As concerns of Food Safety Modernization Act mandates at the grower and food processing levels arise, pilot studies on how the act’s traceability requirements should be applied bolster the case for PTI, first outlined more than five years ago.
On March 4, the Institute of Food Technologists released a 334-page report, “Pilot Projects for Improving Product Tracing along the Food Supply System,” focusing on two specific food segments: processed foods and high-risk fresh fruits and vegetables. For the processed foods, the institute chose peanut butter and Frozen Kung Pao-style meals.
Tomatoes — domestic and imported, field- and greenhouse-grown and whole and sliced — were studied along the supply chain, according to the FDA, from field to foodservice and retail outlets.
“We looked at tomatoes because they have been involved in a number of significant and repeat outbreaks,” according to a news release from the FDA. “Tomatoes represent a complex food supply chain and were identified by most . Industry associations as a top candidate for the produce related pilot.”
The Food and Drug Administration tasked the institute with the research, which will lay the foundation for traceability mandates in the new food safety law.
“The recommendations are very sensible and consistent with PTI,” said Elliot Grant, founder of YottaMark Inc., Redwood City, Calif.
Grant said the company’s HarvestMark traceability system participated in the institute’s pilot as a technology solution providers.
“If you made investments with PTI so far, you should read this report with relief because it is very much substantiates the methodology of PTI,” Grant said.
The alliance recommends that all FDA-regulated foods be subject to uniform record-keeping requirements.
The next step in the process is a public comment period, which ends April 5. Comments can be submitted at http://www.regulations.gov (docket No. FDA-2012-N-1153), according to a news release.
The institute’s proposal aligns with the goals of the traceability initiative, said Ed Treacy, vice president of supply chain efficiencies at the Newark, Del.-based Produce Marketing Association. Treacy said he participated in working groups related to the produce pilots, which focused on eight case studies regarding .
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.