Sunday Supplement: Proposed new FDA food structure leaves pet food out to dry

IN MY OPINION

The proposed new US Food and Drug Administration (FDA) organization structure leaves the Center for Veterinary Medicine (CVM) sucking on a hind teat.

Never a major player in the FDA heirarchy, the CVM has been formally excluded from the Human Foods Program, with only a dotted line connecting it to the Office of the Deputy Commissioner.

Although the CVM will report directly to the Office of the Commissioner of Food and Drugs, its relatively small budget and political profile will leave this essential element of food safety and nutrition with little voice or influence at the table.

Why does this matter?

The CVM is responsible for oversight of animal feed, pet foods and veterinary medicines.

If animal feeds are not properly regulated and supervised, animal nutrition–and ultimately human nutrition–suffers.

If veterinary medicines are not properly regulated and supervised, the health of livestock and the safety of the human diet suffers.

If pet foods are not properly regulated and supervised, the health of companion animals suffers.

Pet health matters

Pets play an important role in the mental and physical health of their human companions.

Those of us who have lost a dog, cat, or other pet to illness, accidents, or simply old age, understand the grief that this loss entails.

In addition, if an animal develops a gastrointestinal illness such as salmonellosis as a result of contaminated pet food, this illness can be passed along to people in the same household.

This is not speculation.

Kibble, raw pet foods, and pet treats contaminated with Salmonella have caused several outbreaks of human illness large enough to attract the attention of the US Centers for Disease Control and Prevention (CDC).

Without a strong voice at the budget table, the CVM will not have the resources to oversee the pet food industry.

We have seen what has happened in the past when a pet food manufacturer has been allowed to operate on a “voluntary compliance” basis. More often than is healthy, the emphasis is on voluntary, and compliance falls by the wayside.

Can this be fixed?

I realize that the CVM has elements both of food and of pharmaceuticals in its regulatory portfolio.

Nevertheless, every component of the CVM’s mandate–animal feed, animal medications, pet food–indirectly supports the safety and nutriton of human or animal food.

I would propose that the scope of the proposed new directorate be expanded to include the CVM, and that the word “Human” be dropped from the title of the new Deputy Commissioner.


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Honey Smacks manufacturer pleads guilty to food safety violations

Kerry, Inc., manufacturer of the breakfast cereal that was responsible for a 2018 Salmonella outbreak that sent thirty-four victims to hospital, has pled guilty in federal court to a charge that it manufactured the cereal under insanitary conditions.

The contaminated Kellogg’s Honey Smacks breakfast cereal caused 135 confirmed illnesses in 36 states.

According to a news release from the US Department of Justice (DOJ), the company has agreed to pay a criminal fine and forfeiture amount totaling $19,228,000.

The plea agreement has not yet been accepted by the court.

According to the DOJ’s news release, if the agreement is accepted, “…the $19.228 million fine and forfeiture will constitute the largest-ever criminal penalty following a criminal conviction in a food safety case.”

The company shut down operations at its Gridley, Illinois, facility in December 2018 due to a drop in demand for the products manufactured at that location.

In October 2022, Ravi Kumar Chermala, Kerry’s former Quality Assurance Director, pled guilty to three misdemeanor counts of introducing adulterated food into Interstate Commerce.

Kerry Inc. released a statement on February 3, 2023, in which the company regretted “…the unacceptable practices and failures that occurred at Gridley.”

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On the Q-T

The FDA’s investigation into this Salmonella outbreak–and the subsequent actions taken against the manufacturer–have been surrounded by a veil of silence from the beginning.

Honey Smacks cereal was manufactured by Kerry Inc. under a third-party contract with the Kellogg Company. At the time of the initial investigation, the FDA declined to reveal the name of the manufacturer it believed to be responsible for the Salmonella outbreak.

It was only after the CDC had declared the outbreak to be over that the FDA revealed the name of the manufacturer.

The FDA also declined to identify the Salmonella serotype it had discovered during the inspection of Kerry’s manufacturing facility and declined to reveal whether the strain it found was a genetic match to the strain recovered from outbreak victims.

In July 2018, Kerry initiated a recall of 82 tons of Soy Honey Cluster. Two days later, General Mills recalled six production batches of Cheerios Protein Oats and Honey cereal. In both cases, the potential for Salmonella contamination was given as the reason for the recall. Yet, no public notice was posted on the FDA website in either case.

What next?

The next step in this process will be for the Court to decide whether or not to accept the plea agreement.

The case has been assigned to U.S. District Court Judge James E. Shadid and Magistrate Judge Jonathan E. Hawley in Peoria, Illinois, and a sentencing date of March 14, 2023, has been set.

Information regarding upcoming court hearings or other significant developments in the case will be posted on the DOJ’s Information for Victims in Large Cases website.


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Chapter 6. Birth of a Pathogen

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FDA, CDC investigating Salmonella outbreak linked to sprouts

The US Food and Drug Administration (FDA), the US Centers for Disease Control and Prevention (CDC) and their state and local partners are investigating a three-state outbreak of Salmonella Typhimurium infections.

To date, the outbreak has sickened fifteen people in Nebraska (8), South Dakota (6), and Oklahoma (1), according to information provided by the CDC. Two people have been hospitalized.

The Nebraska Department of Health and Human Services has reported sixteen illnesses among individuals who consumed SunSprouts alfalfa sprouts between December 4–13. Eight of these have been confirmed genetically to be part of this outbreak. Results are pending on seven other cases.

Tracing the source

Epidemiological evidence collected by the CDC and its state partners identified alfalfa sprouts as a likely source of this outbreak.

Two outbreak victims specifically reported having purchased SunSprouts alfalfa sprouts at their local grocery stores. Others reported having consumed alfalfa sprouts at local restaurants.

A traceback investigation carried out by the FDA identified SunSprouts brand alfalfa sprouts grown by CW Sprouts Inc., doing business as (DBA) SunSprout Enterprises of Fremont, NE as the probable source of the outbreak.

The company has recalled four batches of alfalfa sprouts, identified as Lots ##4211, 5211, 3212, and 4212.

The recalled SunSprouts brand alfalfa sprouts were packaged in 4-ounce clamshells and 2.5 lb packages with best sold by dates between 12/10/2022 and 1/7/2023. The sprouts were supplied directly to restaurants and grocery stores in Nebraska, Kansas, and Iowa.

Inspection history

According to the FDA’s Inspection Database, CW Sprouts, Inc. has been inspected on at least seven occasions since 2009. Although some of its earlier inspections were classified “Voluntary Action Indicated,” there are no posted citations listed for the past ten years.

The most recent FDA inspection was completed in August 2021.

What you need to know

Consumers, restaurants, and retailers

  • Do not eat, sell, or serve recalled SunSprouts brand alfalfa sprouts.
  • Check your refrigerators for recalled SunSprouts brand alfalfa sprouts with best by dates between 12/10/2022 and 1/7/2023, and discard these items.
  • If you purchased or used recalled alfalfa sprouts, use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with these products, to reduce the risk of cross contamination.
  • If you or someone in your household ate SunSprouts alfalfa sprouts and have symptoms of salmonellosis, contact your healthcare provider.

Suppliers and Distributors

  • Do not use, ship or sell recalled alfalfa sprouts grown by SunSprout Enterprises.
  • Do not use any comingled and potentially cross-contaminated product if there has been potential cross-contamination or mixing of recalled alfalfa sprouts with products from other sources, and use extra vigilance in cleaning any surfaces and storage areas that may have come into contact with recalled alfalfa sprouts.

TAINTED formats 3
“Reads like a true crime novel” – Food Safety News

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations? Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Chapter 6. Birth of a Pathogen

TAINTED is available in digital format from all major on-line retailers. Press the button to go directly to your preferred digital bookstore.