FSMA 204 Resources

IFPA Advocacy & Positions on FSMA 204

IFPA has been at the forefront of shaping practical, workable FSMA 204 implementation for the fresh produce and floral supply chain. We strongly support the food safety objectives of the Food Traceability Rule—faster, more accurate traceback and more targeted recalls—while advocating for compliance pathways that reflect how produce actually moves through high-velocity, perishable supply chains. Below is IFPA's public record of comments, proposals, and positions submitted to the FDA, along with recent coverage of the industry's progress.

IFPA Comments & Proposals to FDA

IFPA Comments: FDA Traceability Q&A Guidance — IFPA's formal comments urging FDA to resolve open operational questions—distribution-center implementation, initial-packer determination, cross-docking, and the absence of a data-exchange standard—so the guidance is workable in real produce operations. (Submitted May 20, 2026)
IFPA Comments: Lot-Level Tracking Flexibilities Discussion Paper — IFPA's recommendation that the FDA formally recognize WMS-supported reasonable-range and inferred-TLC methods for distribution-center-to-retail and -restaurant shipments, paired with clear inventory-control guardrails and GS1/PTI-aligned data standards. (Submitted July 15, 2026)
How a WMS Enables End-to-End Traceability — A plain-language explainer of IFPA's proposed alternative method: using a Warehouse Management System to calculate and assign the Traceability Lot Code for last-mile shipments, avoiding costly, error-prone case-by-case scanning. (December 16, 2025)

Regulatory Updates

FDA Extends the Compliance Date — What It Means: FDA has announced its intention to extend the compliance date by 30 months. The extension gives the supply chain additional time to coordinate—but does not change the rule's requirements. IFPA encourages members to keep preparing and to verify customer-specific timelines.

In the News

Opinion: The fresh produce industry has a traceability solution waiting for the FDA's OK (Agri-Pulse)
A big win for produce: Congress backs IFPA's push for practical FSMA 204 traceability (Bluebook Services)

FSMA 204 Explained: The Basics

FDA's FSMA Section 204 Food Traceability Rule is designed to make foodborne-illness investigations dramatically faster—cutting traceback from 5-6 weeks down to just 5-6 days.

Who Is Affected and How It Works

If your company harvests, cools, packs, transforms, ships, or receives food on FDA's Food Traceability List (FTL), you must maintain records at each of these Critical Tracking Events (CTEs). At each CTE, you record specific Key Data Elements (KDEs) and link them to a Traceability Lot Code (TLC) that follows the product through the supply chain.

Term	What It Means
CTE - Critical Tracking Event	A key point where food is handled: harvesting, cooling, initial packing, transformation, shipping, and receiving
KDE - Key Data Elements	The specific information recorded at each CTE—who, what, when, where, how much, and reference document numbers
TLC - Traceability Lot Code	The alphanumeric code that uniquely identifies a production lot and links all records. Only Initial Packing and Transformation can create a TLC; Shipping and Receiving cannot

The Traceability Lot Code Source

The TLC Source is the physical location where the product was packed and assigned its lot code—the packing facility, farm, or ranch—including name, address, and phone number (or an approved alternative such as a GLN or FDA Facility Registration Number). The TLC Source must travel with the product to every subsequent trading partner all the way to the retail store or restaurant, most commonly via an EDI 856 Advance Ship Notice. In an outbreak, FDA uses the TLC Source to contact the exact location where the product was packed.

What Is On the Food Traceability List?

The rule applies to foods on FDA's Food Traceability List (FTL). For fresh produce, this includes leafy greens (including fresh-cut greens), tomatoes, peppers, melons, cucumbers, sprouts, fresh herbs, fresh-cut fruits and vegetables, and tropical tree fruits. Non-produce FTL items include shell eggs, soft cheeses, nut butters, and certain fresh and frozen seafood.

How to Get Started

Create a list of the FTL products your company receives, holds, or ships.
Identify your role-specific CTEs and confirm your inventory or WMS systems can link incoming lots to outbound shipments.
Build the data fields needed to capture and transmit the TLC and TLC Source (most commonly via EDI 856 Advance Ship Notice today).
Implement Produce Traceability Initiative (PTI) standards and the PTI Harmonized Case Label—estimated to cover 90-95% of FSMA 204 data requirements.

Download FSMA 204 Overview Presentation

FSMA 204 applies to all fresh produce items on the Food Traceability List, including imported product from outside the United States. The Final Rule applies to persons (not facilities) who manufacture, process, pack or hold foods that appear on the Food Traceability List or foods that contain a listed food as an ingredient.

Please note that it is expected that the vast majority of buyers will require the Key Data Elements to be shared with them for ALL fresh produce items, not just those items on the FDA Food Traceability List.

The following fresh produce items are included on the Food Traceability List: fresh cucumbers, fresh herbs, fresh leafy greens (including fresh cut leafy greens), fresh melons, fresh peppers, fresh sprouts, fresh tomatoes, fresh tropical tree fruits, all fresh cut fruits, all fresh cut vegetables, ready-to-eat deli salads as well as some seafood, eggs and nut butters.

The traceability lot code assigned at the time of initial packing must be captured, stored and shared through the supply chain from packing all the way to a retail store or foodservice operation/restaurant. As well, the traceability lot code source consisting of the name, address and phone number of the location that the food was packed must be captured, stored and shared through the supply chain from packing to a retail store or food service operation/restaurant.

A common question is “Does FSMA 204 apply to my company?” There are full and partial exemptions for certain entities. FDA have created a tool to determine if your company is exempt.

The Final Rule requires entities to send an electronic sortable spreadsheet to FDA within 24 hours of the FDA notifying them that they are involved in a traceback investigation. The Produce Traceability Initiative volunteer working groups have created a PTI FSMA 204 implementation Guidance Document to assist industry members in complying with FSMA 204 and creating the electronic sortable spreadsheets to send to FDA. They have created sample spreadsheets for each role in the supply chain.

FSMA 204 is applicable to foods listed on the FTL only. However, the major buyers in the U.S. intend to require the same data set for all produce items received. For items not on the Food Traceability List, the Traceability Lot Code Source could be the corporate office contact information rather than the location where the product was packed.

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 and how you assign traceability lot codes to foods on the FTL, if applicable.

A description of how you assign traceability lot codes.

A statement identifying a point of contact for questions regarding your traceability plan and records.

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, including the location and name of each field (or other growing area) in which 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.

You must update your traceability plan as needed to ensure that the information reflects your current practices and to ensure you are compliant with the rule. As well, you must retain your previous traceability plan for two years after you update the plan.

All records required under the rule must be maintained for 2 years from the date they were created and be made available to FDA within 24 hours of a request from FDA via phone, in writing or in person.

Offsite storage of the records is permissible, provided the records can be made available to an FDA representative no later than 24 hours after a request. Electronic records are considered onsite if they are accessible from an onsite location. Electronic records may include electronic links. Records also can be required to be provided in English within a reasonable time if they are maintained in a language other than English. Covered entities may enter into agreements with individuals or firms to create and keep the records required by the rule on their behalf. There is no requirement to create duplicate records or maintain information in a single set.

Countdown to FSMA Compliance

Monthly FSMA Webinar Series

The FSMA Final Rule is aligned with the Produce Traceability Initiative (PTI). All of the Key Data Elements required to be captured, stored and or shared in the Final Rule are incorporated into PTI. The only new Key Data Element is the Traceability Lot Code Source.

The Produce Traceability Initiative created the following resources to assist with the implementation of FSMA 204:

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PTI FSMA 204 Implementation Guidance

This guideline by the PTI FSMA Working Group aids in implementing the FSMA Final Rule on Traceability Records for Specific Foods.

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Guía de Implementación de PTI FSMA 204

Esta guía en español, elaborada por el Grupo de Trabajo de PTI FSMA, ayuda en la implementación de la Regla Final de FSMA sobre Registros de Trazabilidad para Alimentos Específicos.

PTI FSMA 204 Electronic Sortable Spreadsheet Templates

The Final Rule requires that "Firms must provide an electronic sortable spreadsheet containing information FDA requests on CTEs involving particular FTL foods for the date ranges or traceability lot codes specified in our request." The following spreadsheets are a useful tool to determine specific requirements by role.

Harvester/Cooler/Initial Packer/Transformer

Receiver

Shipping icon
Shipping

Final Distribution icon
Final Distributor

Retailer icon
Retail Store

Foodservice Operation / Restaurant

PLU Codes for FTL and Non-FTL Produce

This list differentiates PLU Codes for produce items on the FDA's Food Traceability List and PLUs for non-FTL produce items.

List icon Why and How to Use EDI 856 Advance Ship Notice/Manifest Transaction

This document outlines EDI Advance Ship Notice (ASN) basics, its implementation benefits, and its capability to capture GTIN and Batch/Lot Numbers using a single pallet barcode.

Book icon PTI FSMA 204 Traceability Lot Code Source and Reference Guidance

This guidance, from the PTI FSMA Working Group, aids in understanding Traceability Lot Code (TLC) Source and Source Reference.

List icon GLN Guidance to Support FSMA 204 Implementation

This guideline helps companies in the fruit and vegetable sector and their supply chain partners to understand and share the same information about the unique identification of parties and locations using the GLN (GS1 Global Location Number).