Introduced in late 2007, PTI is sponsored by PMA, the United Fresh Produce Association, the Canadian Produce Marketing Association and GS1 US. The industry effort had a goal of case-level electronic traceability through the supply chain by the end of 2012. PTI leaders continue to work toward that unmet goal, but industry adoption is spotty.
Treacy said that the report recommends that all regulated foods — and companies that handle them — be subject to the traceability rules. The Institute of Food Technologists also recommends that FDA accept electronic records during traceback investigations.
“That is really going to speed up FDA’s ability to eliminate people who aren’t involved in the traceback,” Treacy said, leading to reduction in costs and scope of recalls.
Following the comment period, the FDA will submit recommendations about record-keeping/traceability to Congress, he said.
“If there were some people waiting to implement PTI until they heard where FDA was going, will this move some of them? Yes,” Treacy said, who encourages companies to move ahead on PTI processes.
“The earlier you do it, the more chance you have to make it a benefit to your business,”he said.
The report also includes some of the costs and benefits related to the Produce Traceability Initiative. For example, a Mexican tomato grower/exporter who ships 100,000 cases a year told the institute researchers that it cost him $5,500 to implement PTI.
“Everybody thinks (PTI) is a multi-million dollar investment and is going to put the small guy out of business,” Treacy said. “No, it’s not.”
Treacy said he expects more retailers in coming months will ask their suppliers to be PTI compliant.
With the institute’s recommendations now in hand, the FDA will still have to decide how they will proceed record keeping regulations, said William Kanitz, president of Venice, Fla.-based ScoringAg. Kanitz said the IFT report acknowledged the need for extensive outreach and education once regulations are issued.
*Recommendations of “Pilot Projects for Improving Product Tracing along the Food Supply System:”
- IFT recommends that FDA establish a uniform set of recordkeeping requirements for all FDA-regulated foods and not permit exemptions to recordkeeping requirements based on risk classification.
- FDA should require firms that manufacture, process, pack, transport, distribute, receive, hold, or import food to identify and maintain records of Critical Tracking Events and Key Data Elements as determined by FDA.
- Each member of the food supply chain should be required to develop, document, and exercise a product tracing plan.
- FDA should encourage current industry-led initiatives and issue an Advance Notice of Proposed Rulemaking or use other similar mechanisms to seek stakeholder input.
- FDA should clearly and more consistently articulate and communicate to industry the information it needs to conduct product tracing investigations.
- FDA should develop standardized electronic mechanisms for the reporting and acquiring of Critical Tracking Events and Key Data Elements during product tracing investigations.
- FDA should accept summarized Critical Tracking Events and Key Data Elements data that are submitted through standardized reporting mechanisms and initiate investigations based on such data.
- If available, FDA should request more than one level of tracing data.
- FDA should consider adopting a technology platform that would allow efficient aggregation and analysis of data submitted in response to a request from regulatory officials. The technology platform should be accessible to other regulatory entities.
- FDA should coordinate traceback investigations and develop response protocols between state and local health and regulatory agencies, using existing commissioning and credentialing processes. In addition, FDA should formalize the use of industry subject matter experts in product tracing investigations.