FDA will be holding three virtual public meetings to discuss this proposed rule. Please see the meeting page for more information.
The FDA is proposing to establish additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA). The proposed requirements would help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death. The proposed rule will be available for public comment for 120 days following publication in the Federal Register.
At the core of this proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products. FDA would encourage the voluntary adoption of these practices industry-wide.
The FDA issued a Federal Register notice to solicit comments on our draft approach for developing a list of high-risk foods in 2014. Taking into consideration the comments and other information submitted, we developed a draft risk-ranking model and collected data to populate the model for chemical and microbiological hazards associated with specific foods, with technical assistance from external expert panels. Two separate peer-review panels of independent external experts reviewed the draft model and the data used to generate risk scores with the model, respectively. Subsequently, we refined the model and updated the data, taking into consideration comments from the peer reviews.
Using the results of the risk-ranking model, we tentatively identified foods for the Food Traceability List for which additional traceability records will be required, as shown in Table 1.0. The term “Food Traceability List” (FTL) refers not only to the foods specifically listed, but also to any foods that contain listed foods as ingredients. Each proposed requirement described below therefore pertains to all such foods unless an exemption applies.
Table 1.0 Food Traceability List
|Cheeses, other than hard cheeses||Includes all soft ripened or semi-soft cheeses, and fresh soft cheeses that are made with pasteurized or unpasteurized milk|
|Shell eggs||Shell egg means the egg of the domesticated chicken|
|Nut butter||Includes all types of tree nut and peanut butters; does not include soy or seed butters|
|Cucumbers||Includes all varieties of cucumbers|
|Herbs (fresh)||Includes all types of herbs, such as parsley, cilantro, basil|
|Leafy greens, including fresh-cut leafy greens||Includes all types of leafy greens, such as lettuce, (e.g., iceberg, leaf and Romaine lettuces), kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, collards, and endive|
|Melons||Includes all types of melons, such as cantaloupe, honeydew, and watermelon|
|Peppers||Includes all varieties of peppers|
|Sprouts||Includes all varieties of sprouts|
|Tomatoes||Includes all varieties of tomatoes|
|Tropical tree fruits||Includes all types of tropical tree fruit, such as mango, papaya, mamey, guava, lychee, jackfruit, and starfruit|
|Fruits and Vegetables (fresh-cut)||Includes all types of fresh-cut fruits and vegetables|
|Finfish, including smoked finfish||Includes all finfish species, such as cod, haddock, Alaska pollack, tuna, mahi mahi, mackerel, grouper, barracuda, and salmon; except does not include siluriformes fish, such as catfish |
|Crustaceans||Includes all crustacean species, such as shrimp, crab, lobster, and crayfish|
|Mollusks, bivalves||Includes all species of bivalve mollusks, such as oysters, clams, and mussels; does not include scallop adductor muscle.|
|Ready-to-eat deli salads||Includes all types of ready-to-eat deli salads, such as egg salad, potato salad, pasta salad, and seafood salad; does not include meat salads|
The proposed rule sets forth a process for the FDA to update the Food Traceability List if the agency concludes that updates are appropriate. Under that process, FDA would publish a notice in the Federal Register stating any proposed changes to the list and the reasons for the changes, and requesting information and views on the proposal. After considering any information or views submitted, the FDA would publish a second notice in the Federal Register, stating whether any changes are being made, and the reason for the decision. Any additions to the list would become effective one year after the date of the second Federal Register notice, unless otherwise stated. Any deletions from the list would become effective immediately.
Additional information about the FTL and the Risk-Ranking Model can be found on the Food Traceability List webpage.
 Data for catfish were excluded from the Risk-Ranking Model because siluriformes fish (such as catfish) are primarily regulated by the U.S. Department of Agriculture.
1. Critical Tracking Events
The proposed rule identifies growing, receiving, transforming, creating, and shipping as the CTEs for which records containing KDEs would be required. The KDEs required would vary depending on the CTE that is being performed. The records required at each CTE would need to contain and link the traceability lot code of the food to the relevant KDEs.
Below is a brief description of each CTE. For a detailed description of the KDEs that would be required for each CTE, see Which Key Data Elements Would Apply to Me? In addition, we have made available interactive slides that describe a number of supply chain examples, including the KDEs and CTEs that would be associated with each commodity. As you view the slides, click on the colored boxes for more detailed KDEs.
For products such as fruits and vegetables, growing is generally the first step in the supply chain. In addition to the general KDEs for growing, sprout growers would be required to establish and maintain additional growing KDEs that are specific to sprouts.
Receiving is an event in a food’s supply chain in which a food is received by a customer (other than a consumer) at a defined location after being transported (e.g., by truck or ship) from another defined location. In addition to the general KDEs for receiving, “first receivers” would need to establish and maintain additional KDEs.
- First Receiver
A first receiver is the first person (other than a farm) who purchases and takes physical possession of a listed food. Only foods that are originated (i.e., grown, raised, caught, or, in the case of a non-produce commodity such as eggs, harvested) can have a first receiver. Listed foods that are created (such as a ready-to-eat deli salad that is not made from any listed ingredients) do not have a first receiver.
We introduced the category of first receiver in this proposed rule. We are proposing this category in part because on-farm activities can involve movement of a food between different entities (e.g., growers, harvesters, coolers) without sale of the food, and the relevant business relationships can be complex. In order to ensure that comprehensive records relating to the origination and initial handling of the food are maintained by a single person who both owns and possesses the food, the first receiver of the food was identified as the entity who would be responsible for maintaining certain KDEs relating to originated foods. First receivers are required to maintain different KDEs depending on whether the food was obtained from a fishing vessel or not.
For additional information and supply chain examples, see the First Receiver factsheet (PDF).
Creating is the making or producing of 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 additional information and supply chain example, see Creation and Transformation (PDF).
Transformation is 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.
For additional information and supply chain example, see Creation and Transformation (PDF).
Shipping is 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.
2. Traceability Program Records
In addition to requiring records of KDEs, as discussed above, the proposed rule would require persons who manufacture, process, pack or hold foods on the FTL to establish and maintain traceability program records. These records are intended to help regulators understand an entity’s traceability program, and include:
- A description of relevant reference records
A firm’s KDEs might be kept on various types of reference records, such as bills of lading, purchase orders, or production logs. A firm’s traceability program records would need to include a description of the reference records on which the firm maintains the required KDEs. This description would explain where on the reference record the traceability information appears, and if applicable, a description of how reference records for different tracing events for a food are linked.
- A List of foods on the FTL that are shipped
The proposed rule would require anyone who ships food on the FTL to keep a list of which listed foods they ship, including the traceability product identifier and traceability product description for each food. This list would be part of a firm’s traceability program records.
- A description of how traceability lot codes are assigned
The proposed rule would require traceability lot codes to be established when a food on the FTL is originated, transformed, or created. The traceability lot code allows a food to be uniquely identified throughout the supply chain. As part of a firm’s traceability program records, firms would be required to describe how they establish and assign traceability lot codes. Because of the crucial role that traceability lot codes play in the proposed rule, it is important that regulators know how a firm created and assigned these codes, so that they can better understand the scope of the records they are reviewing.
- Other information needed to understand data provided within the required records
The proposed rule would require a firm’s traceability program records to include any other information needed to understand the data within their traceability records, such as internal or external coding systems or classification schemes, glossaries, and abbreviations. This will help regulators understand the terminology, methods, and systems a firm uses in its traceability operations.
3. Additional Requirements
The proposed rule would also require that:
- records be maintained as either original paper records, electronic records, or true copies; they all must be legible and stored to prevent deterioration or loss.
- traceability records be provided to FDA as soon as possible but no later than 24 hours after a request is made.
- an electronic sortable spreadsheet containing relevant traceability information be provided to FDA within 24 hours of a request when necessary to assist FDA during an outbreak, recall or other threat to public health.
The proposed rule includes exemptions for certain types of foods and certain persons who manufacture, process, pack or hold foods on the Food Traceability List. Some of these exemptions were provided by Congress, while others reflect the FDA’s current thinking about the application of this rule to certain foods and persons.
Exemption for Certain Types of Small Originators
The proposed rule would exempt certain farms and other originators (i.e., persons who grow, raise, or catch listed foods, or harvesters of non-produce listed foods, such as eggs) because they produce relatively small quantities of food. Specifically, the proposed rule would not apply to:
- 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 $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 particular farm, with respect to the shell eggs they produce at that farm.
- Other originators of food whose average monetary value of food sold during the previous 3-year period was no more than $25,000 (on a rolling basis), adjusted for inflation.
Exemption for Farms That Sell Directly to Consumers
The proposed rule would exempt farms with respect to food they produce on their farm that they sell directly to consumers. This would include sales at farmer’s markets, roadside stands, over the internet, and through community-supported agriculture programs (CSAs).
Exemption for Certain Food Produced and Packaged on a Farm
The proposed rule would not apply to food produced and packaged on a farm under the following conditions:
- The packaging of the food remains in place until the food reaches the consumer, the packaging maintains the integrity of the product, and it prevents subsequent contamination or alteration of the product*; and
- The labeling of the food that reaches the consumer includes the name, complete address, and business phone number of the farm where the food was produced and packaged.
*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 because such packaging does not necessarily maintain the product’s integrity and prevent subsequent contamination and alteration.
Exemption for Foods that Receive Certain Types of Processing
We propose exempting produce and shell eggs that undergo certain types of processing. Specifically, the proposed rule would exempt:
- Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, provided the conditions set forth for the commercial processing exemption in the Produce Safety Rule are met
- Shell eggs when all eggs produced at the particular farm receive a treatment (as outlined in the Egg Safety Rule)
These exemptions would apply to the food throughout the supply chain, including before the processing is performed.
In addition, if a person applies a kill step to any food on the FTL, they would not be required to maintain records for their subsequent shipping of the food, as long as they maintain a record documenting the application of the kill step. Subsequent recipients of the food would not need to maintain records relating to the food.
Exemption for Produce that is Rarely Consumed Raw
The proposed rule would exempt produce listed as “Rarely Consumed Raw” (RCR) in the Produce Safety Rule.
Partial Exemption for Commingled RACs
The proposed rule includes a partial exemption for certain commingled raw agricultural commodities (RACs). This partial exemption would not apply to fruits and vegetables that are subject to the Produce Safety Rule. Commingling means that the commodity is combined or mixed after harvesting but before processing. An example of a commingled RAC subject to this exemption would be shell eggs that are mixed from separate farms under different management before packing.
When this exemption applies, exempt entities that are required to register through FDA’s Food Facility Registration system would be required to maintain records identifying the immediate previous source and the immediate subsequent recipient of the food, in accordance with 21 CFR §§ 1.337 and 1.345.
Co-proposal for Small Retail Food Establishments
We are offering two proposals for how this rule would apply to small retail food establishments (RFEs):
- Option 1 Full exemption: RFEs that employ 10 or fewer full-time equivalent employees (FTEs) would be exempt from the requirements of the rule
- Option 2 Partial exemption: RFEs that employ 10 or fewer FTEs would be exempt from the requirement to provide FDA, under specified circumstances, with an electronic sortable spreadsheet containing certain traceability information; however, they would be required to comply with all other aspects of the rule.
The FDA is interested in hearing from stakeholders regarding these options during the public comment period and public meetings.
Partial Exemption for Retail Food Establishments
The proposed rule includes a partial exemption for all RFEs with respect to food on the FTL that they purchase directly from the farm that produced it. In such situations, the RFE would only be required to establish and maintain for 180 days a record documenting the name and address of the farm that was the source of the food.
Partial Exemption for Farm-to-School and Farm-to-Institution Programs
We propose a partial exemption for farm-to-school and farm-to-institution programs operated under the auspices of USDA, State agencies or local jurisdictions. This partial exemption would apply to food that is produced on a farm and sold directly to the school or institution. In such situations, the school food authority or relevant food procurement entity would be required to establish and maintain for 180 days a record documenting the name and address of the farm that was the source of the food.
Partial Exemption for Food from Fishing Vessels
The proposed rule would not apply to the owner, operator or agent in charge of a fishing vessel with respect to a food that is produced through the use of the fishing vessel. Under this partial exemption, activities of fishing vessels such as harvesting, transporting, heading, eviscerating, and freezing fish would generally not be subject to the proposed recordkeeping requirements. However, if the owner, operator or agent in charge of the fishing vessel is required to register through FDA’s Food Facility Registration system with respect to the manufacturing, processing, packing or holding of the applicable food, they would be required to maintain records identifying the immediate previous source and the immediate subsequent recipient of the food, in accordance with 21 CFR §§ 1.337 and 1.345.
Exemption for Transporters
The proposed rule would exempt transporters of food on the FTL.
Exemption for Nonprofit Food Establishments
The proposed rule would exempt nonprofit food establishments from the requirements of this rule. This exemption would apply to charitable entities that prepare or serve food including 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.
Exemption for Personal Consumption
The proposed rule would exempt persons who manufacture, process, pack or hold food for personal consumption. We would consider food prepared in a private home and transported for non-business purposed (e.g., to dinner with friends) to qualify for this exemption.
Exemption for Persons who Hold Food for Individual Consumers
The proposed rule would exempt persons who hold food on behalf of specific individual consumers, provided that they are not parties to the transaction and are not in the business of distributing food. This exemption would cover persons such as a hotel concierge, reception desk staff in an apartment building, and staff at an office complex who may receive and store food.
Special Requirements for Foods Subjected to a Kill Step
As discussed above, under the proposal, if a person applies a kill step (i.e., processing that significantly minimizes pathogens, such as cooking or pasteurization) to a food on the FTL, they would not be required to maintain the records required by this rule for their subsequent shipping of the food, as long as they maintain a record documenting the application of the kill step. Subsequent recipients of a food on the FTL to which a kill step has been applied would not need to maintain records required by this rule.
In addition to the exemptions listed above, the proposed rule would allow the FDA, on its own initiative or in response to a citizen petition, to create modified requirements or exemptions if the FDA determines that the application of the relevant requirements to a given food or type of entity is not necessary to protect the public health. The proposed rule describes the process by which such modified requirements and exemptions can be requested. The proposed rule would also establish a process for the FDA to provide waivers when the agency determines that the application of the requirements would result in economic hardship for an individual entity or type of entity, due to the entity’s unique circumstances.
The FDA proposes that any final rule on additional traceability recordkeeping requirements for foods on the FTL would become effective 60 days after it is published in the Federal Register.
Because an effective traceability system requires all entities in a supply chain to maintain traceability records, we believe all persons subject to the rule should come into compliance by the same date. We propose that the compliance date for all persons subject to the recordkeeping requirements would be 2 years after the effective date of the final regulation.
Under section 301(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the violation of any recordkeeping requirement under section 204 of FSMA is prohibited, except when such violation is committed by a farm. This would apply to the violation of any of the requirements of this proposed rule, if they are finalized. Furthermore, 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 (including the requirements of this proposed rule, if finalized) have not been complied with.
The proposed rule will be available for public comment for 120 days. Comments should be submitted to docket FDA-2014-N-0053 on regulations.gov.
Additional questions, and requests for meetings and speaking engagements can be submitted via the links below. For meeting and speaker requests, please include a request form when you contact us.
- Food Traceability Proposed Rule At-A-Glance
- Food Traceability Proposed Rule Exemptions At-A-Glance
- Food Traceability List
- Tracking and Tracing of Food
- Which Key Data Elements Would Apply to Me?
- Pre-recorded Webinar to Discuss Food Traceability Proposed Rule
- Supply Chain Examples
- First Receiver Examples
- Creation and Transformation