Checklist for the coming FDA food traceability rule

Introduction: traceability rule checklist FDA

According to the Food and Drug Administration (FDA), a stringent new food traceability law will go into effect on November 7. The new law applies to the following food traceability list, which includes “high-risk items” linked to food-borne illnesses: 

The traceability rule by the FDA

Read the article here.

The rule mandates a complete account of food origins and movements throughout manufacturing, processing, and transportation to make these foods safer. This applies even when these foods are changed into other food products or are mixed with other foods. 

Based on the article, keeping vast records is nearly impossible with the means of pen and paper or even simple spreadsheets, as many foods are traced back through several processing stages. Thus barcoding has never been more necessary. Barcode data systems provide cost-effective, dependable, and user-friendly solutions for tracking product origins and destinations from start to finish.

An example is when a whole salmon is processed into filets and afterwards salmon cakes. Each step of the process must be traceable back to the fish and the boat from which it was caught. Similarly to other products such as fresh fruits end up in salads. 

Key Data Elements and Critical Tracking Events

These essential data points are referred to as Key Data Elements (KDEs), in the new FDA rule. Furthermore, Critical Tracking Events (CTEs) are steps in the manufacturing process. The article highlights the Critical Tracking Events and their mandatory KDEs, as seen in table 1.

CTEs	KDEs	Information	Details	Details
Growing	For produce; the grower generates a lot of code for the grown food.
Receiving	At the arrival of any food, the lot code must link the following information:	Location identifier and location description for the food’s immediate preceding source (other than a transporter)
		Entry number assigned to the food (if imported)
		The location identifier and description of the site where the meal was received, as well as the date and time the item was received
		The food’s quantity and unit of measurement (e.g., 6 cases, 25 returnable plastic containers, 100 tanks, 200 pounds)
		Food traceability product identification and traceability product description
		Traceability lot code generator location identification, location description, and point of contact
		Reference record type(s) and reference record number(s) (e.g., “Invoice 750A,” “BOL 042520 Y ”) for the records relating to the receipt of the food
		The sender’s name who delivered the food to the recipient
		The proposed rule will include the initial receiver designation, which will necessitate extra information. A first recipient is the first person (other than a farm) to buy and physically possess a listed food. Only foods that are originated (i.e., produced, raised, captured, or harvested in the case of a non-produce commodity like eggs) can have a first receiver. Stated items that are created do not have a first recipient. *	First Receiver (except for seafood obtained from a fishing vessel)	Traceability lot code, if not previously established
				Location identifier and location description of the originator of the food
				Business name/phone number/ point of contact of the harvester of the food + date and time of harvesting
				Location identifier and location description of the place the food was cooled, + date and time of cooling (if applicable)
				Location identifier and location description of the place where the food was packed; + date and time
			First Receiver of Seafood Obtained from a Fishing Vessel	Traceability lot code, if not previously established
				Harvest date range and locations
Transformation	Changing a food on the Food Traceability List, its package, and/or its label (in relation to the traceability lot code or traceability product identification), The food transformer would be e pected to establish and maintain records containing and linking the food’s new traceability lot code	Traceability product identifier and traceability product description
		The quantity of each traceability lot
		Location identifier and location description for where the food was transformed and the date
		The new traceability product identifier and traceability product description
		The quantity and unit of measure
		Reference record type and number for records
Creation	Making a high-risk product, such as peanut butter, from non-risk ingredients, such as peanuts. Whoever creates a listed product in this manner must establish and maintain documents containing and linking the food’s traceability lot code.	Location identifier and location description of where the food was created, + the date
		The traceability product identifier and traceability product description
		The quantity and unit of measure
		Reference record type(s) and reference record number(s) for records
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.	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
		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
		Location identifier and location description for the location from which the food was shipped + date and time
		Reference record type(s) and reference record number(s) for documents relating to the shipment
		Transporter’s name

* The first receiver rule’s objective is to trace product movement within or between organizations prior to sale. Depending on whether the food was received from a fishing vessel or not, first receivers must maintain distinct KDEs. Furthermore, the proposed rule would require each first receiver, in addition to the records of receipt of food (receiver KDEs), to establish and maintain records containing and linking the traceability lot code of the food received.

Moreover, the shipper would be required to deliver all of the records listed above, with the exception of the reference record type, number, and transporter’s name, to the next-in-line receiver in addition to preserving all of the records listed above. If the shipper is a farm, they must also provide the following details to the next-in-line receiver, if applicable:

• ‘’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” (Sorce: Food Safety News, 2022)

Full details of these rules can be read at the FDA site.

The FDA recognizes that this will compel a shift away from traditional paper-and-pencil record keeping, but the financial gains will significantly surpass the expenses due to the up to 84 percent reduction in traceback time.

Check our iMIS Food platform and tracking system here.

References:

• News Desk,2022, Here’s the checklist for the new FDA food traceability rule that’s coming up. Food Safety News. https://www.foodsafetynews.com/2022/08/heres-the-checklist-for-the-new-fda-food-traceability-rule-thats-coming-up/?utm_source=Food+Safety+News&utm_campaign=e676cece07-RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_f46cc10150-e676cece07-40141479 
• FDA, Which key data elements would apply to me? https://www.fda.gov/food/food-safety-modernization-act-fsma/which-key-data-elements-would-apply-me