The following post is a contribution from Shane Morris, Business Development Director at GS1 US, a not-for-profit information standards organization that collaborates with business and industry to encourage the adoption and use of GS1 Standards-based solutions that can help improve business processes.
In November 2022, the FDA published legislation which implements Section 204(d) of the Food Safety Modernization Act (FSMA). This is often referred to as FSMA 204, or the Final Rule, and it requires companies to keep additional records for designated foods to protect public health.
Essentially, the FSMA 204 final rule establishes the framework for end-to-end traceability throughout the food industry. The requirements outlined in the final rule will assist the FDA in more rapidly and effectively tracking the movement of food to prevent or mitigate a foodborne illness outbreak and to address potential recalls.
Businesses have until January 20, 2026 to comply with the FSMA 204 final rule. While that may seem a long way off, businesses throughout the retail grocery and foodservice industries can start preparing now, using the resources GS1 US and the GS1 US FSMA 204 Workgroup developed. For more information visit gs1us.org/foodsafety.
Why is FSMA 204 important?
Despite being limited to certain foods, the Final Rule establishes a first-of-its-kind standardized approach to traceability recordkeeping, paving the way for the food industry to adopt and use more digital, tech-enabled traceability systems both in the near term and the future. This helps protect consumers by more quickly identifying the source of contaminated products, limiting the scope of recalls, and reducing the risk of foodborne illness or death.
The intended benefits of FSMA 204 include:
- Fewer foodborne illnesses/deaths
- Faster identification of the source of contamination
- Rapid removal of contaminated food from the market
- Limit the scope of recalls
- Harmonized information
- Establishing linkages along supply chains more quickly
- Enhancing the ability to conduct root cause investigations to identify and apply lessons learned from outbreaks
What is included in the Food Traceability List?
The final rule includes a Food Traceability List (FTL), which identifies specific high-risk foods that are subject to additional recordkeeping requirements. These high-risk foods include most fresh cut fruits and vegetables, tree fruits, herbs, most leafy greens, soft cheeses, shell eggs, nut butters, select seafood species, and ready-to-eat deli salads. Make sure to check out the Food Traceability List to see if your company or trading partners are subject to these recordkeeping requirements, as there are some exemptions.
What are the FDA Food Traceability Requirements?
If you manufacture, process, pack, or hold any of the foods on the Food Traceability List, you are required to keep additional records on specific supply chain events. Supply chain events (referred to as Critical Tracking Events or CTEs) that require additional records include harvesting, cooling, initial packing, first land-based receiving (for seafood), shipping, receiving, and transformation. Along with these events, certain attribute information (referred to as Key Data Elements or KDEs) is required to be captured and some need to be shared with downstream partners.
These records may be kept as original paper records, electronic records, or true copies. Additionally, companies must provide an electronic sortable spreadsheet containing specific information FDA requests. These records must be made available, upon request, to an authorized FDA representative within 24 hours.
How is GS1 US involved with FSMA 204?
GS1 US is a non-profit organization that facilitates supply chain visibility and efficiency through the use of GS1 Standards, which are the most widely used supply chain standards system in the world. Hundreds of thousands of companies use GS1 to help optimize their supply chain, drive cost performance and revenue growth, while also enabling regulatory compliance.
New GS1 US initiatives in the food service and retail grocery industries help address challenges where GS1 Standards can have a positive impact in enhancing data quality, enabling end-to-end supply chain visibility, and improving operational efficiencies.
How can GS1 US help companies prepare for the FSMA 204 requirements?
The GS1 US offers the GS1 US FSMA 204 Workgroup, which brings together industry leaders. This Workgroup has created a guideline on how to use GS1 Standards to help meet the Final Rule requirements called the GS1 US Application of GS1 System of Standards to Support FSMA 204. This guideline outlines best practices on how GS1 Standards can be adopted to make traceability programs more scalable, accurate, and interoperable while helping to meet FSMA 204 requirements. The guideline excludes the point of consumption and is limited to batch/lot traceability. If you are interested in joining this workgroup, please reach out to foodsafety@gs1us.org for information.
For a more personalized approach, GS1 US Advisory Services can offer a combination of technical and business expertise to address specific challenges your organization may face in integrating the GS1 System of Standards into your operations. For more information visit: https://www.gs1us.org/foodsafety.
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GS1 US employees are not representatives or agents of the U.S. FDA, and the content of this presentation has not been reviewed, approved, or authorized by the U.S. FDA. Each company is individually responsible for meeting all statutory and/or regulatory requirements for their company and their products. Consult with your company’s legal counsel or compliance team (regulatory or quality) for more specific information about current statutory and regulatory requirements applicable to your company and products.
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