Produce Marketing Association Comments on FSMA Traceability Rule


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Tue. February 16th, 2021 - by Anne Allen

NEWARK, DE - Aiming to continue increasing the safety of fresh produce, the U.S. Food and Drug Administration (FDA) recently proposed a new rule called ‘Requirements for Additional Traceability Records for Certain Foods’. The intention of the rule is to establish recordkeeping requirements for the Food Traceability List, which is ultimately expected to improve the traceability information during foodborne illness outbreaks and increase the speed and precision of trace-back and trace-forward investigations for recall events.

In response to the proposed rule, the Produce Marketing Association (PMA) referenced the challenges our industry has faced in obtaining critical tracing information and the advancements in traceability approaches that we have already begun to implement.

The Produce Marketing Association recently issued a response to the FDA's proposed new ‘Requirements for Additional Traceability Records for Certain Foods’ rule

“PMA supports FDA efforts to use the proposed rule to reduce the harm to consumers caused by foodborne pathogens and limit adverse impacts on industry sectors affected by the outbreaks by improving the ability to trace the movement quickly and efficiently through the supply chain of foods recognized as causing illness, identify and remove products from the marketplace, and develop mitigation strategies to prevent future contamination,” the association said in its press release. “Overall, PMA commends the FDA on release of the proposed rule that we believe will strengthen the industry’s record keeping requirements for certain foods, some of which were linked to outbreaks of foodborne illness. The net result will be much stronger consumer confidence in products produced by the fresh produce and broader food industry.”

In reviewing the proposed rule, PMA noted a number of areas where there were outstanding questions or additional guidance needed from the FDA to properly communicate and enforce the regulations. 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 exempt 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

PMA’s comments were developed by a Task Force of industry stakeholders with extensive experience in food safety, traceability, and regulations.

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Produce Marketing Association