encompass cheese, yogurt, and sour cream sold under the brand names Tio Francisco, Don Francisco, Rizo Bros, Rio Grande, Food City, El Huache, La Ordena, San Carlos, Campesino, Santa Maria, Dos Ranchitos, Casa Cardenas, and 365 Whole Foods Market. Please refer to the recall notice for a complete list of affected products.

As is often the case, the manufacturer’s recall has triggered secondary recalls.

Simply Fresh LLC recalled Rojo’s Black Bean 6 Layer Dip 2-20oz Club Pack (multiple Use-by date codes), because the product contains cotija cheese supplied by Rizo Lopez.
Fresh Creative Foods, a division of Reser’s Fine Foods, Inc. has recalled certain cremas, everything sauces, cilantro cotija dressing, poblano Caesar dressing, cilantro dressing and one taco kit that contain a cheese ingredient supplied by Rizo Lopez.

It is likely that additional secondary recalls will follow.

What to do?

The FDA offers this guidance to consumers, retailers, and restaurants:

Do not eat, sell, or serve recalled brands of cheeses, sour creams (cremas), or yogurts manufactured by Rizo Lopez Foods, Inc.
Check your refrigerators and freezers for any recalled products and throw them away. If you froze a product without the original packaging and can’t tell if it is part of the recall, throw it away.
Consumers, restaurants, and retailers who purchased or received recalled products, including wholesale products, should carefully clean and sanitize any surfaces or containers that it touched. Follow FDA’s safe handling and cleaning advice to reduce the risk of cross-contamination. Listeria can survive in refrigerated temperatures and can easily spread to other foods and surfaces. 
If you have symptoms of listeriosis you should contact your health care provider to report your symptoms and receive care.

At-risk individuals should pay special attention to the following:

Listeria is most likely to sicken pregnant people and newborns, adults aged 65 or older, and people with weakened immune systems. Other people can be infected with Listeria, but they rarely become seriously ill.
Pregnant people typically experience only fever, fatigue, and muscle aches. However, Listeria infection during pregnancy can lead to miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn.
Call your healthcare provider right away if you have symptoms of a Listeria infection.