Fundamental Questions & Answers About FSMA 204

On November 7, 2022, the FDA published the much-anticipated final version of the Food Traceability Rule, also known as FSMA 204. Proactive manufacturing companies are taking the initiative to get their processes and paperwork in order before audits subject to FSMA 204 begin.

We sat down with Dr. Liliana Casal-Wardle, Executive Senior Director of Food Safety & Supply Chain Risk Management at TAG, where she detailed what FSMA 204 changes had occurred, what's needed for building up your food safety culture and data tracing processes to meet 204 compliance, AND how this helps to drive down costs while driving productivity up.

In this blog, we’ll answer common questions about FSMA 204 and supply chain traceability to help you get your entire global supply chain ready for compliance audits.

When does FSMA 204 compliance take effect?

The FSMA 204 compliance date is January 20, 2026. Food manufacturers are highly encouraged to start preparing now to ensure their processes — and their supplier’s processes — align with the supply chain traceability requirements for FSMA 204.

Who does the FSMA 204 apply to?

The FSMA 204 applies to persons who manufacture, process, pack, or hold foods that appear on the Food Traceability List (FTL). The FTL includes, but is not limited to, soft cheeses, eggs, nut butters, finfish, crustaceans, bivalve mollusks, ready-to-eat deli salads, or fresh fruit or vegetables.

To develop the Food Traceability List, FDA developed the Risk-Ranking Model for Food Tracing (RRM-FT), a data-driven, science-based decision support tool. The semi-quantitative risk-ranking model scores food-hazard pairs according to data and seven criteria. Manufacturers can take advantage of the RRM-FT to help them better understand why their foods are considered high-risk and pinpoint how to minimize this risk.

The seven criteria for the FDA’s Risk-Ranking Model for Food Tracing are:

1. Frequency of Outbreaks and Occurrence of Illnesses

2. Severity of Illness

3. Likelihood of Contamination

4. Growth Potential, with Consideration of Shelf Life

5. Manufacturing Process Contamination Probability and Industry-wide Intervention

6. Consumption

7. Cost of Illness

What is required for FSMA 204 compliance?

Entities subject to FSMA 204 are required to keep records of Key Data Elements and a Food Traceability Plan. Furthermore, they must be able to supply this information to the FDA within 24 hours upon request.

Records of Key Data Elements

Manufacturers must maintain records of Key Data Elements (KDEs) that are associated with Critical Tracking Events (CTEs).

CTEs are events in the supply chain of a food that involve its harvesting, cooling (before initial packing), initial packing of a RAC other than food obtained from a shipping vessel, first land-based receiving of food obtained from a fishing vessel, shipping, receiving, or transformation of the food.

The KDEs that must be recorded with respect to the CTEs are specific to their CTE, but may include traceability lot codes; product descriptions, quantities, and units of measure; dates the food was received, shipped, harvested, cooled, packed, and transformed; location description or where activities occurred; and reference document types and reference document numbers.

Food Traceability Plan

Additionally, manufacturers must maintain a Food Traceability Plan. Your Food Traceability Plan must remain current and updated, and you must retain your previous Food Traceability Plan for 2 years after you update the plan.

Specifically, your Food Traceability Plan must include the following information to be compliant with FSMA 204:

• Your point of contact for questions regarding your traceability plan and records

• A description of how you create and maintain records for your Food Traceability Plan, including the format and location of your records

• A description of how you identify which of the foods that you manufacture, process, pack, or hold are subject to the Food Traceability List

• A description of how you assign traceability lot codes to foods on the Food Traceability List in accordance with § 1.1320, if applicable

• A farm map is required if you grow or raise a food on the Food Traceability List (other than eggs). The farm map must clearly identify the name and location of each growing area through geographic coordinates and any other information needed to identify the location of each growing area. For aquaculture farms, the farm map must show the location and name of each container (pond, pool, tank, cage, etc.) in which you raise seafood, including geographic coordinates and any other information needed to identify the location of each container.

How can we ensure our international suppliers are compliant with FSMA 204?

Companies with global supplies have their work cut out for them. Your suppliers may not have the same rules and regulations in their countries, so it’s essential that you communicate effectively to thoroughly understand their key drivers, processes, and how they manage their supply chain.

Some questions that you may want to ask to assess the food safety culture of your international apply chain include:

• Who are their suppliers?

• What requirements do they need to fulfill for their suppliers?

• How do they monitor their suppliers?

• How do your suppliers manage traceability?

Once you open a line of communication, you’ll need to align your supply chain requirements with what your suppliers are doing and assess whether their processes are sufficient for FSMA 204.

One of the best methods for assessing the maturity of your food safety culture for your entire global supply chain is to conduct mock exercises to see if you and your suppliers would be able to respond to requests from the FDA within 24 hours as required by FSMA 204.

Future-proof Your Supply Chain Traceability Plan for FSMA 204 Compliance

FSMA 204 makes supply chain traceability more essential than ever for food manufacturing companies. Now that you have the answers to fundamental questions regarding FSMA 204 compliance, it’s time to dive into the details.

Watch Liliana's presentation to discover tips to prepare for FSMA 204 audits from TAG’s Executive Senior Director of Food Safety & Supply Chain Risk Management, Dr. Liliana Casal-Wardle.

In addition, SafetyChain has created a free guide to walk you through specifics of the Food Traceability Rule, the Food Traceability List, exemptions to the Food Traceability Rule, and get you on the right path to figure out how to start planning for FSMA 204 compliance today.

Read our free Guide: The Finalized FDA Food Traceability Rule to learn more.

About the Author

Dr. Liliana Casal-Wardle is the Executive Sr. Director of Food Safety at The Acheson Group. She holds over 25 years experience in Food Safety, Food Safety Culture, Food Science, Food Defense, Cleaning & Sanitation practices, Environmental Microbiological Monitoring Programs, GFSI requirements and Quality Assurance, amongst others. Liliana is also a certified SQF Practitioner and a FSM