written by Ross Lambert, Director of Software Development
The Food and Drug Administration recently postponed implementation of Section 204 of the Food Safety Modernization Act (FSMA) until July of 2028. The move was somewhat controversial, but I think the FDA was right about one thing: the industry was not ready. Several people I’ve spoken to since that announcement are breathing a huge sigh of relief.
OK, I get it; I’ll give you a day or two to relax and gather your wits, but any more than that, you are likely making a really, really big mistake.
In fact, I am here to suggest it could be a fatal mistake, both literally and financially.
Large customers such as Walmart and Krogers have been upping their “traceability game” for many years now. They are not backtracking on these improvements or the related digital requirements. Even if your customers do not have traceability requirements now, it won’t take too many high-profile food-borne illness outbreaks before those same requirements trickle down to smaller customers. My money says that in two years it will be hard to find buyers who don’t require farm-to-fork traceability.
One of the primary reasons the Big Guys are not backtracking is legal liability. As RedLine Solutions’ CEO Todd Baggett pointed out in his new book, Produce Traceability Integrity, it is no exaggeration to say that thousands of lives are at stake every year:
| | Here are some annual U.S. statistics for foodborne illnesses: 1 in 6 Americans get sick 128,000 of those require hospitalization 3,000 then die from illnesses associated with food products Produce Traceability Integrity, p. 13 |
Nobody wants to be the cause of a delay in a food-borne illness investigation. Delays cost lives. Liability is a big motivator, but hopefully, so is our humanity.
3. It takes time to implement FSMA-style traceability reporting.
I once heard the CEO of an ERP platform suggest they were FSMA-compatible because “…we have the data.”
Having slept with the FSMA reporting requirements under my pillow for the last two years, I smiled at the naivete of the remark: Raw data means nothing in the FSMA world. They call it traceability because it is the right data connected the right way.
An FDA or CDC investigator should be able to scan a product bar code in a grocery store today and walk out into the farmer’s field where it was harvested tomorrow—and visit every stop in between.
Got data?
First, you need to have the right data. I created a chart for myself and my team that detailed every FSMA critical tracking event (CTE) along with the required key data elements (KDEs). The chart is huge, and the font size is tiny. I can pretty much guarantee that many software platforms in use in the produce supply chain do not support tracking every item on my chart. It’s hard.
Here’s one rather rough way you can judge if yours does: FSMA requires the digitization of paper associated with any operation in the food supply chain, whether they are harvest orders, work orders, shipping manifests, or hand-scribbled napkins. Honestly, I was a bit incredulous at this requirement and thus requested a formal ruling from the FDA. They replied in the affirmative: if they exist at all, digitized paper documents are a required part of a traceability report.
If your data collection software doesn’t provide some way to attach scanned paper images to your data—and properly reference those images in a traceability report—your software is deficient and does not meet FSMA reporting requirements.
In case you wondered, this is baked into our MyProduce software.
Got TLC?
The traceability lot code (TLC) is assigned by the “initial packer” when a food item is placed into the packaging in which it is sold to consumers. The initial packer entity must maintain digital tracking for each item packed that points to the farmer, the field, the harvest crew, the truck, and to any cooling or washing done on the way to or at the packing shed.
This is not trivial.
RedLine Solutions created MyProduce with traceability in mind from day one. It is baked into our workflows in ways that do not blow up your workflows.
We generate Traceability Lot Codes automatically when you pack produce and link it to all the raw data that came before… darn near automagically.
My point here is just this: you do not want to implement any software platform in a hurry, but this is especially true for one that is so deeply entwined with your operational workflows. Whether you are a vertically integrated farmer that packs your own produce, a full-blown packing shed (AKA “packer-shipper”), a third-party logistics provider (3PL), or a major distribution center, you want to take ample time to select the software solution that is best for your operations and then allow significant additional time for setup and training.
I’m confident that MyProduce is the most versatile and complete produce operations software on the planet. Oh, by the way, it works very well for all the use cases above!
My dad had a funny saying, “You will never get a second chance to do it right the first time.”
It is wise to take my dad’s advice with FSMA. Get going on your approach to FSMA now so that the calendar does not become a brutal taskmaster. Evaluate all elements of your approach to FSMA, including the tracking of traceability report requests.
When FSMA goes live, a request for a traceability report from an investigator has legal ramifications. For one thing, you will be legally required to generate the required report within 24 hours.
MyProduce is the only solution I know of that treats those requests with the gravity they are due: we generate the spreadsheet the FDA requires and send it to the requestor via a secure download link. We then track when the investigator downloaded the report.
You will have an audit trail of the date and time of the initial request and response—as well as the date and time the recipient downloaded the report itself.
There’s no better place to start digging into FSMA than with Todd Baggett’s new book, Produce Traceability Integrity: Closing the gaps for a safer supply chain.
You can get your free copy here.
For 27 years, RedLine Solutions has been the trusted partner in inventory and traceability for fresh produce stakeholders across North America. Serving a myriad of commodities, we tailor solutions to your workflow. Our offerings, from hardware to software, coupled with deep expertise, ensure your produce operations management is in the best hands.
