Search results for: traceability

  • On February 19, 2026, the U.S. Food and Drug Administration (FDA) announced multiple actions intended to support implementation of the Food Traceability Rule, a key component of the Food Safety Modernization Act (FSMA). These actions include issuing new guidance to address stakeholder questions, finalizing an exemption for certain cottage cheese products, and initiating a series of stakeholder engagement sessions mandated by Congress.
  • The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements pertain to critical tracking events across the supply chain, such as initial packing, shipping, receiving, and transformation, and are intended to enable faster and more accurate identification of potentially contaminated products during a food safety event. As we’ve previously blogged, there have been numerous logistical challenges for industry in implementing the law due to its complexity, and in August 2025 FDA announced a proposal to extend the compliance date.
  • As part of its February 19 announcement, FDA released a detailed Questions and Answers (Q&A) guidance document to help industry better interpret the rule. The guidance covers applicability to different types of entities, including farms, fishing vessels, retail food establishments, and restaurants, as well as clarification on how specific activities such as intracompany shipments, commingling, or initial packing are treated under the rule. It also provides additional detail on exemptions, such as those for raw molluscan shellfish, and guidance on how to determine whether a product qualifies as “fresh‑cut” for inclusion on the FTL.
  • In addition to issuing guidance, FDA finalized an exemption for certain cottage cheese products, removing them from the scope of the Food Traceability Rule. The agency also announced upcoming stakeholder engagement sessions, which will occur quarterly and are required under recent congressional appropriations legislation. These sessions are intended to provide industry with regular opportunities to engage with FDA, ask implementation‑related questions, and raise practical concerns about compliance.
  • Keller and Heckman will continue to monitor and report on any developments related to the Food Traceability Rule and FSMA.
  • On August 6, 2025, the U.S. Food and Drug Administration (FDA) announced its proposal to extend the compliance date for the Food Traceability Rule by 30 months to July 20, 2028.  FDA stated that the extension is needed to allow full compliance across all regulated sectors.
  • The final rule establishes additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods that are on the Food Traceability List.  The new requirements of the rule are intended to achieve faster identification and removal of contaminated food to better prevent foodborne illnesses and death. 
  • To achieve the full public health benefits of the rule, all covered entities of the supply chain must comply.  FDA acknowledged that few entities would be able to meet the rule’s requirements by the initial January 2026 compliance date, partly because all members of the supply chain must be in full compliance in order to work with accurate data.  The announcement stated that the “proposal is designed to afford covered entities the additional time necessary to ensure coordination between supply chain partners in order to fully implement the final rule’s requirements—ultimately providing the FDA and consumers with greater transparency and food safety.”
  • Additionally, FDA issued new tools and Frequently Asked Questions (FAQs) that address the Food Traceability Rule and help covered entities reach compliance.  The rule’s webpage now has new FAQs, new examples of traceability plans, new supply chain examples, and At-A-Glance document on the rule, and new translated documents.
  • Keller and Heckman will continue to monitor this proposal and relay new information.
  • On March 20, 2025, the U.S. Food and Drug Administration (FDA) announced its intention to extend the compliance date for the Food Traceability Rule by 30 months.  This extension aims to provide the food industry with additional time to fully implement the rule’s requirements.
  • The Food Traceability Rule, established under the FDA Food Safety Modernization Act (FMSA), mandates enhanced traceability recordkeeping for entities that manufacture, process, pack, or hold foods listed on the Food Traceability List (FTL) for the purpose of promptly identifying and removing potentially contaminated food from the market.    
  • Notably, in its announcement, FDA made clear that the substance of the rule remains intact, and the only modification is extending the compliance deadline.  The agency will continue to work with stakeholders to provide additional assistance and resources to address challenges with implementation.
  • Keller and Heckman will continue to monitor developments related to the FSMA and the Food Traceability rule.
  • Earlier this month, the National Association of Manufacturers (NAM) and more than 100 manufacturing associations sent a letter to President-Elect Trump making the case that increased regulatory compliance obligations have created a challenging business environment in the U.S. and outlining a list of de-regulatory actions that they believe will support industrial growth.
  • The letter outlines regulatory proposals across a wide range of industrial sectors and regulations, including environmental, chemical, labor and employment, and intellectual property regulations, as well as FDA’s food traceability rule applicable to certain higher risk foods (21 CFR part 1, subpart S).
  • In regard to the food traceability rule, the letter requests that the Trump administration “make these requirements more flexible and streamlined,” extend the 2026 compliance deadline by at least 3 years, and collaborate with industry on pilot projects.
  • This follows significant concerns expressed by the food industry over practical difficulties with the rule’s requirements, including concerns expressed at an October 7, 2024, virtual public meeting hosted by the Reagan-Udall Foundation. Industry comments at that meeting highlighted the complexity of the rule and difficulty in implementation, particularly with challenges related to overhauling IT systems, which are currently unsynchronized throughout the supply chain.  
  • On June 17, 2024, FDA published a proposed exemption for certain cottage cheese products from the Requirements for Additional Traceability Records for Certain Foods rule (the Food Traceability Rule). FDA initially announced its intention to consider an exemption for cottage cheese regulated under the Grade “A” Pasteurized Milk Ordinance (PMO) in the preamble to the final Food Traceability Rule in November 2022.
  • As we have previously blogged, the Food Traceability Rule is one of nine major finalized rules intended to implement the Food Safety Modernization Act and thereby reduce the prevalence of foodborne illness. The Rule is intended to allow for faster identification and removal of potentially contaminated food from the market. The Food Traceability List (FTL) designates the foods subject to the rule, and manufacturers must maintain additional records about critical tracking events in their supply chain related to foods on the list.
  • 21 CFR 1.1360-1400 describe the circumstances and process by which FDA may exempt a food from the Food Traceability Rule requirements. In general, FDA will modify requirements applicable to a food or type of entity, or exempt a food or type of entity, when the Agency determines that application of the Rule’s requirements that would otherwise apply to the food or type of entity is not necessary to protect the public health. FDA may consider a modification or exemption on its own initiative or in response to a citizen petition. FDA uses a risk-ranking model inform the FTL by evaluating known or reasonably foreseeable hazards related to commodities.
  • Cottage cheese is included on the FTL in the commodity “Cheese (made from pasteurized milk), fresh soft or soft unripened” based on the risk for Listeria monocytogenes and other pathogen contamination after pasteurization steps. However, because the PMO has specific processing requirements for Grade “A” cottage cheese that address these risk factors, and because Grade “A” cottage cheese undergoes enhanced regulatory oversight during manufacturing, FDA has tentatively concluded that application of the Food Traceability Rule requirements to Grade “A” cottage cheese is not necessary to protect public health.
  • FDA is accepting comments on the proposed exemption until September 16, 2024. Keller and Heckman will continue to monitor and provide updates on the proposal and the Food Traceability Rule generally.
  • On November 30, 2023, FDA announced that it had released a third wave of tools and FAQs to inform stakeholders about requirements for the Food Traceability Rule and to help covered entities become compliant with the rule. These new resources are available on FDA’s food traceability webpage.  
  • This update includes a new webpage explaining traceability lot codes, a video highlighting technological components of product tracing systems, example traceability plans, new supply chain examples for deli salads, and information on applying for a waiver or exemption. FDA also added to the FAQ page, with questions and answers now encompassing topics throughout the supply chain, including packing and shipping, farms, retail establishments and restaurants, recordkeeping, importing, and more.  
  • As previously reported, the Rule is one of nine major finalized rules intended to implement the Food Safety Modernization Act to reduce the prevalence of foodborne illness. Issued in November 2022, the Rule is intended to facilitate rapid identification and removal of potentially contaminated food from the market. The new FAQs and tools can help covered entities prepare to meet the requirements by the compliance date of January 20, 2026.

  • On June 26, 2023, FDA published a set of FAQs, related to the Food Traceability Rule, along with several new tools on its traceability website intended to help educate and inform industry about the Rule.  
  • For context, the Rule is one of the nine major finalized rules intended to implement the Food Safety Modernization Act and thereby reduce the prevalence of foodborne illness. As we have previously blogged about, the Rule, which was issued in November 2022 and has a compliance date of January 20, 2026, is intended to allow for faster identification and removal of potentially contaminated food from the market.  The Food Traceability List (FTL) designates the foods subject to the rule, and manufacturers of such foods must maintain records about critical tracking events in their supply chain.
  • With the compliance date fast approaching, the new FAQs and tools may help those subject to the Food Traceability Rule determine how the Rule applies and prepare them to meet the requirements. Of note, the new tools include: the results for all foods and associated commodity-hazard pairs in the Risk-Ranking Model for Food Tracing (a tool used by FDA to designate the foods on the FTL); additional descriptions on the Food Traceability List to clarify ambiguous terms; new supply chain examples illustrating how the rule is applied in a variety of scenarios; a new Food Traceability Rule fact sheet; a guide to getting started with the Food Traceability Rule; and additional foreign language translations of tools and supply chain examples.
  • Those who manufacture, process, pack, or hold foods that are on FDA’s Food Traceability List (FTL), including certain cheeses, shell eggs, nut butters, various fresh fruits and vegetables, finfish, crustaceans, mollusks (bivalves), and ready-to-eat deli salads, as well as foods containing non-transformed FTL foods, are subject to further recordkeeping requirements in addition to the traceability requirements that are generally applicable to other foods.  On November 21, 2022, FDA published the FDA Food Safety Modernization Act (FSMA) Final Rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule), discussed here, which requires these entities to maintain records containing information known as key data elements (KDEs) that are associated with critical tracking events (CTEs) in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods.  When requested, these records must be provided to FDA within 24 hours or some reasonable time to which FDA has agreed. 
  • On May 18, 2023, FDA published a Small Entity Compliance Guide (SECG) to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule as established in 21 CFR part 1, subpart S.  The SECG defines key terms of the Food Traceability Rule and, in addition to providing detailed guidance on how to comply with each part of the rule, offers guidance for determining whether an entity may be exempt from the rule and instructions on petitioning for a modification, waiver, or exemption from various requirements of the rule.  The SECG also notes that violation of any recordkeeping requirement under FSMA section 204, including any Food Traceability Rule violation, is prohibited under the Federal Food, Drug, and Cosmetic Act, except when such violation is committed by a farm, and that articles that appear not to comply with the requirements of the Food Traceability Rule are subject to refusal of admission to the U.S. 
  • The compliance date for all persons subject to the recordkeeping requirements of the Food Traceability Rule is Tuesday, January 20, 2026. 
  • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has proposed to amend animal disease traceability regulations and require electronic identification for interstate movement of cattle and bison.  The record requirements would also be revised and provide more clarification.
  • APHIS states that electronic identification and clearer records would strengthen the Agency’s ability to quickly respond to significant animal disease outbreaks.  It adds that USDA is committed to implementing a modern system that tracks animals from birth to slaughter using affordable technology that allows for quick tracing of sick and exposed animals to stop disease spread.
  • The proposed rule would require official eartags to be visually and electronically readable for official use for interstate movement of certain cattle and bison.  It would also require official identification device distribution records to be entered into a Tribal, State, or Federal database, and available to APHIS upon request.
  • Stakeholder comments on the proposed rule must be submitted by March 22, 2023.
  • Keller and Heckman will continue to monitor and report on relevant animal disease issues.
  • On November 17, 2022, FDA announced that it would be hosting an informational webinar on the recently released Food Traceability final rule.
  • As previously reported, the final rule was announced on November 15, 2022, and establishes additional traceability recordkeeping requirements for entities that manufacture, process, pack, or hold certain food types. The final rule includes traceability plans and recordkeeping requirements that aim to more effectively trace contaminated food through the food supply sourced both domestically and internationally.
  • The webinar will be held on December 7, 2022, from 1:00 – 5:00 pm ET. During the webinar, FDA will provide an overview of the rule, discuss recordkeeping requirements, and answer questions. Questions may be submitted during the registration process. The webinar will also be recorded and posted to the meeting page.