In our opinion, the most significant recommendations (of the top 10) for grower/shippers were that the FDA require standardized recordkeeping for all participants in the supply chain – with no exceptions for risk classification. These records would include Key Data Elements (KDEs) such as harvest date, SKU, and so for that each Critical Tracking Event (CTE) such as processing or packing. These recommendations are closely aligned with the PTI in our reading, and the IFT strongly urges the FDA to embrace the work already done by the industry. This is good news for suppliers who embraced the PTI early, and a welcome validation for all the companies and individuals who have contributed to making PTI a reality.
The recommendation stopped short of electronic recordkeeping, and instead concluded that the FDA will have to implement an electronic mechanism to acquire these CTEs and KDEs from participants in the event of a traceback investigation. This seems suboptimal to us – but we interpreted it as the IFT being constrained by FSMA’s allowance of paper based record keeping.
The IFT tackled cost-benefit. The costs reported were all over the map because they often mixed in RFID, ERP upgrades, and even warehouse expansions. We generally agreed with the assessment of growers who cited total costs of approx. 2 cents per case to implement PTI. Inexplicably, some pilot participants reported costs 50 times more expensive than others for the same solution. Guess it pays to shop around for a solution provider! (by the way … HarvestMark starts at $1500 a year).
This wasn’t a big surprise – but it was good to see it spelled out: there will not be a giant Government database in the cloud that everyone needs to send all their data to! “IFT does not advocate the establishment of a common “cloud”-based repository as a continuously standing collection of all CTE and KDE data captured across the supply chain. The information system envisioned here would be managed and hosted by FDA and collect only CTE and KDE data related to past or current outbreak investigations.”