The FDA Food Traceability Final Rule: 7 Ways Aptean Food & Beverage ERP Helps Keep Your Business Compliant

In the survey portion of IDC’s 2022 Global Food and Beverage Industry Trends and Strategic Insights whitepaper commissioned by Aptean, participants ranked a lack of supply chain visibility and flexibility as the most problematic gap for their business if not addressed. Additionally, the combined topics of traceability and food safety were the second-most common focus from a risk mitigation perspective.

These statistics underscore the importance of being able to track raw materials and finished goods from one end of the supply chain to the other. In the United States, the compliance regulations on this front are increasing, with the Federal Register publishing the FDA’s Requirements for Additional Traceability Records for Certain Foods (also known as the FDA Food Traceability Final Rule).

While the FDA has stated that they aim to “educate while they regulate” and set a compliance date of January 20, 2026, your food and beverage company will be more prepared for the future if you implement the solutions you need now. The ideal approach is to set the foundation for your digital transformation with an industry-specific enterprise resource planning (ERP) system.

Looking for some context and background on the new regulations and what they entail? We’ve got you covered. We’ll also explore how Aptean's food ERP is built to keep your operations compliant, with purpose-built traceability tools and robust features that give you the supply chain visibility you need.

The Food Traceability Final Rule, Explained

Back in 2011, the landmark Food Safety Modernization Act (FSMA) was signed into law, setting new standards to which food and beverage manufacturers in the U.S. would be held. It effectively shifted the focus from reacting to issues toward preventing negative health outcomes resulting from unsafe products. The act also gave the FDA greater oversight of the industry’s supply chains and responsibility to enforce the legislation.

Various rules on specific food safety topics—including third-party certifications and sanitary transportation—have been created to put FSMA into practice, including the Food Traceability Final Rule. Designed to supplement Section 204(d) of the original act, the requirements’ main goal is to streamline the identification and rapid removal of potentially contaminated items from the market.

The new rule also dovetails with the New Era of Smarter Food Safety, which centers on leveraging technology and other modern tools to create safer and more traceable systems. Announced in July 2020, the blueprint was created to establish achievable goals to not only enhance traceability but also improve predictive analytics and address emergent business models.

One of the most significant components of the Food Traceability Final Rule is the Food Traceability List (FTL), which names 16 foods that pose an elevated safety risk, as identified by independent academic professionals and industry experts. It includes:

• Cheeses (excluding hard cheeses)

• Crustaceans

• Cucumbers

• Fin fish

• Fresh herbs

• Fresh-cut fruits and vegetables

• Leafy greens

• Melons

• Mollusks

• Nut butters

• Peppers

• Ready-to-eat deli salads

• Shell eggs (from domesticated chickens)

• Sprouts

• Tomatoes

• Tropical tree fruits

Notably, the additional requirements apply not just to these foods as individual items but also to products that contain them as ingredients. The FDA also added a provision that allows them to update the list at their discretion, so other foods may be added to the list in the future.

Meanwhile, the new recordkeeping standards established the concepts of Key Data Elements (KDEs) and Critical Tracking Events (CTEs) to specify what information must be captured and when for the goods on the FTL. Both were introduced in recommendations made by the Institute of Food Technologies back in 2012, but only now have they been embraced and codified by the FDA.

KDEs vary from product to product, but typically cover the most important characteristics, including origin, date of production, quantity and/or weight, shipping dates and, most importantly, traceability lot codes. CTEs align with steps in the supply chain, including creating, growing, receiving, shipping or transforming a food or beverage product.

Lastly, the Food Traceability Final Rule outlines what specific records must be provided to the FDA within 24 hours upon request in the event of a contamination or other food safety emergency. Documentation must include a description of all involved FTL products with relevant KDEs and CTEs, references to transfers in the supply chain and all associated traceability lot codes.

7 Features of Aptean Food & Beverage ERP that Help Ensure Compliance

Aptean Food & Beverage ERP is fully equipped with advanced traceability features to help keep your food and beverage manufacturing company compliant with the new standards. We understand the challenges that your business may face as a result of the latest legislation, and that’s why we’ve packed our offering with tools that will help you overcome these complexities.

Each of the following is a standard functionality of the system, meaning that modifications, customizations or add-ons typically won’t be necessary. Once you’ve successfully implemented the software with the help of Aptean’s teams, you’ll be ready to start leveraging these important features:

1. A perpetual inventory capability that allows you to create lot codes and define their attributes at an ingredient level so that you can drill down into key data and granular details. The same functionality also helps you keep codes organized and track them both backward and forward along the supply chain.

2. The ability to capture the supplier’s lot code at receiving—ideally with electronic integration via advanced shipment notices—to enable tracing of inventory back to its origin. New lot codes can then be assigned when transforming the item into a new SKU while maintaining the original for reference.

3. Automated definition of formulas and bills of materials (BOMs), as well as associated work orders. This helps you keep track of which ingredients go into which finished products, improves your control over material consumption and reduces the risk of human error leading to a violation.

4. Functionality to directly issue item lot codes to a specific work order. This allows you to associate individual lots, at an item level, to a production run to ensure that the materials consumed are those intended for the given use case.

5. A tool to automatically generate new lot codes using a logical method that can be described to the FDA. As the enforcing agency, the administration requires that your coding methods are clearly defined and documented, and this feature helps you meet that requirement.

6. Tracing functionalities that can help you quickly identify the source lot and follow it forward to identify affected shipments. The same tools also record and maintain the contact details of supply chain partners and can export all relevant traceability data to a sortable spreadsheet.

7. Formal recall letter generation via an integrated customer relationship management (CRM) module. This complements tracing functionalities that can identify the contaminated ingredients’ origins and affected products downstream to initiate the recall process in under two minutes.

Aptean: Not Just a Software Provider, but a Partner

As a food and beverage professional, you know just how crucial full FDA compliance is and how complex the matter of traceability can be in busy manufacturing operations like yours. The good news is that you don’t have to take on the new requirements of the Food Traceability Final Rule without the solutions you need to tackle them—we’ve got your back.

With our decades of collective industry expertise, we know well how complex the food and beverage market can be and how vital bidirectional tracking is for food safety. We have an in-depth understanding of both the best practices that modern manufacturers should implement as well as the nuances that come with the various subverticals in the space.

What’s more, we offer flexible cloud deployments on the Software as a Service (SaaS) model that easily scale as your business grows, help unlock potential cost savings and provide better data protection. This implementation method also helps you get back up and running faster after a disruption and facilitates integration with other software.

Finally, Aptean’s food ERP software has the edge on alternatives thanks to unique, industry-specific technology built on the Microsoft Dynamics 365 Business Central platform. That gives the solution a user-friendly and intuitive interface, minimizing the need for extensive training and allowing your organization to start enjoying the benefits of digital transformation sooner.

So, ready to learn more about Aptean Food & Beverage ERP and how our software can help keep your business compliant with the Food Traceability Final Rule? Contact us today or request a personalized demo.