FDA

The FDA's Pathetic Food Safety Proposal

Federal regulators want to impose costly new rules that won't make our food any safer.

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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.

NEXT: White House Staff No Longer So Thrilled With Petition Site

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  1. 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.

    What are the costs? Fees for certifications? Or money for equipment upgrades? Or additional staffing or contractors dedicated to disinfecting facilities? I smell a stimulating multiplier effect.

    I would argue Americans need to be exposed to more foodborne pathogens. Cull the herd in the short run, and build up tolerances for humanity’s future. My dog can eat things he’s killed weeks before and left partially buried and not have an adverse effect. That’s where we need to be.

    1. My dog can eat things he’s killed weeks before and left partially buried and not have an adverse effect. That’s where we need to be.

      If there’s anything the FDA should be enforcing, it’s this. I’d start with the restaurants, mandating, for instance, that all chicken dishes be prepared rare. Local health inspectors aren’t enough, this needs to come form the feds. Like Tom Daschle once wisely remarked, “you can’t professionalize unless your federalize.” Plus, think how all that new federal hiring would really jump-start the economy.

      1. You should have mentioned that the ” you can’t professionalize unless your federalize.” quote was made in reference to the TSA. A quick google search for TSA blunders will reveal very long list of examples of the TSA’s bone crushing stupidity, incompetence and abuses.

        Clearly the word professionalize doesnt mean what Tom thinks it means.

        1. You should have mentioned that the “you can’t professionalize unless your federalize.” quote was made in reference to the TSA.

          I know, I remember hearing him say it back in 2001, when the Senate voted 100-0 to federalize airport security.

          A quick google search for TSA blunders will reveal very long list of examples of the TSA’s bone crushing stupidity, incompetence and abuses.

          Eggs, omelets. Maybe it’s time for the FDA to be given the same sort of broad powers the TSA enjoys. This whole “go it alone” attitude toward food safety needs to be nipped in the bud. The era of rugged individualism with regard to dietary choices is a relic of the past.

          1. No matter how hard I try I just cant make myself be interested in what other people are eating. Or doing. Or how much money they have. Or….well you get the idea.

            “The era of rugged individualism with regard to dietary choices is a relic of the past.” . Some people actually think this.

            1. No matter how hard I try I just cant make myself be interested in what other people are eating. Or doing. Or how much money they have. Or….well you get the idea.

              It’s a sad irony that so much of your wealth and mine goes to support the livelihoods of people whose sole purpose in life is to take a keen interest in these things.

    2. Actually there’s some interesting research showing that this is exactly what’s wrong with us. Not enough hormetic stress, especially from parasites. This is one reason we’ve not evolved a way to shed iron. Blood loss through parasites and injuries usually did the trick for us.

      The success (and need for) fecal transplants to repopulate gut bacteria also seems to be a modern problem.

      1. I blame the ever-present hand sanitizer.

        1. That shit is evil. And try explaining that to it’s users. They look at you like you have a third eye in the middle of your forehead.

    3. 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…

      But, but the media told me we have a foodborne illness…

      EPIDEMIK!!!!

      1. Methinks we have a “media” EPIDEMIC!!!!

  2. Government doing little at great cost. Nothing new here.

    There is the added benefit of adding 2000 more unionized government workers to the voter rolls. I mean payroll.

    1. Let’s see: 2000 inspectors at 100K a year (minimum) is 200 million bucks. But if you include their benefits and new offices, equipment, travel, etc. you are easily talking 1 billion extra dollars a year.

  3. the [FDA]?which can by its own most optimistic estimates achieve very little, and at great cost

    Every time I see the disclaimer “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” I wonder “What *does* the FDA do?”

    1. “I wonder “What *does* the FDA do?””

      http://www.naturalnews.com/033…..eline.html

      1. Well, yes; and don’t forget dragging feet on approving drugs while people die. I meant “What does the FDA do that is truly beneficial?”

        “If they have saved just one life ….” 8-(

        1. “If they have saved just one life ….” 8-(

          Unfortunately, they had to kills hundreds, if not thousands, of people for each life saved while they drag their feet on medical treatments.

      2. They definitely need 2,000 more inspectors. They are busy enough now. Do the inspectors get to carry guns and make raids too?

    2. “What *does* the FDA do?”

      Old exposee. (NSFW)

  4. OT: PA Kindergartner suspended for threatening to shoot classmate with a pink soap-bubble gun:

    http://news.yahoo.com/pa-kinde…..57936.html

    1. the girl didn’t even have the bubble gun with her

      It’d be great if every parent showed up at the next school board meeting with a bubble gun.

      Un-bubbling-believable.

    2. The school system has gone full retard since Sandy Hook.

      They have shown their utter incompetence as teachers with their innate inability to understand the short bus level math involved in the calculating the chances of a school shooting actually happening. I wouldn’t be surprised if their draconian backlash against all things gun, from finger guns to bubble guns, that they’re actually creating future school shooters.

      1. The system was retarded long before Sandy Hook.

        http://www.abcactionnews.com/d…..rn-reports

      2. The system was retarded long before Sandy Hook.

        http://www.abcactionnews.com/d…..rn-reports

      3. Here is the email for the elementary school’s principal.

        nesticos@mca.k12.pa.us

        Source

        Drop her a line and tell her what a laughingstock she is.

    3. Her family has hired an attorney to fight the punishment, which initially was 10 days but was reduced to two.

      Why???

    4. I doubt I will ever have rugrats of my own. But if I do, they are never going within 100 yards of a public school.

  5. The cost of FSMA will be borne by farmers and food producers of all sizes.

    Baylen, Baylen, Baylen.

    Surely you know the cost will be borne by consumers in the form of higher prices.

    1. Some not insignificant number of small farmers will go under while the FDA enjoys an expanded fiefdom at the consumer’s expense.

  6. Sounds like a pretty solid plan to me dude. Wow.

    http://www.NewzAnon.tk

    1. That’s why it’s good movie material. It’s hard to make a movie about standard operating procedure.

  7. OT – my wife has the tv on watching the ‘news’. I have been overhearing this the whole morning while sitting here reading/snarking.
    So far it has been lengthy discussions about some guy that rides a bicycle who took some drugs and got busted, some kid that plays football who got tricked into jerking off online with another dude, and on and on about other non-important tripe.

    The country is 16+ trillion dollars in debt. The president wants unchecked power of the purse and for congress to be irrelevant. He wants to disarm law abiding citizens. Congress and the president are actively wiping their ass with our constitution. Our economy is shit and our freedoms are being attacked and all they want to talk about is oprah? wtf?

    1. As bad as things are, I’m not really sure I’d like the average person to be informed. They’d probably just want the government to “do something.”

      1. Good point.

        The flip side of that is that much of our troubles stem from people being ill informed.

        1. It is the age of the low information voter.

          1. Our forebears elected FDR four times. There’s no such thing as a nation of informed voters; the leviathan is too massive for anyone to grasp even if they had the brains, and most don’t make an effort.

    2. wtf?

      in Rome, it was known as bread and circuses. As long as people had enough to eat and they were kept entertained, the ruling class could do damn near anything.

      Many of the items you cite are in the same vein – distractions to keep people from asking why the serious shit is going ignored.

      1. Remain calm. All is well.

  8. So they are having a “National Day of Service” for the inauguration today. As part of it they have all of theses signs with Obama’s profile waiving with the word “UNITE” underneath it. It is creepy even for this crew. These people really are fascist.

    1. didn’t they try to make 9/11 in his first year into a service day? It’s all about conscripting people into voluntary servitude with these fuckers while couching it as something tasty.

    2. I remember the ‘hope’ poster from the first campaign. The first time I saw it I thought it was a parody of his campaign trying to paint him as a fascist. I was really stunned to learn that it was in fact their official poster.

      Yes, they are what they appear to be. Fascists. Or as it was put yesterday compascists. Seventy five years ago we were putting bullets in fuckers like these.

      1. FDR and the New Deal were fascist too.

      2. I thought those posters were printed by the GOP to smear him as some sort of Soviet-style demagogue. When I found out they were real, I nearly shit. I remember going online and showing my wife comparisons between those posters and Soviet/Nazi/Fascist propaganda.

        1. This post describes what I thought and did exactly.

  9. OT: when Obama is sworn in today, will the testament fly out of Roberts’ hand when POTUS swears to follow the Constitution and follow the laws of the US. Or, will the wording be changed to reflect “laws that I think are okay but not ones I disagree with”?

    1. I’ll just leave this here:

      http://www.timeanddate.com/cou…..0&msg=Time left until Obama leaves office

      1. I wouldnt count on that being accurate. The left has already been openly calling for the constitution to be jettisoned entirely or for term limits to be done away with.

        This really is just an old fashioned cult of personality. I dont think they will willingly accept him leaving office. They just dont have the psychological make-up for it.

        1. What are they going to do, stage a coup sans military or popular support? Convince every Republican they’ve pissed off or humiliated to rescind the 22nd Amendment? It wouldn’t be the first time for them to call for something they can’t have.

          Me, I’m perfectly happy with my books, bullion, and bullets.

          1. They will drum up some kind of emergency/crisis/disaster that will necessitate his staying in.

            1. And yes, it will precipitate a rebellion.

              1. Ever since Obama was elected in 2008, I’ve told friends that 2012 will be our last election. I hope I’m wrong, but I fear I won’t be.

                1. Of course Obozo will leave office when his term is up. The forms will be followed. the same thing was said about Bush, and lo, and behold, we got a new, and improved Bush, aka, Obozo. They’ll find another one just like they found this one. There is no shortage of kings.

    2. It’s tomorrow.

    3. What would happen if he changed the oath on the fly and omitted that part?

      1. Is the official swearing in tomorrow going to be televised? He can say anything he wants.

  10. “I vow to preserve, protect, and defend the Constitution as I interpret it. I’m a constitutional scholar, you know.”

  11. How many hundreds of thousands of rounds of 9mm hollowpoint does this new set of rules authorize?

  12. 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.

    Actually, they will cost consumers about half a billion dollars a year.

  13. Mr. Linnekin seems to miss the point. The new regulations are not intended to improve food safety, they exist to further regulatory overreach; drive smaller producers out of business, thereby coddling bigger operators; and burdening taxpayers with support-for-life of more un-fireable busybodies.

    The long train of abuses and usurpations rolls on and the caboose is not in sight.

    1. “Weighing benefits against costs is the way most people make decisions ? and the way most businesses make decisions, if they want to stay in business. Only in government is any benefit, however small, considered to be worth any cost, however large.” ?Thomas Sowell

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  17. Most things about the FDA are pathetic and foolish. It’s become a self-propelled bureaucracy rife with backroom deals and corruption yet accountable only to itself.

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