Food traceability connects food lots to supply-chain events, records, and locations so investigators can identify sources more quickly during a safety event. The latest figures span the FDA’s covered-food list, CDC outbreak investigations in 2023, FDA economic models in 2020 dollars, and readiness work reported in 2026. Together, they show both the operational burden and the potential value of faster, narrower traceback.
Contents
- Rule scope, covered foods, and deadlines
- Outbreak and traceback measurements
- Tracking events and required data
- Estimated plans by industry segment
- Modeled costs and benefits
- Digital pilots and implementation readiness
Rule scope, covered foods, and deadlines
The FDA’s current Food Traceability List contains 17 top-level food categories. That count treats the three cheese subcategories and three finfish subcategories as listed entries, as presented in the FDA’s current list (Food Traceability List, current list accessed 2026).
Several categories are divided into distinct entries. The list includes three cheese entries: fresh soft or soft unripened pasteurized-milk cheese, soft-ripened or semi-soft pasteurized-milk cheese, and non-hard cheese made from unpasteurized milk. It also groups finfish into three entries: histamine-producing species, ciguatoxin-potential species, and species not associated with either hazard. FDA separately identifies two leafy-greens categories—fresh leafy greens and fresh-cut leafy greens—and two fresh-cut produce categories covering fruits and vegetables other than leafy greens (Food Traceability List).
The final rule requires covered firms to provide requested traceability information to FDA within 24 hours unless FDA agrees to another reasonable time. The original compliance date for all covered persons was January 20, 2026. FDA’s current implementation page says Congress directed that the rule not be enforced before July 20, 2028, following a proposed 30-month extension (FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods).
The list’s risk-ranking model evaluates commodity-hazard pairs against seven criteria: outbreak frequency, illness severity, contamination likelihood, pathogen growth, process contamination, consumption, and illness cost. This means the list is organized around food-hazard risk factors rather than simply the number of products sold (Food Traceability List).
Outbreak and traceback measurements
CDC investigated 181 possible multistate outbreaks of Salmonella, Shiga toxin-producing E. coli (STEC), Listeria monocytogenes, or Campylobacter during 2023. Of those investigations, 84 were determined to be multistate outbreaks, and investigators solved 50. CDC reported the 50 solved outbreaks as a 60% solve rate among the 84 confirmed multistate outbreaks (Summary of Possible Multistate Enteric Disease Outbreaks in 2023).
The 84 multistate outbreaks caused 3,153 illnesses, 942 hospitalizations, and 10 deaths. The 32 solved foodborne outbreaks in the CDC summary caused 1,219 illnesses, 421 hospitalizations, and 9 deaths. These are CDC figures for the definitions and pathogen scope used in its 2023 summary, not an estimate of every foodborne illness in the United States (Summary of Possible Multistate Enteric Disease Outbreaks in 2023).
Fruits were linked to five solved foodborne outbreaks in 2023, the highest count of any food category in the CDC summary. Those fruit-linked outbreaks accounted for 439 illnesses, 177 hospitalizations, and seven deaths. Vegetable row crops and chicken each accounted for four solved foodborne outbreaks (Summary of Possible Multistate Enteric Disease Outbreaks in 2023).
The median illness count per 2023 multistate outbreak varied by pathogen: 32 for Salmonella, 12 for STEC, 12 for Campylobacter, and five for Listeria. Median values describe the middle outbreak in each pathogen group; they do not represent totals or averages (Summary of Possible Multistate Enteric Disease Outbreaks in 2023).
For a longer historical view, CDC’s latest IFSAC overview analyzed 49,848 illnesses linked to 1,390 outbreaks from 1998 through 2023 when each implicated food was assigned to one category. The 1998–2023 scope and single-category assignment rule matter when comparing this overview with the narrower 2023 multistate summary (Annual Reports on Foodborne Illness Source Attribution Estimates).
Tracking events and required data
The FDA traceability guide identifies seven supply-chain critical tracking events: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, and transformation (Food Traceability Rule: Critical Tracking Events and Key Data Elements). Each event is associated with key data elements that help connect a lot to a product, place, date, or business transaction.
For raw agricultural commodities not obtained from a fishing vessel, the guide lists seven harvesting key-data-element categories and seven cooling categories. Shipping and receiving each have eight key-data-element categories linked to the traceability lot code. The counts describe the categories in FDA’s guide, not the number of individual fields in every firm’s system (Food Traceability Rule: Critical Tracking Events and Key Data Elements).
Transformation creates another recordkeeping link. For transformation inputs, FDA lists three required data categories: the ingredient lot code, the ingredient product description, and the quantity and unit used from each lot. For newly produced foods after transformation, FDA lists seven key-data-element categories, including a new lot code, location, completion date, product description, quantity, and reference-document information (Food Traceability Rule: Critical Tracking Events and Key Data Elements).
Some requirements are especially location-specific. The first-land-based receiver section requires one harvest date range and one set of locations for the fishing trip. The initial-packing section requires one traceability lot code assigned to the packed food. A farm map must identify each produce field or growing area with at least two location fields: geographic coordinates and other needed location information. For aquaculture, the farm map must identify each pond, pool, tank, or cage with at least two location fields of the same general types (Food Traceability Rule: Critical Tracking Events and Key Data Elements).
Traceability documentation also has a retention dimension. FDA’s guide says a firm must retain the previous traceability plan for two years after updating it. That requirement preserves the ability to understand how a plan changed over time (Food Traceability Rule: Critical Tracking Events and Key Data Elements).
Estimated plans by industry segment
FDA’s primary estimate in its final-rule analysis projected the following counts of firms needing a new traceability plan. These are modeled counts, not a census of firms that completed one. The analysis used 2020 dollars (Requirements for Additional Traceability Records for Certain Foods).
| Industry segment | Small firms | Large firms | Primary one-time plan hours |
|---|---|---|---|
| Produce farms | 3,303 | 202 | 10 |
| Shell-egg producers | 1,250 | 9 | 10 |
| Fishing or aquaculture | 998 | 24 | 10 |
| Manufacturing or processing | 3,924 | 36 | 20 |
| Wholesale, distribution, warehouse, or storage | 8,002 | 529 | 20 |
| Non-restaurant retailers | 58,168 | 631 | 0.5 |
| Restaurants | 133,983 | 1,309 | 0.5 |
The largest modeled group was restaurants, with 133,983 small and 1,309 large establishments. Non-restaurant retailers were the next largest, with 58,168 small and 631 large establishments. FDA estimated 3,303 small produce farms and 202 large produce farms, while the primary estimate included 3,924 small manufacturing or processing firms and 36 large firms (Requirements for Additional Traceability Records for Certain Foods).
The assumed one-time planning effort differed substantially by segment. FDA used 10 hours for produce farms, shell-egg producers, and fishing or aquaculture firms; 20 hours for manufacturing or processing firms and wholesale, distribution, warehouse, or storage firms; and 0.5 hours for non-restaurant retailers and restaurants. These are assumptions in the economic analysis, not measured time logs from every firm (Requirements for Additional Traceability Records for Certain Foods).
Modeled costs and benefits
FDA estimated total one-time traceability-plan costs at about $15 million to $345 million, with a primary estimate of about $79 million. One-time training costs were estimated at about $13 million to $409 million, with a primary estimate of about $241 million. The figures are modeled estimates in 2020 dollars, not observed 2026 outcomes (Requirements for Additional Traceability Records for Certain Foods).
The analysis used a 20-year period and tested different discount rates. At a 7% discount rate, annualized final-rule costs ranged from about $63 million to $2.3 billion, with a primary estimate of $570 million per year. At 3%, the range was about $53 million to $2.3 billion, with a primary estimate of $551 million per year.
| FDA modeled measure | 7% discounting | 3% discounting |
|---|---|---|
| Annualized final-rule costs, primary estimate | $570 million | $551 million |
| Annualized monetized health benefits, primary estimate | $780 million | $810 million |
| Annualized benefits from avoiding overly broad recalls, primary estimate | $575 million | Not provided |
At 7% discounting, FDA estimated the 20-year present value of final-rule costs at about $0.7 billion to $24.6 billion, with a primary estimate of about $6 billion. Annualized monetized health benefits were estimated at $59 million to $2.2 billion, with a primary estimate of $780 million. At 3% discounting, annualized health benefits ranged from $61 million to $2.3 billion, with a primary estimate of $810 million (Requirements for Additional Traceability Records for Certain Foods).
FDA’s final-rule analysis modeled an estimated 83% reduction in traceback time for four pathogens. It also estimated annualized benefits from avoiding overly broad recalls at 7% discounting of $233 million to $1.8 billion, with a primary estimate of $575 million. FDA estimated 484,124 covered establishments under the final rule (Requirements for Additional Traceability Records for Certain Foods). The cost, benefit, and time-reduction figures are forecasts from the rule analysis, not observed industry-wide results.
Digital pilots and implementation readiness
An FDA-cited mango traceback comparison illustrates the potential difference between conventional and digital approaches. Identifying the source farm from sliced mangoes took six days, 18 hours, and 26 minutes using the conventional effort described. In the same cited pilot, blockchain tracing of mangoes from farms in Mexico to two North American stores reduced trace time from seven days to 2.2 seconds (Deputy Commissioner Champions More Digital, Transparent Food Safety System). FDA notes this as a cited pilot example; it is not a general industry average.
FDA completed one product-tracing pilot program and released its findings in March 2013. It issued one report to Congress describing product-tracing pilot findings in November 2016 (Food Traceability Rule: Critical Tracking Events and Key Data Elements). These milestones show that traceability testing predates the current implementation schedule.
FDA’s 2026 readiness tabletop exercises tested whether firms could locate records for a specified product and date range and return an electronic sortable spreadsheet within 24 hours. FDA reported that most firms in the exercises responded within 24 hours (FDA Releases Report on Traceability Readiness Tabletop Exercises and Updated FAQS). The result applies to participating exercise firms and does not establish a performance rate for every covered business.
GAO reported that FDA interviewed 20 selected stakeholders in its review of implementation. As of October 2023, GAO reported that FDA had finalized zero documented implementation plans. GAO later reported that FDA submitted one implementation plan to Congress in March 2026 and began developing one internal Product Tracing System in 2024, with completion expected by July 2028 after the compliance extension (Food Safety: FDA Should Finalize Plans to Implement Its Rule to Help Trace Source of Outbreaks).