Is eating spinach risky? Per the FDA, it is risky enough to necessitate tracking the life of a bag of spinach from field to fork. Farmers and food distributors will be required to participate in data collection at several stages of production to allow the FDA to trace the origin of fresh produce in the case of an outbreak. This is all outlined in the newly published Food Traceability Final Rule.
The FDA first proposed this rule in the fall of 2020, and they have since responded to 573 comments left by farmers, food safety experts, and others in the industry. Some of those comments sparked changes in the final rule.
One farm-related improvement to the final rule aims to lessen the technological burden on small farms. The proposed rule required an electronic, sortable spreadsheet holding traceability data to be delivered to the FDA within 24 hours in the case of a recall or outbreak investigation. While that wouldn’t necessarily require tech-based traceability solutions, it would be difficult for a farm to transpose voluminous paper records into a sortable spreadsheet within 24 hours if required because of an investigation.
The final rule retains the requirement that most farms and facilities provide an electronic, sortable spreadsheet within 24 hours of the request. However, farms grossing $250,000/year or less are exempt from this specific part of the rule. The FDA will also withdraw a request for an electronic spreadsheet based on the religious beliefs of the farmer.
The FDA also down-shifted some of the data required by the proposed rule. Initially, the FDA proposed requiring growers to record the specific growing area coordinates for each lot of food they harvested. Especially for vegetable farms that rotate crops, this requirement would necessitate investment in GPS technology and frequent management to keep accurate records.
The FDA responded to comments on this topic by removing the lot-specific coordinate requirement and replacing it with a farm map requirement. This map will have to include geographic coordinates and other information needed to identify each field and growing area of the farm. Otherwise, the map will be a static document used as a reference (in conjunction with harvest records) in the case of a recall or outbreak investigation.
Other parts of the rule limit its applicability to some farmers. Notably, the rule only covers produce deemed “high risk” by the FDA, all of which are listed in the Food Traceability List (FTL). Farms that are not covered under the Produce Safety Rule (less than $29,245/year of produce sold, on average, over a three-year period) are also exempt. The traceability rule does not cover any food a farm sells or donates direct-to-consumer.
There is a lot to figure out across the food supply chain about how data will be transferred from farm to final destination. This post focuses on the impact on farms, but food hubs and small food distributors will arguably feel a more significant impact from this rule than farms.
The FDA is offering an informational webinar on December 7th and has promised to issue a Small Entities Compliance Guide in the next six months. Compliance isn’t required until January 20, 2026, but players in the food system will need at least that much time to determine strategies for making this system-wide traceability scheme possible.