FSMA Proposed Rule for Food Traceability

If you grow, receive, transform, create, or ship a food on the Food Traceability List (FTL) under the proposed rule “Requirements for Additional Traceability Records for Certain Foods” you may be wondering which Key Data Elements (KDEs) you might be required to keep if this rule is finalized. On the proposed rule webpage, we describe which categories of KDEs would apply based on your position in the supply chain. Below are additional details on the specific records that you would be required to establish and maintain under this proposed rule.

Growing

For products such as fruits and vegetables, growing is generally the first step in the supply chain.

For each food on the FTL that is grown, the proposed rule would require the grower of the food to establish and maintain records containing and linking the traceability lot code of the food to the following information:

• Growing KDEs
  • Growing area coordinates

Because sprouts pose unique food safety concerns, sprout growers would also be required to establish and maintain the following additional growing KDEs that are specific to sprouts:

• Additional KDEs for growers of sprouts
  • Location identifier and location description of the grower of seeds for sprouting, and the associated seed lot code assigned by the seed grower, and date of seed harvesting
  • Location identifier and location description of the seed conditioner or processor, the associated seed lot code they assigned, and date of conditioning or processing
  • Location identifier and location description of the seed packinghouse (including any repackers), associated seed lot codes, and date of packing/repacking
  • Location identifier and location description of the seed supplier
  • Description of the seeds, including type or taxonomic name, growing specifications, volume, type of packaging, and antimicrobial treatment
  • Seed lot code assigned by the seed supplier, including master lot and sub-lot codes, and any new seed lot code assigned by the sprouter
  • Date of receipt of the seeds by the sprouter
  • For each lot code for seeds received by the sprouter, the sprout traceability lot code(s) and the date(s) of production associated with the seed lot code.

Receiving

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.

For each food on the FTL that is received, the proposed rule would require the receiver to establish and maintain records containing and linking the traceability lot code for the food to the following information: 

• Receiving KDEs
  • Location identifier and location description for the immediate previous source (other than a transporter) of the food
  • Entry number assigned to the food (if imported)
  • Location identifier and location description of where the food was received, and the 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)
  • Traceability product identifier and traceability product description for the food
  • Location identifier, location description, and point of contact for the traceability lot code generator
  • Reference record type(s) and reference record number(s) (e.g., “Invoice 750A,” “BOL 042520 XYX”) for the records relating to receipt of the food
  • The name of the transporter who transported the food to the receiver

• 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.

  The proposed rule would require each first receiver of a food on the FTL to establish and maintain records, in addition to the records of receipt of food (receiver KDEs), containing and linking the traceability lot code of the food received to the following information:

  • First Receiver (except for seafood obtained from a fishing vessel)
    • Traceability lot code (if not previously established, the first receiver would be required to establish the traceability lot code and maintain records linking the traceability lot code to the other KDEs)
    • Location identifier and location description of the originator of the food
    • Business name/phone number/ point of contact of harvester of the food and the date(s) and time(s) of harvesting
    • Location identifier and location description of the place the food was cooled, and the date and time of cooling (if applicable)
    • Location identifier and location description of the place where the food was packed, and the date and time of packing
  • First Receiver of Seafood Obtained from a Fishing Vessel
    • Traceability lot code (if not previously established, the first receiver would be required to establish the traceability lot code and maintain records linking the traceability lot code to the other KDEs)
    • Harvest date range and locations (National Marine Fisheries Service Ocean Geographic Code or geographical coordinates) for the trip during which the seafood was caught

For additional information and supply chain examples, see the First Receiver Factsheet (PDF).

Transformation

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 the food(s) on the FTL used in transformation, the transformer of the food would be required to establish and maintain records containing and linking the new traceability lot code of the food produced through transformation to the following information:

• Transformation KDEs
  • Traceability product identifier and traceability product description for the foods used in transformation
  • The quantity of each traceability lot of the food used in transformation
  • Location identifier and location description for where the food was transformed and the date the transformation was completed
  • The new traceability product identifier and traceability product description for the food produced through transformation
  • The quantity and unit of measure of the food produced through transformation (e.g., 6 cases, 25 returnable plastic containers, 100 tanks, 200 pounds)
  • Reference record type(s) and number(s) for records relating to transformation

For additional information and supply chain example, see Creation and Transformation.

Creation

Creating is the making or producing of a food on the Food Traceability List through manufacturing or processing using only ingredient(s) that are not on the Food Traceability List. Creating does not include originating or transforming of a food.

A person who creates a food on the FTL would be required to establish and maintain records containing and linking the traceability lot code of the food created to the following information:

• Creation KDEs
  • Location identifier and location description of where the food was created, 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
  • Reference record type(s) and reference record number(s) for records relating to creation

For additional information and supply chain example, see Creation and Transformation.

Shipping

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.

The proposed rule would require persons who ship a food on the FTL to establish and maintain records containing and linking the traceability lot code(s) for the food to the following information:

• Shipping KDEs
  • Entry number(s) assigned to the food (if imported)
  • The quantity and unit of measure of the food
  • Traceability product identifier and traceability product description for the food
  • Location identifier, location description, and point of contact for the traceability lot code generator
  • Location identifier and description of the immediate subsequent recipient of the food (other than a transporter)
  • Location identifier and location description for the location from which the food was shipped, and the date and time the food was shipped
  • Reference record type(s) and reference record number(s) for documents relating to shipment
  • Transporter’s name who transported the food from the shipper

In addition to keeping all of the above records, the shipper would need to send all of these records, with the exception of the reference record type and number and the transporter’s name, to the immediate subsequent recipient.

If the shipper is a farm, they would also be required to send the following information (if applicable) to the immediate subsequent recipient:

• A statement that the shipper is a farm
• Location identifier and location description of the originator of the food (if not the shipper)
• The business name, point of contact, and phone number of the harvester of the food (if not the shipper), and the date(s) and time(s) of harvesting
• Location identifier and location description of the place where the food was cooled (if not by the shipper), and the date and time of cooling
• Location identifier and location description of the place where the food was packed (if not by the shipper), and the date and time of packing