My name is Ron Tanner, and I serve as the Vice President for Education, Content, and Advocacy for the Specialty Food Association.
As the trade association for the specialty food industry, SFA supports the overall goal of improved food traceability. We appreciate the opportunity to provide verbal comments on the proposed rule for Food Traceability and will submit comprehensive comments to the docket. We strongly support FDA extending the comment period by at least 60 days.
SFA’s 3,900 members include manufacturers, distributors, importers and retailers of foods included on the proposed rule’s Food Traceability List. As more than 80 percent of our members are small and very small businesses, SFA is particularly concerned as to how they will be impacted. Today, we will focus on some initial comments and questions.
First, we echo the concern expressed by other associations that the general categories of foods for inclusion on the FTL are not clearly defined. Specifically, SFA requests FDA to clarify the definition of soft cheeses, fresh herbs, and tropical tree fruits, and how the latter two would be impacted by drying.
Second, SFA questions how receiving manufacturers and distributors will be able to know whether a product qualifies for exemptions or partial exemptions without any labeling requirements by originating or preceding entities. For example, how will a pasta sauce manufacturer receiving fresh tomatoes know whether the product qualifies for the total commercial processing exemption versus the partial exemption for a kill step?
Third, SFA encourages the agency to focus on the collection of key data elements that are most relevant for ensuring effective traceback. We recommend limiting KDE collection to date and location of a critical tracking event and eliminating time requirements. Time requirements will be especially difficult to define, track, and implement in many contexts and without yielding a comparable return for improved traceback.
Fourth, SFA strongly supports an extended and phased timeline for compliance with this rule based upon business size and entity type. Sophistication of traceability systems varies widely within the industry, and small and very small businesses will need more time to adapt and develop systems to meet the requirements of this rule. SFA opposes parts of the rule which could be a competitive advantage for large food corporations.
Fifth, SFA is concerned about the lack of education and training regarding this rule. The Food Traceability Rule introduces a new lexicon of terminology. However, unlike previous FSMA rules, there is no individual education requirement or program. Without a corresponding education structure, it will be more difficult to establish common understanding to facilitate translating regulation to implementation.
Sixth, what does FDA envision for the enforcement of this rule? Will this rule be enforced during routine regulatory inspections of food facilities and farms or solely during the event of a foodborne illness outbreak? How will compliance by restaurant and retailer entities be monitored by the agency when such entities are not normally subject to regulatory inspection?
The Specialty Food Association looks forward to further clarification from the FDA on each of these issues and continuing to work with the agency on its development of this Rule. Thank you.
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