FDA released the
Proposed Rule for Record Keeping for Food Traceability in September 2020. PMA’s Ed Treacy, VP of Supply Chain & Sustainability has reviewed the rule. Overall, the proposed regulations are more prescriptive than anticipated. We are very pleased that it aligns with the Produce Traceability Initiative.
The regulations require trace-back data to be sent to FDA Investigators in a sortable electronics spreadsheet, with an exemption for very small retail food establishments. The PTI Traceback Template aligns with this requirement.
The proposed regulations cover only the products on the following Food Traceability List.
on behalf of the fresh produce industry on the areas of the proposed regulation that may be problematic for industry members, or that will not assist in trace-back investigations. PMA formed a working group to develop the comments, which included representatives from United Fresh, Western Growers and CPMA to ensure transparency and reduce duplicative efforts.
The comments put forth by PMA were informed by the challenges the industry has faced in obtaining critical tracing information and the advancements in traceability approaches that industry has already begun to implement. PMA's comments on the proposed rule noted the following key points relative to the fresh produce sector:
Clarity on what people, foods and food establishments will be exempted from the rule.
Clarity on a number of definitions in the rule.
Further FDA guidance on the program records required for products on the Food Traceability List.
Concerns that information received from the first receiver will be difficult to capture and verify, or may be inaccurate.
Recommendation to use the case-level GTIN lot number to identify the originator.
Data privacy and corporate confidentiality concerns generated by asking the first receiver to share data that is not their own.
Records required when receiving or transforming foods on the Food Traceability List.
Recordkeeping requirements for foods subject to a kill step.
The circumstances in which FDA will modify requirements or exempt a food or type of entity from requirements.