The food industry now has until January 2026 to comply with the Food Traceability Rule. All of us hope that FDA stays true to its mantra to “educate while it regulates.” With the final rule issued well over a year ago, however, roughly one-third of the time that companies have to prepare has passed. It’s safe to say that most companies are probably not one-third of the way to food traceability compliance.
For those that have not begun to act, the challenge may appear daunting. The rule requires food companies to collect and share key data elements (KDEs) on certain foods and be able to provide those records to FDA, if requested, within 24 hours. The goal is to quickly identify and remove contaminated food from the market, in turn preventing foodborne illnesses.
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No Shortcuts to Compliance
Perhaps unsurprisingly, however, shortcuts to compliance are already being considered that could hamper that goal. One that has come to my attention is that some food entities intend to use advanced shipping notices (ASNs) alone as evidence of a product’s “receipt” throughout the food chain. Indeed, the benefits of ASNs in supply chains are undeniable, but not as the sole means of confirming what was received.
An ASN is generally an electronic notification of a pending delivery sent from a shipper to a receiver, usually before shipment from a facility. While there can be various data elements in an ASN, as long as it’s “accurate” and includes all eight shipping KDEs required by the rule, including the traceability lot code (TLC) and the TLC source or source reference, it meets the requirements of the rule as a shipping record. However, you can’t always trust that what is claimed to be shipped from point A is the same as what’s actually received at point B.
The best way I can explain this is through a common personal anecdote: Recently, I bought a shirt online. When I received the shipping notice, it accurately described what I ordered and said it was on its way. When I received the shirt, however, it was the wrong product.
That was a hassle, to be sure, but at least it wasn’t food involved in an outbreak that could affect the health and well-being of the American public. In that case, not only could a mistake like this have caused illnesses, but it would have been hard to trace and fix the error during an outbreak, when speed and accuracy count. In a nutshell, a notice of what’s claimed to be shipped doesn’t always reflect what’s received. And while the goal is to make the information in ASNs 100% accurate, industry studies show we’re not there yet, and certainly not with food.
Shipping and Receiving Are Distinct Events
That’s why, when the Food Traceability Rule was drafted, shipping and receiving were identified as separate critical tracking events (CTEs) for which traceability data must be collected. The common thread is the TLC, which is used to accurately confirm shipment and receipt and link to other required data.
Not only could a sole reliance on ASNs fail to ensure accurate data about what was received, but when unverified, it also represents a potential weak link in any traceability plan, risking a company’s compliance with the Food Traceability Rule or, worse yet, incorrect assumptions during an outbreak investigation.
Instead of relying solely on ASNs, companies should adopt a “trust but verify” mindset. That involves developing and adhering to verification protocols that confirm what was received is indeed accurate when compared with an ASN.
In today’s food system, many entities will likely leverage some form of technology to do just that. Because of concerns about the cost of labor, some may choose to conduct verification activities of what is received at the pallet level. However, for maximum confidence and accuracy, verification could occur at the case level.
Tech-Enabled Solutions for Collecting and Sharing Food Traceability Data
There are different ways to verify what was received, which I’ll refer to as high-labor, low-labor and no-labor compliance models. They all leverage technology, to some degree, to capture KDEs and TLCs at each CTE in a company’s supply chain system.
In higher-labor models, companies employ industry consensus standards, such as GS1’s GLNs, GTINs, SSCCs and GS1-128s that contain KDEs embedded in 1D or 2D barcode labels. Workers with hand-held devices can scan the barcode labels on cases or pallets, or the cases/pallets are passed by stationary scanners. For many, this is likely to be the easiest path to food traceability compliance. Further, even though most barcode scanners work reliably, they require line-of-sight access to each barcode, and labor to scan or position products to be scanned. Also, human interventions and scans are always susceptible to error.
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In a lower-labor model, companies use higher-tech data carriers (also programmed to capture GS1 standards that contain required KDEs), such as radio frequency identification (RFID) labels and fixed RFID scanners in their facilities, to automatically capture traceability data as cases and/or pallets or other shipping containers move through or are received. Some companies already use RFID “tunnels” or other tracking infrastructure. While this approach can enhance accuracy and require less labor, it can be costly due to the type of scanners and labels needed. When those RFID scanners are of the hand-held, manual and lower-cost variety, there can be added labor costs and still the potential for human error.
As technology evolves, a no-labor, low-cost model is emerging that uses ambient Internet of Things (IoT) technology to communicate automatically and constantly with Bluetooth devices. When so-called ambient IoT pixels (low-cost sensors the size of a postage stamp) are programmed with traceability data in conformance with GS1 standards, and affixed to shipping cases, they transmit information without the need for manual scanning. Also, since Bluetooth devices are everywhere, the infrastructure needed for this approach is significantly less costly. In addition, IoT pixels can do more, like collect data about the location of a food and the environmental conditions it has been exposed to, such as moisture and temperature.
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Any of these models will work. Thanks to GS1 standards, today’s traceability technology can better automate and streamline the food chain while ensuring that companies comply with planning, data-collecting and reporting requirements. Most important, they eliminate any gap in the compliance chain caused by a naive reliance on ASNs alone to perform a tracking function they weren’t designed for.
Adding Value Beyond FSMA Compliance
As companies apply technology to their food traceability requirements, they can use it for more than just food safety compliance, like creating a modernized, more resilient 21st-century supply chain. Whether high-, low- or no-labor tracking is deemed preferable, some investment will be required. If food companies use these compliance investments to, for example, improve supply chain performance, reduce food waste, enhance freshness or lower their carbon footprint, they’ll see far greater returns.
First things first, however: Food companies need to recognize that food traceability compliance is closer than they think. The FDA’s food traceability requirements were created purposefully, and a shipping notice was never intended to be equivalent to a receiving event. How companies decide to confirm receipt of goods — via manual or automated scanning, or ambient IoT — is up to them. But there can’t be any shortcuts when it comes to food safety.