[Editor’s note: This story originally was published by Real Clear Policy.]
By Richard Williams
Real Clear Policy
Facing accusations that (in the words of one senator) Food and Drug Administration errors “have led to outbreaks or critical shortages and individuals getting sick,” FDA Commissioner Dr. Robert Califf has admitted that its food safety program is “stressed” and needs reform, and that a “sub optimal” working environment also “needs to be reformed.” To solve these problems, the agency has taken some early steps and asked a closely related non-profit that it financially supports to come up with the answers.
The food safety process hasn’t just recently been broken — it’s been broken for decades. Dr. Califf’s acknowledgment, while overdue, is a step forward. How big a step will depend on how much the reforms embrace a wide range of innovations.
Much of the job is tasked to the Reagan-Udall Foundation. This is a 501(c)(3) organization set up by Congress in 2007 which struggled for funding until the FDA started giving them money. Given these close ties, it’s not clear how they’ll help break out of the mold. The FDA might also bring in people who are sharp critics of the food safety program, along with people who support the current structure (including agency people) to discuss what can be done and what’s likely to work.
They should start by looking at the food safety figures from the Centers for Disease Control that the FDA uses every year to request funding. In 2011, there were 48 million estimated cases of foodborne disease, 128,000 hospitalizations, and 3,000 deaths. In 2020, the same figures were still being cited.
The foundation has been asked to address FDA food program “structure, function, funding and leadership.” That’s good, if the thinking goes beyond tweaks. The structure and function are pretty much the same as they’ve been for 116 years.
Dr. Califf had it exactly right when he said, “the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain.” It’s only going to get more diverse and more complex. What worked in 1906 — a single agency trying to anticipate problems and treat them with simple regulation — may no longer work. Back then, there were fewer and filthier plants, and manufacturers were intentionally adding poisons to food to improve their looks or make them last longer. The solutions were obvious and fit the entire industry.
Today, we still have this kind of regulation, but more than ever, the FDA needs to focus on how the market can solve many food safety problems. For one thing, that’s how we get the marvelous inventions we enjoy. For another, one agency can’t possibly track everything going on in real time in an indescribably complex global food chain.
They have a good start by recognizing ways to trace food back to its sources using blockchain and sensor technologies. But there are many more technologies coming forward which — while exotic — may prove themselves safe when produced in laboratory conditions (using, for example, precision fermentation) instead of farms (i.e., pathogen swamps). It is, for example, better to produce new foods using genetic engineering instead of practices like bombarding seeds with radiation.
What’s likely to benefit consumers more: the confusing, easily ignored FDA Nutrition Facts Panel, or a watch that tracks what we eat along with personal characteristics and gives us personalized advice? What’s likely to produce safer food: FDA protocols that sick workers don’t always follow, or robots programmed to do the same thing over and over?
These new ideas should not require preclearance, be mandated, or be the subject of never-ending complex regulations. Some innovations will work in some situations and be improved over time, where others will fail.
In addition to waiting for the Reagan-Udall report, FDA has started a new program branded as “Smarter Food Safety.” A brand is fine for political campaigns, but we’re past that point. Next, they predicted success for new program: “Working together, we will bend the curve of foodborne illness in this country, using the right technology, the best data, and the most consistent oversight. Consumers deserve no less.”
Let’s hope so. Considering the many solutions that are out there for the diverse matrix of food production and consumption, the FDA needs to create a role that doesn’t revolve so much around one-size-fits all-regulations. Instead, reformers should focus on helping new technologies get into food production and consumption.
Richard Williams is a senior affiliated scholar with the Mercatus Center at George Mason University and former director for social sciences at the Food and Drug Administration’s Center for Food Safety and Applied Nutrition.
[Editor’s note: This story originally was published by Real Clear Policy.]
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