Industry Insider: “The FDA is mostly worthless”

by | Sep 15, 2010 | Headline News | 6 comments

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    Editor’s Note: The following is a response to our previous article The War on Food: Eggsactly What Is Going On Here? and has been generously contributed by Steven Woskow, Ph.D.

    I read with interest your article entitled The War on Food: Eggsactly What is Going On Here on on the recent Salmonella problem. I started a biotechnology company that develops microbiological based products for animal agriculture and we do a lot of business in the poultry industry. Our company (we sold the company in 2008 but it still exists) develops alternatives to antibiotics, growth hormones etc. for animal production. We do a substantial amount of business with smaller producers (mainly organic or free range producers) and large producers. Below is some information you may find interesting:

    The FDA is mostly worthless. As you correctly point out, they want more power to regulate but they can’t even enforce the current regulations. I have frequently worked with people at FDA so I am familiar with how they work. The political leaders at FDA are always attempting to increase the amount of regulatory control over agriculture producers and companies that support them. However, the people that do the actual work (inspectors etc) are swamped and can hardly keep up with the work load. They take an issue like this, which is fairly isolated, and instead of focusing on the few farms effected, claim they now need new powers and regulations that effect the entire industry (never let a crisis go to waste). The market is more efficient at doing this than the FDA can ever hope to be. The market will punish companies that are negligent – you are an example of that. Companies such as McDonald’s, Burger King etc. have more influence over the industry than the FDA. If McDonald’s were to come out tomorrow and say all their suppliers have to certify the eggs they purchase as salmonella free, it would happen almost overnight. They have done this before and they will do it again if consumers pressure them to do so.

    While you are correct in stating big agribusiness are willing partners with government, don’t underestimate other influences, mainly consumer groups, labor unions and what I like to call the “true believers”. The true believers permeate the FDA. These are people that believe it is their god-given mission in life to guard us from our own behavior. Many so-called consumer groups are anti-free market and unions of course have their own agenda. Not only that but there is inter-agency turf battles between FDA, USDA and HHS for regulatory control. For years FDA has not been satisfied with a regulatory scheme geared to inspection of the end product. Their goal is to regulate the production of food products via HAACP requirements. The industry is fighting this but it is like the Dutch Boy with his finger in the dike. The FDA’s ideal model is Europe.

    The statement by the FDA that they do not know what “caused” the contamination is bullshit. They may not know exactly where it occurred,but they know what caused it. Pathogens are always present (even in free-range or organic birds). Somewhere along the production line something was not cleaned properly or someone did not follow handling procedures. The FDA is supposed to inspect facilities for these types of violations.

    It is interesting that you mention free range type production. Though I am not an advocate that these methods should be adopted for large-scale food production, there are advantages based on sound biology and certainly in a truly free market economy people should have choices in purchasing food. My company develops products that help animals use their natural defense systems to prevent pathogen infection. The intestinal tract is technically outside the body and therefore exposed to the birds environment. It is also the first line of defense against pathogen invasion both physically and via the immune system. Naturally occurring gut bacteria are the animals first line of defense against pathogen infection. We also utilize immunological techniques to determine the effect of the gut bacteria on the immune response. The development of PCR (polymerase chain reaction) and other techniques have created a revolution in microbiology. Microbiologists can bypass traditional plating techniques and use DNA to identify and select unique bacterial strains from a large bacterial populations (such as the gut). We obtain intestinal tracts from birds that are showing symptoms of pathogen infection. We first isolate the pathogen(s) for screening. We also obtain intestinal tracts from healthy birds. The guts of the healthy birds are used to isolate unique bacterial strains utilizing new DNA techniques based on PCR. We screen thousands of naturally occurring bacteria for inhibitory activity against the pathogen(s). We also test the bacterial strains for specific immune reactions Products (feed products) are blended using combinations of these bacterial strains. The goal is to develop products that maintain the bird’s natural defense system. Because pathogens are not static but dynamic (they change), we continuously monitor flocks for changes in pathogen populations and when new pathogens arise, the procedure is repeated and a new product is formulated for the customer. So we are always a step ahead of the pathogens – unlike antibiotics which are now only used for treatment after the bird is infected. The bacteria we use in the products are approved by FDA so they do not require an approval process every time we change the formula. The only problem is we can not advertise that the product reduces a pathogen or prevents infection since that would be a drug claim (thank the FDA for that). We can though publish scientific papers. We could never do this in Europe because they require a lengthy registration process (up to 2 years costing millions of dollars) for feed products (not just drugs).

    We use this approach in all livestock species and it provides a biological reason why animals raised outside conventional production are healthier. In swine we have studied the difference between what we call “pigs grown on dirt” vs “pigs grown in a conventional facility”. Pigs grown on dirt (or chickens) develop a totally different gut micorflora and immune response. We compared the two populations and determined the microbiological and immunological differences between the two populations. It is a well known fact pigs grown on dirt are more resistant to pathogen infection. How an animal or man responds to a pathogen is not only a function of the presence of the pathogen, but it is also dependent on how the animal reacts to that pathogen. A classic example we use is one of our employees grew up on a dairy farm. He and another of our employees that grew up in the city went to visit the dairy. Unfortunately, they forgot to tell the city employee that they drink raw milk on the dairy. Of course the employee that grew up on the dairy had no problem, but the city employee got sick. This is a classic example of “pigs grown on dirt”. The employee from the dairy had a gut and immune system that had been exposed to raw milk – whereas, the employee from the city did not. It is one reason I believe (as do many microbiologists) that our current infatuation with sanitation, and eliminating every pathogen from our food/environment is killing us. We are losing our natural ability to fight off pathogens!

    Quote from The War on Food: Eggsactly What is Going On Here

    Small family farms, once these bills pass (and we assume they will, just like previous crisis legislation), will be annihilated as the government will force them to use only ‘approved’ seeds, feed, equipment and fertilizers. They will be mandated to follow specific regulatory procedures for production and distribution, for which they will pay additional fees. Eventually, the farmers will go out of business, in many cases losing their land to foreclosure. And, we suspect, that large farming corporations will quickly step in to snatch up their farms at significant discounts.

    We are already there. But, it is not really as bad as you think (yet). In fact, there has been a resurgence in family farms mainly because of the organic and local food movement. This has been a great development in agricultural which has saved family farms and the lifestyle that goes with them. I have faith in the American spirit – organic food producers tend to be very libertarian compared to conventional farmers. They are fighters and organic food is big business with some clout.

    I enjoyed you article.


    Steven Woskow received his B.S. from California State University Chico, Masters from Utah State University and Ph.D. from Iowa State University in Food Science and Nutrition. He is the co-founder of a Biotechnology company that developed microbiological based products for animal agriculture (alternatives to antibiotics and biological solutions for the treatment of animal waste). In 2008 the company was sold and now Dr. Woskow works as a private consultant. He is a native Californian and lives with his wife Susan, 2 horses and 4 dogs in Simi Valley CA.

    Also by Steven Woskow: The Art of the Steal


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      1. It all falls down when someone gets something like Ecoli 0157H7 or in my case Brucellosis. Some milk producer somewhere gave me that, live through that and tell me that it don’t matter.  To say that the industry will “regulate” themselves is crap. Oh, wait that is what was in the water they used to wash to lettuce that caused that outbreak. Pastuerization has saved millions of lives, there is nothing in your natural flora that can save you from listeria or Ecoli.

      2. In spite of FDA regulations in place to guard against Brucellosis, you still got sick.  So the answer must be more regulations – I don’t understand that thinking at all.  I don’t believe anywhere in the article I stated “it doesn’t matter” nor did I call for the end of all regulations.  Sorry to inform you, but the industry does regulate itself.  Consumers are the most powerful force for change under a free market system and companies do respond to consumer demands and this is more effective than government regulation  Self regulation also does not mean that companies are free to do what they want.  There are laws and people have the right to bring law suits against companies that are negligent.  Consumers also have the right to take their business somewhere else.  We have the means to punish companies without having the FDA involved in every stage of agriculture production or deciding what we should or should not eat .  Pasteurization has saved lives – I don’t believe anywhere in the article I advocated that milk should not be pasteurized.  However, I am willing to let people make there own choice.  You state, “nothing in your natural flora will save you from listeria or e. coli.”  Yet, not everyone exposed to these pathogens gets sick – generally, the people most effected are those unable to fight off the disease (young children, older people, people with Aids etc).  Why – because for most healthy people the bodies natural defense (the gut bacteria, immune system etc) is able to fight off a pathogen challenge.  This does not mean that people don’t or won’t get sick – they do under a regulated system and they will under a self regulated system also.  It would be correct to state that the bodies natural defense mechanisms do not guarantee that you will not get sick, but it is incorrect to state “there is nothing in your natural flora that can save you.”  If that were the case, we would not live very long.

      3. It was never determined how I got Brucellosis, and you are correct that regulation did not protect me, but some producer did not self regulate either. A  Minnesota farmer decided that he should not be required to pasteurize milk and eight people got E coli 0157h7. One was a child who developed HUS. Almost every food bourne outbreak that has occured can be traced back to negligent producer. If you are comfortable feeding your child unregulated food stuffs, that is your choice. Everyone can agree that government involvement is not always perfect but self regulation would be a disaaster.

      4. Mustardseed,
        Its not self regulation but consumer regulation, take your business elsewhere and tell your family and friends to do the same.  If others get sick from a product then they too, if smart enough, should take their business elsewhere.  Bad businesses going out of business due to consumers going elsewhere is the ultimate form of regulation.  More, importantly didn’t humans live with out a food and drug regulatory body for thousands of years?  The FDA was formed around 130 years after the founding of the conuntry?  The life span has increased but sanitation and good hygiene have more to do with that.  The problem with the FDA and other regulatory agencies is there main reason for existing, which is not stated, is to line the pockets of the policy setters by eliminating competition for the biggest companies and gain more power.  Those who make the big decisions and set policy don’t care about your health and what infections you get from milk or eggs or chicken etc….

      5. JG – you are correct.  self-regulation is a poor term.  Market forces, consumer pressure or market pressure would be much better terms to use.  Business has no incentive to self-regulate outside of consumer pressure (or market pressure).  A true free market will quickly punish companies that treat their customers poorly.

        johnnymustardseed – Having a bureaucracy such as FDA regulate food does not guarantee a safe food supply nor does an end to the FDA mean the industry is unregulated.  We have laws.  Using your example – if a producer sold you raw milk without your knowledge, that is fraud and you have every right to bring a law suite against them.  This is exactly what is happening with the egg recall - their is now a class action lawsuit against the egg producers and I guarantee they are more worried about a lawsuit than they are about the FDA.

        Also, their is nothing to stop us for example, passing laws that require pasteurization which would be enforced via our legal system.

        “If you are comfortable feeding your children unregulated foodstuffs, that is your choice” – exactly and you should have the choice to insist the milk you buy is pasteurized.

        JG – You might be interested in the comments made by the President of Neogen, which makes the only test kit currently available for SE.  “FDA regulation will help us achieve higher sales and profit.   Under new FDA regulations, producers will have to spell out how they will test for safety.  If they change their tests, they will have to refile all their information with FDA and that is a barrier to switching.”
        Who is the FDA protecting?

        johnnymustard seed & JG – Thank you for your thoughtful comments, they are greatly appreciated.

      6. Certainly man lived for thousands of years with out regulation, but they only lived to the age of 50. Federal law prohibits transport milk products across state line unless it is pasteurized. Nothing wrong with that.  Your theory that consumers will decide does nothing for that eight year old  girl with HUS. Her fate is sealed and the outcome is most often death. I would have loved to have a chance to sue however gave me Brucellosis and let them pay for the days spent in intensive care. Do you really think a small family farm can pay the medical bills of a outbreak in say 100 people who might come down with E Coli 0157H7? You might have realized I have strong feelings on this matter and I hope you understand why. I would love those two sick years of my life back.

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