A recent Agri-Pulse op-ed by former FDA deputy commissioner Frank Yiannas and Wiliot Chief Marketing Officer Steve Statler posited that food traceability should be a uniting factor among food business. Leaders at the International Fresh Produce Association agree with this and add that regulatory delays are only compounding – and confounding – the fresh produce community’s traceability implementation efforts.
Since late 2022, the fresh produce industry has endeavored to comply with the Food and Drug Administration’s Food Safety Modernization Act traceability requirements, also known as FSMA 204. IFPA has worked with many companies in the industry to address FSMA 204 implementation challenges through the creation of guidance documents and best practices. Capturing traceability lot code is proving to be one of the most challenging requirements of FSMA 204 implementation.
To remove this barrier, IFPA has developed a solution which alleviates case-level scanning burdens at warehouse and distribution center operations to capture the traceability lot code. This also complies with FSMA 204 and has been formally presented to FDA during the recent Reagan-Udall Foundation FSMA 204 stakeholder meetings.
This proposal is one example of our ongoing advocacy leadership efforts in supply chain. In addition, we are continuing our ongoing collaborations with the FDA as the agency transforms the culture of its human foods program.
What it is
Developed by Andrew Kennedy, the chief traceability officer at iFoodDS, Frank O’Dowd, the chief strategy officer at BFC Systems, and myself, the proposal allows wholesale/distribution/warehouse/storage facilities to calculate traceability lot codes (TLC) that could have been selected and shipped using data from business systems rather than manual capture, RF scanning or other electronic identification data capture. The algorithm used to power the probability calculations is open-source, allowing for widespread industry adoption across warehouse management systems.
The proposal also recommends, for both transparency purposes and assistance to FDA during traceback investigations, that facilities document their methodology in their traceability plan and share the computed probability associated with each TLC with subsequent recipients in sortable spreadsheets.
Why it matters
Persistent confusion throughout the fresh produce industry around FSMA 204 compliance and the likelihood of human error in the picking and scanning process drove this proposal’s creation.
It is important to understand that, while the FDA requires TLCs and TLC sources be shared with recipients, the rule does not require the TLC be included on food labeling or food packaging. Despite this, the food industry remains convinced that it must label and scan every case of food to be 100% confident in the data provided to the agency.
Even if products are labeled by suppliers with TLCs in either human readable or barcode formats, the selection process is not perfect. Pickers may scan one box multiple times instead of each box, likely missing multiple lots. Repacked cases or reusable plastic containers may have more than one label, leading to mis-scans. Also, some cases do not have lot code in the barcode, so a scan will only capture the product's global trade item number (GTIN).
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We found that, in pilot programs conducted by BFC Systems, the TLCs calculated using the proposed methodology yielded a 100% accuracy rate when compared to the TLCs of the cases shipped.
How it happened
The path to the proposal’s acceptance began months ago when the three of us presented our solution to FDA multiple times early in 2024. IFPA then submitted a formal request asking the FDA to accept the proposal. Subsequently, the Reagan-Udall Foundation was contracted by the FDA to conduct a series of three invitation-only industry stakeholder meetings focused on FSMA 204 implementation challenges. IFPA attended all of these.
During the second stakeholder meeting, we were asked to present our solution, which Andy Kennedy and I did. The acceptance by FDA of our proposal remains elusive as of this writing.
Traceability itself has been an issue IFPA’s legacy organizations – the Produce Marketing Association and United Fresh Produce Association – have invested in for more than 15 years, primarily through the establishment of the Produce Traceability Initiative in 2008.
What’s next
Once the solution has been endorsed, it’s likely FDA will publish a FAQ response that accepts this method for tracking traceability lot codes. IFPA will form an industry working group to pilot and develop best practices for calculating lot codes using this method. These best practices are expected by Q1 2025.
Once those best practices are published, IFPA will host a “last-mile innovation challenge” to highlight solutions for calculating (or capturing) and sharing the traceability lot code and TLC source/reference.
Traceability is too important an issue for industry divisions and regulatory delays. Public health depends on it.
Ed Treacy is the vice president of supply chain for the International Fresh Produce Association.