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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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.

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Food Safety Administration: A too-modest proposal

Senator Richard Durbin (D-IL) and Representative Rosa DeLauro (D-CT) have proposed bicameral legislation to split the US Food and Drug Administration (FDA) into two separate entities: the Food Safety Administration (FSA) and the Federal Drug Administration.

The new Food Safety Administration would remain a part of the US Department of Health and Human Services and would be led by a food safety expert whose appointment would require Senate confirmation.

The proposed restructuring of the FDA came in response to agency shortcomings revealed during the recent Abbott Nutrition infant formula recalls and investigations.

Divide and conquer

While the intentions of Senator Durbin and Congresswoman DeLauro are to be lauded, I believe their proposed solution does not address a major underlying flaw in the US food safety regulatory system.

I am referring to the divided and overlapping jurisdictions of the current FDA and the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture.

As now constituted, the FDA is responsible for ensuring the safety of approximately 80% of the US food supply. The FSIS oversees most of the balance, including meat, poultry, eggs and siluriformes (catfish and other related species).

This split jurisdiction has led to some strange and arbitrary divisions of authority. For example, the USDA oversees inspection of open-faced sandwiches containing meat or poultry, while the FDA is responsible for all other open-faced sandwiches as well as for all closed-face sandwiches, regardless of the filling.

Pizzas containing more than 2% meat are regulated by the FSIS; other pizzas come under the purview of the FDA.

As I wrote in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, “[a] fragmented inspection system is expensive, inefficient and unfair to the industry it regulates.”

In addition to the jurisdictional jigsaw puzzle, the FSIS is in a potential conflict of interest vis-à-vis other agencies within the USDA that are responsible for marketing US food commodities domestically and around the world.

Show me the money

The combined discretionary food safety budget allocated to FSIS and the current FDA for 2022 is $2.766 billion.

The FDA’s share of this budget is $1.6 billion, or ~58% of the total amount.

Yet, the FDA is responsible for regulating ~80% of the food supply. The Durbin/DeLauro proposal does nothing to address the funding imbalance between the two principal federal food safety agencies.

In 1998, a joint committee of food safety experts within the US Institute of Medicine and the National Research Council recommended that the US consolidate food safety into a “single, unified agency headed by a single administrator.“

Several US trading partners have done just that.

Canada, the United Kingdom, Ireland, Australia, New Zealand and Denmark, to name just a few, have successfully consolidated their food safety programs. In doing so, these countries have reduced duplication of efforts, streamlined jurisdictions, and removed the appearance of a conflict of interest between agricultural marketing and food safety.

The solution

The United States should have taken the advice of its own experts decades ago.

Representative DeLauro and Senator Durbin, the US food safety system is badly broken. What you are proposing is to apply a Band-Aid when what is needed is an organ transplant.

Instead of splitting the current FDA into two separate components, you should be proposing a single, unified, stronger Food Safety Administration. One with enough muscle to claim a seat at the cabinet table.

It’s time to “go big or go home.”

Learn more about a variety of food safety issues in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.