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FDA Unable To Determine Source of Infection Romaine Lettuce


Although lettuce would appear to be far removed from eggs, both produce growers and our industry fall under the jurisdiction of the FDA. An outbreak of E.coli 0157:H7 infection attributed to Romaine lettuce which commenced in mid-March and continued through early May has claimed at least 125 victims with one fatality in 29 states. The outbreak is characterized by an approximately 40 percent hospitalization rate with 10 percent of the patients developing hemolytic uremic syndrome.

Organizations including the United Fresh Produce Association are frustrated in that their offer to assist the FDA has apparently been spurned. Clearly the FDA does not understand the practices involving the growing and distribution of produce. The Agency is now confronted with a poorly documented system of tracing the supply chain inhibiting identification of the source.

The FDA appears to be concentrated on unraveling the supply chain to determine the source of the affected chopped and whole Romaine lettuce grown in the Yuma, AZ region. The Agency is however aware through an epidemiological happenstance that inmates in a prison in Alaska affected by the implicated strain of E.coli consumed Romaine lettuce heads from a specific farm.

It would behoove the FDA to quit temporizing over a fruitless trace-back and evaluate the methods of production including irrigation, harvesting and processing since the Yuma season for production, if not over, is drawing to a close. In three weeks’ time, the FDA will still be no further in their investigation given the opacity and convolution of the supply chain, but will have missed the opportunity to survey fields and packing plants both in Yuma and also in California which will soon be the principal supplier to the U.S.

Now returning to eggs, it is evident that the FDA does not understand the industries under their jurisdiction. This can be discerned by reading between the lines of the FDA 483 Document served on a large egg producer arising from an inspection following a limited outbreak of Salmonella Braenderup. Deficiencies in understanding were in any event glaringly evident in 2010 with the introduction of the FDA Final Rule on Salmonella Prevention. Wasting time in trying to pinpoint a specific farm or farms in the Romaine lettuce E.coli outbreak is really an exercise in futility. Ascribing an outbreak of salmonellosis to the presence of flies or a few mice or workers in a plant scratching their noses or “gluteal clefts” is equally inane. A thorough and structured field investigation carried out by trained professionals of the Epidemiology Intelligence Service of the Centers for Disease Control would be more appropriate and productive.

It is evident that produce growers should get their house in order and establish a system of trace-back. Given the introduction of blockchain technology, this may be an opportune time to move from paper and pencil records to electronic data.

FDA should confine itself to drugs and medical devices where it has expertise albeit with insufficient field staff to monitor pharmaceutical plants in Asia and leave eggs and produce to agencies with appropriate technology and experience.

The solution to the problem of enhancing food safety does not lie in a complicated Food Safety Modernization Act and the derived regulations but in the development of a new food safety entity paralleling agencies in the E.U.