FDA process filing rejected for acidified mustard: what “microbial reduction” detail is missing?

Hi everyone,

I need some information about process filing for acidified products with the FDA. I have filed a process but it was rejected. In my validation report, I described the batching process, the starting pH and equilibrium pH, GMP, environmental monitoring, pathogen test result, and some studies to back up my report. The FDA microbiologist said that I did not describe microbial reduction. Please I am wondering if any body can help with what else I need to add to the report. This is shelf stable mustard that has been acidified with vinegar.

Any share of knowledge will be appreciated!

Thanks! 

 

 

The FDA microbiologist said that I did not describe microbial reduction

Describe exactly what controls in your process, addressing as a minimum target, the most low pH tolerant organism, are adequately reduced to a safe level by log reduction (5 log etc.). Assuming pH is the only controlling factor for cold fill/hold.

Here is some USDA  process filing data per Journal of Food Protection: USDA Acidified p387.pdf   166.4KB   7 downloads

There is a difference between inhibiting growth and killing off bacteria that are already present. 

The FDA microbiologist didn't see any evidence that the pH monitoring actually killed a sufficient number of microbes.

You need to enter your system with a raw material in the right matrix and then have it come out the other end with a 5 log reduced contamination (or more) on the sturdies microbes. You can't do that with pH alone.