Frequently Asked Questions: FSMA Food Traceability Rule
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Below are frequently asked questions regarding the FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods.
Topics
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| Topic | Question | Answer | Last Updated (YYYY-MM-DD) |
|---|---|---|---|
| Commingled Raw Agricultural Commodities (RACs) | TRAC.1 Could fish and fishery products be considered commingled Raw Agricultural Commodities (RACs) that would be partially exempt from the rule? | In some situations, yes. The definition of “commingled RAC” includes any commodity that is combined or mixed after harvesting but before processing, except that it does not include types of fruits and vegetables to which the Produce Safety Regulation applies. The definition of “commingled RAC” further specifies that for food obtained from a fishing vessel, a commodity is “combined or mixed” only when the combination or mixing involves food from different landing vessels and occurs after the vessels have landed. Similarly, for food not obtained from a fishing vessel (which might include aquacultured seafood), a commodity is “combined or mixed” only when the combination or mixing involves food from different farms under different company management. The FDA also added a partial exemption in § 1.1305(h)(2) of the final rule for RACs that will become commingled RACs, provided that there is a written agreement between entities in the supply chain that the commodity will be included as part of a commingled RAC. The written agreement must include the effective date, printed names and signatures of the persons entering into agreement, and the substance of the agreement. A written agreement must be maintained by both parties for as long as it is in effect and must be renewed at least once every 3 years. If circumstances change and the substance of the written agreement is no longer accurate, the agreement must be updated even if the 3 years has not expired. Under § 1.1305(h)(3), any entity that receives either the partial exemption for commingled RACs or the partial exemption for RACs that will become commingled RACs, and that is required to register through FDA’s Food Facility Registration system, is required to maintain records identifying the immediate previous source and the immediate subsequent recipient of the food, in accordance with §§ 1.337 and 1.345. Such records must be maintained for two years. | 2023-01-10 |
| Commingled Raw Agricultural Commodities (RACs) | The partial exemption for commingled raw agricultural commodities (RACs) in § 1.1305(h) does NOT apply to produce (§ 1.1305(h)). The Food Traceability Rule defines “commingled raw agricultural commodity,” in part, as any commodity that is combined or mixed after harvesting but before processing, except that the term does not include any types of fruits or vegetables to which the produce safety regulations in 21 CFR part 112 apply (§ 1.1310). Furthermore, produce that is exempt from the produce safety regulations because it is listed as rarely consumed raw in § 112.2(a)(1) is already exempt from the Food Traceability Rule under § 1.1305(e). Therefore, there are no types of produce that are eligible for the partial exemption for commingled RACs. | 2023-06-26
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| Commingled Raw Agricultural Commodities (RACs) | TRAC.3 Is seafood from different fishing boats considered commingled? What if seafood is mixed from the catcher vessels? | The Food Traceability Rule defines “commingled raw agricultural commodity,” in part, as any commodity that is combined or mixed after harvesting but before processing. For food obtained from a fishing vessel, a commodity is “combined or mixed” only when the combination or mixing involves food from different landing vessels and occurs after the vessels have landed (§ 1.1310). Therefore, seafood obtained from different fishing boats would be considered commingled only if the seafood was combined or mixed after the boats had landed. Seafood from different vessels that was mixed prior to landing would not be considered commingled and would therefore not be eligible for the commingled RAC exemption in § 1.1305(h). However, note that fishing vessels are already exempt from most requirements of the Food Traceability Rule under § 1.1305(m). | 2023-06-26 |
| Cooling | The cooling CTE is only applicable to raw agricultural commodities (RACs) that are cooled before initial packing. The language in 21 CFR 1.1325(b) specifies that the cooling CTE does not apply to food obtained from a fishing vessel. For seafood not obtained from a fishing vessel (e.g., aquacultured finfish), the cooling CTE would apply if the fish are cooled before initial packing. However, note that the definition of cooling does not include icing of seafood. Generally, eggs are cooled after packing, so the cooling CTE would not typically apply to eggs. | 2023-11-20 | |
| Cooling | TC.2 I store mangos long term, in a room where oxygen is removed from the room to allow slow ripening. The room is cool, but is that considered cooling under the Food Traceability Rule? | Cooling is defined in the rule as active temperature reduction of a raw agricultural commodity using hydrocooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process. Lowering oxygen levels through processes like controlled atmosphere storage is not considered cooling under the Food Traceability Rule unless it is accompanied by active temperature reduction as described in the definition of cooling. | 2023-11-20 |
Enforcement
| TE.1. Upon the rule’s compliance date of January 20, 2026, will FDA begin conducting routine inspections? | Routine inspections under the Food Traceability Rule will not begin until 2027, to give covered entities additional time to work together and ensure that traceability information is being maintained and shared within supply chains per the requirements of the rule. We also want to support widespread compliance by making sure that covered entities have the information needed for the successful implementation of this rule. As has been done with other FSMA rules, the FDA plans to take an “educate before and while we regulate” posture as we begin implementing the food traceability requirements. This may include providing fact sheets and an opportunity for firms to ask questions about the Food Traceability Rule during routine inspections under other FDA regulations. We generally note that, while we aren’t initiating routine inspections until 2027, we may do inspections for compliance with the Food Traceability Rule on a for-cause basis, such as during an outbreak investigation, once the compliance date of January 20, 2026, is reached. | 2023-09-28 |
Farm
| TF.2 Is the definition of farm in the traceability final rule aligned with other rules? | Yes. We have defined “farm” as that term is defined in 21 CFR § 1.328 (except for producers of shell eggs). This is the definition that is used for the existing recordkeeping requirements in 21 CFR Part 1, subpart J, and it is the same as the definition of “farm” in other FSMA rules, such as the Preventive Controls for Human Food Rule (21 CFR Part 117) and the Produce Safety Rule (21 CFR Part 112). For producers of shell eggs, we have defined “farm” to mean all poultry houses and grounds immediately surrounding the poultry houses covered under a single biosecurity program. This is the same definition that is used in the shell egg regulation (21 CFR Part 118). | 2023-01-25 |
| Farms | Generally, farms are subject to the requirements in the final rule if they manufacture, process, pack or hold foods on the Food Traceability List (FTL). The burden on farms is lessened by the fact that there are no specific Key Data Elements (KDEs) related to the growing or raising of foods on the FTL. Also, there are no Shipping KDE requirements when a food is shipped before it has been initially packed. However, note that entities that harvest or cool raw agricultural commodities on the FTL (prior to the initial packing of such commodities) must maintain and send Harvesting and Cooling KDEs. Furthermore, the initial packer of a raw agricultural commodity on the FTL (other than a food obtained from a fishing vessel) must maintain Initial Packer KDEs. All entities covered by the rule, including farms, must keep a traceability plan, per § 1.1315. As part of their traceability plan, any entity that grows or raises a food on the FTL (other than eggs) must maintain a farm map showing the location and name of each field (or, for aquaculture farms, container) in which foods on the FTL are grown or raised, including geographic coordinates and any other information needed to identify the location of each field or container. Presenting this information in the form of a map will provide a greater level of specificity and visual perspective for each field or container on the farm. The final rule also identifies some exemptions for some farms, including produce farms when the average annual sum of the monetary value of produce sold and the market value of produce manufactured, processed, packed, or held without sale (e.g., held for a fee) during the previous three years is no more than $25,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment, among other exemptions. For more information see § 1.1305. | 2023-01-10 | |
| Farms | TF.3 Are harvesters and coolers required to keep records under the final rule? | Yes. Harvesting and Cooling (before initial packing) are Critical Tracking Events and specific Key Data Elements (KDEs) must be kept for those activities. To ensure that the initial packer of a raw agricultural commodity (RAC) has information about the farm where the RAC was grown along with information on the harvesting and cooling of the RAC, § 1.1325 establishes certain recordkeeping and sending requirements for persons who harvest RACs or who cool RACs before they are initially packed. These requirements do not apply to RACs obtained from a fishing vessel. For many harvesters and coolers, the burden of the rule is reduced by the fact that Shipping and Receiving KDEs do not need to be kept for the shipment or receipt of RACs (not obtained from fishing vessels) that occurs before the food is initially packed, nor for the receipt of a food by the first land-based receiver (if the food is obtained from a fishing vessel). | 2023-01-10 |
| Farms | TF.4 Are sales to “qualified end users” as specified in the Produce Safety Regulation (PSR) considered direct sales and therefore exempt from the Food Traceability Rule? | For the reasons described in Response 166 of the preamble to the final rule, we considered and rejected basing eligibility for the small farm exemption in § 1.1305(a)(1) on the PSR’s definition of a “qualified exempt” farm in 21 CFR 112.5 (which is a definition that relates, in part, to the PSR’s definition of a “qualified end-user” in 21 CFR 112.3). The PSR’s definition of a “qualified end-user” relates to either being located in the same State or Indian reservation as the farm that produced the food, or being located within 275 miles of such farm. Neither of these factors are relevant to the Food Traceability Rule. The PSR’s qualified exemption requires both that a farm makes more sales to qualified end-users than to other buyers, and that the value of all food sold by the farm be less than $500,000. The Food Traceability Rule does not have a parallel exemption. There will sometimes be overlap between entities that are exempt from the rule due to one or more exemptions and that are also eligible for the PSR’s qualified exemption. But just because an entity is a “qualified exempt farm” under the PSR or a “qualified end-user” under the PSR, it does not follow that the entity necessarily will be exempt from the Food Traceability Rule. Refer to § 1.1305 to determine whether an entity is exempt from the Food Traceability Rule. | 2023-06-26 |
| Farms | TF.5 How does the Food Traceability Rule apply to farms that grow and sell non-FTL raw agricultural commodities (RACs) that may or may not become FTL foods? For example, an orchard sells whole apples to a wholesaler. The wholesaler sells some of the apples to grocery stores for sale as RACs in the produce section, and others to processors, who slice the apples and package them for sale as fresh-cut fruit at mini-marts. Does the orchard need a traceability plan? What records do the wholesaler and processor need to keep? | In this situation, the orchard does not manufacture, process, pack, or hold a food that is on the Food Traceability List (FTL), and is therefore not subject to the Food Traceability Rule. The orchard therefore does not need a traceability plan and does not need to maintain any records under the rule. Because whole apples are not on the FTL, the wholesaler would also not need to maintain any records under the rule. The required records would start at the processor, who would be required to maintain KDEs for the FTL food they produce through transformation (sliced apples). The processor is not required to keep records for the whole apples they receive, because whole apples are not on the FTL. They also do not need to keep any records under § 1.1350(a)(1), which is about FTL foods used in transformation, because the only incoming ingredient is the whole apples, which are not on the FTL. Therefore, the only transformation records they would need to keep would be under § 1.1350(a)(2), which is about the food produced through transformation (the sliced apples). They would also need to keep records of shipping the sliced apples under § 1.1340. | 2023-06-26 |
| Farms | TF.6 Usually, cucumbers grown on my farm go to the fresh market, but sometimes a person further down the supply chain diverts some of them for processing. Do I need to do anything differently because the cucumbers might be diverted? | No. If you keep the required KDEs for any CTEs you perform, then you will be in compliance with the rule regardless of whether or not the cucumbers get diverted for processing. If you are aware that someone other than a retail food establishment, restaurant, or consumer is going to either apply a kill step to the cucumbers or change them to a form that is not on the Food Traceability List (FTL), then you may choose to enter into a written agreement with the person to whom you ship the cucumbers, as described in 21 CFR 1.1305(d)(6). If you enter into such a written agreement, the cucumbers will be exempt from the requirements of the rule. But you may only enter into such a written agreement if you know that the cucumbers will receive a kill step or be changed to a form that is not on the FTL. If you are unsure, and you think the cucumbers might go to the fresh market, then you are not eligible for the partial exemption in § 1.1305(d)(6) and you should not enter into such a written agreement. | 2023-01-25 |
| First Land-Based Receiver | TLBR.1 Are foreign entities responsible for maintaining First Land-Based Receiving Key Data Elements (KDEs) if the destination of the product is unknown when it is caught? | Yes. In the final rule, the entity, whether foreign or domestic that is the first land-based receiver is required to maintain certain information about the food that was caught. | 2023-01-10 |
| First Land-Based Receiver | TLBR.2 Do fishing vessels have to maintain records for the First Land-Based Receiver? | No. Fishing vessels are largely exempt from the requirements of this rule. However, a fishing vessel could establish and maintain the required records on behalf of the first land-based receiver, in accordance with § 1.1455(b). | 2023-01-10 |
| Food Traceability Plan | Any person who is subject to any of the requirements of the rule must establish and maintain a traceability plan under 21 CFR 1.1315. For persons who grow or raise a food on the FTL (other than eggs), the traceability plan must include a farm map showing the areas in which the food is grown or raised. | 2023-06-26 | |
| Food Traceability Plan | TFTP.2 Do exempt farms have to maintain a traceability plan? What about farms that receive a partial exemption, for example if they produce and package an FTL food on the farm and the packaging “remains in place until the food reaches the consumer, and such packaging maintains the integrity of the product and prevents subsequent contamination or alteration of the product?” | Under § 1.1315, firms must have a traceability plan if they are “subject to the requirements in this subpart” (i.e., subpart S). If a firm is fully exempt from the rule, then there is no requirement to maintain a traceability plan. In the example mentioned above, the food is only exempt as long as the criteria in § 1.1305(c) are met. In that case the firm has a partial exemption (not a full exemption), and they would be required to maintain a traceability plan because they are subject to some of the requirements in the rule. | 2023-06-26 |
| General | TG.1 Does FDA require a specific application or technology for keeping records? | No. In accordance with the Food Safety Modernization Act (FSMA) § 204(d)(1)(C), the final rule does not prescribe specific technologies for the maintenance of records. Records 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). Records 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 final rule. In certain circumstances when the public health is threatened, we may request that information about specific foods and specific date ranges (or traceability lot code ranges) be provided to us in an electronic sortable spreadsheet in accordance with § 1.1455(c)(3)(ii), along with any other information needed to understand the information in the spreadsheet. We believe that firms that maintain their records on paper will be able to create such a spreadsheet, using the information contained in their paper records, under those limited circumstances. Moreover, we note that § 1.1455(c)(3)(ii) does not prescribe a specific technology for creating the sortable spreadsheet. | 2023-01-10 |
| General | The final rule applies to all persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL), including food importers. Persons who do not physically possess the food offered for import are not engaged in “holding” of food within the meaning of the rule. This means that some persons who are part of the importation process may not be subject to the rule because they do not “hold” the food. For example, a person who coordinates the importation of a food on the FTL but never takes physical possession of the food would not be subject to the rule, while a person who imports a listed food and physically possesses the food would be subject to the rule, unless an exemption applies. Entities covered by the rule may designate entities that are not covered, such as importers or brokers who do not hold the food, to maintain traceability records on behalf of the covered entity (§ 1.1455(b)). However, the covered entity would remain responsible for ensuring that the subpart S requirements are met for the food that they manufacture, process, pack, or hold. The FDA encourages U.S. importers to work with their foreign suppliers to ensure there is an understanding of the traceability requirements for foods exported to the U.S. | 2023-06-26 | |
| General | TG.3 What more do we need to do if we already are able to trace one-up/one-back? What if we already have a tracing program in place? How does this rule interact with the Bioterrorism Act traceability requirements? | The “one-up, one-back” recordkeeping requirements, which refers to the traceability recordkeeping requirements in 21 CFR Part 1, subpart J (the subpart J regulation) established in accordance with the Bioterrorism Act of 2002, are currently in effect and will remain in effect once the Food Traceability Rule compliance date occurs. The Food Traceability Rule, codified in 21 CFR Part 1, subpart S, requires additional recordkeeping for certain foods listed on the Food Traceability List (FTL). If you are covered by the rule, you must maintain records as indicated in the rule. We discuss the relationship between the subpart J regulation mentioned above and the Food Traceability Rule in the preamble of the final rule (see section III. Background, A. Need for the Regulation/History of This Rulemaking). | 2023-06-26 |
| General | TG.4 What if products are private label but manufactured and packaged by a third party – who is responsible for maintaining the records? | The requirements of the Food Traceability Rule apply to persons who manufacture, process, pack, or hold Food Traceability List (FTL) foods. If a third party manufactures and packages FTL foods on behalf of another company, such as a private label owner, the third party would be responsible for maintaining the required records for the CTEs they perform. However, under § 1.1455(b), the third-party manufacturer/packager could have another entity, such as the private label owner, establish and maintain the required records on its behalf, though the third-party manufacturer/packager would remain responsible for ensuring that these records could be provided onsite within 24 hours of an FDA request for official review. | 2023-06-26 |
| General | TG.5 Are shipping records required when foods on the FTL are sold to an organization that meets the non-profit exemption? | In the case of food on the Food Traceability List (FTL) sold to a nonprofit food establishment, only the nonprofit food establishment is exempt from the rule under § 1.1305(o); none of the other entities in the supply chain are exempt. The nonprofit food establishment therefore does not have to keep records. Records must be kept, however, by other entities in the supply chain, including the entity who shipped the food to the nonprofit food establishment. Furthermore, even though the nonprofit food establishment is exempt, the shipper of the food is still required under § 1.1340(b) to provide the required shipping KDEs to the nonprofit food establishment. This information could be helpful during an outbreak if the nonprofit food establishment voluntarily decides to maintain it. We note that the definition of shipping in § 1.1310 does not include the donation of surplus food. Therefore, if a shipper is donating surplus food to a nonprofit food establishment (or other entity), they would not be required to keep records of the shipment of the donated food. | 2023-06-26 |
| General | TG.6 Why are there technical amendments to the final rule “Requirements for Additional Traceability Records for Certain Foods”? | FDA published the Food Traceability final rule with some editorial and inadvertent errors in the preamble and in one of the provisions added to the Code of Federal Regulations. To correct these errors and to improve the accuracy of the regulatory text, the FDA is amending the final rule. Four changes are being made:
| 2023-09-25
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| Implementation | TI.2 When do I need to provide records in an electronic sortable spreadsheet? | Requests for an electronic sortable spreadsheet would only occur during certain circumstances as described in § 1.1455(c)(3), such as in the event of a foodborne illness outbreak, recall, or other public health threat. Certain smaller entities are exempt from the requirement to provide this information in an electronic sortable spreadsheet, though they must still provide the information in other electronic or paper form. To help speed our access to information in such exigent circumstances, we may request the information remotely (e.g., by phone) instead of onsite at the entity’s place of business. During a routine inspection that does not meet the conditions described in § 1.1455(c)(3), a covered entity would not be required to provide FDA with an electronic sortable spreadsheet. | 2023-01-25 |
| Implementation | TI.3 What is the penalty for not complying with the final rule? | As stated in § 1.1460(a) of the final rule, the violation of any recordkeeping requirement under section 204 of FSMA or subpart S (except when such violation is committed by a farm) is a prohibited act under section 301(e) of the Food Drug & Cosmetics Act. While we intend to work to educate industry before and while we regulate to assist industry in understanding and coming into compliance with the subpart S requirements, there are various actions the Federal government may take if an entity commits a prohibited act under section 301(e) of the FD&C Act. Depending on the nature of the violation, it is generally FDA’s practice to give individuals and firms an opportunity to take prompt and voluntary corrective action before we initiate an enforcement action. We may issue advisory action letters, which include Untitled Letters and Warning Letters, to notify firms of violations and to prompt voluntary compliance. When voluntary compliance is not forthcoming, the Federal government may bring a civil action in Federal court to enjoin persons who commit a prohibited act. The Federal government may also bring a criminal action in Federal court to prosecute persons who commit a prohibited act. (FDA does not have the authority to impose fines for violations of section 204 of FSMA or subpart S.) As appropriate, FDA may hold multiple entities responsible for the failure to maintain traceability records in accordance with subpart S. Furthermore, as stated in § 1.1460(b) of the final rule, an article of food is subject to refusal of admission under section 801(a)(4) of the FD&C Act if it appears that the recordkeeping requirements under section 204 of FSMA (other than the requirements under section 204(f)), including the requirements of subpart S, have not been complied with regarding such article. | 2023-01-10 |
| Implementation | All covered persons will need to comply with the final rule requirements on or before Tuesday, January 20, 2026. | 2023-01-25 | |
| Implementation | TI.5 Will FDA be providing a portal or other way to submit traceability data to the agency? | The final rule does not require covered entities to regularly submit traceability data to the agency. However, FDA will request the required information from covered entities in certain situations, for example during a foodborne illness outbreak investigation. In some cases, FDA will request information to be provided in a sortable spreadsheet in accordance with § 1.1455(c)(3)(ii). We are currently considering various mechanisms by which electronic sortable spreadsheets, as well as digitized records and other requested information, can be made available to FDA. Approaches under consideration include sending requested information to a dedicated email box or through an online reporting mechanism, such as a web-based portal to allow for submission of traceability information that we might create in accordance with section 204(c) of FSMA. A request for records under § 1.1455(c)(3) will specify how the information may be shared with FDA. In addition, we expect to issue communication on how firms may make electronic sortable spreadsheets and records (whether in paper or electronic form) available to FDA. | 2023-01-10 |
| Implementation | TI.6 Upon the rule’s compliance date of January 20, 2026, are entities expected to have any records from before that date? | Firms subject to the rule will not have to keep records required under the rule until the compliance date for the rule, which is January 20, 2026. From that point forward, firms will have to keep required FTL records, including their traceability plan and KDEs for CTEs in which they engage, including harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, and transformation of FTL foods. Firms will need to keep these records generally for 2 years, with certain exceptions specified in the rule. Firms will not be required to keep any FTL records from before the compliance date. We recognize that when the compliance date arrives, there will be FTL foods in various stages of distribution, including on store shelves, for which there may not be complete tracing records, due to the fact that the product was produced before the compliance date. We will not expect these products to have records associated with them if the foods were already in distribution before the compliance date. | 2023-06-26 |
| Implementation | TI.7 Will you be auditing foreign food businesses for compliance with the rule or is the U.S. importer responsible for demonstrating that the foreign firms are in compliance? Are foreign governments expected to oversee that the rule is being applied for applicable foods exported to the U.S.? | Foreign entities covered by the rule are responsible for complying with the portions of the rule that apply to them, based on the CTEs they perform. Importers might not be subject to the rule, depending on whether they manufacture, process, pack, or hold any FTL foods; and if they are subject to the rule, they are only responsible for complying with the portions of the rule that apply to them, based on the CTEs they perform. FDA may conduct onsite inspections of foreign entities to determine compliance with regulatory requirements, including those in the rule, and we may communicate directly with foreign entities during our evaluation of inspectional outcomes or corrective actions. During an outbreak investigation involving an FTL food, we might seek to obtain information directly from foreign entities in the food’s supply chain, through the U.S. importer of the food, or through other means. All entities in the supply chain who manufacture, process, pack, or hold the FTL food, whether foreign or domestic, will need to determine how they will maintain required records and make them available to us upon request (unless the entity is subject to an exemption). Section 1.1455(b) of the Food Traceability Rule allows firms to have another entity establish and maintain records on their behalf, although covered firms remain responsible for ensuring that the records are provided onsite to us within 24 hours of our request for the records. Thus, foreign entities may enter into an agreement with their U.S. importer or another entity to maintain records on their behalf, while remaining responsible for compliance with applicable requirements in the rule. The rule does not require importers of FTL foods to verify that entities in their supply chain are in compliance with the rule requirements as a condition of importation. However, importers may wish to be aware of whether their suppliers are subject to, and in compliance with, the rule requirements because under section 801(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), an article of food is subject to refusal of admission if it appears that the requirements under the rule have not been met for that food (see 21 CFR 1.1460(b)). We are still determining our approach to enforcement of the rule and the appropriate circumstances regarding refusal of admission for non-compliance with the rule. | 2023-06-26 |
| Implementation | TI.8 Will FDA update the Reportable Food Registry (RFR) to require a firm to report a product that is not in compliance with the Food Traceability Rule? Will the RFR be updated to capture a firm’s KDEs when reporting about a violative product? | FDA will not be updating the RFR to require firms to report products that are not in compliance with the Food Traceability Rule. The requirements in the rule are separate from the requirements for the RFR, under which registered food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to report to the RFR when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals (section 415(a) of the FD&C Act). | 2023-06-26 |
| Implementation | TI.9 Will FDA issue fines if firms are not in compliance with the rule? | FDA does not have the authority to impose fines for violations of this rule. Regarding firms that are not in compliance with the rule, while we intend to work to educate industry before and while we regulate to assist industry in understanding and coming into compliance with the rule requirements, there are various actions the Federal government may take if an entity does not comply. Note that we are still developing our enforcement and compliance strategy for the rule. As stated in § 1.1460, the violation of any requirement of the rule is a prohibited act under section 301(e) of the FD&C Act (except when such violation is committed by a farm). Depending on the nature of the violation, it is generally FDA’s practice to give individuals and firms an opportunity to take prompt and voluntary corrective action before we initiate an enforcement action. We may issue advisory action letters, which include Untitled and Warning Letters, to notify firms of violations and to prompt voluntary compliance. When voluntary compliance is not forthcoming, the Federal government may bring a civil action in Federal court to enjoin persons who commit a prohibited act. The Federal government may also bring a criminal action in Federal court to prosecute persons who commit a prohibited act. As appropriate, FDA may hold multiple entities responsible for the failure to maintain traceability records in accordance with the rule. For imported foods, § 1.1460(b) incorporates section 801(a)(4) of the FD&C Act, which authorizes FDA to refuse admission to an article of food if it appears that the recordkeeping requirements under section 204 of the FDA Food Safety Modernization Act have not been met. | 2023-06-26
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| Importers | Importers who engage in “holding” of food within the meaning of the rule are subject to the rule for the CTEs that apply to them. These CTEs are most likely to be receiving (see 21 CFR 1.1345) and shipping (see 21 CFR 1.1340), but you should evaluate your own practices to confirm which CTEs apply to your particular situation. Importers that do not physically possess food on the Food Traceability List (FTL) are not subject to the rule. | 2023-06-26 | |
| Importers | TIM.3 Is an importer required to collect and store all traceability information from the upstream supply chain? Does the FDA entry number have to be included or sent to the U.S. company? | As noted above, importers might not be subject to the rule, depending on whether they manufacture, process, pack, or hold any Food Traceability List (FTL) foods; and if they are subject to the rule, they are only responsible for complying with the portions of the rule that apply to them, based on the CTEs they perform. Foreign entities covered by the rule are responsible for complying with the portions of the rule that apply to them, based on the CTEs they perform. There is no requirement for any covered entity to record or send the entry number assigned to an imported FTL food. | 2023-06-26 |
| Importers | TIM.4 How does the Food Traceability Rule apply to foreign firms, farms, packers, etc.? | Unless a specific exemption applies, the rule applies to foreign persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) that are imported into the United States, including food exporters, foreign farmers, packers, manufacturers, and distributors who engage in such activities. | 2023-06-26 |
Importers
| TIM.2 Do the recordkeeping requirements in the final rule apply to foods prior to import into the United States or only after import? | The recordkeeping requirements of the Food Traceability Rule apply to imported Food Traceability List (FTL) foods (unless exempt) both before and after importation. Thus, the requirements apply to any CTEs (for example, initial packing and shipping) that occur before an FTL food is imported into the United States as well as those that occur after the food has entered the U.S. (for example, receiving, transformation, and shipping). | 2023-06-26 |
Importers
| TIM.5 How does this rule tie in with the foreign supplier verification program (FSVP) requirements? Will traceability records be requested of U.S. importers during an FSVP inspection? | While the Food Traceability rule focuses on improving traceability for both domestic and foreign foods on the Food Traceability List (FTL), the FSVP regulation (21 CFR Part 1, subpart L) is intended to help ensure that importers take certain steps to verify, before importing food, that the imported food meets applicable FDA food safety requirements. While we do not anticipate routinely doing so, we may request traceability records for a food on the FTL from an FSVP importer covered by the traceability rule. The rule requires that traceability records be made available to an authorized FDA representative, upon request according to requirements in § 1.1455(c). As stated in Response 149 of the final rule preamble, FDA investigators may request the records required under the rule under a range of circumstances, including during routine inspections and in the event of an outbreak investigation, recall, or other threat to public health. | 2023-06-26 |
| Initial Packer | TIP.1 Why does the Initial Packer have to establish a Traceability Lot Code (TLC)? | Under § 1.1320(a) of the final rule, an entity must assign a TLC when it initially packs a raw agricultural commodity (RAC) other than a food obtained from a fishing vessel; performs the first land-based receiving of a food obtained from a fishing vessel; or transforms a food. The TLC is essential for the FDA to be able to track a specific lot of food through the food supply in the event of a foodborne illness outbreak. We have determined that initial packers are better suited to assign TLCs than growers of raw agricultural commodities (RAC). | 2023-01-10 |
| Initial Packer | TIP.2 Why does the Initial Packer have to maintain records from harvesters and coolers? | Quickly identifying the nodes in the supply chain where product was handled is essential for effective traceability. Being able to access information maintained by the initial packer about what farm a raw agricultural commodity (RAC) came from, who harvested it, when/if it was cooled, and where and when cooling was performed will shorten the time it takes to perform tracebacks. | 2023-01-10 |
| Intracompany Shipments and Cross-Docking | TISCD.1 Would intracompany shipments be covered by the rule? | Yes. Effective traceability requires that records be kept when a product changes physical location, regardless of whether the shipper and receiver are under the ownership or operational control of the same company (as in an intracompany shipment). Therefore, the definition of “shipping” in the final rule specifies that it includes 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; we have added a similar clarification to the definition of “receiving.” However, we note that movement of a product within a particular location of a firm (i.e., at a particular street address) does not constitute “shipping” or “receiving” under the final rule. | 2023-01-10 |
| Intracompany Shipments and Cross-Docking | TISCD.2 Would traceability records be required if a firm is conducting cross-docking, such as when a pallet of food products is sent from a firm through a distribution center or cross-docker and then sent on to the next point in the supply chain? | The final rule defines shipping to mean 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. Records must be kept regarding both locations, i.e., the location where the shipping event began and the location where it ended (i.e., where the food was received). However, it is not necessary to have records of the route the food took, including any instances where it may have been moved from one carrier to another. In a cross-docking situation where food is arranged for transport from point A to point B, but it is briefly placed on a loading dock at point X to be transferred from one truck to another truck, we would not consider the food to have been shipped to point X (or to have been received at point X). Therefore, records would not need to be kept for point X. The required shipping and receiving records would reflect that the food was shipped from point A and received at point B. However, we recognize that questions might arise in situations where food is arranged for transport from point A to point B, with an understanding that there will be an intermediary step during which the food is held at point X for a period of time. To determine whether the food was received at point X (and then subsequently shipped to point B), we would consider factors such as how long the food was held at point X, whether it was held there under temperature-controlled conditions that differ from transportation conditions, and whether it was taken into inventory at point X. | 2023-01-10 |
| Kill Step | TKS.1 If a kill step is applied to an ingredient before it is used to make a food on the Food Traceability List (FTL), such as nuts before they are made into nut butter or milk before it is made into cheese, would the final rule still apply to the FTL foods (such as nut butter or soft cheese)? | Yes. It is the nut butter, not the nuts, (or the soft cheese, not the milk), that is on the Food Traceability List (FTL) and covered by the final rule. The commodity on the FTL, regardless of whether a kill step was applied to the ingredients, ranked high in the Risk-Ranking Model for Food Tracing (RRM-FT), which is why it is covered by the final rule. | 2023-01-10 |
| Kill Step | TKS.2 What are the requirements for entities who receive a food to which a kill step has been applied? | Persons in the supply chain who receive a food on the Food Traceability List (FTL) to which a kill step has already been applied would not be required to maintain any traceability records under the final rule. | 2023-01-25 |
| Product Tracing System | TPTS.1. Why is FDA developing a Product Tracing System and what will this system do? | The FDA is directed under FSMA Section 204(c) to, as appropriate, “… establish within the Food and Drug Administration a product tracing system to receive information that improves the capacity of the Secretary to effectively and rapidly track and trace food that is in the United States or offered for import into the United States.” The FDA is currently developing an internal Product Tracing System (PTS) to receive and analyze industry’s food traceability data and more effectively and rapidly trace food within the United States. The PTS will enhance existing foodborne outbreak response processes, especially those by the FDA Coordinated Outbreak Response and Evaluation (CORE) Network. Upon FDA request, industry stakeholders will have the option to upload electronic sortable spreadsheets or other traceability records into FDA’s Safety Reporting Portal (SRP), which is a secure web-based portal that will be updated to include a traceability-specific landing page. Alternatively, industry stakeholders could send their electronic sortable spreadsheets or other traceability records to FDA via email and have FDA upload their data directly into the PTS. An electronic sortable spreadsheet is required in certain situations, as outlined in § 1.1455(c)(3)(ii); but because there are other situations where the electronic sortable spreadsheet is not required, FDA is preparing to receive traceability records in a variety of formats. Once the data are uploaded, the PTS will automatically process the information into a supply chain visibility data standard called EPCISExternal Link Disclaimer (Electronic Product Code Information Services). This data standard is intended to promote data interoperability within FDA’s PTS. While this openly accessible data standard is one option available for use by industry to promote interoperability across their supply chains, it is not a requirement to comply with the Food Traceability Rule and it is not a requirement to send FDA food traceability data in EPCIS format. After data processing, the data are available for use by authorized government users in an open-sourced data visualization platform called FoodChain LabExternal Link Disclaimer (FCL). FCL creates automatic end-to-end supply chain diagrams from the processed data and can overlay these supply chain diagrams onto an interactive geographic map. This automated visualization functionality will assist FDA in identifying potentially contaminated foods or ingredients during a foodborne outbreak investigation. The PTS will have very strict data security and network security protocols. Only permissioned government users can access the data and FDA will protect confidential information from disclosure in accordance with all applicable statutes and regulations, including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905, and 21 CFR part 20, as it does for confidential information on other FDA-regulated products. More information on uploading documents to the SRP will be coming as we approach the compliance date. | 2023-09-28 |
| Records Maintenance and Availability | TRMA.1 What are the elements that will be required as part of the electronic sortable spreadsheet? | The electronic sortable spreadsheet must include the required key data elements (KDEs) under §§ 1.1325 through 1.1350, as requested by FDA, along with any other information needed to understand the information in the spreadsheet. When requesting an electronic sortable spreadsheet, FDA will specify the specific foods and the date ranges (or traceability lot codes) for which we seek required traceability information. We will strive to tailor the information request as much as possible so that firms can focus their efforts on the most relevant information. | 2023-06-26 |
| Records Maintenance and Availability | TRMA.2 Will FDA issue a template for the electronic sortable spreadsheet that firms can use to provide requested records? | We posted to our website an electronic sortable spreadsheet template that can be used to fulfill data submission requests for FDA in accordance with the Food Traceability Rule. The template is presented for illustrative purposes. You are not required to use this specific electronic sortable spreadsheet template to comply with the rule. | 2023-06-26 |
Records Maintenance and Availability
| TRMA.3 What is meant by "reference document type” and “reference document number”? | Reference document is defined in § 1.1310 as a business transaction document, record, or message, in electronic or paper form, that may contain some or all of the key data elements (KDEs) for a critical tracking event (CTE) in the supply chain of a food. A reference document may be established by you or obtained from another person. Reference document types may include, but are not limited to, bills of lading, purchase orders, advance shipping notices, work orders, invoices, database records, batch logs, production logs, field tags, catch certificates, and receipts. Reference document number is defined as the identification number assigned to a specific reference document. | 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | TRFE.1 Are small Retail Food Establishments (RFEs) or restaurants covered by the final rule? | The final rule does not apply to Retail Food Establishments (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 (21 CFR 1.1305(i). 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 (21 CFR 1.1305(j)). 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. | 2023-01-10 |
| Retail Food Establishments (RFEs) and Restaurants | 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. Additional resources for Retail Food Establishments and Restaurants are available below:
| 2023-01-10 |
| Retail Food Establishments (RFEs) and Restaurants | 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 Food Traceability List (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. | 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | TRFE.4 For the exemption related to small retail food establishments (RFEs) and restaurants, does the average annual monetary value of food sold apply only to the items covered by the rule or is it gross annual sales for the establishment? | The exemption in § 1.1305(i) applies to 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. The exemption considers the value of all food sold or provided at a single establishment.
| 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | TRFE.5 In the exemption for small retail food establishments (RFEs) and restaurants in § 1.1305(i), does the average annual monetary value of $250,000 refer to food sales under $250,000 in each of the 3 previous years or over the 3 years combined? | The exemption applies to the average yearly value of food sold or provided over the last 3 years (on a rolling basis), not to the sum total sales over the 3-year period. For example, Restaurant A has total food sales of $240,000 in year 1, $250,000 in year 2, and $230,000 in year 3. The average yearly total over the 3 years would be $240,000, which means Restaurant A would qualify for this exemption. | 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | TRFE.6 Are direct sales from farms to a grocery store exempt from the Food Traceability Rule? | Under § 1.1305(j), there is a partial exemption for retail food establishments (RFEs) and restaurants with respect to food that is sold and shipped directly to them by the farm that produced the food. In such a situation, the RFE or restaurant only needs to maintain a record documenting the name and address of the farm that was the source of the food, which they only need to keep for 180 days. However, there is no exemption for the farm in this situation. | 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | 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. | 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | 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 Food Traceability List (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)). | 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | 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. | 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | 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. | 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | 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 Food Traceability List (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. | 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | 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. | 2023-06-26 |
| Retail Food Establishments (RFEs) and Restaurants | 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). | 2023-06-26 |
| Risk-Ranking Model for Food Tracing (RRM-FT) | TRRM.1 Would the number of hazards associated with a commodity impact its risk score? | The number of hazards associated with a commodity does not necessarily impact its risk score. In the Risk-Ranking Model for Food Tracing (RRM-FT), for each commodity a comprehensive list of commodity-hazard pairs is identified without a priori assumption about the risk scores the pairs might receive. The Model independently scores each of the commodity-hazard pairs associated with a commodity, and then aggregates risk scores for the pairs to calculate a risk score for the commodity. The aggregation method is not sensitive to the number of commodity-hazard pairs associated with the commodity; rather, the commodity risk score is driven by the highest-scored commodity-hazard pair(s). The risk score for a commodity-hazard pair depends on the data across seven criteria in the Model, but it is not affected by the number of hazards associated with the commodity. | 2023-01-10 |
| Risk-Ranking Model for Food Tracing (RRM-FT) | TRRM.2 How does FDA identify hazards for each commodity in the Risk-Ranking Model for Food Tracing (RRM-FT)? | We identify hazards for each commodity based on associated known or reasonably foreseeable hazards, using outbreak and contamination data and other information, such as foods and hazards associated with outbreaks and illnesses, and detection of hazards in foods (not necessarily implicated in illnesses). For example, we use data and information from the FDA outbreak database, the CDC National Outbreak Reporting System, FDA recalls and Reportable Food Registry reports, FDA surveillance and sampling data, a review of world-wide published risk assessments, and scientific studies and technical reports from governmental and other organizations. We also consider commodity-hazard pairs suggested by peer reviewers, external expert panels, and FDA subject matter experts during the iterative Model development and review process. For more detail, including considerations for identifying an emerging hazard, see “Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204.” | 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.1 How did FDA determine which foods are included on the Food Traceability List (FTL)? | To determine which foods should be included on the Food Traceability List (FTL), the FDA developed a risk-ranking model for food tracing (“the Model”) based on factors that Congress identified in Section 204(d)(2) of the Food Safety Modernization Act (FSMA). The Model scores commodity-hazard pairs (e.g., Shiga toxin-producing E.coli O157 (STEC O157) in Leafy Greens) according to data and information relevant to seven criteria described in the report Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204:
The Model is designed to be flexible and to consider a wide range of known and reasonably foreseeable contaminants in FDA-regulated human foods. It evaluates and ranks a comprehensive list of commodity-hazard pairs and the associated commodities to inform the Food Traceability List. For additional information, see the Designation of the Food Traceability List Using the Risk-Ranking Model for Food Tracing memo. | 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.2 Does the Food Traceability List (FTL) include only biological hazards? | In developing the Food Traceability List (FTL), FDA focused on results from the Model for biological hazards and acute chemical toxins that present an immediate public health risk and for which traceability recordkeeping would be necessary to rapidly identify the source of contamination and prevent additional illnesses. For more information about development of the Model, see “Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204.” For information on the designation of the FTL, see the Designation of the Food Traceability List Using the Risk-Ranking Model for Food Tracing memo. | 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.3 Does the Food Traceability List (FTL) that published with the final rule include new foods? | The list of foods on the Food Traceability List (FTL) in the final rule did not change from the proposed rule. However, there is additional clarity in the descriptions, for example:
| 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.4 Under what circumstances and how often will FDA revise and update the Food Traceability List (FTL)? | We intend to update the Food Traceability List (FTL) approximately every five years, subject to available resources. Within this timeframe we would update the Risk-Ranking Model for Food Tracing (RRM-FT) with new data and information; develop a proposed revised FTL; publish a notice in the Federal Register stating the proposed changes and the reasons for the changes; request and review comments from the public on the proposal; and publish a second notice in the Federal Register to announce any changes to the FTL and the reasons for the decision, as set forth in § 1.1465. As part of this process and before proposing any changes to the FTL, the FDA intends to provide stakeholders with a mechanism to submit relevant data for the RRM-FT for the agency’s consideration. Any deletions to the FTL would become effective immediately, while any additions to the FTL would become effective two years after the date of the Federal Register notice announcing the revised list, unless otherwise stated. | 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.5 Are dried or frozen versions of Food Traceability List (FTL) foods covered by the final rule? | If a food, designated as fresh on the Food Traceability List (FTL), has been changed through freezing, drying, etc., and is no longer “fresh” then the food would no longer be on the list. For example, fresh spinach, peppers, and herbs are on the list, but frozen spinach, dried peppers, or dried herbs would not be covered by the rule because only the fresh form of these products is listed on the FTL. However, for finfish, crustaceans, and molluscan shellfish, both the fresh and frozen forms of those products are on the list and covered by the final rule. | 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.6 Are foods that contain a Food Traceability List (FTL) food as an ingredient also covered by the final rule? | Yes, if the ingredient remains in the form in which it appears on the list. Thus, if a commodity designated as “fresh” is used in its fresh form as part of a multi-ingredient food, then the multi-ingredient food would also be covered under the final rule. For example, a bagged salad mix with fresh lettuce, a prepared smoothie with fresh cantaloupe, or a sandwich containing fresh tomato slices would be covered. However, a frozen pizza with spinach topping or trail mix with dried papaya would not be covered. For foods on the Food Traceability List (FTL) that are not designated as “fresh” that are used as ingredients in a multi-ingredient food, if no kill step is applied and the FTL food is not otherwise changed such that it is no longer on the FTL, then the multi-ingredient food would be covered by the final rule. For example, peanut butter in a sandwich cracker for which no kill step is applied (to either the peanut butter or the peanut butter sandwich cracker) is covered by the rule. | 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.7 Is frozen cheese used on a frozen pizza, covered by the rule? | No. Frozen cheese is not on the Food Traceability List (FTL) and therefore not covered by the final rule. | 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.8 Are foods for animals (such as pet food or animal feed) covered by the final rule? | No. Foods for animals are not included in our current risk-ranking model and are not included on the Food Traceability List (FTL), and therefore not covered by the final rule. | 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.9 How is the Food Traceability List (FTL) different from the FDA’s designation for high-risk food facilities for the purposes of inspection? | FDA designation of high-risk foods for which additional recordkeeping requirements must be kept is based on specific factors that Congress identified in section 204(d)(2) of FSMA. These factors are different from the factors that FDA must consider when designating food facilities as high-risk under section 201 of FSMA. The Food Traceability List (FTL) concerns commodity-specific risks that are relevant to the need for additional traceability records. High-risk facility designations concern the risk profile of specific food facilities for the purpose of determining the frequency of domestic inspections. Specifically, section 204(d)(2) of the Food Safety Modernization Act (FSMA) requires FDA to use a specific set of criteria to identify foods for which additional traceability records are appropriate and necessary to protect the public health. A separate part of FSMA (section 201) requires FDA to inspect domestic high-risk facilities at least once every 3 years and domestic non-high-risk facilities at least once every 5 years. This same section of FSMA provides factors for determining which facilities should be designated as “high-risk”, for the purpose of implementing these requirements relating to inspectional frequency. These factors include the known safety risks of the food that is manufactured, processed, packed, or held at the facility, but they also include factors such as the compliance history of the facility, and the rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls. | 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.10 What if I produce a food on the Food Traceability List (FTL), then cook the food, apply high-pressure processing to the food, or otherwise apply a kill step to the food? | If you apply a kill step (i.e., lethality processing that significantly minimizes pathogens in a food) to a food on the Food Traceability List (FTL), and you maintain a record of your application of the kill step, the requirements of the final rule would not apply to your subsequent shipping of the food (21 CFR 1.1305(d)(3)). Further, any subsequent receivers of a food to which a kill step has been applied are not subject to the requirements of the final rule. In addition, if an FTL food will be subjected to a kill step in the future (by an entity other than a retail food establishment, restaurant, or consumer), that food is partially exempt from the rule, providing the shippers and receivers of the food enter into written agreements stating that the kill step will be applied by the receiver or a subsequent entity in the supply chain (21 CFR 1.1305(d)(6)). | 2023-01-10 |
| The Food Traceability List (FTL) | TFTL.11 Are live seafood products (e.g., live lobsters, live crabs, live crawfish) covered by the Food Traceability rule? Do I need to maintain key data elements (KDEs) for live seafood products? | Live seafood products, such as live lobsters, crabs and crawfish, are covered by the rule. For finfish, crustaceans, and mollusks raised on aquaculture operations, the aquaculture farm must maintain a farm map showing the areas in which they raise the seafood, and the map must show the location and name of each container (e.g., pond, pool, tank, cage) in which the seafood are raised, including geographic coordinates and any other information needed to identify the location of each container (see 21 CFR 1.1315(a)(5) and (a)(5)(ii)). For seafood obtained from a fishing vessel, note that fishing vessels are exempt from most requirements of the rule under 21 CFR 1.1305(m). The first land-based receiver of seafood obtained from a fishing vessel must maintain the KDEs described in 21 CFR 1.1335. As the seafood moves through the supply chain, the records that must be kept at each critical tracking event (CTE) (e.g., harvesting, initial packing, shipping, receiving) would not change regardless of whether the seafood is still alive. However, § 1.1305 sets forth various exemptions that might apply to the seafood, including exemptions and partial exemptions for foods that receive certain types of processing, such as a kill step (see § 1.1305(d)). | 2023-06-26 |
| The Food Traceability List (FTL) | TFTL.12 Does the rule apply to fresh-cut fruit or vegetables that have been frozen, flash frozen, or individually quick frozen? If we get fresh-cut fruit from a supplier and then freeze it, what KDEs do we need to maintain? | Frozen “fresh-cut” fruits and vegetables are not covered by the rule. This is the case whether the food has been frozen, flash frozen, or individually quick frozen (IQF). This is because for foods that are designated as “fresh” on the Food Traceability List (FTL), if the form of the food is no longer fresh and has been changed (e.g., through freezing, drying, or another change in the form of the food), then the food would no longer be an FTL food (21 CFR 1.1305(d)(4)). If you receive fresh-cut fruit from a supplier and then freeze it, you will need to maintain receiving KDEs for the fresh-cut fruit but will not need to maintain any additional records. Any subsequent persons who handle the frozen fruit will also not need to maintain any records. However, if you have a written agreement with your supplier as described in § 1.1305(d)(6) which says you will freeze the fruit, then you would not need to maintain any KDEs. | 2023-06-26 |
| The Food Traceability List (FTL) | All cheeses other than hard cheeses are on the Food Traceability List (FTL) and covered by the rule, unless an exemption applies. “Hard cheese” includes hard cheeses as defined in 21 CFR 133.150, colby cheese as defined in 21 CFR 133.118, and caciocavallo siciliano as defined in 21 CFR 133.111. The FTL specifically notes that cheeses that are frozen, shelf stable at ambient temperature, or aseptically processed and packaged are not on the FTL. Further, we note that if a person applies a kill step, such as pasteurization, to a cheese on the FTL, the person is eligible for a partial exemption from the food traceability recordkeeping requirements in the rule under § 1.1305(d)(3), and anyone who receives the cheese after the kill step has been applied is eligible for a full exemption under § 1.1305(d)(5). For example, pasteurized process and pasteurized prepared cheese and cheese products (e.g., pasteurized process cheese, pasteurized process cheese food, pasteurized cheese spread, pasteurized blended cheese, pasteurized prepared cheese product), as well as processed mozzarella cheese, would be eligible for these exemptions. Cheeses that are processed under the low-acid canned food regulations are a separate commodity in the risk-ranking model for food traceability (RRM-FT) used to help develop the FTL and are not on the FTL. | 2023-06-26
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| The Food Traceability List (FTL) | FDA regulations do not define “nut butter.” We note that the standard of identify for peanut butter (21 CFR 164.150) allows seasoning and stabilizing ingredients to be included as part of the peanut butter. While there are no standards of identity for other nut butters, FDA expects that seasonings and stabilizing ingredients could be added to other nut butters in a similar manner. | 2023-06-26
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| The Food Traceability List (FTL) | TFTL.15 Is peanut paste included in the category “nut butters?” | Peanut paste is included within the commodity “nut butters” and therefore is covered by the rule. | 2023-06-26
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| The Food Traceability List (FTL) | TFTL.16 Does the rule apply to semi-finished, pre-mixed paste with nut flavor that is for industrial use only (added to ice cream) and not for direct consumption? | “Flavorings” is a separate commodity in the Risk-Ranking Model for Food Tracing (RRM-FT) and is not on the Food Traceability List (FTL), so it is not covered by the rule. Thus, flavorings such as walnut flavor extract and almond extract are not covered by the rule. However, if nut butters such as walnut butter and almond butter are ingredients added to provide the nut flavor to another product (such as ice cream), the finished product would be covered by the rule. If you are not sure how your product is classified, it might be helpful to consult Table A-2 in Appendix A of the “Methodological Approach to Developing a Risk-Ranking Model for Food Tracing” document or our online tool. This table lists all of the commodities that were considered for possible inclusion on the FTL, including “nut butters.” If your product falls into one of the commodities in Table A-2 that is not on the FTL, such as “nut meal and powder” and “flavorings,” then it would not be on the FTL (unless it includes an ingredient on the FTL that is still in the form in which it appears on the FTL). | 2023-06-26
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| The Food Traceability List (FTL) | Yes. The Risk-Ranking Model for Food Tracing analyzed data for nut butters as a commodity. The commodity includes all forms of nut butters, including shelf-stable, refrigerated, and frozen products. Consequently, all forms of nut butters, including frozen nut butter, are on the Food Traceability List (FTL) and covered by the rule. Multi-ingredient products that contain frozen nut butter are therefore also covered by the rule. | 2023-06-26
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| The Food Traceability List (FTL) | TFTL.18 Would chocolate peanut butter cups be covered by the rule, even if the ingredient label does not list peanut butter? | Nut butters, including peanut butter, are on the FTL. A multi-ingredient food that contains peanut butter is therefore covered by the rule. However, such a multi-ingredient product would be exempt from the rule if a kill step has been applied, subject to § 1.1305(d)(3) and (5). Peanut butter itself can be a multi-ingredient food, such as if it is made from peanuts and salt. Under FDA’s food labeling requirements, when a multi-ingredient food such as peanut butter is itself an ingredient in another food, such as a chocolate peanut butter cup, there are two options for declaring the ingredients (see 21 CFR 101.4(b)(2)). One option is that “peanut butter” can be declared on the label as an ingredient, with the sub-ingredients (e.g., peanuts and salt) declared parenthetically after the declaration of “peanut butter.” The second option is that the individual ingredients (e.g., peanuts and salt) can be displayed in their order of predominance in the ingredient statement, without naming “peanut butter” as an ingredient. The decision to include or not include “peanut butter” on the ingredient statement does not determine whether the food is covered by the Food Traceability Rule. If the food contains peanut butter as an ingredient, it is covered by the rule, even if “peanut butter” is not listed on the ingredient statement. | 2023-06-26
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| The Food Traceability List (FTL) | TFTL.19 Are raw or roasted nuts covered? Are roasters of nuts covered? | Nuts, whether they are raw or roasted, are not on the Food Traceability List (FTL) and are not covered by the rule. Thus, roasters of nuts are not covered, unless the roasters are also making nut butter. In that case, they would need to maintain traceability records for the nut butter only. | 2023-06-26
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| The Food Traceability List (FTL) | TFTL.20 Does the rule apply to human food that is used as an ingredient in animal food? Is pet food covered? What about fish feed? | Animal food and feed, including pet food and fish feed, are not on the Food Traceability List (FTL) and therefore are not covered by the rule. Animal food that is made with food (or by-products from production of food) on the FTL is also not subject to the rule. | 2023-06-26
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| The Food Traceability List (FTL) | TFTL.21 Are dietary supplements covered by the rule? What about dietary ingredients or mineral supplements? | While dietary supplements are included in the Risk-Ranking Model for Food Tracing (RRM-FT), they do not have a risk score high enough to merit inclusion on the Food Traceability List (FTL) and therefore are not covered by the rule. However, if a dietary supplement uses an ingredient on the FTL, and that ingredient is in the same form in which it appears on the FTL (e.g., “fresh”), then the dietary supplement would be covered by the rule. For example, some refrigerated dietary supplements contain fresh herbs and therefore would be covered by the rule. | 2023-06-26
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| The Food Traceability List (FTL) | TFTL.22 If I make cheese that is on the FTL, do I need to keep traceability records that include the origin of all the ingredients in the cheese, including components such as powdered milk, powdered whey, and dairy protein? Or do the traceability requirements begin at the moment the cheese is produced, and it is not necessary to identify the ingredients? | Milk and most other ingredients for cheese are not on the Food Traceability List (FTL) and so are not covered by the final rule. Cheeses, other than hard cheeses, are on the FTL. Therefore, in general no records are required for the milk or other ingredients for cheese. See the "How the Food Traceability Rule works: Cheese Supply Chain ExampleExternal Link Disclaimer" video for more information. Manufacturers of cheeses on the FTL would need to maintain transformation Key Data Elements (KDEs) as described in § 1.1350 as well as shipping KDEs as described in § 1.1340, unless an exemption applies. Some cheeses might include an ingredient that is on the FTL, such as a fresh herb. In that situation, the manufacturer of the cheese would need to maintain receiving KDEs for the fresh herb as described in § 1.1345. The fresh herb would also be an FTL food used in the transformation process, and the relevant records would need to be kept under § 1.1350(a)(1). | 2023-11-20 |
| The Food Traceability List (FTL) | TFTL.23 The seafood items on the FTL are specified as “fresh and frozen.” Does the Food Traceability Rule also cover previously frozen fish that are thawed for processing or distribution as they would no longer be considered a fresh product? | Yes, previously frozen fish that is thawed for processing or distribution is covered by the rule. It is not uncommon for seafood products to be thawed and then refrozen, or to be frozen and then thawed, as they move through the supply chain, which is one reason why, for many seafood commodities, we have classified fresh and frozen products together within the Model, rather than separating them into different commodities. | 2023-11-20 |
| The Food Traceability List (FTL) | TFTL.24 What is the status of previously frozen foods on the FTL? For example, if a manufacturer receives the frozen form of an FTL food and then thaws it, do records need to be kept for the thawed version of that FTL food? | The status of previously frozen foods depends on the type of food and how it is described on the Food Traceability List (FTL). In a March 2024 update to the FTL, we noted that the designations “fresh” and “fresh-cut” on the FTL do not include previously frozen (i.e., thawed) forms of the food. We also clarified that previously frozen cheeses are not on the FTL. (Prior to this update, the FTL had stated that frozen cheeses were not included, but it had been silent with respect to previously frozen cheeses.) For all of these products – all of the cheeses on the FTL, as well as all of the products that are designated as “fresh” or “fresh-cut” on the FTL – freezing the food is considered a change in the form of the food such that it is no longer on the FTL, and the food continues not to be on the FTL after it is thawed. But for seafood, ready-to-eat deli salads, and nut butters, our March 2024 update clarified that previously frozen versions of these foods are on the FTL. Thus, if a manufacturer receives frozen spinach and thaws it for further use, the manufacturer would not need to maintain KDEs for the frozen spinach nor for the thawed spinach, because these forms of spinach are not on the FTL. If a manufacturer receives fresh herbs and freezes them, the manufacturer must maintain receiving KDEs for the fresh herbs (which are on the FTL), but would not need to maintain any additional KDEs, because frozen herbs are not on the FTL. If a subsequent member of the supply chain thaws the herbs, that person would also not need to maintain KDEs, because previously frozen herbs are also not on the FTL. If a processor receives fresh finfish and freezes it, then ships the frozen finfish to a distribution center that will thaw the fish before sending it to retail, all of the firms must maintain all applicable KDEs because all of these forms of the finfish – fresh, frozen, and previously frozen – are on the FTL. | 2024-03-20 |
| Traceability Lot Code (TLC) | TTLC.1 Do I have to assign a Traceability Lot Code (TLC) to the food I manufacture, process, pack, or hold? | It depends on the CTE you are performing. A TLC must be assigned when you do any of the following: Initially pack a raw agricultural commodity 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 (21 CFR 1.1320). That TLC must be shared with the next step in the supply chain, along with the relevant Key Data Elements (KDEs). Persons may not change the TLC if they are not performing those Critical Tracking Events (CTEs). For example, a distributor should not change the TLC provided to them. | 2023-01-25 |
| Traceability Lot Code (TLC) | TTLC.2 What is a Traceability Lot Code source reference? How does it work? | A TLC source reference is a method for giving FDA access to the TLC source location description required under subpart S without providing the TLC source location information directly to subsequent recipients. To protect the confidentiality of business information, a shipper could choose to provide its customers with the TLC source reference, instead of directly identifying the location description of the TLC source of an FTL food they handle. Examples of TLC source reference types include, but are not limited to, the FDA Food Facility Registration Number assigned to the TLC source or a web address that provides FDA with the location description for the TLC source. Other examples include a web address in a QR code or a GS1 Digital Link. Such a web address may employ reasonable security measures, such as only being accessible to a government email address, provided FDA has access to the information at no cost and without delay. We believe that the option to use a TLC source reference is an appropriate measure for those entities concerned with sharing the TLC source information through the supply chain. | 2023-01-10 |
| Traceability Lot Code (TLC) | TTLC.3 Do I need to include the TLC on the product label or product packaging? | No, the final rule does not require that the TLC be included on food labeling or food packaging. The TLC can be sent to the next recipient of the food in a variety of ways, such as via a bill of lading, an advance shipment notice (ASN), in a separate email, or by embedding the information in a quick response (QR) code that appears on the packaging of the food or on a related document. The information does not have to physically accompany the food sent to the recipient but must be provided in a way that permits the receiver of the food to keep the records it is required to maintain under the rule. | 2023-01-25 |
| Transformation | TT.1 If I use ingredients that are not on the Food Traceability List (FTL) to make an FTL food (such as a deli salad), do I need to keep records under the final rule? | As described in § 1.1350, you must keep Key Data Elements (KDEs) for each new traceability lot of an FTL food you produce through transformation. However, you do not need to maintain KDEs for any non-FTL foods used as ingredients in the new FTL food. For example, if you are making a deli salad with tomatoes, cucumbers, and olives, you would need to keep receiving records and records described in § 1.1350(a)(1) for the tomatoes and cucumbers as incoming ingredients since both of those foods are on the FTL. You would not need to keep records for the olives as an incoming ingredient since olives are not on the FTL. You would need to keep records as described in § 1.1350(a)(2) for the deli salad, as well as any subsequent shipping records for the deli salad. | 2023-01-10 |
| Transformation | TT.2 Is “repacking” a transformation event that would require a new Traceability Lot Code (TLC)? | Repacking an FTL food is always a transformation event, and it often (but not always) requires a new traceability lot code. We define transformation in the final rule as an event in a food’s supply chain that involves manufacturing/processing a food or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or packing, when the output is a food on the FTL. A new traceability lot code will usually need to be assigned to the repacked product. However, repacked product can retain the traceability lot code from the original traceability lot if the food is repacked within the same traceability lot (repacking “like into like”). In this situation, the repacker would keep the required transformation records under § 1.1350, with the lot codes in § 1.1350(a)(1)(i) and (2)(i) being the same. The traceability lot code source would be changed to reflect the place where the repacking occurred. | 2023-01-10 |
| Transformation | TT.3 What records need to be kept for a product where peanuts are roasted, turned into peanut butter, and then used as part of a confection, all in the same facility? | In some cases, nuts might be processed into nut butter and then incorporated into other foods as part of a continuous processing operation. For example, if a food that is not on the Food Traceability List (FTL) (e.g., nuts) is processed into an intermediate food that is on the FTL (e.g., nut butter) and is very soon thereafter fully processed at the same location into a finished food containing an FTL food that has not been subjected to a kill step (e.g., a confection with nut butter), we would consider this to be one processing event. The food produced through transformation would be the confection, which would be on the FTL because it contains nut butter. The incoming ingredients would include nuts, which are not on the FTL. Nut butter would not be considered an incoming ingredient of an FTL food because the manufacturing of the nut butter was incidental to the overall process of manufacturing the confection. Records of incoming ingredients for transformation under § 1.1350(a)(1) would therefore not be required (assuming none of the other incoming ingredients are on the FTL), and the only records of the transformation event would be those required under § 1.1350(a)(2) (for the food produced through transformation). However, there are some situations where an ingredient such as nut butter is manufactured as a stand-alone product, and then later—not as part of a continuous processing operation—the nut butter is used as an ingredient in a confection. In such situations, the nut butter would have been packed in some way and possibly stored before its incorporation into the confection. Factors such as these indicate that it was not a continuous processing operation, and that instead there were two separate manufacturing events (one for the nut butter, one for the confection). In that situation, transformation records would be kept for each manufacturing event, including the assigning of a traceability lot code to the nut butter and then assigning of a different traceability lot code to the confection containing the nut butter. | 2023-06-26
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| Transformation | TT.4 How does the Food Traceability rule apply to repack facilities? | Repacking is considered “transformation,” which is defined in § 1.1310 to mean an event in a food's supply chain that involves manufacturing/processing a food or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or packing, when the output is a food on the FTL. Transformation does not include the initial packing of a food or activities preceding that event (e.g., harvesting, cooling). Repackers therefore will generally be required to maintain transformation records under § 1.1350 for any FTL foods they repack. Note that at the repacking stage, the traceability lot code can be changed or the traceability lot code of the original lot can be retained (assuming there has been no commingling of lots, i.e., the repacking was “like into like”), but a new traceability lot code source would be required to identify the repacker, and the KDEs identified in § 1.1350 would need to be maintained. Repackers will also generally be required to maintain receiving records under § 1.1345 for any FTL foods they receive, and shipping records under § 1.1340 for any FTL foods they ship. | 2023-06-26
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