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The Romaine Fix: Let’s Go Beyond the Label


The Romaine Fix: Let’s Go Beyond the Label

In last week’s newsletter, we discussed the most recent romaine lettuce E. coli outbreak and the voluntary source labeling plan instituted by FDA through discussions with the romaine lettuce industry. While such labeling is currently being used by consumers to determine that romaine in the market place is not from the growing areas that FDA is concerned about, that is just the start. This type of information, if captured in detail at the point of sale would also be helpful when incidents occur.


So where do we go from here? Some immediate questions arise such as:

  1. What traceability standards need to be implemented to enable this source labeling to be effective?

  2. Is the growing site and harvest date enough for traceability?

  3. How can one involve everyone in the produce supply chain from growers to the point of sale to consumers?

  4. What more can be done to prevent contamination and outbreaks associated with leafy greens and other produce?

  5. How can we effectuate rapid communication from the government (local, state and federal) when the first few cases emerge?

Let’s take a couple of these individually.


Traceability. Current regulation requires registered firms (not including growers, retailers or restaurants) to be able to trace one forward/one back. While this may have seemed to be a viable tracing system at the time of implementation – or at least better than having no requirements, it has been found to be significantly lacking for real traceability from consumer to source due to a number of reasons:

  • Implemented with the Bioterrorism Act of 2002, it requires registered firms in the food chain to keep records to “identify the immediate previous sources and immediate subsequent recipients of food.” However, those records need only include the previous/subsequent source name, address and phone number; type of food; date received; lot number or other identifier if available; quantity; and transporter name, address and phone number. While it states that the records are to be available within four hours of an FDA request – the “if available” statement for lot number or other identifier significantly dilutes the traceability aspect.

  • Today’s food safety system is very complex, with there often being numerous “one forwards/one backs” related to a single product. (Think of the many ingredients in soup or pizza and the number of producers and retailers to whom that product or its ingredients are sent.)

  • Consider, as well, the comingling of produce from various field locations, growers, re-packers, and distributors. Assume the investigators are able to determine which ingredient is the culprit in an outbreak and trace it back to a distributor. How do they know which head(s) of romaine (for example) from which field were actually consumed by the person that was sick?

As we said last week, one-forward/one-back may be the law, but it is no longer enough. Thus, it is up to the industry to take the initiative, to make source traceability more than “voluntary labeling” for romaine. So, again, I ask: How many of your ingredients can you trace all the way back to the source? You may think this is a costly endeavor, but what might be your costs of not knowing?


Prevention. But let’s go a critical step forward. Even if you are able to trace all your ingredients back to the source, what are you doing to ensure they are safe? Traceability is a necessity, but it is still a reaction. It assumes there has been a contamination of some sort and we need to pull product to keep it from being consumed. Thus, it is not only reactive, it can be incredibly slow and costly – particularly if your traceability isn’t thorough and you have to recall a range of product lots because you don’t know which may be impacted.

So, let’s expand the traceability question. For produce processors: What are you doing to prevent contamination? Would an inspection show you to be in full compliance with FSMA’s Produce Safety Rule? Are you ensuring that your preventive efforts take into consideration all hazards and risks of your specific produce? And even ask the question: Is compliance with the Produce Rule enough?


For those further down the supply chain: For how many of your ingredients do you have supplier requirements and verification – all the way back to the field? Do you keep requirements updated and conduct your own or third-party inspections? Do your own practices focus on prevention and verification? Also ask yourself, even if you do have those requirements, are they really effective?


Government Involvement. Outbreaks almost inevitably begin with involvement of local health departments and then escalate to the state level. They may or may not further escalate to the federal level. We currently have a shelf life for leafy greens somewhere up to 21 days – if you are lucky – from harvest to the point where it is inedible. It takes at least that long for cases of illness to move from diagnosis to genome sequencing (WGS) at the local/state level. Thus, some serious effort needs to be placed on shortening the time from diagnosis to the time of WGS analysis, then following up with the point of sale. Even with the best traceability possible and optimum preventive controls, the time lags on the front end of an outbreak result in potentially high numbers of consumer exposure that are preventable through faster public health actions.


The challenges of reducing the number of produce-related outbreaks are significant and will require cooperation all along the supply chain from grower to point of sale to consumers, as well as the public health agencies at all levels. There is no one size fits all, and there is no perfect system for traceability.


There will be those who object to the cost at all levels of the supply chain and, unfortunately, that may be a deal breaker for some. So, the only way forward may be for those who are leaders in food safety at the grower, processor, distributor, retail, and restaurant levels to step up and set the standards that the rest of the industry can choose to emulate or not. But for this to work, the government has to move much faster and has to recognize those that have put in first-rate systems. Absent that, we will continue to see the same outbreak patterns into the future.


About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods 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. www.AchesonGroup.com

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