The SFA has submitted comments to the FDA regarding the agency's final proposed rule under the Food Safety Modernization Act, introduced in September. The FSMA Food Traceability Proposed Rule identifies and creates increased traceability requirements for certain high-risk foods and products that contain those high-risk foods.
The proposed rule identifies five “critical tracking events” that would require records containing “key data elements,” which would vary depending on the event being performed. Food makers, co-packers, labelers, distributors, and retailers would have roles in this new proposed rule.
“The SFA strongly supports the overall goal of improving food traceability,” said the SFA in its comments. “The manufacturers, distributors, and importer members that make, purchase, and handle foods appearing on the food traceability list care deeply about the health and safety of consumers. A clear Traceability Rule would provide a great opportunity to improve efficiency and efficacy of traceback during foodborne illness outbreak investigations.”
The comments continued, “However, the Association believes this rule is overly broad in its prescription of additional records to be kept by industry than what is needed to serve the statutory objective to ‘rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak.’”
The SFA lists ten suggestions for the FDA to strengthen and clarify the proposed rule, including:
1. Revisit the determination of listed foods to list particular foods – not broad categories of food—consistent with Section 204 of FSMA.
2. Establish requirements for labeling of foods exempt or no longer subject to rule, from the rule to reduce the burden on receiving entities.
3. Consider complexities presented for implementing this rule under common commercial arrangements in the specialty food industry
4. Eliminate the collection of burdensome, often duplicative information that is not necessary to traceback.
5. Respect data privacy and confidentiality concerns of firms and limit the collection of information to better safeguard sensitive commercial information.
6. Follow the statutory mandate not to prescribe particular technologies.
7. Establish education requirements and dedicate resources for education relating to this rule.
8. Increase and establish a phased timeline for compliance with the Traceability Rule.
9. Clarify mechanisms for the enforcement of the rule by the FDA with different entities in the supply chain.
10. The Association requests that FDA clarify retail entities subject to the rule overall mechanisms for the enforcement of the Rule.
“The Association much appreciates the ‘educate while we regulate’ approach taken by the agency in its enforcement strategy for each of the other FSMA rules,” the comments concluded. “Our members are deeply committed to providing a safe and traceable food supply; however, the complexities of this rule will take considerable time and effort to translate from regulation to understanding to implementation. Thus, we strongly encourage the agency to adopt a similar approach with the Traceability Rule.”
The SFA wants to recognize the SFA Regulatory & Legislative Industry Working Group and SFA legal counsel Jennifer Lamb Rogers of PSL Law Group, who jointly worked to put together these comments.
Related: Regulatory Movement Amid the Pandemic; SFA Testifies on Proposed FSMA Food Traceability Rule.