• Karl Kolb

The New FDA Traceability Rule is Utter Nonsense.

Read this first and then tell me I’m not wrong:


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The new FDA Traceability rule is utter nonsense and further, it will not work, cannot be enforced and anyone claiming to be able to perform it as written is sadly mistaken.

It will not make traceback at critical times any faster or better. In fact, it will slow down the process significantly authenticating information, red herrings and the entire mass of information to weed through.


This is further and absolute evidence that the FDA has no clue as to what is going on in the field. This is piled high on their inability to trace any contamination event to its origin, and a lot more that I don’t have the time to discuss.


There, I said it.


While I could spin off into oblivion on the absolute shortfalls of this new rule. Let's just take one aspect of it. But first, the industry is clamoring for it without even a wonder if it will work (clue, it won’t). Big box stores, distributors, those who live under a rock and just collect profits are clamoring for it. Why? Because they don’t know any better, that’s why. If they knew anything about how hard it is to take a lot number from a grower and then trace it through the maze of fields, blends, harvesters, coolers, packing houses, distribution systems and the rabbit hole of a supply chain in this industry they would do the right thing and rebel. With signs, sticks and rocks (hypothetically, of course).


Here is the really sad, dark and costly downside of this new rule. FDA, certifiers, big box stores, customers and others will push and push and cost this industry untold time, money and hours trying to make it work. In the end it will be modified, ignored or hopefully that there is a produce god, rescind it. Yes, better traceability is a top priority. But, not like this. Its shades of the COVID debacle or worse anything else that rhymes with FUBAR.

Ok, so let’s get back to how this won’t work.


Take the effort and lack of systems for gathering the location identifier, location description, and point of contact for the traceability lot code generator. Really? Just take the location identifier. A farmer below the border has let’s say, 5 growing areas (not unreasonable) that he blends into one pallet (all the same commodity). This is 5 location identifiers, 5 different location descriptions (this could be pages of agricultural and to numerous to count certification documents) times a point of contact for each, and the different types of lot code generators with their information and point of contact? Do they need to provide calibration for lot code generators? OMG, does it ever end?


I hope you see my point?


Let’s take this up the chain. These five fields are transported to a processor who washes, cuts and bags many different blends from many growers which we multiply by how many blends in the mix. Then there are those cartons that are broken up by onesies and twosies and go hither and dither up other supply chains to be further broken down into more blends. Get my point. It’s going to take more computing power than the Artemis program to perform this stunt with just one purchase order.


I know a tomato repacker that often blends over 80 different lot numbers into one carton.


This is a classic case of the blind leading the unknowing. Get ready of another non-starter.


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