Is FSMA 204 the answer to current traceability problems? Yes and no

With the deadline to submit public comments looming, there is much to be commended in the Food and Drug Administration’s 199-page proposed Food Traceability rule (FSMA 204). 

What works

A notable positive is that FSMA 204 uses language common to the industry, which should reduce the potential for the requirements to get lost in translation. Gone is the term High Risk Foods, which would have had an adverse impact. Instead, FSMA 204 refers to the Food Traceability List. 

Another positive is that the proposed rule requires capture and storage of a lot number from packing to the point of sale and includes lot code tracking. FDA will be able to accept traceback data electronically in a sortable spreadsheet.

Exempt from FSMA 204 are transporters and commodity brokers who do not own and possess the product at the same time.

The FDA has also allowed ample time for implementation. Non-exempt entities have two years plus 60 days after the final rule is published to enforce the regulations.

What needs work

The “First Receiver” requirements are confusing given the reality of our industry’s complex supply chain. Furthermore, under the “First Receiver from a Farm” section, the term farm is not defined.

The Import Entry Number Assigned, if the food is imported, is to be shared and kept all the way through the supply chain. Aside from privacy concerns, verification of the accuracy of this information will be burdensome.

While most of the proposed regulations are clear, the language regarding the inability to change the Traceability Lot Code unless the product is transformed needs to be clarified. Distributors can assign their own internal control number (i.e., pallet license plate number) as long as they store and share the original lot number with customers.

The proposed rule also states that traceability records would not be required after a kill step, but there is no clear scientific explanation of acceptable kill steps.
 
The final issue is timing. Commodities currently listed have two years plus 60 days from the publish date of the final rule to be compliant; however, items added to the Food Traceability List have only one year from that time. The effort required to implement this type of data tracking and sharing can be significant. 

The above issues, determined through the work of PMA’s FSMA 204 Task Force, were sent to the FDA on Feb. 2.

What industry members should do

To ensure compliance with FSMA 204, it is time to begin implementing PTI.

Non-exempt industry members should:

• Label their cases with a PTI compliant case label at the time of packing or request that suppliers label theirs;
• Develop the ability to send or receive electronic Advance Shipment Notifications (ASNs);
• Plan on tracking the lot number on each shipment. Receive and send an ASN and/or Bill of Lading; and
• Complete PTI implementation long before January 2025!

Completion of these steps will help ensure that the industry is ready as the FSMA 204 enforcement date approaches.

Ed Treacy is vice president of supply chain and sustainability for the Produce Marketing Association.

Read more:
PMA comments on FSMA traceability rule
FDA publishes materials from food traceability public meetings
FDA extends comment period for food traceability rule