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The Failure Of The FDA
And The Nature Of Information

At the core of the behavior of the FDA on food safety is a misunderstanding of the kind of information that has value.

Various kinds of information cross the desks of FDA officials every day: This person got sick, this test came back positive. Sometimes, this kind of information is tied to a company or a commodity and, when it is, the executives at FDA feel a need to act.

Some action is certainly prudent. For example, if a test comes back positive, FDA should certainly want to see other tests around that product.

Despite our present problems, we are a phenomenally rich country, and if we want to force companies that have a positive test result to recall all the product between their last negative or thorough sanitation and today, it won’t do too much harm. Adopting a clear policy would, in fact, encourage companies to maintain clear breaks on their production lines so as to minimize the extent of any recalls.

But the banning of production by a company as we saw with the Honduran cantaloupes, or issuing recommendations not to consume products — which are defacto bans on whole industries as we saw with spinach, the tomato/chili pepper imbroglio and now with the pistachios — requires a different standard of proof.

We’ll leave aside for a moment the issue of whether the FDA ought to issue these broad recommendations not to consume at all — as opposed to simply informing people of the facts and letting them decide. For the moment let us just say this: If the FDA is going issue such recommendations, it ought to do so only when doing so enhances public health.

But, you may ask, isn’t that obvious? Isn’t every such FDA action enhancing public health? The answer is no, and the reason has to do with the usefulness of different classifications of information.

The thing to remember is that pathogens are not uncommon in the food supply. The CDC’s best estimate is that there are 76 million cases of foodborne illness in the United States each year. Since not every exposure to a pathogen results in an illness, there must be many more pathogens than this in the food supply.

We pointed out during the import alert against Agropecuaria Montelibano that the FDA’s position made no sense. Even if there had been salmonella on the company’s melons at one time, there was no reason to think that the product from this producer — an audited and widely praised producer — was more dangerous than unaudited product from a farm next door.

Equally, because pathogens are common in the food supply, the issue is not whether some other bit of salmonella can be found in pistachios somewhere; it is whether the pistachios being banned are less safe than the alternatives people will eat.

In the case of the Agropecuaria Montelibano cantaloupes, the answer clearly was no. It is also not clear at all that the FDA is helping public health by destroying the pistachio industry.

The problem is that the FDA treats its knowledge of something as in and of itself significant and it is not.

If you need an analogy, think of two large kiddie pools, each filled with a 1,000 children from infants to six years old. Now imagine Dr. Acheson is swimming with a child in one of the kiddie pools, call it Pool A, and a little boy comes up and reports to him that his brother just urinated in the pool, a fact the brother confirms.

We can leave aside issues of safety for now and just assume people would prefer not to swim in urine. The question is: Would Dr Acheson be acting prudently if, as a result of this knowledge, he got out of the pool and went to swim in the other kiddie pool, pool B?

The answer is that no, Dr. Acheson would be behaving irrationally because he would be putting weight on evidence — the child told him that his brother had urinated in the pool — as opposed to putting weight on the facts themselves.

As any parent knows, in a kiddie pool of a thousand little kids, there is plenty of urination going on — whether one gets a report on it or not. In fact, there is no reason at all to think that there is more urination going in Pool A than in Pool B, so Dr. Acheson, determined to swim with his young ward, might as well stay and swim in Pool A.

This situation is analogous to all of FDA’s bans. The FDA acquires some piece of information that, in and of itself, simply means nothing. If we tested every leaf of spinach, every cantaloupe, every chili pepper and every pistachio nut produced every day, we would find some baseline level of pathogens in the food supply. So a particular positive test result is not shocking, nor indicative of any horror. It may simply reflect that baseline.

The real problem with the pool analogy is that Dr. Acheson is not making decisions for himself. It is a free country and if he, as an individual, wants to switch pools that is his right. But, instead, he orders everyone out of the pool — although moving to the other pool does no good at all.

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