Another Lingering Outbreak: Another Call for Traceback

With all of today’s technology to detect pathogens and trace product, why does it take so long to determine a source and thus trigger the appropriate level of recall? Why hasn’t a source been identified — and removed from the market? And how, if Colorado Premium has “100% test-and-hold for all ground products” as its website states, did contaminated product reach the consumer?

The recall notices answer the third question, as they state, “Many clinical laboratories do not test for non-O157 STEC, such as O103 because it is harder to identify than STEC (O157:H7).” I didn’t say it was a good answer ... but no reasonable amount of finished product testing can rule out the presence of a pathogen. And it is a reality that even with the world of FSMA being one of prevention vs. reaction, some things are not seen as a concern until after they become a concern, especially if they are “harder” or expensive or complex. And other things still don’t raise enough concern even after they’ve been proven to be of extensive concern because they are hard, expensive, or complex. And that, I would say, is precisely the answer to why it is taking so long; why no source has been identified. Again, not a good answer — because we do have the technology to detect contamination at extremely low levels and the technology to trace product to its source. But it’s not easy, cheap, or simple. And, it’s not required by regulation.

In fact, in its writing of FSMA (and I know that FSMA does not apply to meat plants), Congress specifically limited the ability of FDA to require traceback to the source. As stated in Sec. 204 on tracking and tracing of high-risk foods, recordkeeping regulations “shall not require — (i) a full pedigree, or a record of the complete previous distribution history of the food from the point of origin of such food; (ii) records of recipients of a food beyond the immediate subsequent recipient of such food; or (iii) product tracking to the case level by persons subject to such requirements.” Additionally, the requirements must “relate only to information that is reasonably available and appropriate,” “be scale-appropriate and practicable for facilities of varying sizes and capabilities with respect to costs and recordkeeping burdens,” and “not prescribe specific technologies for the maintenance of records.” This clearly ties the hands of FDA from doing much more than they have already, and the same would likely apply to FSIS.

This means that, as much as our new Deputy Commissioner for Food Policy and Response Frank Yiannas may want to require industry traceback to the source, his hands are tied. In fact, he had more power to do so at Walmart than he does now with FDA. FDA can “evaluate new technologies and upgrade its abilities to rapidly track and trace food through the supply chain” and “look at how to leverage emerging technologies and other approaches,” as is discussed in its “New Era of Smarter Food Safety” announcement. But it can only require one forward/one back tracing for registered firms. This does not take you to the farm or include retail and food service.

So it’s up to the private sector. It’s up to the food industry to move beyond hard, expensive, and complex to take a stand, to voluntarily build out a process, and to work together to enable a “full pedigree,” transparent traceability chain from source to consumer. So far this has not happened — why? Is it too costly, no ROI, too much regulatory risk — lots of possible reasons. But I believe we need a champion at the foodservice end of the supply chain to take this on. Prove that it can be done using modern technology and then demonstrate that it really can reduce risk, protect the consumer, protect a brand, and be leveraged as a logistical advantage.