Search results for: traceability

  • 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.
  • On November 15, FDA announced a finalized rule to more effectively trace contaminated food through the food supply sourced both domestically and internationally. Foodborne illness affects millions of Americans each year. FDA’s action progresses its commitment to better protect the public by ensuring a safe and wholesome food supply through enhanced recordkeeping requirements which will allow for fast identification and removal of contaminated food from the US market.
  • The final rule, entitled “Requirements for Additional Traceability Records for Certain Foods,” establishes additional traceability recordkeeping requirements for entities that manufacture, process, pack, or hold certain food types.
  • Working closely with industry, FDA will be able to more effectively identify the origin and route of travel of certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death, and minimize overly broad advisories or recalls that implicate unaffected food products.
  • “This rule lays the foundation for even greater end-to-end food traceability across the food system that we’re working on as part of the New Era of Smarter Food Safety initiative,” shared Frank Yiannas, FDA’s duty commissioner for food policy and response.
  • The traceability recordkeeping requirements purport to create a universal and harmonized approach to tracing certain foods included on the Food Traceability List (FTL). In determining what foods to include on the FTL, FDA has developed a risk-ranking model for food tracing based on the factors that Congress identified in Section 204 of the FDA Food Safety Modernization Act. Examples of identified food categories include, but are not limited to, fresh leafy greens, melons, peppers, nut butters, fresh fruits, and crustaceans.
  • The final rule, which will go into effect on November 21, 2022, includes the following key features:
    • Tracking specific points in the supply chain – such as the harvesting, cooling, initial packing, receiving, transforming, and shipping FTL foods;
    • Instituting traceability plans that contain information essential to help regulators understand an entity’s traceability program, including a description of the procedures used to maintain required records, descriptions of procedures used to identify foods on the FTL, descriptions of how traceability lot codes are assigned, a point of contact for questions regarding the traceability plan, and a farm map for those that grow or raise a FTL product;
    • Requiring industry to maintain records as original paper or electronic records, or true copies, provide requested records to the FDA within 24 hours of a request (or within a reasonable time to which the FDA has agreed), and offer records in an electronic spreadsheet when necessary to assist the FDA during an outbreak, recall, or other threat to public health.
  • Keller and Heckman will continue to provide updates on this final rule and its applications to the food industry
  • Earlier this year we reported on FDA’s launch of the FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge. The public challenge sought to encourage the development of affordable, tech-enabled traceability tools to protect people and animals from contaminated foods. The public challenge ran from June 1, 2021 to July 31, 2021.
  • On September 13, 2021, FDA announced the winners of the challenge. FDA selected 12 winners representing the United States, Canada and New Zealand from over 90 submissions from around the world.  FDA stated that it “is committed to and will continue to do its part to help ensure that companies of all sizes, including small to midsize ones, can use and benefit from new tracing technologies.”
  • FDA will host a webinar on Tuesday, September 28 at 11 a.m. ET, in which the winning teams will present their solutions and take questions during a live Q&A session.
  • Last year we reported on FDA’s New Era of Smarter Food Safety Blueprint, which outlines the Agency’s plan to create a safer food system over the next decade. The Blueprint focused on tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and retail modernization, and promotion of food safety culture.
  • On June 1, the FDA launched a public challenge in tangent with the New Era of Smarter Food Safety initiative to encourage the development of affordable, tech-enabled traceability tools to protect people and animals from contaminated foods.  The FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge aims to develop scalable traceability hardware, software, or data analytics platforms that are low- or no-cost to the end user, while promoting innovation.  Entries will be evaluated on the following criteria:
    • Ability to address the needs of the targeted segment of the food supply chain.
    • Uniqueness and innovativeness of the technology developed.
    • Likelihood of utilization and ease of navigation.
    • Affordability to enable inclusive and viable traceability approaches.
    • Scalability and interoperability for the solution to be used by a majority of the targeted segment of the food supply chain.
  • FDA’s Office of Food Policy and Response is overseeing the public challenge, which runs from June 1, 2021 to July 30, 2021.  Up to 12 entrants will be announced as challenge winners, with their respective video submissions posted to FDA’s website and shared at an FDA webinar.  Entrants are not required to transfer any intellectual property rights to FDA nor provide an open source code.
  1. The Agency made clarifying edits to the Food Traceability List (FTL), which lists the foods for which additional traceability recordkeeping requirements in the proposed rule would apply. Edits to certain commodity descriptions were made for clarity, but do not change which foods are on the FTL. For example, the word “fresh” was added to certain fruit and vegetable commodities to clarify the scope. Similarly, the description for “cheeses, other than hard cheeses” was revised to clarify which cheeses apply, and included examples of such cheeses. A description of the edits is available in the memo “Food Traceability List of ‘Requirements for Additional Traceability Records for Certain Foods’ Proposed Rule – Clarified Language.”
  2. The Agency published an FAQ on the proposed rule to assist stakeholders in providing feedback during the comment period, which was extended until February 22, 2021. Comments can be submitted at https://www.regulations.gov/ Docket ID: FDA-2014-N-0053. Those submitting comments to the proposed rule are encouraged to provide real life examples and details about specific arrangements for consideration.
  • As previously discussed on this blog here and here, FDA’s proposed rule would establish additional traceability requirements for persons who manufacture, process, pack, or hold certain foods designated on the FTL. The proposed requirements would apply to foods listed on the FTL, including certain cheeses, shell eggs, nut butter, various fruits and vegetables, finfish, Crustaceans, Mollusks (bivalves), and ready-to-eat deli salads, as well as foods containing FTL foods. At the core of the proposed rule is a requirement for those who manufacture, process, pack or hold foods on the FTL to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products. FDA encourages the voluntary adoption of these practices industry-wide.
  • As mentioned above, the proposed rule is available for public comment until February 22, 2021. Keller and Heckman attorneys are well-versed in food safety and traceability-related issues and are available to assist interested parties in preparing comments for submission. For assistance, please email: fooddrug@khlaw.com.