How Digital Traceability Is Reshaping Food Safety? – II

Where Food Safety Management Systems Meet Digital Traceability

For food businesses operating under ISO 22000:2018 or FSSC 22000, the relationship between their existing food safety management system and emerging digital traceability requirements is not a new challenge. It is an extension of existing requirements that the standard already anticipates, even if implementation has historically lagged behind regulatory intent.
 
Clause 8.3 of ISO 22000:2018 establishes traceability as a fundamental system requirement, requiring the organization to ensure that the end products, work-in-process, and intermediate products can be identified by lot and linked to raw material batches, processing and packaging records, and distribution records. The standard requires that traceability records be maintained for a defined period sufficient to allow system evaluation and handling of potentially unsafe products, and be available to competent authorities and customers upon request. Critically, ISO 22000:2018 Clause 8.9 on handling of nonconformities and Clause 8.9.4 on withdrawals and recalls require the organization to be able to notify relevant interested parties and competent authorities in a timely manner, which is a requirement whose practical adequacy is directly determined by the speed and completeness of the traceability records supporting it.
 
What FSMA 204 and the corresponding EU regulatory framework are effectively doing is operationalizing and digitizing what ISO 22000 has required in principle since its first edition. The key data elements of FSMA 204: lot identification, location identifiers, dates of key events, quantities, and reference documents, map directly to the traceability record requirements of ISO 22000:2018. Businesses that have implemented ISO 22000:2018 rigorously and systematically are therefore not starting from zero; they are translating existing paper-based or partially digital record systems into the interoperable, machine-readable formats that regulators and major retail customers are increasingly requiring.

The competence requirements of Clause 7.2 and the awareness requirements of Clause 7.3 are also directly relevant: ensuring that the people responsible for data entry, system management, and supply chain communication have the skills to operate digital traceability systems, and understand why accurate data capture at each critical tracking event matters for food safety, is as important as the technology investment itself. A blockchain-backed traceability system populated by operators who do not understand what they are recording, or who take shortcuts under production pressure, delivers no meaningful improvement in food safety outcomes.
 
The ISO 22000 Connection, the Business Case and Beyond Compliance

The argument for digital traceability investment is sometimes framed exclusively as a compliance obligation — as though, absent regulatory requirements, there would be no business case for the capability. This framing is both strategically shortsighted and factually inaccurate.
 
The costs of a major recall without robust digital traceability are substantial and well-documented. The direct costs, such as product removal, destruction, logistics, retesting, and regulatory response, are significant. The indirect costs, such as brand damage, retailer delisting, litigation exposure, and long-term market share loss, are often larger. The Boar's Head outbreak resulted in the permanent closure of a production facility, extensive litigation, and reputational damage to a brand that had been established for over a century. McDonald's removed slivered onions from its menu nationally as a precaution while traceback investigations were ongoing — a decision that imposed supply chain disruption across a network of hundreds of thousands of restaurants [1].
 
A food business with robust digital traceability such as lot-level identification, real-time supply chain visibility, and the ability to query the full distribution of a specific lot within minutes can execute a targeted, surgical recall. Rather than recalling all product from a broad date range or all product from a facility, a targeted recall isolates the specific contaminated lot and removes only that product from commerce. The difference in scope, cost, and consumer impact between a targeted and a broad recall can be enormous. FDA research and industry experience consistently show that the speed of product removal is the single most important variable in limiting the number of illnesses in a foodborne outbreak, where speed of removal depends entirely on the quality and accessibility of traceability data.
 
Beyond recall management, the business case extends to supply chain efficiency, food waste reduction, and consumer trust. Digital traceability data, when properly structured and shared, enables better inventory management, more precise shelf-life optimization, and faster response to quality deviations before they become safety events. For retailers and food service operators, the ability to demonstrate verified provenance and supply chain transparency to consumers represents a growing source of competitive differentiation, particularly as consumer interest in food origin, sustainability, and safety continues to rise.
 
The Barriers: A Realistic Assessment
An honest treatment of digital traceability requires acknowledging the barriers that explain why adoption has been slower and more uneven than the technology's proponents might suggest.
 
Cost and Scalability for Small and Medium Enterprises

The cost of implementing FSMA 204-compliant systems such as ERP integration, barcode labelling infrastructure, EPCIS event capture, and EDI capability represents a significant investment for small and medium-sized food businesses. Industry feedback to the FDA has consistently cited cost as a primary barrier, and such concern is not abstract: a small leafy greens producer or a regional seafood processor may face implementation costs that represent a meaningful fraction of their annual revenue [9]. The 30-month extension to the FSMA 204 compliance deadline was granted in part because FDA acknowledged that smaller operators needed more time and, implicitly, more affordable implementation options.
 
This is where the FDA's Low/No-Cost Traceability Challenge, and the work of GS1 US in providing open standards and accessible resources, play a meaningful role. The FDA has also explicitly stated that the rule does not prescribe specific technologies, where a paper-based lot code on a bill of lading meets the technical definition of a Traceability Lot Code under the rule, even if it is far less efficient than a GS1-128 barcode [7]. The practical question for smaller operators is therefore not whether to comply, but how to do so in a way that is technically sufficient now and provides a foundation for more sophisticated digital capability over time.
 
Data Quality and System Integration
Traceability data is only as valuable as its accuracy. A traceability system that captures lot codes at the receiving dock but does not reliably link those codes through the transformation events on the production floor, or that has gaps in its data when product crosses from one software system to another, provides incomplete and potentially misleading information when a traceback investigation begins. Data quality problems are frequently a function of human factors such as inconsistent scanning practices, manual data entry errors, and lot code assignment gaps when incoming product lacks codes, rather than technology limitations per se [8].
 
Integrating traceability functions into existing ERP and production management systems, rather than running them as parallel processes, is the most effective way to reduce the data quality gap. When the system that generates a production order automatically populates the transformation CTE record, and the system that generates an outbound shipment automatically creates the shipping CTE record, the opportunities for human error are minimized and the data trail becomes a natural output of normal operations rather than an additional compliance burden.
 
Global Harmonization: A Work in Progress
As noted above, the multiplicity of regulatory frameworks such as FSMA 204 in the United States, EC Regulation 178/2002 and the EUDR in the EU, national frameworks in China, Japan, and elsewhere, creates compliance complexity for multinational food businesses and for exporters serving multiple markets. The lack of a single harmonized global traceability standard means that a company operating in multiple regulatory environments may need to maintain multiple data sets in multiple formats, potentially with different granularity requirements and different timelines for data provision to authorities.

Efforts toward harmonization are ongoing. The Global Food Safety Initiative (GFSI) and the International Featured Standards (IFS) both address traceability requirements in ways that are designed to be internationally recognizable, and GFSI's benchmarking work aims to ensure that food safety certification schemes recognized by major retailers reflect consistent traceability expectations [13]. However, the convergence of national regulatory requirements around a genuinely interoperable global standard remains a medium-term aspiration rather than a near-term reality.
 
What Food Safety Professionals and Businesses Must Do Now
The extension of FSMA 204's compliance deadline to July 2028 provides breathing room for technical implementation. But it does not change the strategic trajectory, and companies that treat it as an opportunity to defer planning rather than to improve their implementation are likely to find themselves in a difficult position as the deadline approaches.
 
Based on the current regulatory landscape, the industry intelligence available from IFT, FMI, FDA, and the peer-reviewed literature, and the practical experience of companies that are already implementing digital traceability systems, the following priorities merit immediate attention.
 
Map Your Traceability Data Gaps Now

The first step is a systematic internal assessment: for each product line subject to the Traceability Rule, trace the data chain from raw material receipt through processing, packaging, and outbound shipment. Identify where lot-level data is currently captured in a machine-readable format, where it is captured on paper, and where it is not captured at all. Such gap analysis provides the foundation for an implementation plan that prioritizes the highest-risk data gaps and the steps that are prerequisite to others.
 
Align on GS1 Standards Across the Supply Chain
Companies that have not yet adopted GS1 standards for product and location identification should treat this as a foundational priority. GS1 GTINs and GLNs provide the unique identifiers that allow KDE data to be exchanged between different supply chain actors and different software systems — they are the common language without which interoperability is impossible [12]. Engaging suppliers and distribution partners in conversations about GS1 adoption is not merely a courtesy; it is a supply chain risk management necessity.
 
Invest in System Integration, Not Parallel Processes
The most common implementation failure in traceability projects is the creation of a parallel traceability system that operates alongside existing ERP and production management systems rather than being integrated into them. Data that must be manually entered twice — once into the production system and once into the traceability system — will not be entered accurately and consistently. The implementation goal should be a single workflow in which normal operational transactions automatically generate the required traceability records.
 
Engage the Supply Chain Upstream and Downstream
The FDA's own stakeholder engagement has repeatedly confirmed that the most significant traceability gaps tend to be at the boundaries between supply chain actors, particularly at the farm and first-receiver level where digital systems are least mature [9]. Food manufacturers who have invested in internal traceability systems but whose produce suppliers are still using paper manifests need to actively support their suppliers' transition to digital traceability, whether through technical assistance, financial support, or trading partner agreements that set data quality expectations.
 
Build ISO 22000 Traceability Competence
Organizations certified to ISO 22000:2018 should ensure that their competence and awareness programs (Clauses 7.2 and 7.3) explicitly address digital traceability. This means not just ensuring that people know how to operate the relevant systems, but ensuring that they understand why accurate and complete data capture at each critical tracking event is a food safety function, and not merely an administrative one. The food safety management system documentation should explicitly connect the traceability requirements of Clause 8.3 to the specific KDEs and CTEs required under FSMA 204 or the applicable national regulatory framework.
 
Looking Ahead: The Direction of Travel

The regulatory and technological direction is unambiguous. A 2025 Frontiers review of European agri-food digitalization concluded that the further deployment of IoT, RFID, and QR code technologies, combined with investment in harmonized standards, shared APIs, and common data taxonomies, will progressively reduce the cost and complexity barriers that currently slow adoption [14]. The FDA's active engagement with stakeholders through mid-2026, including its June 2026 public meeting on lot-level tracking, signals that the agency is working to make the final requirements as practically implementable as possible, without stepping back from the fundamental commitment to digital, lot-level, interoperable traceability [9].
 
IFT's Global Food Traceability Center, led by Managing Director Blake Harris, has been a consistent source of practical guidance and educational resources throughout the FSMA 204 implementation cycle, and its role in helping organizations navigate the transition from compliance planning to operational capability is likely to grow [3]. The academic literature, particularly the rapidly expanding body of peer-reviewed research on blockchain, IoT, and AI applications in food supply chains, is generating an increasingly evidence-based understanding of what works, what fails, and why — providing food safety professionals with more reliable guidance than was available at any prior point in the traceability technology's development.
 
The analogy that is perhaps most instructive is HACCP. When the HACCP system was first mandated for meat and poultry in the United States in 1996, and for seafood shortly after, the food industry faced a transition of comparable scope and complexity: a systematic, science-based approach to hazard identification and control that required new documentation, new competencies, and new thinking about the relationship between food safety and production operations. The industry built that capability over time, and HACCP is now so deeply embedded in food safety practice that it is almost invisible — it is simply how food safety is done. Digital traceability is following the same trajectory. The companies that invest in building the capability now, before the compliance deadline creates a scramble, will not merely be compliant — they will be competent. And in food safety, competence is the only standard that matters.
 
Conclusion

Digital traceability is not a trend. It is a transition, from a food safety architecture built on reactive traceback to one built on proactive data infrastructure. The human cost of the gap between where the industry is and where it needs to be was visible in 2024, in the delayed identification of contaminated deli meat and the drawn-out investigation of an outbreak that reached 14 states before the contaminated onion supply was removed. It is visible in the 44 percent of outbreak investigations that still cannot identify a food vehicle of illness. And it will remain visible for as long as the industry's traceability systems depend on paper, incompatible formats, and the patience of epidemiologists rather than on machine-readable data that can be queried in minutes.
 
The regulatory framework is now moving, whereas in the United States, the European Union, and globally — to make digital traceability mandatory, not aspirational. The technologies to implement it exist and are improving. The standards infrastructure, led by GS1, is in place. What remains is the organizational commitment to translate regulatory obligation into operational capability, supply chain collaboration to close data gaps at the boundaries between actors, and investment in the people and systems that make the data reliable.
 
For food safety professionals, the question is not whether digital traceability is coming. It is already here, in the requirements of major retailers, in the FDA's New Era of Smarter Food Safety Blueprint, in the FSMA 204 rule whose compliance date is firm at July 2028, and in the expectations of consumers who are paying closer attention to what they eat than at any prior point in history. The question is whether your organization is building the capability now, deliberately and systematically, or waiting for the deadline to force a scramble that will cost more and deliver less.
 
The data that traces food through the supply chain is, ultimately, the data that protects the people who eat it. It is time to take it seriously.
 
 

References

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[2] Prabhukhot, G. (2026). Regulatory responses to foodborne illness outbreaks in the United States and their implications for food safety. Frontiers in Nutrition, 12, 1717980. https://doi.org/10.3389/fnut.2025.1717980

[3] Niemira, B. (December 2025). What's on the Menu for 2026? IFT's Top Five Food Trends. Institute of Food Technologists. https://www.ift.org/news-and-publications/blog/2025/whats-on-the-menu-for-2026

[4] Eisenbeiser, A. (February 9, 2026). Building the Safest Food System Together: FMI's 2026 Food Safety Priorities. FMI – The Food Industry Association. https://www.fmi.org/blog/view/fmi-blog/2026/02/09/building-the-safest-food-system-together--fmi-s-2026-food-safety-priorities

[5] Reitano, A., et al. (2025). Agri-food traceability today: Advancing innovation towards efficiency, sustainability, ethical sourcing, and safety in food supply chains. Trends in Food Science & Technology. https://www.sciencedirect.com/science/article/pii/S0924224425002900

[6] Frontiers in Sustainable Food Systems. (April 2026). Food safety and its digital traceability strategies: a supplier-processor profit distribution perspective. https://www.frontiersin.org/journals/sustainable-food-systems/articles/10.3389/fsufs.2025.1707114/full

[7] U.S. Food and Drug Administration. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule). https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods

[8] INECTA. (2026). FSMA 204 Compliance Guide: KDEs, CTEs & July 2028 Deadline. https://www.inecta.com/blog/fsma-204-compliance-guide

[9] OFW Law. (June 23, 2026). FDA's Next Steps on Traceability: Challenges and Solutions in Lot-Level Food Traceability. https://ofwlaw.com/fdas-next-steps-on-traceability-challenges-and-solutions-in-lot-level-food-traceability

[10] Gottschald, M. (2024). Advancing food safety through digital traceability, interoperability, harmonized data and collaborative partnerships. Journal of Consumer Protection and Food Safety, 19, 257–258. https://doi.org/10.1007/s00003-024-01522-8

[11] Natural Trace. (2024). Recent Regulations Driving Traceability in Food and Agriculture Sectors. https://natural-trace.com/recent-regulations-driving-traceability-in-food-and-agriculture-sectors/

[12] GS1 US. Food Safety Modernization Act (FSMA 204): How GS1 Standards Can Help. https://www.supplychain.gs1us.org/standards-and-regulations/food-safety-modernization-act

[13] Vasileiou, K., et al. (2025). Digital Transformation of Food Supply Chain Management Using Blockchain: A Systematic Literature Review Towards Food Safety and Traceability. Business & Information Systems Engineering. https://doi.org/10.1007/s12599-025-00948-0

[14] Frontiers in Blockchain. (October 2025). Digitalization in the European agri-food supply chain: a scoping review of traceability, transparency, and sustainability. https://www.frontiersin.org/journals/blockchain/articles/10.3389/fbloc.2025.1701872/full