November 2008: FDA Solicits Public Comment on Enhanced Produce Traceability
(November 13, 2008) OAKLAND, California. The FDA held the second of two public hearings to gather input on ways to enhance produce traceability, and the potential role of regulators. As at the Oct. 16 meeting in College Park, MD, FDA officials again raised concerns about gaps in the traceability system that have hindered investigators during trace-back efforts, including: lack of electronic records, inconsistent naming schemes, commingling, vulnerability to weak links, and a lack of produce identifiers. The FDA also acknowledged that a trace-back system that relies on asking sickened consumers what and where they ate in the past two weeks is deeply flawed. Representatives of the produce industry emphasized that most companies have internal traceability systems in place, and comply with the 2002 Bioterrorism Act's recordkeeping mandates. They suggested that recent initiatives such as the Produce Traceability Initiative (PTI), the California Leafy Greens Marketing Agreement, and the California Tomato Growers' food safety practices make 'reinventing the wheel' unnecessary.
The session returned frequently to several central questions:
- Are the PTI guidelines sufficient for the FDA? And if so, would the FDA mandate compliance (and punish non-compliance), or rely on voluntary adoption?
- Assuming compliance was voluntary, the FDA questioned what were the incentives for the produce industry to comply?
- What would compliance cost, both for industry and for regulators? And would the industry support a charge to cover the increased enforcement cost?
- What data specifically would the FDA want the industry to share? What authority would the FDA have to request such data, and how would confidential information be protected?
During the public comments session, several technology providers shared details of their systems both real and theoretical. Scott Carr, CEO of HarvestMark, shared the company's 2 year's experience of deploying its HarvestMark produce traceability solutions in a wide variety of commodities, workflows, and packaging types. Scott noted that HarvestMark is fully compatible with the PTI standards, and the company is helping customers implement external traceability with minimal impact on productivity. Furthermore, external traceability with HarvestMark opens opportunities to create real business value. Examples of traceable clamshells of tomatoes from Del Campo were shared with the FDA panel, and the advantages of extending traceability beyond the case all the way through to the end consumer were discussed.
Transcripts of presentations will be available from the FDA in the near future. Meanwhile, you can download a copy of the Notice in the Federal Register