Imagine this, you buy a pack of your favorite sliced mangoes. Would you believe if we say that it is now possible to trace back to their origin farm using blockchain technology in just 2.2 seconds, even before you finish your first delightful bite?

This was a technological advancement brought forth under the revolutionary initiative, the ‘New Era of Smarter Food Safety’ by the U.S. Food and Drug Administration (FDA), championed by the former FDA Deputy Commissioner, Frank Yiannas. This venture aims to leverage new technologies, digital tools and approaches for implementing the science and risk-based requirements of the FDA Food Safety Modernization Act (FSMA) and promote food supply chain traceability and transparency to protect consumers from foodborne illnesses.

As the affordability of such tech-enabled traceability can be a barrier for smaller food enterprises, the FDA New Era of Smarter Food Safety Low-or No-Cost Traceability Challenge was introduced on June 1st, 2021. The primary objective of the challenge was to inspire stakeholders, including technology providers, public health advocates, entrepreneurs, and innovators around the world, to develop traceability hardware, software, or data analytics platforms that are accessible at low or no cost for end users, thereby creating traceability systems that are affordable for food businesses of all sizes, encouraging widespread adoption, generating shared value, and facilitating scalability.

Traceability systems serve as the foundation for ensuring food safety, maintaining food quality, substantiating sustainability claims, and setting up transactional mechanisms to mitigate the risks of food fraud and food defense incidents. The much-anticipated Food Traceability Final Rule, published by the FDA on November 21st, 2022, came as a boon for boosting the effectiveness of food traceability systems globally. However, the compliance date of the rule is January 20th, 2026, and there is much to do for the food industry to prepare in these three years due to the complicated nature of the rule.

How Food Traceability Drives Food Supply Chain Efficiency

Traceability is the process of establishing the movement of materials, packaging, products, and processing aids throughout the supply chain. It encompasses two key elements, namely tracking and tracing. Tracing involves the capability to follow a product’s journey in reverse, starting from the retail shelf and moving back to the manufacturer, the ingredient supplier, and their respective suppliers. Tracking entails monitoring the passage of materials from the suppliers throughout the entire production process till they become finished products.

A vital concept that determines the effectiveness of traceability systems is the granularity of traceability. It refers to how detailed and specific we can be when tracking and tracing food products. It involves two main aspects: time and distance. Time granularity means we can trace products based on different time periods, like a week, a day, or even a specific shift. For example, we can trace the production of a food item between two events in the food production process. Distance granularity, on the other hand, refers to how far we can track a product along the supply chain. It ranges from a simple “one step forward, one step back” approach, where we can trace the immediate suppliers and customers, to a more comprehensive “field to fork” traceability, which covers the entire journey from the farm where the food was grown to the final consumer.

From an organizational standpoint, transparency should be recognized as a crucial tool in addressing stakeholder and customer distrust while improving and proving an organization’s responsible management practices. In the realm of the food industry, it is imperative for executives of large food companies to contemplate the establishment and enforcement of a culture of transparency. Such a shift would have profound implications for their internal operations, as well as for their shareholders and customers. Undoubtedly, food companies face mounting pressures to deliver safe, affordable, and nutritionally rich products to the market amid escalating disruptions and conflicts.

Another essential component of transparency and traceability is supply chain visibility. It contains understanding activities both upstream (e.g., suppliers) and downstream (e.g., organizations involved from the business to end-user) by capturing the identity, location, and status of entities as they traverse the supply chain, accompanied by timely updates on events, including planned and actual dates/times for these occurrences. Visibility goes beyond the passive and transactional aspects of traceability. While traceability maps the logistical interconnections between products and their ingredients, supply chain visibility seeks to provide insights into what transpired at each stage, involving individuals, processes, equipment, materials, and the resulting impact on food safety.

By accurately documenting the transition of food products from their origin to the point of sale, traceability in the food supply chain can optimize the efficiency of the food sector. This is attained through the transparency generated by traceability systems, which enables stakeholders to identify and address potential bottlenecks, streamline operations, and minimize waste, and furthermore, instilling consumer trust by offering them visibility into the source and quality of the food they consume, empowering them to make informed choices.

Current Status of FSMA 204: Food Traceability Rule

The FSMA Section 204, that is, the Food Traceability Final Rule, establishes additional record-keeping requirements for individuals involved in manufacturing, processing, or packing certain foods listed in the Food Traceability List (FTL). The rule applies to foods present in the FTL and foods containing those listed items as ingredients. The FTL includes various foods such as leafy greens, melons, peppers, sprouts, herbs, tomatoes, cucumbers, tropical tree fruits, shell eggs, nut butter, fresh-cut fruits and vegetables, deli salads, cheeses, finfish, and crustaceans.

The rule emphasizes collecting appropriate records of Key Data Elements (KDE) based on critical Tracking Events (CTE) in the food supply chain. KDE refers to standardized data containing crucial information that food companies must possess and share with their supply chain partners to quickly link a food safety incident to a specific product. CTE represents significant activities such as harvesting, cooling, packing, receiving, shipping, and transformation. The Traceability Lot Code (TLC) is a vital aspect of the rule, enabling the FDA to track food movement throughout the production system to prevent recalls. The TLC assigned to a product determines its traceability rate, enhancing overall traceability.

Entities subject to the rule must maintain records in the original paper, electronic data, or true copies and provide them to the FDA within 24 hours or a reasonable time frame as agreed upon for official review. Adhering to these guidelines presents food manufacturers and suppliers with a competitive advantage to comply with the rule and improve their approach to food safety oversight.

While striving for compliance with the Food Traceability Rule, food industry actors should take into account various challenges related to traceability information, differences in stakeholder processes, and technology. It is equally important to have appropriate action plans in place to effectively address these issues to attain compliance in time.

Data Governance and Privacy

In terms of data governance and privacy, data-sharing procedures for traceability purposes may require extra attention to protect privacy considerations. To effectively capture critical tracking events, modifications to architectural data systems might be necessary. Meanwhile, inconsistent data formats can create disruptions in sharing and using the data effectively, thus preventing interconnectivity among supply chain partners.

To harness the benefits of traceability strategies, it’s crucial to prioritize homogeneity, digitization, and unique identification throughout the entire system. Since data loses reliability and becomes costlier to maintain as it travels away from its origin, it’s best to establish effective standardization practices from the very beginning. Companies can explore using standards or frameworks to handle supply chain data, gain clarity on the data’s source and storage locations, and identify missing key data elements that need to be captured going forward.

Standardized System for Processes

With a multitude of stakeholders involved, each with their unique systems and practices, ensuring consistency and transparency becomes complex. Variable data formats, incompatible software systems, and varying levels of technological adoption further impede the exchange and tracking of information across the supply chain. Without standardized processes, it is difficult to institute an integrated system for traceability, resulting in fragmented records and incomplete data that hinder the identification of the source and path of a food product.

Companies should review their current procedures to identify any potential weaknesses to ensure traceability is not compromised. Unified data formats, compatible technologies, and common protocols for information exchange should be put into practice. It would enable a rapid response in case of recalls or contamination incidents, such that the industry can overcome these obstacles and ensure a more reliable and safe food supply chain.

Provision of Globally Unique Identifiers

Currently, numerous suppliers and producers do not adhere to a standardized system that allows the usage of globally unique identifiers. This means that some incoming products may not have scannable labels with lot codes, leading to a loss of traceability at the lot level. Also, labeling methods like labeling at the pallet level or combining different lots on a single pallet might not offer granularity, i.e., the level of detail required by the food traceability rule.

Keeping track of products as they progress through the value chain using a distinct lot code to maintain the physical-to-digital link is essential. Assessments involving checking if lot codes for food products are being recorded, determining where traceability might be lost within physical processes, and pinpointing any gaps in the physical-to-digital link are also recommended.

Transfer of Key Data Elements (KDE)

When essential data elements are shared between partners in the supply chain, there is a higher risk of compliance issues if upstream partners fail to provide the necessary traceability data for their own compliance. Moreover, there will be an increased dependency on suppliers for obtaining ingredient details, which might become more difficult due to the potential confidentiality of intellectual property. Employees at supply chain partners may need training to understand how the new culture of traceability practices affects their day-to-day tasks and responsibilities.

Adherence to the rule will probably demand extensive collaboration and coordination throughout a company’s supply chain. It will be necessary to introduce agreements among supply chain partners on mechanisms to exchange traceability data, encouraging the digitalization of such information. Therefore, company leaders should contemplate strategies to ensure suppliers and customers comply with traceability requirements, manage suppliers who may be exempt from certain obligations, and determine the most efficient and effective way to transmit traceability data to customers.

Management of Traceability Data

Updating processes to validate and record traceability data across the supply chain can add complications, especially when working with outdated legacy systems. If traceability data is scattered across various source systems, it might be necessary to centralize the information. This is particularly important if companies are required to provide the FDA with an electronically sortable document within 24 hours of the agency’s request. Organizations may also need to develop data-sharing systems that cater to stakeholders with varying levels of technological expertise.

The rule doesn’t specify any specific digital technologies to be used. Nevertheless, managing the huge volume of data needed for a granular level of traceability can be troublesome without digital records. Although adopting digital systems for lot-level traceability may seem expensive, it can greatly improve recall processes, which is a notable upside. In light of this, leaders should assess which supply chain technologies need adjustments or improvements to support data capture, how to handle the growing volume of traceability data that needs to be retained, and whether the management of traceability data will be done internally or by third-party services.

Inspecting the challenges faced by food enterprises to comply with FSMA section 204 by 2026, it becomes evident that it calls for the adoption of new solutions, particularly those driven by automation technology. This not only serves to fulfill the regulatory requirement but also opens doors for an industry-wide overhaul for a future of optimized food safety management. Thus, what initially appears as a regulatory requirement reveals itself as a chance to revolutionize the industry and achieve higher levels of food safety and quality assurance.

SmartFoodSafe Software Solutions as Enablers of Digital Traceability & Compliance to Food Traceability Rule

SmartFoodSafe’s manifold of software solutions offer end-to-end traceability for modern food production chains and equip the food sector to tackle barriers in achieving compliance with Food Traceability Rule. This is made possible with powerful characteristics such as a consolidated data source that connects people, processes, and information, documentation management, real-time access to product-related data, automated workflow for supply chain processes, complete visibility through thorough monitoring and trend analysis, and tech-enabled system to ensure that stringent quality and compliance standards are consistently upheld. By deploying automation and digitalization as tools, SmartFoodSafe not only enhances traceability capacities but also complements performance, integrity, and responsiveness throughout the food supply chain, promoting effective recall management and proactive quality assurance measures.