FSMA 204 for Canadian Food Exporters: Building a Traceability Plan Before July 2028

If your company exports food to the United States, a rule you may have filed under not yet is about to demand real work. FDA's Food Traceability Rule, known as FSMA 204, sets detailed record-keeping requirements for a specific list of higher-risk foods. It applies to foreign firms, including Canadian producers, processors, and distributors that make food for US consumption. The headline that lets many exporters relax, a compliance date pushed to 2028, is also the reason to start now.

FDA has proposed extending the compliance date by 30 months, from 20 January 2026 to 20 July 2028, and Congress has directed FDA not to enforce the rule before that date. That gives Canadian exporters a defined planning window rather than a reprieve. Building the traceability records this rule requires takes time, coordination across suppliers, and changes to how lot codes travel through the supply chain. This article explains what FSMA 204 requires, how it differs from Canada's own traceability rules, and how to build a traceability plan before the deadline.

Executive summary

FSMA 204 is the most detailed food traceability rule US importers have faced, and it reaches back to their foreign suppliers. Canadian exporters of listed foods will be asked to supply lot-level records that follow a product through defined supply-chain events. The compliance date is being moved to 20 July 2028, which is a planning window, not a pause.

Scope: foods on FDA's Food Traceability List, and foods that contain them as ingredients.
Reach: domestic and foreign firms producing food for US consumption, across the whole supply chain.
Core duty: capture Key Data Elements at Critical Tracking Events and keep a written traceability plan.
Speed: provide records, including an electronic sortable spreadsheet, within 24 hours of an FDA request.
Timeline: compliance proposed for 20 July 2028, with Congress directing no enforcement before that date.

What is FSMA 204?

FSMA 204 is the short name for FDA's final rule, Requirements for Additional Traceability Records for Certain Foods, which implements Section 204(d) of the Food Safety Modernization Act. FDA published it in November 2022. It requires anyone who manufactures, processes, packs, or holds foods on the Food Traceability List to keep additional records that let FDA trace those foods quickly through the supply chain during an outbreak or recall.

The rule was published on 21 November 2022, became effective on 20 January 2023, and set an original compliance date of 20 January 2026, three years after the effective date. The goal is faster, more accurate tracebacks. When contaminated food reaches the market, investigators often lose days reconciling paper records and mismatched lot codes. FSMA 204 standardises the data so a product can be followed from the farm or vessel to the store.

When is the FSMA 204 compliance date?

FDA has proposed to extend the compliance date by 30 months, to 20 July 2028, and Congress directed FDA not to enforce the rule before that date. FDA has stated it intends to comply with that direction. Treat 20 July 2028 as the working deadline, while recognising that the compliance date extension is still being finalised. Older FDA web text in places still refers to the January 2026 date, so verify against the current notice rather than legacy pages.

Milestone	Date	Note
Final rule published	21 November 2022	Implements Section 204(d) of FSMA
Rule effective	20 January 2023	Start of the three-year clock
Original compliance date	20 January 2026	Three years after the effective date
Proposed extended compliance date	20 July 2028	FDA proposed a 30-month extension; Congress directed no enforcement before this date

Does FSMA 204 apply to Canadian companies?

Yes. FDA states that the rule covers domestic, as well as foreign firms producing food for US consumption, along the entire food supply chain in the farm-to-table continuum. A Canadian grower, processor, packer, or distributor that handles a Food Traceability List item destined for the US market is a covered entity. In practice, the pressure often arrives through your US customer, who needs your records to meet their own obligation.

Canadian growers and packers of leafy greens, herbs, cucumbers, peppers, tomatoes, melons, and sprouts.
Fish and seafood exporters handling finfish, crustaceans, and molluscan shellfish.
Cheese makers producing fresh soft, soft ripened, or semi-soft cheeses.
Processors of fresh-cut produce, nut butters, shell eggs, and refrigerated ready-to-eat deli salads.
Distributors and importers who receive, transform, or ship any of these foods.

What the rule requires: KDEs, CTEs, and a traceability plan

The rule is built on three ideas. Critical Tracking Events (CTEs) are the points in the supply chain where you must keep records. Key Data Elements (KDEs) are the pieces of information you record at each event. A traceability lot code ties the records together so FDA can follow a specific lot from one event to the next.

The Critical Tracking Events are harvesting, cooling before initial packing, initial packing of a raw agricultural commodity, first land-based receiving of a food obtained from a fishing vessel, shipping, receiving, and transformation. A traceability lot code is assigned at initial packing, first land-based receiving, or transformation, and it must be linked to the Key Data Elements at each later event. Key Data Elements include the traceability lot code, a product description, the quantity and unit, and location identifiers for where events happened.

On top of the event records, the rule requires a written traceability plan under 21 CFR 1.1315, plus the ability to give FDA your records, including an electronic sortable spreadsheet, within 24 hours of a request. Many Canadian plants already struggle with lot traceability inside the warehouse, which is exactly where FSMA 204 gaps tend to appear.

Traceability plan element	What it must describe
Record-keeping procedures	How and where traceability records are kept, including their format and location
Food identification	Procedures to identify which Food Traceability List foods you handle
Lot code assignment	How traceability lot codes are assigned, when that applies to you
Point of contact	A named contact for questions about the plan and the records
Farm map, for growers	For those who grow or raise a listed food, a map of the areas of growth or raising

Which foods are covered: the Food Traceability List

FSMA 204 does not apply to all foods. It applies only to foods on FDA's Food Traceability List, and to foods that contain a listed food as an ingredient when the listed food stays in the same form. The list targets foods associated with higher outbreak risk.

Fresh leafy greens and fresh-cut leafy greens.
Fresh herbs, cucumbers, peppers, tomatoes, melons, sprouts, and tropical tree fruits.
Fresh-cut fruits and fresh-cut vegetables other than leafy greens.
Shell eggs, nut butters, and certain cheeses that are not hard cheeses, including fresh soft, soft ripened, and semi-soft cheeses.
Finfish, including smoked finfish, crustaceans, and molluscan shellfish (bivalves).
Refrigerated ready-to-eat deli salads.

Hard cheeses such as cheddar and parmesan are excluded, and some foods are carved out by footnote, so confirm your exact products against the current list rather than assuming. Because the list reaches ingredients, a listed food used inside another product can pull that product into scope.

FSMA 204 is not the same as the SFCR

Canadian exporters already keep traceability records under the Safe Food for Canadians Regulations (SFCR), which require one step back and one step forward traceability. That is a strong base, but it is not the same as FSMA 204. The US rule is more granular: it ties specific Key Data Elements to specific Critical Tracking Events and follows a traceability lot code through the chain. Meeting the SFCR does not automatically meet FSMA 204, and an exporter usually needs to satisfy both.

Feature	SFCR traceability (Canada)	FSMA 204 (US FDA)
Scope	All SFCR-regulated foods	Foods on the Food Traceability List and foods containing them
Core requirement	One step back and one step forward records	Key Data Elements tied to Critical Tracking Events, linked by a traceability lot code
Records to the regulator	Provide on request	Within 24 hours, including an electronic sortable spreadsheet when requested
Written plan	Preventive control plan and traceability records	A written traceability plan under 21 CFR 1.1315

Recent FDA activity: lot-level meeting and small-business flexibility

On 6 November 2026, FDA held a virtual public meeting titled Challenges and Solutions in Lot-Level Food Traceability, to discuss implementation and possible flexibilities for lot-level tracking. FDA is also considering a draft enforcement discretion policy for certain small retail food establishments and restaurants. These steps refine how the rule will operate, but they do not remove the core obligations for exporters of listed foods. The public comment period for the meeting runs to 6 December 2026.

Compliance checklist

Confirm which of your products, including ingredients, are on the Food Traceability List.
Map your Critical Tracking Events: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, and transformation.
Decide where traceability lot codes are assigned and how they travel through your operation.
List the Key Data Elements to capture at each event and confirm your systems can record them.
Write the traceability plan with all five required elements under 21 CFR 1.1315.
Build the ability to produce an electronic sortable spreadsheet of relevant records within 24 hours.
Align lot codes and data with your US customers and your own suppliers, one step back and one step forward.
Run a mock traceback to test whether your records actually connect across events.

Common mistakes to avoid

Assuming the SFCR already covers FSMA 204. The US rule is more granular and lot-code driven.
Treating 2028 as far away and leaving supplier data alignment until the last year.
Missing ingredient scope: a listed food inside another product can pull that product into the rule.
Keeping records that cannot be exported as a sortable spreadsheet within 24 hours.
Relying on old FDA web text that still cites the January 2026 date instead of the current notice.
Writing a traceability plan but never testing it with a mock traceback.

Frequently asked questions

Does FSMA 204 apply to Canadian food companies?

Yes. The rule covers foreign firms that produce food for US consumption. A Canadian producer, processor, packer, or distributor that handles a food on the Food Traceability List destined for the US is a covered entity.

What is the FSMA 204 compliance date?

FDA proposed extending it by 30 months to 20 July 2028, and Congress directed FDA not to enforce before that date. Plan your work around 20 July 2028, and confirm the final notice as it is published.

What are Key Data Elements and Critical Tracking Events?

Critical Tracking Events are specific supply-chain events such as harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, and transformation. Key Data Elements are the pieces of information you record at each event, such as the traceability lot code, product description, quantity, and location identifiers.

Which foods are covered by FSMA 204?

Only foods on FDA's Food Traceability List and foods that contain them as ingredients. The list includes fresh leafy greens, fresh-cut produce, certain soft cheeses, shell eggs, nut butters, cucumbers, herbs, melons, peppers, sprouts, tomatoes, tropical tree fruits, finfish, crustaceans, molluscan shellfish, and refrigerated ready-to-eat deli salads.

How fast must records be provided to FDA?

Within 24 hours of a request, or a reasonable time FDA agrees to. When needed for an outbreak, recall, or other threat, you may have to provide an electronic sortable spreadsheet of the relevant traceability information within 24 hours.

Is FSMA 204 the same as the SFCR traceability rule?

No. The Safe Food for Canadians Regulations require one-step-back and one-step-forward traceability for SFCR foods. FSMA 204 is more detailed, tying Key Data Elements to Critical Tracking Events at the lot level for listed foods. An exporter typically needs to meet both.

How MFLRC can help

MFLRC helps Canadian food exporters turn FSMA 204 into a clear, auditable plan. We run a gap assessment that maps your SFCR traceability against FSMA 204, so you can see exactly where the US rule asks for more. We help you map Critical Tracking Events, design how your traceability lot codes travel, write the traceability plan under 21 CFR 1.1315, and build the ability to produce a sortable spreadsheet within 24 hours. We also pair this work with FSVP readiness for your US importers and mock recall exercises that test whether your records actually connect across events. The result is one US-ready food exporter package rather than three disconnected projects.

Book a FSMA 204 Readiness Consultation

Conclusion

FSMA 204 is coming, and it reaches Canadian exporters through the US customers who depend on their records. The proposed 20 July 2028 compliance date is not a reason to wait. It is a window to confirm scope, map events, align lot codes, write the plan, and test it with a mock traceback. Exporters who use that window will meet the rule calmly and keep their US business. Those who wait will scramble when a customer asks for records they cannot produce in 24 hours.