Even while extending the comment period for the proposed Traceability Rule and its Food Traceability List (FTL), FDA has already made some clarifying edits and acted on comments and questions received at a public meeting.
Comment Period. Although the comment period closed on November 23, FDA reopened it in mid-December, extending the period to February 22. The extension was in response to stakeholder concerns that more time was needed to adequately review and analyze the provisions with consideration to the entire proposed rule.
Clarifying Edits. The clarifications were made to the FTL. While not reflecting a change of the foods that are included on the list, the edits clarify the descriptions of two of the foods, and specifies that only “fresh” products would be included for several other FTL categories:
- Cheeses, other than hard cheeses. Revised to clarify the included cheeses and give examples. The new description is: “Includes all cheeses made with either pasteurized or unpasteurized milk, other than hard cheeses. Includes soft-ripened/semi-soft cheeses (e.g., brie, camembert, feta, mozzarella, taleggio, blue, brick, fontina, Monterey jack, and muenster) and soft unripened/fresh soft cheeses (e.g., cottage, chevre/goat, cream, mascarpone, ricotta, queso blanco, queso fresco, queso de crema, and queso de puna).” Hard cheese is defined as cheese with less than 39% moisture, such as cheddar, Romano, and parmesan.
- Leafy greens (fresh). The word fresh was added to clarify the scope of these commodities. The description is revised to: “Includes all types of leafy greens, such as lettuce, (e.g., iceberg, leaf and Romaine lettuces), kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, endive, etc.” The earlier version included “collards” as an example of leafy greens; however, since collards are listed as “rarely consumed raw” in the produce safety regulation, they would be exempt from the requirements of this rule.
- Fresh. The term “fresh” was added to the following other categories to indicate that only fresh items in these categories would be included and subject to the rule: cucumbers, melons, peppers, sprouts, tomatoes, and tropical tree fruits.
FAQ Published. The 12-page document contains answers to 34 question grouped by topic, including the FTL; the newly proposed Critical Tracking Events (originating, growing, first receiver, transformation, and creation); as well as sections on movement within an organization, farms, food retail establishments (including restaurants), RACs, traceability lot codes – and a catchall: miscellaneous.
A few of the questions TAG saw as key were:
- FTL: Adding/Removing Foods & FDA Review. Under the proposed process (§ 1.1465), when FDA sees a need for additions or deletions, it would publish a notice in the Federal Register stating the proposed changes and reasons and request input. After considering the input, a Federal Register notice would be posted as to the final decision and reasons. Deletions would be effective immediately; additions would become effective one year after publication of the Federal Register notice, unless otherwise stated in that notice. The revised list also would be posted on FDA.gov. There is not a set timeframe for review but FDA plan to perform a periodic review of new, relevant scientific data or other scientific information.
- FTL Produce Grower Records.
- FDA is proposing that all entities subject to the rule must establish and maintain the traceability program records described in proposed § 1.1315. This would include all originators of foods on the FTL, unless they are exempt under proposed § 1.1305.
- This would include records that “link the traceability lot code of the food to the growing area coordinates,” which would mean the geographical coordinates (under the global positioning system or latitude/longitude) for the entry point of the physical location where the food was grown and harvested. However, growing area coordinates are not among the key data elements that farms or other entities would be required to send to the recipient of a shipment of food on the FTL. So growing area coordinates would only need to be maintained as part of a firm’s own traceability records, and made available to FDA upon request. There is other information that a farm will be required to send to recipients of the food it ships, which the FDA would use to facilitate traceback to the farm in order to get access to the specific growing coordinates maintained in the farm’s internal records.
- Kill Step Application. If a kill step has been applied to an FTL food, subsequent persons/entities receiving that food would not be required to maintain any traceability records under the proposed rule.
- Intra-Organization “Shipping.” Interestingly, FDA did not directly address the question as to whether movement of FTL foods to other locations of the same organization would be regarded as “shipping.” Rather, the agency stated the definitions of shipping (“an event in a food’s supply chain in which a food is arranged for transport (e.g., by truck or ship) from a defined location to another defined location at a different farm, a first receiver, or a subsequent receiver”) and receiving (“an event in a food's supply chain in which a food is received by a customer (other than a consumer) at a defined location after being transported (e.g., by truck or ship) from another defined location”). Then asked for comment on how the proposed definitions would fit with different types of business structures, “bearing in mind the goal of efficient and effective traceability.” The FDA is likely hesitant to answer this question directly since intra-organization transfer may meet the definitions of shipping or receiving in some cases, but not others. So each company will need to assess whether these transfers constitute a critical tracking event pursuant to their specific scenario.
With the 34 FAQs addressing further specifics of each of the Critical Tracking Events as well as other topics, TAG recommends that all readers take a look at the document to determine those areas that are most relevant to you. Use the extended time FDA has allotted to make comment as relevant – particularly in areas where FDA has specifically requested input, such as the Intra-organization shipping above.
If you have other questions about how the rule will apply to you or need assistance, give TAG a call. We can help.