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3 months ago, the USFDA sent out a “call to action” letter to the manufacturers, packers, distributors, exporters, importers and retailers of infant formula. and you can find their letter here:

FDA Calls for Enhanced Safety Measures in Letter to Powdered Infant Formula Industry | FDA

I read their letter with great interest, because it raised some key points, which resonated with me as a “pathogen hunter”. During my travels in the global dairy industry, I have come across enough examples to confirm that: ?

If you are in infant formula business; please take note of the USFDA letter!

The USFDA mentions 5 areas of concern and here are some of my thoughts:

Water in dry production

If we are in the “dry game”, water is our enemy. Alas, we still need to clean and sanitise our dry equipment and sometimes wet washing is the only option. This means that the design of our cleaning systems is critical. Essentially, if we clean anything wet, we will need to make time for a “dry-out” step (ideally, in a dedicated dry-out room). I know this can be painful (time is money), but a validated “dry out” step is essential before we use the equipment in production.

Implement a robust Environmental Monitoring program

I have been promoting environmental monitoring for some time now and to be effective, a monitoring plan needs to be designed well. A good EM plan is risk-based and targeted. Swabbing should focus on the areas that are the highest risk to the product and target the sample points where we know pathogens can hide.

Also remember that Eb ≠ Cb (where Eb is Enterobacteriaceae and Cb is Cronobacter spp.). Eb monitoring is very useful to give us a good view of the hygiene standard in our plant but does not tell us whether we have Cb in our plant. In most dairy factories, Cb is still found when the Eb counts are very low.

Corrective actions

If we start looking for pathogens in our factory and/or our product, we start looking for something dangerous. It’s like going on a bear hunt! So, if we bump into a bear it is too late to start thinking about our next step (other than “run!”). This means that we need to be prepared and have a plan before we find a pathogen; and our corrective actions should reflect where we have found the pathogen; i.e risk-based.

Supply chain controls

The intensity of our supply chain controls should match the use of the ingredient. If we add the ingredient to the mix after the validated kill step, we will need to increase our raw material and supply chain controls. Our HACCP should identify all these ingredients. When we are making infant formula, we are feeding the most treasured people on the planet, and we should source our ingredients with the mindset of a 3 Michelin star chef.

Identify all relevant biological hazards

Currently, Cb is seen as a high-risk pathogen for infants <12 months of age. Sometimes this leads operators to believe that Cb is not important for any of the other products and blends that are made in the factory. I have seen operators monitor for Cb during IF campaigns only and stop monitoring for Cb when they are making a non-IF product.

My approach is to set the environmental monitoring program based on the highest risk product and keep it running, regardless of what we make. Remember, we monitor the environment to verify that our food safety controls are working, so the results will tell us whether we are “fit for purpose”, that is, ready to make our infant formula at any time.

I think Cb will not care too much about what we make, and probably will use the period of “reduced vigilance” to really make themselves at home in our factory.

Jack

Disclaimer: This article is my personal opinion and does not represent the opinions of my employer(s)