FDA Publishes Report on Product Traceability Pilots

Earlier today, the FDA issued a report on two product traceability pilot projects that were undertaken as a part of the Food Safety Modernization Act (FSMA), signed into law in January, 2011.  This milestone demonstrates further progress in moving FSMA forward.

Report on Pilot Studies

Report on Pilot Studies

You can download the entire 334 page document titled Pilot Projects for Improving Product Tracing along the Food Supply System – Final Report here. It was prepared by Jennifer McEntire of Leavitt Partners and Tejas Bhatt of the Institute of Food Technologists. According to the executive summary of the report (which is three pages long):

In September 2011, the U.S. Food and Drug Administration (FDA) asked the Institute of Food Technologists (IFT) to execute product tracing pilots as described in Section 204 of the FDA Food Safety Modernization Act (FSMA). IFT collaborated with representatives from more than 100 organizations—including the U.S. Department of Agriculture, state departments of agriculture and public health, industry, consumer groups, and not-for-profit organizations—to implement the pilots. To complete the task, IFT conducted two product tracing pilots of foods (including ingredients) that had been implicated in food-borne illness outbreaks between 2005 and 2010, assessed the costs and benefits of efficient and effective methods for tracking the designated foods, and determined the feasibility of such methodologies (including the use of technology) being adopted by different sectors of the food industry. One food pilot focused on the tracing of chicken, peanuts, and spices in processed foods; the other pilot focused on the tracing of tomatoes.

The objectives of the pilot projects were 1) to identify and gather information on methods to improve product tracing of foods in the supply chain, and 2) to explore and evaluate methods to rapidly and effectively identify the recipient of food to prevent or mitigate a food-borne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated or mis-branded.

The recommendations that the report makes are as follows:

  1. From an overarching perspective, IFT recommends that FDA establish a uniform set of record keeping requirements for all FDA-regulated foods and not permit exemptions to record keeping requirements based on risk classification.
  2. FDA should require firms that manufacture, process, pack, transport, distribute, receive, hold, or import food to identify and maintain records of CTEs and KDEs as determined by FDA.
  3. Each member of the food supply chain should be required to develop, document, and exercise a product tracing plan.
  4. FDA should encourage current industry-led initiatives and issue an Advance Notice of Proposed Rulemaking or use other similar mechanisms to seek stakeholder input.
  5. FDA should clearly and more consistently articulate and communicate to industry the information it needs to conduct product tracing investigations.
  6. FDA should develop standardized electronic mechanisms for the reporting and acquiring of CTEs and KDEs during product tracing investigations.
  7. FDA should accept summarized CTE and KDE data that are submitted through standardized reporting mechanisms and initiate investigations based on such data.
  8. If available, FDA should request more than one level of tracing data.
  9. 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
  10. FDA should coordinate trace-back 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.

Conclusion
In summary, IFT found that there are several areas (such as uniformity and standardization, improved record keeping, enhanced planning and preparedness, better coordination and communication, and the use of technology) in which industry improvements and enhancements to FDA’s processes would enable trace-backs and trace-forwards to occur more rapidly. There was a range of costs associated with improving product tracing capabilities for certain sectors of the industry based on the specific technologies used to achieve the data capture and communication objectives. Case studies demonstrated the range of public health benefits from reduction in illnesses from improved product tracing. The recommendations outlined in this final report will enable FDA to conduct more rapid and effective investigations during food-borne illness outbreaks and other product tracing investigations, significantly enhancing protection of public health.

No doubt, it will take some time for the industry to digest the entire document but it’s good progress that the FDA, under FSMA guidelines, is moving the process forward and that track-and-trace will now get more focus and attention.

Kevin Payne
Senior Director of Marketing

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