In September, the Food and Drug Administration (FDA) announced a new proposed rule regarding food traceability. This rule, which would be part of section 204 of the Food and Safety Modernization Act (FSMA), establishes event tracking requirements for specific foods and ingredients throughout the supply chain.
Many food and beverage manufacturers had anticipated this rule, and some already participate in programs like the Produce Traceability Initiative, which have similar standards. But the new requirements will still have a significant impact on the industry, especially for companies that still rely on manual processes. To keep from getting bogged down in time-consuming and error-prone data entry, food and beverage producers need an integrated EDI solution that is built with traceability in mind.
What Is the Food Safety Modernization Act (FSMA)?
The Food Safety Modernization Act itself is not new; the original act was implemented in January of 2011. Prompted by a wave of produce recalls in the early 2000’s (remember when we couldn’t buy romaine lettuce?), the FSMA sought to revolutionize food supply chains to prevent foodborne illnesses. It was also designed to help the FDA respond to, and control, foodborne illnesses if/when they do occur.
The FSMA gave the FDA more authority over processes like recalls, but also required the agency to create and set specific rules and create guidance documents to help businesses comply to their standards. Section 204 outlined requirements for plans that would “enhance” food tracking and tracing, including a requirement for new “Additional Recordkeeping Requirements for High-Risk Foods,” also known as the New Proposed Food Traceability Rule (it’s in subsection (d) if you want to give it a read).
What Is the New Proposed Food Traceability Rule?
The New Proposed Food Traceability Rule sets new recordkeeping requirements for foods that are considered “high risk” for foodborne illness. These rules are in addition to the existing requirements already covered by regulations like the Federal Food, Drug, and Cosmetic Act. The full document is 55 pages long, and impacted businesses should read it thoroughly to understand the rule—but here are the basics:
- First, the rule establishes a Food Traceability List, which outlines which foods will need additional recordkeeping. These were chosen based on their level of risk for carrying illnesses like e. coli and others.
- Second, the rule identifies four Critical Tracking Events (CTEs) throughout the food supply chain: Growing, Receiving, Transforming, and Shipping. Each of these “events” has several Key Data Elements (KDEs) which need to be reported on.
Here’s an example of how it will work. Let’s say your company receives tomatoes from farmers and distributes them to grocery stores. As a “First Receiver” (the first party to receive the food, who is not a consumer or end customer), you would be responsible for keeping a record of incoming tomato batches, commonly referred to as lots. As each lot arrives at your facility, you’ll need to record the following Key Data Elements:
- Traceability Lot Code: if one hasn’t been created yet, you’ll need to assign a code to the lot
- Location identifier for the origin of the food (the farm)
- Contact information and business name of the originating farm
- The date and time the tomatoes were harvested
- Location information for anywhere/anytime the tomatoes were cooled/stored
- Location information, plus date and time that the tomatoes were packed into crates
If you were a “Transformer” like a marinara sauce company, who receives tomatoes and makes sauce, you would also need to record KDEs for locations, times, and dates involving the tomatoes; additionally, you’d also need to record the quantity of sauce you made using that lot of tomatoes. And you’d need to create a NEW lot tracking code for the finished product: the sauce!
Here’s what it comes down to: from the moment those tomatoes are harvested, every time they are moved or used, that activity needs to be tracked. That way, no matter how those tomatoes appear to consumers—as produce, canned varieties, sauce, or anything else—both you, your customer, and the FDA will be able to trace them all the way back to the farm.
How Can EDI Technology Help with Food Traceability?
When a Critical Tracking Event happens, you will likely input the KDEs into your manufacturing system, ERP system (be it Microsoft Dynamics, NetSuite, Sage, or another solution) or other internal platforms. This creates an electronic record, fulfilling one aspect of the new proposed rule’s requirements. However, you’ll also need to receive tracking data and KDEs from your upstream partners like farmers or suppliers and deliver it to downstream partners, if you have them.
Here, integrated technology can play a key role. Take the example of creating an EDI 856 Advance Shipping Notice (ASN) for an order. Without integration, your team would need to rekey product traceability KDEs from your internal system into each ASN field for each shipment. Additionally, those fields may change from customer to customer.
First off, entering all that data by hand is time consuming and costly; it requires significant overhead, and can limit your growth potential. You may also have issues meeting customer mandated ASN timeframes. Second, manual data entry is error prone. In general, data errors can be costly to your business, resulting in returns, chargebacks, and other issues. But in the case of the new food traceability requirements, mistakes in KDE reporting could result in more severe consequences.
When a foodborne illness arises, incorrect food tracking information could result in broader mandatory recalls, which result in product and sales losses. What’s more, because consumer protection laws require manufacturers and suppliers to pay for product recalls and their associated costs, the losses are compounded. The FDA may also choose to audit your business to ensure other mistakes in your processes don’t put the public at risk. Violations of the FSMA, such as non-compliance, are also criminal acts.
Integrated technology like cloud-based EDI helps prevent these issues and protect your business. If you’re a supplier, an integrated EDI solution can pull traceability information from your ERP or Warehouse Management Solution and automatically populate KDEs on documents like an ASN. The best EDI solutions are supported by proactive monitoring and mapping updates, which ensure your ASNs have the right required fields, and are properly filled in before sending. The result? No time or resources wasted on data entry, no costly typos, and better compliance with both your trading partners and the FDA.
The same idea applies to retailers and other buyers. Using integrated EDI, you can receive, translate, and send the relevant lot information to your ERP automatically. And finally, you can also use integrated EDI to source lot numbers and other KDEs from 3PLs and warehouses that receive, store, cool, and ship products on the Food Traceability List. That way, you’ll have all the right information at your fingertips if the FDA ever comes a-knocking.
Make Sure Your Business is Ready
No matter where your business lies on the food supply chain, you are responsible for creating, recording, and communicating food traceability elements required by the FDA. Integrated EDI makes it easier to stay compliant by automating data communication to all your systems and partners. In doing so, you can safeguard your company while also protecting the public from foodborne illnesses.
The proposed rule is open for comments on the Federal Register until January 21st, 2021, after which the FDA is expected to issue a “final rule.” The final rule would go into effect 60 days after its publication in the Federal Register, and the compliance date (by which all impacted businesses must be compliant) would be 2 years after that.
By investing in integrated EDI now, you can ensure you’ll be prepared when the final rule goes into effect. You might also enjoy some of the other benefits of EDI, like cost savings, increased sales, new trading partner opportunities, and more! Ready to get started? Contact us today to speak with a specialist about your EDI needs.