FDA食品追溯指南草案：年销售额25万至100万美元的小餐馆与零售店拟获执法宽免
美国食品药品监督管理局（FDA）10月8日发布一份指南草案，就《食品追溯规则》对小型零售食品店与餐馆的豁免作出安排，并于10月9日在《联邦公报》公示征求意见，意见截止日期为11月23日，案卷号为FDA-2025-D-6952。按现行规则，过去三年平均年食品销售额不超过25万美元（滚动计算、以2020年为基数经通胀调整）的小型零售食品店与餐馆，可完全豁免于该规则的额外记录保存要求。草案提出，FDA拟对年销售额超过25万美元、但不超过100万美元的零售店与餐馆，就该规则的全部要求行使执法宽免，即暂不予执行。FDA表示，销售额在100万美元以下的零售店与餐馆约占此类商家总数的一半，但合计仅占相关总销售额的约6%，因此这一灵活性将维持规则预期的公共卫生效益，同时为众多小商家减轻负担；全美此类小商家中有不少由华人经营。《食品追溯规则》源于2011年签署的《食品安全现代化法案》，FDA于2022年发布最终规则，要求生产、加工、包装或持有《食品可追溯清单》所列食品的企业保存追溯批次代码等关键数据记录，以便在食源性疾病暴发时更快锁定污染食品的来源与流向。国会已立法推迟该规则的执法，FDA在2028年7月20日之前不会启动执法。FDA还定于11月6日举行公开会议，讨论批次级食品追溯在实施中的难点及可能的进一步灵活安排，议题包括分销环节的追溯批次代码范围、单个食品的关键数据要素、退货与回收、食物废弃物回收利用及公司内部调拨等；会议免费向公众开放，但需提前注册，会议案卷意见征集至12月6日。此次拟议宽免只适用于零售食品店与餐馆，农场、生产商、加工商与分销商不在范围内，仍须按规则准备合规。
FDA Draft Guidance: Food Traceability Enforcement Relief Proposed for Small Restaurants and Retailers With Sales Up to $1 Million
The U.S. Food and Drug Administration (FDA) on October 8 issued a draft guidance addressing the small-business exemption under the Food Traceability Rule for retail food establishments and restaurants. The guidance was announced in a Federal Register notice published on October 9, with public comments due by November 23 under docket FDA-2025-D-6952. Under the existing rule, retail food establishments and restaurants with average annual food sales of no more than $250,000 over the prior three years, calculated on a rolling basis and adjusted for inflation using 2020 as the baseline year, are fully exempt from the rule's additional recordkeeping requirements. Under the draft guidance, the FDA intends to exercise enforcement discretion for all requirements of the Food Traceability Rule for establishments with average annual food sales of more than $250,000 but no more than $1,000,000. The agency said retailers and restaurants at or below $1 million in sales account for roughly half of all such establishments but only about 6 percent of total sales, so the flexibility would maintain the rule's intended public health benefits while providing relief to numerous smaller businesses, many of them immigrant- and Chinese-owned shops and restaurants across the United States. The Food Traceability Rule was mandated by the Food Safety Modernization Act, signed on January 4, 2011, and the FDA issued the final rule in 2022. It requires entities that manufacture, process, pack or hold foods on the FDA's Food Traceability List to keep additional records, including traceability lot codes and other key data elements, so contaminated food can be traced faster during foodborne-illness outbreaks. Congress has barred enforcement of the rule before July 20, 2028. The FDA will also hold a public meeting on November 6 on implementation challenges and possible additional flexibilities for lot-level traceability, covering topics such as distributor traceability lot code ranges, key data elements for individual items, returns and reclamations, food waste recovery and intracompany shipments. The meeting is free and open to the public, with registration required, and comments to the meeting docket are open through December 6. The FDA said the proposal responds to compliance challenges that small retailers and restaurants brought to the agency after the final rule was issued in 2022, with stakeholders telling the agency that such businesses struggle to stay in business, can employ only a very small staff, and often lack money for training, technology or new hires. The agency said it plans to keep the enforcement-discretion policy in place while it studies the challenges these firms face. As a draft guidance, the document states the FDA's current thinking, does not establish any rights for any person, and is not binding on the FDA or the public. The proposed relief applies only to retail food establishments and restaurants; farms, manufacturers, processors and distributors are not covered and must still prepare to comply with the rule.
发布：GSM·美国（发布链接）
图片来源：图：超市货架上陈列的包装食品，这类标有批次信息的食品正是食品追溯规则要求保存来源记录的对象（资料图）。Photo: Packaged foods on a supermarket shelf; lot-coded packaged foods are among the products subject to food traceability recordkeeping (file photo). 图源：維基小霸王／Wikimedia Commons，CC BY-SA授权。
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