Traceability in the Era of Smarter Food Safety

As a first step towards its goal of enhancing traceability systems in the food sector, the US Food and Drug Administration (FDA) has released a final rule on ‘Requirements for Additional Traceability Records for Certain Foods’.

The rule mandates the use of standardised key data elements pertaining to seven critical tracking events along the supply chain of foods at particular risk of contamination.

FDA Deputy Commissioner for Food Policy and Response, Frank Yiannis, called this federal regulation a ‘landmark rule’ that would be ‘nothing short of a game-changer for the food industry’.

‘This regulation will help fill critical gaps in a traceability system that has been largely paper-based and lacking standardisation. Previously, we took one step forward to identify where the food has gone and one step back to identify the previous source, without a harmonised approach to the data elements needed to do this effectively,’ said Mr Yiannis.

All parties concerned by the rule will have until January 2026 to comply with it. The rule establishes traceability record keeping requirements, beyond those already applied under other regulations, for foods included on a Food Traceability List (FTL).

These range from fish to soft cheeses to nut butters to several types of fresh fruits and vegetables.

The rule requires those who manufacture, process, pack, or hold foods listed on the FTL to collect and maintain records of key data elements (such as type and quantity of food, and location and date of harvesting/processing), for seven critical tracking events: harvesting, cooling, initial packing, first land-based receiving (from a fishing vessel), shipping, receiving, and transformation.

Each participant must share their key data elements with the next recipient of the food. This allows information to be more easily connected so that a food can be tracked from farm to retail.

The information can be stored as paper or electronic records, on- or off-site, as long as it can be provided to the FDA as an electronic sortable spreadsheet within 24 hours of a request.

In addition, all FTL foods must carry an associated traceability lot code, which is assigned during initial packing, first land-based receiving, or transformation. The code consists of a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the participant who has assigned the code. Once a food has received a lot code, the records required at each critical tracking event must include that code.

The new traceability regulation is a key component of the FDA’s ‘New Era of Smarter Food Safety Blueprint,’ ¹ launched in 2020, which aims to advance the use of end-to-end, technology- enabled traceability throughout the food safety system.

Encouraging low-cost technologies

While the FDA’s focus is on interoperability, governance, and the use of common terminology, rather than on specific solutions, it is encouraging traceability technology providers to develop creative, low-cost, financial models that are accessible to food producers of all sizes. The FDA is convinced that many producers will voluntarily leverage digital traceability tools to facilitate compliance, if they have access to such models.

To this end, in 2021, the FDA launched the ‘New Era of Smarter Food Safety Low- or No-Cost Food Traceability Challenge’. 90 teams of entrepreneurs and thought leaders from the world over participated in the challenge, which culminated in the selection of 12 winners ².

The winners included established companies such as Kezzler and atma. io (an Avery Dennison company), as well as smaller operations such as FarmTabs and Freshly. In many cases, the winning companies offer serialised, unit-level traceability, based on 2D barcodes or NFC/ RFID tags. In some cases, the companies propose the use of blockchain, and include mobile apps in their offering.

While FDA, as a technology-agnostic organisation, does not endorse or specifically recommend the solutions of the companies participating in the Challenge, these solutions represent a snapshot of tools that could be considered when developing traceability systems.

Ripple effect

The FDA’s vision for food safety is not confined to specific food groups. Nor is it confined within US borders. Rather, the FDA intends to play a lead role in promoting governance and harmonisation between US and international regulatory counterparts through bodies such as GS1 and Codex.

Frank Yiannis sees the new traceability regulation producing a ripple effect across the global food system.

‘As food is a global asset, the foods on the Food Traceability List will be required to comply with recordkeeping requirements in order to be sold in the United States, whether sourced in the US or abroad,’ he said. ‘I believe that other nations will follow FDA’s lead and develop their own harmonised traceability requirements and infrastructures. In today’s global food system, borders between nations are blurred in the face of our shared commitment to food safety for consumers worldwide.’ While the FDA’s focus is, clearly, on safeguarding public health by being able to more quickly identify contaminated food and remove it from the market, enhanced traceability systems would also allow for the increased detection of food fraud.

It is for this reason that the FDA’s initiatives towards creating a new era of smarter food safety are also highly significant for other stakeholders, such as government tax authorities and authentication solution providers. These groups would therefore do well to keep a close watch on FDA developments in this domain.

1 - www.fda.gov/media/139868/download 

2 - www.fda.gov/food/new-era-smarter-food-safety/meet-winners-fdas-low-or-no-cost-food-traceability-challenge