Understanding the ProposeD Traceability Rule
In a follow-up to its proposed Traceability Rule released in October, the FDA has developed resources to help the industry understand the proposed rule requirements and whether or not a facility or product is subject to the Rule.
First, of critical importance to businesses is determining if they are subject to the Rule or if they are exempt. For that, the FDA has provided the flowchart: Who Is Subject to the Rule? (pdf). Following a yes/no format, those who manufacture, process, pack, or hold foods can determine if they are subject to the Rule. The first, most expansive question being whether or not your foods appear on the Food Traceability List. If not, you are not subject to the Rule. If your food appears on the list, you must continue following the flowchart to determine if you are (a) subject to the Rule; (b) exempt from the Rule, or (c) exempt from the Rule with exceptions.
A second resource developed by the FDA is a Risk-Ranking Model for Food Tracing Tool (RRM-FT), which provides information on the methods and criteria used to score commodity-hazard pairs and the results of scoring. The RRM-FT was developed as a data-driven science-based decision support tool to help FDA determine the “high-risk” foods to be included on the Food Traceability List (FTL), as required by FSMA Section 204. Along with an introductory overview, the RRM-FT webpage includes tabs for:
Methods and Criteria: Explaining that the RRM-FT is a semi-quantitative risk-ranking model that scores commodity-hazard pairs according to data and seven criteria, the page discusses and links to further information on each of the seven criteria, which include frequency of outbreaks and occurrence of illnesses; severity of illness; likelihood of contamination; growth potential, with consideration of shelf-life; manufacturing process contamination probability and industry-wide intervention; consumption, and; the cost of illness. The page provides an example of how a risk score is calculated for a commodity-hazard pair or a commodity. The page also includes examples of how criteria scores are calculated and links to the full “Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204” document and list of references evaluated and used to obtain data for the scoring of the criteria.
RRM-FT Results: Three separate tabs link to further information on the evaluated commodities, including a table of commodity categories, commodities, commodity scores, along with commodity-hazard pairs and their scores; a colorful interactive graph of the commodity-hazard pairs; and an interactive graph on commodity risk scores.
Other FDA resources include a pre-recorded webinar in which FDA personnel discuss the benefits of the proposed rule, who would be subject to the rule, the proposed key requirements, exemptions, etc.; a key terms glossary; and virtual public meetings to be held Nov. 6, Nov. 18, and Dec. 2.
Even with these additional resources, the proposed Traceability Rule is complex, requiring a full reading and review for understanding and implementation. In October, TAG presented and recorded a webinar on the proposed Rule which discussed the affected foods and ingredients; key terms (CTEs, KDEs, etc.); rules for each step of the supply chain; kill-step requirements; recordkeeping; and timelines and enforcement. Additionally, TAG can help businesses understand and implement the requirements specifically related to them in preparation for the final Rule. Contact us to learn more.