13 Common Questions Asked About FSMA 204
July 17, 2023
iFoodDS is committed to helping those who must comply with FSMA 204 – also known as the Final Food Traceability Rule – understand what’s asked of them and what resources are available to help. The rule is complex and, for the first time, FDA is requiring anyone covered by the rule to establish and maintain a Traceability Plan.
1. When does FSMA 204 take effect?
The compliance date is January 20, 2026, which means the time is now to start formulating that plan if your organization manufactures, processes, packs, or holds at least one food on the Food Traceability List (FTL), for which additional recordkeeping is required.
That realization has prompted questions about next steps, especially from our grocery and foodservice customers. What follows are some of those questions with links to resources that we hope will help smooth the way forward.
2. Why do I need to comply with FSMA 204? What happens if I don’t?
The overarching goal of FSMA 204 is to allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths.
At its core, the rule requires companies that manufacture, process, pack, or hold foods on the FTL to maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs). They must provide that information to FDA within 24 hours or within a reasonable time to which the FDA has agreed.
All that said, this is a rule – not a suggestion. There are various actions the government can take if voluntary compliance is not forthcoming. These include civil or criminal actions in Federal court. An imported product can be refused admission to the U.S. marketplace if the recordkeeping requirements have not been met.
3. Are there any benefits beyond being in compliance?
Many companies recognize that FSMA 204 is going to cost them more money and add more work for their teams, which may already be overworked and short-staffed. This said, there are many benefits to managing by traceability lot and date code, including improved food freshness and reduced food waste.
However, the primary benefit is a world in which consumers know that the food industry is doing everything it can to keep them safe from contaminated food. The benefit is a world in which billions of dollars aren’t lost every year from lost productivity by sick workers. In short, the benefit is public health and we all have a stake in that.
It’s also good business. Food traceability data will provide valuable insights into your supply chain, enabling you and your trading partners to make proactive sourcing decisions. That can lead to improved quality, stronger supplier relationships, and greater returns on your investment.
4. How do I manage suppliers with different levels of sophistication?
There is no one-size-fits-all when it comes to managing your network of suppliers. The consideration you give to each one must be unique, depending on the format they will use to transmit KDEs and the means of communication that is most effective in reaching them.
In communicating your data collection requirements to your suppliers, it is critical to stress that while they must have the ability to collect, store and share data as required for FSMA 204 compliance, the process and/or solution they choose should be one that is best for their specific organization.
5. Some of my supply chain partners are refusing to comply and want to wait until 2026 to figure out a plan. How do I convince them they need to do this?
Once again, communication is key. Companies that produce safe foods are prepared and, ultimately, their reputation will suffer if that is not the case. In addition to your powers of persuasion, we strongly recommend writing a schedule for meeting your traceability requirements into your contract.
6. What information do my suppliers need to share with me? For example, do they need to share their harvest and cooling records?
The rule stipulates that you must maintain records containing the following information about the food:
- The traceability lot code;
- The quantity and unit of measure;
- The product description;
- The location description for the immediate previous source and for where the food was received;
- The date you received the food;
- The location description for the traceability lot code source, or the traceability lot code source reference; and the reference document type and number.
For foods received from a person who is exempt from the rule, if a traceability lot code is not assigned, you must assign one. The traceability lot code source would be the location where the food was received.
Lot-based recordkeeping is not required at harvest or any point before initial packing or first land-based receiving.
7. What are the four giant numbers in the lower right-hand corner on my traceability label and how do those help me with compliance?
Those numbers are the Voice Pick Code, which was designed to eliminate the need to scan long bar codes at large distribution centers. It’s a short digital signature based on the Global Trace Item Number (GTIN), Lot Code and optional Date. The role of the Voice Pick Code is to provide a quick and simple way to identify a case. For example, you could use it to sort a mixed pallet into single lot pallets or verify that the advanced ship notice information matches the delivered products. Stores and restaurants could use it as a simple way to confirm actual lots received.
8. Will the industry come up with one universal solution?
No, the final rule does not require specific technologies for the maintenance of records and the food industry is really too large and complex for a universal solution. Rather than pick a specific technology, the food industry has elected to use a single technology standard (GS1). You should pick the technology that works best for your operation as long as the records are interoperable with trading partners, legible, and stored to prevent deterioration or loss. Per the rule, they may be kept as original paper or electronic records or true copies (such as photocopies, pictures, scanned copies, or other accurate reproductions of the original records).
9. What’s so special about a Traceability Lot Code (TLC)? Are the Lot Codes I assign today sufficient? Do I need to have GTIN in my TLC?
The Traceability Lot Code is a key component of traceability, one that must be shared with the next step in the supply chain along with relevant KDEs. The short answer is yes, you can use the lot codes you assign today if they meet the criteria for a true traceability lot code. FDA wants the industry to go beyond lot assignment for the sake of internal identification and tracking. Under FSMA 204, businesses need to create traceability lots, each with its own lot code assigned at distinct points in the supply chain and must link that code to other KDEs.
If you are using GS1 standards, your TLC includes the GTIN and an internal batch/lot number. You can use the Lot Codes you assign today because the traceability lot code source location description provides a way for FDA to ask you about your TLC, but if you drop the GTIN, you will make receiving harder for your customers and you will lose a lot of rich data. A GTIN provides a common language for trading partners worldwide to uniquely identify and communicate information about the item.
For more information on Traceability Lot Codes, read this Traceability Lot Code FAQ written by our friends at New Era Partners.
10. If I donate food, do I need to record shipping KDEs?
No. If you are donating food to a nonprofit food establishment or other entity you would not be required to keep records of the shipment of the donated food. If you are selling the food, however, you do have to keep records.
11. Retail Distribution Centers: Do I need to record shipping and receiving KDEs when cross docking?
No, a distribution center that qualifies as a cross-dock is not required to capture shipping and receiving KDEs. From FDA, in a cross-docking situation in which food is arranged for transport from point A to point B, but it is briefly placed on a loading dock at an intermediate location (point X) to be transferred from one truck to another truck, it would not be considered that the food was shipped to point X (or was received at point X). Therefore, records would not need to be kept for point X.
This may change if any actions are taken at point X, such as breaking down a pallet or holding the shipment under temperature-controlled conditions that differ from transportation conditions.
12. Store to store or distribution center to distribution center, do I need to record shipping and receiving KDEs?
Yes. All entities covered by the rule, including both supermarkets and supermarket distribution centers, must establish and execute a traceability plan when shipping foods on the FTL even if they are under the same ownership or operational control. This includes recording shipping KDEs when food on the FTL leaves distribution centers and receiving KDEs on food received by stores.
13. How often will FDA be changing the FTL?
FDA says it plans to update the FTL about every five years. You will have opportunities to weigh in. For example, stakeholders will be able to submit data for FDA to consider related to the Risk-Ranking Model on which the list is based. Once the amended list is proposed, there will be opportunity for public comment. Any deletions would be effective immediately but any additions would become effective two years after they are announced in the Federal Register.
Learn More About FSMA 204 Compliance
While we are covering the most common questions we hear, we have extensive articles on what you need to know about the various aspects of FSMA 2004. You can learn more by visiting our FSMA Rule 204 Information Hub.
As you work on your compliance plan, you might consider enlisting the help of traceability experts for guidance tailored to your organization. iFoodDS had a key role in launching New Era Partners, an advisory service providing objective, independent advice.
A conversation with someone who knows the rule inside and out will help you decide your plan of action. You’re not in this alone.