National Editor Tom Karst
National Editor Tom Karst

The FDA has just announced the release of the IFT report on pilot projects on food traceability. In keeping with the epic size of the produce safety rule and the preventive control rule released earlier, the IFT report on product tracing pilots is 334 pages.

Of course, one of the questions about IFT pilot on produce tracing is what kind of judgment it will render on the existing Produce Traceability Initiative.

Trying to find the "gist" of a 334-page report is the challenge; a good place to start may be the recommendations.

Let's look at what the IFT says about its findings and conclusions:

Key Findings

IFT was successful in conducting mock tracebacks/ traceforwards, ranging from simple (e.g.tracing one shipment of tomatoes or one lot code of peanut butter) to complex (e.g.finding convergence when tomatoes were sourced from two different growers; finding a common lot of ingredient between different processed food products manufactured in different facilities). The process of conducting a step - wise product tracing investigation was complicated and often times confusing.

Inconsistencies in the terminology, numbering systems, formatting, legibility, and occasionally the language sometimes required IFT to contact the submitting firm to gain clarity, increasing the time required to capture data before any meaningful analysis could begin. However , 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 information (i.e., Key Data Elements; KDEs) at critical points of product transfer and transformation (i.e., Critical
Tracking Events; CTEs).

IFT observed that firms provided product tracing data in several ways. Ultimately, the way in which data were readily accessed and transmitted to IFT was dependent on the systems and processes in place within a firm to capture, store, and report this information.


Upon completion of the task, IFT determined that costs associated with implementing a product tracing system can vary widely as determined by numerous factors: the size of the firm facility, the method of product tracing already in use (i.e., manual or electronic), and the range of each firm’s capabilities to implement or improve its product tracing system, to name a few. Nevertheless, IFT is confident that a product tracing system incorporating its recommendations would greatly benefit the FDA as well as other state and federal partners,the food industry, and consumers. The recommendations are as follows:
1. From an overarching perspective, IFT recommends that FDA establish a uniform set of recordkeeping requirements for all FDA-regulated foods and not permit exemptions to recordkeeping 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 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.


In summary, IFT found that there are several areas (such as uniformity and standardization, improved recordkeeping, enhanced planning and preparedness, better coordinationand communication, and the use of technology) in which industry improvements and enhancements to FDA’s processes would enable tracebacks and traceforwards 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 foodborne illness outbreaks and other product tracing investigations, significantly enhancing protection of public health.

TK: An initial reading seems positive for PTI; go no further than recommendation number 4, which tells the FDA to "encourage industry-led initiatives."  Also, the IFT pilot study wants to include all FDA-regulated food in a tracing system, and not only "high-risk" commodities. Also, the trade will find a section in the report on the costs and benefits of implementing PTI to be instructive.

More coverage coming later today....