Produce Marketing Association
Produce Marketing Association
Produce Marketing Association

PMA Comments on FSMA Traceability Rule

The Produce Marketing Association submitted comments on the rule that aims to establish recordkeeping requirements for foods on the Food Traceability List.

February 12, 2021

Editor's Note: Read Dr. David Acheson's column on The ABCs of the Proposed Food Traceability Rule, and our new feature Seeing the Potential, for more info on traceability.

NEWARK, Del. — The Produce Marketing Association (PMA) submitted comments on the proposed Food and Drug Administration (FDA) rule Requirements for Additional Traceability Records for Certain Foods. The intention of the rule is to establish recordkeeping requirements for foods on the Food Traceability List (FTL) designed to improve the traceability information during foodborne illness outbreaks and to increase the speed and precision of trace-back and trace-forward investigations for recall events.  

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 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.

Overall, PMA commends the FDA on release of the proposed rule that it believes 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 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 exempted from the rule.  
  • Clarity on a number of definitions in the rule, including:
    Critical Tracking
    First Receiver
    Food Traceability List
    Physical Location
    Kill Step
    Location Identifier
    Nonprofit Food Establishment
    Physical Location Name
    Point of Contact
    Reference Record
    Retail Food Establishment
    Traceability Product Description
    Traceability Product Identifier
  • 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.