The word “transformation” is commonly understood to mean a thorough change in form or appearance. However, for the manufacturers and processors of certain foods, it’s more than that. For them, that word both describes their work and represents new record-keeping requirements designed to enhance the traceability of the foods they produce through the global supply chain.
FSMA 204’s Critical Tracking Events (CTEs)
Transformation is one of seven Critical Tracking Events (PDF download) established by FSMA 204, FDA’s Final Food Traceability Rule. The others are harvesting, cooling, initial packing, first land-based receiving, shipping, and receiving. These are junctures in the food supply chain at which traceability records called Key Data Elements are collected.
Of particular importance to food manufacturers and processors, the Transformation CTE targets the kind of work they do to create food products. Thus, there is a specific set of data required and, in most cases, a new traceability lot code.
New Era Partners is committed to helping those who must meet these new requirements understand the rule. So, let’s take a step closer to look at what is required of those covered by the Transformation CTE.
What is Transformation Exactly?
The final rule defines “transformation” as manufacturing and/or processing a food, either using ingredients on the Food Traceability List (FTL) or by producing a food that itself is on the list. The foods on this list are ones that FDA has identified as requiring additional recordkeeping to protect public health.
Transformation can also be changing a food on the FTL by, for example, comingling foods from different suppliers, or changing the packaging or packing (including relabeling). FDA considers repackaging (and repacking) to be transformation events because they may introduce contamination, and have the potential to impede traceability by dividing one lot into several lots, or by commingling lots.
When is a New Traceability Lot Code Required?
A key requirement under transformation is the creation of a new traceability lot code (TLC) because this is essentially a new product. Otherwise, the only other time a TLC is created is during the initial packing of a food on the FTL. The TLC, a key component of traceability, is a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the company’s records, enabling the FDA to make linkages within a company and across a supply chain.
There are certain times when a new TLC would not necessarily be required, such as when whole fresh produce is repacked within the same traceability lot. For example, if tomatoes within the same traceability lot are transported to a distributor, where they are ripened, sorted, washed, and repacked, the TLC could be changed or the TLC of the original lot could be retained. However, because repacking is considered transformation, a new traceability lot code source would be required to identify who did the repacking and the required KDEs would have to be maintained. That said, if the repacked produce is from different traceability lots, a new TLC would be required.
Another example is when a master case of product on the TLC is broken down into smaller units, a common practice during foodservice distribution. If the product is not being repacked or repackaged but simply being broken down into separate shipments, that would not constitute transformation, so no TLC or TLC source would be required. An example of this would be a candy manufacturer that sends its peanut butter cups (peanut butter being on the FTL) in cartons containing 12 boxes. Each of those boxes contain 36 packages of candy. The boxes are removed from the carton and sent to a store or restaurant. There has been no repacking in this case.
KDEs Required When FTL Foods Are Used as Ingredients
Here are examples of the KDEs required when foods on the FTL are used as ingredients and when a new food is created. They must all be linked to the new traceability lot for the food.
Transformation KDEs for FTL food(s) used as ingredient(s):
For each ingredient you use that’s on the FTL, KDEs must include:
- The traceability lot code for the food;
- A product description of the food to which the traceability lot code applies; and
- For each traceability lot used, the quantity and unit of measure of the food used from that lot.
Even for ingredients not on the FTL, there are still records required. They must include information reasonably available to you to identify the specific source of each ingredient used to make every lot of finished product, according to requirements established by the Bioterrorism Act of 2022. This is information that would be reasonably available If, for example, food suppliers are sending all ingredients with GS1-128 Barcodes including GTIN + Lot because of consumer demand for transparency and food processors are identifying their finished products that way for the same reason.
For simplicity, you may elect to treat all ingredients as if they are on the FTL, but this is not required.
KDEs Required When a New FTL Food is Produced
For raw agricultural commodities and sprouts that were not initially packed prior to your transformation of the food, and thus do not have a TLC, you must maintain records containing information that includes the date you received the food, the quantity, and the location of where the food was harvested. The rule lists more records that you’ll need for these foods.
FDA gives this example of record-keeping for ingredients. If you are making a deli salad with tomatoes, cucumbers, and olives, you would need to keep KDEs for the tomatoes and cucumbers since both of those foods are on the FTL. The olives are not on the FTL but, as explained above, you would need records to identify their source.
The finished product – the deli salad – is on the FTL and you would need to keep the records that follow.
Transformation KDEs for a new FTL food produced:
- The new traceability lot code for the food;
- A location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference;
- The date transformation was completed;
- A product description of the food;
- The quantity and unit of measure of the food; and
- The type of reference document that may contain some or all of the key data elements and the reference document number.
For the ingredients in this food, the requirements described earlier both for those on and off the FTL apply.
Examples of a New Foods Being Produced
FDA gives the production of soft cheese as an example of how this works. The ingredients sent by the farm and other suppliers are not on the FTL so they are not covered by the rule. But soft cheese is on the FTL and the cheese manufacturer must keep transformational KDEs and any subsequent shipping records.
The rule itself gives this example about the transformation of whole apples into sliced apples: An apple farm, harvester, cooler, and initial packer would not be covered by the rule because whole apples are not on the FTL. Deliveries (shipping and receiving) from the apple packer to the fresh-cut processor would also not be subject to the rule. However, the fresh-cut processor who transforms the whole apples into apple slices (which are included on the FTL under “Fruits and Vegetables (fresh-cut)”) and packages the sliced apples would be required to keep the transformation records, as well as the shipping records.
These KDEs must also be collected by those repackaging, or repacking a food on the FTL. The product description, for example, includes the product name, packaging size and packaging style.
Exceptions
There are exceptions: These requirements do not apply to retail food establishments and restaurants with respect to foods they sell or send directly to consumers. They also don’t apply to foods within the jurisdiction of the U.S. Department of Agriculture, including meat, poultry, and egg products (e.g., liquid, frozen, and dried pasteurized).
Next Steps
The compliance date is January 20, 2026, which means the time is now to start formulating your plans and working with suppliers to ensure that you capture the KDEs that you need.
There are resources available from FDA, New Era Partners and our colleagues at iFoodDS to help you navigate the complexities of FSMA 204.
- At fda.gov you’ll find the rule itself on the page entitled FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods, as well as information on key components of the rule and how to prepare for compliance.
- View the FSMA 204 Timeline prepared by New Era Partners to start learning about and planning for FSMA 204 compliance. Other topics include:
- iFoodDS has a FSMA Rule 204 Information Hub that is designed to be an educational resource for the full supply chain. Topics include:
Experts at New Era Partners can help you align your supplier networks and optimize your processes so you can collect the right data on both raw and finished products.
