FSMA update: FDA issues Proposed Rule for food traceability and tentative Food Traceability List

The Proposed Rule, released alongside a tentative list of foods to which those requirements would apply¹, would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA) and improve the agency’s ability to rapidly track and trace food by identifying food by a traceability lot code and requiring records linking the traceability lot code to additional information that must be maintained by entities in the supply chain.

This memorandum provides a roadmap for the proposed requirements. First, we provide  an overview of the rule and then share several key takeaways. Next, we summarize  the Proposed Rule, addressing:

• The Food Traceability List;
• Entities and foods covered by the Proposed Rule;
• The role of traceability lot codes;
• Recordkeeping requirements at various points in the supply chain, including for foods subject to a kill step;
• Traceability program record requirements;
• Record retention and availability provisions;
• Procedures for establishing new modified requirements and waivers;
• Compliance dates; and
• Enforcement.

We encourage the entire food industry to carefully review the Proposed Rule, both due to its detailed requirements and its broad reaching impact beyond those handling foods on the Food Traceability List. Comments on the proposal are due January 21, 2021.

Overview of the Proposed Rule

The Proposed Rule would establish additional recordkeeping requirements to facilitate tracing a food through the supply chain in the event of a foodborne illness outbreak or recall. The proposal aims to improve current tracing capabilities by:

• Expanding the type of entities required to keep certain records;
• Standardizing the information that must be maintained and sent across the supply chain;
• Mandating linking information for incoming and outgoing products;
• Requiring covered entities to explain their traceability systems and records; and
• Encouraging a transition from paper-based to electronic records.

The proposed additional recordkeeping requirements would apply to any persons who manufacture, process, pack, or hold foods on the Food Traceability List. The Proposed Rule would require covered entities to establish and maintain records containing certain information (Key Data Elements (KDEs)) associated with different events in the food supply chain (Critical Tracking Events (CTEs)). The CTEs for which the Proposed Rule would require recordkeeping are growing, receiving (including additional requirements for first receivers), transforming, creating, and shipping a listed food. Depending on the CTE being performed, the KDEs would vary.

The recordkeeping requirements emphasize the importance of documenting the applicable traceability lot code and linking this code to other KDEs along the supply chain. If a covered entity originates, transforms, or creates a food on the Food Traceability List, it would be responsible for establishing and assigning a traceability lot code for the food. Creating a new  traceability  lot code for a food would be prohibited outside of these three events.

In addition to the records specific to CTEs, covered entities would be required to establish and maintain general traceability program records to describe their traceability operations (which records contain required information, how lot codes are assigned, and other information) and the listed foods they handle. These traceability program records are intended to provide a roadmap of relevant information in the event FDA needs to review a firm’s records during a recall or similar traceback activity.

Traceability records could be kept in paper or electronic form, although FDA strongly encourages the use of electronic records. In addition, covered entities would be required to provide FDA with an electronic, sortable spreadsheet for specified foods and date ranges within 24 hours when requested by FDA in certain situations.

Key takeaways

Here are 10 significant takeaways from the Proposed Rule and tentative Food Traceability List, which are discussed in more detail elsewhere in this memorandum:

1. The Food Traceability List includes more than just produce. Soft cheeses, shell eggs, nut butters, ready-to-eat deli salads, finfish, crustaceans, and bi-valve mollusks also are included.
2. The recordkeeping requirements would apply not just to the foods listed on the Food Traceability List, but also foods that include listed foods as an ingredient. This means that food such as a sandwich containing iceberg lettuce as an ingredient, or a confection containing peanut butter, would be subject to the rule’s requirements, because iceberg lettuce and peanut butter are listed foods. 
3. Recordkeeping requirements would apply not just to manufacturers, but also to entities in the food supply chain such as growers, distributors, retailers (including grocery stores, vending machine locations, and convenience stores), restaurants, online food retailers, and meal-kit delivery companies.
4. Foods subject to certain processing would be exempt from or have modified recordkeeping requirements. The FDA proposes to exempt produce that receives commercial processing, provided the conditions in the Produce Safety Rule commercial processing exemption are met, as well produce listed as “Rarely Consumed Raw” (RCR) in the Produce Safety Rule. Also, the Proposed Rule would exempt shell eggs when all eggs at the farm receive a treatment. In addition, once a kill step is applied to a listed food, the only further recordkeeping required under the Proposed Rule would be documentation of the application of the kill step.
5. The Proposed Rule would establish new terminology and standardize information for food tracing. By specifying the data elements and information (KDEs) firms must establish, maintain, and send to the next entity at certain points along the food supply chain (CTEs), the Proposed Rule would standardize these elements and the terms used to describe them. These KDEs include items such as category, location description, location identifier, traceability product description, and traceability product identifier.
6. The proposed recordkeeping requirements would be role-based. Entities would determine what records they must establish, maintain, and send, based on whether they are a grower, first receiver, receiver, transformer, creator, or shipper of a food on the Food Traceability List.
7. The use of traceability lot codes is central to the proposal. The rule would require the assignment of a traceability lot code to a food at any step where a listed food is originated, created, or transformed, and it would prohibit creating new traceability lot codes outside of these steps. Records would be required to link the traceability lot code to other information about the food to connect shipments of food between different entities in the supply chain.
8. The Proposed Rule does not prescribe a type of technology that must be used to maintain the required records, though it strongly favors electronic recordkeeping. Whatever technology is used, covered entities must be able to provide FDA with requested records within 24 hours. In addition, when necessary to assist FDA during an outbreak, recall, or other threat to public health, covered entities must provide the agency with the requested data for the requested foods and date ranges in an electronic, sortable spreadsheet within 24 hours. FDA also strongly encourages electronic recordkeeping and urges the use of electronic communication procedures.
9. The proposed recordkeeping requirements are much more detailed than existing Bioterrorism Act recordkeeping requirements. While there is some overlap among the Bioterrorism Act’s requirements and the Proposed Rule’s requirements, records under the Proposed Rule would be far more detailed. Critically, the Proposed Rule requires the establishment and maintenance of traceability lot codes and records that link such lot codes to other information. Further, the Proposed Rule would require entities to develop records explaining their traceability program. In addition, while the Bioterrorism Act’s requirements extend only one step up and one step back in the supply chain, the Proposed Rule’s requirements would occasionally require retaining information on entities more than one step back in the supply chain.
10. The FDA’s proposal would set the bar for traceability programs for all foods. FDA explains in the preamble that although section 204 of FSMA limits recordkeeping requirements to foods on the Food Traceability List, “the types of records required to be maintained under the proposed rule could be used by entities in the supply chains of all foods to improve traceability.” Moreover, “[t]o realize the full benefits of end-to-end traceability . . . [FDA] encourage[s] all firms involved in food production, distribution, and sale to consumers to adopt the recordkeeping practices set forth in the proposed rule for all the foods they manufacture, process, pack, and hold.” As part of its efforts under the New Era of Smarter Food Safety, FDA will pursue methods to help all supply chain entities adopt methods for rapid tracing of foods.

Food Traceability List

The rule’s requirements are linked to the foods the FDA identifies in its proposed Food Traceability List. Appendix 1 to this memorandum provides a complete list of such foods. In February 2014, the FDA issued a Federal Register notice providing the agency’s draft approach to identifying high-risk foods and soliciting comments and scientific data to help the agency refine the draft approach.² The FDA developed the proposed Food Traceability List taking into account public feedback and using a risk- ranking model for food tracing (the “Model”) based on the six factors Congress identified in Section 204 of FSMA.³ The Model scores commodity-hazard pairs, such as E. coli O157 in leafy greens, according to data and information relevant to seven criteria: (1) frequency of outbreaks and occurrences of illnesses; (2) severity of illnesses; (3) likelihood of contamination; (4) potential for pathogen growth, with consideration of shelf life; (5) manufacturing process contamination  probability and industry-wide intervention; (6) consumption rate and amount consumed; and (7) cost of illness.

The FDA ranked the commodities and associated commodity-hazard pairs produced by the Model, and commodities with associated commodity-hazard pairs with criteria scores in the moderate to strong range were considered for inclusion on the list. The FDA discusses its process for assessing and identifying commodities for inclusion in the Food Traceability List in an agency memorandum, “Designation of the Food Traceability List Using the Risk-Ranking for Food Tracing Memo.”⁴

The FDA will publish a finalized Food Traceability List on its website when it issues a Final Rule. The FDA states in the preamble to the Proposed Rule that it anticipates periodically conducting a review to determine whether it is appropriate to revise the Food Traceability List, and the Proposed Rule includes procedures for the FDA to update the Food Traceability List, once finalized. Specifically, the FDA will publish a notice in the Federal Register stating the proposed changes to the list, its reasoning for these changes, and requesting information and views on the proposed changes. After considering comments, FDA will publish a notice stating whether it is making any changes to the list and the reasons. The FDA will publish the revised list on its website. Any deletions from the list would take effect immediately, and any additions to the list would become effective one year after the publication of the notice announcing the revised list, unless otherwise stated in the notice. Although there is a procedure for the FDA to update the list, the agency does not outline a mechanism for stakeholders to initiate or request changes to the list.

Entities and types of foods covered by the Proposed Rule

The Proposed Rule would apply to persons who manufacture, process, pack, or hold foods that appear on the Food Traceability List, with several exceptions based on the food or the type of entity involved.

FDA proposes the following complete exemptions based on the type of entity involved:

• Farms (or the farm activities of farm mixed-type facilities) with respect to the produce they grow, when the farm is not subject to the Produce Safety Rule because it has no more than
• US$25,000 in average annual produce sales as calculated under 21 CFR 112.4(a);
• Shell egg producers with fewer than 3,000 laying hens at a farm, with respect to the shell eggs they produce at that farm;
• Originators of food with an average annual monetary value of food sold during the previous 3-year period of no more than $25,000, on a rolling basis, adjusted for inflation using 2019 as the baseline year for calculating the adjustment. According to FDA, this exemption would apply to, for example, small aquaculture farms and small farms that grow non-produce foods that may be on the Food Traceability List in the future;
• Food produced on a farm, including food packaged on a farm, when the owner, operator, or agent in charge of the farm sells the food directly to a consumer;
• Transporters of food;
• Nonprofit food establishments;
• Persons who manufacture, process, pack, or hold food for personal consumption; and
• Certain persons who hold food on behalf of individual consumers (e.g., hotel desk concierge, reception desk staff in an apartment building, staff at an office complex).

The FDA also proposes complete exemptions for the following categories of food:

• Certain food produced and packaged on a farm if three conditions are met: (1) the packaging of the food remains in place until the food reaches the consumer; (2) the packaging maintains the integrity of the product and prevents subsequent contamination or alteration of the product;⁵ and (3) the labeling of the food that reaches the consumer includes the name, complete address, and business phone number of the farm on which the food was produced and packaged;
• Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, provided the conditions in Section 112.2(b) of the Produce Safety Rule are satisfied;
• Shell eggs from farms where all eggs produced receive a treatment in accordance with Section 118.1(a)(2) of the Shell Egg Rule; and
• Produce that is identified as rarely consumed raw in 21 C.F.R. § 112.2(a)(1).

The following foods and entities would receive partial exemptions from the rule:

• Commingled raw agricultural commodities (RACs)⁶ would be exempted from the rule’s requirements, except that if the entity that manufactures, processes, packs, or holds the RACs is required to register with the FDA, that entity would be required to maintain records identifying the immediate previous source and the immediate subsequent recipient of the food under the FDA’s Bioterrorism Act regulations (21 C.F.R. §§ 1.337, 1.345). Such records must be retained for two years.
• Retail food establishments would be exempted from the rule’s requirements when they receive listed foods directly from a farm, except that they would be required to establish and maintain a record documenting the name and address of the farm that was the source of the food and maintain those records for 180 days. The FDA would adopt the definition of “retail food establishment” used in the food facility registration regulations (i.e., an establishment that sells food products directly to consumers as its primary function). Though not specified in  the definition, the FDA states in the preamble that it considers restaurants, online food retailers, and meal kit delivery companies as other examples of such establishments.
• Farm to school and farm to institution programs would be exempt from the rule, except that the school food authority or other relevant procurement entity would be required to establish and maintain a record documenting the name and address of the farm that was the source of the listed food and maintain those records for 180 days.
• The owner, operator, or agent in charge of a fishing vessel would be exempt from the rule as it relates to food produced through the use of fishing vessels, except that if the entity is required to register with the FDA, it would be required to maintain records identifying the immediate previous source and immediate subsequent recipient of the food under the FDA’s Bioterrorism Act regulations (21 C.F.R. §§ 1.337, 1.345).
• The FDA provides two options for the treatment of small retail food establishments, defined as having 10 or fewer full-time equivalent employees. The number of full-time equivalent employees would be based on the number of employees at each retail food establishment and not the entire business, which may own numerous retail stores. Option 1 for small retail food establishments would provide a total exemption from the rule, and Option 2 would provide a partial exemption that would only eliminate the requirement to provide the FDA data in an electronic, sortable spreadsheet, discussed below.

Traceability lot codes

A key element of the proposed requirements is the use of traceability lot codes in documenting CTEs and linking that information to other KDEs. A “traceability lot code” is defined as a descriptor, often alphanumeric, used to identify a “traceability lot,” which means a lot of food that has been originated, transformed, or created. The term “lot” would mean food produced during a period of time at a  single physical location and identified by a specific code, and may also be referred to as a “batch” or “production run.” The FDA explains that while each firm would determine the size or quantity of a lot, the agency recommends that that lots consist of product produced under uniform conditions, be as small as possible, and generally not exceed 24 hours of production.

Covered entities would be responsible for establishing and assigning a traceability lot code when they originate, transform, or create a food on the Food Traceability List.

• “Originating means” an event in a food’s supply chain involving the growing, raising, or catching of a food (typically on a farm, a ranch, or at sea), or the harvesting of a non-produce commodity.
• “Transformation” means an event in a food’s supply chain that involves changing a food on the Food Traceability List, its package, and/or its label (regarding the traceability lot code or traceability product identifier), such as by combining ingredients or processing a food (e.g., by cutting, cooking, commingling, repacking, or repackaging). Transformation does not include the initial packing of a single-ingredient food or creating a food.
• “Creating” means making or producing a food on the Food Traceability List (e.g., through manufacturing or processing) using only ingredient(s) that are not on the Food Traceability List. Creating does not include originating or transforming a food. For example, manufacturing peanut butter, which is on the Food Traceability List, would constitute creating a listed food because none of the ingredients of peanut butter are listed foods.

Notably, the Proposed Rule would prohibit creating a new traceability lot code by entities that conduct other activities (e.g., receiving, shipping).

Recordkeeping requirements for each CTE

The rule includes distinct recordkeeping requirements for the CTEs of growing, receiving (including additional requirements for first receivers), transforming, creating, and shipping a listed food. Covered entities must satisfy the recordkeeping requirements for each CTE for which they are involved. While there is some overlap between the information that would be required under the Proposed Rule and the one up, on back recordkeeping requirements under the Bioterrorism Act, the records in the Proposed Rule would contain substantially more detailed information, and each required KDE would be required to be linked to the listed food’s traceability lot code. In addition, the Proposed Rule would sometimes require covered entities to retain information from other entities more than one step previous in the supply chain (e.g., the food’s originator or the traceability lot code generator).⁷

Recordkeeping requirements for growing a food on the Food Traceability List

For each food grown, covered entities must maintain records containing and linking the traceability lot code of the food to the growing area coordinates. Additional location identification information also would be required for growing sprouts.

Recordkeeping requirements for the first receiver of a food on the Food Traceability List

The FDA proposes to define a “first receiver” as the first person (other than a farm) who purchases and takes physical possession of a food on the Food Traceability List that has been grown, raised, caught, or (in the case of a non-produce commodity) harvested.⁸ As an example, in a scenario where cantaloupe is grown on a farm, transferred to an on-farm cooler, purchased by a distributor, and transported by the distributor to a retailer, the distributor would be the “first receiver.”

In addition to establishing a traceability lot code if one has not yet been assigned, first receivers would be required to establish and maintain records containing and linking the traceability lot code of the food received to the following information:

• The location identifier⁹ and location description¹⁰ of the originator of the food;
• The business name, point of contact, and phone number of the harvester of the food and the date(s) and time(s) of harvesting;
• The location identifier and location description of the place where the food was cooled and the date and time of cooling (if applicable); and
• The location identifier and location description of the place where the food was packed and the date and time of packing.

These recordkeeping requirements would apply in addition to the recordkeeping requirements for receiving a listed food, discussed below. More limited information would be required for the first receiver of a seafood product on the Food Traceability List.

Recordkeeping requirements for receiving a food on the Food Traceability List

Receiving occurs when a food is received by a customer, other than a consumer, at a defined location after being transported from another defined location. For each food on the Food Traceability List a covered entity receives, the Proposed Rule would require that records must be established and maintained to link the traceability lot code of the food to the following information:

• The location identifier and location description for the immediate previous source (other than a transporter) of the food;
• The entry number(s) assigned to the food (if the food is imported);
• The location identifier and location description of where the food was received and date and time the food was received;
• The quantity and unit of measure of the food (e.g., 6 cases, 25 returnable plastic containers, 100 tanks, 200 pounds);
• The traceability product identifier¹¹ and traceability product description¹² for the food;
• The location identifier, location description, and point of contact for the traceability lot code generator;
• The reference record type(s)¹³ and reference record number(s) (e.g., “Invoice 750A,” “BOL 042520 XYZ”) for the document(s) containing the information listed above; and
• The name of the transporter who transported the food to the entity.

Building upon the previous cantaloupe example above where cantaloupe is grown on a farm, transferred to an on-farm cooler, purchased by a distributor, and transported by the distributor to a retailer, the on-farm cooler, distributor, and retailer all would be responsible for creating and maintaining receiving records. As the first receiver, the distributor would be required to maintain the receiving records in addition to its recordkeeping requirement as the first receiver.

Recordkeeping requirements for transforming a food on the Food Traceability List

Transformation would occur when an event in a listed food’s supply chain involves changing the food, its package, and/or its label (as it relates to the traceability lot code or traceability product identifier), such as by combining ingredients or processing a food (e.g., by cutting, cooking, commingling, repacking, or repackaging). For example, a transformation occurs when an entity  takes peanut butter, a listed food, and crackers, and makes peanut butter sandwich crackers. Transformation also would occur when an entity chops and bags iceberg lettuce, or when an entity repacks cucumbers.

The FDA proposes that for each new traceability lot of food produced through transformation, records must be established and maintained to contain and link the new traceability lot code for the food to the following information:

• For the food(s) on the Food Traceability List used in transformation:
  • the traceability lot code(s) for the food;
  • the traceability product identifier and traceability product description for the food to which the traceability lot code applies; and
  • the quantity of each traceability lot of the food;
• For the food produced through transformation:
  • the location identifier and location description for where the food was transformed (e.g., by a manufacturing/processing step), and the date transformation was completed;
  • the new traceability product identifier and traceability product description for the food to which the new traceability lot code applies; and
  • the quantity and unit of measure of the food for each new traceability lot code (e.g., 6 cases, 25 returnable plastic containers, 100 tanks, 200 pounds); and
• The reference record type(s) and reference record number(s) (e.g., “Production Log 123,” “Batch Log 01202021”) for the document(s) containing the above.

Retail food establishments would not be required to create or maintain this information for foods they sell or send directly to consumers. However, this proposed exemption for retail food establishments would not apply when an establishment transforms a listed food it then ships to a distributor or another retail food establishment instead of selling the food directly to consumers.

Recordkeeping requirements for creating a food on the Food Traceability List

Creation of a listed food would occur whenever a listed food is made or produced using only ingredients that are not on the Food Traceability List. For instance, creation would occur whenever peanut butter is made, because none of the ingredients in peanut butter is a listed food. The manufacture of peanut butter sandwich crackers, however, would not be considered creation because one of the ingredients in the finished food (peanut butter) is a listed food. The manufacture of the peanut butter sandwich crackers would be transformation of a listed food.

Similarly, creation would occur when soft cheese is produced from milk, salt, and other non-listed ingredients. Conversely, creation would not occur when fresh herbs (a listed food) are used as an ingredient to make fresh cheese (another listed food). The manufacture of the cheese in this instance would be considered transformation.

For each food on the Food Traceability List that is created, the Proposed Rule would require that records must be established and maintained that contain and link the traceability lot code to the following information:

• The location identifier and location description for where the food was created (e.g., by a manufacturing/processing step) and the date creation was completed;
• The traceability product identifier and traceability product description for the food;
• The quantity and unit of measure of the food (e.g., 6 cases, 25 returnable plastic containers, 100 tanks, 200 pounds); and
• The reference record type(s) and reference record number(s) (e.g., “Production Log 123,” “Batch Log 01202021”) for the document(s) containing the information listed above.

Like the proposed limited exemption from the recordkeeping requirements for transforming a listed food, retail food establishments that create a listed food similarly would not be required to establish or maintain these records for foods they sell or send directly to consumers.

Recordkeeping requirements for shipping a food on the Food Traceability List

Shipping would be 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 a defined location to another defined location at a different farm, a first receiver, or a subsequent receiver. Shipping would not include the sale or shipment of a food directly to a consumer or the donation of surplus food.

Covered entities that ship a listed food would be required to establish and maintain records containing and linking the traceability lot code of the food to the following information:

• The entry number(s) assigned to the food (if the food is imported);
• The quantity and unit of measure of the food (e.g., 6 cases, 25 returnable plastic containers, 100 tanks, 200 pounds);
• The traceability product identifier and traceability product description for the food;
• The location identifier, location description, and point of contact for the traceability lot code generator;
• The location identifier and location description for the immediate subsequent recipient (other than a transporter) of the food;
• The location identifier and location description for the location from which the food was shipped and date and time it shipped the food;
• The reference record type(s) and reference record number(s) (e.g., “BOL No. 123,” “ASN 10212025”) for the document(s) containing the information listed above; and
• The name of the transporter who transported the food from the covered entity.

In addition, covered entities that ship food would be required to send the following information to the immediate subsequent recipient, other than the transporter, for each traceability lot shipped:

• The entry number(s) assigned to the food (if the food is imported);
• The quantity and unit of measure of the food (e.g., 6 cases, 25 returnable plastic containers, 100 tanks, 200 pounds);
• The traceability product identifier and traceability product description for the food;
• The location identifier, location description, and point of contact for the traceability lot code generator;
• The location identifier and location description for the immediate subsequent recipient (other than a transporter) of the food; and
• The location identifier and location description for the location from the food was shipped and date and time the food was shipped.

Farms would be required to provide the following additional information to the immediate subsequent recipient:

• A statement that they are a farm (which will help signal to non-farms when they are the first receiver);
• The location identifier and location description of the originator of the food (if not the farm);
• The business name, point of contact, and phone number of the harvester of the food (if not the farm) and the date(s) and time(s) of harvesting;
• The location identifier and location description of the place where the food was cooled (if not by the farm) and the date and time of cooling; and
• The location identifier and location description of the place where the food was packed (if not by the farm) and the date and time of packing.

Recordkeeping requirements for foods that are subject to a kill step

The Proposed Rule would include much more limited recordkeeping requirements for foods that are subjected to a kill step, defined as “processing that significantly minimizes pathogens in a food.” If a covered entity applies a kill step, the recordkeeping requirements do not apply to that entity’s subsequent shipping of the food, provided that the entity maintains a record of its application of the kill step. The entity would, however, be subject to other applicable recordkeeping requirements under the rule such as receiving and transforming a food on the Food Traceability List. For entities that receive a food on the Food Traceability List that has been subjected to a kill step, the recordkeeping requirements would not apply to the receipt or subsequent transformation and/or shipping of the food.

General traceability program recordkeeping requirements

All entities subject to the Proposed Rule would be required to establish and maintain records containing:

• A description of the reference records that maintain the information required by the Proposed Rule, an explanation of where on the records the required information appears, and, if applicable, a description of how reference records for different tracking events for a food (e.g., receipt, transformation, shipment) are linked;
• A list of foods on the Food Traceability List that the entity ships, including the traceability product identifier and traceability product description for each food;
• A description of how the entity establishes and assigns traceability lot codes to foods on the Food Traceability List it originates, transforms, or creates, if applicable; and
• Any other information needed to understand the data provided within any records required by this subpart, such as internal or external coding systems, glossaries, and abbreviations.

The FDA states in the preamble that these records are intended to help FDA investigators understand the entity’s traceability procedures and records when reviewing them during a foodborne illness  outbreak or a routine inspection. Covered entities would be required to retain the records for two years after their use is discontinued.

Notably, the FDA explains that for these and all other records required by the rule, covered entities may enter into agreements with individuals or firms to create and keep the records required by the rule on their behalf.

Record retention and availability requirements

Except for the general traceability program records, the records required under the Proposed Rule would have to be maintained for two years from the date they were created. This differs from the recordkeeping requirements under the Bioterrorism Act, where retention periods are based on the shelf life of the food. Records could be maintained as original paper or electronic records or true copies. Electronic records would not be required to comply with Part 11. Offsite storage of the records would be permissible, provided the records could be made available to an FDA representative no later than 24 hours after a request. Electronic records would be considered onsite if they are accessible from an onsite location. The records also must be provided in English within a reasonable time if they are maintained in a language other than English.

The Proposed Rule would require entities to provide records to the FDA in an electronic, sortable spreadsheet for specified foods and date ranges when requested by the FDA in certain situations. Providing information in this format would be required when necessary to help the FDA prevent or mitigate a foodborne illness outbreak, to assist in the implementation of a recall, or to otherwise address a threat to the public health, including situations where the FDA has a reasonable belief that a food presents a threat of serious adverse health consequences or death to humans or animals.

Covered entities would not be required to duplicate existing records, to the extent they include information required under the Proposed Rule, and would be able to supplement existing records as needed to include all required information. The FDA also makes clear that covered entities would not be required to keep all required information in a single set of records.

Establishing new modified requirements and exemptions

The Proposed Rule includes procedures for the FDA to modify the requirements or exempt a food or type of entity from the rule’s requirements if the agency determines the application of the rule would not protect the public health. The FDA will consider modifying requirements or granting an exemption on its own initiative or in response to a citizen petition submitted by an interested party.

Even when modified requirements or an exemption would apply, entities required to register with the FDA would be required to maintain records identifying the immediate previous source of the food and the immediate subsequent recipient of the food under the FDA’s Bioterrorism Act regulations (21 C.F.R. §§ 1.337, 1.345), and such records must be retained for 2 years. While many firms are already required to comply with Sections 1.337 and 1.345 because they are subject to the Bioterrorism Act regulations, this provision would create an independent obligation to comply with these provisions with respect to foods on the Food Traceability List.

The Proposed Rule also lays out procedures for revising or revoking modified requirements or exemptions when such action is necessary to protect the public health.

Waivers for economic hardship

The Proposed Rule would allow the FDA to waive one or more of the requirements of the rule for an individual entity or type of entity if the agency determines that the application of the requirement would result in an economic hardship, due to the unique circumstances of the individual entity or type of entity; the waiver will not significantly impair the FDA’s ability to identify recipients of food and prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequence or death resulting from an adulterated or misbranded food; and the waiver would not otherwise be contrary to public interest. The FDA clarifies in the preamble that merely having relatively low revenue or relatively few employees would not ordinarily constitute an economic hardship sufficient to qualify for a waiver.
 
The FDA would issue a waiver either on its own initiative, in response to a written request (for an individual entity), or in response to a citizen petition (for a type of entity). The FDA also would be able to modify or revoke a waiver if it determines compliance with the waived requirement would no longer impose a unique economic hardship, the waiver could significantly impair the agency’s ability to identify recipients of a food to prevent or mitigate a foodborne illness outbreak, or the waiver is otherwise contrary to the public interest. One way in which the FDA might become aware that the circumstances under which it had granted a waiver to a firm had changed might be through a routine inspection of the firm or an inspection in the course of an investigation into a foodborne illness outbreak.

Compliance dates

The FDA proposes that the final rule would become effective 60 days after the date on which it is published in the Federal Register, but would provide additional time before covered entities must comply with the new requirements. Although FSMA directed the traceability recordkeeping requirements to have staggered compliance dates based on the size of the covered entity, the FDA believes it can more effectively and efficiently implement the new requirements by having all covered entities come into compliance at the same date. Accordingly, the FDA proposes that the compliance date for all covered entities would be two years after the effective date of the final regulations, which was the timeframe Congress had provided for very small businesses.

In October 2018, two consumer groups sued the FDA seeking to compel the agency to implement Section 204.¹⁴ FDA reached a settlement with the two consumer groups in June 2019, in which FDA committed to issue the final rule by November 7, 2022.¹⁵

Enforcement

Any violation of the recordkeeping requirements of the Proposed Rule would be a prohibited act under Section 301 of the FFDCA, except when committed by a farm. For imported foods, if it appears that the recordkeeping requirements have not been complied with for a particular food, that food would be subject to refusal of admission under Section 801(a)(4) of the FFDCA.

We will continue to monitor developments related to FDA’s implementation of FSMA and the traceability Proposed Rule. If you have any questions on this or any other matter, or if we can assist in developing comments on this proposal, please do not hesitate to contact us.

For the full Tentative Food Traceability List, please click here.

References

¹ Requirements for Additional Records for Certain Foods, 85 Fed. Reg. 59987 (Sept. 23, 2020), available at https://www.govinfo.gov/content/pkg/FR-2020-09-23/pdf/2020-20100.pdf.

² 79 Fed. Reg. 6596 (Feb. 4, 2014).   See Hogan Lovells memorandum dated February 10, 2014, FDA Requests Comments and Data on Designation of High-Risk Foods for Traceability Purposes Under FSMA.

³ Methodological Approach to Developing a  Risk-Ranking  Model  for  Food  Tracing  FSMA Section 204 (21 U.S.C. § 2223) (Aug. 2020), available at https://www.fda.gov/media/142247/download.

⁴ Available at https://www.fda.gov/media/142282/download.

⁵ According to the preamble, produce packed or packaged in containers such as clamshells     with holes, cardboard boxes, vented crates, plastic bags with holes or netted bags would not be eligible for this exemption.

⁶ FDA proposes to define “commingled raw agricultural commodity” for the purposes of this exemption as any commodity that is combined or mixed after harvesting but before processing, except that the term would not include types of fruits and vegetables that are RACs subject to the Produce Safety Rule. For the purpose of the definition of “commingled raw agricultural commodity,”  a commodity would be regarded as “combined or mixed . . . before processing” only when the combination or mixing involves food from different farms. An example of a RAC that would be exempt from the proposed traceability recordkeeping requirements when they are commingled is shell eggs.

⁷ By contrast, the Bioterrorism Act’s regulations require nontransporters that receive/ship food maintain contact information for the nontransporter immediate previous source/immediate subsequent recipient and transporter; a description of the food, including brand name and variety; the date the food was received; the quantity and how the food is packaged; contact information; and, for persons who manufacture, process, or pack food, the lot or code number or other identifier of the food (to the extent this information exists). 21 C.F.R. § 1.337(a) and 1.345(a). For food they ship, nontransporters also must maintain records that include information reasonably available to identify the specific source of each ingredient used to make every lot of finished product. 21 C.F.R. § 1.345(b) (emphasis added).

⁸ Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, roots, or stems), collecting eggs, taking of fish and other seafood in aquaculture operations, milking, field coring, filtering, gathering, hulling, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm.  Cooling would not be a harvesting activity.

⁹ The “location identifier” would be a unique identification code that an entity assigns to the  physical location name identified in the corresponding location description.

¹⁰ The “location description” is the complete physical  address  and  other  key  contact information, such as business name, physical location name (e.g., Facility #345).

¹¹ The “traceability product identifier” is the unique identification code that an entity assigns to designate a specific type of food product. They are often printed in human and machine-readable format on food packaging.

¹² The “traceability product description” includes  the  food  category  term  or code,  category name, and trade description, which includes the brand name, commodity, variety, product name, and packaging size and style depending on whether it is a single or multi-ingredient product.

¹³ Examples of reference records include bills of lading, purchase orders, advance shipping  notices (ASNs), work orders, invoices, batch logs, production logs, and receipts.

¹⁴ Center for Food Safety v. Azar, No. 3:18-cv-06299 (N.D. Cal. Oct. 14, 2018).  See Hogan  Lovells memorandum dated October 22, 2018, Lawsuit Seeks to Compel FDA to Implement FSMA Traceability Requirements.

¹⁵ See Hogan Lovells memorandum dated June 12, 2019, Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions.

Authored by Elizabeth Fawell, Maile Hermida, and Leigh Barcham.