December 2009: IFT Publishes Traceability Report for FDA
The IFT recently published a report on food traceability systems, commissioned by the FDA. We have deployed PTI solutions at multiple customers, so we wanted to understand what the 200 page report had to say that may influence future features that we need to support. In general, the report was aligned with PTI:
- Electronic recordkeeping is a must-have. In the event of a recall, the FDA needs the ability to rapidly retrieve detailed records of product movement and transformation.
- A single, Government-run database of all trace transactions is implicitly rejected. Instead, each participant in the supply chain is responsible for capturing in electronic format their product movements and transformations (or using a third party), and submitting them to the FDA only in the event of a recall.
- A standardized, global nomenclature for key data elements (such as product name, lot number, date, locations) is required.
- A company's ability to trace and record in accordance with these guidelines should be part of a third-party audit.
However, it's also important to recognize what the report did not say, particularly with respect to PTI. The report did not evaluate, modify or endorse PTI. There are many commonalities with PTI, but there are also differences in the detail of the report:
- The medium and content for case-level identification was left open. Although the report specifies that a lot number and manufacturing facility should appear on the case - it was not clear whether product name also needed to be on the case, nor whether it should be in a barcode (pg. 111, para. 3 "The medium used to convey lot information, production date, and location of manufacture is relatively unimportant and independent of the system used (e.g. barcode, RFIDs, electronic, or pen and paper)". This is surprising in our opinion, given the possible need for scanning cases, for example when rebuilding pallets or picking.
- The format of the Lot Number was not specified. Whereas in the PTI guidelines, the lot number must be 'date specific', the IFT report leaves the specificity to the grower/packer/shipper based on a pragmatic evaluation of risk and economics. We think this makes a lot of sense.
- A logical choice for data nomenclature would be GS1 - but although the report did not specifically recommend it, it was heavily hinted at throughout. The report was not prescriptive about the product naming specificity.
In sum, the report generally supports the direction and methodology of the PTI, but there are some suggestions from the IFT that could be addressed by the PTI - such as lot number and product specificity. The ambiguity around case labeling in the report should be clarified, as this is where the rubber hits the road for produce shippers implementing PTI this year.
Finally, the report cited surveys that showed strong interest from consumers in item-level traceability and the FDA was interested in methods that enhanced consumer confidence during and after a recall. In spite of this, the report's authors acknowledged that their methodology would not achieve these "because the recommendations propose tracking at the case level and not the item level, there would not be any additional information on the package that would enable consumers to know where their food came from." As we have discussed in previous editions of the Traceability Insider, item-level traceability remains the only way to engage consumers and enhance consumer trust, and is a complement to case-level traceability.
Bottom line: IFT agrees with PTI that electronic 'whole chain' traceability is the future for the produce industry. The good news is that the HarvestMark PTI solution meets the requirements laid out in the IFT report, and is designed to easily accommodate future enhancements.