I hope you ISO 22000 folks can help me out on a "loading bulk trucks / iso-containers" question for a liquid chemical product used in a feed ingredient for livestock animals. Lets assume our liquid chemical product is used by our customer "as is" (no treatment or kill step) and they dilute it down to a 10% portion of the feed that they make which will be fed to the animal daily.
The FDA regulations say that one must inspect the "packaging container" prior to loading (to validate that there are not any contaminants, debris, etc.. in the truck or container prior to loading.)
The FDA regulations also say that if our product is exposed to the environment then an assessment of "environmental pathogens" is required as part of the hazard analysis evaluation. We have a fully closed, dedicated manufacturing process that runs continuously so we anticipate that environmental pathogens are not a concern for us.
However, if we open the top hatch of the truck prior to loading our product - in order to do a visual inspection of the empty truck.... does this mean we are exposing the product to the "environment" prior to packaging? Or can I safely assume that the product is not exposed to the environment prior to packaging?
I just want to know what is typical industry practice in interpreting this requirement for bulk loading liquids that are otherwise manufactured in a fully enclosed process through the loading process (with the exception of inspecting the bulk container).
I hope I explained myself well enough... = )
Thanks!
Karen