• Karl Kolb

REVISITED: New FDA Traceability Rule is Utter Nonsense

Revisiting this blog entry makes me think about what will work. I’m not back peddling mind you. It’s just that I expected better of the FDA who is to be the best and the brightest.


So, the system we have now has been around since the beginning of commercial farming – my mom would visit truck farmers in San Jose circa 1930, 40 and 50’s, the date of sale was the start of the trace system. It works in simple situations but it works best to promote the small farmer. Everyone in government, the big box stores, restaurant chains and down to organic distributors of the produce industry promote small family farms, local farming as their priority.


I understand the “First Receiver” concept but where is the First Receiver to get the information they need? Where the supply chain begins.


This new rule outright ignores the small farmer.


But, moving on. The date of 1 November is too soon. This will take at least a year to implement and more time to make it function properly. The new rule must be chargeable. Its complexity is overwhelming even for the highly functional computer-based tracking programs.


But what will work?


The produce conventions and the software booths that flood the convention floors will hail their ability to conform or align with the new rule. Of course, they can. If we can compute the trajectory of a star with the Webb Telescope, software magic can handle the new produce rule. But here is what they are missing. Read on.


Performing a root-cause-analysis results in a volume, time and distribution issue.


Volume: More than calculable. And the amount of produce and blends in the system grows daily to supply new demands and marketing ideas.


Time: Volume drives time. The time to supply the rule required information becomes a manpower issue which will increase and drive the price of produce into new inflationary levels. The small farmer cannot keep up. They are left in the dust unable to supply the basic requirements needing equipment and software to code their product.


Distribution: Once produce leaves the farm it seldom reaches its retail destination in the same configuration pallet-wise, carton-wise or even retain its commodity designation after blending or display requirements. And given these different scenarios the traceability, ability becomes, to use one of my favorite words – insane. $75 billion annually. That is roughly $205 million a day. That is a lot of broccolis.


Do I know the right way to do this, admittedly no. But the FDA should, the best and the brightest, we hope.


Step One: Find someone with muddy boots,


Step Two: Rescind the implementation date, make it a WIP with benchmarks,



Step Three: Try a pilot program until it works.

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