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June 10, 2026
The U.S. Food and Drug Administration has released a report on a series of traceability readiness tabletop exercises held with industry between March 9 and April 1, 2026. The exercises were designed to help the food industry prepare to comply with the Food Traceability Rule (FTR). The Agency has also released updated Frequently Asked Questions to provide clarity on a number of topic related to the rule.
The FTR —established under Section 204 of the FDA Food Safety Modernization Act —requires covered entities that manufacture, process, pack, or hold foods on the FDA Food Traceability List to maintain additional records that allow FDA to more rapidly and accurately trace food through the supply chain. As part of the tabletop exercises, the FDA worked with industry participants to simulate an FTR records request from FDA. The exercises tested whether participants could locate traceability records associated with the handling of a specific product during a short, defined date range, and provide the information from those records in an electronic sortable spreadsheet within 24 hours, which is consistent with the requirements of the FTR.
The exercises demonstrated that meaningful progress is being made toward meeting the FTR requirements. Most firms responded within 24 hours, and proactive supply chain coordination—more than any particular technology—drove the strongest results. These results are encouraging overall, even though the exercises also demonstrated that some challenges remain with certain data elements. Understanding firm readiness will help both the FDA and industry further prepare for compliance.
The FDA will use the findings of these exercises to inform its ongoing outreach, education, and technical assistance efforts. These exercises, coupled with ongoing engagements, will also help inform potential flexibilities regarding the lot-level tracking requirements in the FTR. The FDA recently issued a discussion paper on this topic and is looking forward to hearing more from interested stakeholders at the public meeting on June 15th and through feedback that can be submitted to a docket as described in the discussion paper.
Additionally, to further support implementation of the rule’s requirements, the FDA has updated its frequently asked questions on the FTR to provide greater clarity on a number of topics, including the Traceability Lot Code source reference, food traceability plans, and intracompany shipments.
The tabletop exercises fulfilled a Congressional directive under the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (P.L. 119-37).
Additional Information
FDA Public Meeting- Challenges and Solutions in Lot-Level Food Traceability
FDA Releases Discussion Paper Ahead of Traceability Public Meeting in June
FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
Frequently Asked Questions
An unofficial translation of this announcement is provided below.
翻译参考：
FDA 发布食品可追溯规则桌面演练准备情况报告及更新版常见问题
在 FDA 官网查看
2026 年 6 月 10 日
美国食品药品监督管理局（FDA）发布了一份报告，内容涵盖 2026 年 3 月 9 日至 4 月 1 日期间与行业共同开展的一系列食品可追溯准备情况桌面演练。此次演练旨在帮助食品行业为遵守《食品可追溯规则》（FTR）做好准备。FDA 还同步发布了更新版常见问题解答，就该规则的多项相关议题提供了进一步说明。
《食品可追溯规则》依据《FDA 食品安全现代化法》第 204 条设立，要求从事 FDA 食品可追溯清单所列食品的生产、加工、包装或储存的相关主体保存额外记录，以便 FDA 能够更迅速、更准确地对供应链中的食品进行追溯。在桌面演练中，FDA 与行业参与者合作，模拟了 FDA 发出 FTR 记录请求的场景。演练测试了参与者能否在较短的特定日期范围内找到与特定产品处理相关的可追溯记录，并在 24 小时内以可排序电子表格的形式线上提供相关信息——这与 FTR 的要求相符。
演练结果表明，各方在满足 FTR 要求方面正取得实质性进展。大多数企业在 24 小时内作出响应，主动的供应链协调——而非某种特定技术——是取得最佳成效的关键驱动因素。总体而言，上述结果令人鼓舞，尽管演练也表明某些数据元素方面仍存在一定挑战。了解企业的合规准备情况，将有助于 FDA 和行业双方进一步做好合规准备。
FDA 将借助本次演练的发现，为其持续开展的外联、教育和技术援助工作提供参考。这些演练与持续开展的互动相结合，也将有助于为 FTR 中批次级追踪要求的潜在灵活性调整提供依据。FDA 近期就此议题发布了一份讨论文件，期待在 6 月 15 日的公众会议上听取更多利益相关方的意见，并通过讨论文件所述的案卷渠道收集反馈意见。
此外，为进一步支持规则要求的落实，FDA 已更新了其关于 FTR 的常见问题解答，就多项议题提供了更清晰的说明，包括可追溯批次代码来源参考、食品可追溯计划以及公司内部货物转运等内容。
本次桌面演练履行了《2026 年持续拨款、农业、立法机构、军事建设与退伍军人事务及延伸法案》（公法第 119-37 号）项下的国会指令。
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Sincerely,
Sarah McMullen
Country Director
FDA China Office
Office of Global Operations
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