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Environmental Pathogens in a Bulk Truck

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oxkjs1

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Posted 31 August 2022 - 11:33 PM

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



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Posted 01 September 2022 - 05:24 AM

Hi Karen,

 

I think this is about control of the hygiene of the food contact surfaces of the bulk container.

 

Are you cleaning (CIP) the bulk container prior to loading?

 

Ideally the bulk container would be cleaned (CIP), inspected, swabbed (ATP) then loaded if all okay.

 

As this is and FSSC 22000 topic, refer to FSSC 22000 V5.1 FSMA PCHF Addendum Version 2 May 2021:

Organizations seeking FSMA compliance should ensure that PRPs, OPRPs, CCPs and labelling provisions of meeting the requirements of Preventive Controls are identified and implemented according to §117.135 of the PCHF rule.

 

For animal food that would be Preventive Controls for Food for Animals - Subpart C - Hazard Analysis and Risk-Based Preventive Controls - Sec. 507.34 Preventive controls:

 

© Preventive controls include, as appropriate to the facility and animal food:

 

(2) Sanitation controls. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling*. Sanitation controls must include, as appropriate to the facility and the animal food, procedures, practices, and processes for the:

 

(i) Cleanliness of animal food-contact surfaces, including animal food-contact surfaces of utensils and equipment; and

 

(ii) Prevention of cross-contamination from insanitary objects and from personnel to animal food, animal food-packaging material, and other animal food-contact surfaces and from raw product to processed product.

 

CIP validation and product samples taken from the bulk container can be used as evidence of evaluation of risk of contamination with environmental pathogens.

 

Hygienic inspection and loading procedures* should also mitigate risk of contamination from food safety hazards including environmental pathogens.

 

Kind regards,

 

Tony





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