From Records to Readiness: A Practical Path to FSMA 204

FSMA 204 brings new record-keeping requirements to foods on the FDA Food Traceability List, but the path to readiness is broader than a single compliance project.

In this episode, Liz Sertl chats with Hilary Thesmar, Chief Science Officer and Senior Vice President, Food Safety, at FMI. Hilary explains how critical tracking events (CTEs) and key data elements (KDEs) fit into the rule, why each supply chain participant is responsible for its own records, and why companies need to be ready to provide FDA with an electronic sortable spreadsheet within 24 hours when records are requested. She also outlines practical first steps: form a cross-functional team, assess current systems and data, align around GS1 Standards, begin with ready suppliers and a small set of products, then expand as the process proves out.

The conversation also covers data quality, warehouse and inventory system changes, supplier readiness, exception handling, and business uses for better traceability data, from returns and invoicing to labor and inventory visibility. It closes with a look at where AI may help future traceability work and Hilary's favorite use of AI outside the office.

In this episode, you'll learn:

• How FSMA 204 makes each company responsible for traceability records tied to its own critical tracking events and key data elements.

• Why cross-functional coordination across IT, master data, food safety, regulatory, legal, suppliers, and customers matters for readiness.

• How better traceability data can support returns, invoicing, inventory management, labor review, and supply chain visibility.

Things to listen for:
(00:00) Introducing Next Level Supply Chain

(01:07) Hilary's background and FMI's work on FSMA 204

(02:00) What FSMA 204 is and its path from 2010 legislation to the 2022 final rule

(05:53) The foodborne illness outbreaks that led to the traceability rule

(09:57) Why the 2028 compliance date is closer than it feels

(10:54) The cross-functional lift required to prepare for compliance

(13:03) How key data elements and critical tracking events work together

(15:55) How GS1 US standards help map key data elements

(19:15) Why starting small with a few suppliers and categories matters

(22:53) Best practices for prioritizing normal processes over exceptions

(25:54) Why progress matters more than perfection ahead of 2028

(29:03) The ROI and efficiencies available beyond compliance

(32:08) Hilary's favorite technology and what she wants to learn next

Connect with GS1 US:
Our website - www.gs1us.org
GS1 US on LinkedIn

Connect with the guest:
Hilary Thesmar on LinkedIn
Visit FMI at https://www.fmi.org/