Hygienic Zoning
I am working on my map for hygienic zoning for the new Sanitation Preventive Controls. We ferment vegetables outside in uncovered tanks. The fermentation process results in a 5 log reduction of pathogens. Once fermentation is completed, we pasteurize jalapenos outside in totes. After pasteurization the totes are left to cool and then brought into the vegetable room when they are needed. They are then diced and put into a final brine. How do I do Hygienic zoning for this? I don't know where my Primary pathogen control area-Controlled Access would be. I have no way to control the outside area. I would assume my primary pathogen control area-Controlled Access would be inside in the vegetable room. I'm just confused on if this will be acceptable with the FDA.
It is not clear if your "totes" are sealed from environmental pathogens or not. I would think that your pasteurization would be considered a Preventive Control, as well as your fermentation. I would think that the totes (food contact) would be a Zone 1, where the highest level of sanitation would need to be maintained.
If your totes are not covered during and after pasteurization, then you have a problem, because they are probably considered "Ready to Eat" and then need to be fully protected from pathogen contamination. If your totes are sealed during pasteurization, then as long as the seals are intact, you have less of a problem.
When the totes are brought in from outside, are they sanitized at all so they don't introduce pathogens into your vegetable room? The cutting surfaces would definitely be considered Zone 1, food contact.
After your vegetables are put into brine, are they subsequently treated to remove pathogens? If so, then what goes before is not as important, since your Preventive Control is that last heat treatment, a kill step. If they are just put into jars and lids put on or into plastic bags with no kill step, then you have no way to guarantee that no pathogens have been introduced into the vegetables during all that time they are exposed to an uncontrolled environment.
The FDA will definitely want to see if that outside environment is sanitary, and if there is a risk of contamination by them sitting outside after the fermentation is complete, unless you have a kill step before it is put into commerce.
Also, your facility is required under FSMA (unless you are an exempt entity) to have a PCQI (Preventive Controls Qualified Individual) who designs the Food Safety Program. If you are not PCQI certified, I suggest that you take a course. It will help you better understand FSMA. There is a fully online course offered by HACCP Mentor, Amanda Evans, at a reasonable price.
https://haccpmentor....an-food-course/ (scroll down for the Virtual Delivery course)
Martha