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)
| Cheeses, other than hard cheeses, specifically: | |
| Includes soft unripened/fresh soft cheeses. Examples include, but are not limited to, cottage, chevre, cream cheese, mascarpone, ricotta, queso blanco, queso fresco, queso de crema, and queso de puna. Does not include cheeses that are frozen, shelf stable at ambient temperature, or aseptically processed and packaged. |
| Includes soft ripened/semi-soft cheeses. Examples include, but are not limited to, brie, camembert, feta, mozzarella, taleggio, blue, brick, fontina, monterey jack, and muenster. Does not include cheeses that are frozen, shelf stable at ambient temperature, or aseptically processed and packaged. |
| Includes all cheeses made with unpasteurized milk, other than hard cheeses. Does not include cheeses that are frozen, shelf stable at ambient temperature, or aseptically processed and packaged. |
| Shell eggs | Shell egg means the egg of the domesticated chicken. |
| Nut butters | Includes all types of tree nut and peanut butters. Examples include, but are not limited to, almond, cashew, chestnut, coconut, hazelnut, peanut, pistachio, and walnut butters. Does not include soy or seed butters. |
| Cucumbers (fresh) | Includes all varieties of fresh cucumbers. |
| Herbs (fresh) | Includes all types of fresh herbs. Examples include, but are not limited to, parsley, cilantro, and basil. Herbs listed in 21 CFR 112.2(a)(1), such as dill, are exempt from the requirements of the rule under 21 CFR 1.1305(e). |
| Leafy greens (fresh) | Includes all types of fresh leafy greens. Examples include, but are not limited to, arugula, baby leaf, butter lettuce, chard, chicory, endive, escarole, green leaf, iceberg lettuce, kale, red leaf, pak choi/bok choi, Romaine, sorrel, spinach, and watercress. Does not include whole head cabbages such as green cabbage, red cabbage, or savoy cabbage. Does not include banana leaf, grape leaf, and leaves that are grown on trees. Leafy greens listed in § 112.2(a)(1), such as collards, are exempt from the requirements of the rule under § 1.1305(e). |
| Leafy greens (fresh-cut) | Includes all types of fresh-cut leafy greens, including single and mixed greens. |
| Melons (fresh) | Includes all types of fresh melons. Examples include, but are not limited to, cantaloupe, honeydew, muskmelon, and watermelon. |
| Peppers (fresh) | Includes all varieties of fresh peppers. |
| Sprouts (fresh) | Includes all varieties of fresh sprouts (irrespective of seed source), including single and mixed sprouts. Examples include, but are not limited to, alfalfa sprouts, allium sprouts, bean sprouts, broccoli sprouts, clover sprouts, radish sprouts, alfalfa & radish sprouts, and other fresh sprouted grains, nuts, and seeds. |
| Tomatoes (fresh) | Includes all varieties of fresh tomatoes. |
| Tropical tree fruits (fresh) | Includes all types of fresh tropical tree fruit. Examples include, but are not limited to, mango, papaya, mamey, guava, lychee, jackfruit, and starfruit. Does not include non-tree fruits such as bananas, pineapple, dates, soursop, jujube, passionfruit, Loquat, pomegranate, sapodilla, and figs. Does not include tree nuts such as coconut. Does not include pit fruits such as avocado. Does not include citrus, such as orange, clementine, tangerine, mandarins, lemon, lime, citron, grapefruit, kumquat, and pomelo. |
| Fruits (fresh-cut) | Includes all types of fresh-cut fruits. Fruits listed in § 112.2(a)(1) are exempt from the requirements of the rule under § 1.1305(e). |
| Vegetables other than leafy greens (fresh-cut) | Includes all types of fresh-cut vegetables other than leafy greens. Vegetables listed in § 112.2(a)(1) are exempt from the requirements of the rule under § 1.1305(e). |
| Finfish (fresh and frozen), specifically: | |
| Includes all histamine-producing species of finfish. Examples include, but are not limited to, tuna, mahi mahi, mackerel, amberjack, jack, swordfish, and yellowtail. |
| Includes all finfish species potentially contaminated with ciguatoxin. Examples include, but are not limited to, grouper, barracuda, and snapper. |
| Includes all species of finfish not associated with histamine or ciguatoxin. Examples include, but are not limited to, cod, haddock, Alaska pollock, salmon, tilapia, and trout.[2] Siluriformes fish, such as catfish, are not included.[3] |
| Smoked finfish (refrigerated and frozen) | Includes all types of smoked finfish, including cold smoked finfish and hot smoked finfish.[4] |
| Crustaceans (fresh and frozen) | Includes all crustacean species. Examples include but are not limited to shrimp, crab, lobster, and crayfish. |
| Molluscan shellfish, bivalves (fresh and frozen)[5] | Includes all species of bivalve mollusks. Examples include, but are not limited to, oysters, clams, and mussels. Does not include scallop adductor muscle. Raw bivalve molluscan shellfish that are (1) covered by the requirements of the National Shellfish Sanitation Program; (2) subject to the requirements of 21 CFR part 123, subpart C, and 21 CFR 1240.60; or (3) covered by a final equivalence determination by FDA for raw bivalve molluscan shellfish are exempt from the requirements of the rule under § 1.1305(f). |
| Ready-to-eat deli salads (refrigerated) | Includes all types of refrigerated ready-to-eat deli salads. Examples include, but are not limited to, egg salad, potato salad, pasta salad, and seafood salad. Does not include meat salads. |
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
Key Features
1. Critical Tracking Events (CTE) (§ 1.1325 through 1.1350)
The final rule identifies Critical Tracking Events (CTEs) for which records containing Key Data Elements (KDEs) will be required. The KDEs required will vary depending on the CTE that is being performed.
The Critical Tracking Events in the final rule are harvesting; cooling (before initial packing); initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel; first land-based receiving of a food obtained from a fishing vessel; shipping; receiving; and transformation of the food.
Below is a brief description of each CTE. For a detailed description of the KDEs that would be required for each CTE, see Critical Tracking Events and Key Data Elements. You can also see how the final rule applies in three different supply chain examples below, including the KDEs and CTEs that would be associated with each commodity.
Harvesting
Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agriculture commodities (RACs) from the place they are grown or raised and preparing them for use as food.
Cooling
Cooling means active temperature reduction of a raw agricultural commodity (RAC) using hydrocooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process.
Initial Packing
Initial Packing means packing a raw agricultural commodity (RAC), other than a food obtained from a fishing vessel, for the first time.
First Land-Based Receiver
First Land-based Receiver is the person taking possession of a food for the first time on land directly from a fishing vessel.
Shipping
Shipping is an event in a food’s supply chain in which a food is arranged for transport (e.g., by truck or ship) from one location to another location. Shipping does not include the sale or shipment of a food directly to a consumer or the donation of surplus food. Shipping does include sending an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm.
Receiving
Receiving is an event in a food’s supply chain in which a food is received by someone other than a consumer after being transported (e.g., by truck or ship) from another location. Receiving includes receipt of an intracompany shipment of food from one location at a particular street address of a firm to another location of the firm at a different street address.
Transformation
Transformation is an event in a food’s supply chain that involves manufacturing/processing or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or packing, when the output is a food on the Food Traceability List (FTL). Transformation does not include the initial packing of a food or activities preceding that event (e.g., harvesting, cooling).
2. Traceability Lot Code
Traceability lot code (TLC) means a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.
You must assign a traceability lot code to a food on the Food Traceability List (FTL) when you do any of the following: initially pack a raw agricultural commodity (RAC) other than a food obtained from a fishing vessel; perform the first land-based receiving of a food obtained from a fishing vessel; or transform a food. If you receive an FTL food from an entity that is exempt from the final rule, you must assign a TLC if one has not already been assigned (unless you are a retail food establishment or restaurant). Otherwise, you must not establish a new TLC when you conduct other activities (e.g., shipping) for a food on the Food Traceability List.
Once a food has been assigned a TLC, the records required at each Critical Tracking Event (CTE) must include that TLC. All of the Key Data Elements (KDEs), including the TLC, must be linked to the relevant traceability lot.
3. Traceability Plan (§ 1.1315)
If you are subject to the requirements of the final rule, you must establish and maintain a traceability plan containing the following information:
A description of the procedures you use to maintain the records you are required to keep under this rule, 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, 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.
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 instead 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.
4. Additional Requirements (§ 1.1455)
The final rule also requires that:
Records must be maintained as original paper or electronic records, or true copies; they all must be legible and stored to prevent deterioration or loss. Electronic records may include valid, working electronic links to the information required to be maintained under the rule.
All records required under this rule, along with any information required to understand the records, must be made available to the FDA within 24 hours after a request is made (or within a reasonable time to which the FDA has agreed).
Unless exempt from this requirement, an electronic sortable spreadsheet containing relevant traceability information must be provided to the FDA within 24 hours of a request (or within some reasonable time to which the FDA has agreed) when necessary to assist the FDA during an outbreak, recall, or other threat to public health.
Transformation KDEs
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
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
For RACs (other than a food obtained from a fishing vessel) that were not initially packed prior to your transformation of the food, you must maintain records containing the information specified in § 1.1330(a) or (c).
For sprouts that were not initially packed prior to your transformation of the food, you must maintain records containing the information specified in § 1.1330(a) or (c), and also § 1.1330(b)
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