Trustwell Leaders Speak at FDA Public Meeting on Lot-Level Traceability and FSMA 204 

The FDA continues to engage closely with the food industry as companies work toward successful implementation of the Food Traceability Rule under FSMA 204. On June 15, 2026, the agency hosted a virtual public meeting, “Challenges and Solutions in Lot-Level Food Traceability,” to gather feedback from industry stakeholders on implementation challenges, lot-level tracking, and potential flexibilities for compliance before the 2028 deadline.

The meeting brought together representatives from across the food supply chain to discuss what is working, where gaps remain, and how industry and regulators can continue moving traceability forward in practical, scalable ways.

Trustwell was represented by two members of its leadership team with deep experience in food traceability: Katy Jones, CEO, and Julie McGill, Vice President of Supply Chain Strategy and Insights, speaking as chair of the AIM North America Food Supply Chain Work Group and member of the AIM North America board.

FDA Focuses on Practical Traceability Challenges

Ahead of the meeting, the FDA released a discussion paper outlining several areas where the agency is seeking industry input on implementation challenges and potential flexibilities. These topics included the use of reasonable ranges of traceability lot codes for certain shipping events, inferred traceability lot codes, tracking individual items broken out from cases, returns and reclamations, food waste recovery, intracompany shipments, retailer transformations, and data standardization.

The FDA also released its Traceability Readiness Tabletop Exercises Final Report which showed that many companies are making meaningful progress toward FSMA 204 readiness. At the same time, the findings highlighted ongoing gaps in data completeness, traceability lot code capture, and trading partner alignment.

These conversations reflect a clear opportunity for the industry. Companies have more time before enforcement begins, but traceability work takes planning, coordination, and strong data practices. Food safety risks, recall events, and partner expectations continue to move forward regardless of regulatory timelines.

Lot-Level Traceability Is Possible

Julie McGill’s comments focused on the role of technology neutrality, global standards, and operational execution in advancing FSMA 204 readiness.

“Discussions should no longer focus on whether lot-level traceability is possible. It is possible. The challenge is implementation maturity, operational alignment, and change management across highly complex supply chains.”

— Julie McGill, VP of Supply Chain Strategy & Insights, Trustwell

Speaking on behalf of AIM North America, a non-profit standardizing automatic identification and data capture (AIDC) technologies, McGill began by acknowledging “The FDA’s continued commitment to technology neutrality,” an approach that she said “preserves innovation and choice, while simultaneously elevating expectations for data accuracy, interoperability, and system reliability.”

Julie also noted the importance of the FSPCA Food Traceability Rule Training for the Food Industry, describing its release as a meaningful transition point as the industry moves from regulatory definition toward operational execution. Like many meeting attendees, McGill explained how foundational data standards and interoperable tools enable industry stakeholders to rise to the very challenges in lot-level traceability they were there to discuss.

“A wide range of solutions — including GS1-128 barcodes, 2D symbols, RFID, vision systems, temperature sensors, scanners and traceability platforms — are being deployed to address FSMA 204 compliance by enabling data capture, improving accuracy, auditability, data sharing, and consumer safety.”

Her message to the industry was direct: the conversation should shift from whether lot-level traceability can be done to how companies can mature their implementation programs.

“Discussions should no longer focus on whether lot-level traceability is possible,” McGill told the FDA and meeting attendees. “It is possible. The challenge is implementation maturity, operational alignment, and change management across highly complex supply chains.”

She went on to acknowledge that: “Change is hard but achievable when industry and regulators work together around realistic operational models, technology neutrality, and shared data standards. The future of food traceability will not depend on one technology or one approach, but on the collective commitment to building systems that are accurate, scalable, and capable of protecting public health.”

The next phase of traceability work will require operational alignment, change management, and collaboration across complex supply chains. No single technology or approach will solve every challenge. Progress will depend on shared commitment across regulators, standards organizations, technology providers, and trading partners.

“The future of food traceability will not depend on one technology or one approach, but on the collective commitment to building systems that are accurate, scalable, and capable of protecting public health.”

— Julie McGill, VP of Supply Chain Strategy & Insights, Trustwell

Traceability Requires Speed, Certainty, and Strong Data

Katy Jones used her comments to address two areas from the FDA’s discussion paper: inferred traceability data and data standards, highlighting Trustwell’s long-standing work helping food companies implement traceability through FoodLogiQ. To date, Trustwell has helped customers capture nearly 500 million critical tracking events across every point in the supply chain.

“Probabilistic methods cannot be used to advance traceability. That should be kept to a threshold of low single-digit percentages, and documented lot-level records should remain the gold standards against which all other approaches measured.”

— Katy Jones, CEO, Trustwell

Thanking the FDA for its continued engagement with industry as stakeholders work toward successful implementation of the Food Traceability Rule, Jones encouraged the industry to keep moving toward whole-chain lot-level traceability, with documented lot-level records serving as the benchmark.

“At its core, FSMA 204 is about increasing speed and certainty,” Jones said, echoing the FDA and attending colleagues by cautioning that “relying too heavily on inferred data will not advance safety for consumers and will weaken the effectiveness of the rule. Probabilistic methods cannot be used to advance traceability. That should be kept to a threshold of low single-digit percentages, and documented lot-level records should remain the gold standards against which all other approaches measured.”

“A data standard is the underpinning of whole chain traceability and the underpinning of data integrity and audit and critical for success and traceability.”

— Katy Jones, CEO, Trustwell

Jones went on to address the importance of shared data standards, agreeing that companies should have flexibility in the software, systems, and processes they use, while aligning around a common foundation for traceability data. “The FDA should maintain flexibility and technology but not flexibility in standards,” she said, pointing to GS1 standards as a critical foundation for interoperability and seamless information exchange across the food supply chain.

Acknowledging that it may be an unexpected stance or the CEO of a software company to take, she went on: “We believe companies should have the flexibility to choose the software or processes that they go with. Innovation should be encouraged, but the FDA should remain and continue to remain technology neutral.”

From my perspective, a data standard is not technology,” Jones went on. “A data standard is the underpinning of whole chain traceability and the underpinning of data integrity and audit and critical for success and traceability.”

Moving FSMA 204 Readiness Forward

The FDA’s public meeting reinforced a message Trustwell has shared consistently: traceability should be treated as a strategic business priority, not only a regulatory requirement.

The extended FSMA 204 timeline gives companies an opportunity to build stronger foundations. That includes engaging trading partners, aligning internal teams, improving data capture processes, adopting shared standards, and testing whether traceability records can be accessed and shared when they are needed most.

Strong traceability programs can support recall response, supplier collaboration, operational visibility, and consumer trust. They can also help companies move with more confidence when a food safety event occurs.

As McGill said in her remarks, “The future of food traceability will not depend on one technology or one approach, but on the collective commitment to building systems that are accurate, scalable, and capable of protecting public health.”

At Trustwell, we are proud to participate in these industry conversations and support food companies as they build practical, scalable traceability programs. The work ahead requires collaboration, clear standards, and steady progress. Companies that start now will be better prepared for FSMA 204 and better positioned to lead the industry forward.

Related FSMA 204 Resources:

The resources below provide additional context on the Food Traceability Rule, current FDA guidance, and practical steps companies can take to strengthen FSMA 204 readiness.

• Review the FDA meeting details and materials related to lot-level traceability implementation and potential compliance flexibilities: FDA Public Meeting: Challenges and Solutions in Lot-Level Food Traceability
• Access the FDA’s central resource for the Food Traceability Rule under FSMA 204: FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
• See how Trustwell’s food traceability software helps companies capture and analyze critical tracking data, support FSMA 204 readiness, and improve transparency across the supply chain: FoodLogiQ Traceability
• Work with Trustwell’s traceability experts to assess your current readiness, identify data capture and partner alignment needs, and build a practical path toward FSMA 204 implementation: FSMA 204 Consulting Services