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FDA Pattern of Shame:
In Order To Seem Relevant,
It Acts After The Outbreaks Are Over

Hopefully all of us in the industry would put food safety over profit and so if warning people not to eat something would save a life or avoid a serious illness, few would object to the FDA issuing such a warning.

However, as has become its practice, it appears the FDA was a day late and a dollar short — as such, its warnings have reduced consumer confidence in the food supply, destroyed businesses, led to the needless destruction of food — without helping to avoid illness in any way.

The current CDC update is very clear. Nobody has reported an onset of illness later than May 27, 2008. This date has remained constant even as the number of people interviewed has risen to 73.

Just to be clear, the FDA actually issued its recommendation extending its warning not to consume certain tomatoes nationwide on June 7, 2008. Salmonella has an incubation period of 12 to 72 hours after infection. This means that by the time the FDA imposed its warning, the outbreak was finished.

As we carefully discussed, this is the exact pattern that the FDA followed in its imposition of an “import alert” regarding cantaloupes produced in Honduras by Agropecuaria Montelibano. In that outbreak, the last person to become ill did so on March 5, 2008. The FDA imposed an Import Alert on March 22, 2008. As a result, the unemployment, the destruction of food, the crushing of businesses… all this was done for absolutely no purpose.

We see the same pattern here. The CDC/FDA/State Health Department/Local Health Department combo is too slow in its epidemiology. This was pointed out in an important letter we published under the title, Tomato/Salmonella Situation Cries For Improved Epidemiology, by James R. Gorny, Ph.D., Executive Director of the Postharvest Technology Research & Information Center, University of California, Davis.

As Dr. Gorny asked:

Why did it take upwards of 6 weeks for public health officials to identify this cluster of illnesses… and then only due to the diligence of state public health officials in New Mexico?

Obviously one issue is how to improve the public health system so that it can intervene while it can still do some good.

Another issue is how the produce industry can improve so that such intervention will not be necessary.

Yet another, and perhaps the most proximate issue, is how to change the standard operating procedure at FDA so that food is not needlessly destroyed and business not needlessly disrupted.

Shortening a bit, the FDA press release should have been written in this manner:

There has been a salmonella outbreak which our epidemiology has traced back to certain types of tomatoes. The last person to get sick as a result of the outbreak got sick on May 27, 2008. As such, the outbreak is over; any tomatoes currently in the market would not be affected by this outbreak. We regret that the epidemiology did not proceed quickly enough for us to identify this outbreak while we could have acted to prevent people from getting ill.

As a precaution, we are issuing a Consumer Advisory urging consumers to destroy any tomatoes or uncooked products — such as a fresh salsa — made with round red, red Roma or red plum tomatoes that had been purchased or may have been purchased on May 27, 2008 or earlier.

We will, of course, continue our full trace back procedure in an attempt to identify what the cause of this outbreak was with the goal of preventing such outbreaks in the future.

The FDA did not issue such a release — and never does — because it wants to appear to be acting to enhance public health. An honest release such as the one above might have FDA officials testifying before congressional committees as to why FDA couldn’t act sooner.

This is understandable, as this instinct might be as a survival mechanism of FDA officials, but it simply causes too much waste and destruction to allow this mode of operation to continue.

Right now the problem is simple. The incentive is 100% on FDA officials to restrict commerce or advise against consumption. If they did not do this and one person got seriously ill or died, these FDA officials will be hung out to dry.

On the other hand, if they crush an industry, deprive the world of a needed food, cause unemployment… that is not something they will be held accountable for.

This is the same problem we have on the drug side where people with terminal illnesses plead for FDA approval of drugs. Once again, the FDA officials have little personal upside in speedy action.

In perishables, FDA should adopt — – and if it does not, Congress should require it to adopt — a policy that when it wishes to restrict commerce — as with an Import Alert — or restrict consumer behavior — as with a Consumer Warning — FDA shall be obliged to issue a Public Finding that the outbreak is ongoing. Such a finding will have to be signed by each member of a relevant committee set up for this purpose.

This way the judgments of those individuals can be subjected to scrutiny. If it turns out that they are consistently incorrect, they can be terminated.

As it is now, perfectly healthy produce that could feed people gets destroyed because FDA officials have an incentive to appear relevant to safeguarding public health — even when they are not.

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