Last month, the U.S. Food and Drug Administration (FDA) released its first sortable spreadsheet template to outline traceability requirements. It is a step closer to the obligations set out in the U.S. Food Traceability Final Rule 2022, which governs certain types of fresh fruit and vegetables, cheese, shell eggs, seafood products, nut butters and deli salads included in the Food Traceability List (FTL)¹.
The Food Traceability Final Rule and stakeholders
In 2011, the U.S CDC (Centres for Disease Control and Prevention) estimated that one in six² Americans become ill or die from foodborne illness each year. The FDA published a new food traceability final rule in 2022, to help address this issue. The new rule is designed to enable faster identification and rapid removal of potentially contaminated food from entering the U.S. market. Manufacturers, packers, processors or those who are responsible for holding food under the FTL must comply by January 20, 2026¹. Essentially, the rule requires these organisations to undertake additional and specific record-keeping activities to maintain complete traceability from farm to fork.
Data and format requirements of the Food Traceability Final Regulation
Lot Codes
In addition to a traceability plan, the FDA has outlined the need for traceability lot codes, which enable the FDA to identify the organisations that have handled the product. By understanding how the product moves through the supply chain and the different stages of the food cycle, the FDA can begin to understand where an outbreak originated.
CTEs and KDEs
In addition to the codes, there are also Critical Tracking Events (CTEs) and Key Data Elements (KDEs) required by the FDA, which have been made more explicit in this new template. The data requirements are in accordance with 21 CFR Part 1 Subpart S of the regulation, which also specifies that the data must be submitted as a sortable electronic spreadsheet.
Spreadsheet
Routine inspections will begin in 2027³ following compliance in 2026. Manufacturers, packers, processors or those in possession of the product must submit a fully sortable electronic spreadsheet¹ (link to template from the FDA site) upon FDA request within 24 hours. This data must be retained for a minimum of two years.
Automated solutions to support initial packaging traceability data practices
Integrated business systems
AutoCoding Systems is a world-class software product for automatic line set-up of food packaging lines. Our packaging line control solutions have been installed on around 2000 packaging lines on three continents. As a workflow-based solution, we can interface with business and planning systems, meaning that information such as products, weight, packaging, quantity, country of origin, harvest location, relevant contact details and more can be incorporated into the AutoCoding master database. This contextual information can support dynamic data captured from packing line equipment such as line counts, temperature, gas content, metal detection etc., combined with data capture from front-line workers, which can be used for different applications in our modularised solutions.
Paperless quality
From our data acquisition and data reporting and visualisation module, such as Paperless Quality, customised reports can be set up to comply with the new Food Traceability Final Rule.
Keith Prior, AutoCoding Systems Sales Engineer based in the USA, said:
“We have seen a lot of interest in packaging data capture recently, particularly from a quality perspective. Food manufacturers are recognising the value of capturing data electronically where previously it was all manually recorded on paper. Companies have a desire to automate and are looking to fill any process gaps for a complete digital factory – we can certainly help with this when it comes to the packing process.”
“The great thing about AutoCoding’s solutions is that it’s all about empowering the frontline to make decisions by presenting information. Whether it’s communicating information about the packaging errors, pulling statistics from devices on the packing line, or even reporting real-time live information from a remote device, our solutions support this ideology of getting it right the first time. As we are able to organise unique coding, all of this plays a part in the creation of a system that supports traceability”.
Unique coding for traceability
The FDA does not specify the format for traceability lot codes. However, the lot code must be unique in order to be identified at the source. AutoCoding Systems can assist with unique coding and ensure an appropriate audit trail is automatically captured for traceability.
Label verification and date code control
Of course, when it comes to food safety and quality-related standards, we can’t ignore the role that packaging verification and date code control plays in ensuring traceability. This is one of the fundamental products offered by AutoCoding System. An ‘AutoCoding System’ automates the process of verifying the packaging and the printing of the date codes. When changes are made on the packaging line, the AutoCoding System automatically captures this through a series of line events with associated timestamps, responsible operators and escalated procedures that were in place during the packaging production run.
The AutoCoding System is able to verify unique coding or marking, such as 1D and 2D codes, associated with the correct version of packaging to be used. The ability to verify labels and provide date code control greatly minimises the risk of human error while ensuring that the correct date codes are always applied. To find out more about AutoCoding System’s solutions and how they can help you meet the requirements of the Food Traceability Final Rule, please contact us. Ask for a demonstration of our AutoCoding Systems and paperless quality modules, or ask for assistance in implementing unique coding.
Source:
- Food & Beverages, Last updated 27 June 2024, ‘FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods,’ FDA.
FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods | FDA - CDC, 2011, ‘Burden of Foodborne Illness: Findings’, CDC.
Burden of Foodborne Illness: Findings | Estimates of Foodborne Illness | CDC - Food & Beverages, Food Safety Modernization Act, Last updated 20 March 2024, ‘Frequently Asked Questions: FSMA Food Traceability Rule, FDA.
Frequently Asked Questions: FSMA Food Traceability Rule | FDA