Feb 10, 2021PMA comments on proposed FSMA traceability rule
The FDA is proposing to establish additional traceability record-keeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods the agency has designated for inclusion on the Food Traceability List.
The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA). The proposed requirements would help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death. The comment periods for the proposed rule and information collection provisions have been extended and will now be available for public comment until February 22, 2021.
At the core of this proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products. FDA would encourage the voluntary adoption of these practices industry-wide.
PMA comments on FSMA traceability rule
The Produce Marketing Association (PMA) submitted comments on the proposed U.S. 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 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 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 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
- Non-profit 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.
- Record-keeping 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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