Comment from Altibbe Inc.

Comment of Altibbe Inc. — Docket No. FDA-2014-N-0053 (91 FR 31723, May 28, 2026) — re: FDA Discussion Paper "Identifying Additional Flexibilities for Satisfying the Food Traceability Rule's Lot-Level Tracking Requirement." Altibbe Inc. is an independent research organisation (California) publishing the SGPIS open-access series on food product-information architecture. We have no commercial interest in the rule's outcome and represent no industry or consumer body. THE FULL COMMENT IS ATTACHED AS A PDF; this box summarises it. SUMMARY: We support pragmatic flexibility in HOW lot-level records are kept and transmitted (format, system, interoperability pathway) and urge FDA to hold the line on WHAT must be preserved: lot-level granularity and KDE linkage across CTEs. Record-format flexibility is not data-element flexibility. The Traceability Lot Code is the atomic unit that makes downstream product information trustworthy. 1. GOVERNING PRINCIPLE (cross-cutting): frame every candidate flexibility against one outcome-equivalence test — can the receiving entity (and FDA, on request) reconstruct the same lot-to-CTE linkage that full compliance would have produced? A flexibility that passes changes only the means of compliance; one that fails changes the substance of the rule. Specify this test in any Section 780 recommendations rather than enumerating approved technologies. 2. REASONABLE RANGE OF TLCs (Topic 1, Qs 1, 2, 6, 8): a range substitutes set-membership for identity — the receiver learns the lot is one of N, not which one — and ranges compound across successive nodes. If entertained, guardrails should include a hard, small ceiling on range size; restriction to a single TLC source; application to a defined quantity rather than an entire shipment; a documented, auditable derivation method; and a sunset so the range is a bridge, not a destination. 3. INFERRED TLCs (Topic 2, Qs 1, 3) are structurally preferable to open ranges: a definite lot assertion plus a bounded, declared uncertainty statement keeps the data element intact and auditable, and gives firms a convergence path to full compliance ("steppingstone"). If either Topic 1 or 2 is adopted, Topic 2's structure should be the template. 4. EVALUATE FLEXIBILITIES AGAINST ALL FUNCTIONS OF LOT IDENTITY, not recall speed alone (Topics 1, 2, 6): published research distinguishes admissibility (what movement records establish) from intelligibility (what a downstream party can know about the product); the lot is load-bearing for verification, attribution and any disclosure built on the supply-chain record, and downstream functions inherit whatever granularity the traceability layer preserves. Trade-documentation experience shows instruments optimised for the moment of clearance shed information needed downstream. For intracompany shipments (Topic 6, Q4), TLC and TLC-source information should remain reconstructible where food re-enters inter-company commerce. 5. DATA STANDARDIZATION (Topic 8, Q1): define the outcome any standard must achieve — lossless carriage of the KDE set and TLC linkage, testable by receiver reconstruction — and remain neutral on syntax and carrier. References (open access): Ahmed S., Traceability Without Disclosure (SGPIS-GQ-02), Altibbe Inc., 2026, https://doi.org/10.5281/zenodo.20375829; Ahmed S., The Information Gap in Food Trade Corridors (SGPIS-TC-01), 2026, https://doi.org/10.5281/zenodo.20375811; Ahmed S., The Disclosure Layer (SGPIS-DL-01), 2026, https://doi.org/10.5281/zenodo.20375837. Contact: Shams Ahmed, Founder & CEO, Altibbe Inc., shams@altibbe.com, ORCID 0009-0005-9676-8827.