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....