This article was originally published in Reason on January 19. 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. Outrageous. 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.

  • RoyCosta

    What is pathetic is that the best our society can do is fund a public health agency at a rate that makes in ineffectual. I see abuse of basic sanitation in facility after facility. These abuses can only be stopped when there is a strong deterrent. Our industry led prevention programs only go so far. It is very clear that unless there are severe penalties and effective enforcement the worst of the industry will continue to operate business as usual.
    It’s unfortunate that  the 90% of the operators who operate with regard for public health must bear the burden of the 10% that disregard it, but almost all of the major outbreaks in the last few years, some of which I have personally investigated, would have been stopped by a diligent FDA inspection. To say we do not need to fix this system is incredibly naïve.

    • Oginikwe

       Or purposefully obtuse.

  • You write

    “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?”

    And then you note that there are an estimated 48 million foodborne illness incidents a year. Can you note see that the two statements contradict each other? If the producers and farmers are doing a bang up job, how do you account for 48 million illnesses a year?
    And if the two million illnesses prevented each year are among the worst illnesses–the ones where lives are threatened, or permanent harm is done–than I would count the reduction to be worthwhile. You’re focusing on numbers, not types of illnesses or severity. My understanding of these rules is they would help reduce some of the more serious outbreaks. 

    You also write

    “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.”
    You seem to be basing this on text taken out of context from Mother Jones. In addition, you make a statement that the number of foodborne illnesses has been decreasing, but that same Mother Jones article states that–with the sole exception of E.coli–the number of foodborne illnesses has been rising. 

    Leaving aside all of these errors, what do you propose instead? You mention a nebulous reduction of waste, but you don’t provide a concrete proposal we can discuss. You seem more to be just complaining about the rules than providing sound argument against them. 

    If anything, I don’t think the new rules go far enough. Nor is there adequate funding for the FDA to do a really great job. But that doesn’t seem to be your plaint.  Or at, least that’s what I can deduce. To repeat, you’re not providing concrete alternatives that we can discuss. 

  • Linnekin latches onto to the FDA’s estimates to deride the costs of the new rules, but he conveniently dismisses the FDA’s estimates that show the new rules having a net economic benefit. 

    Linnekin also has the false impression that foodborne illnesses have been on a “downward trend” over the past decade. This myth was even trumpeted on the floor of the Senate during the debate on FSMA. What’s misleading is that practically all of the decline occurred almost two decades ago. Since then, foodborne illnesses have held a relatively steady overall level. Ironically, the CDC attributes what improvements have occurred to regulatory and surveillance practices that will be strengthened and expanded by FSMA throughout the food system. (See bottom of page:

    It’s anyone’s guess why Linnekin chooses to ignore the money that these new rules will save through less frequent and more limited recalls, better consumer confidence, and reduced health care costs. It’s also a bit of a mystery why he so casually brushes approximately 2 million incidences of illness, some serious or fatal, to the side like those people do not amount to much. My suspicion is that he spends more energy focusing on opposing government for the sake of opposition itself than he does on exploring ways to reduce illnesses, improve our economy, and strengthen our food system.

    • Oginikwe

       Your cdc link is 2010 data, too.  This was before people started getting sick and/or dying from eating cantaloupe and all of the other things that were contaminated in 2011 and 2012.

      According to Bloomberg, in 2011 47.8 million people contracted food-borne illnesses and of those, 127,839 were hospitalized and 3,037 died.

      Food Sickens Millions as Company-Paid Checks Find It
      Safe (Bloomberg) 10/11/2012:

      It shouldn’t be about money–it should be about not making our citizens sick and/or dead.

  • lsasman

    Mr. Lineken, I think you underestimate the power of a well run staff to intelligently enforce safety rules where producers may be tempted to cut corners.   

     You may be a superbly safe producer but  those who aren’t or don’t care  about safety can give you  and your industry a bad name.  You should welcome inspectors putting the pressure on the multi-violators who can undercut the prices of better run  producers.    Just the fact of inspections makes safety protocols more important to those who may ignore them.Fines are not as important in many industries as requirements that cause behavioral changes and keep business going. A very small percent of your industry are criminally intentioned –  but maybe 20+% will be come lax without the threat of inspection.

  • underthewybluesky

    How about bring back food safety (a k a Home Economics or Nutrition and Food Safety) into high school classrooms, as a mandatory program, so our future consumers can prepare food in a safe manner and stop being the bulk of the problem, but it’s much easier putting the burden on the farmer or the tax payer to fund yet another government project.  A half billion dollars would teach a lot of teenagers and young adults to safely prepare food, avoid food poisoning and take kitchen responsibly seriously,  image a shift of responsibility back to the consumer.

  • henry buehler

    This is not about making food safer, it is about exclusion from production of food by a device of those who produce safe food by those who dominate the market and repeatedly are forgiven for sickening the public

  • Many of these numbers and ‘facts’ are incorrect. For example, Linnekin states:  “Two rules…apply solely to imported foods — which are responsible for just a tiny percentage of foodborne illness cases.”
    Imports are responsible for half of food safety outbreaks. Sixty per cent of fruits and vegetables are imported, not to mention 80 per cent of fish and seafood. As others have commented, his mistakes don’t end there.

    I understand this is an opinion piece, but I am disappointed to see such erroneous data on Food Safety News, a site I otherwise like and respect.