FDA Issues Proposed Rule Extending Compliance Date for Food Traceability Rule

Topic

Question

Answer

Farms

TF 7 Do geographic coordinates for a field or other growing area need to be passed through the supply chain?

The rule does not require the geographic coordinates of a field or other growing area to be passed along the supply chain. Under§ 1.1315(a)(5), if you grow or raise a Food Traceability List(FTL) food (other than eggs), your traceability plan must include a farm map showing the areas in which you grow or raise such foods. That farm map must show the location and name of each field (or other growing area) in which you grow an FTL food, including geographic coordinates and any other information needed to identify the location of each field or growing area. (For an aquaculture farm, similar information is required for each container in which you raise FTL seafood.) The farm map stays in the farm’s traceability plan; it is not provided to anyone else in the supply chain.

Under21 CFR 1.1325(a)(1)(v)and(vi), the harvester of the food must maintain a record containing the name of the field or other growing area (or container) from which the food was harvested, which must correspond to the name used by the grower. Under21 CFR 1.1325(a)(2), the harvester must provide this information to the initial packer, either directly or through the supply chain. Also under that provision, the harvester provides the initial packer with the location description for the farm where the food was harvested. The location description consists of the business name, phone number, and address of the farm. It does not contain more specific information, such as the geographic coordinates for each field or other growing area.

Under21 CFR 1.1330, the initial packer must maintain a record of the location description for the farm where the food was harvested, as well as the name of the field or other growing area (or container) from which the food was harvested. By obtaining the farm’s location description and the name of the relevant field or growing area (or container) from the initial packer, FDA will then be able to visit the farm in question and identify the field (or container) location by reviewing the farm’s traceability plan, which will include the farm map.

Food Traceability Plan

TFTP 3 We are a restaurant company with multiple locations. Do we need a traceability plan for each location, or can we have one for the whole company? Can the traceability plan be maintained at headquarters?

It is acceptable for an individual restaurant’s traceability plan to be maintained by the headquarters location for a chain of restaurants, as long as the individual restaurant is able to provide the traceability plan to FDA within 24 hours of request by FDA. The rule provides flexibility that allows covered entities to have another entity establish and maintain the required records on their behalf, although the covered entity remains responsible for ensuring the records can be provided onsite to FDA within 24 hours of a request by FDA for official review (see21 CFR 1.1455(b)).

The rule also provides flexibility in how a firm creates their traceability plan, as long as it contains the required information as outlined in21 CFR 1.1315. If the required information is consistent across all locations, then a chain could maintain a single traceability plan that applies to some or all of its locations, as long as this fact (the application of the plan to multiple locations) is made clear. If there are some differences in the required information for certain locations, this could still be expressed in a single document, provided it is clear which information applies to which location. If, for example, a different statement for identifying the point of contact is necessary for each location, the statements could be included in a single traceability plan used across the chain or a customized traceability plan could be created for each location.

General

TG 7 Do I need to maintain shipping records for donations to charitable organizations or food banks?

The definition of “shipping” in the Food Traceability Rule states, in part, that shipping does not include the donation of surplus food (see21 CFR 1.1310). Thus, although an entity (such as a farm, manufacturer, or distributor) that donates some of theirFood Traceability List(FTL) food would be subject to other requirements under the rule, the entity would not be required to keep shipping records for the donated food.

General

TG 8 Are school cafeterias covered by the Food Traceability Rule?

A school cafeteria is generally covered under the rule in the same way as any other entity that handles a food on the Food Traceability List(FTL). School cafeterias are responsible for any records that they are required to keep under the rule. As with any other entity that is covered by the rule, if a school cafeteria is required to keep receiving records, you can expect that the supplier will provide shipping records under§ 1.1340(b)that will contain most of the information the school cafeteria is required to maintain. (Unless the supplier is exempt, in which case the school cafeteria must only maintain the receiving records under§ 1.1345(b).)

Under21 CFR 1.1455(b), a school cafeteria could have another entity, such as their supplier or the school district, establish and maintain the required records on their behalf. In that situation, the cafeteria would be responsible for ensuring that such records can be retrieved and provided onsite within 24 hours of request for official review.

The rule does include a partial exemption for farm to school programs (21 CFR 1.1305(l)).When a school conducting a farm to school program obtains a food from a farm in accordance with21 CFR 1.1305(l), the school food authority or relevant food procurement entity must only maintain a record documenting the name and address of the farm that was the source of the food. The school food authority or relevant food procurement entity must maintain such record for 180 days.

Note that some school cafeterias might be eligible for the exemption for nonprofit food establishments in21 CFR 1.1305(o).

General

TG 9 How does the Food Traceability Rule apply to food moving throughout a college campus or other multi-outlet venue (such as an amusement park) that receives, transforms, and distributes Food Traceability List (FTL) foods to their own outlets on their property?

For the foods on the Food Traceability List(FTL) that you receive and distribute to various locations on a college campus or other multi-outlet venue, you are required to maintain the appropriate receiving and shipping key data elements (KDEs) unless an exemption applies. Shipping is defined as an event in a food's supply chain in which a food is arranged for transport (e.g., by truck or ship) from one location to another location. Shipping does not include the sale or shipment of a food directly to a consumer or the donation of surplus food. The definition of shipping also 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. For example, if a college receives an FTL food at one location on campus and then sends the FTL food to another on-campus location that is at a separate address, this would be considered a shipping event. Therefore, the corresponding receiving and shipping records would be required to be maintained as outlined in the rule. If there’s an intracompany movement of FTL food between two spaces at the same street address (e.g., down a hallway that connects the prep kitchen to the cafeteria), then there is no requirement to maintain shipping KDEs.

Additionally, for those FTL foods that you are transforming, you may be required to maintain transformation KDEs. For example, when an on-campus entity such as a production kitchen uses whole tomatoes to prepare sandwiches that are then shipped to other locations on the campus, transformation KDEs would need to be maintained for that event. (In addition, receiving KDEs would need to be maintained for the incoming tomatoes, and shipping KDEs would need to be maintained for the outgoing sandwiches, as discussed above.) However, under21 CFR 1.1350(c), retail food establishments (RFEs) and restaurants do not need to keep transformation KDEs for foods they do not ship (e.g., foods they sell or send directly to consumers). Therefore, if similar sandwiches are prepared on-site at a campus cafeteria and then sold or provided to consumers at the same cafeteria, no transformation KDEs would need to be kept. If some of the sandwiches are sold on-site at the same place where they were prepared, while others are shipped to a different location on campus, then transformation and shipping KDEs would only need to be kept for the sandwiches that are shipped to another location. Receiving KDEs for the incoming whole tomatoes would need to be kept under all of these scenarios.

Please note that offsite storage of records is permitted under21 CFR 1.1455(c)(2), as long as the records can be retrieved and provided onsite within 24 hours of request for official review. It is also permissible to have another entity establish and maintain records on your behalf as described in21 CFR 1.1455(b), although the covered entity remains responsible for ensuring that such records can be retrieved and provided onsite within 24 hours of request for official review. It is therefore not necessary for each individual location on a campus or other multi-outlet venue to establish and maintain their own records. The organization as a whole can choose to establish and maintain the records in a centralized manner, as long as the records can be provided to FDA at any specific location that is covered by the rule within 24 hours of FDA making a request.

Please also note that nonprofit food establishments are exempt from the rule under§ 1.1305(o). The rule defines “nonprofit food establishment” to mean a charitable entity that prepares or serves food directly to the consumer or otherwise provides food or meals for consumption by humans or animals in the United States. The term includes central food banks, soup kitchens, and nonprofit food delivery services. To be considered a nonprofit food establishment, the establishment must meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code. Some colleges and universities meet the definition of a nonprofit food establishment, and are therefore eligible for this exemption. However, to the extent that they utilize for-profit companies to provide on-campus food services, those companies would not be eligible for this exemption.

General

TG 10 I make an uncooked sausage product that contains soft cheese. My manufacturing of this product is done under exclusive USDA jurisdiction. However, the manufacturing takes place in a dual-jurisdiction facility. Do I need to keep any records under the Food Traceability Rule?

Under21 CFR 1.1305(g), persons who manufacture, process, pack, or hold food on the Food Traceability List(FTL) during or after the time when the food is within the exclusive jurisdiction of the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act are exempt from the Food Traceability Rule. The sausage product with soft cheese would therefore be exempt from the rule, as discussed below. However, depending on how the soft cheese is received at your facility, you might be required to maintain receiving records for that cheese.

Some dual-jurisdiction facilities maintain a receiving room for all incoming ingredients to be used by the whole facility. In that case, receiving Key Data Elements(KDEs) for Food Traceability List(FTL) foods, such as soft cheese, must be maintained, because the receiving room is not under exclusive USDA jurisdiction. But transformation records would not need to be maintained if the cheese is then used as an ingredient in a product that is manufactured in the part of the facility that is under exclusive USDA jurisdiction, such as the sausage product described above. This is because once the cheese moves into the USDA part of the facility, it is exempt under21 CFR 1.1305(g). That exemption applies both during and after the time that the product is under exclusive USDA jurisdiction, which means that no additional records would need to be maintained by anyone who subsequently handles the sausage product.

Some dual-jurisdiction facilities keep their operations totally separate, including the receiving rooms. In that situation, if the soft cheese is received at a part of the facility that is under exclusive USDA jurisdiction, the exemption under21 CFR 1.1305(g)would apply. The facility would therefore not need to keep any receiving records for the soft cheese (or any records for the sausage product, as described above). Similarly, when an entire facility is under exclusive USDA jurisdiction, receiving KDEs are not required, nor are any other records required under the rule.

General

TG 11 If I assemble a meat and cheese plate that contains soft cheese in a central kitchen or commissary, what records must I maintain? Since the meat was previously processed in a facility that was under exclusive USDA jurisdiction, is the meat and cheese plate exempt under 21 CFR 1.1305(g)?

The fact that the meat was previously under exclusive USDA jurisdiction is not relevant in this situation, because the exemption in21 CFR 1.1305(g)relates to whether or not the Food Traceability List(FTL) food (the cheese) has ever been under exclusive USDA jurisdiction. In this case, assuming the cheese was never under exclusive USDA jurisdiction, the exemption does not apply. You therefore must maintain receiving Key Data Elements (KDEs) for the soft cheese per21 CFR 1.1345and transformation KDEs for the meat and cheese plate per21 CFR 1.1350. You would also need to maintain and send shipping KDEs per21 CFR 1.1340when you ship the meat and cheese plate to the next point in the supply chain.

General

TG 12 If I manufacture a Food Traceability List (FTL) food that I send to a USDA-regulated facility, do I need to keep records under the Food Traceability Rule?

If an FDA-regulated entity ships a Food Traceability List(FTL) food to an exclusively U.S. Department of Agriculture (USDA)-regulated facility, the shipper must maintain and sends hipping key data elements(KDEs) to the USDA facility in accordance with the rule. These records can be used by the USDA facility if traceback of the food products is necessary. (See Response 82.) KDEs are not required to be maintained by the USDA facility or any subsequent receivers of food from the USDA facility. This is because under21 CFR 1.1305(g)of the rule, there is a full exemption for persons who manufacture, process, pack, or hold food on the FTL during or after the time when the food is within the exclusive jurisdiction of the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.

General

TG 13 If a manufacturer sends a Food Traceability List (FTL) food to a 3rd party cold storage facility before the food is sent on to another point in the supply chain, what records need to be kept in that situation?

A 3rd party cold storage facility is holding the Food Traceability List(FTL) food, so they are covered by the rule and would need to maintain records for the Critical Tracking Events (CTEs) they are performing.

For the purposes of this example, let’s say that the manufacturer is selling an FTL food to a retail store, but the food is being kept in a cold storage facility prior to being sent to the retail store. In that situation, the manufacturer would need to maintains hipping key date elements(KDEs) for the FTL food, indicating that the product was sent to the cold storage facility. The cold storage facility would need to maintain receiving KDEs for the FTL food they receive from the manufacturer, as well as shipping KDEs for the FTL food they are sending to the retail store. The retail store would need to maintain receiving KDEs for the FTL food they receive from the cold storage facility.

Per21 CFR 1.1455(b), one entity may establish and maintain records on behalf of another entity. In the situation above, the manufacturer may decide to maintain the receiving KDEs on behalf of the cold storage facility since the manufacturer is the one sending them the FTL food. That is acceptable under the rule, provided the cold storage facility can retrieve the records from the manufacturer upon request by FDA. Other entities in the supply chain could also choose a similar strategy.

Implementation

TI10 Our firm is exploring various ways to comply with the Food Traceability Rule, including solutions that rely on manual actions by employees and solutions that rely more heavily on technology. However, given the large number of key data elements (KDEs) that we will be required to capture, we are concerned that any solution will sometimes have errors. Does FDA expect 100% accuracy of KDEs?

The goal for any covered entity should be to provide FDA with accurate key data elements (KDEs) upon request, regardless of what tools are used to achieve that goal. As a practical matter, we routinely work to educate and inform industry of regulatory requirements and allow an opportunity to make voluntary corrections when needed. If we request records under the rule and find that the data provided contains inaccuracies, we would expect the covered entity to work in a timely manner to provide accurate information whenever possible. When determining regulatory follow-up, we consider factors such as the public health impact and any voluntary corrective action.

As you develop and refine your approach to compliance with the rule, you are likely to encounter opportunities to improve the accuracy of your KDEs. Practices such as providing employees with regular training, developing traceability-specific SOPs, performing spot checks for quality control, and periodically reevaluating any relevant processes or algorithms, can help firms work toward the goal of providing FDA with accurate KDEs upon request.

Interoperability and Data Standards

TPTS 2 How does FDA see interoperability as contributing to improved traceability?

FDA does not require firms to maintain electronic records or to ensure that data systems are interoperable under the Food Traceability Rule. However, for entities that choose to use electronic recordkeeping systems, we recognize that the ability to exchange information digitally between different devices and data systems, i.e., interoperability, can improve the sharing of traceability information between trading partners, across supply chains, and with FDA. Effective interoperability does not require every entity in a supply chain to use the same software, but it does require common data standards and frameworks to capture and communicate information. To that end, we support industry efforts to develop agreed-upon data standards across various industries and supply chains that will support interoperability across a variety of technology solutions, working towards outcomes that are achievable for all sectors.

Kill Step

TKS 3 What is an acceptable record to document a kill step?

In order to receive the kill step exemption in21 CFR 1.1305(d)(3), you must maintain a record of your application of the kill step. The rule provides flexibility regarding the type of documentation that can be used to fulfill this requirement. We note that21 CFR 1.1455(f)allows firms to use records they keep in accordance with other regulations or for any other purpose to meet their recordkeeping requirements under the Food Traceability Rule. We anticipate that many manufacturers/processors would be able to use records required under other regulations, such as those requiring documentation of monitoring of a preventive control (see21 CFR 117.190(a)(2)) or documentation of thermal processing of low-acid canned foods (LACF) (see21 CFR 113.100), to meet the requirement in21 CFR 1.1305(d)(3)(ii)to document the application of a kill step to a food.

Records Maintenance and Availability

TRMA 4 If a restaurant company has multiple locations, is a sortable spreadsheet required for each location or can there be one for the entire restaurant chain?

As set forth in21 CFR 1.1455(c)(3)of the Food Traceability Rule, firms are only required to provide an electronic sortable spreadsheet when necessary to help FDA prevent or mitigate a foodborne illness outbreak, assist in the implementation of a recall, or otherwise address a threat to public health. Information requests will vary depending on each specific situation. In some circumstances, there may be data requests that span multiple locations of a single chain. In these cases, a company has the flexibility to provide all of the required information for multiple locations in a single electronic sortable spreadsheet or the company can send data in a separate spreadsheet for each location included in the data request.

Records Maintenance and Availability

TRMA 5 Do I need to keep records for all foods I handle, or only foods on the Food Traceability List (FTL)?

FDA has no expectations that firms would be keeping records for foods not on the Food Traceability List(FTL). The Food Traceability Rule applies only to the foods specifically listed on the FTL, as well as any foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list. The rule does not require that you maintain records for other foods that are not on the FTL.

Records Maintenance and Availability

TRMA 6 If another entity is maintaining required records on my behalf, can this third party also send the records to FDA on my behalf If FDA requests the records?

If another entity establishes and maintains required records on your behalf,21 CFR 1.1455(b)states that you are responsible for ensuring that such records can be retrieved and provided onsite within 24 hours of request for official review. In practice, when an FDA representative requests records, they often engage in a dialogue with the firm about how the records will be provided. If the records are being maintained by a third party, it may make sense for the third party to send the records directly to FDA, rather than providing them onsite at the location of the inspection, if applicable. However, if the representative prefers an onsite review of the records, then the records would need to be retrieved and provided onsite within 24 hours of request for official review, as stated in21 CFR 1.1455(b). (Note that under21 CFR 1.1455(c)(2), electronic records are considered to be onsite if they are accessible from an onsite location.) If FDA requests that the records be sent in an electronic sortable spreadsheet, as is sometimes required under21 CFR 1.1455(c)(3)(ii), then it may make sense for the third party to send the electronic sortable spreadsheet directly to FDA. As mentioned above, the logistics of how to provide records (including an electronic sortable spreadsheet) can be discussed with the FDA representative.

Records Maintenance and Availability

TRMA 7 If I keep records in multiple locations, as opposed to a single set of records, how do I provide the information to FDA?

The Food Traceability Rule allows firms to have flexibility in how they choose to format and maintain their required key data elements (KDEs). As stated in21 CFR 1.1455(g), you do not have to keep all of the information required by the rule in a single set of records. For example, you might decide to keep some of the required receiving KDEs by maintaining the advanced shipping notices (ASNs) you receive from your suppliers, while keeping some of the other required receiving KDEs in a hand-written log. In this situation, if FDA requests your receiving KDEs for a given food during a given timeframe, you could provide FDA with both the relevant ASNs and with your log for the relevant time period.

Your traceability plan must indicate the format and location of the records you are required to keep, in accordance with21 CFR 1.1315(a)(1). Your traceability plan must also identify a point of contact for questions regarding your traceability plan and records, as described in21 CFR 1.1315(a)(4). In the event of a records request from FDA, this information will help FDA understand how and where you maintain the required records. In addition,21 CFR 1.1455(c)(1)states that when you provide your records to FDA, you must also include any information needed to understand the records, such as internal or external coding systems, glossaries, abbreviations, and a description of how the records you provide correspond to the information required by the rule.

In the event of an outbreak, recall or other public health threat, records must be provided to FDA in an electronic sortable spreadsheet as described in21 CFR 1.1455(c)(3). Some entities may be exempt from the requirement to provide records in an electronic sortable spreadsheet under21 CFR 1.1455(c)(3)(iii)or21 CFR 1.1455(c)(3)(iv). In that case, records must still be provided to FDA within 24 hours of a request (or within some reasonable time to which FDA has agreed).

Records Maintenance and Availability

TRMA 8 If a shipper and a receiver have agreed to maintain their records in the same place, how should the shipper pass along the relevant shipping key data elements (KDEs)?

21 CFR 1.1455(b)and(c)(2)provide flexibility for the offsite storage of records, including (but not limited to) having another entity establish and maintain records on your behalf. There might therefore be situations where multiple supply chain partners all agree to have their records maintained in the same place. For example, a shipper and a receiver might agree to use the same cloud-based storage system to maintain their records, or they might contract with the same third party to maintain their records.

Under21 CFR 1.1340(b), the shipper of a food on the Food Traceability List must provide, in electronic, paper, or other written form, the relevant shipping KDEs to the receiver of the food. There is flexibility as to how this information can be provided. If the shipper is aware that the receiver uses a cloud-based storage system to maintain their records, or that the receiver contracts with a third party to maintain their records, then the shipper can provide the relevant information to the receiver by sending it to the cloud-based storage system or to the third party (or to any other location that is utilized by the receiver).

If the shipper and receiver are using the same system to maintain their records, the shipper is not required to provide the same information twice. The shipping KDEs in21 CFR 1.1340(a)(1),(2),(3),(4),(5), and(7), which are among the KDEs that must be provided to the receiver under21 CFR 1.1340(b), correspond directly to the receiving KDEs in21 CFR 1.1345(a)(1),(2),(3),(4),(5), and(7). Therefore, if the shipper and receiver are maintaining their KDEs in the same place, this information does not need to be repeated. Both the shipper and the receiver must be able to retrieve the KDEs for which they are responsible and to provide those KDEs onsite within 24 hours of a request for official review, as required under21 CFR 1.1455(b)and(c)(2). Note that under21 CFR 1.1455(c)(2), electronic records are considered to be onsite if they are accessible from an onsite location.

The Food Traceability List (FTL)

TFTL.25 How does the Food Traceability Rule relate to the Shell Egg Rule? What are the requirements for entities who handle shell eggs?

The Shell Egg Rule requires preventive safety measures during the production, storage and transportation of shell eggs. The Food Traceability Rule requires entities who handle foods on the Food Traceability List(FTL) to maintain traceability records for faster identification and rapid removal of potentially contaminated food from the market, in the event of an outbreak or other threat to public health.

Shell eggs are on the FTL. Therefore, under the Food Traceability Rule, persons who manufacture, process, pack or hold shell eggs must maintain the relevant Key Data Elements (KDEs), including a traceability lot code (TLC) for the Critical Tracking Events (CTEs) they perform. They must also maintain a traceability plan, as described in21 CFR 1.1315.Examples of the requirements for certain shell egg supply chains can be found here.

Some exemptions in the Food Traceability Rule align with exemptions in the Shell Egg Rule. For example,21 CFR 1.1305(a)(2)creates an exemption from the Food Traceability Rule for shell egg producers with fewer than 3,000 laying hens at a particular farm, with respect to the shell eggs they produce at that farm. This mirrors the Shell Egg Rule, which does not apply to shell egg producers with fewer than 3,000 laying hens at a particular farm (see21 CFR 118.1(a)). In addition, just as21 CFR 118.1(a)(2)exempts shell egg producers from most of the requirements of the Shell Egg Rule if all of their eggs that are produced at a particular farm receive a certain type of treatment, the Food Traceability Rule exempts shell eggs when all of the eggs produced at a particular farm will receive that type of treatment (see21 CFR 1.1305(d)(2)). This exemption applies even before the treatment has been applied.

The Food Traceability List (FTL)

TFTL.26 If a food contains eggs as an ingredient, is it covered by the Food Traceability Rule?

Shell eggs appear on the Food Traceability List(FTL), which means that foods that contain shell eggs as an ingredient are covered by the rule. If a manufacturer receives shell eggs from a supplier and then cracks the eggs to use them as an ingredient, that situation would be covered by the rule. The manufacturer would need to keep receiving records for the incoming shell eggs under21 CFR 1.1345. If they use the eggs to make a product that receives a kill step, they would need to keep a record of the kill step per21 CFR 1.1305(d)(3). (Note that a partial exemption is available if they have entered into a written agreement with their supplier under21 CFR 1.1305(d)(6)regarding their intent to apply a kill step.) If no kill step is applied, the food that contains the raw eggs would remain on the FTL, and all of the required records (e.g., transformation, shipping, and receiving) would need to be kept as the product moves through the supply chain.

However, many multi-ingredient foods that contain eggs are made with pasteurized liquid eggs. Pasteurized liquid eggs have already received a kill step and are therefore no longer covered by the rule under21 CFR. 1.1305(d)(5). While the kill step is sufficient to exempt the pasteurized liquid eggs from the rule, we also note that the rule does not apply to entities that handle FTL foods during or after the time when the food is within the exclusive jurisdiction of the U.S. Department of Agriculture (USDA), as described in21 CFR 1.1305(g). The rule also does not apply to shell eggs when all eggs produced at the particular farm receive a treatment, as described in21 CFR 1.1305(d)(2). There are therefore several exemptions that could be relevant; but the bottom line is that if a product is made with pasteurized liquid eggs, then the presence of the eggs does not cause the product to be covered by the Food Traceability Rule.

Similarly, frozen egg yolks have generally been pasteurized or otherwise treated as described in21 CFR 160.190and160.180. They would therefore be exempt from the Food Traceability Rule. Powdered eggs are also not covered by the rule.

The Food Traceability List (FTL)

TFTL.27 If I am commingling eggs from a farm I own and another farm that I don’t own, would I be eligible for the partial exemption in21 CFR 1.1305(h)?

Yes. The partial exemption in21 CFR 1.1305(h)applies to raw agricultural commodities (RACs), such as eggs, that meet the definition of commingled RACs in 21 CFR 1.1310. That definition refers to non-produce RACs that are combined or mixed after harvesting but before processing. The definition further states that a commodity is “combined or mixed” only when the combination or mixing involves food from different farms under different company management. Therefore, if you are combining or mixing eggs from two farms under different company management in a manner that meets the commingled RAC definition, you would be eligible for the partial exemption. The fact that you own one of the farms does not affect your eligibility, if the other farm is owned by someone else.

Traceability Lot Code (TLC)

TTLC 4 Is the traceability lot code source the location where the traceability lot code (TLC) was determined, or the place where the food was physically located when it became associated with the TLC? In some cases, TLCs are determined by corporate headquarters, even though the food is not handled at headquarters.

The rule defines “traceability lot code source” as the place where a food was assigned a traceability lot code (TLC). The preamble to the final rule further explained that unless the relevant entity is exempt from the rule, the TLC source will be the place where the food was initially packed (for RACs not obtained from a fishing vessel), received by the first land-based receiver (for food obtained from a fishing vessel), or transformed. (See Response 296.) While we recognize that the decision about what TLCs to use might be made at another location, such as corporate headquarters, this does not mean that the other location is the TLC source. The TLC source will always be a place where the food was physically handled.

Traceability Lot Code (TLC)

TTLC 5 Can I assign a lot code to Food Traceability List (FTL) foods that I receive (but that I do not transform), for the purposes of my firm’s internal tracking system? If so, what traceability lot code (TLC) would I send to the next person in the supply chain?

We know that some firms assign their own lot codes for internal tracking purposes. If that does occur, the firm would then maintain their internal lot code as well as the traceability lot code (TLC) assigned by the TLC source. When shipping the food, the firm must send, in either written or electronic format, the TLC assigned by the TLC source. The firm can also choose to send their internal lot code (in addition to the TLC), but this is optional.

Traceability Lot Code (TLC)

TTLC 6 Several of the required key data elements (KDEs) involve a “location description.” Is it acceptable to use a Global Location Number (GLN) as the location description?

“Location description” is defined to mean key contact information for the location where a food is handled, specifically the business name, phone number, physical location address (or geographic coordinates), and city, State, and zip code for domestic locations and comparable information for foreign locations, including country. It would be acceptable to use a GLN as a location description, as long as FDA can use the GLN to access all of this information.

If the GLN can be used to access some but not all of the required information, then it could still be used as part of the location description as long as the missing information is also provided. For example, a firm’s location description could be recorded as “Manny’s Firm, (123) 456-7890, GLN 1 2 3 4 5 6 7 8 9 0 1 2 3.” This approach could be used if the GLN can be used to access the full address of the physical location where the food is handled, but not the business name or the phone number.

It would also be acceptable to use the GLN as the traceability lot code (TLC) source reference if FDA can use the GLN to access the full location description for the TLC source.