FDA Posts Final Report on Product Tracing Pilot Program

FDA is requested comments on IFT’s report by April 4 in a Federal Register notice available here.

Participation from Across Supply Chain, Including One Importer

The product tracing pilots included one on processed foods (frozen or dried Kung Pao chicken containing one or more of peanuts, spices, and chicken) and one on fresh produce (fresh tomatoes). One peanut butter manufacturer was also added to the pilot upon request by the company. In total, the pilot included the following participants:

• 5 tomato growers (U.S. and Mexico)
• 7 tomato re-packers
• 3 tomato processors (sliced tomatoes)
• 15 distributors (12 tomato and 3 processed food)
• 5 retailers (4 tomato and 3 processed food)
• 2 food service chains
• 3 processed food manufacturers
• 4 ingredient suppliers
• 1 importer

IFT noted that since companies had to request participation in the pilots, the participating companies were likely more advanced in their product tracing practices, and not necessarily representative of the average.

IFT Conducts 14 Tracebacks; Data Confusing, but Collection Possible

IFT conducted 14 mock tracebacks, it said. The process of conducting step-wise tracebacks was “complicated and often times confusing,” because of submission and data formats, as well as language barriers. For example, most firms submitted product tracing data in PDF documents, which could not be directly manipulated and instead had to be re-entered manually or extracted by optical character recognition software for analysis, said IFT.

Some participating companies were surprised by the process used for tracebacks, and had never considered how their records would need to be pieced together in the context of a traceback, IFT said.

Nonetheless, the pilot participants “appeared to have many of the tools and processes in place which are required to allow the capture and communication of critical track and trace data (KDEs)¹ at critical control points of product transfer and transformation (CTEs), the report said.

Gathering Data Costly, but Benefits Include Improved Supply Chain Management

Costs of capturing data for use in tracebacks varied for the companies that participated in the pilot, IFT said. For companies capturing data by hand or that manually converted data to spreadsheets, the cost ranged from $40 to $350,000. For companies capturing the same data by scanning bar codes, the data collection was more expensive at $125,000 to $4.5 million, the report said.

But besides benefits to FDA in the form of more efficient use of resources, and to public health through improving the process of determining causes of public health outbreaks, industry would benefit as well, IFT said. Companies would see improved brand reputation, increased consumer confidence, improved supply chain management, increased supply chain confidence, and process improvement, among other things, the report said.

Recommendations for Data Element Requirements, Against Two-Tiered System

“The pilots demonstrated that improvements in product tracing are achievable, given existing technologies, and IFT recommends that FDA should proceed with rulemaking ad proposed in FSMA,” the report said. IFT included a list of ten recommendations in its report to improve the collection of data, as well as the quality of the data itself, including the following:

Uniform recordkeeping requirements. IFT said FDA should establish a uniform set of recordkeeping requirements for all FDA-regulated foods, and not permit exemptions to these requirements based on risk classification. Two different recordkeeping requirements for high- and low-risk foods would create confusion, especially in cases where risk classification of a particular food changes, the report said.

Require companies to record and maintain data. FDA should require companies involved in the food supply chain to capture and maintain internal trace records, IFT said. Key data elements that companies collect at each critical tracking event include the following:

• Lot/batch/serial number
• Activity type
• Activity ID number
• Transfer type
• Transfer number
• Carrier ID
• Trailer number

Because there are barriers to collecting batch/lot/serial numbers for all depletion and transport events, collection and reporting of these data should be encouraged as a best practice, while activity ID and type should be required, the report said.

Require product tracing plans. FDA should require each facility in the food system, from farm to food manufacturing facility to retail and foodservice establishments, to develop product tracing plans. This would improve communication between industry and the government, and raise awareness of industry’s responsibilities during investigations.

Develop program with industry input. Instead of prescribing specific product tracing requirements, FDA should request input from industry on the form product testing should take, IFT said. Industry-led development would allow for more rapid implementation, the report said.

Clearly communicate with industry. FDA should clearly communicate with industry when it requests product tracing records to help the food industry decide which records contain the needed information, the report said.

Electronic submission only in investigations. FDA should develop standardized, electronic mechanisms for companies to provide product testing data, IFT said. Furthermore, food companies should be allowed to maintain the data in their internal records unless the data is requested, and should not have to report data unless in the context of an investigation.

Accept summaries of product tracing data. To speed up investigations, FDA should accept summary data at first to determine whether companies can be easily excluded from an investigation.

(See ITT’s Online Archives 12041132 for summary of FDA’s announcement of the pilot in September 2011, and 11090811 for summary of the foods selected for the pilot.

The IFT report, as well as instructions for submitting comments, is available on FDA’s website here. An IFT press release is available here, and an IFT FAQ document is available here.