Earlier this month the FDA released drafts of two highly anticipated food-safety rules. The agency has billed the proposed regulations as key tools for implementing the Food Safety Modernization Act (FSMA), the biggest FDA food-safety update in more than seven decades, which President Obama signed into law in January 2011.
The new rules would cost about half a billion dollars per year. The cost of FSMA will be borne by farmers and food producers of all sizes. The FDA estimates the FSMA will cost America’s small farms about $13,000 each per year. Larger farms—much more capable of bearing the costs—will be out about $30,000 per year. Other food producers are likely to face varying fees.
But will the proposed rules make America’s food supply—already quite safe and getting safer thanks to conscientious farmers, producers, and sellers of all sizes, vigilant watchdog groups, and eagle-eyed food-safety lawyers—any safer?
Before its passage, the FSMA had its predictable supporters in big business, academia, public health, the media, and government.
Another camp—one in which I was a charter member—argued against adopting the rules because they were likely to be costly and ineffective.
For examaple, in a Northeastern University Law Journal article published last year, “The Food Safety Fallacy,” I argued that the FSMA would increase the FDA’s power and budget but questioned whether the new law would have any impact on food safety.
Now that I've seen the key rules the agency has proposed to implement the FSMA, the facts appear to support my contention. How can I be so confident?
In pushing for passage of the law, the FDA and its supporters billed the law as a necessary solution to a problem of great magnitude.
Indeed, some 48 million Americans suffer from some form of foodborne illness each year—a figure the FDA cites at several of its FSMA web pages.
The agency claims the FSMA will “better protect public health by strengthening the food safety system” and helping to eliminate the “largely preventable” problem of foodborne illnesses.
But if we can largely prevent foodborne illness, we won’t have the new FSMA regulations to thank. In truth, the law’s real impact on food safety will be minimal.
The FSMA would permit the FDA to hire about 2,000 new food-safety inspectors in order to increase the frequency of food-safety inspections. Specifically, the proposed rules would require that “[a]ll high-risk domestic facilities must be inspected within five years of enactment and no less than every three years, thereafter.” Given that the FSMA rules are just now open to public comment and won’t be final for another year or two, this translates into a likely total of exactly two inspections of what the FDA refers to as the most “high-risk domestic facilities” over the next decade.
How’s that for impact?
Even if these inspections were to take place more than once in a blue moon, just how effective at preventing foodborne illness are FDA inspections? Not very.
The Center for Science in the Public Interest, for example, notes that FDA food safety inspections dropped by 47 percent between 2003 and 2006. During that same period, according to CDC data, rates of infection from bacteria like listeria were flat, and below traditional averages. This reflects what the CDC has reported—that despite the misconception that cases of foodborne illnesses are mushrooming, there has been a general "downward trend in foodborne infections."
That's no thanks to the FDA.
“Even when it does uncover health violations at food-processing plants,” wrote Barry Estabrook in Mother Jones in November, “the FDA takes enforcement action in only about half of the cases and almost never imposes fines.
In other words, foodborne illness cases have been decreasing without the FSMA, fewer FDA inspections over a period of several years did not translate into any detectable difference in cases of foodborne illness, and even FDA inspections that uncover violations rarely translate into perceptible agency action.
But if the impact of the proposed FSMA rules seems scant in light of these facts, consider the utterly feeble effect these rules would have on the 48 million cases of foodborne illness under the FDA’s own best-case scenario: A four-percent reduction in cases of foodborne illness.
“The new rules could prevent nearly two million illnesses annually, according to the FDA,” wrote the Philadelphia Inquirer in an editorial supporting adoption of the proposed rules. Indeed, the data estimates come straight from the FDA.
In other words, the proposed rules—if implemented to absolute perfection—would only reduce incidences of foodborne illness from 48,000,000 a year to 46,000,000 a year.
Remember, this is the same agency that claims its FSMA is a key tool to help eliminate the “largely preventable” problem of foodborne illnesses.
Critics of my argument might contend that these are just the first of several regulations the FDA will propose in order to implement the FSMA.
That’s true. But while there are still three "FSMA Provisions in the Works," they appear to be even less impactful than the expensive and pathetic rules proposed this month. Two rules “in the works” apply solely to imported foods—which are responsible for just a tiny percentage of foodborne illness cases. Another would "enhance" the "capacities" of foreign and domestic food-safety agencies at the federal, state, and local levels—which is agency-speak for things like training and technical assistance, white papers, guidance documents, conferences, and the like.
So anyone waiting for future FSMA rules to provide more bang for their buck is likely to be even more disappointed with the next set of proposed rules.
"I'm really not confident—doing the math, based on the FDA's figures,” I said in a television appearance to discuss the rules last week, “that there's going to be the sort of impact that the FDA's promising.”
That was last week. The more I learn about and reflect on the proposed regulations—which number more than 1,000 pages in length—the more I want Congress and the FDA to stop trying to do as much as possible in the area of food safety. Rather, I want the agency—which can by its own most optimistic estimates achieve very little, and at great cost—to focus on doing (and wasting) as little as necessary.