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The future of food traceability: Insights into the FDA’s new rule

Why is food safety important?

“The doctor of the future will no longer treat the human frame with drugs, but rather will cure and prevent disease with nutrition.” – Thomas Edison

For survival and optimal health, proper nourishment is essential. However, it’s crucial to know that unsafe food can harbour harmful bacteria, viruses, parasites, or chemicals that pose significant health risks, including severe illness or death. Ensuring food safety is a collective responsibility shared by every supply chain member. From farmers to retailers, each participant plays a vital role in maintaining the security of the food they provide, necessitating careful attention and adherence to food safety practices.

What is FDA’s new traceability rule?

The FDA’s new traceability rule is part of the Food Safety Modernization Act (FSMA). It aims to enhance food traceability throughout the supply chain. Under this rule, certain foods designated as “high-risk” must establish and maintain additional traceability records. These records should enable the FDA to quickly and accurately trace the origin of a food product in case of a foodborne illness outbreak or other food safety incidents.

The new rule focuses on the Food Traceability List (FTL), which includes specific food commodities prone to safety risks, such as fruits and vegetables, dairy products, shell eggs, and more. The FTL will be expanded over time to include other foods.

How does this rule work?

The Food Traceability Final Rule mandates the establishment of a traceability data association for food products listed in the Food Traceability List (FTL). This requirement applies to both domestic and foreign food manufacturers, processors, and packagers, as well as any food companies, regardless of origin, that sell or distribute food intended for consumption within the United States and includes ingredients that are listed on the FTL.

The Food Traceability final rule consists of two essential components, which necessitate the following actions from firms:

  • Ensure the maintenance of records that encompass Key Data Elements (KDEs).
  • Associate the previous records with Critical Tracking Events (CTEs).

All individuals and entities participating in the supply chain process are responsible for maintaining and providing Key Data Elements (KDEs) to both their supply chain partners and the FDA. The FDA has identified specific data points known as Critical Tracking Events (CTEs) that hold the utmost importance in achieving enhanced traceability across the supply chain, thereby contributing to higher food safety. It is important to note that the KDEs and CTEs can vary depending on the product type and the specific activities within the supply chain. Therefore, no universal guideline applies to all food products listed on the Food Traceability List (FTL).

Upon receiving a data request, it is essential to promptly provide the Key Data Elements (KDEs) to the FDA within 24 hours or within a mutually agreed reasonable timeframe.

When do companies need to comply?

The deadline for compliance with this regulation is January 20th, 2026, for all corporations impacted by it. While it may appear to be a distant date, it’s essential to consider the comprehensive list of requirements that numerous companies need to follow. Moreover, these companies are obligated to exchange information with one another across the entire supply chain. The FDA emphasises the significance of having all entities subject to the requirements achieve compliance by the same date, as it is deemed the most effective and efficient approach. This extended timeframe allows ample opportunity for simultaneous compliance among all stakeholders.

How is traceability beneficial for complying with this rule?

The FDA’s new traceability rule under the Food Safety Modernization Act (FSMA) aims to enhance food safety by implementing stricter recordkeeping requirements throughout the food supply chain. Traceability plays a crucial role in meeting these requirements. Here’s how traceability helps with compliance:

  • Product Identification: Traceability enables the unique identification and tracking of food products throughout the supply chain. Each product is assigned a unique identifier, such as a barcode or QR code, that contains essential information about its origin, processing, and distribution.
  • Recordkeeping: The FDA’s traceability rule mandates detailed recordkeeping of Critical Tracking Events (CTEs) and Key Data Elements (KDEs) at various supply chain stages. Traceability systems facilitate capturing and storing this information, ensuring accurate and reliable records are maintained.
  • Rapid Response to Recalls and Outbreaks: In a foodborne illness outbreak or product recall, traceability allows for quick and targeted identification of affected products. With the ability to trace products back to their source, companies can swiftly remove contaminated items from the market, preventing further harm to consumers.
  • Supply Chain Transparency: Traceability promotes transparency by providing visibility into the movement and handling of food products. It enables stakeholders to access relevant information about a product’s journey, including its origin, processing, storage conditions, and distribution channels.
  • Compliance Verification: Traceability systems facilitate easier compliance verification by enabling the efficient retrieval and sharing of the required information. In case of an audit or inspection, companies can provide accurate and complete records, demonstrating their adherence to the traceability rule.
  • Improved Food Safety Practices: By implementing traceability systems, companies are encouraged to adopt robust food safety practices. The ability to track and trace products motivate better quality control, more effective risk management, and faster response to potential safety issues.

    Traceability is a critical component of complying with the FDA’s new rule. It enables accurate recordkeeping, rapid response to incidents, transparency, and enhanced food safety practices throughout the supply chain.

Conclusion

The FDA’s new traceability rule represents a significant step towards ensuring transparency and accountability in the food industry. By implementing a robust traceability solution like ours, brands can effectively navigate the complexities of the rule and streamline their compliance efforts. Our blockchain-enabled solution offers multi-tier ESG data collection, aggregation, and traceability, empowering companies to execute ESG strategies, meet regulatory requirements, and mitigate risks.

With our Supply Chain Traceability & ESG Intelligence suite, brands can enhance supply chain transparency, improve product traceability, and gain a competitive edge in the market. By embracing traceability, brands can build consumer trust, enhance brand reputation, and contribute to a more sustainable and responsible future. Together, we can forge a path towards a safer, more transparent, and resilient food supply chain.

To learn more about how RightOrigins, our Supply Chain Traceability and ESG Intelligence suite can
support your ESG & Sustainability goals for 2024 & beyond, consult with our in-house expert.

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