The “ready-to-eat” versus “not-ready-to-eat” conundrum

Posted in Recall Management

For some time, I have predicted that a recall of bakery products for pathogen concerns was likely imminent.  Typically, we think of bakery items as being extremely low-risk due to the fact that the products are (or will be) baked.  Many bakery operations, however, struggle to control harmful pathogens in their environment.

Recently, a series of notices have been published on FDA’s website announcing for the first time that frozen biscuit products produced over multiple months were being recalled for Listeria Monocytogenes concerns.  These developments have generated significant debate among food safety professionals questioning whether the recalls were necessary or not, considering the fact that the products were intended to be baked by consumers prior to consumption.  This question also puts the FDA and the companies involved squarely back into the “ready-to-eat” versus “not-ready-to eat” conundrum which has surrounded a number of recent food product recalls.

So, the question is, are the recalls warranted? 

While it is true that, like raw animal products, if frozen biscuits known to be contaminated with Listeria Monocytogenes are handled and prepared properly, the chance of illness is highly unlikely.  This is for the obvious reason that frozen biscuits are not edible until they are baked to very high temperatures which will kill any pathogens that might be present.  For this reason, as a FDA regulatory lawyer, I could reasonably argue to the agency that, even if not ready-to-eat frozen biscuits were discovered to be contaminated with Listeria Monocytogenes, they are not adulterated and need not be recalled. 

On the other hand, before any decisions concerning adulteration or recalls are made, one must also question how the products might foreseeably be used by consumers in non-traditional ways. 

For instance, we know that any contamination existing on the surface of the biscuits has the potential to be introduced and spread throughout the home kitchen when the biscuits are removed from their packaging.  We can also conclude that the biscuits will certainly contaminate the hands of any individual who prepares them, and could easily cross-contaminate any utensils and surfaces, or even spread in the absence of handwashing from person to person. Plus, it is not unreasonable to think that at least a few parents will likely thaw the biscuits and then hand the pliable dough to their children to play with.  Finally, some consumers could even thaw and role the biscuits (using a wooden roller) for something such as a pizza dough, which may not bake adequately in the center.  I could continue to go on, but the point is that there are endless foreseeable ways as to how the product might be used which could potentially lead to illness.

In this case, the company that manufactured the frozen biscuits had a very important recall decision to make.  Regardless of the merits of that decision, these recalls should serve as a notice to a portion of the industry that, until now, has remained relatively unnoticed by FDA.  In light of these developments, an increase in the numbers of FDA inspections and scope of sampling within bakery operations may soon be on the horizon.