IFT’s Traceability Pilot Projects: Should All Food Be Treated Equally?

Uniform recordkeeping requirements. FDA should establish uniform recordkeeping requirements for all FDA-regulated foods and not permit exemptions based on risk classification. While FSMA restricts FDA recordkeeping requirements to high-risk foods, the IFT anticipates that confusion will arise if companies maintain different standards. GS1 US’s Fernandez explains why. “If we have to maintain dual processes based on high-risk and non-high risk foods, people will have to have multiple methodologies in place. One-size-fits-all can be more efficient. It will also address future scenarios: A food is non-high risk only if it hasn’t been subject to a recall. If a new non-high risk product does get recalled, we won’t have to change tracing processes for it,” she said. This recommendation “bubbled up” from industry itself, Dr. McEntyre adds.

Product tracing plans. FDA should require each member of the food supply chain, regardless of its size, to develop, document, and exercise a product tracing plan. While product tracing plans are currently not required by federal agencies, some companies have them as best practices, IFT says. Product tracebacks are different from product recalls in that the details of the product of interest in a traceback are not known. Having and exercising a product tracing plan “will increase the speed with which a firm can respond to an investigation and reduce the likelihood of errors,” IFT says. And while FSMA limits the FDA’s reach in seeking data to “one up, one back” in a company’s supply chain, the IFT recommends the agency should request additional information from companies in hopes that “capable supply chain partners” will have the extra information and will make it available.

Standardized, structured, electronic recordkeeping. FDA should develop mechanisms for industry to provide key data elements (date, time, item, lot, or batch number) and critical tracking events (transportation or exchange of goods, transformation or creation or manipulation of products, and depletion or exit from system) during a specific food safety investigation. “The pilot project verified that if all the information is stored electronically, the tracing process can be sped up significantly compared to having to manually go through paper records and manifests by hand,” says Ed Treacy, vice president of supply chain efficiencies at the Produce Marketing Association (PMA). “Electronic records could be Excel spreadsheets. This should not be a burden on companies as there are very few companies that do not use computers in their business,” he tells Food Quality & Safety magazine.

Nevertheless, while having data in electronic format would be ideal, IFT believes industry shouldn’t be required to maintain electronic records, especially since small and large firms have different needs and capabilities. However, providing data in a standardized and structured way may be required of all companies, says IFT. In the baseline study, most traceback records consisted of printed and handwritten documents sent by fax to regulatory agencies. In the pilot studies, most records were submitted in Adobe Acrobat pdf format. But even then, a pdf of a handwritten note could not be analyzed in a structured and standardized way, the report noted.

“The key point is, different size companies in the food chain are going to capture and hold that data in different ways,” says Fernandez. “Not everyone has robust databases and electronic capabilities, but if they can make sure their records are capturing those elements around a product or transaction, however they choose to do so, that is going to help FDA when a product is identified around a possible outbreak.”

Technology platform. FDA should adopt a technology platform that will allow it to aggregate and analyze data reported in response to a specific request. Such a secure platform could be a central repository of information for investigators and for other regulatory agencies. It could reduce the need for companies to send their data to multiple agencies. Because such a platform would require submissions in electronic format, it may not become a requirement, Fernandez notes. “But some of the larger and mid-size firms do have these electronic records and it could definitely help in doing a traceback,” she adds.