Traceability: Costs, Benefits, and the Future

Although official establishments did have some recordkeeping requirements, those for retail were voluntary, based on guidance. The Supplementary Information in the proposed rule shows that the Hannaford-associated outbreak was not the first time Food Safety and Inspection Service (FSIS) was unable to trace ground beef at retail. In the 28 foodborne disease investigations conducted by FSIS from October 2007 through 2012 in which beef products were ground or re-ground at retail stores, 11 retailers had complete records available for USDA review, as shown in Table 1, enabling product to be recalled in six investigations. When the retailers’ records were unavailable or incomplete, product was able to be recalled in only two of 17 instances.

IFT Recommendations

The food industry is still waiting to see what additional recordkeeping requirements FDA will propose. FSMA authorized FDA to issue such requirements, although only for “high risk foods.” The law requires the agency to perform several studies and analyses and issue some reports before proposing a regulation related to traceability, and FDA is still going through these steps. FDA worked through the Institute of Food Technologists (IFT) to conduct several product tracing pilots aimed at exploring effective approaches to improve the accuracy and speed with which traceability could be achieved system wide. The IFT provided FDA with 10 recommendations, which are discussed in a comprehensive report. In short, IFT made the following recommendations.

1. FDA should establish a uniform set of recordkeeping requirements for all FDA-regulated foods and not permit exemptions to recordkeeping requirements based on risk classification.
2. The agency should require firms that manufacture, process, pack, transport, distribute, receive, hold, or import food to identify and maintain records of critical tracking events (CTEs) and key data elements (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. As noted above, this could be quite different from some recall plans that companies have in place today.
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. The agency 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. The agency 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.

The Investment

Most food companies would like to believe that an outbreak won’t be associated with them. While everyone wants to do the right thing for food safety, most companies feel that it’s better to invest in prevention as opposed to response. And since the application of traceability described above, both in the Cyclospora as well as ground beef examples, is system wide, why should a company invest in traceability if they don’t feel that they are the weak link in the supply chain?
From a company perspective, it’s important to look at the other benefits of traceability. What is the cost to enhance traceability (both long-term and short-term, and one-time and ongoing investments) and what does the company get in return?