FDA Issues Small Entity Compliance Guide for Traceability Rule

FDA issued its Small Entity Compliance Guide for the Requirements for Additional Traceability Records for Certain Foods. "This guidance document is intended 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 regulations are binding and have the full force and effect of law."

The compliance date is Jan 20, 2026.

The certain food items are those listed on the FTL (Food Traceability List).

Food Traceability List | FDA

• Cheeses, other than hard cheeses, specifically:  
• Cheese (made from pasteurized milk), fresh soft or soft unripened
• Cheese (made from pasteurized milk), soft ripened or semi-soft
• Cheese (made from unpasteurized milk), other than hard cheese[1]
• Shell eggs Shell egg means the egg of the domesticated chicken.
• Nut butters
• Cucumbers (fresh) Includes all varieties of fresh cucumbers.
• Herbs (fresh) Includes all types of fresh herbs. Examples include, but are not limited to, parsley, cilantro, and basil. Herbs listed in 21 CFR 112.2(a)(1), such as dill, are exempt from the requirements of the rule under 21 CFR 1.1305(e).
• Leafy greens (fresh) Includes all types of fresh leafy greens. 
• Leafy greens (fresh-cut) Includes all types of fresh-cut leafy greens, including single and mixed greens.
• Melons (fresh) Includes all types of fresh melons. 
• Peppers (fresh) Includes all varieties of fresh peppers.
• Sprouts (fresh) Includes all varieties of fresh sprouts (irrespective of seed source), including single and mixed sprouts. 
• Tomatoes (fresh) Includes all varieties of fresh tomatoes.
• Tropical tree fruits (fresh) Includes all types of fresh tropical tree fruit. 
• Fruits (fresh-cut) Includes all types of fresh-cut fruits. 
• Vegetables other than leafy greens (fresh-cut) Includes all types of fresh-cut vegetables other than leafy greens. 
• Finfish (fresh and frozen), specifically:  
• Finfish, histamine-producing species
• Finfish, species potentially contaminated with ciguatoxin
• Finfish, species not associated with histamine or ciguatoxin
• Smoked finfish (refrigerated and frozen) Includes all types of smoked finfish, including cold smoked finfish and hot smoked finfish.[4]
• Crustaceans (fresh and frozen) Includes all crustacean species. 
• Molluscan shellfish, bivalves (fresh and frozen)[5]
• Ready-to-eat deli salads (refrigerated)

There is an entire list of full and partial exemptions and what is required for each.  Each operation will need to determine what actions are required based upon the specific applications.

But for those subject to the Rule, these are the requirements?

What Traceability Plan Must I Have for Foods on the FTL that I Manufacture, Process, Pack, or Hold? (§ 1.1315) If you are subject to the requirements of the Food Traceability Rule, you must establish and maintain a traceability plan containing the following information: 

1. A description of the procedures you use to maintain the records you are required to keep under the Food Traceability Rule, including the format and location of these records; 
2. A description of the procedures you use to identify foods on the FTL that you manufacture, process, pack, or hold; 
3.  A description of how you assign traceability lot codes to foods on the FTL in accordance with § 1.1320, if applicable; 
4.  A statement identifying a point of contact for questions regarding your traceability plan and records; and 
5.  If you grow or raise a food on the FTL (other than eggs), a farm map showing the areas in which you grow or raise such foods. The farm map must show the location and name of each field or other growing area where you grow a food on the FTL, including geographic coordinates and any other information needed to identify the location of each field or growing area. For aquaculture farms, the farm map must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the FTL, including geographic coordinates and any other information needed to identify the location of each container