FDA's Final Food Traceability Rule (2022)

Table of Contents

1. What the FDA Did in November 2022
2. The Law Behind It and the Stated Purpose
3. The Foods Covered: the Food Traceability List
4. Critical Tracking Events and Key Data Elements
5. Traceability Lot Codes and the Traceability Plan
6. Handing Records to the FDA Within 24 Hours
7. Who Is Covered and Who Is Exempt
8. How the FDA Chose the Listed Foods
9. What the Rule Does Not Do
10. Dates and Legal Status as of October 18, 2026
11. How It Fits Other FDA Food Safety Actions
12. Primary Documents
13. Key Research Papers
14. Connections
15. Featured Videos

1. What the FDA Did in November 2022

The FDA announced the rule in a constituent update dated November 15, 2022: “Today, the U.S. Food and Drug Administration (FDA) issued a final rule on food traceability designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.”

The rule was published in the Federal Register, the U.S. government’s daily publication of rules and official notices, on November 21, 2022, under the title “Requirements for Additional Traceability Records for Certain Foods” (87 FR 70910–71088, a 179-page document; Docket No. FDA-2014-N-0053; Regulation Identifier Number 0910-AI44). It is a final rule, meaning a binding regulation, not a proposal or guidance. It adds requirements to title 21 of the Code of Federal Regulations, part 1; the FDA’s program page points to the codified text as subpart S, “Additional Traceability Records for Certain Foods.” The Federal Register record states: “This rule is effective January 20, 2023.”

The Federal Register abstract summarizes the action in these words: the FDA is “issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL).” A Federal Register docket is the public file for an action, where its documents and the public comments are kept; this docket had been opened in 2014 and also holds the 2020 proposed rule.

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2. The Law Behind It and the Stated Purpose

The rule carries out a requirement of a federal food safety law. The constituent update states that the rule “implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA)” and calls it “a key component of the FDA’s New Era of Smarter Food Safety Blueprint.” The FDA’s Food Traceability List page explains that Section 204 of FSMA “requires the FDA to designate foods for which additional recordkeeping requirements are appropriate and necessary to protect public health.”

The Federal Register abstract gives the purpose: the requirements “will help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded.”

Traceability here means being able to follow a food step by step through the supply chain — from the farm or fishing vessel, through packers, processors and distributors, to the store or restaurant — so that, when people fall ill, investigators can find where a contaminated batch came from and where else it went. The rule sets out which records make that possible for the listed foods. The FDA program page notes that these requirements are “beyond those in existing regulations,” meaning firms already kept some supply-chain records before this rule.

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3. The Foods Covered: the Food Traceability List

The rule applies only to foods on the FDA’s Food Traceability List. The November 2022 constituent update summarized it: “The FTL includes fresh cut fruits and vegetables, shell eggs, and nut butters, as well as certain fresh fruits, fresh vegetables, ready-to-eat deli salads, cheeses, and seafood products.” The FDA’s list page sets out these categories:

• Cheeses other than hard cheeses: fresh soft or soft unripened cheeses made from pasteurized milk (the FDA’s examples include cottage cheese, cream cheese, ricotta and queso fresco); soft ripened or semi-soft cheeses made from pasteurized milk (such as brie, feta and mozzarella); and all cheeses made from unpasteurized milk other than hard cheeses.
• Shell eggs of the domesticated chicken, including products that contain raw, unpasteurized eggs as ingredients.
• Nut butters, meaning all tree nut and peanut butters in every form; soy and seed butters are not included.
• Fresh produce: cucumbers, herbs (such as parsley, cilantro and basil), leafy greens (such as lettuces, kale and spinach, but not whole-head cabbages), melons (such as cantaloupe, honeydew and watermelon), peppers, sprouts, tomatoes, and tropical tree fruits (such as mango and papaya).
• Fresh-cut produce: fresh-cut leafy greens, fresh-cut fruits, and fresh-cut vegetables other than leafy greens.
• Seafood: finfish (fresh, frozen and previously frozen), including histamine-producing species such as tuna and mackerel, species that can carry ciguatoxin such as grouper and snapper, and others such as cod, salmon and tilapia; smoked finfish; crustaceans such as shrimp, crab and lobster; and bivalve molluscan shellfish such as oysters, clams and mussels, with exemptions for raw shellfish covered by the National Shellfish Sanitation Program and certain other programs.
• Refrigerated ready-to-eat deli salads, such as egg, potato, pasta and seafood salads; meat salads are not included.

The list reaches beyond the listed foods themselves. In the FDA’s words, the requirements apply “to foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list.” The list page also notes that foods for animals are not on the list and are therefore not covered.

The list can change. The FDA page explains that the agency would first publish a proposed update in the Federal Register and ask for comment, then publish a second notice with its decision; additions would take effect two years after that second notice unless stated otherwise, and deletions would take effect immediately. The list page shown today also notes one later change: an exemption, granted in February 2026, for cottage cheese listed under a federal–state milk safety program (section 10).

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4. Critical Tracking Events and Key Data Elements

The core of the rule, according to the constituent update, is “a requirement that persons who manufacture, process, pack or hold food on the FTL maintain records including Key Data Elements (KDEs) related to Critical Tracking Events (CTEs).”

A Critical Tracking Event is a point in the supply chain where the food changes hands or form. The FDA program page lists the events in the final rule:

• Harvesting on farms, removing a raw agricultural commodity from where it is grown or raised;
• Cooling a raw agricultural commodity before initial packing, by methods such as hydrocooling, icing or forced-air cooling;
• Initial packing of a raw agricultural commodity for the first time (other than food from a fishing vessel);
• First land-based receiving of food taken directly from a fishing vessel;
• Shipping a food from one location to another, including shipments between two addresses of the same firm, but not sales directly to a consumer or donations of surplus food;
• Receiving a food after transport, by anyone other than a consumer;
• Transformation, meaning processing or changing a listed food, for example by commingling, repacking or relabeling.

Key Data Elements are the specific pieces of information that have to be recorded at each of these events. The program page explains that the required elements “will vary depending on the CTE that is being performed,” and that firms must keep these elements and pass them on to their supply-chain partners. The FDA published worked examples for several supply chains, including fresh cucumbers, tuna steaks and soft cheese.

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5. Traceability Lot Codes and the Traceability Plan

The thread that ties the records together is the traceability lot code. The FDA program page defines it as “a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.” Under the rule a lot code is assigned when a raw agricultural commodity is first packed, when food from a fishing vessel is first received on land, or when a food is transformed. Other activities, such as shipping, do not create a new code; every later record has to carry the existing code, and all key data elements must be linked to the relevant lot.

Each business covered by the rule must also keep a written traceability plan (section 1.1315 of the rule). The program page lists its contents: a description of how the required records are kept, including their format and location; how the business identifies listed foods it handles; how it assigns lot codes, where that applies; a point of contact for questions; and, for a farm that grows or raises a listed food other than eggs, a farm map showing each field or growing area with geographic coordinates (for aquaculture farms, each pond, tank or cage). The FDA notes that no specific format is required for the plan.

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6. Handing Records to the FDA Within 24 Hours

Speed is the point of the rule. The constituent update states that covered firms and farms, retail food establishments and restaurants “will be required to provide information to the FDA within 24 hours, or some reasonable time to which the FDA agrees.”

The program page adds the details under section 1.1455 of the rule:

• Records may be original paper or electronic records or true copies; they must be legible and stored to prevent deterioration or loss, and electronic records may include working electronic links to the required information.
• All required records, along with any information needed to understand them, must be made available to the FDA within 24 hours of a request, or within a reasonable time the FDA has agreed to.
• Unless exempt from this part, a business must give the FDA an electronic sortable spreadsheet of the relevant tracing information within 24 hours of a request when the FDA needs it to assist during an outbreak, recall or other threat to public health. The FDA has published a template for this spreadsheet, and states that using that specific template is not required.

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7. Who Is Covered and Who Is Exempt

The constituent update states that the rule “covers domestic firms, retail food establishments, restaurants, and farms, as well as foreign firms and farms producing food for U.S. consumption,” and that it “aligns with current industry best practices.” The program page describes the reach as “along the entire food supply chain in the farm-to-table continuum.”

There are full and partial exemptions, listed in section 1.1305 of the rule. The constituent update gives examples: “certain small producers, small retail food establishments and restaurants, farms that sell food directly to consumers, and foods that receive certain types of processing, among others.” The Food Traceability List page notes further exemptions written into the list itself, such as produce items listed in 21 CFR 112.2(a)(1) (the FDA’s examples are dill among herbs, collards among leafy greens, and figs among tropical tree fruits) and pasteurized eggs, which can be fully exempt or fall under the rule’s exemptions relating to kill steps. The FDA published an online question-and-answer tool to help businesses check whether an exemption applies.

The rule also lets the FDA change its own reach. The program page explains that the FDA will modify the requirements for a food or type of business, or exempt it, when it determines the requirements are “not necessary to protect the public health,” and that it may grant waivers where the requirements would cause economic hardship for a business because of its unique circumstances, provided the waiver does not significantly impair tracing and is not contrary to the public interest.

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8. How the FDA Chose the Listed Foods

The FDA’s list page sets out the history. In February 2014 the FDA published a Federal Register notice asking for comments and scientific data on its draft approach to designating high-risk foods for tracing (79 FR 6596). It then built a draft risk-ranking model, collected data for chemical and microbiological hazards associated with specific foods, and had the model and its data reviewed by two panels of independent outside experts. The model was developed with an FDA project advisory group that included members from the FDA and the Centers for Disease Control and Prevention (CDC).

The model scores “commodity-hazard pairs” — the FDA’s example is Shiga toxin-producing E. coli O157 in leafy greens — on seven criteria based on factors Congress named in Section 204(d)(2) of FSMA:

1. frequency of outbreaks and occurrences of illnesses;
2. severity of illness;
3. likelihood of contamination;
4. the potential for pathogen growth, with consideration of shelf life;
5. manufacturing process contamination probability and industry-wide intervention;
6. consumption rate and amount consumed;
7. cost of illness.

Foods with criteria scores in the moderate to strong range were considered for the list. A tentative list was announced with the proposed rule on September 23, 2020 (85 FR 59984), and the comment period on that proposal was extended to February 22, 2021 (85 FR 82393). The FDA has published the model’s results for the listed foods and for every commodity it evaluated.

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9. What the Rule Does Not Do

• It does not change food labels. It is a recordkeeping rule. It requires no consumer-facing code or label statement; the lot codes and records are kept within the supply chain and shown to the FDA on request.
• It does not cover every food. It applies only to foods on the Food Traceability List, and to foods containing a listed food that stays in its listed form. Foods for animals are not covered.
• It does not ban, approve or set safety limits for any food. It governs what records are kept, not what may be sold.
• It is not yet enforced. The original compliance date of January 20, 2026 has been pushed back in practice to July 20, 2028 (section 10). The rule itself has been in effect since January 20, 2023.
• Its requirements have not been changed by the delay. The FDA’s March 2025 update states that “the compliance date extension does not amend, nor do we intend to amend, the requirements of the final rule.”

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10. Dates and Legal Status as of October 18, 2026

• February 4, 2014: the FDA asks for comments and data on designating high-risk foods for tracing (79 FR 6596).
• September 23, 2020: the proposed rule and a tentative Food Traceability List are published (85 FR 59984).
• November 15, 2022: the FDA issues the final rule; it is published on November 21, 2022 (87 FR 70910).
• January 20, 2023: the rule takes effect.
• February 1 and September 26, 2023: the FDA publishes a correction (88 FR 6624) and a technical amendment correcting “some editorial and inadvertent errors” in the final rule (88 FR 65815).
• March 20, 2025: the FDA announces that it intends to extend the compliance date by 30 months. It explains that the rule “requires a higher degree of coordination between members of the food industry than has been required in the past,” and that even firms well positioned to comply by January 2026 had expressed concern, “in part because of their reliance on receiving accurate data from their supply chain partners.”
• August 7, 2025: the FDA proposes the extension in the Federal Register. The proposal states that, if finalized, it “would extend the compliance date by 30 months from January 20, 2026, to July 20, 2028” (90 FR 38084; comments were due September 8, 2025).
• After the August 2025 proposal: Congress, in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026 (P.L. 119-37), “directed FDA not to enforce the Food Traceability Rule prior to that same date,” according to the FDA program page, which adds: “FDA intends to comply with this Congressional directive.”
• February 19–20, 2026: the FDA issues a draft question-and-answer guidance on the rule (91 FR 8243; Docket No. FDA-2025-D-2837; comments to May 21, 2026) and grants an exemption, effective February 20, 2026, for Grade “A” cottage cheese listed under the Interstate Milk Shippers program (91 FR 8256; Docket No. FDA-2024-N-1939). The FDA had proposed that exemption in 2024. Facilities that must register with the FDA and handle that cottage cheese still have to keep records of the immediate previous source and immediate next recipient of the food. The FDA also announces quarterly engagement with farms, restaurants, retailers and warehouses, as Congress directed.
• May 28 and June 15, 2026: the FDA announces, then holds, a public meeting titled “Challenges and Solutions in Lot-Level Food Traceability,” with a discussion paper on possible added flexibilities for meeting the rule’s lot-level tracking requirement (91 FR 31723).
• October 8–9, 2026: the FDA issues draft guidance under which, if finalized, it would not intend to enforce any of the rule’s requirements for retail food establishments and restaurants whose average monetary value of food sold or provided during the previous three-year period is greater than $250,000 but not more than $1 million, adjusted for inflation using 2020 as the baseline year. These are businesses the rule’s own full exemption for small retail food establishments and restaurants did not capture. The Federal Register notice (FR Doc. 2026-20721) takes comments until November 23, 2026. The FDA also announces a second public meeting on lot-level tracing for November 6, 2026 (91 FR 64656).

Status as of October 18, 2026: final rule, in effect since January 20, 2023, but not yet enforced. The FDA has proposed moving the compliance date to July 20, 2028, and Congress has directed the FDA not to enforce the rule before that date. A check of the Federal Register record for the rule’s docket through October 2026 found no final rule adopting the extension, so the July 20, 2028 date rests on the 2025 proposal and the congressional directive, not on a final FDA rule. The rule’s requirements stand as issued in 2022, apart from the 2023 corrections and the 2026 cottage cheese exemption; the October 2026 enforcement policy for smaller retailers and restaurants is a draft.

A guidance document, such as the 2026 question-and-answer draft, explains how the FDA reads and applies a rule. The FDA’s February 2026 update states: “Guidance documents do not impose legally enforceable requirements.”

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11. How It Fits Other FDA Food Safety Actions

The rule is written for the moment an outbreak investigation begins. Several other actions reported on this site show those investigations in practice. In 2022 the FDA investigated infant Cronobacter infections linked to powdered formula from one plant and illnesses linked to a frozen lentil product; in 2023 it investigated a Salmonella outbreak linked to cantaloupe, a melon that is on the Food Traceability List; and in 2025 it investigated an infant botulism outbreak linked to powdered formula.

Among the other 2022 food actions are the proposed rule on the “healthy” nutrient content claim, the draft action levels for lead in juice and the revocation of phthalate uses in food packaging. Three bacteria that cause foodborne illness are described on the site’s Salmonella Typhimurium, Listeria monocytogenes and Escherichia coli pages.

No later FDA page on this site covers the traceability rule; its story after 2022 is the compliance-date delay and the 2026 flexibilities described in section 10.

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12. Primary Documents

1. Food and Drug Administration, HHS (2022). Requirements for Additional Traceability Records for Certain Foods. Final rule. Federal Register 87 FR 70910, November 21, 2022. Docket No. FDA-2014-N-0053 — FR Doc. 2022-24417
2. U.S. Food and Drug Administration. FDA Announces the Final Rule for Food Traceability Under FSMA. Constituent Update, November 15, 2022 — fda.gov constituent update
3. U.S. Food and Drug Administration. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. Program page, content current as of October 8, 2026 — fda.gov Food Traceability Rule page
4. U.S. Food and Drug Administration. Food Traceability List. Program page — fda.gov Food Traceability List
5. Food and Drug Administration, HHS (2020). Requirements for Additional Traceability Records for Certain Foods. Proposed rule. Federal Register 85 FR 59984, September 23, 2020. Docket No. FDA-2014-N-0053 — FR Doc. 2020-20100
6. Food and Drug Administration, HHS (2023). Requirements for Additional Traceability Records for Certain Foods; Technical Amendment. Final rule; technical amendment. Federal Register 88 FR 65815, September 26, 2023. Docket No. FDA-2014-N-0053 — FR Doc. 2023-20746
7. U.S. Food and Drug Administration. FDA Intends to Extend Compliance Date for Food Traceability Rule. Constituent Update, March 20, 2025 — fda.gov constituent update
8. Food and Drug Administration, HHS (2025). Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension. Proposed rule. Federal Register 90 FR 38084, August 7, 2025. Docket No. FDA-2014-N-0053 — FR Doc. 2025-14967
9. U.S. Food and Drug Administration. FDA Takes Several Actions Related to the Food Traceability Rule. Constituent Update, February 19, 2026 — fda.gov constituent update
10. Food and Drug Administration, HHS (2026). Questions and Answers About Requirements for Additional Traceability Records for Certain Foods; Draft Guidance for Industry; Availability. Notice of availability. Federal Register 91 FR 8243, February 20, 2026. Docket No. FDA-2025-D-2837 — FR Doc. 2026-03363
11. Food and Drug Administration, HHS (2026). Requirements for Additional Traceability Records for Certain Foods; Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance. Notification of exemption. Federal Register 91 FR 8256, February 20, 2026. Docket No. FDA-2024-N-1939 — FR Doc. 2026-03362
12. Food and Drug Administration, HHS (2026). Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments. Notice. Federal Register 91 FR 31723, May 28, 2026. Docket No. FDA-2014-N-0053 — FR Doc. 2026-10603
13. U.S. Food and Drug Administration. Food Traceability: FDA Issues Draft Enforcement Discretion Policy for Certain Small Retailers and Restaurants and Announces Public Meeting. Constituent Update, October 8, 2026 — fda.gov constituent update
14. Food and Drug Administration, HHS (2026). Challenges and Solutions in Lot-Level Food Traceability; Public Meeting. Notice. Federal Register 91 FR 64656, October 9, 2026. Docket No. FDA-2014-N-0053 — FR Doc. 2026-20720
15. Public docket FDA-2014-N-0053 — regulations.gov FDA-2014-N-0053

The draft guidance of October 2026 on enforcement for certain retail food establishments and restaurants (FR Doc. 2026-20721) and the FDA’s guidance records for the rule are listed on the FDA’s guidance-documents pages, named here as plain text: “Guidance for Industry: Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants” and “Small Entity Compliance Guide: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation.”

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Key Research Papers

1. Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson MA, Roy SL, Jones JL, Griffin PM (2011). Foodborne illness acquired in the United States—major pathogens. Emerging Infectious Diseases 17(1):7-15 — PubMed PMID: 21192848
2. Bhatt T, Hickey C, McEntire JC (2013). Pilot projects for improving product tracing along the food supply system. Journal of Food Science 78(Suppl 2):B34-9 — PubMed PMID: 24171802
3. Marshall KE, Hexemer A, Seelman SL, Fatica MK, Blessington T, Hajmeer M, Kisselburgh H, Atkinson R, Hill K, Sharma D, Needham M, Peralta V, Higa J, Blickenstaff K, Williams IT, Jhung MA, Wise M, Gieraltowski L (2020). Lessons Learned from a Decade of Investigations of Shiga Toxin-Producing Escherichia coli Outbreaks Linked to Leafy Greens, United States and Canada. Emerging Infectious Diseases 26(10):2319-2328 — PubMed PMID: 32946367
4. Irvin K, Viazis S, Fields A, Seelman S, Blickenstaff K, Gee E, Wise ME, Marshall KE, Gieraltowski L, Harris S (2021). An Overview of Traceback Investigations and Three Case Studies of Recent Outbreaks of Escherichia coli O157:H7 Infections Linked to Romaine Lettuce. Journal of Food Protection 84(8):1340-1356 — PubMed PMID: 33836048
5. Viazis S, Bazaco MC, Blessington T, Seelman Federman SL, Lindsay M, Minor T, Nork B, Mattioli MC, Marshall KE, Wise ME, Weed B, Haendiges J, Gieraltowski L, Nolte K (2025). An Overview of Farm Investigation Findings Associated with Outbreaks of Shiga Toxin-Producing Escherichia coli Infections Linked to Leafy Greens: 2009-2021. Journal of Food Protection 88(7):100542 — PubMed PMID: 40398571
6. Canning M, Bazaco M, Weed B, Birhane MG, Whichard J, Gieraltowski L, Robyn MP, Marshall K, Torres J, Viazis S, Carstens CK, Armstrong M, Schwensohn C (2025). Outbreaks Linked to Melons, United States, 2012-2021. Journal of Food Protection 88(7):100536 — PubMed PMID: 40348087

The first paper estimates how much foodborne illness in the United States is caused by the major known pathogens. The second reports pilot projects on tracing products through the food supply. The remaining four review outbreak and traceback investigations for foods that appear on the Food Traceability List: leafy greens and melons.

PubMed Topic Searches

1. PubMed: food traceability and outbreaks
2. PubMed: traceback investigations of foodborne outbreaks
3. PubMed: Food Safety Modernization Act

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Connections

• FDA Actions of 2022
• FDA and Regulation
• Bacterial Illnesses
• Salmonella Typhimurium
• Listeria Monocytogenes
• Escherichia Coli
• Eggs
• Peanuts
• Watermelon
• Cantaloupe Salmonella Outbreak (2023)
• Infant Botulism Formula Outbreak (2025)
• Infant Formula Recall and Plant Shutdown (2022)
• Illnesses Linked to Frozen Lentil Crumbles (2022)
• “Healthy” Claim Proposed Rule (2022)
• Lead in Juice Draft Action Levels (2022)
• Phthalates in Food Packaging Revocation (2022)

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