The U.S. Federal Drug Administration (FDA) recently announced 12 winners of the FDA’s New Era of Smarter Food Safety Low- or No Cost Tech Enabled Traceability Challenge.

The goal of this FDA initiative was for the participants to demonstrate end-to-end traceability – from source to table – throughout the food safety system. The FDA wanted to explore ways to encourage firms to voluntarily adopt tracing technologies and harmonize tracing activities, working toward outcomes that are achievable for all sectors of the system producing human and animal foods.

Launched at the beginning of June with the submissions window extending thru the end of July, there were upwards of 90 submissions with the winning teams representing the United States, Canada and New Zealand. Submitting teams further hailed from Australia, China, England, France Germany, India, Ireland, Singapore, Spain, Switzerland and Taiwan. Truly, a global based competition.

The FDA announcement includes the names of the twelve winning teams with web links to individual videos.

 

Supply Chain Matters Perspectives

  • What impressed Supply Chain Matters was the variety of different technology approaches that ranged from:
  • Downloadable software run on Microsoft Excel
  • Traceability and batch-tracking software
  • Leveraged use of Avery Dennison systems and proprietary blockchain technology
  • Self-service portals to generate item-level identifiers and datasets at the grower level.
  • Leveraged use of geospatial, machine learning and Internet of Things (IoT) technology.

Role based data capture framework approaches that update an open sourced blockchain technology.

Each of these technical approaches were judged on the criteria of low or no cost which provides the evidence that it doesn’t take megabucks to initiate such item level food traceability efforts. If further provides evidence of the breath of technology approaches that are available.

Supply Chain Matters extends congratulations and our tip-of-the-hat recognition to all twelve of the winning teams:

FarmTabs                                            OpsSmart

Freshly                                                 Precise

HeavyConnect                                    Roambee

ItemChain                                           Rfider

Kezzler                                               TagOne

Mojix                                                  Wholechain

 

A Larger Challenge

A much bigger challenge involves the FDA’s efforts in overseeing item level visibility and traceability of pharmaceuticals. The Drug Supply Chain Security Act (DSCSA) which was enacted into law in 2013 calls for the existence of a fully interoperable electronic system for sharing product and transaction data for nearly every pharma package in commercial distribution.

The U.S. drug agency has subsequently delayed enforcement of a number of interim requirements to November 27, 2023 while evaluating various business process and technology proposals for managing such a system. There have been a series of pilot proof-of-concept phases for definable segments that have drawn the interest of technology providers. At the same time the FDA has had to continually clarify process definitions as well as viable approaches.

In June, the drug agency released four guidance documents (two final, two draft) for resolving at least some of the long-standing issues that industry has been wrestling with since the passage of this traceability act. That includes the systems architecture approach which is now clarified as to how industry intends to collect, store and transmit product and transaction information.

Obviously, this area is an entirely different scope with a lot of conflicting stakeholder interests in process and technology dimensions.

If only a competition runoff could uncover the lowest cost and most flexible approaches for the pharmaceutical and drug industry. Instead, multiple phases of pilots and the clarifications of basic definition and approach assumptions will continue and the notion of who pays will remain elusive.

Another case where supply chain stakeholder alignment precedes demonstrations of technology.

 

Bob Ferrari

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