In comments submitted to the U.S. Food and Drug Administration (FDA) last Monday, AHPA has requested significant revisions and clarifications to a proposed rule that would establish new, additional traceability recordkeeping requirements for categories of foods on a newly published “Food Traceability List.” (FTL)
The new rule implements a Congressional directive from the Food Safety Modernization Act (FSMA) to require additional recordkeeping for foods that the FDA designates as “high risk.” The FDA issued the proposed rule on September 23, 2020, with the title “Requirements for Additional Traceability Records for Certain Foods”. Proposed entries on the FTL include the category “Herbs (fresh)”, with the examples of parsley, cilantro and basil. Under the proposed rule, the creator or first receiver of listed foods would be required to create a lot-specific “traceability lot code” for the food. Finished food products containing ingredients from the FTL would be subject to the same traceability requirements. This code would then follow the lot through the supply chain until a documented kill step is applied or the lot enters retail sale. Other companies that ship, receive or transform the food throughout the supply chain would also be required to maintain additional records depending upon their operations.
“Our comments respectfully emphasize Congress’s mandate that this system must not affect foods that are not high risk” said AHPA President Michael McGuffin. “These new recordkeeping requirements are not supposed to become a one-size-fits-all model for the food system.”
AHPA’s comments ask the FDA to revise the “Herbs (fresh)” category on the FTL to identify that it specifically refers to culinary herbs. AHPA’s comments also note that the FTL does not provide definitions, and requests that the final rule define specific commodities or plant parts as necessary to provide clear guidance to industry. AHPA’s comments also request additional consistency for industry in proposed procedures for adding or removing foods from the FTL.
The comments include addenda restating AHPA’s comments from 2013 and more recently requesting to reevaluate the Produce Safety Rule’s expansive definition of “produce” to place it in line with Congressional intent, and to reform the list of produce rarely consumed raw (the RCR list). Commodities on the RCR list are exempt from the proposed recordkeeping requirements. Due to the breadth of issues identified, AHPA joins a request from other trade associations that the FDA consider issuing a supplemental proposed rule to engage further with stakeholders and identify ways in which the proposed rule could be simplified to achieve its public health goals.
The comments were produced with the support of a working group of the AHPA Government Relations Committee. Please contact AHPA President Michael McGuffin or AHPA Director of Regulatory Affairs Robert Marriott with any questions regarding the comments, or to learn more about the Government Relations Committee.