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 |
|---|---|---|
| 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 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. |
| The Food Traceability List (FTL) |
TFTL.2 Does the Food Traceability List (FTL) include only biological hazards? |
In developing the 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. |
| 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 FTL in the final rule did not change from the proposed rule. However, there is additional clarity in the descriptions, for example:
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| 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 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. |
| 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 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. |
| 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 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. |
| 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 FLT and therefore not covered by the final rule. |
| 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 FTL, and therefore not covered by the final rule. |
| 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 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. |
| 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 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. 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. |
| 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 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. |
| 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.” |
| 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 RACs. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
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| Farms |
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). |
| 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). |
| 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 RFEs and restaurants with an average annual monetary value of food sold or provided during the previous three years of no more than $250,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment. Other exemptions may apply to other RFEs or restaurants depending on the action being performed. For example, the rule does not apply to RFEs and restaurants regarding food produced on a farm and both sold and shipped directly to the RFE or restaurant by the farm’s owner, operator, or agent in charge. However, the RFE or restaurant would have to keep a record (for 180 days) of the name and address of the farm that was the source of the food. See other exemptions that apply to RFEs or restaurants. |
| 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:
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| 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. |
| 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. 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. |
| 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. |
| Implementation |
TI.1 How and when will FDA request records required by the final rule? |
Once the compliance date arrives on Tuesday, January 20, 2026, we expect to conduct routine records inspections to ensure that entities subject to subpart S are satisfying the requirements. Routine records inspections primarily will focus on understanding an entity’s subpart S recordkeeping practices, identifying any gaps in compliance, and achieving compliance through prompt voluntary corrective actions if we observe deficiencies. In exigent circumstances, e.g., foodborne illness outbreaks, recalls, or other food safety emergencies, the FDA may request specific subpart S records from covered entities to facilitate a traceback or traceforward operation. The final rule states that covered entities must make all records required under subpart S available to an authorized FDA representative, upon request, within 24 hours (or within some reasonable time to which FDA has agreed) after the request, along with any information needed to understand these records. |
| 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. |
| 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. |
| Implementation | All covered persons will need to comply with the final rule requirements on or before Tuesday, January 20, 2026. | |
| 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. |
| 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 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. |
| 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 FTL to which a kill step has already been applied would not be required to maintain any traceability records under the final rule. |
| 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. |
| 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. |