Comment from James Forshay

I am the owner-operator of a small fresh-cut produce business in Manhattan, Kansas. Whole produce comes in our door; washed, cut, ready-to-eat products go out the same day. Under the Food Traceability Rule we are a transformer: when compliance is required, we must assign new traceability lot codes to what we make and keep records linking it back to the lots we received. I am writing because most of what FDA will hear on this docket comes from trade associations and large distributors, and the flexibility discussion is partly carried out in the name of operations like mine. My position is simple: keep lot-level tracking, and put the flexibility into how small operations can practically satisfy it. Here is what the requirement will look like on our floor. On a typical morning we receive 20 to 30 cases of whole fruit (pineapple, melons, berries) across 8 to 12 supplier lots. By late morning those have become several hundred retail units. One incoming lot becomes many outgoing products, and keeping the linkage between them is the whole job. On a floor like ours that record gets made at the bench, during the rush, by the people doing the cutting and packing. When we first tried keeping floor records with clipboards and end-of-shift paperwork, entries were written late or from memory, and the gap showed exactly when volume was highest. What fixed our record-keeping was making capture part of the work step itself, so the record is created at the moment the work happens. Lot-level tracking will only work on a floor like mine the same way: captured at the bench during the work, not reconstructed after the shift. For context on my interest: after that experience we built our own floor software in-house, and we now offer traceability software built on the same approach to other operators. I am an operator with a commercial stake in traceability, and my comments here are from the operator side. The reason I want the data kept strong is recall arithmetic. With true lot-level records, if a supplier lot is implicated I can identify exactly which day's production used it and pull only that. Without them, everything shipped in the exposure window comes back, and few operations my size would survive a recall scoped that broadly. Lot-level records are what make a food-safety event survivable for a small business. For anyone selling into mainstream retail, several major retailers already require lot-level data beyond the Food Traceability List, on timelines ahead of FDA's, so weakening the federal requirement would not remove the burden for operators like me. Only practicality does that. On the specific topics in the paper: On the reasonable-range topic, question 2 (guardrails): any range or inference flexibility should be required to resolve to true lot identity somewhere in the chain, and the party electing the flexibility should carry the duty of that resolution. If a range simply arrives at the last step of the chain, then when FDA comes tracing, the smallest business in it is left holding uncertainty it did not create. On the inferred-lot-codes topic, question 3 (the steppingstone question): workable where the inference is declared as inferred in the records and measured against periodic physical verification. An inference whose accuracy is measured and improving is a path to full compliance; an inference nobody checks becomes the permanent standard. I would also scope this flexibility to shipping and distribution, where the lot identity existed upstream and went unrecorded at a handling step. It cannot substitute at transformation, where the link between incoming lots and outgoing product is created for the first time. If that linkage is not captured when the work happens, there is nothing downstream to infer from. On data standardization: plain formats matter more to a business my size than new technology. The industry already has workable identifiers in GS1 standards (GTIN plus lot code). What small operations lack is plain-language guidance written for a prep room: model records for the transformation data elements, an example of a compliant sortable spreadsheet, and phased expectations. Recognition matters more than new mandates: it would help to confirm that compliance can be built on what is already in the room, meaning the barcodes printed on the cases we receive and a sortable spreadsheet. If it would help to hear what lot-level capture looks like inside a small transformation operation, I would be glad to take part in the November 6 public meeting or future working sessions, and to trial draft model records or small-entity templates on a working floor. I understand the pressure behind these discussions. But please do not let flexibility become a synonym for less precise data. The precision is the public-health benefit, and it is the small operator's own protection. Thank you for the opportunity to comment. James Forshay Owner-operator, fresh-cut produce operation Manhattan, Kansas