At last count (as of this writing), a total of 196 people from 10 states had been reported as infected with the outbreak strain of E. coli O103. This included 28 people who were hospitalized, and two cases of hemolytic uremic syndrome. Thankfully, no deaths have been reported ... yet.
While there have been “worse” outbreaks related to number of illnesses and deaths, this one has a “worse” aspect of its own when one considers the timeline:
- March 1: The first illness begins.
- March 28: Officials in Kentucky and Georgia notify CDC of the outbreak; CDC begins multistate investigation.
- April 12: CDC announces that “preliminary information suggests that ground beef is the source of this outbreak.”
- April 23: K2D Foods (dba Colorado Premium Foods), Carrollton, Ga., recalls approximately 113,424 pounds of raw ground beef products.
- April 24: Grant Park Packing, Franklin Park, Ill., recalls approximately 53,200 pounds of raw ground beef products on, 2019.
- May 13: USDA-FSIS and state regulatory officials continue to collect products for testing and continue their traceback investigations to determine the source of ground beef supplied to grocery stores and restaurants where ill people ate.
- ????: A common source supplier is implicated.
As of May 13 (the date of the last CDC notice before this article went to print), no common supplier, distributor, or brand of ground beef had been identified that could account for the whole outbreak. The two companies that recalled product are not only further processors of the meat, but the recall notices of both also include the disclaimer, “At this time, there is no definitive link between this positive product and the ongoing E. coli O103 outbreak. Further traceback and product analysis continues to determine if the recalled products are related to the E. coli O103 outbreak.”
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.