On December 9-10, FDA, in collaboration with the Food Safety and Inspection Service (FSIS), held a joint public meeting focused on gathering stakeholders to receive feedback on the key issues and challenges involving food product tracing systems. FDA and FSIS had presented a detailed analysis of the issues in a Federal Register notice announcing the meeting. Key themes from regulators' presentations included increased coordination with state and local authorities and standardization of traceback processes and tracing requirements with uniformity, standardization, and consistency throughout the distribution chain.

What all of the regulators seemed to agree on were the challenges facing product-tracing reform, including multiple-ingredient products, commingled products and fresh produce, together with frequently deficient recordkeeping practices throughout the supply chain. The regulators emphasized that efficient and effective outbreak investigations depend upon records for the accuracy, completeness and timeliness of recalls and said that electronic records can greatly speed the investigation and execution of a recall. On the epidemiological side, one suggestion from state and federal regulators was the standardization of patient questionnaires to assist in outbreak investigations. These regulators acknowledged that while no single questionnaire may be able to obtain all of the necessary information to assist or complete an investigation, having standard forms across localities that patients complete after being sickened by food could help speed up the investigation process. Industry and consumer representatives spoke at the meeting about how club cards could be used to locate customers who have purchased recalled product to help minimize public exposure to contaminated products.

We expect that the next step for FDA and FSIS may be the development of a draft guidance document on product-tracing systems after the agencies have time to distill the information learned from the public meeting and public comment period (which closes March 3, 2010). The President's Food Safety Working Group had recommended in July of this year that FDA issue such a guidance document by the end of October, but it appears as though FDA is carefully considering what its recommendations for product-tracing systems should look like before issuing a draft for industry to review.

Further complicating the objective of making product tracing more efficient and effective is a recently released report of the Office of Inspector General at the Department of Health and Human Services, which found that seven percent of food facilities surveyed had failed to register or cancel their registrations and that almost half of the facilities surveyed had failed to provide accurate information to FDA when registering. A deficient registration system is yet another hurdle facing FDA in improving the food safety system.