The new Traceability Rule, as part of the FSMA set of regulations, goes into effect in January, 2026. AS you may know, it requires entities who perform certain tasks (Critical Tracking Events or CTEs) along the food supply chain to keep and share information, termed (Key Data Elements or KDEs) and maintain a traceability plan, but only for those items on the Food Traceability List (FTL). We have more on this posted here - Penn State Food Safety Blog: FDA Rolls Out Traceability Rule as Part of FSMA Regulations
FDA released on 6/26/2023 its FAQ's that attempt to provide 'clarification' to this overly complex rule.Frequently Asked Questions: FSMA Food Traceability Rule
https://www.fda.gov/food/food-safety-modernization-act-fsma/frequently-asked-questions-fsma-food-traceability-rule
One group that will have to face this is Retail Food Establishments (RFEs) and restaurants. There are two important parts - who is covered and how, and what information is needed? As for the later, the only information need to be kept is receiving records with the KDEs for those items on the FTL.
https://www.fda.gov/food/food-safety-modernization-act-fsma/frequently-asked-questions-fsma-food-traceability-rule
One group that will have to face this is Retail Food Establishments (RFEs) and restaurants. There are two important parts - who is covered and how, and what information is needed? As for the later, the only information need to be kept is receiving records with the KDEs for those items on the FTL.
And what information would they need to keep (KDEs)
The following key data elements (KDEs) must be maintained and linked to the traceability lot for the food:
- Traceability lot code for the food
- Quantity and unit of measure of the food
- Product description for the food
- Location description for the immediate previous source of the food
- Location description for where the food was received
- Date you received the food
- Location description for the traceability lot code source, or the traceability lot code source
- reference
- Reference document type and reference document number
Who is covered, including muti-store locations (question 10) commissaries (question 12) and supermarket distribution centers (question 13).
TRFE.1 Are small Retail Food Establishments (RFEs) or restaurants covered by the final rule?
The final rule does not apply to RFEs and restaurants with an average annual monetary value of food sold or provided during the previous three years of no more than $250,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment. Other exemptions may apply to other RFEs or restaurants depending on the action being performed. For example, the rule does not apply to RFEs and restaurants regarding food produced on a farm and both sold and shipped directly to the RFE or restaurant by the farm’s owner, operator, or agent in charge. However, the RFE or restaurant would have to keep a record (for 180 days) of the name and address of the farm that was the source of the food. See other exemptions that apply to RFEs or restaurants.
Quesitons 5 and 6 apply to size exemptions.
TRFE.10 In the case of a franchise owner who owns multiple establishments, does the retail food establishments (RFEs) and restaurant exemption in 21 CFR 1.1305(i) apply to the owner or to each individual establishment?
The exemption in § 1.1305(i) applies to the individual establishment. So a franchise owner who owns multiple establishments could have one establishment which meets the requirements of the exemption while another establishment may not, because its annual average monetary value of food sold exceeds the threshold in the exemption.
TRFE.11 Does responsibility for compliance with the rule fall with the individual franchisee or the franchisor in a restaurant chain?
Unless they are exempt from the Food Traceability Rule, the individual restaurant franchise locations will be responsible for compliance with the applicable requirements of the rule because the franchise location is engaged in the “holding” of FTL foods, as that term is defined in § 1.1310 of the rule (see 21 CFR 1.1300). (Note that § 1.1305(i) exempts from the rule individual retail food establishments (RFEs) and restaurants with an average annual monetary value of food sold or provided during the previous 3-year period of no more than $250,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment.) Under § 1.1455(b) of the rule, an individual franchisee could have another entity, such as corporate headquarters, establish and maintain the required records on its behalf. However, the franchisee would be responsible for ensuring that the records could be provided to FDA within 24 hours of a request for review.
TRFE.12 Does the rule apply to commissaries or central kitchens that produce and ship product to stores? If so, what KDEs would they have to maintain?
Yes, the rule applies to commissaries and central kitchens that prepare food and then ship the food to a restaurant or RFE. If the preparation of the food meets the definition of transformation, the required KDEs under 21 CFR 1.1350 would need to be maintained. The commissary or central kitchen would also need to maintain receiving KDEs under § 1.1345 for any incoming FTL foods and shipping KDEs under § 1.1340 for any outgoing FTL foods.
TRFE.13 How does the Food Traceability Rule apply to supermarket distribution centers?
In most situations, supermarket distribution centers are going to be performing receiving and shipping CTEs and are required to maintain the corresponding KDEs. If the distribution center received product from an exempt entity, they would be required to keep a reduced set of KDEs as outlined in § 1.1345(b). Note that in this situation, the supermarket distribution center would be required to assign a traceability lot code if one had not already been assigned (see § 1.1345(b)(1)). It should also be noted that the rule does account for intracompany shipments and crossdocking as outlined in the preamble to the Final Rule in Response 243 and Response 244, respectively. All entities covered by the rule, including both supermarkets and supermarket distribution centers, must establish and maintain a traceability plan (see § 1.1315).
TRFE.1 Are small Retail Food Establishments (RFEs) or restaurants covered by the final rule?
The final rule does not apply to RFEs and restaurants with an average annual monetary value of food sold or provided during the previous three years of no more than $250,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment. Other exemptions may apply to other RFEs or restaurants depending on the action being performed. For example, the rule does not apply to RFEs and restaurants regarding food produced on a farm and both sold and shipped directly to the RFE or restaurant by the farm’s owner, operator, or agent in charge. However, the RFE or restaurant would have to keep a record (for 180 days) of the name and address of the farm that was the source of the food. See other exemptions that apply to RFEs or restaurants.
Quesitons 5 and 6 apply to size exemptions.
TRFE.10 In the case of a franchise owner who owns multiple establishments, does the retail food establishments (RFEs) and restaurant exemption in 21 CFR 1.1305(i) apply to the owner or to each individual establishment?
The exemption in § 1.1305(i) applies to the individual establishment. So a franchise owner who owns multiple establishments could have one establishment which meets the requirements of the exemption while another establishment may not, because its annual average monetary value of food sold exceeds the threshold in the exemption.
TRFE.11 Does responsibility for compliance with the rule fall with the individual franchisee or the franchisor in a restaurant chain?
Unless they are exempt from the Food Traceability Rule, the individual restaurant franchise locations will be responsible for compliance with the applicable requirements of the rule because the franchise location is engaged in the “holding” of FTL foods, as that term is defined in § 1.1310 of the rule (see 21 CFR 1.1300). (Note that § 1.1305(i) exempts from the rule individual retail food establishments (RFEs) and restaurants with an average annual monetary value of food sold or provided during the previous 3-year period of no more than $250,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment.) Under § 1.1455(b) of the rule, an individual franchisee could have another entity, such as corporate headquarters, establish and maintain the required records on its behalf. However, the franchisee would be responsible for ensuring that the records could be provided to FDA within 24 hours of a request for review.
TRFE.12 Does the rule apply to commissaries or central kitchens that produce and ship product to stores? If so, what KDEs would they have to maintain?
Yes, the rule applies to commissaries and central kitchens that prepare food and then ship the food to a restaurant or RFE. If the preparation of the food meets the definition of transformation, the required KDEs under 21 CFR 1.1350 would need to be maintained. The commissary or central kitchen would also need to maintain receiving KDEs under § 1.1345 for any incoming FTL foods and shipping KDEs under § 1.1340 for any outgoing FTL foods.
TRFE.13 How does the Food Traceability Rule apply to supermarket distribution centers?
In most situations, supermarket distribution centers are going to be performing receiving and shipping CTEs and are required to maintain the corresponding KDEs. If the distribution center received product from an exempt entity, they would be required to keep a reduced set of KDEs as outlined in § 1.1345(b). Note that in this situation, the supermarket distribution center would be required to assign a traceability lot code if one had not already been assigned (see § 1.1345(b)(1)). It should also be noted that the rule does account for intracompany shipments and crossdocking as outlined in the preamble to the Final Rule in Response 243 and Response 244, respectively. All entities covered by the rule, including both supermarkets and supermarket distribution centers, must establish and maintain a traceability plan (see § 1.1315).
Types of Information Needed
TRFE.2 Are Retail Food Establishments (RFEs) and restaurants required to keep records for Food Traceability List (FTL) foods that are transformed and sold directly to consumers (e.g., a salad prepared in a restaurant kitchen and then sold to a restaurant customer)?
No. § 1.1350(c) states that the transformation Key Data Elements (KDEs) do not apply to RFEs and restaurants with respect to foods they do not ship (e.g., foods they sell or send directly to consumers). However, an entity such as a central kitchen that transforms a food and ships it to a business, such as a restaurant or RFE, is functioning as a manufacturer/processor, and must keep the transformation KDE records.
TRFE.3 How does the rule affect restaurants? What KDEs are required to be kept by restaurants? Do we have to link KDEs and traceability lot codes (TLCs) to recipes made by restaurants?
Restaurants are covered by the rule, unless an exemption applies. Restaurants will generally be receiving foods from their suppliers and therefore must maintain receiving KDEs under § 1.1345 for any FTL foods they receive. Most receiving KDEs will be sent to the restaurant by the supplier. For food that is prepared in the restaurant and then sold or sent directly to the consumer, neither transformation nor shipping KDEs need to be maintained (see TRFE. 7 below). Restaurants therefore do not have to link KDEs and TLCs to the recipes or specific foods they prepare and sell or send to their consumers.
TRFE.7 How does this rule apply to retail food establishments (RFEs) and restaurants where the end products are assembled (transformed) at the RFE or restaurant and then sold to the consumer? If an RFE or restaurant sells to the end consumer, what KDEs need to be maintained?
Under the rule, RFEs and restaurants need to maintain receiving KDEs for all FTL foods they receive. However, § 1.1350(c) states that the requirement to maintain transformation KDEs does not apply to RFEs and restaurants with respect to food they do not ship (e.g., foods they sell or send directly to consumers). Similarly, RFEs and restaurants do not need to maintain shipping records for food they sell to consumers, because the definition of shipping in § 1.1310 states that shipping does not include the sale or shipment of a food directly to a consumer. Therefore, in the situation described in the question, the only KDEs the RFE or restaurant would need to maintain would be the receiving KDEs for the incoming FTL food under § 1.1345.
TRFE.8 Does the kill step exemption in § 1.1305(d)(3) apply to foods made in restaurants or retail food establishments (RFEs) for consumers? For example, if a restaurant is baking soft cheese and vegetables in an entrée, is this considered a kill step and does the rule still apply?
If a restaurant receives a food on the FTL (such as certain fresh vegetables and soft cheeses), the restaurant must keep receiving records for that food as described in § 1.1345. What happens to the food after that (such as the baking described in the question) is not relevant to whether the rule applies to those handling the food because in general the restaurant’s receiving records are the last records that are required under the rule. The rule does not require firms to keep information on sales to consumers and does not require maintenance of records linking traceability lot codes for FTL foods received from manufacturers or distributors with sales to consumers. The rule also does not require transformation records when a restaurant or RFE transforms a food that they then sell or send directly to the consumer (see § 1.1350(c)).
TRFE.9 Since distribution centers deliver foods to the restaurants and have internal traceability systems, can they maintain and store KDEs for my restaurant?
Generally, RFEs and restaurants must maintain receiving records as described in § 1.1345. Most of those records will be sent to the RFE or restaurant by the person shipping the food. However, the rule specifies that you may have another entity establish and maintain required records on your behalf, although you remain responsible for ensuring the records can be provided onsite to FDA within 24 hours of our request for official review (§1.1455(b)).
We encourage firms to work with their supply chain partners to determine the most appropriate method for storing and retrieving the required information.
TRFE.2 Are Retail Food Establishments (RFEs) and restaurants required to keep records for Food Traceability List (FTL) foods that are transformed and sold directly to consumers (e.g., a salad prepared in a restaurant kitchen and then sold to a restaurant customer)?
No. § 1.1350(c) states that the transformation Key Data Elements (KDEs) do not apply to RFEs and restaurants with respect to foods they do not ship (e.g., foods they sell or send directly to consumers). However, an entity such as a central kitchen that transforms a food and ships it to a business, such as a restaurant or RFE, is functioning as a manufacturer/processor, and must keep the transformation KDE records.
TRFE.3 How does the rule affect restaurants? What KDEs are required to be kept by restaurants? Do we have to link KDEs and traceability lot codes (TLCs) to recipes made by restaurants?
Restaurants are covered by the rule, unless an exemption applies. Restaurants will generally be receiving foods from their suppliers and therefore must maintain receiving KDEs under § 1.1345 for any FTL foods they receive. Most receiving KDEs will be sent to the restaurant by the supplier. For food that is prepared in the restaurant and then sold or sent directly to the consumer, neither transformation nor shipping KDEs need to be maintained (see TRFE. 7 below). Restaurants therefore do not have to link KDEs and TLCs to the recipes or specific foods they prepare and sell or send to their consumers.
TRFE.7 How does this rule apply to retail food establishments (RFEs) and restaurants where the end products are assembled (transformed) at the RFE or restaurant and then sold to the consumer? If an RFE or restaurant sells to the end consumer, what KDEs need to be maintained?
Under the rule, RFEs and restaurants need to maintain receiving KDEs for all FTL foods they receive. However, § 1.1350(c) states that the requirement to maintain transformation KDEs does not apply to RFEs and restaurants with respect to food they do not ship (e.g., foods they sell or send directly to consumers). Similarly, RFEs and restaurants do not need to maintain shipping records for food they sell to consumers, because the definition of shipping in § 1.1310 states that shipping does not include the sale or shipment of a food directly to a consumer. Therefore, in the situation described in the question, the only KDEs the RFE or restaurant would need to maintain would be the receiving KDEs for the incoming FTL food under § 1.1345.
TRFE.8 Does the kill step exemption in § 1.1305(d)(3) apply to foods made in restaurants or retail food establishments (RFEs) for consumers? For example, if a restaurant is baking soft cheese and vegetables in an entrée, is this considered a kill step and does the rule still apply?
If a restaurant receives a food on the FTL (such as certain fresh vegetables and soft cheeses), the restaurant must keep receiving records for that food as described in § 1.1345. What happens to the food after that (such as the baking described in the question) is not relevant to whether the rule applies to those handling the food because in general the restaurant’s receiving records are the last records that are required under the rule. The rule does not require firms to keep information on sales to consumers and does not require maintenance of records linking traceability lot codes for FTL foods received from manufacturers or distributors with sales to consumers. The rule also does not require transformation records when a restaurant or RFE transforms a food that they then sell or send directly to the consumer (see § 1.1350(c)).
TRFE.9 Since distribution centers deliver foods to the restaurants and have internal traceability systems, can they maintain and store KDEs for my restaurant?
Generally, RFEs and restaurants must maintain receiving records as described in § 1.1345. Most of those records will be sent to the RFE or restaurant by the person shipping the food. However, the rule specifies that you may have another entity establish and maintain required records on your behalf, although you remain responsible for ensuring the records can be provided onsite to FDA within 24 hours of our request for official review (§1.1455(b)).
We encourage firms to work with their supply chain partners to determine the most appropriate method for storing and retrieving the required information.
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