It is time to rebuild the US food safety system

Several weeks ago, food safety advocate Bill Marler launched his campaign to “Get the ‘F’ out of the FDA.”

Marler proposed that Congress split the Food and Drug Administration into two separate agencies—one with responsibility for food safety and human nutrition, and the other for drugs, cosmetics and medical devices.

While I agree with the need for a separate agency to oversee food safety and human nutrition, I believe Marler’s proposal does not go far enough.

It is time to consolidate all food safety activities at the federal level under a single umbrella.

Here’s why.

Split jurisdiction

At present, responsibility for overseeing food safety is split between two main federal agencies: the FDA and the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA).

The USDA is responsible for the safety of meat and poultry, catfish, and egg products.

The FDA is responsible for the safety of all food products that do not contain meat or poultry, for intact eggs, and for all fish other than catfish.

This division of responsibility by commodity has led to some strange and confusing situations.

  • canned foods containing meat or poultry come under FSIS jurisdiction, while all other canned foods are FDA-regulated.
  • pizzas containing more than 2% meat are the responsibility of FSIS; less than 2% meat, and the FDA takes over.
  • open-faced sandwiches containing meat are overseed by FSIS; closed sandwiches are the responsibility of the FDA, whether or not meat is present.

These arbitrary distinctions mean that many food processing plants must answer to two separate federal agencies.

Conflict of interest

The USDA operates under a double mandate.

On the one hand, it is responsible for certifying that the food products under its jurisdiction are safe for human consumption.

On the other hand, the USDA also is charged with promoting US agricultural products both domestically and to overseas markets.

This is akin to having the quality assurance department of a food company report to the head of the marketing department.

We have seen the consequences of this conflict most recently in the FSIS draft proposal to allow as much as one Salmonella per gram of chicken in raw, breaded stuffed chicken products. 

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An immodest proposal

It is time to demolish the current ineffective, wasteful, and conflicted system and build a new one, centered on a new Food Safety and Nutrition Agency (FSNA) with a seat at the Cabinet table.

The FSNA would take over all of the food safety and nutrition program activities currently performed by the FDA. In addition, all responsibility for meat, poultry, egg products and catfish would fall under the FSNA umbrella.

The USDA would retain responsiblity for certifying the fitness of livestock for slaughter and certifying the fitness of their meat for human consumption.

At the moment meat or poultry leaves the slaughterhouse, jurisdiction would shift to the FSNA.

This approach would have the benefit of eliminating the conflict of interest inherent in the USDA’s double mandate. It would also unscramble the arbitrary and confusing overlap of jurisdictions between the FDA and the FSIS.

The consolidation of all food safety responsibilities within a single, independent agency is not a new idea.

The Canadian Food Inspection Agency (CFIA) was created in 1997 by consolidating into a single agency the food safety components of the Health Protection Branch (then the Canadian equivalent to the FDA), the Department of Agriculture, and the Department of Fisheries and Oceans.

Other countries, including the United Kingdom, Australia, and New Zealand have followed a similar path.

The bottom line

Congress created the current dysfunctional structure over a span of many decades. 

Therefore, it is up to Congress to deconstruct this broken system and build a new one that will work to the benefit of the public it has been elected to represent.


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

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Chapter 6. Birth of a Pathogen

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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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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.

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.


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.