2006:  E. coli-contaminated spinach causes outbreak resulting in 199 illnesses in 26 states, including 102 hospitalizations and three deaths. 2018:  E. coli-contaminated romaine causes outbreak resulting in 210 illnesses in 36 states and five deaths. Have we not learned anything in 12 years? What will it take to keep this from happening again … and again and again? Not only are the outbreaks of the two E. coli-contaminated leafy greens incidents scarily similar, both took an inordinate length of time to trace the contamination back to the source. Only recently was the romaine contamination linked to canal water – three months after the onset. The 2006 traceback was admittedly longer with investigators implicating feces-contaminated irrigation water as the source, or feral pigs in a spinach field – six months after onset. What makes the similarity of the incidents even more disturbing is the statement by then-FDA CFSAN Director Robert Brackett that the investigation of the 2006 outbreak “yielded valuable information we can use to determine how best to reduce the likelihood of similar outbreaks." Apparently that value is yet to be fully implemented. While I do place some of the onus of insufficient traceability on FDA, the entire food industry not just produce – is just as challenged with this issue. But let’s start with FDA. First, FSMA did mandate that FDA conduct industry-cooperative traceability pilot projects –Following that FDA was to establish an internal product tracing system for the receipt of information that would improve traceability and establish further recordkeeping requirements for foods it designates as high risk. While the pilot projects were conducted very comprehensively in 2011 by the Institute of Food Technologists, we’ve not seen further advances since then. But – and in this aspect, Congress also holds some onus – the traceability provisions had as many restrictions as they had mandates. For example, FDA could not prescribe specific technologies or require a facility to have duplicate records or change business systems. Nor could it require “a record of the complete previous distribution history of the food from the point of origin of such food; records of recipients of a food beyond the immediate subsequent recipient of such food; or product tracking to the case level.” Thus, even with the new mandates, FDA is pretty much held to the same tracking requirements of the 2002 Bioterrorism Act: one forward/one back. And that is not going to get us any further than we are now. When FSMA was first being discussed in Congress, one of the House versions included a provision that the FDA traceability initiative be able to have full pedigree traceback within two business days. That was eventually deleted – everyone felt it would be great, but it was not practical or economically feasible. While I agree with that, it does seem that we should be able to get closer to “a full pedigree in two days” than the one forward/one back that keeps us in the same place we’ve been for 12 years. So … that takes us to industry responsibility. Which, as I stated, is not just produce, rather it is all those in food as well as all suppliers, retailers – and technology experts. And it will require a coordinated, collaborative effort with all – including FDA. There are technologies that can trace product from sale all the way back to the field, but at present, they do each also have implementation challenges. For instance, one may require that each step of the chain be able to digitally communicate with all the others; another may provide some minor enhancement but may warrant excessive expense; another may be applicable to food facilities but not growers – or vice versa. But moving forward with implementation of technologies while working toward reduction of their limitations would at least begin steps of improvement. If adding just two or three steps forward and/or back would save lives – isn’t it worthwhile? But it is more than saving lives. It is protecting economic consequences when a commodity is implicated. To go ack to my examples at the start of this newsletter: Many will remember the “don’t eat spinach” message from FDA in 2006 and the impact of that on the spinach industry. Now in 2018 we had the “don’t eat romaine from Yuma, AZ.” Let’s talk blockchain; is that the answer? It’s not perfect, it’s likely not even the answer, but it does have some very beneficial components, and its big-player advocacy (i.e., Walmart, IBM, Nestle, Dole, Unilever, etc.) makes it a significant technology and one that is continually being integrated by technology companies large and small into other (traceability?!) programs. But blockchain is only as good as the data that is put into it – which is always the catch when talking data at multiple levels from multiple handlers of produce both large and small. Let’s talk GPS. SMART farms are quickly becoming a way of life for many. Granted, these are generally large corporate farms or those growing for large corporations. But the application of IoT, GPS, and other such technologies is being used and could be applied for further traceability. Let’s talk cannabis and what we can learn from that industry. With “seed to sale” requirements, the cannabis industry needs to be able to trace each individual product item back to the plant from which the THC or CBD was extracted. And it must designate a plant – and all resulting products – as medicinal or recreational right from the start. Technically the cannabis industry approaches this problem with having a label on every plant – clearly not a solution for the produce industry; but is there a lesson from this that we use? Although cannabis-infused edibles is still an emerging industry, and only the cannabis component of the final product needs to be so specifically traced back, the very fact that it is being done with that food product ingredient means it can be done with any single ingredient … which means it can be done with all ingredients. I’ll be the first to admit that I am not an expert in such technologies and, thus, am not advocating any one of the above – or any other specific technology. But why not pull together those who are experts in that area with those who know the industry and those who regulate the industry – and make something happen? Is it easy? No. Is it necessary? Yes. And I would encourage FDA to take the lead on such an initiative; food leaders (from grower to retailer) to join with their knowledge, skills, and monies; and technologists to provide the technology expertise and piloting to get a program rolling. If FDA is not able or willing to take the initiative, then those of us in the private sector need to take the initiative and find solutions that really will work for all in the supply chain. I know that such initiatives are underway which is encouraging – but this has happened before (e.g. with PTI) and the problem has not been solved. Inaction on these needs will undoubtably result in more food commodity hits and prolonged outbreaks. What do we have to lose? – except, maybe, another foodborne illness outbreak that kills Americans and food companies because we couldn’t identify the source quickly enough. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at: www.AchesonGroup.com