Food Defense

What foods are subject to the FSMA 204 rule?

February 7, 2024 | 2 Min Read

The FSMA’s Section 204 Food Traceability List (FTL) designates the initial foods subject to enforcement. Be sure to bookmark out page, as the list will evolve over time.

The FTL identifies the foods for which the additional traceability records are required. The additional recordkeeping requirements apply to the foods specifically listed on the FTL, and to foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list.

In February 2014, the FDA issued a Federal Register notice to solicit comments on the draft approach for developing a list of high risk foods. Taking into consideration the comments and other information submitted, the FDA developed a draft risk-ranking model (“the Model”) and collected data to populate the Model for chemical and microbiological hazards associated with specific foods, with technical assistance from external expert panels. Two peer-review panels of independent external experts reviewed the draft Model and the types of data used to generate risk scores with the model, respectively. The FDA refined the Model and updated the data, taking into consideration comments from the peer reviews.

If you have questions regarding food traceability or the FSMA, check out this previous article on those topics.

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