End Flap: To Fix Food Safety, Fix the FDA First

July 27, 2022
A dysfunctional structure inhibits the agency’s ability to deal with vital issues.

A few years ago I had the pleasure of hearing Frank Yiannas, the FDA’s deputy commissioner for food policy and response, give a talk about food safety policy. Yiannas lived up to his reputation of being engaging and informative as he spoke about some of the biggest challenges facing the agency.

A part of his lecture I vividly remember is a photo of a feedlot in Yuma, Ariz., next to a vegetable field. The significance was that Yuma was the source of a major E. coli contamination of lettuce in 2018 that hospitalized 96 consumers and killed five. During the lecture, Yiannas made it clear that he didn’t consider it acceptable to put cattle feedlots, with their huge manure loads, next to crops that require irrigation.

But it’s four years and counting since the Yuma outbreak, and the FDA nor USDA have done virtually nothing about contaminated irrigation water. On April 8, Politico published a terrific investigative piece that goes a long way toward explaining why.

The FDA’s Food Failure talks about how food safety very much takes a back seat at the FDA to regulation of medicine and medical devices. A large part of this was due to the pandemic, which was of course the agency’s top priority in the past few years. But the Politico article outlined how the FDA’s food-safety oversight system is just about set up to fail.

Yiannas reports directly to the agency’s commissioner. That sounds good – except so does Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition. That leaves no clear chain of command, a situation exacerbated because, as the Politico article reports, the two of them don’t work together well. They have different approaches, with Yiannas having a bias for action and Mayne more fond of building consensus.

This setup has led to a situation described this way in the article: “Current and former officials and industry professionals used terms like ‘ridiculous,’ ‘impossible,’ ‘broken,’ ‘byzantine’ and ‘a joke’ to describe the state of food regulation at FDA.”

This dysfunction goes a long way toward explaining why there have been no regulations about irrigation water contamination since the Yuma outbreak — indeed, since they were promised in the Food Safety Modernization Act, which was passed 11 years ago. It accounts for the agency’s inaction in matters large and small, ranging from safe levels of heavy metals in baby food to deciding that French dressing didn’t need its own standard of identity — which took 22 years.

Lately, we’ve seen the consequences of this clunky approach in one of the most vexing, persistent problems to plague the food industry in recent years: the baby formula shortage.

As you’re doubtlessly aware, an Abbott Laboratories baby formula plant shut down due to unsanitary conditions, interrupting the production of formula to the point where out-of-stocks reached ridiculous proportions. As the situation worsened, exasperation grew over the slowness of the FDA’s response. It received a whistleblower’s report about the plant in October; it took two months to interview him, another month to inspect the plant, and another two weeks to get Abbott to recall the product and shutter the plant.

We can debate whether the FDA should have had the authority to shut down the plant on its own, but that’s not the point. The agency doesn’t seem to be able to exercise the authority it does have. A revamp, with a clarified mission and lines of authority, is a necessary first step. Before the FDA can protect the rest of us from food poisoning, it needs to protect itself from paralysis.

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