When it comes to FSMA’s food traceability rule, challenge is opportunity (2024)

Years ago, I worked with a sandwich company that was looking to reinvent its supply chain operations by implementing a traceability system that would track fresh ingredients from source to store. Not only to streamline operations and reduce waste, but also to ensure food safety. It was an ambitious, laudable vision, which included wireless tags for tracking lettuce shipments, among others. But the plan proved too ambitious, costly, and, frankly, ahead of its time.

Things are different today. Witness the Food Safety Modernization Act of 2011. Included in the voluminous law signed by then-President Obama is section 204, which requires traceability for certain foods identified by the Food and Drug Administration. It doesn’t specify how to achieve traceability, just that people and companies that manufacture, process, pack, or hold the specified foods must maintain certain data records about their handling and be able to share that data with the FDA within 24 hours. And they must be able to do it by Jan. 20, 2026 — admittedly, a real challenge.

As Winston Churchill (or former White House Chief of Staff and former Chicago Mayor Rahm Emanuel) might say, the food industry shouldn’t let a good crisis go to waste. Food safety mandates are a chance to reimagine supply chains for the better. It may have been too early for my sandwich client, but today, traceability technology exists that won’t just ease companies’ compliance with FSMA section 204, but will also help them operate more efficiently, eliminate waste in the food chain, and even help protect the planet while they’re at it.

Food traceability is now critical

According to data from the Centers for Disease Control (CDC), 1-in-six Americans — about 48 million people — get sick each year from unsafe food. Among the most infamous examples of food-borne illness was a 2006 E. coli outbreak that was linked to fresh spinach. Three people died, including a two-year-old boy from Idaho. Hundreds were sickened as authorities and industry scrambled to issue a recall.

Over the years, such occurrences have continued. As recently as this spring, a grower in Michigan voluntarily recalled salad kits for fear of listeria contamination. It can be hard to pinpoint the source of food-borne illness, leading to sweeping recalls that often include perfectly safe products. For its part, industry groups like the International Fresh Produce Association (IFPA) have worked hard to implement systems for more precisely tracking food products and improving the precision of food safety monitoring. At the same time, the government has been rolling out rules for FSMA. And for many in the food chain, there are only a few years left before they must comply with traceability requirements.

But here’s a key challenge for companies in the food supply chain: FSMA section 204 doesn’t apply to all food. Just some. Fresh tomatoes must be tracked, but not oranges. Ricotta cheese, yes; but hard cheeses, no. Traceability data must only be kept for foods on the FDA’s traceability list. Which could pose a conundrum for many.

“In our industry, major buyers have indicated they can’t support one process for tomatoes and leafy greens and another for other foods,” explained one industry expert who works on food traceability and previously ran distribution centers for major grocers. “They have to have one process for all produce.”

In other words, even though they don’t have to turn over traceability data for everything they handle, whatever process they use to collect traceability data should be uniform across their operations. After all, some food on this list needs to be stored at one temperature, some at another. Experts estimate that for every 20 pallets of fresh food, perhaps four include items that are on the FDA traceability list. It would be tricky to set up a distribution center where tracking is done on one area and not another. Not to mention, at a time when it can be difficult to find workers to do jobs required throughout the food chain, creating handling instructions for some products and not others will likely lead to human error. As I’ll explain, it’s the human component of the solution that represents the biggest challenge.

So although FSMA 204 is agnostic about how companies must collect traceability data, it’s clear that automation technology must come into play. Which is an opportunity cloaked in a regulatory requirement.

The emergence of traceability solutions

In 2010, the IFPA joined with the Canadian Produce Marketing Association and GS1, the international standards organization for barcode technology, to create the Produce Traceability Initiative (PTI) and develop a harmonized tracking label for cases of food. Participating companies include Albertsons, Costco, and Walmart. Already, it’s estimated 70% of food cases in the U.S. supply chain carry PTI-compliant tracking labels, which must be scanned as they’re distributed to stores.

Keep in mind, produce is just one food type on the FDA’s traceability list, and other industry groups are exploring how their members will comply with FSMA 204. But as produce has often been at the center of food recalls in the past, what IFPA and PTI do will be noteworthy. And as they work to help companies comply, they understand that digitalization will be critical. The question becomes, how to digitalize? And why?
Barcodes, QR codes, and RFID are certainly options, but they require expensive, human-initiated scanning infrastructure. If it were feasible to track just the 20% of pallets that include FDA-identified foods, maybe it would be worth the expense and effort.

The other option is to track everything, using digital systems to send to the FDA only the tracking data they need. Now you’re in compliance. All the other data will allow food companies to create better supply chains.

Doing so requires new technology, what’s known as ambient IoT, whereby postage stamp-sized, ultra-low-cost Bluetooth radios can be affixed to anything in the supply chain and communicate their status wirelessly. They harvest their own power, so no batteries are needed, and create universal real-time visibility into production, distribution, shipping, and retail.

Indeed, complying with FSMA section 204 by 2026 will be a challenge. And it will require new solutions to constantly collect traceability data. But solutions now exist that turn the challenge into an industry-changing opportunity. We can agree that saving lives by protecting against food-borne illness is critical. With ambient IoT, an automated traceability system can also reduce food waste, ensure freshness and quality, and even provide real-time insight into the carbon footprint of supply chain operations.

It’s a vision other companies have had in the past. Now it’s feasible. And if we get started now, it’s even feasible by 2026.

When it comes to FSMA’s food traceability rule, challenge is opportunity (2024)

FAQs

What are the challenges of food traceability? ›

One of the biggest challenges with implementing effective traceability systems in food supply chains is the complexity of the supply chains themselves. Food products can pass through multiple intermediaries, including producers, processors, distributors, and retailers, before reaching the end consumer.

What is the food traceability rule? ›

The Food & Drug Administration's (FDA) Food Traceability Rule (also called 'FSMA 204') is intended to quickly identify, and remove from distribution, potentially contaminated foods. The rule is expected to result in fewer foodborne illnesses and deaths.

What is the food traceability solution? ›

Food traceability software allows users the ability to research, track, and store information regarding the makeup of food products. Companies use the software to keep well-documented records of food orders and their origins.

What are the three biggest challenges of the food system? ›

Growing competition and scarcity of land, water and energy for food production and over exploitation of the wild fisheries will affect our ability to produce food.

What are the factors affecting traceability? ›

Environmental, organiza- tional, and technical factors influence the implementa- tion of requirements traceability. In this article, we identify and discuss how such influences impact the adoption and use of traceability.

What is the FSMA rule? ›

The FSMA rule on Accredited Third-Party Certification establishes a voluntary program for the accreditation of third-party certification bodies, also known as third-party auditors, to conduct food safety audits and issue certifications of foreign entities and the foods for humans and animals they produce.

What is an example of a food traceability system? ›

Food traceability examples

The customer would take the food and its packaging back to the retailer. The retailer can then trace the product and report the issue. This might mean that other products in the same batch are recalled and taken off the shelves.

What is the overview of FSMA? ›

Under FSMA, FDA was given a legislative mandate to require comprehensive, science-based preventive controls across the food supply, including mandatory preventive controls for food facilities. Food facilities are required to implement a written preventive controls plan.

What does FSMA focus on? ›

The FDA Food Safety Modernization Act (FSMA) is transforming the nation's food safety system by shifting the focus from responding to foodborne illness to preventing it.

What is the FSMA primary objective? ›

The ultimate goal of FSMA is to ensure the safety of our nation's food supply by shifting the focus to the prevention of – rather than strictly response to – food contamination and disease outbreak.

What is the food traceability law? ›

Section 204 of the FDA Food Safety Modernization Act (FSMA) requires the FDA to designate foods for which additional recordkeeping requirements are appropriate and necessary to protect public health.

Who is responsible for food traceability? ›

In article 18, the requirement to be able to trace food is the responsibility of the food business operator. The food business operator is defined in 178/2002 as: 3.

What is traceability solution? ›

Traceability solutions, or track and trace solutions, allow businesses to document data about the physical movement of parts and products, both internally and throughout the supply chain.

What is the future of food traceability? ›

Emerging Trends in Food Traceability

Blockchain technology offers a decentralized and tamper-resistant ledger that ensures the immutability of data. It is revolutionizing food traceability by creating a transparent and secure platform for recording every stage of the supply chain, from farm to table.

What is traceability concerned with? ›

Traceability is the capability to trace something. In some cases, it is interpreted as the ability to verify the history, location, or application of an item by means of documented recorded identification.

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