An intro to the FDA's Food Traceability Rule, the compliance deadline, and the list of foods covered – from fruits and vegetables to dairy and seafood
In November 2022, the U.S. Food and Drug Administration ("FDA") finalized a rule imposing additional recordkeeping requirements for certain foods to "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" (the "Food Traceability Rule"). 21 C.F.R. §§ 1.1300 et seq. It is an important set of requirements to become familiar with, and each entity in the supply chain of one of the foods (or an ingredient in one of the foods) on the list below needs to be aware of whether these requirements apply to them and how.
The regulations are a bit confusing and use a lot of new acronyms and terms; this advisory is intended to provide a high-level overview to introduce folks to the rule. Please reach out to a food regulatory attorney or consultant if you have questions about whether (and how) the rule applies to you.
When Do I Need to Come Into Compliance?
The compliance date for all persons subject to the Food Traceability Rule is Tuesday, January 20, 2026. Although that date is just under two years away, putting all of these procedures into place will take time, and we recommend starting to work on this sooner than later.
What Foods Fall Within the Rule?
The Food Traceability Rule applies to foods on the FDA's Food Traceability List ("FTL"), including both the foods specifically listed and foods that contain the 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 FTL may be amended from time to time. The current FTL is as follows (referred to herein as "Covered Food"):
- Cheeses, other than hard cheeses (see FTL for more specifics)
- Shell eggs
- Nut butters
- Cucumbers (fresh)
- Herbs (fresh)
- Leafy greens (fresh)
- Leafy greens (fresh-cut)
- Melons (fresh)
- Peppers (fresh)
- Sprouts (fresh)
- Tomatoes (fresh)
- Tropical tree fruits (fresh)
- Fruits (fresh-cut)
- Vegetables other than leafy greens (fresh-cut)
- Finfish (fresh and frozen) (see FTL for more specifics)
- Smoked finfish (refrigerated and frozen)
- Crustaceans (fresh and frozen)
- Molluscan shellfish, bivalves (fresh and frozen)
- Ready-to-eat deli salads (refrigerated)
Who Is Subject to the Rule?
The Food Traceability Rule's requirements apply to persons who manufacture, process, pack, or hold foods that appear on the FTL, and although that language may remind you of FDA Food Facility Registration requirements (as it should), the requirements of the Food Traceability Rule require participation from entities that may not qualify as "food facilities" (e.g., a farm). There are numerous exemptions from this rule – if your supply chain involves one of the foods on the FTL, it is worth reviewing the list of exemptions to determine if one applies.
What Activities Are Covered by the Rule?
Certain records are required to be kept upon harvesting a Covered Food, cooling before initial packing, initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel, first land-based receiving of a food obtained from a fishing vessel, shipping, receiving, and transforming food. These are referred to in the rule as "critical tracking events."
What General Records Must I Keep if I'm Subject to the Rule?
Anyone who manufactures, processes, packs, or holds food that appears on the FTL must establish a "traceability plan" that includes, among other things, a description of the procedures you use to maintain the required records (including the format and location of the records); a description of the procedures you use to identify foods on the FTL that you manufacture, process, pack, or hold; a description of how you assign "traceability lot codes" to foods on the FTL; and a statement identifying a contact person for questions regarding the traceability plan and records.
What Specific Information Must I Gather and Keep?
The specific information that must be gathered and kept depends on the particular activity being conducted on the food at that time. For example:
- when a food that is or will go into a Covered Food is harvested, information such as the following must be kept (this is not an exhaustive list): the commodity and, if applicable, the variety of the food; the quantity and unit of measure; the location description for where the food was harvested; for produce, the name of the field or other growing area from which the food was harvested; the date of harvesting; and, the reference document type and reference document number (defined in the regulations); and,
- when food is transformed into a Covered Food, the final Covered Food must have the following information kept about it: the quantity and unit of measure; the new traceability lot code (defined in the regulations); the product description for the food; the date transformation was completed; the location description for where you transformed the food (i.e., the traceability lot code source) and (if applicable) the traceability lot code source reference; and, the reference document type and reference document number for the transformation event.
The FDA's webpage on the Food Traceability Rule contains a number of resources, including a Small Entity Compliance Guide to assist in understanding the rule.
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