When do fruit and vegetable plants have to comply with FSMA 204?

The final rule set a compliance date of January 20, 2026. In August 2025 FDA proposed extending it by 30 months to July 20, 2028 (Federal Register document 2025-14967, 90 FR 38084); that is a proposed rule. Separately, Congress barred FDA from using funds under the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law 119-37, Division B, Sec. 780) to administer or enforce the rule before July 20, 2028, and FDA says it intends to comply with that directive. That is a limit on enforcement, not a change to the rule's compliance date.

Which fresh produce is on the Food Traceability List?

Fresh cucumbers, fresh herbs, fresh and fresh-cut leafy greens, fresh melons, fresh peppers, fresh sprouts, fresh tomatoes, fresh tropical tree fruits, fresh-cut fruits and fresh-cut vegetables. Whole-head cabbages are not covered as leafy greens, and produce listed as rarely consumed raw in 21 CFR 112.2(a)(1), such as dill and collards, is exempt.

Are frozen or IQF fruits and vegetables covered?

Not when the listed form is fresh or fresh-cut. FDA says frozen fresh-cut fruits and vegetables, including IQF, are not covered. A plant that receives a fresh FTL food and freezes it keeps receiving KDEs for the fresh food but no further records for the frozen product.

How fast must records be produced for FDA?

Within 24 hours of a request, or within a reasonable time FDA agrees to. During an outbreak, recall or other public-health threat, FDA can ask for the information as an electronic sortable spreadsheet; certain smaller entities are exempt from the spreadsheet format but must still provide the information.

Does the rule require specific software?

No. Records can be paper or electronic, or true copies, as long as they are legible and stored to prevent deterioration or loss. FDA does not prescribe a technology.

Guide

FSMA 204 food traceability rule explained for fruit and vegetable plants

What the FDA Food Traceability Rule (21 CFR Part 1, Subpart S) requires of plants that pack, process or hold fresh produce on the Food Traceability List, and where the compliance date stands.

By Dan Ghadiri · Updated November 11, 2026 · 8 min read

Key takeaway

FSMA 204, FDA's Food Traceability Rule, requires firms that manufacture, process, pack or hold foods on the Food Traceability List to keep Key Data Elements for each Critical Tracking Event they perform, keep a written traceability plan, and give FDA the records within 24 hours of a request, or within a reasonable time FDA agrees to. The original compliance date was January 20, 2026. FDA has proposed moving it to July 20, 2028, and Congress has directed FDA not to enforce the rule before that date.

The Food Traceability Rule is codified at 21 CFR Part 1, Subpart S, and implements section 204(d) of the FDA Food Safety Modernization Act. FDA published it on November 21, 2022 (87 FR 70910). This guide covers what it asks of fruit and vegetable packers and processors. It is a plain-language summary, not legal advice: check the rule text and FDA's guidance for your own products and operations.

Where the compliance date stands

Original date. The final rule took effect January 20, 2023, with a compliance date of January 20, 2026 (90 FR 38084, background).
Proposed extension, not a final date. On August 7, 2025, FDA published a proposed rule (Federal Register document 2025-14967, 90 FR 38084) to extend the compliance date by 30 months, to July 20, 2028. FDA said the extension would not change the rule's requirements. As of November 11, 2026, the Federal Register docket for the rule (FDA-2014-N-0053) lists the extension as a proposed rule.
No enforcement before July 20, 2028. Section 780 of Division B of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law 119-37, enacted November 12, 2025) says no funds appropriated by that Act may be used to administer or enforce the rule, or any other rule under FSMA section 204, before July 20, 2028. FDA says it intends to comply with this directive (FDA rule page). This limits enforcement; it does not by itself change the rule's compliance date.

In practice, plants have more time, but the requirements themselves are unchanged. Because each firm depends on data from its suppliers and passes data to its customers, FDA has tentatively concluded that a phased approach is not feasible and that everyone in the chain is expected to come into compliance by the same date.

Who is covered

The rule applies to persons who manufacture, process, pack or hold foods on the Food Traceability List, domestic and foreign, unless an exemption in 21 CFR 1.1305 applies (FDA). For a produce plant that usually means the initial packer, the fresh-cut processor, repackers, cold storage and distribution. Two exemptions matter often in processing:

Kill step. If you apply a kill step to an FTL food and keep a record of it, the rule no longer applies to your shipping of that food or to later receivers. A partial exemption also applies when a written agreement says the receiver or a subsequent entity in the supply chain will apply the kill step (FDA FAQ TFTL.10).
Change of form. If a food listed as fresh is frozen, dried or otherwise changed so it is no longer on the list, the changed product is not covered. You still keep receiving KDEs for the incoming fresh FTL food, unless a qualifying written agreement under 21 CFR 1.1305(d)(6) is in place (FDA FAQ TFTL.5 and TFTL.12).

Coverage can start partway down the chain. FDA's example: an orchard selling whole apples is not covered, because whole apples are not on the list; the processor that slices them into fresh-cut fruit keeps transformation and shipping records for the sliced product (FDA FAQ TF.5).

Which produce is on the list

The produce entries on the Food Traceability List (FDA) are:

Cucumbers (fresh)
Herbs (fresh), for example parsley, cilantro and basil
Leafy greens (fresh) and leafy greens (fresh-cut)
Melons (fresh)
Peppers (fresh)
Sprouts (fresh)
Tomatoes (fresh)
Tropical tree fruits (fresh), for example mango and papaya
Fruits (fresh-cut) and vegetables other than leafy greens (fresh-cut)

Whole-head cabbages (green, red, savoy) are not included in leafy greens. Produce listed as rarely consumed raw in 21 CFR 112.2(a)(1), such as dill and collards, is exempt. “Fresh” and “fresh-cut” do not include previously frozen forms. Multi-ingredient foods are covered when a listed ingredient stays in its listed form, such as a bagged salad with fresh lettuce (FDA FAQ TFTL.6).

Critical tracking events

The rule names seven Critical Tracking Events: harvesting; 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 transformation (FDA, FDA At-A-Glance). The Key Data Elements you keep depend on which events you perform. For a packing or processing plant the usual set is:

Receiving FTL foods from suppliers.
Initial packing of a raw agricultural commodity, which includes keeping the harvesting and cooling information passed on by the farm.
Transformation: manufacturing or processing a food, or changing it by commingling, repacking or relabeling, when the output is on the list. Repacking is always a transformation (FDA FAQ TT.2).
Shipping, including intracompany shipments between addresses of the same firm.

Traceability lot codes

You must assign a Traceability Lot Code when you initially pack a raw agricultural commodity other than a food obtained from a fishing vessel, perform the first land-based receiving of a food obtained from a fishing vessel, or transform a food. You must not assign a new one at other events such as shipping (FDA). If you receive an FTL food from an entity that is exempt from the rule, you must assign a TLC if one has not already been assigned, unless you are a retail food establishment or restaurant. The TLC does not have to appear on the label or packaging; it can travel on a bill of lading, an advance shipment notice, a separate email or a QR code (FDA FAQ TTLC.3).

The traceability plan

Under 21 CFR 1.1315, a covered firm keeps a traceability plan that describes (FDA):

How you maintain the required records, including their format and location.
How you identify the FTL foods you manufacture, process, pack or hold.
How you assign traceability lot codes, if you assign them.
A point of contact for questions about the plan and records.
For growers of FTL foods (other than eggs), a farm map with field names and geographic coordinates.

Records and the 24-hour rule

Records can be original paper or electronic records, or true copies, legible and stored to prevent deterioration or loss.
Records, and anything needed to understand them, must reach FDA within 24 hours of a request, or within a reasonable time FDA agrees to.
In an outbreak, recall or other public-health threat, FDA can ask for an electronic sortable spreadsheet. Certain smaller entities are exempt from that format but must still provide the information (FDA FAQ TI.2).
Records are generally kept for 2 years (FDA FAQ TI.6).
FDA cannot fine firms under this rule; violations are prohibited acts under section 301(e) of the FD&C Act (except for farms), and FDA can refuse admission of imported food (FDA FAQ TI.9).

When you compare suppliers of lines or software that will touch lot data, add traceability to the scorecard in our supplier comparison checklist: how lot codes are captured at transformation, and how records are exported.

Key terms

Definitions follow 21 CFR 1.1310 (eCFR), in plain language.

Food Traceability List (FTL): The list of foods for which the additional traceability records are required. It covers the listed foods and foods that contain a listed food as an ingredient, as long as that ingredient stays in the form in which it is listed (for example, fresh).
Critical Tracking Event (CTE): An event in a food's supply chain that triggers a record: harvesting, 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, or transformation.
Key Data Element (KDE): Information tied to a critical tracking event that must be kept, and in some cases passed to the next firm in the chain. The KDEs required depend on which CTE is performed.
Traceability Lot Code (TLC): A descriptor, often alphanumeric, that uniquely identifies a traceability lot within the records of the firm that assigned it. It is assigned at initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel, at first land-based receiving of a food obtained from a fishing vessel, or at transformation, and carried forward at the other events.

Questions

When do fruit and vegetable plants have to comply with FSMA 204?: The final rule set a compliance date of January 20, 2026. In August 2025 FDA proposed extending it by 30 months to July 20, 2028 (Federal Register document 2025-14967, 90 FR 38084); that is a proposed rule. Separately, Congress barred FDA from using funds under the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law 119-37, Division B, Sec. 780) to administer or enforce the rule before July 20, 2028, and FDA says it intends to comply with that directive. That is a limit on enforcement, not a change to the rule's compliance date.
Which fresh produce is on the Food Traceability List?: Fresh cucumbers, fresh herbs, fresh and fresh-cut leafy greens, fresh melons, fresh peppers, fresh sprouts, fresh tomatoes, fresh tropical tree fruits, fresh-cut fruits and fresh-cut vegetables. Whole-head cabbages are not covered as leafy greens, and produce listed as rarely consumed raw in 21 CFR 112.2(a)(1), such as dill and collards, is exempt.
Are frozen or IQF fruits and vegetables covered?: Not when the listed form is fresh or fresh-cut. FDA says frozen fresh-cut fruits and vegetables, including IQF, are not covered. A plant that receives a fresh FTL food and freezes it keeps receiving KDEs for the fresh food but no further records for the frozen product.
How fast must records be produced for FDA?: Within 24 hours of a request, or within a reasonable time FDA agrees to. During an outbreak, recall or other public-health threat, FDA can ask for the information as an electronic sortable spreadsheet; certain smaller entities are exempt from the spreadsheet format but must still provide the information.
Does the rule require specific software?: No. Records can be paper or electronic, or true copies, as long as they are legible and stored to prevent deterioration or loss. FDA does not prescribe a technology.

Sources

FDA, Requirements for Additional Traceability Records for Certain Foods, final rule, 87 FR 70910, November 21, 2022 (FR Doc. 2022-24417). federalregister.gov
FDA, Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension, proposed rule, 90 FR 38084, August 7, 2025 (FR Doc. 2025-14967). federalregister.gov
Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, Public Law 119-37 (H.R. 5371), Division B, Sec. 780, 139 Stat. 558, November 12, 2025. govinfo.gov
21 CFR Part 1, Subpart S, Additional Traceability Records for Certain Foods. eCFR
FDA, FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. fda.gov
FDA, Food Traceability List. fda.gov
FDA, Frequently Asked Questions: FSMA Food Traceability Rule. fda.gov
FDA, The FDA Food Traceability Rule At-A-Glance (March 2025). fda.gov (PDF)

This page summarizes public FDA material for general information. It is not legal advice.