Are you ready for FDA’s new food traceability rule?

The United States Food and Drug Administration’s (FDA’s) new food traceability rule is due to become official on November 7. Are you ready?

The new rule covers the following high-risk foods:

• cheeses other than hard cheese;
• crustaceans;
• cucumbers;
• fin fish;
• fresh herbs;
• fresh-cut fruits and vegetables;
• leafy greens;
• melons;
• mollusks;
• nut butters;
• peppers;
• ready-to-eat deli salads;
• shell eggs from domesticated hens;
• sprouts;
• tomatoes; and
• tropical tree fruits.

To make these foods safer, the rule requires a detailed account of food origins and movements throughout production, processing, and shipping, even as these foods are transformed into other food products, or as other foods are added to them.

This poses special challenges, as many foods trace back through multiple processing stages, each adding to traceability challenges.

Keeping records this extensive is often nearly impossible with pencil and paper, or even with ordinary spreadsheets, so barcoding has never been more important. Barcode data systems offer affordable, robust, user-friendly solutions that trace product origins and destinations from end to end.

In the new FDA rule, required data points are called key data elements (KDEs). The stages in the production process are referred to as critical tracking events (CTEs).

Below are the CTEs and required KDEs.

Growing

For produce, the grower initiates a lot code for the food grown.

Receiving

When any listed food is received, the lot code must link to the following information:

• 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. six cases, 25 returnable plastic containers, 100 tanks, 200 lb);
• 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; and
• the name of the transporter who transported the food to the receiver.

First receiver

The proposed rule will introduce the first receiver designation, which carries additional information needs. 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.

The purpose of the first receiver rule is to track movements of products within or between organizations before sale.

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 food traceability list (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 below 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 co-ordinates) for the trip during which the seafood was caught.

Transformation

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). The transformer of the food would be required to establish and maintain records containing and linking the new traceability lot code of the food 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. six cases, 25 returnable plastic containers, 100 tanks, 200 lb)
• Reference record type(s) and number(s) for records relating to transformation

Creation

Creating a product on the high-risk list, such as peanut butter, from items not on the list, such as peanuts. Whoever creates a listed food this way would be required to establish and maintain records containing and linking the traceability lot code of the food created to the following information:

• 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; and
• reference record type(s) and reference record number(s) for records relating to creation.

Shipping

When food is transported 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 listed food to establish and maintain records containing and linking the traceability lot code(s) for the food to the following information:

• 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; and
• 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; and
• 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.

At each of these events, KDE’s must include lot codes for traceability. Full details are on the FDA site. While FDA acknowledges this will force changes away from old-fashioned paper-and-pencil record keeping, financial benefits will far outweigh costs as traceback time is reduced by up to 84 per cent.

Simba from Dynamic Systems is one of the companies offering solutions to manage your production, inventory and shipping traceability needs.

David Camp is president of Camp Creative, LLC.