FDA released (11/15/22) their latest rule,
Food Traceability as a means to allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths. (https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods)
Basically, if the food item is on the FTL, the Food Traceability List, there are traceability requirements.
The items that are currently on the list (below) require a Food Traceability Plan (except for those where there is an exemption)
- A description of the procedures you use to maintain the records you are required to keep under this subpart, including the format and location of these records.
- A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold;
- A description of how you assign traceability lot codes to foods on the Food Traceability List in accordance with § 1.1320, if applicable;
- A statement identifying a point of contact for questions regarding your traceability plan and records; and
- If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods.
- Except as specified in paragraph (a)(5)(ii) of this section, the farm map must show the location and name of each field (or other growing area) in which you grow a food on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each field or growing area.
- For aquaculture farms, the farm map must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container
You must update your traceability plan as needed to ensure that the information provided reflects your current practices and to ensure that you are in compliance with the requirements of this subpart. You must retain your previous traceability plan for 2 years after you update the plan.
Specific records (KDE) must be kept for each Critical Tracking Event (CTE) - harvesting, cooling, initial packing, shipping, receiving, and transforming the product.
There is more information summarized on the FDA website for what needs to be recorded for each of the steps (below) However, one can expect that most processors will already have the required tracking systems in place including lot coding. So the KDEs for the CTL of Transformation (processing).
Transformation KDEs (Key Data Elements)
FTL food(s) used as ingredient(s)
KDEs must be linked to the new traceability lot for the food
• Traceability lot code for the food
• Product description for the food to which the traceability lot code applies
• For each traceability lot used, the quantity and unit of measure of the food used from that lot
Transformation KDEs for New food produced
KDEs must be linked to the new traceability lot for the food
• New traceability lot code for the food
• Location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable)
the traceability lot code source reference
• Date transformation was completed
• Product description for the food
• Quantity and unit of measure of the food
• Reference document type and reference document number
So for the the items on the FTL, you will need KDEs for each of the CTLs (oh brother).
So what items are on the FTL for now. (And items can be added to this list over time by FDA)
