Wednesday, April 19, 2023

FSMA 204: Initial Packing CTE’s and KDE’s


The FDA Final Rule on FSMA Section 204 published in November 2022 adds the requirement to capture and record Critical Tracking Events or CTE’s. The FDA defines a “Critical Tracking Event” to mean an event in the food supply chain involving the harvesting, pre-packing cooling, and initial packing of a Raw Agricultural Commodity (RAC), which applies to any food, “…not obtained from a fishing vessel, shipping, receiving, or transformation of the food.”

In prior blogs we looked at the overall CTE requirements and explored harvesting and cooling CTE’s. Today we will deep dive into Initial Packing and the associated Key Data Elements (KDE’s) for that event.

For produce, as the event name implies, “Initial Packing” means the first packing of a RAC.

Under the final rule, lot-based recording keeping is not required at harvest or any other point before initial packing. While this information is not required, most growers have already assigned some form of unique lot identifier that tracks the seeds, processes and application of nutrients or pesticides associated with growing the commodity in the given lot. It is likely wise to store this data for later use.

The Initial Packing of a Raw Agricultural Commodity (RAC), is where the FDA states the lot traceability code gets assigned. Most produce companies will not need to alter their current lot traceability assignment process. However, they will need to add this data to the initial packing event and pass it through for use in subsequent Critical Tracking Events. It needs to follow the product through the supply chain.

Under section 1.1330 of the final rule the initial packer must maintain records including:

·         The commodity and variety (if applicable) of the received RAC
·         The date the RAC was received
·         The unit of measure and the quantity of the RAC received
·         The farm and location description or reference identifier from where the commodity was harvested
·         The field or growing area name
·         The business name and phone number of the company that harvested the product, regardless of ownership
·         The date of harvest
·         The pre-packing cooling location
·         The date the product was cooled
·         The traceability lot code assigned
·         The description of the packed food
·         The quantity and unit of measure of the packed food
·         The description of the packing location
·         The initial packing date
·         The reference document type and number

If you are packing sprouts, except for soil or substrate sprouts harvested with roots, there are additional required records:

·         The location description for the grower of seeds for sprouting and date of seed harvesting, if available

·         The description of the location for the seed conditioner or processor, the associated seed lot code and date of conditioning or processing
·         The description of the location of the seed packing, and repacking, the date of packing and repacking, if applicable, and any associated seed lot code assigned by the seed packing house
·         The description of the location of the seed supplier and any seed lot code assigned by the sprouter
·         A description of the seeds, including the taxonomic name, growing specifications, type of packing and any antimicrobial treatments applied to the seeds
·         The date and of receipt of the seeds by the spouter and the reference document type and number

The FDA clarified that if there is a transformation of a RAC prior to its initial packing, for example cutting whole apples into slices before packing, the entity that slices the apples is required to create and keep the Initial Packing records KDE’s instead of the Transformation CTE KDE’s.

The data associated with FSMA 204’s critical tracking events are what enables traceability and therefore the improvement in food safety we all desire. The number of data points is not huge compared to some other industries, but enabling their acquisition and reporting is challenging, mostly since it is a new requirement. It also may require a significant investment in both hardware and software. Nevertheless, understanding the data requirements is crucial and easiest when tackled one bite at a time.


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FSMA 204: Initial Packing CTE’s and KDE’s

The FDA Final Rule on FSMA Section 204 published in November 2022 adds the requirement to capture and record Critical Tracking Events or CT...