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Lots To Think About When It Comes To Recalling Lots

Jim Prevor’s Perishable Pundit, April 24, 2012

We often receive requests to think about issues in the news. This letter is an example:

The recent salad recall  got me thinking. The pattern is very familiar. A recall is triggered by a random test that showed positive for a pathogen — in this case salmonella. The processor attempts to do the “right thing” by recalling the entire lot — in this case 756 cases — even though no illnesses have been reported and the possibility exists that the test may have resulted in a false positive.

My question is if there is a possibility of contamination, how can any processor only recall the salads from the specific lot tested?

Certainly, these particular recalled cases of a specific blend were not the only product run over the packing line that day. Do they stop the line and sanitize the processing and bagging equipment each time they change the product mix?

Even if they do sanitize after every run, I assume the test didn’t identify definitively what item in the bag might have introduced the pathogen.

I’m pretty certain that most of the same product from the grower’s lots used in this “contaminated” lot were also used in different salads produced that day.

If processors have no idea where the contamination came from, how do they not recall everything was either run on that packing line or any other product that contains the same grower’s lots used in the recalled lot?

— Alan L. Siger
President & CEO
Consumers Produce Company
Pittsburgh, Pennsylvania 

Indeed, this is a pattern that we often see when there are test results positive for a pathogen — recall the whole lot to reassure the industry, regulators and consumers that steps have been taken to address any problem.

Alan is shrewdly drawing attention to the Achilles heel of this issue — do the lot numbers mean anything and, if so, what do they mean as far as food safety goes?

It is not a new issue. As far back as June, 17, 2008, we urged in this piece that lot sizes needed to be defined in such a way that they would be meaningful in terms of food safety — that is to say that there needed to be some action — a firewall, so to speak — such as sanitation by which a recall of just one lot would be meaningful.

Now most top processors are doing this, but there has not been success at getting industry consensus on this issue. We would consider it a significant hole yet to be plugged in the various food safety metrics and auditing standards.

One academic very involved in developing standards put the issue this way:

Lot definition has always been and remains a controversial topic with no clear Best Practice definition or science-based resolution that will be uniformly accepted by industry and public health regulators; certainly seems likely that current variable approaches to lot definition and lot segregation will be problematic from a consumer advocate or lay juror perspective in any litigation involving the scope of a recall.

In general, industry has adopted a Clean Up to Clean Up approach for what to include as a linked lot for a single line, as we are talking about processed salad mix. They do manage lines to specifically limit the scope of a recall impact by blend and by customer (requires or doesn’t require/forbids Test to Release for pathogens on finished goods).

Beyond that, tying things back to a harvest lot or ranch block gets even more complex. There are no standard approaches that I am aware of and multiple drivers for how things are handled. 

The absence of a consensus, of course, means that no standard is incorporated into popular industry audit programs. So only buyers who explore this issue really can be certain what their processor is doing. It is worth noting, of course, that although the issue typically arises in the context of processed product, the same question would bedevil any recall of bulk product run on any packing line or even cut in the field. What is the assurance that one lot is a meaningful dividing point in terms of food safety?

Industry leadership has been aware of the problem and United Fresh has long been working to find consensus. The initiative has been stewarded on staff by David Gombas, Ph.D., Senior Vice President Food Safety and Technology,and Barry Eisenberg, Ph.D., Vice President Food Safety Services at United Fresh, and they were kind enough to give us an update on the issue:

The United Fresh Food Safety & Technology Council is continuing to work on a Lot Separability white paper. Clearly, it is important for a grower (or anyone in the supply chain) to know how much product is implicated if any produce is determined to be adulterated, particularly if it’s a food safety concern.

If a company doesn’t know whether or how lots are separated, or whether they can’t be separated, they are either going to recall too much (unnecessary economic risk) or too little (unacceptable public health risk). However, we’ve learned that companies typically designate “lots” based on business reasons (e.g., which customer is/was harvested/processed for, day of the week), not on a food safety basis, so it’s been difficult writing a document that provides guidance without implying that those who don’t follow the guidance are wrong and following a bad practice.  Same reason that we don’t want FDA to tell us how to define lots — once defined, it removes flexibility that may be necessary for other reasons.

When FDA is notified that food in the supply chain is adulterated, they are obligated to take action and make sure that adulterated product is removed from consumer access and that any consumers who may have the product are warned not to eat it (all stuff you know).  My experience with companies contacted by FDA is that FDA generally doesn’t tell the company to recall the product; they ask “are you going to recall the lot?” or “what are you going to do?”, leaving it to the company to make the decision. 

If the company says “no”, then FDA may push the company to justify that decision.  If they say “yes”, then the next question is typically “how much”, followed closely by “how do you know that is all that is contaminated?”  That’s where lot separability becomes important and, if a company can’t justify why adjacent or related lots are not reasonably likely to be contaminated too, the recall tends to grow.

To your second question, it’s not whether recalls of small numbers make sense – no one wants consumers to get sick from their product – it’s whether there is enough information to conclude that the “lot” is really contaminated (rather than someone finding the needle in the haystack), and whether there is reasonably still enough product on shelves or in consumers’ hands to warrant a public notification.  For FDA, the answer is easy — “yes” to both.  That’s the conservative approach. 

For the industry, the answer has not been that easy. We’ve had too much evidence from too many recalls suggesting that these lots were not a public health risk.  First, the “adulteration” is usually based on a single test result — neither the point nor extent of contamination is ever identified — and by the time FDA (or the State or local public health agency — it’s not always FDA) notifies the brand owner or grower of the contamination, the lot is frequently past shelf-life, meaning that most of that lot has already been consumed and there is very little, if any, left to consume. 

Okay, not every illness ends up in PulseNet  I think the estimate for Salmonella is 1 in 40 illnesses  but I’m not aware of any of these single-positive-test pathogen isolates showing up in PulseNet and linked to the recalled product. How can that be? 

Again, the intent of recalls is to remove contaminated product from consumer access.  Does it make sense to identify and recall everything that remotely may have been associated with the contaminated lot when there is so little likely still left in commerce (and, so, little left to physically recall, whether the announcement is for 700 or 7,000 cases) and so little evidence that the lot was, in fact, contaminated? 

After a while, it is human nature to eventually begin to think that none of these positive-test recalls are really a public health issue.  Fortunately, none appear to have been, so far.  But we (industry, government and consumers) need a better diagnostic tool to tell us when and how much of a product lot really represents a public health risk, and in enough time to do something meaningful about it.

David Gombas
Ph.D., Senior Vice President Food Safety and Technology

United Fresh Produce Association

David’s search for what makes sense is completely appropriate. The problem here, though, is that the trade’s failure to come to a consensus is leaving the industry vulnerable to an accusation of doing PR stunts rather than meaningful food safety recalls.

Just imagine the outcry that would ensue if, one day, a company tries to do the “right thing,” recalls a complete lot and someone gets sick from the lot before or after the recalled lot and it turns out that the lot was defined for business purposes — not food safety purposes? Imagine how you would feel if you were the shipper or processor on that product and you had made the call to recall just the lot as a way of assuring consumers that the problem had been contained.

The truth is that even when a pathogen is found on a test, very often tests of other leaves in the SAME BAG come back negative.

Once in a while, of course, we have had serious and substantial food safety recalls that are motivated by many people getting sick. If, however, one removes those few incidents from the database, we are not aware of any research that indicates the product in the bag produced right before or right after the bag that is found to test positive is any more likely to test positive than any other bag ten lots away.

This means, of course, that no recall at all is actually justified by science. The recall is really, in the spirit of the famous Tylenol recall, a confidence-building measure. The size of the recall is a kind of split-the-difference number to avoid extraordinary expense and yet still be seen as doing something.

Of course, it is not clear that all this specificity actually means much anyway. As David Gombas points out, most of the product is typically long gone by the time such recalls are announced. Beyond this, though, many retailers ignore such detailed recalls and remove all of that product from the shelves, everything from that shipper, etc.

Partly they do this because most retail executives don’t trust their own systems and employees to get rid of specific lot numbers, partly because it is expensive to check each bag individually and, partly, because they have the luxury of billing back suppliers for the product the retailer removes from distribution.

When one is not paying for the recall, it is easier to opt for a more expansive recall.

Alan Siger’s comments about the other uses to which product from growers may have been put is less discussed but no less important. Maintaining these types of records is as much a part of traceability as anything else and, once again, the industry leaves itself vulnerable if we recall a lot of salad that includes Romaine but we don’t do anything regarding the rest of that farmer’s Romaine that was probably used in ten different products.

We discussed this issue in an interview with Michael McCartney, which you can read here

Because the science here is so limited and so our ability to say that we have significantly reduced food safety risk through any of these actions is so weak, we have to view these lot-based recalls as sort of common-sense expression of reasonable action.

This means that if the trade’s policy toward this was on the front page of The New York Times — and it is reasonable to think that one day it will be — we want a policy that would be perceived as intellectually coherent.

Consumers have an interest in economical food, so simply taking a maximal position and saying that everything that can be recalled should be — damn the expense, full speed ahead — is probably not prudent. But if the question Alan Siger asked the Pundit was instead put to the California Leafy Greens Marketing Agreement or WGA or United or PMA — all of them should be able to offer a definition of what a lot means, be able to articulate standards by which the trade goes back to the grower lot and, in general, be upstanding, logical and straight-forward.

That probably means that United ought to get that White Paper done, which means the trade needs to make it a priority.

All these things are easy to set aside, but the whole point is to settle the issue before a crisis hits and before we have to explain things before Congress or the public.

Many thanks to Alan Siger of Consumers Produce in Pittsburgh for leading us to think through this important topic.

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