Earlier this week, the Food and Drug Administration (FDA) announced a blueprint for improving the safety of the foods the agency regulates. The approach, dubbed the “New Era of Smarter Food Safety,” while light on details, “outlines the approach FDA will take over the next decade to usher in the New Era of Smarter Food Safety.”
Though the blueprint is new, plans for it have been underway for more than a year. In an April 2019 statement, then-acting FDA commissioner Ned Sharpless teased a “new era of smarter food safety that is people-led, FSMA-based, and technology-enabled!“
FSMA is the acronym for the Food Safety Modernization Act. That law, passed early in 2011, was—at least according to Congress, the FDA, many large food businesses, and food-safety activists—a bold move that would prevent many cases of foodborne illnesses from ever happening once the law took effect.
“FSMA has been a centerpiece of our work to help ensure food safety and prevent foodborne illnesses through the use of science and risk-based standards,” current FDA commissioner Stephen Hahn said in a statement announcing the agency’s plans this week. “The blueprint we release today represents the next stage in this process[.]”
That blueprint describes vague efforts to “leverage[e] technology and other tools to create a safer and more digital, traceable food system,” which suggests the agency will ramp up its own use of technology to limit the spread of foodborne illnesses and may require food businesses to do the same.
Response to the blueprint has been muted this week.
“Now that the blueprint document is out, it is clear that parts of the project are not yet clear,” Food Safety News reported this week after reviewing the document.
While details are lacking, we can look outside the FDA’s own words to learn more about the blueprint’s proposed approach.
In 2018, Frank Yiannas, then Walmart’s top food-safety official, published an excellent article in MIT’s Innovations, “A New Era of Food Transparency Powered by Blockchain,” that features some of the same details as this week’s FDA blueprint, including using blockchain to improve food traceability. In the “new era” article, Yiannas—who’s since left Walmart and now, not coincidentally, heads the FDA’s food-policy work—describes how using blockchain reduced the amount of time it took Walmart to trace the origins of a single package of sliced mangoes back to the farm on which the mangoes were grown, from more than 162 hours to 2.2 seconds. That change suggests how technology can dramatically improve the ability to trace and halt the sources of foodborne illness outbreaks rapidly and effectively.
While that’s really great for Walmart and consumers—and bad for foodborne illness—I have a couple of concerns about the approach. And it turns out my concerns are shared by some commenters who responded last year when the FDA invited the public to comment on an even rougher sketch of the “new era” plan.
First, how might the “new era” impact small food businesses, particularly small farmers, if the agency’s focus on using technology such as blockchain evolves into rules requiring some or even all businesses to do the same? One commenter wondered just that.
“While I love the idea of utilizing new technology, such as blockchain, for increased traceability and transparency, this type of technology is not readily available to all sectors of the food chain,” wrote commenter Barbara Williams, who wondered if Amish farmers, for example, won’t invest in the technology, will they find the FDA has determined “that their product cannot be used?”
Second, if FSMA’s proactive stance was supposed to prevent cases of foodborne illness and reduce the need to react to those cases, why does it appear the FDA is reversing course? After all, supporters invariably claimed FSMA was the most sweeping reform of U.S. food safety laws in nearly 80 years. At FSMA’s heart was this clear agency paradigm shift: “transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it.”
“While we believe that enhancing trace[ability] capabilities is important, it seems that the agency is placing emphasis on reacting to failures in the food safety system,” the group wrote. “FSMA was enacted to turn FDA’s food safety program from one that reacted to foodborne illness outbreaks to one that prevented foodborne illness.”
That’s exactly what FSMA was supposed to accomplish. But the Centers for Disease Control estimates of foodborne illness cases have remained virtually unchanged since FSMA became law.
“The incidence of most infections transmitted commonly through food has not declined for many years,” the agency reported in May, while also noting that “targets for reducing foodborne illness will not be met” by the end of this year.
That doesn’t surprise me at all. As I’ve noted many, many times, the FDA itself predicted FSMA would have only the tiniest impact on rates of foodborne illness. Just look at the agency’s own estimates of the impact of the two key FSMA rules on cases of foodborne illness. Even if implemented to absolute perfection—as I detail in my book, Biting the Hands that Feed Us: How Fewer, Smarter Laws Would Make Our Food System More Sustainable— the FDA’s own best-case scenario is that those rules would spur a 2.6% reduction in total annual foodborne illness cases.
So it’s no surprise at all that CDC data suggest FSMA has had little or no impact on cases of foodborne illness. And it’s no surprise that the FDA appears to be sweeping that fact under the rug, here moving on to a “new era of the next shiny object.”
None of this is to say that the FDA’s new blueprint—something like ramping up the use of technology to improve traceability and reduce the spread and impact of future cases of foodborne illness—is a bad one. It’s not. In fact, one successful federal government effort to improve food safety already relies on a similar approach. The CDC-led PulseNet program, which I wrote about in a 2016 column, is an exceptional tool for tracing, tracking, and halting foodborne illness outbreaks. The program, now more than 20 years old, “prevents more than 275,000 cases of foodborne illness each year,” I wrote. “And it does so with a tiny budget.”
Four years ago, in that piece on PulseNet, I asked Robert Scharff, a professor at Ohio State University whose study on the PulseNet network formed the basis for my column, about how governments choose to allocate (or, as the case may be, misallocate) resources in the fight against foodborne illness.
“There is too much emphasis in government on regulation (often promulgated with a weak scientific basis) and too little on helping market[s] work better through the provision of information,” Scharff told me.
It’s not clear yet what exactly the FDA means when it refers to a “New Era of Smarter Food Safety.” And there’s no suggestion the FDA wants to stop enforcing FSMA. But it certainly seems like this week’s blueprint suggests a much more promising agency approach than FSMA (even if the FDA claims the New Era of Smarter Food Safety is meant to work with or as part of FSMA).
FSMA hasn’t made our food system demonstrably safer. With its New Era of Smarter Food Safety, the FDA appears finally to be acknowledging that fact and maybe—just maybe—proposing something better in its place.